AUSTEDO
(+1 other brands)
Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied AUSTEDO XR extended-release tablets are supplied in the following configurations: Strength Description Package Configuration NDC Code 6 mg Round, grey-coated tablets, with “Q6” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-470-56 12 mg Round, blue-coated tablets, with “Q12” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-471-56 18 mg Round, light grey-coated tablets, with “Q18” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-479-56 24 mg Round, purple-coated tablets, with “Q24” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-472-56 30 mg Round, light orange-coated tablets, with “Q30” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-473-56 36 mg Round, light purple-coated tablets, with “Q36” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-474-56 42 mg Round, orange-coated tablets, with “Q42” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-475-56 48 mg Round, pink-coated tablets, with “Q48” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-476-56 AUSTEDO XR Patient Titration Kits are supplied in the following configuration: Strength Description Package Configuration NDC Code 4-Week Patient Titration Kit 12 mg Round, blue-coated tablets, with “Q12” printed in black ink on one side Titration Kit / 28 count Each Titration Kit contains 1 child-resistant blister pack, containing one foil card with extended-release tablets in the following configuration: Seven 12 mg tablets taken during Week 1; seven 18 mg tablets taken during Week 2; seven 24 mg tablets taken during Week 3; and seven 30 mg tablets taken during Week 4. 68546-477-29 18 mg Round, light grey-coated tablets, with “Q18” printed in black ink on one side 24 mg Round, purple-coated tablets, with “Q24” printed in black ink on one side 30 mg Round, light orange-coated tablets, with “Q30” printed in black ink on one side AUSTEDO tablets are supplied in the following configurations: Strength Description Package Configuration NDC Code 6 mg Round, purple-coated tablets, with “SD” over “6” printed in black ink on one side Bottle with child-resistant cap / 60 count 68546-170-60 9 mg Round, blue-coated tablets, with “SD” over “9” printed in black ink on one side Bottle with child-resistant cap / 60 count 68546-171-60 12 mg Round, beige-coated tablets, with “SD” over “12” printed in black ink on one side Bottle with child-resistant cap / 60 count 68546-172-60 16.2 Storage Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Protect from light and moisture. Dispense in original containers or in tight containers as defined in USP.; Package/Label Display Panel NDC 68546- 470 -56 ONCE-DAILY Austedo XR ® (deutetrabenazine) extended-release tablets 6 mg Medication Guide Required: Each time AUSTEDO XR is dispensed, give the patient a Medication Guide. Print Medication Guides at: www.tevausa.com/medguides 30 tablets image; Package/Label Display Panel NDC 68546- 471 -56 ONCE-DAILY Austedo XR ® (deutetrabenazine) extended-release tablets 12 mg Medication Guide Required: Each time AUSTEDO XR is dispensed, give the patient a Medication Guide. Print Medication Guides at: www.tevausa.com/medguides 30 tablets image; Package/Label Display Panel NDC 68546- 479 -56 ONCE-DAILY Austedo XR ® (deutetrabenazine) extended-release tablets 18 mg Medication Guide Required: Each time AUSTEDO XR is dispensed, give the patient a Medication Guide. Print Medication Guides at: www.tevausa.com/medguides 30 tablets image; Package/Label Display Panel NDC 68546- 472 -56 ONCE-DAILY Austedo XR ® (deutetrabenazine) extended-release tablets 24 mg Medication Guide Required: Each time AUSTEDO XR is dispensed, give the patient a Medication Guide. Print Medication Guides at: www.tevausa.com/medguides 30 tablets image; Package/Label Display Panel NDC 68546- 473 -56 ONCE-DAILY Austedo XR ® (deutetrabenazine) extended-release tablets 30 mg Medication Guide Required: Each time AUSTEDO XR is dispensed, give the patient a Medication Guide. Print Medication Guides at: www.tevausa.com/medguides 30 tablets image; Package/Label Display Panel NDC 68546- 474 -56 ONCE-DAILY Austedo XR ® (deutetrabenazine) extended-release tablets 36 mg Medication Guide Required: Each time AUSTEDO XR is dispensed, give the patient a Medication Guide. Print Medication Guides at: www.tevausa.com/medguides 30 tablets image; Package/Label Display Panel NDC 68546- 475 -56 ONCE-DAILY Austedo XR ® (deutetrabenazine) extended-release tablets 42 mg Medication Guide Required: Each time AUSTEDO XR is dispensed, give the patient a Medication Guide. Print Medication Guides at: www.tevausa.com/medguides 30 tablets image; Package/Label Display Panel NDC 68546- 476 -56 ONCE-DAILY Austedo XR ® (deutetrabenazine) extended-release tablets 48 mg Medication Guide Required: Each time AUSTEDO XR is dispensed, give the patient a Medication Guide. Print Medication Guides at: www.tevausa.com/medguides 30 tablets image; Package/Label Display Panel NDC 68546-490- 52 ONCE-DAILY Austedo ® XR (deutetrabenazine) extended-release tablets 6 mg, 12 mg, 24 mg Once Daily Patient Titration Kit 4 WEEKS Rx Only Medication Guide Required: Each time AUSTEDO XR is dispensed, give the patient the accompanying Medication Guide. Print Medication Guides at: www.tevausa.com/medguides Dispense in this sealed carton. Monthly carton contains 42 tablets in 2 child-resistant packs including, 14 grey tablets, each containing 6 mg of deutetrabenazine, 14 blue tablets, each containing 12 mg of deutetrabenazine, and 14 purple tablets, each containing 24 mg of deutetrabenazine. teva image; Package/Label Display Panel NDC 68546- 477 -29 ONCE-DAILY Austedo XR ® (deutetrabenazine) extended-release tablets 12 mg, 18 mg, 24 mg, 30 mg One Tablet, Once-Daily Patient Titration Kit 4 WEEKS Rx only Medication Guide Required: Each time AUSTEDO XR is dispensed, give the patient the accompanying Medication Guide. Print Medication Guides at: www.tevausa.com/medguides Dispense in this sealed carton. Monthly carton contains 28 tablets in a child-resistant blister pack, including, 7 blue tablets, each containing 12 mg of deutetrabenazine, 7 light grey tablets, each containing 18 mg of deutetrabenazine, 7 purple tablets, each containing 24 mg of deutetrabenazine, 7 light orange tablets, each containing 30 mg of deutetrabenazine. teva image; Package/Label Display Panel NDC 68546- 170 -60 Austedo ® (deutetrabenazine) tablets 6 mg Medication Guide Required: Each time AUSTEDO is dispensed, give the patient a Medication Guide. 