DIMETHYL FUMARATE kit DIMETHYL FUMARATE capsule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIMETHYL FUMARATE (UNII: FO2303MNI2) (MONOMETHYL FUMARATE - UNII:45IUB1PX8R)

Available from:

Accord Healthcare Inc.

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Dimethyl fumarate delayed-release capsules are contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of dimethyl fumarate delayed-release capsules. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions ( 5.1)]. Risk Summary There are no adequate data on the developmental risk associated with the use of dimethyl fumarate delayed-release capsules in pregnant women. In animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl fumarate (DMF) was administered during pregnancy and lactation at clinically relevant doses [ see Data] . In the U.S. general population, the estimated background risk of majo

Product summary:

Dimethyl fumarate delayed-release capsules are available as hard gelatin delayed-release capsules in two strengths containing either 120 mg or 240 mg of dimethyl fumarate. The 120 mg capsules have a green cap and white body, printed with "HR1" in black ink on capsule body containing white to off-white, round, biconvex enteric coated tablets plain on both the sides. The 240 mg capsules have a green cap and a green body, printed with "HR2" in black ink on capsule body containing white to off-white, round, biconvex enteric coated tablets plain on both the sides. 30-day Starter Pack, (NDC 16729-418-12): Store at 15°C to 30°C (59 to 86°F). Protect the capsules from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIMETHYL FUMARATE- DIMETHYL FUMARATE
DIMETHYL FUMARATE- DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE
ACCORD HEALTHCARE INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIMETHYL FUMARATE
DELAYED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DIMETHYL FUMARATE DELAYED-RELEASE CAPSULES.
DIMETHYL FUMARATE DELAYED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2013
RECENT MAJOR CHANGES
Warnings and Precautions, Lymphopenia ( 5.4) 02/2023
INDICATIONS AND USAGE
Dimethyl fumarate delayed-release capsules are indicated for the
treatment of relapsing forms of multiple
sclerosis (MS), to include clinically isolated syndrome,
relapsing-remitting disease, and active secondary
progressive disease, in adults.( 1)
DOSAGE AND ADMINISTRATION
Starting dose: 120 mg twice a day, orally, for 7 days ( 2.1)
Maintenance dose after 7 days: 240 mg twice a day, orally ( 2.1)
Swallow dimethyl fumarate delayed-release capsules whole and intact.
Do not crush, chew, or sprinkle
capsule contents on food ( 2.1)
Take dimethyl fumarate delayed-release capsules with or without food (
2.1)
DOSAGE FORMS AND STRENGTHS
Delayed-release capsules: 120 mg and 240 mg ( 3)
CONTRAINDICATIONS
Known hypersensitivity to dimethyl fumarate or any of the excipients
of dimethyl fumarate delayed-release
capsules. ( 4)
WARNINGS AND PRECAUTIONS
Anaphylaxis and angioedema: Discontinue and do not restart dimethyl
fumarate delayed-release
capsules if these occur. ( 5.1)
Progressive multifocal leukoencephalopathy (PML): Withhold dimethyl
fumarate delayed-release
capsules at the first sign or symptom suggestive of PML. ( 5.2)
Herpes zoster and other serious opportunistic infections: Consider
withholding dimethyl fumarate
delayed-release capsules in cases of serious infection until the
infection has resolved. ( 5.3)
Lymphopenia: Obtain a CBC including lymphocyte count before initiating
dimethyl fumarate delayed-
release capsules, after 6 months, and every 6 to 12 months