IMPORTANT SAFETY INFORMATION

INDICATION

• LYVISPAH^™ (baclofen) oral granules 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.
• LYVISPAH may also be of some value in patients with spinal cord injuries and other spinal cord diseases.

Limitations of Use:
LYVISPAH is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

Contraindication
LYVISPAH is contraindicated in patients with hypersensitivity to baclofen.

Warnings and Precautions

• Abrupt discontinuation of baclofen, regardless of the cause, has resulted in adverse reactions that include hallucinations, seizures, high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death. Therefore, reduce the dosage slowly when LYVISPAH is discontinued, unless the clinical situation justifies a rapid withdrawal.
• Neonatal withdrawal can occur; gradually reduce the dosage and discontinue LYVISPAH before delivery.
• LYVISPAH can cause drowsiness and sedation. Patients should avoid the operation of automobiles or other dangerous machinery until they know how the drug affects them. Advise patients that the central nervous system effects of LYVISPAH may be additive to those of alcohol and other CNS depressants.
• LYVISPAH can cause exacerbation of the following: psychotic disorders, schizophrenia, or confusional states; autonomic dysreflexia; epilepsy. Use with caution in patients with these conditions.
• LYVISPAH should be used with caution in patients who have had a stroke.

Adverse Reactions

• The most common adverse reactions (>1%) in patients treated with baclofen for spasticity are drowsiness, dizziness, weakness, nausea, confusion, hypotension, headache, insomnia, constipation, urinary frequency, and fatigue.

Drug Interactions

• LYVISPAH can cause CNS depression, including drowsiness and sedation, which may be an additive when used concomitantly with other CNS depressants or alcohol.

Use in Specific Populations

• Pregnancy: There are no adequate data on the developmental risks associated with the use of LYVISPAH in pregnant women. LYVISPAH should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Lactation: Nursing mothers should exercise caution, as oral baclofen has been shown to pass into milk at therapeutic doses. Withdrawal symptoms can occur in breastfed infants when maternal administration of LYVISPAH is stopped, or when breastfeeding is stopped.
• Pediatrics: Safety and effectiveness in pediatric patients below the age of 12 have not been established.
• Elderly Patients: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease of other drug therapy.
• Renal Impairment: Because baclofen is primarily excreted unchanged through the kidneys, LYVISPAH should be given with caution to patients with renal impairment, and it may be necessary to reduce the dosage.

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For more information, refer to LYVISPAH full Prescribing Information.

Reference: 1. Office of Clinical Pharmacology Review (Lyvispah^®). NDA number 215422. EDR: \\CDSESUB1\evsprod\NDA215422\ 0001. Submission date 1/22/2021. Submission type: Original NDA (505(b)(2)).