60 tablets image; Package/Label Display Panel NDC 68546- 171 -60 Austedo ® (deutetrabenazine) tablets 9 mg Medication Guide Required: Each time AUSTEDO is dispensed, give the patient a Medication Guide. 60 tablets image; Package/Label Display Panel NDC 68546- 172 -60 Austedo ® (deutetrabenazine) tablets 12 mg Medication Guide Required: Each time AUSTEDO is dispensed, give the patient a Medication Guide. 60 tablets image; Package/Label Display Panel NDC 68546-182- 70 AUSTEDO ® (deutetrabenazine) tablets 6 mg, 9 mg, 12 mg 4 Week Patient Titration Kit 12 mg Starting Dose SAMPLE – NOT FOR SALE Rx Only Medication Guide Required: Each time AUSTEDO is dispensed, give the patient the accompanying Medication Guide. Dispense in this sealed carton. Monthly carton contains 70 tablets in 3 child-resistant packs including, 28 purple tablets, each containing 6 mg of deutetrabenazine, 28 blue tablets, each containing 9 mg of deutetrabenazine, and 14 beige tablets, each containing 12 mg of deutetrabenazine. teva image; Package/Label Display Panel NDC 68546-181- 49 Rx Only Chorea associated with Huntington's disease 4 Week Patient Titration Kit 6 mg Starting Dose AUSTEDO ® (deutetrabenazine) tablets 6 mg, 9 mg, 12 mg Week Tablets per day 1 Take 1 (6 mg) tablet every morning 2 Take 1 (6 mg) tablet every morning and 1 (6 mg) tablet every evening 3 Take 1 (9 mg) tablet every morning and 1 (9 mg) tablet every evening 4 Take 1 (12 mg) tablet every morning and 1 (12 mg) tablet every evening SAMPLE – NOT FOR SALE Medication Guide Required: Each time AUSTEDO is dispensed, give the patient the accompanying Medication Guide. Dispense in this sealed carton. Monthly carton contains 49 tablets in 2 child-resistant packs including, 21 purple tablets, each containing 6 mg of deutetrabenazine, 14 blue tablets, each containing 9 mg of deutetrabenazine, and 14 beige tablets, each containing 12 mg of deutetrabenazine. teva HD 4-week kit; Package/Label Display Panel NDC 68546-176- 28 Rx Only 1 PRESS AND HOLD HERE Tardive Dyskinesia Titration Pack 12 mg Starting Dose AUSTEDO ® (deutetrabenazine) tablets 6 mg and 9 mg SAMPLE – NOT FOR SALE 1 Press & hold button 2 Pull out card Medication Guide Required: Each time AUSTEDO is dispensed, give the patient the accompanying Medication Guide. 1 tablet dispenser containing 28 tablets in the following order: Week 1: 14 purple tablets containing 6 mg deutetrabenazine Week 2: 14 blue tablets containing 9 mg deutetrabenazine 2 PULL OUT HERE teva image; Package/Label Display Panel NDC 68546-177- 21 Rx Only 1 PRESS AND HOLD HERE Chorea associated with Huntington's disease Titration Pack 6 mg Starting Dose AUSTEDO ® (deutetrabenazine) tablets 6 mg SAMPLE – NOT FOR SALE 1 Press & hold button 2 Pull out card Medication Guide Required: Each time AUSTEDO is dispensed, give the patient the accompanying Medication Guide. 1 tablet dispenser containing 21 tablets in the following order: Week 1: 7 purple tablets containing 6 mg deutetrabenazine Week 2: 14 purple tablets containing 6 mg deutetrabenazine 2 PULL OUT HERE teva image
- 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied AUSTEDO XR extended-release tablets are supplied in the following configurations: Strength Description Package Configuration NDC Code 6 mg Round, grey-coated tablets, with “Q6” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-470-56 12 mg Round, blue-coated tablets, with “Q12” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-471-56 18 mg Round, light grey-coated tablets, with “Q18” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-479-56 24 mg Round, purple-coated tablets, with “Q24” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-472-56 30 mg Round, light orange-coated tablets, with “Q30” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-473-56 36 mg Round, light purple-coated tablets, with “Q36” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-474-56 42 mg Round, orange-coated tablets, with “Q42” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-475-56 48 mg Round, pink-coated tablets, with “Q48” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-476-56 AUSTEDO XR Patient Titration Kits are supplied in the following configuration: Strength Description Package Configuration NDC Code 4-Week Patient Titration Kit 12 mg Round, blue-coated tablets, with “Q12” printed in black ink on one side Titration Kit / 28 count Each Titration Kit contains 1 child-resistant blister pack, containing one foil card with extended-release tablets in the following configuration: Seven 12 mg tablets taken during Week 1; seven 18 mg tablets taken during Week 2; seven 24 mg tablets taken during Week 3; and seven 30 mg tablets taken during Week 4. 68546-477-29 18 mg Round, light grey-coated tablets, with “Q18” printed in black ink on one side 24 mg Round, purple-coated tablets, with “Q24” printed in black ink on one side 30 mg Round, light orange-coated tablets, with “Q30” printed in black ink on one side AUSTEDO tablets are supplied in the following configurations: Strength Description Package Configuration NDC Code 6 mg Round, purple-coated tablets, with “SD” over “6” printed in black ink on one side Bottle with child-resistant cap / 60 count 68546-170-60 9 mg Round, blue-coated tablets, with “SD” over “9” printed in black ink on one side Bottle with child-resistant cap / 60 count 68546-171-60 12 mg Round, beige-coated tablets, with “SD” over “12” printed in black ink on one side Bottle with child-resistant cap / 60 count 68546-172-60 16.2 Storage Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Protect from light and moisture. Dispense in original containers or in tight containers as defined in USP.
