What is LYVISPAH?

• LYVISPAH is a prescription medicine used to treat muscle stiffness, spasms, and pain from multiple sclerosis.
• LYVISPAH may be used to treat people with spinal cord injuries and other spinal cord diseases.
• LYVISPAH should not be used to treat muscle spasms from inflammatory (rheumatic) disorders.
• It is not known if LYVISPAH is safe and effective in children under 12 years of age.

Do not take LYVISPAH if you:

• are allergic to baclofen. See the end of this Patient Information leaflet for a complete list of ingredients in LYVISPAH.

Before taking LYVISPAH, tell your healthcare provider about all of your medical conditions, including if you:

• take certain medicines that cause drowsiness.
• have had a stroke.
• are being treated for mental illness, especially a psychotic disorder, schizophrenia, or other illness that may cause you to become confused.
• have or have had high blood pressure.
• have or have had seizures.
• have kidney problems.
• have problems with posture and balance.
• have a history of ovarian cysts
• drink alcohol.
• are pregnant or plan to become pregnant. It is not known if LYVISPAH will harm your unborn baby.
• are breastfeeding or plan to breastfeed. LYVISPAH can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take LYVISPAH.

Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements.

How should I take LYVISPAH?
See the “Instructions for Use” at the end of this Patient Information leaflet for instructions on how to take or give LYVISPAH.

• Take LYVISPAH exactly as your healthcare provider tells you to.
• Your healthcare provider will start you on a low dose of LYVISPAH and slowly increase your dose as needed.
• LYVISPAH can be taken the following different ways:
  • LYVISPAH granules can be emptied into the mouth. You can let the granules dissolve in your mouth or you can swallow them. LYVISPAH can be taken with or without liquids or with soft foods.
  • LYVISPAH granules from a packet can be mixed with a tablespoonful of liquid or soft foods like apple sauce, yogurt, or pudding. Take LYVISPAH within 2 hours of mixing.
  • LYVISPAH can be given through feeding tubes.

  See the Instructions for Use for more information.

• Do not stop taking LYVISPAH without talking to your healthcare provider first. Stopping LYVISPAH suddenly can cause serious problems such as severe muscle spasms, organ failure, and death. See “What are the possible side effects of LYVISPAH?”.

What should I avoid while taking LYVISPAH?

• Do not drive, operate dangerous machinery, or do any other dangerous activities until you know how LYVISPAH affects you. LYVISPAH can make you drowsy and less alert when you first start taking LYVISPAH and when your LYVISPAH dose is increased.

What are the possible side effects of LYVISPAH?

LYVISPAH can cause serious side effects, including:

• risk of symptoms from stopping LYVISPAH. Stopping LYVISPAH suddenly can cause severe muscle problems, organ failure, and death. Early symptoms include increased muscle stiffness, itching, and tingling in hands and feet. Other symptoms include seeing or hearing things that are not there (hallucinations), seizures, high fever, and confusion (altered mental status). Your healthcare provider will slowly reduce your dose of LYVISPAH when stopping treatment.
• withdrawal symptoms in infants (Neonatal Withdrawal Symptoms). LYVISPAH can cause withdrawal symptoms in infants after delivery. Symptoms of withdrawal of LYVISPAH in infants include stiffness in arms or legs, tremor, jitteriness, and seizure.
• drowsiness and sedation. If you take certain medicines or drink alcohol while taking LYVISPAH, your drowsiness may get worse. See “What should I avoid while taking LYVISPAH?” and “Before taking LYVISPAH, tell your healthcare provider about all of your medical conditions, including if you:”.
• decreased effectiveness. People who have had a stroke may not respond to or tolerate baclofen, the active ingredient in LYVISPAH.
• increase in symptoms of mental illness especially in people with psychotic disorders, schizophrenia, or other illness that may cause you to become confused.
• sudden increase in high blood pressure (autonomic dysreflexia).
• decrease in seizure control. People who have seizures (epilepsy) may have seizures more often than normal.
• changes in posture and balance. People who take LYVISPAH may have more problems standing or sitting up straight (posture) and keeping their balance.
• fluid filled sac on ovary (ovarian cysts). People may be at increased risk of developing ovarian cysts while taking LYVISPAH.

The most common side effects of LYVISPAH include drowsiness, dizziness, and weakness.

These are not all the side effects of LYVISPAH. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or Saol Therapeutics at 1-833-644-4216.

How should I store LYVISPAH?
Store LYVISPAH at room temperature between 68°F to 77°F (20°C to 25°C).

General information about the safe and effective use of LYVISPAH.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use LYVISPAH for a condition for which it was not prescribed. Do not give LYVISPAH to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about LYVISPAH that is written for health professionals.

What are the ingredients in LYVISPAH?

Active ingredient: baclofen

Inactive ingredients: amino methacrylate copolymer, calcium stearate, colloidal silicon dioxide, crospovidone, hypromellose, mannitol, saccharin sodium, strawberry flavor, talc, and xylitol.