Diroximel Fumarate

Diroximel fumarate is used to treat adults with various forms of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control) including:

• clinically isolated syndrome (CIS; nerve symptom episodes that last at least 24 hours),
• relapsing-remitting forms (course of disease where symptoms flare up from time to time), or
• secondary progressive forms (course of disease where relapses occur more often).

Diroximel fumarate is in a class of medications called Nrf2 activators. It works by decreasing inflammation and preventing nerve damage that may cause symptoms of multiple sclerosis.

Diroximel fumarate comes as a delayed-release (releases the medication in the intestine to prevent breakdown of the medication by stomach acids) capsule to take by mouth. It is usually taken twice daily. Take diroximel fumarate at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take diroximel fumarate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Diroximel fumarate may be taken with or without food. However, do not take it with a high-fat, high-calorie meal or snack; the meal or snack must contain less than 700 calories and less than 30 grams of fat.

Do not drink alcoholic beverages at the same time you take diroximel fumarate.

Swallow the delayed-release capsules whole; do not split, chew, crush, or sprinkle them.

You may take a non-enteric coated aspirin (325 mg or less) 30 minutes before taking diroximel fumarate to reduce the chance of flushing (facial redness) during your treatment.

Your doctor will probably start you on a low dose of diroximel fumarate and increase your dose after 7 days.

Diroximel fumarate may help to control multiple sclerosis, but will not cure it. Continue to take diroximel fumarate even if you feel well. Do not stop taking diroximel fumarate without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking diroximel fumarate,

• tell your doctor and pharmacist if you are allergic to diroximel fumarate, dimethyl fumarate (Tecfidera), any other medications, or any of the ingredients in diroximel fumarate delayed-release capsules. Ask your pharmacist for a list of the ingredients.
• tell your doctor if you are taking dimethyl fumarate (Tecfidera). Your doctor will probably tell you not to take diroximel fumarate if you are taking this medication.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had chickenpox or herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past); ve a low white blood cell count; or liver or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking diroximel fumarate, call your doctor.
• do not have any vaccinations without talking to your doctor.
• you should know that diroximel fumarate may decrease your ability to fight infection from bacteria, viruses, and fungi and increase the risk that you will get a serious infection. Tell your doctor if you often get any type of infection or if you have or think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as herpes or cold sores), and chronic infections that do not go away. If you experience any of the following symptoms during or shortly after your treatment with diroximel fumarate, call your doctor immediately: fever, sweats, or chills, muscle aches, cough, shortness of breath, warm, red, or painful skin or sores on your body, weight loss, diarrhea, stomach pain, frequent, urgent, or painful urination, or other signs of infection.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Diroximel fumarate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• warmth, redness, itching, or burning of the skin
• stomach pain
• diarrhea
• nausea
• vomiting
• heartburn
• hair loss

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• difficulty breathing or swallowing
• hives
• rash
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• weakness on one side of the body, clumsiness in your arms or legs, vision problems, changes in thinking and memory, confusion, or personality changes
• tiredness, loss of appetite, pain on the right side of your stomach, dark urine, or yellowing of skin or eyes
• burning, tingling, itching, or skin sensitivity on one side of the body or face with painful rash or blisters appearing several days later

Diroximel fumarate may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Your doctor may order a blood test before you begin your treatment and may order certain lab tests during your treatment to check your body's response to diroximel fumarate.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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