- Package/Label Display Panel NDC 68546- 470 -56 ONCE-DAILY Austedo XR ® (deutetrabenazine) extended-release tablets 6 mg Medication Guide Required: Each time AUSTEDO XR is dispensed, give the patient a Medication Guide. Print Medication Guides at: www.tevausa.com/medguides 30 tablets image
- Package/Label Display Panel NDC 68546- 471 -56 ONCE-DAILY Austedo XR ® (deutetrabenazine) extended-release tablets 12 mg Medication Guide Required: Each time AUSTEDO XR is dispensed, give the patient a Medication Guide. Print Medication Guides at: www.tevausa.com/medguides 30 tablets image
- Package/Label Display Panel NDC 68546- 479 -56 ONCE-DAILY Austedo XR ® (deutetrabenazine) extended-release tablets 18 mg Medication Guide Required: Each time AUSTEDO XR is dispensed, give the patient a Medication Guide. Print Medication Guides at: www.tevausa.com/medguides 30 tablets image
- Package/Label Display Panel NDC 68546- 472 -56 ONCE-DAILY Austedo XR ® (deutetrabenazine) extended-release tablets 24 mg Medication Guide Required: Each time AUSTEDO XR is dispensed, give the patient a Medication Guide. Print Medication Guides at: www.tevausa.com/medguides 30 tablets image
- Package/Label Display Panel NDC 68546- 473 -56 ONCE-DAILY Austedo XR ® (deutetrabenazine) extended-release tablets 30 mg Medication Guide Required: Each time AUSTEDO XR is dispensed, give the patient a Medication Guide. Print Medication Guides at: www.tevausa.com/medguides 30 tablets image
- Package/Label Display Panel NDC 68546- 474 -56 ONCE-DAILY Austedo XR ® (deutetrabenazine) extended-release tablets 36 mg Medication Guide Required: Each time AUSTEDO XR is dispensed, give the patient a Medication Guide. Print Medication Guides at: www.tevausa.com/medguides 30 tablets image
- Package/Label Display Panel NDC 68546- 475 -56 ONCE-DAILY Austedo XR ® (deutetrabenazine) extended-release tablets 42 mg Medication Guide Required: Each time AUSTEDO XR is dispensed, give the patient a Medication Guide. Print Medication Guides at: www.tevausa.com/medguides 30 tablets image
- Package/Label Display Panel NDC 68546- 476 -56 ONCE-DAILY Austedo XR ® (deutetrabenazine) extended-release tablets 48 mg Medication Guide Required: Each time AUSTEDO XR is dispensed, give the patient a Medication Guide. Print Medication Guides at: www.tevausa.com/medguides 30 tablets image
- Package/Label Display Panel NDC 68546-490- 52 ONCE-DAILY Austedo ® XR (deutetrabenazine) extended-release tablets 6 mg, 12 mg, 24 mg Once Daily Patient Titration Kit 4 WEEKS Rx Only Medication Guide Required: Each time AUSTEDO XR is dispensed, give the patient the accompanying Medication Guide. Print Medication Guides at: www.tevausa.com/medguides Dispense in this sealed carton. Monthly carton contains 42 tablets in 2 child-resistant packs including, 14 grey tablets, each containing 6 mg of deutetrabenazine, 14 blue tablets, each containing 12 mg of deutetrabenazine, and 14 purple tablets, each containing 24 mg of deutetrabenazine. teva image
- Package/Label Display Panel NDC 68546- 477 -29 ONCE-DAILY Austedo XR ® (deutetrabenazine) extended-release tablets 12 mg, 18 mg, 24 mg, 30 mg One Tablet, Once-Daily Patient Titration Kit 4 WEEKS Rx only Medication Guide Required: Each time AUSTEDO XR is dispensed, give the patient the accompanying Medication Guide. Print Medication Guides at: www.tevausa.com/medguides Dispense in this sealed carton. Monthly carton contains 28 tablets in a child-resistant blister pack, including, 7 blue tablets, each containing 12 mg of deutetrabenazine, 7 light grey tablets, each containing 18 mg of deutetrabenazine, 7 purple tablets, each containing 24 mg of deutetrabenazine, 7 light orange tablets, each containing 30 mg of deutetrabenazine. teva image
- Package/Label Display Panel NDC 68546- 170 -60 Austedo ® (deutetrabenazine) tablets 6 mg Medication Guide Required: Each time AUSTEDO is dispensed, give the patient a Medication Guide. 60 tablets image
- Package/Label Display Panel NDC 68546- 171 -60 Austedo ® (deutetrabenazine) tablets 9 mg Medication Guide Required: Each time AUSTEDO is dispensed, give the patient a Medication Guide. 60 tablets image
- Package/Label Display Panel NDC 68546- 172 -60 Austedo ® (deutetrabenazine) tablets 12 mg Medication Guide Required: Each time AUSTEDO is dispensed, give the patient a Medication Guide. 60 tablets image
