DIMETHYL FUMARATE capsule, delayed release

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

SOLA Pharmaceuticals, LLC

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 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 major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data In rats administered DMF orally (25, 100, 250 mg/kg/day) throughout organogenesis, embryofetal toxicity (reduced fetal body weight and delayed ossification) were observed at the highest dose tested. This dose also produced evidence of maternal toxicity (reduced body weight). Plasma exposure (AUC) for monomethyl fumarate (MMF), the major circulating metabolite, at the no-effect dose is approximately three times that in humans at the recommended human dose (RHD) of 480 mg/day. In rabbits administered DMF orally (25, 75, and 150 mg/kg/day) throughout organogenesis, embryolethality and decreased maternal body weight were observed at the highest dose tested. The plasma AUC for MMF at the no-effect dose is approximately 5 times that in humans at the RHD. Oral administration of DMF (25, 100, and 250 mg/kg/day) to rats throughout organogenesis and lactation resulted in increased lethality, persistent reductions in body weight, delayed sexual maturation (male and female pups), and reduced testicular weight at the highest dose tested. Neurobehavioral impairment was observed at all doses. A no-effect dose for developmental toxicity was not identified. The lowest dose tested was associated with plasma AUC for MMF lower than that in humans at the RHD. Risk Summary There are no data on the presence of DMF or MMF in human milk. The effects on the breastfed infant and on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dimethyl fumarate delayed-release capsules and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition. Safety and effectiveness in pediatric patients have not been established. Clinical studies of dimethyl fumarate delayed-release capsules did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

Tóm tắt sản phẩm:

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 green and white 120 mg capsules are printed with “120” in black ink. The green 240 mg capsules are printed with “240” in black ink. Dimethyl fumarate delayed-release capsules are available as follows: 30-day Starter Pack, (NDC 70512-858-60):      7-day bottle 120 mg capsules, quantity 14      23-day bottle 240 mg capsules, quantity 46 120 mg capsules:      7-day bottle of 14 capsules (NDC 70512-852-14) 240 mg capsules:      30-day bottle of 60 capsules (NDC 70512-853-60) Store at 20°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect the capsules from light. Store in original container.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

DIMETHYL FUMARATE- DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE
SOLA PHARMACEUTICALS, 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
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)
_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 delay