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FLEQSUVYTM is an FDA-approved ready-to-use* oral liquid baclofen that may meet your needs for relief of spasticity from multiple sclerosis, spinal cord injuries and other spinal cord diseases.

*Shake well before taking

ADDITIONAL IMPORTANT SAFETY INFORMATION +
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FLEQSUVYTM (baclofen oral suspension) 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.

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. Discard unused portion 2 months after first opening.

Azurity specializes in providing innovative products that address the specific needs of underserved patient segments, including a broad portfolio of alternative dosage formulations of established FDA-approved products.

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Understanding spasticity

Spasticity in Multiple Sclerosis (MS)

Spasticity is a tightness or stiffness of the muscles that help people to stand and balance in an upright position. These muscles may be in the legs, groin, and buttocks. Some people may have spasticity in their backs.1

Spasticity in MS happens when there is damage to the myelin—the protective coating covering the nerves of the brain and spinal cord. These nerves control movement. Mild spasticity may not be painful. But spasticity can become painful when it is more severe. Spasticity can also make it hard to perform daily activities because of discomfort or difficulty moving.1

Spasticity in Spinal Cord Injury (SCI)

Spasticity in SCI happens when the flow of signals between the brain and spinal cord is broken. In a normal response, information travels from the spinal cord to the brain. The brain receives the signal and sends commands back through the spinal cord to tell the body what to do. A reaction like jerking away from something hot is a reflex, and it happens automatically. In SCI, the signal can’t reach the brain. It goes back to the spinal cord and the reflex is a muscle spasm.2

Symptoms are similar to the symptoms for MS.
They can include2:

  • Sudden bending or straightening of limbs or jerking of muscles
  • Muscle spasms
  • Stiffness or tight muscles at rest or during activity that makes it hard to relax or to control movements

How common is spasticity?

If you have spasticity, you are not alone.

Percent of people in the US with spasticity

Multiple Sclerosis3
Spinal Cord Injury3

Understanding dysphagia

If you have spasticity, you may also have dysphagia—any difficulty in swallowing.4 This may affect swallowing food and also medicine like pills or capsules. Dysphagia may happen in different areas—when you first feel something in your mouth, move it around in your mouth, or actually try to swallow.5

Percent of people in the US with dysphagia

Multiple Sclerosis4
Spinal Cord Injury5

Did you know?

Baclofen has been prescribed as a treatment for spasticity for over 40 years and is a commonly used medicine for treating spasticity in MS.1,6

About FLEQSUVYTM— a liquid form of baclofen

FLEQSUVYTM provides:

Grape flavor

May help with the taste

Flexible dosing

Get the right dose your doctor tells you to take, every time†

Ease in taking your oral liquid

Oral liquid may help you keep taking your medication

Consistent potency

From the first drop to the last

Easy to store

No need to refrigerate or keep cold. Throw away any unused medicine 2 months after 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. Discard unused portion 2 months after first opening.

A different option for taking your medicine

If you need to take medicine for spasticity—and you also have difficulty swallowing pills—a liquid form of baclofen may make it easier for you to take your medicine.

FLEQSUVYTM is a ready-to-use‡
oral liquid suspension, which means no need for:

crushing
compounding

‡Shake well before taking.

Talk to your doctor to see if FLEQSUVYTM may be right for you.

Taking FLEQSUVYTM

FLEQSUVYTM is a liquid form of baclofen. It contains 25 mg per 5 mL—or 5 mg/mL— of baclofen as an orange- to yellow-colored, grape-flavored liquid. Because FLEQSUVYTM is a suspension, you need to shake the bottle thoroughly to make sure all of the baclofen particles are equally spread out throughout the liquid. This will ensure that you are taking the right amount of medication.

  • Your doctor will decide how much FLEQSUVYTM you need to take. FLEQSUVYTM is a medicine where you start at a lower amount and your dose is slowly increased until you take the amount of medicine your doctor tells you to take
  • You can take FLEQSUVYTM with or without food
  • FLEQSUVYTM does not have to be refrigerated or kept cold. Keep FLEQSUVYTM at room temperature
  • You must throw away the bottle 2 months after opening it—even if there is medicine left inside

Tips to help you manage your spasticity

  • Let your doctor know how you are feeling about your spasticity and about your medicine
  • Understanding your condition is important. Work with your doctor to answer any questions or concerns you may have
  • If you don’t understand what the doctor is telling you, say so. You may need more help to understand
  • It is important to take your medicine as your doctor tells you to

Pharmacists can provide useful information and support. They can:

  • Provide a measuring device that you can use to measure your medicine as your doctor tells you to
  • Explain what your medicine is for and answer questions you have on how to take it

Coverage for your medicine doesn’t have to be complicated

For answers to your questions about FLEQSUVYTM financial support, visit azuritysolutions.com.

