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

Bafiertam may also be used for purposes not listed in this medication guide.

You should not use Bafiertam if you also use dimethyl fumarate or diroximel fumarate.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Bafiertam.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take Bafiertam with or without food.

When you begin taking Bafiertam you will use a "starter dose" for 7 days, and then you will use a "maintenance dose" as you continue taking the medicine.

Swallow the capsule whole and do not crush, chew, or open it. Do not mix the medicine from a capsule with food.

Bafiertam can cause flushing (a sensation of warmth or tingling under your skin). Your doctor may recommend you take aspirin 30 minutes before taking Bafiertam to help prevent flushing. Take only the type and amount of aspirin your doctor recommends.

Call your doctor if you have signs of infection, such as fever, chills, flu-like-symptoms, or skin sores. Further doses may be delayed until your infection clears up.

You will need frequent medical tests.

Store an unopened bottle of the capsules in a refrigerator, do not freeze.

After opening, store the bottle at room temperature, away from moisture, heat, and light. Keep the capsules in the original bottle. Throw away any unused capsules 3 months after you first opened the bottle.

You should not use Bafiertam if you are allergic to it, or if:

• you are also using dimethyl fumarate or diroximel fumarate.

Tell your doctor if you have ever had:

• low white blood cell (WBC) counts;

• an infection; or

• liver disease.

Tell your doctor if you are pregnant or breastfeeding.

Bafiertam is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Bafiertam may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Also call your doctor at once if you have:

• severe warmth, redness, burning, or itching under your skin;

• liver problems--loss of appetite, stomach pain (upper right side), tiredness, dark urine, jaundice (yellowing of the skin or eyes);

• signs of infection --fever, chills, sweating, mouth sores, headache, confusion, neck stiffness, sensitivity to light, vomiting, severe diarrhea; or

• symptoms of herpes virus--flu-like symptoms, cold sores around your mouth, tingly or painful blistering rash, burning pain in your thigh or lower back.

Common side effects of Bafiertam may include:

• flushing (sudden warmth, redness, or tingly feeling);

• stomach pain, indigestion;

• nausea, vomiting; or

• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect Bafiertam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.