Diroximel Fumarate

Diroximel Fumarate is a prescription medication used for the treatment of relapsing forms of multiple sclerosis (MS).

• Diroximel Fumarate is available under the following different brand names: Vumerity.

Common side effects of Diroximel Fumarate include:

• Indigestion,
• Nausea,
• Vomiting,
• Stomach pain,
• Skin rash,
• Itching,
• Redness,
• Diarrhea, and
• Flushing (sudden warmth, redness, or tingly feeling)

Serious side effects of Diroximel Fumarate include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Problems with speech thought, vision, or muscle movement,
• Loss of appetite,
• Stomach pain (upper right side),
• Tiredness,
• Dark urine,
• Yellowing of the skin or eyes (jaundice),
• Fever,
• Chills,
• Sweating,
• Cough,
• Shortness of breath,
• Headache,
• Neck stiffness,
• Increased sensitivity to light,
• Nausea,
• Vomiting,
• Flu-like symptoms,
• Cold sores around the mouth,
• Tingly or painful blistering rash, and
• Burning in the thigh or lower back

Rare side effects of Diroximel Fumarate include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule, delayed-release

• 231 mg

Multiple Sclerosis

Adult dosage

• Initial: 231 mg orally two times a day
• Maintenance: After 7 days, increase to 462 mg (two 231-mg capsules) orally two times a day
• Unable to tolerate maintenance dose.
• Consider temporarily reducing the dose to 231 mg orally two times a day if the maintenance dose is not tolerated.
• Within 4 weeks, resume dose at 462 mg orally two times a day.
• Consider discontinuing treatment for patients unable to tolerate a return to the maintenance dosage.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Diroximel Fumarate has severe interactions with the following drug:
  • dimethyl Fumarate
• Diroximel Fumarate has serious interactions with the following drugs:
  • axicabtagene ciloleucel
  • brexucabtagene autoleucel
  • ciltacabtagene autoleucel
  • ethanol
  • idecabtagene vicleucel
  • lisocabtagene maraleucel
  • tisagenlecleucel
• Diroximel Fumarate has moderate interactions with the following drugs:
  • isavuconazonium sulfate
  • ozanimod
  • ponesimod
  • siponimod
  • ublituximab
• Diroximel Fumarate has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to diroximel Fumarate, dimethyl Fumarate, or to any of the excipients
• Taking dimethyl Fumarate

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Diroximel Fumarate?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Diroximel Fumarate?”

Cautions

• Anaphylaxis and angioedema may occur; discontinue and do not restart treatment if these occur.
• Progressive multifocal leukoencephalopathy (PML) has occurred; withhold dose at the first sign or symptom suggestive of PML.
• May decrease lymphocyte counts; consider interruption of treatment if lymphocyte counts below 0.5 x109/L persist above 6 months.
• Clinically significant cases of liver injury have been reported; discontinue treatment if clinically significant liver injury induced by diroximel Fumarate is suspected.
• May cause flushing (. g, warmth, redness, itching, burning sensation); administration of dose with food may reduce flushing incidence.
• PML cases have occurred predominantly in patients with lymphocyte counts less than 0.8×109/L persisting for more than 6 months.
• Herpes zoster and opportunistic infections:
  • Serious cases of herpes zoster have occurred in patients treated with dimethyl Fumarate (which has the same active metabolite diroximel Fumarate) including disseminated herpes zoster, herpes zoster ophthalmicus, herpes zoster meningoencephalitis, and herpes zoster meningomyelitis
  • Events may occur at any time during treatment; monitor patients for signs and symptoms of herpes zoster; if herpes zoster occurs, appropriate treatment for herpes zoster should be administered.
  • Other serious opportunistic infections have occurred with dimethyl Fumarate, including cases of serious viral (herpes simplex virus, West Nile virus, cytomegalovirus), fungal (Candida and Aspergillus), and bacterial (Nocardia, Listeria monocytogenes, Mycobacterium tuberculosis) infections.
  • These infections have been reported in patients with reduced absolute lymphocyte counts (ALC) as well as in patients with normal ALC.
  • Infections have affected the brain, meninges, spinal cord, gastrointestinal tract, lungs, skin, eye, and ear; patients with symptoms and signs consistent with these infections should undergo prompt diagnostic evaluation and receive appropriate treatment.
  • Consider withholding treatment in patients with herpes zoster or other serious infections until the infection has resolved.
• Drug interaction overview
  • Concomitant use of dimethyl Fumarate and diroximel Fumarate is contraindicated, as both are metabolized to monomethyl Fumarate; initiate diroximel Fumarate the day following the discontinuation of dimethyl Fumarate.

Pregnancy and Lactation

• No adequate data on the developmental risk associated with the use of dimethyl Fumarate (which has the same active metabolite as diroximel Fumarate) in pregnant women.
• Lactation
  • There are no data on the presence of diroximel Fumarate or metabolites (MMF, 2-hydroxyethyl succinimide [HES]) in human milk.
  • Effects on  breastfed infant and milk production are unknown.