ZEPBOUND
(+1 other brands)
Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied ZEPBOUND (tirzepatide) is a clear, colorless to slightly yellow solution available in cartons containing 4 pre-filled single-dose pens, 1 single-dose vial, 4 single-dose vials, 1 multi-dose vial, or 1 single-patient-use KwikPen as follows: Single-Dose Vial and Prefilled Pen Strength 4 pack Single-dose Pen NDC 1 pack Single-dose Vial NDC 4 pack Single-dose Vial NDC 2.5 mg/0.5 mL 0002-2506-80 0002-0152-01 0002-0152-04 5 mg/0.5 mL 0002-2495-80 0002-0243-01 0002-0243-04 7.5 mg/0.5 mL 0002-2484-80 0002-1214-01 0002-1214-04 10 mg/0.5 mL 0002-2471-80 0002-1340-01 0002-1340-04 12.5 mg/0.5 mL 0002-2460-80 0002-1423-01 0002-1423-04 15 mg/0.5 mL 0002-2457-80 0002-2002-01 0002-2002-04 Multi-Dose Vial Doses per Vial Strength 1 pack Multi-Dose Vial NDC 4 doses of 2.5 mg/0.6 mL 10 mg/2.4 mL (4.17 mg/mL) 0002-6052-11 4 doses of 5 mg/0.6 mL 20 mg/2.4 mL (8.33 mg/mL) 0002-6103-11 4 doses of 7.5 mg/0.6 mL 30 mg/2.4 mL (12.5 mg/mL) 0002-6210-11 4 doses of 10 mg/0.6 mL 40 mg/2.4 mL (16.7 mg/mL) 0002-6304-11 4 doses of 12.5 mg/0.6 mL 50 mg/2.4 mL (20.8 mg/mL) 0002-6523-11 4 doses of 15 mg/0.6 mL 60 mg/2.4 mL (25 mg/mL) 0002-6612-11 Single-Patient-Use KwikPen (with four weekly doses) Doses per KwikPen Strength 1 pack Single-Patient-Use KwikPen NDC 4 doses of 2.5 mg 10 mg/2.4 mL (4.17 mg/mL) 0002-3566-11 4 doses of 5 mg 20 mg/2.4 mL (8.33 mg/mL) 0002-3555-11 4 doses of 7.5 mg 30 mg/2.4 mL (12.5 mg/mL) 0002-3544-11 4 doses of 10 mg 40 mg/2.4 mL (16.7 mg/mL) 0002-3533-11 4 doses of 12.5 mg 50 mg/2.4 mL (20.8 mg/mL) 0002-3522-11 4 doses of 15 mg 60 mg/2.4 mL (25 mg/mL) 0002-3511-11 16.2 Storage and Handling Do not freeze ZEPBOUND. Do not use ZEPBOUND if frozen. Protect ZEPBOUND from heat and light. Store ZEPBOUND in the original carton to protect from light. ZEPBOUND Single-dose Pen and Single-dose Vial Store ZEPBOUND single-dose pen and single-dose vial in a refrigerator at 2°C to 8°C (36°F to 46°F). If needed, each single-dose pen or single-dose vial can be stored unrefrigerated at temperatures not to exceed 30°C (86°F) for up to 21 days. If single-dose pen or single-dose vial is stored at room temperature, it should not be returned to the refrigerator. Discard single-dose pen and single-dose vial if not used within 21 days after removing from the refrigerator. ZEPBOUND Multi-dose Vial or Single-Patient-Use KwikPen Unopened vial or single-patient-use KwikPen: Store unopened multi-dose vial or single-patient-use KwikPen in the refrigerator at 2°C to 8°C (36°F to 46°F). The unopened multi-dose vial or single-patient-use KwikPen can be used until the expiration date on the label if kept in the refrigerator. If stored at room temperature [up to 30°C (86°F)], throw away unopened multi-dose vial or single-patient-use KwikPen after 30 days. After vial or single-patient-use KwikPen has been opened: Store opened (in-use) multi-dose vial or single-patient-use KwikPen in the original carton in the refrigerator at 2°C to 8°C (36°F to 46°F) or at room temperature [up to 30°C (86°F)]. Throw away opened multi-dose vial or single-patient-use KwikPen after a total of 30 days at room temperature, 30 days after first use, or after taking 4 weekly doses, even if there is medicine left in it.; 16.1 How Supplied ZEPBOUND (tirzepatide) is a clear, colorless to slightly yellow solution available in cartons containing 4 pre-filled single-dose pens, 1 single-dose vial, 4 single-dose vials, 1 multi-dose vial, or 1 single-patient-use KwikPen as follows: Single-Dose Vial and Prefilled Pen Strength 4 pack Single-dose Pen NDC 1 pack Single-dose Vial NDC 4 pack Single-dose Vial NDC 2.5 mg/0.5 mL 0002-2506-80 0002-0152-01 0002-0152-04 5 mg/0.5 mL 0002-2495-80 0002-0243-01 0002-0243-04 7.5 mg/0.5 mL 0002-2484-80 0002-1214-01 0002-1214-04 10 mg/0.5 mL 0002-2471-80 0002-1340-01 0002-1340-04 12.5 mg/0.5 mL 0002-2460-80 0002-1423-01 0002-1423-04 15 mg/0.5 mL 0002-2457-80 0002-2002-01 0002-2002-04 Multi-Dose Vial Doses per Vial Strength 1 pack Multi-Dose Vial NDC 4 doses of 2.5 mg/0.6 mL 10 mg/2.4 mL (4.17 mg/mL) 0002-6052-11 4 doses of 5 mg/0.6 mL 20 mg/2.4 mL (8.33 mg/mL) 0002-6103-11 4 doses of 7.5 mg/0.6 mL 30 mg/2.4 mL (12.5 mg/mL) 0002-6210-11 4 doses of 10 mg/0.6 mL 40 mg/2.4 mL (16.7 mg/mL) 0002-6304-11 4 doses of 12.5 mg/0.6 mL 50 mg/2.4 mL (20.8 mg/mL) 0002-6523-11 4 doses of 15 mg/0.6 mL 60 mg/2.4 mL (25 mg/mL) 0002-6612-11 Single-Patient-Use KwikPen (with four weekly doses) Doses per KwikPen Strength 1 pack Single-Patient-Use KwikPen NDC 4 doses of 2.5 mg 10 mg/2.4 mL (4.17 mg/mL) 0002-3566-11 4 doses of 5 mg 20 mg/2.4 mL (8.33 mg/mL) 0002-3555-11 4 doses of 7.5 mg 30 mg/2.4 mL (12.5 mg/mL) 0002-3544-11 4 doses of 10 mg 40 mg/2.4 mL (16.7 mg/mL) 0002-3533-11 4 doses of 12.5 mg 50 mg/2.4 mL (20.8 mg/mL) 0002-3522-11 4 doses of 15 mg 60 mg/2.4 mL (25 mg/mL) 0002-3511-11; PACKAGE LABEL - Zepbound Prefilled Pen (Autoinjector) - 2.5 mg/0.5 mL Dose NDC 0002-2506-80 Zepbound ® (tirzepatide) injection 2.5 mg/0.5 mL 4 x 2.5 mg/0.5 mL prefilled pens Rx Only For Subcutaneous Use Dispense enclosed Medication Guide to each patient. Use one pen every week. 4 Single-dose prefilled pens Lilly PACKAGE LABEL - Zepbound Prefilled Pen (Autoinjector) - 2.5 mg/0.5 mL Dose; PACKAGE LABEL - Zepbound Prefilled Pen (Autoinjector) - 5 mg/0.5 mL Dose NDC 0002-2495-80 Zepbound ® (tirzepatide) injection 5 mg/0.5 mL 4 x 5 mg/0.5 mL prefilled pens Rx Only For Subcutaneous Use Dispense enclosed Medication Guide to each patient. Use one pen every week. 4 Single-dose prefilled pens Lilly PACKAGE LABEL - Zepbound Prefilled Pen (Autoinjector) - 5 mg/0.5 mL Dose; PACKAGE LABEL - Zepbound Prefilled Pen (Autoinjector) - 7.5 mg/0.5 mL Dose NDC 0002-2484-80 Zepbound ® (tirzepatide) injection 7.5 mg/0.5 mL 4 x 7.5 mg/0.5 mL prefilled pens Rx Only For Subcutaneous Use Dispense enclosed Medication Guide to each patient. Use one pen every week. 4 Single-dose prefilled pens Lilly PACKAGE LABEL - Zepbound Prefilled Pen (Autoinjector) - 7.5 mg/0.5 mL Dose; PACKAGE LABEL - Zepbound Prefilled Pen (Autoinjector) - 10 mg/0.5 mL Dose NDC 0002-2471-80 Zepbound ® (tirzepatide) injection 10 mg/0.5 mL 4 x 10 mg/0.5 mL prefilled pens Rx Only For Subcutaneous Use Dispense enclosed Medication Guide to each patient. Use one pen every week. 4 Single-dose prefilled pens Lilly PACKAGE LABEL - Zepbound Prefilled Pen (Autoinjector) - 10 mg/0.5 mL Dose; PACKAGE LABEL - Zepbound Prefilled Pen (Autoinjector) - 12.5 mg/0.5 