- Package/Label Display Panel NDC 68546-182- 70 AUSTEDO ® (deutetrabenazine) tablets 6 mg, 9 mg, 12 mg 4 Week Patient Titration Kit 12 mg Starting Dose SAMPLE – NOT FOR SALE Rx Only Medication Guide Required: Each time AUSTEDO is dispensed, give the patient the accompanying Medication Guide. Dispense in this sealed carton. Monthly carton contains 70 tablets in 3 child-resistant packs including, 28 purple tablets, each containing 6 mg of deutetrabenazine, 28 blue tablets, each containing 9 mg of deutetrabenazine, and 14 beige tablets, each containing 12 mg of deutetrabenazine. teva image
- Package/Label Display Panel NDC 68546-181- 49 Rx Only Chorea associated with Huntington's disease 4 Week Patient Titration Kit 6 mg Starting Dose AUSTEDO ® (deutetrabenazine) tablets 6 mg, 9 mg, 12 mg Week Tablets per day 1 Take 1 (6 mg) tablet every morning 2 Take 1 (6 mg) tablet every morning and 1 (6 mg) tablet every evening 3 Take 1 (9 mg) tablet every morning and 1 (9 mg) tablet every evening 4 Take 1 (12 mg) tablet every morning and 1 (12 mg) tablet every evening SAMPLE – NOT FOR SALE Medication Guide Required: Each time AUSTEDO is dispensed, give the patient the accompanying Medication Guide. Dispense in this sealed carton. Monthly carton contains 49 tablets in 2 child-resistant packs including, 21 purple tablets, each containing 6 mg of deutetrabenazine, 14 blue tablets, each containing 9 mg of deutetrabenazine, and 14 beige tablets, each containing 12 mg of deutetrabenazine. teva HD 4-week kit
- Package/Label Display Panel NDC 68546-176- 28 Rx Only 1 PRESS AND HOLD HERE Tardive Dyskinesia Titration Pack 12 mg Starting Dose AUSTEDO ® (deutetrabenazine) tablets 6 mg and 9 mg SAMPLE – NOT FOR SALE 1 Press & hold button 2 Pull out card Medication Guide Required: Each time AUSTEDO is dispensed, give the patient the accompanying Medication Guide. 1 tablet dispenser containing 28 tablets in the following order: Week 1: 14 purple tablets containing 6 mg deutetrabenazine Week 2: 14 blue tablets containing 9 mg deutetrabenazine 2 PULL OUT HERE teva image
- Package/Label Display Panel NDC 68546-177- 21 Rx Only 1 PRESS AND HOLD HERE Chorea associated with Huntington's disease Titration Pack 6 mg Starting Dose AUSTEDO ® (deutetrabenazine) tablets 6 mg SAMPLE – NOT FOR SALE 1 Press & hold button 2 Pull out card Medication Guide Required: Each time AUSTEDO is dispensed, give the patient the accompanying Medication Guide. 1 tablet dispenser containing 21 tablets in the following order: Week 1: 7 purple tablets containing 6 mg deutetrabenazine Week 2: 14 purple tablets containing 6 mg deutetrabenazine 2 PULL OUT HERE teva image
Overview
AUSTEDO XR extended-release tablets and AUSTEDO tablets are formulated with deutetrabenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor for oral administration. The molecular weight of deutetrabenazine is 323.46; the pKa is 6.31. Deutetrabenazine is a hexahydro-dimethoxybenzoquinolizine derivative and has the following chemical name: ( RR, SS )-1, 3, 4, 6, 7, 11b-hexahydro-9, 10-di(methoxy-d 3 )-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one. The molecular formula for deutetrabenazine is C 19 H 21 D 6 NO 3 . Deutetrabenazine is a racemic mixture containing the following structures: Deutetrabenazine is a white to slightly yellow crystalline powder that is sparingly soluble in water and soluble in ethanol. AUSTEDO XR AUSTEDO XR extended-release tablets contain 6 mg, 12 mg, 18 mg, 24 mg, 30 mg, 36 mg, 42 mg, or 48 mg deutetrabenazine, and the following inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, cellulose acetate, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, magnesium stearate, polyethylene glycol, polyethylene glycol 3350, polyethylene oxide, polyvinyl alcohol, propylene glycol, shellac, sodium chloride, talc, titanium dioxide, and FD&C red #40 lake. The 6 mg, 12 mg, 18 mg, 30 mg, 36 mg, and 42 mg extended-release tablets also contain FD&C yellow #6 lake. The 6 mg, 12 mg, 24 mg, and 36 mg extended-release tablets also contain FD&C blue #2 lake. The 18 mg extended-release tablets also contain carmine. AUSTEDO XR Delivery System Components and Performance AUSTEDO XR uses osmotic pressure to deliver deutetrabenazine at a controlled rate. The delivery system, which resembles a round tablet in appearance, consists of a bilayer core tablet that contains deutetrabenazine along with other excipients. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool. AUSTEDO AUSTEDO tablets contain 6 mg, 9 mg, or 12 mg deutetrabenazine, and the following inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, polysorbate 80, polyvinyl alcohol, povidone, propylene glycol, shellac, talc, titanium dioxide, and FD&C blue #2 lake. The 6 mg tablets also contain FD&C red #40 lake. The 12 mg tablets also contain FD&C yellow #6 lake. chemical-structure.jpg
