DIMETHYL FUMARATE capsule, delayed release DIMETHYL FUMARATE kit

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Amneal Pharmaceuticals NY LLC

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 capsule are contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of dimethyl fumarate delayed-release capsule. 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 recogni

Product samenvatting:

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. Dimethyl Fumarate Delayed-Release Capsules, 120 mg are supplied as opaque green cap printed "AN" on cap with black ink and opaque white body printed "1318" on body with black ink. They are available as follows: 7-day bottle of 14 capsules:                              NDC 69238-1318-4 Dimethyl Fumarate Delayed-Release Capsules, 240 mg are supplied as opaque green cap printed "AN" on cap with black ink and opaque green body printed "1319" on body with black ink. They are available as follows: 30-day bottle of 60 capsules:                            NDC 69238-1319-6 Dimethyl Fumarate Delayed-Release Capsules are also supplied as 30-day Starter Pack which contain 14 capsules of 120 mg as starter dose for 7 days and 46 capsules of 240 mg as regular dose for 23 days. 30-day Starter Pack: (7-day bottle of 120 mg capsules, quantity 14)   (23-day bottle of 240 mg capsules, quantity 46) Carton of 60 Capsules:                         NDC 69238-1626-3 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect the capsules from light. Store in original container.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

DIMETHYL FUMARATE- DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE
DIMETHYL FUMARATE- DIMETHYL FUMARATE
AMNEAL PHARMACEUTICALS NY LLC
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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
capsule. (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 f