mL Dose NDC 0002-2460-80 Zepbound ® (tirzepatide) injection 12.5 mg/0.5 mL 4 x 12.5 mg/0.5 mL prefilled pens Rx Only For Subcutaneous Use Dispense enclosed Medication Guide to each patient. Use one pen every week. 4 Single-dose prefilled pens Lilly PACKAGE LABEL - Zepbound Prefilled Pen (Autoinjector) - 12.5 mg/0.5 mL Dose; PACKAGE LABEL - Zepbound Prefilled Pen (Autoinjector) - 15 mg/0.5 mL Dose NDC 0002-2457-80 Zepbound ® (tirzepatide) injection 15 mg/0.5 mL 4 x 15 mg/0.5 mL prefilled pens Rx Only For Subcutaneous Use Dispense enclosed Medication Guide to each patient. Use one pen every week. 4 Single-dose prefilled pens Lilly PACKAGE LABEL - Zepbound Prefilled Pen (Autoinjector) - 15 mg/0.5 mL Dose; PACKAGE LABEL - Zepbound Single-Dose Vial - 2.5 mg/0.5 mL Dose NDC 0002-0152-04 Zepbound ® (tirzepatide) injection 2.5 mg/0.5 mL Rx Only For Subcutaneous Use Needles and Syringes are not included Dispense enclosed Medication Guide to each patient. Use one vial every week. 4 Single-dose vials Discard unused portion Lilly PACKAGE LABEL - Zepbound Single-Dose Vial - 2.5 mg/0.5 mL Dose PACKAGE LABEL - Zepbound Single-Dose Vial - 2.5 mg/0.5 mL Dose; PACKAGE LABEL - Zepbound Single-Dose Vial - 5 mg/0.5 mL Dose NDC 0002-0243-04 Zepbound ® (tirzepatide) injection 5 mg/0.5 mL Rx Only For Subcutaneous Use Needles and Syringes are not included Dispense enclosed Medication Guide to each patient. Use one vial every week. 4 Single-dose vials Discard unused portion Lilly PACKAGE LABEL - Zepbound Single-Dose Vial - 5 mg/0.5 mL Dose PACKAGE LABEL - Zepbound Single-Dose Vial - 5 mg/0.5 mL Dose; PACKAGE LABEL - Zepbound Single-Dose Vial - 7.5 mg/0.5 mL Dose NDC 0002-1214-04 Zepbound ® (tirzepatide) injection 7.5 mg/0.5 mL Rx Only For Subcutaneous Use Needles and Syringes are not included Dispense enclosed Medication Guide to each patient. Use one vial every week. 4 Single-dose vials Discard unused portion Lilly PACKAGE LABEL - Zepbound Single-Dose Vial - 7.5 mg/0.5 mL Dose PACKAGE LABEL - Zepbound Single-Dose Vial - 7.5 mg/0.5 mL Dose; PACKAGE LABEL - Zepbound Single-Dose Vial - 10 mg/0.5 mL Dose NDC 0002-1340-04 Zepbound ® (tirzepatide) injection 10 mg/0.5 mL Rx Only For Subcutaneous Use Needles and Syringes are not included Dispense enclosed Medication Guide to each patient. Use one vial every week. 4 Single-dose vials Discard unused portion Lilly PACKAGE LABEL - Zepbound Single-Dose Vial - 10 mg/0.5 mL Dose PACKAGE LABEL - Zepbound Single-Dose Vial - 10 mg/0.5 mL Dose; PACKAGE LABEL - Zepbound Single-Dose Vial - 12.5 mg/0.5 mL Dose NDC 0002-1423-04 Zepbound ® (tirzepatide) injection 12.5 mg/0.5 mL Rx Only For Subcutaneous Use Needles and Syringes are not included Dispense enclosed Medication Guide to each patient. Use one vial every week. 4 Single-dose vials Discard unused portion Lilly PACKAGE LABEL - Zepbound Single-Dose Vial - 12.5 mg/0.5 mL Dose PACKAGE LABEL - Zepbound Single-Dose Vial - 12.5 mg/0.5 mL Dose; PACKAGE LABEL - Zepbound Single-Dose Vial - 15 mg/0.5 mL Dose NDC 0002-2002-04 Zepbound ® (tirzepatide) injection 15 mg/0.5 mL Rx Only For Subcutaneous Use Needles and Syringes are not included Dispense enclosed Medication Guide to each patient. Use one vial every week. 4 Single-dose vials Discard unused portion Lilly PACKAGE LABEL - Zepbound Single-Dose Vial - 15 mg/0.5 mL Dose PACKAGE LABEL - Zepbound Single-Dose Vial - 15 mg/0.5 mL Dose; PACKAGE LABEL - Zepbound Multi-Dose Vial - 2.5 mg/0.6 mL Dose (10 mg/2.4 mL [4.17 mg/mL]) Rx Only NDC 0002-6052-11 Zepbound ® (tirzepatide) injection 10 mg/2.4 mL (4.17 mg/mL) ATTENTION: Contains 4 doses of 2.5 mg/0.6 mL 2.4 mL MULTI-DOSE VIAL For Subcutaneous Use Needles and Syringes are not included Dispense enclosed Medication Guide to each patient. Lilly PACKAGE LABEL - Zepbound Multi-Dose Vial - 2.5 mg/0.6 mL Dose (10 mg/2.4 mL [4.17 mg/mL]); PACKAGE LABEL - Zepbound Multi-Dose Vial - 5 mg/0.6 mL Dose (20 mg/2.4 mL [8.33 mg/mL]) Rx Only NDC 0002-6103-11 Zepbound ® (tirzepatide) injection 20 mg/2.4 mL (8.33 mg/mL) ATTENTION: Contains 4 doses of 5 mg/0.6 mL 2.4 mL MULTI-DOSE VIAL For Subcutaneous Use Needles and Syringes are not included Dispense enclosed Medication Guide to each patient. Lilly PACKAGE LABEL - Zepbound Multi-Dose Vial - 5 mg/0.6 mL Dose (20 mg/2.4 mL [8.33 mg/mL]); PACKAGE LABEL - Zepbound Multi-Dose Vial - 7.5 mg/0.6 mL Dose (30 mg/2.4 mL [12.5 mg/mL]) Rx Only NDC 0002-6210-11 Zepbound ® (tirzepatide) injection 30 mg/2.4 mL (12.5 mg/mL) ATTENTION: Contains 4 doses of 7.5 mg/0.6 mL 2.4 mL MULTI-DOSE VIAL For Subcutaneous Use Needles and Syringes are not included Dispense enclosed Medication Guide to each patient. Lilly PACKAGE LABEL - Zepbound Multi-Dose Vial - 7.5 mg/0.6 mL Dose (30 mg/2.4 mL [12.5 mg/mL]); PACKAGE LABEL - Zepbound Multi-Dose Vial - 10 mg/0.6 mL Dose (40 mg/2.4 mL [16.7 mg/mL]) Rx Only NDC 0002-6304-11 Zepbound ® (tirzepatide) injection 40 mg/2.4 mL (16.7 mg/mL) ATTENTION: Contains 4 doses of 10 mg/0.6 mL 2.4 mL MULTI-DOSE VIAL For Subcutaneous Use Needles and Syringes are not included Dispense enclosed Medication Guide to each patient. Lilly PACKAGE LABEL - Zepbound Multi-Dose Vial - 10 mg/0.6 mL Dose (40 mg/2.4 mL [16.7 mg/mL]); PACKAGE LABEL - Zepbound Multi-Dose Vial - 12.5 mg/0.6 mL Dose (50 mg/2.4 mL [20.8 mg/mL]) Rx Only NDC 0002-6523-11 Zepbound ® (tirzepatide) injection 50 mg/2.4 mL (20.8 mg/mL) ATTENTION: Contains 4 doses of 12.5 mg/0.6 mL 2.4 mL MULTI-DOSE VIAL For Subcutaneous Use Needles and Syringes are not included Dispense enclosed Medication Guide to each patient. Lilly PACKAGE LABEL - Zepbound Multi-Dose Vial - 12.5 mg/0.6 mL Dose (50 mg/2.4 mL [20.8 mg/mL]); PACKAGE LABEL - Zepbound Multi-Dose Vial - 15 mg/0.6 mL Dose (60 mg/2.4 mL [25 mg/mL]) Rx Only NDC 0002-6612-11 Zepbound ® (tirzepatide) injection 60 mg/2.4 mL (25 mg/mL) ATTENTION: Contains 4 doses of 15 mg/0.6 mL 2.4 mL MULTI-DOSE VIAL For Subcutaneous Use Needles and Syringes are not included Dispense enclosed Medication Guide to each patient. Lilly PACKAGE LABEL - Zepbound Multi-Dose Vial - 15 mg/0.6 mL Dose (60 mg/2.4 mL [25 mg/mL]); PACKAGE LABEL – ZEPBOUND KwikPen – 2.5 mg per dose (10 mg/2.4 mL [4.17 mg/mL]) NDC 0002-3566-11 Rx Only Zepbound ® KwikPen ® (tirzepatide) injection 2.5 mg per dose 10 mg/2.4 mL (4.17 mg/mL) 1 Pen with 4 doses of 2.5 mg TURN THE DOSE KNOB ALL THE WAY UNTIL YOU SEE A . THIS IS ONE DOSE. For Single-Patient-Use Only For Subcutaneous Use Needles not included Dispense enclosed Medication Guide to each patient. Use