Indications & Usage
AUSTEDO XR ® and AUSTEDO ® are indicated in adults for the treatment of: chorea associated with Huntington’s disease [see Clinical Studies ( 14.1 )] tardive dyskinesia [see Clinical Studies ( 14.2 )] AUSTEDO XR and AUSTEDO are vesicular monoamine transporter 2 (VMAT2) inhibitors indicated in adults for the treatment of: Chorea associated with Huntington’s disease ( 1 ) Tardive dyskinesia ( 1 )
Dosage & Administration
AUSTEDO XR AUSTEDO Recommended Starting Dosage 12 mg once daily (12 mg per day) 6 mg twice daily (12 mg per day) Titrate at weekly intervals by 6 mg per day based on reduction of chorea or tardive dyskinesia, and tolerability, up to a maximum recommended daily dosage of 48 mg ( 2.1 ) Administer AUSTEDO XR with or without food in once-daily doses ( 2.1 ) Administer AUSTEDO with food and administer total daily dosages of 12 mg or above in two divided doses ( 2.1 ) Swallow tablets whole; do not chew, crush, or break ( 2.1 ) If switching patients from tetrabenazine, discontinue tetrabenazine and initiate AUSTEDO XR or AUSTEDO the following day. See full prescribing information for recommended conversion table ( 2.2 ) Maximum recommended dosage of AUSTEDO XR or AUSTEDO in poor CYP2D6 metabolizers is 36 mg per day ( 2.4 , 8.7 ) 2.1 Dosing Information The dose of AUSTEDO XR and AUSTEDO is determined individually for each patient based on reduction of chorea or tardive dyskinesia and tolerability. Table 1 displays the recommended dosage and important administration instructions of AUSTEDO XR and AUSTEDO when first prescribed to patients who are not being switched from tetrabenazine (a related VMAT2 inhibitor). Table 1: Recommended Dosage and Important Administration Instructions for AUSTEDO XR and AUSTEDO AUSTEDO XR extended-release tablet AUSTEDO tablet Recommended Starting Dosage 12 mg once daily (12 mg per day) 6 mg twice daily (12 mg per day) Recommended Dose Titration The dosage of AUSTEDO XR or AUSTEDO may be increased at weekly intervals in increments of 6 mg per day based on reduction of chorea or tardive dyskinesia, and tolerability, up to a maximum recommended daily dosage of 48 mg [see Clinical Trials ( 14.1 , 14.2 )] . Important Administration Instructions Administer AUSTEDO XR with or without food [see Clinical Pharmacology ( 12.3 )] . Swallow AUSTEDO XR whole. Do not chew, crush, or break tablets. Administer AUSTEDO XR once daily. Administer AUSTEDO with food [see Clinical Pharmacology ( 12.3 )] . Swallow AUSTEDO whole. Do not chew, crush, or break tablets. Administer AUSTEDO total daily dosages of 12 mg or above in two divided doses. Switching Between AUSTEDO and AUSTEDO XR When switching between AUSTEDO tablets (twice daily) and AUSTEDO XR extended-release tablets (once daily), switch to the same total daily dosage. 2.2 Switching Patients from Tetrabenazine to AUSTEDO XR or AUSTEDO Discontinue tetrabenazine and initiate AUSTEDO XR or AUSTEDO the following day. The recommended initial dosing regimen of AUSTEDO XR or AUSTEDO in patients switching from tetrabenazine to AUSTEDO XR or AUSTEDO is shown in Table 2. Table 2: Recommended Initial Dosing Regimen when Switching from Tetrabenazine to AUSTEDO XR or AUSTEDO Current tetrabenazine daily dosage Initial regimen of AUSTEDO XR extended-release tablet Initial regimen of AUSTEDO tablet 12.5 mg 6 mg once daily 6 mg once daily 25 mg 12 mg once daily 6 mg twice daily 37.5 mg 18 mg once daily 9 mg twice daily 50 mg 24 mg once daily 12 mg twice daily 62.5 mg 30 mg once daily 15 mg twice daily 75 mg 36 mg once daily 18 mg twice daily 87.5 mg 42 mg once daily 21 mg twice daily 100 mg 48 mg once daily 24 mg twice daily After patients are switched to AUSTEDO XR or AUSTEDO, the dose may be adjusted at weekly intervals [see Dosage and Administration ( 2.1 )] . 2.3 Dosage Adjustment with Strong CYP2D6 Inhibitors In patients receiving strong CYP2D6 inhibitors, the total daily dosage of AUSTEDO XR or AUSTEDO should not exceed 36 mg [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 )] . 2.4 Dosage Adjustment in Poor CYP2D6 Metabolizers In patients who are poor CYP2D6 metabolizers, the total daily dosage of AUSTEDO XR or AUSTEDO should not exceed 36 mg [see Use in Specific Populations ( 8.7 )]. 2.5 Discontinuation and Interruption of Treatment Treatment with AUSTEDO XR or AUSTEDO can be discontinued without tapering. Following treatment interruption of greater than one week, AUSTEDO XR or AUSTEDO therapy should be re-titrated when resumed. For treatment interruption of less than one week, treatment can be resumed at the previous maintenance dose without titration.
