DIMETHYL FUMARATE capsule, delayed release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

DIMETHYL FUMARATE (UNII: FO2303MNI2) (monomethyl fumarate - UNII:45IUB1PX8R)

Commercializzato da:

Dr. Reddy's Laboratories Inc.

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 is 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 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 major birth defects and miscarriage in clinically recognized pregnancies is

Dettagli prodotto:

Dimethyl fumarate is available as hard gelatin delayed-release capsules in two strengths containing either 120 mg or 240 mg of dimethyl fumarate. The 120 mg capsules are white to off white colored enteric coated mini tablets filled in size "0" empty hard gelatin capsule shell with white opaque cap and white opaque body imprinted with "120 mg" with black ink. The 240 mg capsules are white to off white colored enteric coated mini tablets filled in size "0" empty hard gelatin capsule shell with white opaque cap and white opaque body imprinted with "240 mg" with black ink. Dimethyl fumarate delayed-release capsules are available as follows: 120 mg capsules: 240 mg capsules: Store at 15°C to 30°C (59 to 86°F). Protect the capsules from light.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

DIMETHYL FUMARATE- DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE
DR. REDDY'S LABORATORIES 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
INDICATIONS AND USAGE
Dimethyl fumarate is 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 capsule 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 if these occur. (5.1)
Progressive multifocal leukoencephalopathy (PML): Withhold dimethyl
fumarate at the first sign or
symptom suggestive of PML. (5.2)
Herpes zoster and other serious opportunistic infections: Consider
withholding dimethyl fumarate in
cases of serious infection until the infection has resolved. (5.3)
Lymphopenia: Obtain a CBC including lymphocyte count before initiating
dimethyl fumarate, after 6
months, and every 6 to 12 months thereafter. Consider interruption of
dimethyl fumarate if lymphocyte
counts <0.5 x 10 /L persist for more than 6 months. (5.4)
Liver injury: Obtain serum aminotransferase, alkaline phosphatase, and
total bilirubin levels before
initiating