ZEPBOUND KwikPen once weekly Read the INSTRUCTIONS FOR USE. This product may have different steps than other products. PACKAGE LABEL – ZEPBOUND KwikPen – 2.5 mg per dose (10 mg/2.4 mL [4.17 mg/mL]); PACKAGE LABEL – ZEPBOUND KwikPen – 5 mg per dose (20 mg/2.4 mL [8.33 mg/mL]) NDC 0002-3555-11 Rx Only Zepbound ® KwikPen ® (tirzepatide) injection 5 mg per dose 20 mg/2.4 mL (8.33 mg/mL) 1 Pen with 4 doses of 5 mg TURN THE DOSE KNOB ALL THE WAY UNTIL YOU SEE A . THIS IS ONE DOSE. For Single-Patient-Use Only For Subcutaneous Use Needles not included Dispense enclosed Medication Guide to each patient. Use ZEPBOUND KwikPen once weekly Read the INSTRUCTIONS FOR USE. This product may have different steps than other products. PACKAGE LABEL – ZEPBOUND KwikPen – 5 mg per dose (20 mg/2.4 mL [8.33 mg/mL]); PACKAGE LABEL – ZEPBOUND KwikPen – 7.5 mg per dose (30 mg/2.4 mL [12.5 mg/mL]) NDC 0002-3544-11 Rx Only Zepbound ® KwikPen ® (tirzepatide) injection 7.5 mg per dose 30 mg/2.4 mL (12.5 mg/mL) 1 Pen with 4 doses of 7.5 mg TURN THE DOSE KNOB ALL THE WAY UNTIL YOU SEE A . THIS IS ONE DOSE. For Single-Patient-Use Only For Subcutaneous Use Needles not included Dispense enclosed Medication Guide to each patient. Use ZEPBOUND KwikPen once weekly Read the INSTRUCTIONS FOR USE. This product may have different steps than other products. PACKAGE LABEL – ZEPBOUND KwikPen – 7.5 mg per dose (30 mg/2.4 mL [12.5 mg/mL]); PACKAGE LABEL – ZEPBOUND KwikPen – 10 mg per dose (40 mg/2.4 mL [16.7 mg/mL]) NDC 0002-3533-11 Rx Only Zepbound ® KwikPen ® (tirzepatide) injection 10 mg per dose 40 mg/2.4 mL (16.7 mg/mL) 1 Pen with 4 doses of 10 mg TURN THE DOSE KNOB ALL THE WAY UNTIL YOU SEE A . THIS IS ONE DOSE. For Single-Patient-Use Only For Subcutaneous Use Needles not included Dispense enclosed Medication Guide to each patient. Use ZEPBOUND KwikPen once weekly Read the INSTRUCTIONS FOR USE. This product may have different steps than other products. PACKAGE LABEL – ZEPBOUND KwikPen – 10 mg per dose (40 mg/2.4 mL [16.7 mg/mL]); PACKAGE LABEL – ZEPBOUND KwikPen – 12.5 mg per dose (50 mg/2.4 mL [20.8 mg/mL]) NDC 0002-3522-11 Rx Only Zepbound ® KwikPen ® (tirzepatide) injection 12.5 mg per dose 50 mg/2.4 mL (20.8 mg/mL) 1 Pen with 4 doses of 12.5 mg TURN THE DOSE KNOB ALL THE WAY UNTIL YOU SEE A . THIS IS ONE DOSE. For Single-Patient-Use Only For Subcutaneous Use Needles not included Dispense enclosed Medication Guide to each patient. Use ZEPBOUND KwikPen once weekly Read the INSTRUCTIONS FOR USE. This product may have different steps than other products. PACKAGE LABEL – ZEPBOUND KwikPen – 12.5 mg per dose (50 mg/2.4 mL [20.8 mg/mL]); PACKAGE LABEL – ZEPBOUND KwikPen – 15 mg per dose (60 mg/2.4 mL [25 mg/mL]) NDC 0002-3511-11 Rx Only Zepbound ® KwikPen ® (tirzepatide) injection 15 mg per dose 60 mg/2.4 mL (25 mg/mL) 1 Pen with 4 doses of 15 mg TURN THE DOSE KNOB ALL THE WAY UNTIL YOU SEE A . THIS IS ONE DOSE. For Single-Patient-Use Only For Subcutaneous Use Needles not included Dispense enclosed Medication Guide to each patient. Use ZEPBOUND KwikPen once weekly Read the INSTRUCTIONS FOR USE. This product may have different steps than other products. PACKAGE LABEL – ZEPBOUND KwikPen – 15 mg per dose (60 mg/2.4 mL [25 mg/mL])
- 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied ZEPBOUND (tirzepatide) is a clear, colorless to slightly yellow solution available in cartons containing 4 pre-filled single-dose pens, 1 single-dose vial, 4 single-dose vials, 1 multi-dose vial, or 1 single-patient-use KwikPen as follows: Single-Dose Vial and Prefilled Pen Strength 4 pack Single-dose Pen NDC 1 pack Single-dose Vial NDC 4 pack Single-dose Vial NDC 2.5 mg/0.5 mL 0002-2506-80 0002-0152-01 0002-0152-04 5 mg/0.5 mL 0002-2495-80 0002-0243-01 0002-0243-04 7.5 mg/0.5 mL 0002-2484-80 0002-1214-01 0002-1214-04 10 mg/0.5 mL 0002-2471-80 0002-1340-01 0002-1340-04 12.5 mg/0.5 mL 0002-2460-80 0002-1423-01 0002-1423-04 15 mg/0.5 mL 0002-2457-80 0002-2002-01 0002-2002-04 Multi-Dose Vial Doses per Vial Strength 1 pack Multi-Dose Vial NDC 4 doses of 2.5 mg/0.6 mL 10 mg/2.4 mL (4.17 mg/mL) 0002-6052-11 4 doses of 5 mg/0.6 mL 20 mg/2.4 mL (8.33 mg/mL) 0002-6103-11 4 doses of 7.5 mg/0.6 mL 30 mg/2.4 mL (12.5 mg/mL) 0002-6210-11 4 doses of 10 mg/0.6 mL 40 mg/2.4 mL (16.7 mg/mL) 0002-6304-11 4 doses of 12.5 mg/0.6 mL 50 mg/2.4 mL (20.8 mg/mL) 0002-6523-11 4 doses of 15 mg/0.6 mL 60 mg/2.4 mL (25 mg/mL) 0002-6612-11 Single-Patient-Use KwikPen (with four weekly doses) Doses per KwikPen Strength 1 pack Single-Patient-Use KwikPen NDC 4 doses of 2.5 mg 10 mg/2.4 mL (4.17 mg/mL) 0002-3566-11 4 doses of 5 mg 20 mg/2.4 mL (8.33 mg/mL) 0002-3555-11 4 doses of 7.5 mg 30 mg/2.4 mL (12.5 mg/mL) 0002-3544-11 4 doses of 10 mg 40 mg/2.4 mL (16.7 mg/mL) 0002-3533-11 4 doses of 12.5 mg 50 mg/2.4 mL (20.8 mg/mL) 0002-3522-11 4 doses of 15 mg 60 mg/2.4 mL (25 mg/mL) 0002-3511-11 16.2 Storage and Handling Do not freeze ZEPBOUND. Do not use ZEPBOUND if frozen. Protect ZEPBOUND from heat and light. Store ZEPBOUND in the original carton to protect from light. ZEPBOUND Single-dose Pen and Single-dose Vial Store ZEPBOUND single-dose pen and single-dose vial in a refrigerator at 2°C to 8°C (36°F to 46°F). If needed, each single-dose pen or single-dose vial can be stored unrefrigerated at temperatures not to exceed 30°C (86°F) for up to 21 days. If single-dose pen or single-dose vial is stored at room temperature, it should not be returned to the refrigerator. Discard single-dose pen and single-dose vial if not used within 21 days after removing from the refrigerator. ZEPBOUND Multi-dose Vial or Single-Patient-Use KwikPen Unopened vial or single-patient-use KwikPen: Store unopened multi-dose vial or single-patient-use KwikPen in the refrigerator at 2°C to 8°C (36°F to 46°F). The unopened multi-dose vial or single-patient-use KwikPen can be used until the expiration date on the label if kept in the refrigerator. If stored at room temperature [up to 30°C (86°F)], throw away unopened multi-dose vial or single-patient-use KwikPen after 30 days. After vial or single-patient-use KwikPen has been opened: Store opened (in-use) multi-dose vial or single-patient-use KwikPen in the original carton in the refrigerator at 2°C to 8°C (36°F to 46°F) or at room temperature [up to 30°C (86°F)]. Throw away opened multi-dose vial or single-patient-use KwikPen after a total of 30 days at room temperature, 30 days after first use, or after taking 4 weekly doses, even if there is medicine left in it.