Warnings & Precautions
QT Prolongation: Avoid use in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval ( 5.3 ) Neuroleptic Malignant Syndrome (NMS): Discontinue if this occurs ( 5.4 ) Akathisia, agitation, restlessness, and parkinsonism: Reduce dose or discontinue if this occurs ( 5.5 , 5.6 ) Sedation/somnolence: May impair the patient’s ability to drive or operate complex machinery ( 5.7 ) 5.1 Depression and Suicidality in Patients with Huntington’s Disease Patients with Huntington’s disease are at increased risk for depression, and suicidal ideation or behaviors (suicidality). AUSTEDO XR and AUSTEDO may increase the risk for suicidality in patients with Huntington’s disease. In a 12-week, double-blind, placebo-controlled trial, suicidal ideation was reported by 2% of patients treated with AUSTEDO, compared to no patients on placebo; no suicide attempts and no completed suicides were reported. Depression was reported by 4% of patients treated with AUSTEDO. When considering the use of AUSTEDO XR or AUSTEDO, the risk of suicidality should be balanced against the need for treatment of chorea. All patients treated with AUSTEDO XR or AUSTEDO should be observed for new or worsening depression or suicidality. If depression or suicidality does not resolve, consider discontinuing treatment with AUSTEDO XR or AUSTEDO. Patients, their caregivers, and families should be informed of the risks of depression, worsening depression, and suicidality associated with AUSTEDO XR and AUSTEDO, and should be instructed to report behaviors of concern promptly to the treating physician. Patients with Huntington’s disease who express suicidal ideation should be evaluated immediately. 5.2 Clinical Worsening and Adverse Events in Patients with Huntington’s Disease Huntington’s disease is a progressive disorder characterized by changes in mood, cognition, chorea, rigidity, and functional capacity over time. VMAT2 inhibitors, including AUSTEDO XR and AUSTEDO, may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO XR or AUSTEDO in their patients by assessing the effect on chorea and possible adverse effects, including sedation/somnolence, depression and suicidality, parkinsonism, akathisia, restlessness, and cognitive decline. It may be difficult to distinguish between adverse reactions and progression of the underlying disease; decreasing the dose or stopping the drug may help the clinician to distinguish between the two possibilities. In some patients, the underlying chorea itself may improve over time, decreasing the need for AUSTEDO XR or AUSTEDO. 5.3 QTc Prolongation AUSTEDO XR and AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO XR or AUSTEDO is administered within the recommended dosage range [see Clinical Pharmacology (12.2)] . AUSTEDO XR and AUSTEDO should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias. Certain circumstances may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including (1) bradycardia; (2) hypokalemia or hypomagnesemia; (3) concomitant use of other drugs that prolong the QTc interval; and (4) presence of congenital prolongation of the QT interval. 5.4 Neuroleptic Malignant Syndrome (NMS) A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with drugs that reduce dopaminergic transmission. While NMS has not been observed in patients receiving AUSTEDO XR or AUSTEDO, it has been observed in patients receiving tetrabenazine (a closely related VMAT2 inhibitor). Clinicians should be alerted to the signs and symptoms associated with NMS. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatinine phosphokinase, myoglobinuria, rhabdomyolysis, and acute renal failure. The diagnosis of NMS can be complicated; other serious medical illness (e.g., pneumonia, systemic infection) and untreated or inadequately treated extrapyramidal disorders can present with similar signs and symptoms. Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system pathology. The management of NMS should include (1) immediate discontinuation of AUSTEDO XR and AUSTEDO; (2) intensive symptomatic treatment and medical monitoring; and (3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for NMS. Recurrence of NMS has been reported with resumption of drug therapy. If treatment with AUSTEDO XR or AUSTEDO is needed after recovery from NMS, patients should be monitored for signs of recurrence. 5.5 Akathisia, Agitation, and Restlessness AUSTEDO XR and AUSTEDO may increase the risk of akathisia, agitation, and restlessness in patients with Huntington’s disease and tardive dyskinesia. In a 12-week, double-blind, placebo-controlled trial in patients with Huntington’s disease, akathisia, agitation, or restlessness was reported by 4% of patients treated with AUSTEDO, compared to 2% of patients on placebo; in patients with tardive dyskinesia, 2% of patients treated with AUSTEDO and 1% of patients on placebo experienced these events. Patients receiving AUSTEDO XR or AUSTEDO should be monitored for signs and symptoms of restlessness and agitation, as these may be indicators of developing akathisia. If a patient develops akathisia during treatment with AUSTEDO XR or AUSTEDO, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy. 5.6 Parkinsonism AUSTEDO XR and AUSTEDO may cause parkinsonism in patients with Huntington’s disease or tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. Because rigidity can develop as part of the underlying disease process in Huntington’s disease, it may be difficult to distinguish between potential drug-induced parkinsonism and progression of underlying Huntington’s disease. Drug-induced parkinsonism has the potential to cause more functional disability than untreated chorea for some patients with Huntington’s disease. Postmarketing cases of parkinsonism in patients treated with AUSTEDO for tardive dyskinesia have been reported. Signs and symptoms in reported cases have included bradykinesia, gait disturbances, which led