DIMETHYL FUMARATE- dimethyl fumarate kit DIMETHYL FUMARATE capsule, delayed release

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Lupin Pharmaceuticals, Inc.

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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. 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 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 2-4% an

Descriptif du produit:

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 yellow cap and white body 120 mg capsules are imprinted with circular LU on cap and D76 on body in black ink. The yellow cap and body 240 mg capsules are imprinted with circular LU on cap and D77 on body in black ink. Dimethyl fumarate delayed-release capsules are available as follows: 30-day Starter Pack, (NDC 68180-778-13): 7-day bottle 120 mg capsules, quantity 14 (NDC 68180-776-65) 23-day bottle 240 mg capsules, quantity 46 (NDC 68180-777-48) 120 mg capsules: 7-day bottle of 14 capsules (NDC 68180-776-14) 240 mg capsules: 30-day bottle of 60 capsules (NDC 68180-777-07) Store at 15° to 30°C (59° to 86°F). Protect the capsules from light. Store in original container.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

DIMETHYL FUMARATE - DIMETHYL FUMARATE
DIMETHYL FUMARATE- DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE
LUPIN PHARMACEUTICALS, INC.
----------
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 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 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 six months. (5.4)
Liver injury: Obtain serum aminotransferase, alkaline phosphatase, and
total bilirubin lev