- 16.1 How Supplied ZEPBOUND (tirzepatide) is a clear, colorless to slightly yellow solution available in cartons containing 4 pre-filled single-dose pens, 1 single-dose vial, 4 single-dose vials, 1 multi-dose vial, or 1 single-patient-use KwikPen as follows: Single-Dose Vial and Prefilled Pen Strength 4 pack Single-dose Pen NDC 1 pack Single-dose Vial NDC 4 pack Single-dose Vial NDC 2.5 mg/0.5 mL 0002-2506-80 0002-0152-01 0002-0152-04 5 mg/0.5 mL 0002-2495-80 0002-0243-01 0002-0243-04 7.5 mg/0.5 mL 0002-2484-80 0002-1214-01 0002-1214-04 10 mg/0.5 mL 0002-2471-80 0002-1340-01 0002-1340-04 12.5 mg/0.5 mL 0002-2460-80 0002-1423-01 0002-1423-04 15 mg/0.5 mL 0002-2457-80 0002-2002-01 0002-2002-04 Multi-Dose Vial Doses per Vial Strength 1 pack Multi-Dose Vial NDC 4 doses of 2.5 mg/0.6 mL 10 mg/2.4 mL (4.17 mg/mL) 0002-6052-11 4 doses of 5 mg/0.6 mL 20 mg/2.4 mL (8.33 mg/mL) 0002-6103-11 4 doses of 7.5 mg/0.6 mL 30 mg/2.4 mL (12.5 mg/mL) 0002-6210-11 4 doses of 10 mg/0.6 mL 40 mg/2.4 mL (16.7 mg/mL) 0002-6304-11 4 doses of 12.5 mg/0.6 mL 50 mg/2.4 mL (20.8 mg/mL) 0002-6523-11 4 doses of 15 mg/0.6 mL 60 mg/2.4 mL (25 mg/mL) 0002-6612-11 Single-Patient-Use KwikPen (with four weekly doses) Doses per KwikPen Strength 1 pack Single-Patient-Use KwikPen NDC 4 doses of 2.5 mg 10 mg/2.4 mL (4.17 mg/mL) 0002-3566-11 4 doses of 5 mg 20 mg/2.4 mL (8.33 mg/mL) 0002-3555-11 4 doses of 7.5 mg 30 mg/2.4 mL (12.5 mg/mL) 0002-3544-11 4 doses of 10 mg 40 mg/2.4 mL (16.7 mg/mL) 0002-3533-11 4 doses of 12.5 mg 50 mg/2.4 mL (20.8 mg/mL) 0002-3522-11 4 doses of 15 mg 60 mg/2.4 mL (25 mg/mL) 0002-3511-11
- PACKAGE LABEL - Zepbound Prefilled Pen (Autoinjector) - 2.5 mg/0.5 mL Dose NDC 0002-2506-80 Zepbound ® (tirzepatide) injection 2.5 mg/0.5 mL 4 x 2.5 mg/0.5 mL prefilled pens Rx Only For Subcutaneous Use Dispense enclosed Medication Guide to each patient. Use one pen every week. 4 Single-dose prefilled pens Lilly PACKAGE LABEL - Zepbound Prefilled Pen (Autoinjector) - 2.5 mg/0.5 mL Dose
- PACKAGE LABEL - Zepbound Prefilled Pen (Autoinjector) - 5 mg/0.5 mL Dose NDC 0002-2495-80 Zepbound ® (tirzepatide) injection 5 mg/0.5 mL 4 x 5 mg/0.5 mL prefilled pens Rx Only For Subcutaneous Use Dispense enclosed Medication Guide to each patient. Use one pen every week. 4 Single-dose prefilled pens Lilly PACKAGE LABEL - Zepbound Prefilled Pen (Autoinjector) - 5 mg/0.5 mL Dose
- PACKAGE LABEL - Zepbound Prefilled Pen (Autoinjector) - 7.5 mg/0.5 mL Dose NDC 0002-2484-80 Zepbound ® (tirzepatide) injection 7.5 mg/0.5 mL 4 x 7.5 mg/0.5 mL prefilled pens Rx Only For Subcutaneous Use Dispense enclosed Medication Guide to each patient. Use one pen every week. 4 Single-dose prefilled pens Lilly PACKAGE LABEL - Zepbound Prefilled Pen (Autoinjector) - 7.5 mg/0.5 mL Dose
- PACKAGE LABEL - Zepbound Prefilled Pen (Autoinjector) - 10 mg/0.5 mL Dose NDC 0002-2471-80 Zepbound ® (tirzepatide) injection 10 mg/0.5 mL 4 x 10 mg/0.5 mL prefilled pens Rx Only For Subcutaneous Use Dispense enclosed Medication Guide to each patient. Use one pen every week. 4 Single-dose prefilled pens Lilly PACKAGE LABEL - Zepbound Prefilled Pen (Autoinjector) - 10 mg/0.5 mL Dose
- PACKAGE LABEL - Zepbound Prefilled Pen (Autoinjector) - 12.5 mg/0.5 mL Dose NDC 0002-2460-80 Zepbound ® (tirzepatide) injection 12.5 mg/0.5 mL 4 x 12.5 mg/0.5 mL prefilled pens Rx Only For Subcutaneous Use Dispense enclosed Medication Guide to each patient. Use one pen every week. 4 Single-dose prefilled pens Lilly PACKAGE LABEL - Zepbound Prefilled Pen (Autoinjector) - 12.5 mg/0.5 mL Dose
- PACKAGE LABEL - Zepbound Prefilled Pen (Autoinjector) - 15 mg/0.5 mL Dose NDC 0002-2457-80 Zepbound ® (tirzepatide) injection 15 mg/0.5 mL 4 x 15 mg/0.5 mL prefilled pens Rx Only For Subcutaneous Use Dispense enclosed Medication Guide to each patient. Use one pen every week. 4 Single-dose prefilled pens Lilly PACKAGE LABEL - Zepbound Prefilled Pen (Autoinjector) - 15 mg/0.5 mL Dose
- PACKAGE LABEL - Zepbound Single-Dose Vial - 2.5 mg/0.5 mL Dose NDC 0002-0152-04 Zepbound ® (tirzepatide) injection 2.5 mg/0.5 mL Rx Only For Subcutaneous Use Needles and Syringes are not included Dispense enclosed Medication Guide to each patient. Use one vial every week. 4 Single-dose vials Discard unused portion Lilly PACKAGE LABEL - Zepbound Single-Dose Vial - 2.5 mg/0.5 mL Dose PACKAGE LABEL - Zepbound Single-Dose Vial - 2.5 mg/0.5 mL Dose
- PACKAGE LABEL - Zepbound Single-Dose Vial - 5 mg/0.5 mL Dose NDC 0002-0243-04 Zepbound ® (tirzepatide) injection 5 mg/0.5 mL Rx Only For Subcutaneous Use Needles and Syringes are not included Dispense enclosed Medication Guide to each patient. Use one vial every week. 4 Single-dose vials Discard unused portion Lilly PACKAGE LABEL - Zepbound Single-Dose Vial - 5 mg/0.5 mL Dose PACKAGE LABEL - Zepbound Single-Dose Vial - 5 mg/0.5 mL Dose
- PACKAGE LABEL - Zepbound Single-Dose Vial - 7.5 mg/0.5 mL Dose NDC 0002-1214-04 Zepbound ® (tirzepatide) injection 7.5 mg/0.5 mL Rx Only For Subcutaneous Use Needles and Syringes are not included Dispense enclosed Medication Guide to each patient. Use one vial every week. 4 Single-dose vials Discard unused portion Lilly PACKAGE LABEL - Zepbound Single-Dose Vial - 7.5 mg/0.5 mL Dose PACKAGE LABEL - Zepbound Single-Dose Vial - 7.5 mg/0.5 mL Dose
- PACKAGE LABEL - Zepbound Single-Dose Vial - 10 mg/0.5 mL Dose NDC 0002-1340-04 Zepbound ® (tirzepatide) injection 10 mg/0.5 mL Rx Only For Subcutaneous Use Needles and Syringes are not included Dispense enclosed Medication Guide to each patient. Use one vial every week. 4 Single-dose vials Discard unused portion Lilly PACKAGE LABEL - Zepbound Single-Dose Vial - 10 mg/0.5 mL Dose PACKAGE LABEL - Zepbound Single-Dose Vial - 10 mg/0.5 mL Dose
- PACKAGE LABEL - Zepbound Single-Dose Vial - 12.5 mg/0.5 mL Dose NDC 0002-1423-04 Zepbound ® (tirzepatide) injection 12.5 mg/0.5 mL Rx Only For Subcutaneous Use Needles and Syringes are not included Dispense enclosed Medication Guide to each patient. Use one vial every week. 4 Single-dose vials Discard unused portion Lilly PACKAGE LABEL - Zepbound Single-Dose Vial - 12.5 mg/0.5 mL Dose PACKAGE LABEL - Zepbound Single-Dose Vial - 12.5 mg/0.5 mL Dose
- PACKAGE LABEL - Zepbound Single-Dose Vial - 15 mg/0.5 mL Dose NDC 0002-2002-04 Zepbound ® (tirzepatide) injection 15 mg/0.5 mL Rx Only For Subcutaneous Use Needles and Syringes are not included Dispense enclosed Medication Guide to each patient. Use one vial every week. 4 Single-dose vials Discard unused portion Lilly PACKAGE LABEL - Zepbound Single-Dose Vial - 15 mg/0.5 mL Dose PACKAGE LABEL - Zepbound Single-Dose Vial - 15 mg/0.5 mL Dose
- PACKAGE LABEL - Zepbound Multi-Dose Vial - 2.5 mg/0.6 mL Dose (10 mg/2.4 mL [4.17 mg/mL]) Rx Only NDC 0002-6052-11 Zepbound ® (tirzepatide) injection 10 mg/2.4 mL (4.17 mg/mL) ATTENTION: Contains 4 doses of 2.5 mg/0.6 mL 2.4 mL MULTI-DOSE VIAL For Subcutaneous Use Needles and Syringes are not included Dispense enclosed Medication Guide to each patient. Lilly PACKAGE LABEL - Zepbound Multi-Dose Vial - 2.5 mg/0.6 mL Dose (10 mg/2.4 mL [4.17 mg/mL])
- PACKAGE LABEL - Zepbound Multi-Dose Vial - 5 mg/0.6 mL Dose (20 mg/2.4 mL [8.33 mg/mL]) Rx Only NDC 0002-6103-11 Zepbound ® (tirzepatide) injection 20 mg/2.4 mL (8.33 mg/mL) ATTENTION: Contains 4 doses of 5 mg/0.6 mL 2.4 mL MULTI-DOSE VIAL For Subcutaneous Use Needles and Syringes are not included Dispense enclosed Medication Guide to each patient. Lilly PACKAGE LABEL - Zepbound Multi-Dose Vial - 5 mg/0.6 mL Dose (20 mg/2.4 mL [8.33 mg/mL])
