CNS

Myellobiox®

Brand Name:

Myellobiox®

Dosage:

120mg & 240 mg

Generic Name:

Dimethyl fumarate

Pharmacotherapeutic Group:

Immunomodulator(systemic)

Therapeutic Indication:

Myellobiox used in treatment of adult patients with relapsing remitting MS.

Dosage and Administration:

The dose is 120 mg twice a day for the first seven days, after which it is increased to 240 mg twice a day.

Side Effects:

Swallow Dimethyl fumarate capsules whole and intact. Do not crush, chew, or sprinkle capsule contents on food.
Take Dimethyl fumarate with or without food.
Discontinuation of Dimethyl fumarate should be considered for patients unable to tolerate return to the maintenance dose. The incidence of flushing may be reduced by administration of Dimethyl fumarate with food. Alternatively, administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to Dimethyl fumarate dosing may reduce the incidence or severity of flushing .
Obtain a complete blood cell count (CBC) including lymphocyte count before initiation of therapy Dimethyl fumarate can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms have included difficulty breathing, urticaria, and swelling of the throat and tongue. Patients should be instructed to discontinue Dimethyl fumarate and seek immediate medical care should they experience signs and symptoms of anaphylaxis or angioedema.
Pregnancy: Pregnancy Category C. Dimethyl fumarate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dimethyl fumarate is administered to a nursing woman.
Inform patients that progressive multifocal leukoencephalopathy (PML) has occurred in a patient who received Dimethyl fumarate. Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months. Instruct the patient of the importance of contacting their doctor if they develop any symptoms suggestive of PML.
Inform the patient that typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes

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