Diroximel fumarate

Generic name: Diroximel Fumarate
Brand names: Vumerity
Dosage form: oral delayed release capsule (231 mg)
Drug class: Selective immunosuppressants

Usage of Diroximel fumarate

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

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

Diroximel fumarate side effects

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

Diroximel fumarate 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:

  • 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, cough, shortness of breath, headache, neck stiffness, increased sensitivity to light, nausea, vomiting; 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 diroximel fumarate may include:

  • indigestion, nausea, vomiting, stomach pain;
  • skin rash, itching, or redness;
  • diarrhea; or
  • flushing (sudden warmth, redness, or tingly feeling).
  • 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.

    Before taking Diroximel fumarate

    You should not use this medicine if:

  • you have had a severe allergic reaction to diroximel fumarate or dimethyl fumarate (Tecfidera); or
  • you also use dimethyl fumarate.
  • Tell your doctor if you have ever had:

  • liver disease;
  • kidney disease;
  • infections; or
  • low white blood cell (WBC) counts.
  • Tell your doctor if you are pregnant or breastfeeding.

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

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    How to use Diroximel fumarate

    Usual Adult Dose for Multiple Sclerosis:

    Initial dose: 231 mg orally twice a day for 7 daysMaintenance dose: 462 mg orally twice a dayUse: For the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease

    Warnings

    You should not use diroximel fumarate if you have had a severe allergic reaction to diroximel fumarate, or if you also use dimethyl fumarate (Tecfidera).

    What other drugs will affect Diroximel fumarate

    Other drugs may affect diroximel fumarate, 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.

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