- PACKAGE LABEL - Zepbound Multi-Dose Vial - 7.5 mg/0.6 mL Dose (30 mg/2.4 mL [12.5 mg/mL]) Rx Only NDC 0002-6210-11 Zepbound ® (tirzepatide) injection 30 mg/2.4 mL (12.5 mg/mL) ATTENTION: Contains 4 doses of 7.5 mg/0.6 mL 2.4 mL MULTI-DOSE VIAL For Subcutaneous Use Needles and Syringes are not included Dispense enclosed Medication Guide to each patient. Lilly PACKAGE LABEL - Zepbound Multi-Dose Vial - 7.5 mg/0.6 mL Dose (30 mg/2.4 mL [12.5 mg/mL])
- PACKAGE LABEL - Zepbound Multi-Dose Vial - 10 mg/0.6 mL Dose (40 mg/2.4 mL [16.7 mg/mL]) Rx Only NDC 0002-6304-11 Zepbound ® (tirzepatide) injection 40 mg/2.4 mL (16.7 mg/mL) ATTENTION: Contains 4 doses of 10 mg/0.6 mL 2.4 mL MULTI-DOSE VIAL For Subcutaneous Use Needles and Syringes are not included Dispense enclosed Medication Guide to each patient. Lilly PACKAGE LABEL - Zepbound Multi-Dose Vial - 10 mg/0.6 mL Dose (40 mg/2.4 mL [16.7 mg/mL])
- PACKAGE LABEL - Zepbound Multi-Dose Vial - 12.5 mg/0.6 mL Dose (50 mg/2.4 mL [20.8 mg/mL]) Rx Only NDC 0002-6523-11 Zepbound ® (tirzepatide) injection 50 mg/2.4 mL (20.8 mg/mL) ATTENTION: Contains 4 doses of 12.5 mg/0.6 mL 2.4 mL MULTI-DOSE VIAL For Subcutaneous Use Needles and Syringes are not included Dispense enclosed Medication Guide to each patient. Lilly PACKAGE LABEL - Zepbound Multi-Dose Vial - 12.5 mg/0.6 mL Dose (50 mg/2.4 mL [20.8 mg/mL])
- PACKAGE LABEL - Zepbound Multi-Dose Vial - 15 mg/0.6 mL Dose (60 mg/2.4 mL [25 mg/mL]) Rx Only NDC 0002-6612-11 Zepbound ® (tirzepatide) injection 60 mg/2.4 mL (25 mg/mL) ATTENTION: Contains 4 doses of 15 mg/0.6 mL 2.4 mL MULTI-DOSE VIAL For Subcutaneous Use Needles and Syringes are not included Dispense enclosed Medication Guide to each patient. Lilly PACKAGE LABEL - Zepbound Multi-Dose Vial - 15 mg/0.6 mL Dose (60 mg/2.4 mL [25 mg/mL])
- PACKAGE LABEL – ZEPBOUND KwikPen – 2.5 mg per dose (10 mg/2.4 mL [4.17 mg/mL]) NDC 0002-3566-11 Rx Only Zepbound ® KwikPen ® (tirzepatide) injection 2.5 mg per dose 10 mg/2.4 mL (4.17 mg/mL) 1 Pen with 4 doses of 2.5 mg TURN THE DOSE KNOB ALL THE WAY UNTIL YOU SEE A . THIS IS ONE DOSE. For Single-Patient-Use Only For Subcutaneous Use Needles not included Dispense enclosed Medication Guide to each patient. Use ZEPBOUND KwikPen once weekly Read the INSTRUCTIONS FOR USE. This product may have different steps than other products. PACKAGE LABEL – ZEPBOUND KwikPen – 2.5 mg per dose (10 mg/2.4 mL [4.17 mg/mL])
- PACKAGE LABEL – ZEPBOUND KwikPen – 5 mg per dose (20 mg/2.4 mL [8.33 mg/mL]) NDC 0002-3555-11 Rx Only Zepbound ® KwikPen ® (tirzepatide) injection 5 mg per dose 20 mg/2.4 mL (8.33 mg/mL) 1 Pen with 4 doses of 5 mg TURN THE DOSE KNOB ALL THE WAY UNTIL YOU SEE A . THIS IS ONE DOSE. For Single-Patient-Use Only For Subcutaneous Use Needles not included Dispense enclosed Medication Guide to each patient. Use ZEPBOUND KwikPen once weekly Read the INSTRUCTIONS FOR USE. This product may have different steps than other products. PACKAGE LABEL – ZEPBOUND KwikPen – 5 mg per dose (20 mg/2.4 mL [8.33 mg/mL])
- PACKAGE LABEL – ZEPBOUND KwikPen – 7.5 mg per dose (30 mg/2.4 mL [12.5 mg/mL]) NDC 0002-3544-11 Rx Only Zepbound ® KwikPen ® (tirzepatide) injection 7.5 mg per dose 30 mg/2.4 mL (12.5 mg/mL) 1 Pen with 4 doses of 7.5 mg TURN THE DOSE KNOB ALL THE WAY UNTIL YOU SEE A . THIS IS ONE DOSE. For Single-Patient-Use Only For Subcutaneous Use Needles not included Dispense enclosed Medication Guide to each patient. Use ZEPBOUND KwikPen once weekly Read the INSTRUCTIONS FOR USE. This product may have different steps than other products. PACKAGE LABEL – ZEPBOUND KwikPen – 7.5 mg per dose (30 mg/2.4 mL [12.5 mg/mL])
- PACKAGE LABEL – ZEPBOUND KwikPen – 10 mg per dose (40 mg/2.4 mL [16.7 mg/mL]) NDC 0002-3533-11 Rx Only Zepbound ® KwikPen ® (tirzepatide) injection 10 mg per dose 40 mg/2.4 mL (16.7 mg/mL) 1 Pen with 4 doses of 10 mg TURN THE DOSE KNOB ALL THE WAY UNTIL YOU SEE A . THIS IS ONE DOSE. For Single-Patient-Use Only For Subcutaneous Use Needles not included Dispense enclosed Medication Guide to each patient. Use ZEPBOUND KwikPen once weekly Read the INSTRUCTIONS FOR USE. This product may have different steps than other products. PACKAGE LABEL – ZEPBOUND KwikPen – 10 mg per dose (40 mg/2.4 mL [16.7 mg/mL])
- PACKAGE LABEL – ZEPBOUND KwikPen – 12.5 mg per dose (50 mg/2.4 mL [20.8 mg/mL]) NDC 0002-3522-11 Rx Only Zepbound ® KwikPen ® (tirzepatide) injection 12.5 mg per dose 50 mg/2.4 mL (20.8 mg/mL) 1 Pen with 4 doses of 12.5 mg TURN THE DOSE KNOB ALL THE WAY UNTIL YOU SEE A . THIS IS ONE DOSE. For Single-Patient-Use Only For Subcutaneous Use Needles not included Dispense enclosed Medication Guide to each patient. Use ZEPBOUND KwikPen once weekly Read the INSTRUCTIONS FOR USE. This product may have different steps than other products. PACKAGE LABEL – ZEPBOUND KwikPen – 12.5 mg per dose (50 mg/2.4 mL [20.8 mg/mL])
- PACKAGE LABEL – ZEPBOUND KwikPen – 15 mg per dose (60 mg/2.4 mL [25 mg/mL]) NDC 0002-3511-11 Rx Only Zepbound ® KwikPen ® (tirzepatide) injection 15 mg per dose 60 mg/2.4 mL (25 mg/mL) 1 Pen with 4 doses of 15 mg TURN THE DOSE KNOB ALL THE WAY UNTIL YOU SEE A . THIS IS ONE DOSE. For Single-Patient-Use Only For Subcutaneous Use Needles not included Dispense enclosed Medication Guide to each patient. Use ZEPBOUND KwikPen once weekly Read the INSTRUCTIONS FOR USE. This product may have different steps than other products. PACKAGE LABEL – ZEPBOUND KwikPen – 15 mg per dose (60 mg/2.4 mL [25 mg/mL])
Overview
ZEPBOUND (tirzepatide) injection, for subcutaneous use, contains tirzepatide, a GIP receptor and GLP-1 receptor agonist. Tirzepatide is based on the GIP sequence and contains aminoisobutyric acid (Aib) in positions 2 and 13, a C-terminal amide, and Lys residue at position 20 that is attached to 1,20-eicosanedioic acid via a linker. The molecular weight is 4813.53 Da and the empirical formula is C 225 H 348 N 48 O 68 . Structural formula: ZEPBOUND is a clear, colorless to slightly yellow, sterile solution for subcutaneous use. Each single-dose pen or single-dose vial contains a 0.5 mL solution of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide and the following excipients: sodium chloride (4.1 mg), sodium phosphate dibasic heptahydrate (0.7 mg), and water for injection. Each multi-dose vial or single-patient-use KwikPen contains 2.4 mL of solution, which provides 4 doses of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide per 0.6 mL. Each dose contains the following excipients: benzyl alcohol (5.4 mg), glycerin (4.8 mg), phenol (1.08 mg), sodium chloride (1.05 mg), sodium phosphate dibasic heptahydrate (0.8 mg), and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH. ZEPBOUND has a pH of 6.5 to 7.5. Each single-patient-use KwikPen contains additional volume to allow for device priming. Structural Formula
Indications & Usage
ZEPBOUND ® is indicated in combination with a reduced-calorie diet and increased physical activity: to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. ZEPBOUND is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated in combination with a reduced-calorie diet and increased physical activity: to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. ( 1 ) Limitations of Use: Coadministration with other tirzepatide-containing products or with any GLP-1 receptor agonist is not recommended. ( 1 ) Limitations of Use ZEPBOUND contains tirzepatide. Coadministration with other tirzepatide-containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.
