Lyvispah

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.

Who should not take Lyvispah?

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.

Description

LYVISPAH (baclofen) oral granules is a gamma-aminobutyric acid (GABA-ergic) agonist available as 5 mg, 10 mg, or 20 mg of baclofen oral granules in a packet. Its chemical name is 4-amino-3-(4- chlorophenyl)-butanoic acid and its structural formula is:

Molecular formula is C10H12ClNO2

Molecular Weight is 213.66.

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.

LYVISPAH (baclofen) oral granules inactive ingredients include amino methacrylate copolymer, calcium stearate, colloidal silicon dioxide, crospovidone, hypromellose, mannitol, saccharin sodium, strawberry flavor, talc, and xylitol.

 Mechanism of Action

The precise mechanism of action of baclofen is not fully understood. Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level, possibly by decreasing excitatory neurotransmitter release from afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Baclofen is a structural analog of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), and may exert its effects by stimulation of the GABA-β receptor subtype.

What should I tell my healthcare provider before taking 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 “What should I tell my healthcare provider before taking Lyvispah?”.
• 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.

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.

How should I store Lyvispah?

Store Lyvispah at room temperature between 68°F to 77°F (20°C to 25°C).

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.

For more information visit www.lyvispah.com or contact Saol Therapeutics at 1-833-644-4216

Instructions for use for Lyvispah

Lyvispah (lye vis’ pah)
(baclofen)
oral granules

Important information to know before taking Lyvispah

Lyvispah can be taken without liquids.

If needed, Lyvispah can be mixed with liquids or soft foods. Lyvispah should be taken within 2 hours of mixing into liquids or soft foods.

How to take Lyvispah?

Opening Lyvispah

Shake the packet to distribute settled granules to the bottom of the packet. Carefully open the Lyvispah packet by cutting the dotted lines across the top of the packet.

Taking Lyvispah by emptying the granules into the mouth

Empty all the granules in the Lyvispah packet directly into your mouth. The granules will dissolve in your mouth or can be swallowed. After taking Lyvispah, you can drink water if needed to swallow any granules left in your mouth.

Taking Lyvispah with liquids or soft foods

Lyvispah can be taken or given by mouth as a mixture with liquids such as milk or apple juice. Lyvispah can also be taken or given by mouth as a mixture with soft foods such as apple sauce, yogurt, or pudding.

1. Open 1 packet of Lyvispah (see the figure above).
2. Empty the full contents of the Lyvispah packet into 1 tablespoon (15 mL) liquid or soft food and mix it.
3. Take Lyvispah within 2 hours of mixing into liquids or soft foods
4. If more than 1 packet of Lyvispah is needed for your prescribed dose, mix each packet with a separate amount of liquid or soft food.

Giving Lyvispah through a feeding tube

Lyvispah can be given through enteral feeding tubes such as nasogastric (NG), gastrostomy (G), percutaneous endoscopic gastrostomy (PEG), and gastrojejunostomy (GJ) tubes.

1. Flush the feeding tube with up to 1 tablespoon (15 mL) of water using a catheter tip syringe.
2. Open and empty the full contents of 1 packet of Lyvispah into a clean container and mix with 1 tablespoon (15 mL) of liquid (apple juice or milk).
3. Stir the mixture to make sure all the granules are wet.
4. Draw up the mixture of granules into a dosing syringe right away after stirring.
5. Give the dose of Lyvispah through the feeding tube within 2 hours after mixing. If the mixture is in the dosing syringe for 15 minutes and not given, turn the dosing syringe upside down 3 times before you give the dose.
6. Fill the dosing syringe with 1 tablespoon (15 mL) of water and flush the feeding tube.
7. If more than 1 packet of Lyvispah is needed for the prescribed dose, mix each packet with a separate amount of liquid.
8. Throw away (dispose of) any unused mixture.

Important Information

Take the entire packet of Lyvispah to get the prescribed dose. Do not take only part of the medicine. Do not save a portion for later.

Label

PRINCIPAL DISPLAY PANEL – NDC: 70257-412-87 – 5MG CARTON

PRINCIPAL DISPLAY PANEL – NDC: 70257-412-87 – 5MG CONTAINER

PRINCIPAL DISPLAY PANEL – NDC: 70257-414-87 – 10MG CONTAINER