Bafiertam

What is Bafiertam?

Bafiertam is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

It is not known if Bafiertam is safe and effective in children.

Do not take Bafiertam if you:

• have had an allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing) to monomethyl fumarate, dimethyl fumarate, diroximel fumarate, or any of the ingredients. See “What are the ingredients?” for a complete list of ingredients.
• are taking dimethyl fumarate or diroximel fumarate.

What to tell your health provider before taking?

Before taking and while you take Bafiertam, tell your doctor about all of your medical conditions, including if you:

• have liver problems
• have or have had low white blood cell counts or an infection
• are pregnant or plan to become pregnant. It is not known if Bafiertam will harm your unborn baby
• are breastfeeding or plan to breastfeed. It is not known if it passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using.

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

How should I take?

• Take exactly as your doctor tells you to take it.
• You will be given 1 strength of Bafiertam when starting your treatment.
• The recommended starting dose is one 95 mg capsule taken by mouth 2 times a day for 7 days.
• The recommended dose after 7 days is two 95 mg capsules taken by mouth 2 times a day.
• It can be taken with or without food.
• Swallow Bafiertam capsules whole and intact. Do not crush, chew, or mix the contents with food.
• If you take too much, call your doctor or go to the nearest hospital emergency room right away.

What are the possible side effects?

Bafiertam may cause serious side effects including:

• allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing). Stop taking it and get emergency medical help right away if you get any of these symptoms.
• PML (progressive multifocal leukoencephalopathy) a rare brain infection that usually leads to death or severe disability over a period of weeks or months. Tell your doctor right away if you get any of these symptoms of PML:
  • weakness on one side of the body that gets worse
  • clumsiness in your arms or legs
  • vision problems
  • changes in thinking and memory
  • confusion
  • personality changes
• herpes zoster infections (shingles), including central nervous system infections
• other serious infections
• decreases in your white blood cell count Your doctor should do a blood test to check your white blood cell count before you start treatment with Bafiertam and while you are on therapy. You should have blood tests after 6 months of treatment and every 6 to 12 months after that.
• liver problems. Bafiertam may cause serious liver problems that may lead to liver failure, a liver transplant, or death. Your doctor should do blood tests to check your liver function before you start taking Bafiertam and during treatment if needed. Tell your doctor right away if you get any of these symptoms of a liver problem during treatment:
  • severe tiredness
  • loss of appetite
  • pain on the right side of your stomach
  • have dark or brown (tea color) urine
  • yellowing of your skin or the white part of your eyes

The most common side effects of Bafiertam include:

• flushing, redness, itching, or rash
• nausea, vomiting, diarrhea, stomach pain, or indigestion
• Flushing and stomach problems are the most common reactions, especially at the start of treatment, and may decrease over time. Call your doctor if you have any of these symptoms and they bother you or do not go away. Ask your doctor if taking aspirin before taking Bafiertam may reduce flushing.

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Bafiertam

Medicines are sometimes prescribed for purposes other than those listed in this Patient Information. Do not use Bafiertam for a condition for which it was not prescribed. Do not give Bafiertam to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information, talk to your doctor or pharmacist. You can ask your pharmacist or doctor for information about Bafiertam that is written for health professionals.

How should I store?

• Store Bafiertam in the original container.
• Protect the capsules from light.
• Store unopened bottles of Bafiertam in the refrigerator between 35°F to 46°F (2°C to 8°C)
• Store opened bottles of Bafiertam at room temperature between 68°F to 77°F (20°C to 25°C). Bafiertam capsules are good for 3 months after the bottle is opened. Throw away Bafiertam capsules if the bottle has been opened for more than 3 months.
• Capsules may become deformed if kept at high temperatures.
• Keep all medicines out of the reach of children.

What are the ingredients?

Active ingredient: monomethyl fumarate

Inactive ingredients: Glyceryl caprylate/caprate; lactic acid; polyoxyl 40 hydrogenated castor oil; and povidone K30.

The capsule shell, printed with black ink, contains the following inactive ingredients: gelatin; solution of sorbitans and sorbitol; and titanium dioxide.

The coating system includes the following inactive ingredients: colloidal anhydrous silica, GMCC Type 1 mono and di-glycerides, hypromellose type 2910, methacrylic acid and ethyl acrylate copolymer, polyethylene glycol (MW=400), polyvinyl alcohol part hydrolyzed, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate.

For more information see www.BAFIERTAM.com or call 1-800­456-2255.

Source:NLM.