Dosage & Administration
Recommended Dose Escalation Schedule The recommended starting dosage is 2.5 mg injected subcutaneously once weekly for 4 weeks. Increase the dosage in 2.5 mg increments after at least 4 weeks until recommended maintenance dosage is achieved. ( 2.1 ) Consider treatment response and tolerability when selecting the maintenance dosage. ( 2.1 ) Recommended Maintenance and Maximum Dosage Weight Reduction and Long-Term Maintenance: 5 mg, 10 mg, or 15 mg injected subcutaneously once weekly. ( 2.2 ) Obstructive Sleep Apnea: 10 mg or 15 mg injected subcutaneously once weekly. ( 2.2 ) Maximum Recommended Dosage: 15 mg injected subcutaneously once weekly. ( 2.2 ) Administration Instructions Refer to the Full Prescribing Information for additional important administration instructions about ZEPBOUND presentations. ( 2.4 ) 2.1 Recommended Dose Escalation Schedule The recommended starting dosage of ZEPBOUND for all indications is 2.5 mg injected subcutaneously once weekly for 4 weeks. The 2.5 mg dosage is for treatment initiation and is not approved as a maintenance dosage. Follow the dosage escalation below for all indications to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.1 )] . After 4 weeks, increase the dosage to 5 mg injected subcutaneously once weekly. The dosage may be increased in 2.5 mg increments, after at least 4 weeks on the current dose [see Dosage and Administration ( 2.2 )] . Consider treatment response and tolerability when selecting the maintenance dosage. If patients do not tolerate a maintenance dosage, consider a lower maintenance dosage. 2.2 Recommended Maintenance and Maximum Dosage Recommended Maintenance Dosage Weight Reduction and Long-Term Maintenance The recommended maintenance dosage is 5 mg, 10 mg, or 15 mg, injected subcutaneously once weekly. OSA The recommended maintenance dosage is 10 mg or 15 mg injected subcutaneously once weekly. Maximum Recommended Dosage The maximum dosage of ZEPBOUND for all indications is 15 mg injected subcutaneously once weekly. 2.3 Recommendations Regarding Missed Dose If a dose is missed, instruct patients to administer ZEPBOUND as soon as possible within 4 days (96 hours) after the missed dose. If more than 4 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule. The day of weekly administration can be changed, if necessary, as long as the time between the two doses is at least 3 days (72 hours). 2.4 Important Administration Instructions Inform patients and their caregiver(s) which ZEPBOUND presentation (e.g., vial, prefilled single-dose pen, single-patient-use KwikPen) they will receive and ensure they receive training appropriate for that specific presentation. If the prescribed ZEPBOUND presentation changes, ensure patients and caregivers receive appropriate training and instruct them to consult the Instructions for Use for the newly prescribed presentation. Prior to initiation, train patients and their caregiver(s) on proper injection technique for the prescribed ZEPBOUND presentation [see Instructions for Use ] . After training, a patient may self-inject ZEPBOUND if the healthcare provider determines that it can be properly administered, except for the following: ZEPBOUND KwikPen is not recommended for self-administration by those who are visually impaired. Instruct patients using ZEPBOUND vials to use a syringe appropriate for dose administration (e.g., a 1 mL syringe capable of measuring a 0.5 mL or 0.6 mL dose) and always use a new syringe and needle for each injection. Inspect ZEPBOUND visually before use. It should appear clear and colorless to slightly yellow. Do not use ZEPBOUND if particulate matter or discoloration is seen. Administer ZEPBOUND in combination with a reduced-calorie diet and increased physical activity. Administer ZEPBOUND once weekly at any time of day, with or without meals. Inject ZEPBOUND subcutaneously in the abdomen, thigh, or another person should inject in the back of the upper arm. Rotate injection sites with each dose.
Warnings & Precautions
Severe Gastrointestinal Adverse Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. ZEPBOUND is not recommended in patients with severe gastroparesis. ( 5.2 ) Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. ( 5.3 ) Acute Gallbladder Disease: Has been reported in clinical trials. If cholecystitis is suspected, gallbladder studies and clinical follow-up are indicated. ( 5.4 ) Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, or ZEPBOUND. Discontinue if pancreatitis is suspected. ( 5.5 ) Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported postmarketing with tirzepatide. If suspected, advise patients to promptly seek medical attention and discontinue ZEPBOUND. ( 5.6 ) Hypoglycemia: Concomitant use with insulin or an insulin secretagogue may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing dose of insulin or insulin secretagogue may be necessary. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. ( 5.7 ) Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus: Has not been studied in patients with non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema. Monitor patients with a history of diabetic retinopathy for progression. ( 5.8 ) Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts. Discontinue ZEPBOUND if symptoms develop. ( 5.9 ) Pulmonary Aspiration During General Anesthesia or Deep Sedation: Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures. ( 5.10 ) Never share a ZEPBOUND KwikPen between patients, even if the pen needle is changed. ( 5.11 ) 5.1 Risk of Thyroid C-Cell Tumors In rats, tirzepatide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) in a 2-year study at clinically relevant plasma exposures [see Nonclinical Toxicology ( 13.1 )] . It is unknown whether ZEPBOUND causes thyroid C-cell tumors, including MTC, in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined. ZEPBOUND is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of ZEPBOUND and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with ZEPBOUND. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin values may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated. 5.2 Severe Gastrointestinal Adverse Reactions Use of ZEPBOUND has been associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions ( 6.1 )] . In a pool of two ZEPBOUND clinical trials for weight reduction (Studies 1 and 2), severe gastrointestinal adverse reactions were reported more frequently among patients receiving ZEPBOUND (5 mg 1.7%, 10 mg 2.5%, 15 mg 3.1%) than placebo (1%). Similar rates of severe gastrointestinal adverse reactions were observed in ZEPBOUND clinical trials for weight reduction and in ZEPBOUND clinical trials for OSA. ZEPBOUND is not recommended in patients with severe gastroparesis. 5.3 Acute Kidney Injury Due to Volume Depletion There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with GLP-1 receptor agonists, or ZEPBOUND [see Adverse Reactions ( 6.2 )] . The majority of the reported events occurred in patients who experienced gastrointestinal adverse reactions leading to dehydration such as nausea, vomiting, or diarrhea [see Adverse Reactions ( 6.1 )] . Monitor renal function in patients reporting adverse reactions to ZEPBOUND that could lead to volume depletion, especially during dosage initiation and escalation of ZEPBOUND. 5.4 Acute Gallbladder Disease Treatment with ZEPBOUND and GLP-1 receptor agonists is associated with an increased occurrence of acute gallbladder disease. In a pool of two ZEPBOUND clinical trials for weight reduction (Studies 1 and 2), cholelithiasis was reported in 1.1% of ZEPBOUND-treated patients and 1% of placebo-treated patients, cholecystitis was reported in 0.7% of ZEPBOUND-treated patients and 0.2% of placebo-treated patients, and cholecystectomy was reported in 0.2% of ZEPBOUND-treated patients and no placebo-treated patients. Acute gallbladder events were associated with weight reduction. Similar rates of cholelithiasis were reported in ZEPBOUND clinical trials for weight reduction and in ZEPBOUND trials for OSA. If cholecystitis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated. 5.5 Acute Pancreatitis Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, or ZEPBOUND [see Adverse Reactions ( 6.1 )] . After initiation of ZEPBOUND, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, discontinue ZEPBOUND and initiate appropriate management. 5.6 Hypersensitivity Reactions There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) in patients treated with tirzepatide. In a pool of two ZEPBOUND clinical studies for weight reduction (Studies 1 and 2), 0.1% of ZEPBOUND-treated patients had severe hypersensitivity reactions compared to no placebo-treated patients. Similar rates of severe hypersensitivity reactions were observed in ZEPBOUND clinical trials for weight reduction and in ZEPBOUND trials for OSA. If hypersensitivity reactions occur, advise patients to promptly seek medical attention and discontinue use of ZEPBOUND. Do not use in patients with a previous serious hypersensitivity reaction to tirzepatide or any of the excipients in ZEPBOUND [see Contraindications ( 4 ) and Adverse Reactions ( 6.2 )] . Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with GLP-1 receptor agonists. Use caution in patients with a history of angioedema or anaphylaxis with a GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to these reactions with ZEPBOUND. 5.7 Hypoglycemia ZEPBOUND lowers blood glucose and can cause hypoglycemia. In a trial of patients with type 2 diabetes mellitus and BMI ≥27 kg/m 2 (Study 2), hypoglycemia (plasma glucose <54 mg/dL) was reported in 4.2% of ZEPBOUND-treated patients versus 1.3% of placebo-treated patients. In this trial, patients taking ZEPBOUND in combination with an insulin secretagogue (e.g., sulfonylurea) had increased risk of hypoglycemia (10.3%) compared to ZEPBOUND-treated patients not taking a sulfonylurea (2.1%). There is also increased risk of hypoglycemia in patients treated with tirzepatide in combination with insulin [see Drug Interactions ( 7.1 )] . Hypoglycemia has also been associated with ZEPBOUND and GLP-1 receptor agonists in adults without type 2 diabetes mellitus [see Adverse Reactions ( 6.1 )] . Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. In patients with diabetes mellitus, monitor blood glucose prior to starting ZEPBOUND and during ZEPBOUND treatment. The risk of hypoglycemia may be lowered by a reduction in the dose of insulin or sulfonylurea (or other concomitantly administered insulin secretagogue). 5.8 Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. Tirzepatide has not been studied in patients with non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy. 5.9 Suicidal Behavior and Ideation Suicidal behavior and ideation have been reported in clinical trials with other weight management products. Monitor patients treated with ZEPBOUND for the emergence or worsening of depression, suicidal thoughts or behaviors, and/or any unusual changes in mood or behavior. Discontinue ZEPBOUND in patients who experience suicidal thoughts or behaviors. Avoid ZEPBOUND in patients with a history of suicidal attempts or active suicidal ideation. 5.10 Pulmonary Aspiration During General Anesthesia or Deep Sedation ZEPBOUND delays gastric emptying [see Clinical Pharmacology ( 12.2 )] . There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations. Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking ZEPBOUND, including whether modifying preoperative fasting recommendations or temporarily discontinuing ZEPBOUND could reduce the incidence of retained gastric contents. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking ZEPBOUND. 5.11 Never Share a ZEPBOUND KwikPen Between Patients Never share ZEPBOUND KwikPen between patients, even if the pen needle is changed. Sharing poses a risk for transmission of blood-borne pathogens.
Boxed Warning
RISK OF THYROID C-CELL TUMORS In rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether ZEPBOUND causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ) and Nonclinical Toxicology ( 13.1 )]. ZEPBOUND is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Contraindications ( 4 )] . Counsel patients regarding the potential risk for MTC with the use of ZEPBOUND and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with ZEPBOUND [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. In rats, tirzepatide causes thyroid C-cell tumors. It is unknown whether ZEPBOUND causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined ( 5.1 , 13.1 ). ZEPBOUND is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors ( 4 , 5.1 ).
Contraindications
ZEPBOUND is contraindicated in patients with: A personal or family history of MTC or in patients with MEN 2 [see Warnings and Precautions ( 5.1 )] . Known serious hypersensitivity to tirzepatide or any of the excipients in ZEPBOUND. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with tirzepatide [see Warnings and Precautions ( 5.6 ) and Adverse Reactions ( 6.2 )] . Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 ( 4 ) Known serious hypersensitivity to tirzepatide or any of the excipients in ZEPBOUND ( 4 )
Adverse Reactions
The following serious adverse reactions are described below or elsewhere in the prescribing information: Risk of Thyroid C-cell Tumors [see Warnings and Precautions ( 5.1 )] Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.2 )] Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.3 )] Acute Gallbladder Disease [see Warnings and Precautions ( 5.4 )] Acute Pancreatitis [see Warnings and Precautions ( 5.5 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.6 )] Hypoglycemia [see Warnings and Precautions ( 5.7 )] Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus [see Warnings and Precautions ( 5.8 )] Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.9 )] Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.10 )] The most common adverse reactions, reported in ≥5% of patients treated with ZEPBOUND are: nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, gastroesophageal reflux disease. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Patients for Weight Reduction and Long-Term Maintenance Pool of Placebo - Controlled Weight Reduction Trials in Adults with Obesity or Overweight, with or without Type 2 Diabetes (Study 1 and Study 2) ZEPBOUND was evaluated for safety in a pool of two randomized, double-blind, placebo-controlled trials that included 2,519 adult patients with obesity or overweight treated with ZEPBOUND for up to 72 weeks and a 4-week off drug follow-up period (Study 1 and Study 2) [see Clinical Studies ( 14.1 )] . The mean age of patients was 47 years and 37% were male. The population was 72% White, 12% Asian, 8% Black or African American, and 7% American Indian or Alaska Native; 51% identified as Hispanic or Latino ethnicity. Baseline characteristics included an average BMI of 37.4 kg/m 2 , 29% with a BMI ≥40 kg/m 2 , 41% with hypertension, 37% with dyslipidemia, 25% with type 2 diabetes mellitus, 7% with obstructive sleep apnea, and 4% with cardiovascular disease. Across both trials, 4.8%, 6.3%, and 6.7% of patients treated with 5 mg, 10 mg, and 15 mg of ZEPBOUND, respectively, permanently discontinued treatment as a result of adverse reactions compared to 3.4% of patients treated with placebo. The majority of patients who discontinued ZEPBOUND due to adverse reactions did so during the first few months of treatment due to gastrointestinal adverse reactions. Common Adverse Reactions Table 1 shows common adverse reactions associated with the use of ZEPBOUND in the pool of two placebo-controlled trials for weight reduction (Study 1 and Study 2). These adverse reactions occurred more commonly with ZEPBOUND than with placebo and occurred in at least 2% of patients treated with ZEPBOUND. Table 1: Adverse Reactions (≥2% and Greater than Placebo) in ZEPBOUND-Treated Adults with Obesity or Overweight in Weight Reduction and Long-term Maintenance Trials (Study 1 and Study 2) a Includes diarrhea, frequent bowel movements. b Includes constipation, feces hard. c Includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness. d Includes multiple related adverse event terms, such as injection site bruising, injection site erythema, injection site pruritus, injection site pain, injection site rash, injection site reaction. e Includes asthenia, fatigue, lethargy, malaise. f Includes blood pressure decreased, hypotension, orthostatic hypotension. Adverse Reaction Placebo (N=958) % ZEPBOUND 5 mg (N=630) % ZEPBOUND 10 mg (N=948) % ZEPBOUND 15 mg (N=941) % Nausea 8 25 29 28 Diarrhea a 8 19 21 23 Vomiting 2 8 11 13 Constipation b 5 17 14 11 Abdominal Pain c 5 9 9 10 Dyspepsia 4 9 9 10 Injection Site Reactions d 2 6 8 8 Fatigue e 3 5 6 7 Hypersensitivity Reactions 3 5 5 5 Eructation 1 4 5 5 Hair Loss 1 5 4 5 Gastroesophageal Reflux Disease 2 4 4 5 Flatulence 2 3 3 4 Abdominal Distension 2 3 3 4 Dizziness 2 4 5 4 Hypotension f 0 1 1 2 In a clinical trial for weight reduction that included an intensive lifestyle intervention lead-in period (Study 3), 287 patients were treated with ZEPBOUND for up to 72 weeks. In a randomized withdrawal trial (Study 4), 783 patients were treated with ZEPBOUND for up to 36 weeks, and 335 of these patients were treated for up to 88 weeks [see Clinical Studies ( 14.1 )] . In Study 3, 10% of ZEPBOUND-treated patients and 2% of placebo-treated patients discontinued drug due to adverse reactions. In Study 4, 7% of patients discontinued ZEPBOUND treatment before randomized withdrawal at Week 36 due to adverse reactions. In Study 3 and Study 4, adverse reactions were similar to those reported in the two pooled ZEPBOUND clinical trials (Study 1 and Study 2). Gastrointestinal Adverse Reactions In a pool of Study 1 and 2, gastrointestinal adverse reactions occurred more frequently among patients receiving ZEPBOUND (5 mg 56%, 10 mg 56%, 15 mg 56%) than placebo (30%). More patients receiving ZEPBOUND 5 