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  • Eligible patients may pay as little as $0 co-pay
  • Instant co-pay savings at 70,000+ pharmacies
  • Available at most pharmacies within 24 hours and can be accessed by mail

§View Eligibility Restrictions, Terms, and Conditions at azuritysolutions.com.

Resources

Below are organizations that may be able to support you and your family.

National Foundation of Swallowing Disorders

The National Foundation of Swallowing Disorders is a nonprofit, patient-advocacy organization for those impacted by dysphagia. The organization is committed to providing patients hope and helping to improve quality of life for those suffering from all types of swallowing disorders by enhancing direct patient support, education, and research and by raising public, professional, and governmental awareness.

Learn More

Multiple Sclerosis Association of America

The Multiple Sclerosis Association of America (MSAA) is a leading resource for the entire MS community, improving lives today through vital services and support. MSAA is a national, nonprofit organization founded in 1970 and provides ongoing support and direct services to individuals with MS, their families, and their care partners.

Learn More

Can Do Multiple Sclerosis

Can Do Multiple Sclerosis is a national organization that delivers health and wellness education programs on exercise, nutrition, symptom management, and motivation to help families living with multiple sclerosis thrive.

Learn More

MS Focus

The Multiple Sclerosis Foundation, known as MS Focus, provides free services that address the critical needs of people with multiple sclerosis and their families to help them maintain the best quality of life.

Learn More
Fullwidth scrollable Important safety information

Important Safety Information for FLEQSUVYTM (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 prescribing, dispensing, and administering.

Important Safety Information

CONTRAINDICATIONS:

FLEQSUVY is contraindicated in patients with hypersensitivity to baclofen.

WARNINGS AND PRECAUTIONS:

Adverse Reactions from Abrupt Withdrawal of FLEQSUVY: 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 FLEQSUVY is discontinued, unless the clinical situation justifies a rapid withdrawal.

Neonatal Withdrawal Symptoms: Withdrawal symptoms in neonates whose mothers were treated with oral baclofen throughout pregnancy have been reported starting hours to days after delivery. The symptoms of withdrawal in these infants have included increased muscle tone, tremor, jitteriness, and seizure. If the potential benefit justifies the potential risk to the fetus and FLEQSUVY is continued during pregnancy, gradually reduce the dosage and discontinue FLEQSUVY before delivery. If slow withdrawal is not feasible, advise the parents or caregivers of the exposed neonate of the potential for neonatal withdrawal.

Drowsiness and Sedation: Drowsiness and sedation have been reported in up to 63% of patients taking baclofen, the active ingredient in FLEQSUVY. Patients should avoid operation of automobiles or other dangerous machinery and activities made hazardous by decreased alertness when starting FLEQSUVY or increasing the dose until they know how the drug affects them. Advise patients that the central nervous system depressant effects of FLEQSUVY may be additive to those of alcohol and other CNS depressants.

Poor Tolerability in Stroke Patients: FLEQSUVY should be used with caution in patients who have had a stroke. Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug.

Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States: FLEQSUVY should be used with caution in patients suffering from psychotic disorders, schizophrenia, or confusional states. If treated with FLEQSUVY, these patients should be kept under careful surveillance because exacerbations of these conditions have been observed with oral baclofen administration.

Exacerbation of Autonomic Dysreflexia: FLEQSUVY should be used with caution in patients with a history of autonomic dysreflexia. The presence of nociceptive stimuli or abrupt withdrawal of FLEQSUVY may cause an autonomic dysreflexic episode.

Exacerbation of Epilepsy: FLEQSUVY should be used with caution in patients with epilepsy. Deterioration in seizure control has been reported in patients taking baclofen.

Posture and Balance Effects: FLEQSUVY should be used with caution in patients where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain increased function.

Ovarian Cysts: A dose‐related increase in incidence of ovarian cysts was observed in female rats treated chronically with oral baclofen. 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. Ovarian cysts are estimated to occur spontaneously in approximately 1% to 5% of the normal female population.

ADVERSE REACTIONS:

The most common (up to 15% or more) adverse reactions in patients were drowsiness, dizziness, and weakness.

DRUG INTERACTIONS:

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.

USE IN SPECIAL POPULATIONS:

Pregnancy: Based on animal data, may cause fetal harm.

Because baclofen is excreted unchanged through the kidneys it may be necessary to reduce the dosage in patients with impaired renal function.

The Important Safety Information does not include all the information needed to use FLEQSUVY safely and effectively. Visit FLEQSUVY.com for full prescribing information.

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.

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