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

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Camber Pharmaceuticals, Inc.

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 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 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 to 4% and 15 to 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.

Podsumowanie produktu:

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 light blue opaque size '0' hard gelatin capsules imprinted with 'H' on cap and 'D12' on body filled with white to off white tablets. They are available as follows: 30-day Starter Pack                                                                NDC 31722-680-60 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 31722-657-31 Blister Pack of 100 (10x10) unit dose capsules                      NDC 31722-657-32 The 240 mg capsules are white opaque size '0el' hard gelatin capsules imprinted with 'H' on cap and 'D15' on body filled with white to off white tablets. They are available as follows: 240 mg capsules: 23-day bottle of 46 capsules                                                    NDC 31722-658-31 30-day bottle of 60 capsules                                                    NDC 31722-658-32 Blister Pack of 100 (10x10) unit dose capsules NDC 31722-658-33 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect the capsules from light. Store in original container.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

DIMETHYL FUMARATE - DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE
DIMETHYL FUMARATE- DIMETHYL FUMARATE
CAMBER PHARMACEUTICALS, 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
RECENT MAJOR CHANGES
Warnings and Precautions, Lymphopenia ( 5.4) 02/2023
Warnings and Precautions, Serious Gastrointestinal Reactions ( 5.7)
12/2023
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
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 lymp