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

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Zydus Pharmaceuticals USA Inc.

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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 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 2% to 4% and 15% to 20%, respect

Přehled produktů:

Dimethyl Fumarate Delayed-release Capsules, 120 mg are hard gelatin, delayed release, size '0' capsules with opaque light green cap printed with '1204' in black ink and opaque white body. The capsules are filled with orange, round, coated tablets and are supplied as follows: 7-day bottle of 14 capsules (NDC 70710-1204-7) Dimethyl Fumarate Delayed-release Capsules, 240 mg are hard gelatin, delayed release, size '0' capsules with opaque light green cap printed with '1205' in black ink and opaque light green body. The capsules are filled with orange, round, coated tablets and are supplied as follows: 23-day bottle of 46 capsules (NDC 70710-1205-8) 30-day bottle of 60 capsules (NDC 70710-1205-6) 30-Day Starter Pack (NDC 70710-1416-3) contains: 7-day bottle of 120 mg capsules with 14 capsules (Starter dose pack) NDC 70710-1204-1 23-day bottle of 240 mg capsules with 46 capsules (Regular dose pack) NDC 70710-1205-2 Store at 15°C to 30°C (59 to 86°F). Protect the capsules from light. Store in original container.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

DIMETHYL FUMARATE - DIMETHYL FUMARATE
DIMETHYL FUMARATE- DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE
ZYDUS PHARMACEUTICALS USA 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 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 thereafter.
Consider interruption of
dimethyl fumarate delayed-release capsules if lymphocyte coun