mg (1.9%), ZEPBOUND 10 mg (3.3%), and ZEPBOUND 15 mg (4.3%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (0.5%). The majority of nausea, vomiting, and/or diarrhea events occurred during dose escalation and decreased over time. Acute Pancreatitis In clinical trials of tirzepatide for a different indication, 14 events of acute pancreatitis were confirmed by adjudication in 13 tirzepatide-treated patients (0.23 patients per 100 years of exposure) versus 3 events in 3 comparator-treated patients (0.11 patients per 100 years of exposure). In a pool of two ZEPBOUND clinical trials for weight reduction (Studies 1 and 2), 0.2% of ZEPBOUND-treated patients had acute pancreatitis confirmed by adjudication (0.14 patients per 100 years of exposure) versus 0.2% of placebo-treated patients (0.15 patients per 100 years of exposure). The exposure-adjusted incidence rate for treatment-emergent adjudication-confirmed pancreatitis in the pooled clinical studies for OSA (Studies 5 and 6) was 0.84 patients per 100 years for ZEPBOUND and 0 for placebo-treated patients. Hypotension In a pool of Study 1 and 2, hypotension occurred more frequently among patients taking ZEPBOUND (1.6%) than patients taking placebo (0.1%). Hypotension was more frequently seen in ZEPBOUND-treated patients on concomitant antihypertensive therapy (2.2%) compared to ZEPBOUND-treated patients not on antihypertensive therapy (1.2%). Hypotension also occurred in association with gastrointestinal adverse events and dehydration. Hypersensitivity Reactions In a pool of Study 1 and 2, immediate hypersensitivity reactions (within one day after drug administration) occurred in 2.1% of ZEPBOUND-treated patients compared to 0.4% of placebo-treated patients, while non-immediate hypersensitivity reactions occurred in 3.5% of ZEPBOUND-treated patients compared to 2.7% of placebo-treated patients. Among ZEPBOUND-treated patients, hypersensitivity reactions were more frequent in those with anti-tirzepatide antibodies (6.2%) compared to those who did not develop anti-tirzepatide antibodies (3%) [see Clinical Pharmacology ( 12.6 )] . The majority of the hypersensitivity reactions in trials were skin reactions (e.g., rash, itching). Injection Site Reactions In ZEPBOUND-treated patients in a pool of Study 1 and 2, injection site reactions were more frequent in those with anti-tirzepatide antibodies (11.3%) compared to those who did not develop anti-tirzepatide antibodies (1%) [see Clinical Pharmacology ( 12.6 )] . Hair Loss Hair loss adverse reactions in ZEPBOUND-treated patients were associated with weight reduction. In a pool of Study 1 and 2, hair loss was reported more frequently in female than male patients in the ZEPBOUND (7.1% female versus 0.5% male) and placebo (1.3% female versus 0% male) treatment groups. No ZEPBOUND-treated patients and one placebo-treated patient discontinued study treatment due to hair loss. Other Adverse Reactions Acute Kidney Injury In a pool of Study 1 and 2, acute kidney injury was reported in 0.5% of ZEPBOUND-treated patients compared to 0.2% of placebo-treated patients. Acute Gallbladder Disease In a pool of Study 1 and 2, cholelithiasis was reported in 1.1% of ZEPBOUND-treated patients and 1% of placebo-treated patients, cholecystitis was reported in 0.7% of ZEPBOUND-treated patients and 0.2% of placebo-treated patients, and cholecystectomy was reported in 0.2% of ZEPBOUND-treated patients and no placebo-treated patients. Hypoglycemia In Study 2, a trial of patients with type 2 diabetes mellitus and BMI ≥27 kg/m 2 , hypoglycemia (plasma glucose <54 mg/dL) was reported in 4.2% of ZEPBOUND-treated patients versus 1.3% of placebo-treated patients. In Study 1, a trial of ZEPBOUND in adults with obesity/overweight without type 2 diabetes mellitus, there was no systematic capturing of hypoglycemia, but plasma glucose <54 mg/dL was reported in 0.3% of ZEPBOUND-treated patients versus no placebo-treated patients. Heart Rate Increase In a pool of Study 1 and 2, treatment with ZEPBOUND resulted in a mean increase in heart rate of 1 to 3 beats per minute compared to no increase in placebo-treated patients. Dysesthesia In a pool of Study 1 and 2, dysesthesia occurred more frequently among patients receiving ZEPBOUND (5 mg 0.2%, 10 mg 0.2%, 15 mg 0.4%) than placebo (0.1%). Dysgeusia In a pool of Study 1 and 2, dysgeusia was reported by 0.4% of ZEPBOUND-treated patients and no placebo-treated patients. Dry Mouth In a pool of Study 1 and 2, dry mouth or dry throat was reported by 1% of ZEPBOUND-treated patients and 0.1% of placebo-treated patients. Laboratory Abnormalities Amylase and Lipase Increase In a pool of Study 1 and 2, treatment with ZEPBOUND resulted in mean increases from baseline in serum pancreatic amylase concentrations of 20% to 25% and serum lipase concentrations of 28% to 35%, compared to mean increases from baseline in pancreatic amylase of 2.1% and serum lipase of 5.8% in placebo-treated patients. The clinical significance of elevations in amylase or lipase with ZEPBOUND is unknown in the absence of other signs and symptoms of pancreatitis. Adverse Reactions in Patients with Obstructive Sleep Apnea ZEPBOUND was evaluated in 2 randomized, double-blind, placebo-controlled trials (Study 5 and Study 6) that included a total of 467 adult patients with moderate to severe OSA and obesity [see Clinical Studies ( 14.2 )] . Study 5 enrolled 234 patients who were unable or unwilling to use Positive Airway Pressure (PAP) therapy and Study 6 enrolled 235 patients who were on PAP therapy. The adverse reactions observed with ZEPBOUND 10 mg or 15 mg administered subcutaneously once weekly were similar to those reported in the two pooled placebo controlled clinical trials for weight reduction (Study 1 and Study 2). 6.2 Postmarketing Experience The following adverse reactions have been reported during post-approval use of tirzepatide, the active ingredient in ZEPBOUND. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure. Gastrointestinal: acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death, ileus Hypersensitivity: anaphylaxis, angioedema Pulmonary: Pulmonary aspiration has occurred in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation. Renal: acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis
Drug Interactions
ZEPBOUND delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. ( 7.2 ) 7.1 Concomitant Use with Insulin or an Insulin Secretagogue (e.g., Sulfonylurea) ZEPBOUND lowers blood glucose. When initiating ZEPBOUND, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (e.g., sulfonylureas) to reduce the risk of hypoglycemia [see Warnings and Precautions ( 5.7 )] . 7.2 Oral Medications ZEPBOUND delays gastric emptying and thereby has the potential to impact the absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with ZEPBOUND. Monitor patients on oral medications dependent on threshold concentrations for efficacy and those with a narrow therapeutic index (e.g., warfarin) when concomitantly administered with ZEPBOUND. Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation with ZEPBOUND and for 4 weeks after each dose escalation. Hormonal contraceptives that are not administered orally should not be affected [see Use in Specific Populations ( 8.3 ) and Clinical Pharmacology ( 12.2 , 12.3 )] .
Storage & Handling
16.2 Storage and Handling Do not freeze ZEPBOUND. Do not use ZEPBOUND if frozen. Protect ZEPBOUND from heat and light. Store ZEPBOUND in the original carton to protect from light. ZEPBOUND Single-dose Pen and Single-dose Vial Store ZEPBOUND single-dose pen and single-dose vial in a refrigerator at 2°C to 8°C (36°F to 46°F). If needed, each single-dose pen or single-dose vial can be stored unrefrigerated at temperatures not to exceed 30°C (86°F) for up to 21 days. If single-dose pen or single-dose vial is stored at room temperature, it should not be returned to the refrigerator. Discard single-dose pen and single-dose vial if not used within 21 days after removing from the refrigerator. ZEPBOUND Multi-dose Vial or Single-Patient-Use KwikPen Unopened vial or single-patient-use KwikPen: Store unopened multi-dose vial or single-patient-use KwikPen in the refrigerator at 2°C to 8°C (36°F to 46°F). The unopened multi-dose vial or single-patient-use KwikPen can be used until the expiration date on the label if kept in the refrigerator. If stored at room temperature [up to 30°C (86°F)], throw away unopened multi-dose vial or single-patient-use KwikPen after 30 days. After vial or single-patient-use KwikPen has been opened: Store opened (in-use) multi-dose vial or single-patient-use KwikPen in the original carton in the refrigerator at 2°C to 8°C (36°F to 46°F) or at room temperature [up to 30°C (86°F)]. Throw away opened multi-dose vial or single-patient-use KwikPen after a total of 30 days at room temperature, 30 days after first use, or after taking 4 weekly doses, even if there is medicine left in it.
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