to falls in some cases, and the emergence or worsening of tremor. In most cases, the development of parkinsonism occurred within the first two weeks after starting or increasing the dose of AUSTEDO. In cases in which follow-up clinical information was available, parkinsonism was reported to resolve following discontinuation of AUSTEDO therapy. If a patient develops parkinsonism during treatment with AUSTEDO XR or AUSTEDO, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy. 5.7 Sedation and Somnolence Sedation is a common dose-limiting adverse reaction of AUSTEDO XR and AUSTEDO. In a 12-week, double-blind, placebo-controlled trial examining patients with Huntington’s disease, 11% of AUSTEDO-treated patients reported somnolence compared with 4% of patients on placebo and 9% of AUSTEDO-treated patients reported fatigue compared with 4% of placebo-treated patients. Patients should not perform activities requiring mental alertness to maintain the safety of themselves or others, such as operating a motor vehicle or operating hazardous machinery, until they are on a maintenance dose of AUSTEDO XR or AUSTEDO and know how the drug affects them. 5.8 Hyperprolactinemia Serum prolactin levels were not evaluated in the AUSTEDO XR and AUSTEDO development program. Tetrabenazine, a closely related VMAT2 inhibitor, elevates serum prolactin concentrations in humans. Following administration of 25 mg of tetrabenazine to healthy volunteers, peak plasma prolactin levels increased 4- to 5-fold. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin-dependent in vitro , a factor of potential importance if AUSTEDO XR or AUSTEDO is being considered for a patient with previously detected breast cancer. Although amenorrhea, galactorrhea, gynecomastia, and impotence can be caused by elevated serum prolactin concentrations, the clinical significance of elevated serum prolactin concentrations for most patients is unknown. Chronic increase in serum prolactin levels (although not evaluated in the AUSTEDO XR, AUSTEDO, or tetrabenazine development programs) has been associated with low levels of estrogen and increased risk of osteoporosis. If there is a clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing should be done and consideration should be given to discontinuation of AUSTEDO XR and AUSTEDO. 5.9 Binding to Melanin-Containing Tissues Since deutetrabenazine or its metabolites bind to melanin-containing tissues, it could accumulate in these tissues over time. This raises the possibility that AUSTEDO XR and AUSTEDO may cause toxicity in these tissues after extended use. Neither ophthalmologic nor microscopic examination of the eye has been conducted in the chronic toxicity studies in a pigmented species such as dogs. Ophthalmologic monitoring in humans was inadequate to exclude the possibility of injury occurring after long-term exposure. The clinical relevance of deutetrabenazine’s binding to melanin-containing tissues is unknown. Although there are no specific recommendations for periodic ophthalmologic monitoring, prescribers should be aware of the possibility of long-term ophthalmologic effects [see Clinical Pharmacology ( 12.2 )].
Boxed Warning
DEPRESSION AND SUICIDALITY IN PATIENTS WITH HUNTINGTON’S DISEASE AUSTEDO XR and AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyone considering the use of AUSTEDO XR or AUSTEDO must balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Patients, their caregivers, and families should be informed of the risk of depression and suicidality and should be instructed to report behaviors of concern promptly to the treating physician. Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in Huntington’s disease. AUSTEDO XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. WARNING: DEPRESSION AND SUICIDALITY IN PATIENTS WITH HUNTINGTON’S DISEASE See full prescribing information for complete boxed warning. Increases the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease ( 5.1 ) Balance risks of depression and suicidality with the clinical need for treatment of chorea when considering the use of AUSTEDO XR or AUSTEDO ( 5.1 ) Monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior ( 5.1 ) Inform patients, caregivers, and families of the risk of depression and suicidality and instruct to report behaviors of concern promptly to the treating physician ( 5.1 ) Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation ( 5.1 ) AUSTEDO XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression ( 4 , 5.1 )
Contraindications
AUSTEDO XR and AUSTEDO are contraindicated in patients: With Huntington’s disease who are suicidal, or have untreated or inadequately treated depression [see Warnings and Precautions ( 5.1 )] . With hepatic impairment [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )] . Taking reserpine. At least 20 days should elapse after stopping reserpine before starting AUSTEDO XR or AUSTEDO [see Drug Interactions ( 7.2 )] . Taking monoamine oxidase inhibitors (MAOIs). AUSTEDO XR and AUSTEDO should not be used in combination with an MAOI, or within 14 days of discontinuing therapy with an MAOI [see Drug Interactions ( 7.3 )] . Taking tetrabenazine or valbenazine [see Drug Interactions ( 7.6 )] . Suicidal, or untreated/inadequately treated depression in patients with Huntington’s disease ( 4 , 5.1 ) Hepatic impairment ( 4 , 8.6 , 12.3 ) Taking reserpine, MAOIs, tetrabenazine, or valbenazine ( 4 , 7.2 , 7.3 , 7.6 )
Adverse Reactions
