25mg per 5mL (5 mg/mL)
Concentrated Formulation Click for Full Prescribing Information
Important Safety Information for FLEQSUVY® (baclofen oral suspension)
INDICATIONS AND USAGE:
- 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 concentrated formulation. Verify the strength and the dose of the product prior to dispensing and administering. Use an oral dosing syringe and not a household teaspoon to correctly measure the prescribed amount of medication. Oral dosing syringes may be obtained from your pharmacy. Shake well before using.
Important Safety Information
Do not take FLEQSUVY if you have a hypersensitivity to baclofen.
WARNINGS AND PRECAUTIONS:
Sudden withdrawal of FLEQSUVY can result in serious complications that include
hallucinations, seizures, high fever, confusion, muscle stiffness, multiple organ-system failure, and death.
Call your doctor right away if you have any signs of FLEQSUVY withdrawal.
Do not drive or operate heavy machinery after taking your dose of FLEQSUVY until you know how it affects you.
FLEQSUVY may cause drowsiness. Do not operate other dangerous machinery or engage in activities made hazardous by decreased alertness until you know how FLEQSUSVY affects you. Do not increase your dose until advised to do so by your healthcare provider and you know how the drug affects you.
Drowsiness associated with FLEQSUVY can be worsened by alcohol and other CNS depressants.
Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients who were treated with oral baclofen for up to one year. In most cases, these cysts disappeared spontaneously while patients continued to receive the drug.
Before taking FLEQSUVY, tell your healthcare provider if you:
- –have a hypersensitivity to baclofen or any component of FLEQSUVY
- –have or have had a stroke. Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug
- –have or have had seizures, FLEQSUVY can cause a worsening of this condition
- –have or have had history of psychotic disorders, schizophrenia, or confusional states, FLEQSUVY can cause a worsening of these conditions
- –have or have had history of autonomic dysreflexia, FLEQSUVY can cause a worsening of this condition
- –are pregnant, plan to become pregnant, or plan to breastfeed. Withdrawal symptoms in neonates whose mothers were treated with oral baclofen throughout pregnancy have been reported. You and your healthcare provider will decide if you should take FLEQSUVY while you are pregnant
- –have or have had difficulty with balance, or sustaining upright posture
- –have or have had kidney problem or are on hemodialysis
- –have any other medical conditions
Read all medicine labels carefully and tell your healthcare provider about all medicines you take,
including prescription and non-prescription medicines.
Store FLEQSUVY at room temperature and discard unused portion 2 months after first opening.
The most common side effects of FLEQSUVY include
drowsiness, dizziness, and weakness. Tell your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of FLEQSUVY.
The Important Safety Information does not include all the information needed to use FLEQSUVY safely and effectively. Please talk to your healthcare professional and see complete Prescribing Information for Fleqsuvy.
To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
PP-FLE-US-0090