FLEQSUVY

FLEQSUVY (baclofen oral suspension) is a gamma-aminobutyric acid (GABA-ergic) agonist available as 25 mg per 5 mL (5 mg/mL) suspension for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is: Molecular formula is C 10 H 12 C1NO 2 . Molecular Weight is 213.66 g/mol. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. The FLEQSUVY (baclofen oral suspension) inactive ingredients are: artificial grape flavor, citric acid anhydrous, D&C yellow No. 10, FD&C red No. 40, hydroxyethyl cellulose, propylene glycol, purified water, simethicone emulsion, sodium benzoate, and sucralose. Structural Formula

FLEQSUVY is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. FLEQSUVY may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use FLEQSUVY is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. FLEQSUVY is a gamma-aminobutyric acid (GABA-ergic) agonist indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. ( 1 ) FLEQSUVY may also be of some value in patients with spinal cord injuries and other spinal cord diseases. ( 1 ) Limitations of Use FLEQSUVY is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. ( 1 )

FLEQSUVY is a concentrated formulation. Verify the dose of the product prior to dispensing. ( 2.1 ) Initiate FLEQSUVY with a low dosage, preferably in divided doses, administered orally. Increase gradually based on clinical response and tolerability. ( 2.2 ) The maximum dosage is 80 mg daily (20 mg four times a day). ( 2.2 ) When discontinuing, reduce the dosage slowly. ( 2.3 ) 2.1 Important Information FLEQSUVY is a concentrated formulation. Verify the strength and the dose of the product prior to prescribing, dispensing, and administering. 2.2 Recommended Dosage Initiate FLEQSUVY with a low dosage, preferably in divided doses, administered orally. The following gradually increasing dosage regimen is suggested, but should be adjusted based on clinical response and tolerability: 1 mL (5 mg) three times a day for three days 2 mL (10 mg) three times a day for three days 3 mL (15 mg) three times a day for three days 4 mL (20 mg) three times a day for three days Additional increases may be necessary up to the maximum recommended dosage of 80 mg daily [4 mL (20 mg) four times a day]. 2.3 Administration Instructions Shake well FLEQSUVY oral suspension before administration. Discard unused portion 2 months after first opening. A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device. Nasogastric Tube Administration FLEQSUVY can be administered via a nasogastric (NG) tube at sizes 8 French or larger using the following steps: Ensure the NG feeding tube is flushed with appropriate amount of purified water (15 to 30 mL) prior to administration of FLEQSUVY. Draw the required dose of FLEQSUVY in the appropriate oral or enteral syringe and administer the dose via the feeding tube. The medication may remain in the dosing syringe for up to 4 hours prior to administration. If residual drug remains in the dosing syringe, draw up purified water into the syringe, shake gently, and administer through the feeding tube. Flush the feeding tube with at least 25 mL of purified water. 2.4 Discontinuation of FLEQSUVY When discontinuing FLEQSUVY, reduce the dosage slowly and avoid abrupt withdrawn from the drug to help minimize the risk of adverse reactions [see Warnings and Precautions ( 5.1 )] .

FLEQSUVY is contraindicated in patients with hypersensitivity to baclofen. Hypersensitivity to baclofen ( 4 )

The following clinically significant adverse reactions are described elsewhere in the labeling: Adverse Reactions from Abrupt Withdrawal of FLEQSUVY [see Warnings and Precautions ( 5.1 )] Neonatal Withdrawal Symptoms [see Warnings and Precautions ( 5.2 )] Drowsiness and Sedation [see Warnings and Precautions ( 5.3 )] Poor Tolerability in Stroke Patients [see Warnings and Precautions ( 5.4 )] Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States [see Warnings and Precautions ( 5.5 )] Exacerbation of Autonomic Dysreflexia [see Warnings and Precautions ( 5.6 )] Exacerbation of Epilepsy [see Warnings and Precautions ( 5.7 )] Posture and Balance Effects [see Warnings and Precautions ( 5.8 )] Ovarian Cysts [see Warnings and Precautions ( 5.9 )] The most common (up to 15% or more) adverse reactions in patients were drowsiness, dizziness, and weakness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals at 1-800-461-7449 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 most common adverse reaction is transient drowsiness. In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving baclofen compared to 36% of those in the placebo group. Other common adverse reactions (up to 15%) are dizziness and weakness. Adverse reactions with a frequency of ≥1% are listed in Table 1 . Table 1. Common (≥1%) Adverse Reactions in Patients Treated with Baclofen for Spasticity ADVERSE REACTION PERCENT Drowsiness 10-63% Dizziness 5-15% Weakness 5-15% Nausea 4-12% Confusion 1-11% Hypotension 0-9% Headache 4-8% Insomnia 2-7% Constipation 2-6% Urinary Frequency 2-6% Fatigue 2-4% The following adverse reactions not included in Table 1, classified by body system, were also reported: Neuropsychiatric: euphoria, excitement, depression, hallucinations, paresthesia, muscle pain, tinnitus, slurred speech, coordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizure Cardiovascular: dyspnea, palpitation, chest pain, syncope Gastrointestinal: dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool Genitourinary: enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, hematuria Other: rash, pruritus, ankle edema, excessive perspiration, weight gain, nasal congestion The following laboratory tests have been found to be abnormal in patients receiving baclofen: increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar.

7.1 CNS Depressants and Alcohol FLEQSUVY can cause CNS depression, including drowsiness and sedation, which may be additive when used concomitantly with other CNS depressants or alcohol [see Warnings and Precautions ( 5.3 )] .

16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15° and 30° (59° and 86° F) (see USP Controlled Room Temperature). Discard unused portion 2 months after first opening.