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Depression and Suicidality in Patients with Huntington’s disease [see Warnings and Precautions ( 5.1 )] QTc Prolongation [see Warnings and Precautions ( 5.3 )] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions ( 5.4 )] Akathisia, Agitation, and Restlessness [see Warnings and Precautions ( 5.5 )] Parkinsonism [see Warnings and Precautions ( 5.6 )] Sedation and Somnolence [see Warnings and Precautions ( 5.7 )] Hyperprolactinemia [see Warnings and Precautions ( 5.8 )] Binding to Melanin-Containing Tissues [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (>8% of AUSTEDO-treated patients with Huntington’s disease and greater than placebo): somnolence, diarrhea, dry mouth, and fatigue ( 6.1 ) Most common adverse reactions (that occurred in 4% of AUSTEDO-treated patients with tardive dyskinesia and greater than placebo): nasopharyngitis and insomnia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 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. The studies described below were conducted with AUSTEDO tablets; adverse reactions with AUSTEDO XR extended-release tablets are expected to be similar to AUSTEDO tablets. Patients with Huntington’s Disease Study 1 [see Clinical Studies ( 14.1 )] was a randomized, 12-week, placebo-controlled study in patients with chorea associated with Huntington’s disease. A total of 45 patients received AUSTEDO, and 45 patients received placebo. Patients ranged in age between 23 and 74 years (mean 54 years); 56% were male, and 92% were Caucasian. The most common adverse reactions occurring in greater than 8% of AUSTEDO-treated patients were somnolence, diarrhea, dry mouth, and fatigue. Adverse reactions occurring in 4% or more of patients treated with AUSTEDO, and with a greater incidence than in patients on placebo, are summarized in Table 3. Table 3: Adverse Reactions in Patients with Huntington's Disease (Study 1) Experienced by at Least 4% of Patients on AUSTEDO and with a Greater Incidence than on Placebo Adverse Reaction AUSTEDO (N = 45) % Placebo (N = 45) % Somnolence 11 4 Diarrhea 9 0 Dry mouth 9 7 Fatigue 9 4 Urinary tract infection 7 2 Insomnia 7 4 Anxiety 4 2 Constipation 4 2 Contusion 4 2 One or more adverse reactions resulted in a reduction of the dose of study medication in 7% of patients in Study 1. The most common adverse reaction resulting in dose reduction in patients receiving AUSTEDO was dizziness (4%). Agitation led to discontinuation in 2% of patients treated with AUSTEDO in Study 1. Patients with Tardive Dyskinesia The data described below reflect 410 tardive dyskinesia patients participating in clinical trials. AUSTEDO was studied primarily in two 12-week, placebo-controlled trials (fixed dose, dose escalation) [see Clinical Studies ( 14.2 )] . The population was 18 to 80 years of age, and had tardive dyskinesia and had concurrent diagnoses of mood disorder (33%) or schizophrenia/schizoaffective disorder (63%). In these studies, AUSTEDO was administered in doses ranging from 12-48 mg per day. All patients continued on previous stable regimens of antipsychotics; 71% and 14% respective atypical and typical antipsychotic medications at study entry. The most common adverse reactions occurring in greater than 3% of AUSTEDO-treated patients and greater than placebo were nasopharyngitis and insomnia. The adverse reactions occurring in >2% or more patients treated with AUSTEDO (12-48 mg per day) and greater than in placebo patients in two double-blind, placebo-controlled studies in patients with tardive dyskinesia (Study 1 and Study 2) are summarized in Table 4. Table 4: Adverse Reactions in 2 Placebo-Controlled Tardive Dyskinesia Studies (Study 1 and Study 2) of 12-week Treatment on AUSTEDO Reported in at Least 2% of Patients and Greater than Placebo Adverse Reaction AUSTEDO (N=279) (%) Placebo (N=131) (%) Nasopharyngitis 4 2 Insomnia 4 1 Depression/ Dysthymic disorder 2 1 Akathisia/Agitation/Restlessness 2 1 One or more adverse reactions resulted in a reduction of the dose of study medication in 4% of AUSTEDO-treated patients and in 2% of placebo-treated patients.
Drug Interactions
Concomitant use of strong CYP2D6 inhibitors: Maximum recommended dose of AUSTEDO XR or AUSTEDO is 36 mg per day ( 2.3 , 7.1 ) Alcohol or other sedating drugs: May have additive sedation and somnolence ( 7.5 ) 7.1 Strong CYP2D6 Inhibitors A reduction in AUSTEDO XR or AUSTEDO dose may be necessary when adding a strong CYP2D6 inhibitor in patients maintained on a stable dose of AUSTEDO XR or AUSTEDO. Concomitant use of strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine, bupropion) has been shown to increase the systemic exposure to the active dihydro-metabolites of deutetrabenazine by approximately 3-fold. The daily dose of AUSTEDO XR or AUSTEDO should not exceed 36 mg per day in patients taking strong CYP2D6 inhibitors [see Dosage and Administration ( 2.3 ) and Clinical Pharmacology ( 12.3 )]. 7.2 Reserpine Reserpine binds irreversibly to VMAT2 and the duration of its effect is several days. Prescribers should wait for chorea or dyskinesia to reemerge before administering AUSTEDO XR or AUSTEDO to help reduce the risk of overdosage and major depletion of serotonin and norepinephrine in the central nervous system. At least 20 days should elapse after stopping reserpine before starting AUSTEDO XR or AUSTEDO. AUSTEDO XR and AUSTEDO should not be used concomitantly with reserpine [see Contraindications ( 4 )] . 7.3 Monoamine Oxidase Inhibitors (MAOIs) AUSTEDO XR and AUSTEDO are contraindicated in patients taking MAOIs. AUSTEDO XR and AUSTEDO should not be used in combination with an MAOI, or within 14 days of discontinuing therapy with an MAOI [see Contraindications ( 4 )] . 7.4 Neuroleptic Drugs The risk of parkinsonism, NMS, and akathisia may be increased by concomitant use of AUSTEDO XR or AUSTEDO with dopamine antagonists or antipsychotics. 7.5 Alcohol or Other Sedating Drugs Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence [see Warnings and Precautions ( 5.7 )]. 7.6 Concomitant Tetrabenazine or Valbenazine AUSTEDO XR and AUSTEDO are contraindicated in patients currently taking tetrabenazine or valbenazine. AUSTEDO XR or AUSTEDO may be initiated the day following discontinuation of tetrabenazine [see Dosage and Administration ( 2.2 )].
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