Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
DIMETHYL FUMARATE (UNII: FO2303MNI2) (MONOMETHYL FUMARATE - UNII:45IUB1PX8R)
Cipla USA Inc.
ORAL
PRESCRIPTION DRUG
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 Available data from the dimethyl fumarate (DMF) Pregnancy Registry, observational studies, and pharmacovigilance with dimethyl fumarate use in pregnant women have not indicated an increased risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Most of the reported exposures to dimethyl fumarate occurred during the first trimester of pregnancy (see Data).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) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. Data Human Data In a prospective observational dimethyl fumarate (DMF) Pregnancy Registry (2013-2022), the rate of major birth defects among 362 live births and stillbirths from women who were exposed to dimethyl fumarate during pregnancy was 3.6% (95% CI: 1.9-6.1). No specific pattern of major birth defects was identified. Important potential study limitations include exposure misclassification, no adjustment for confounders, and lack of an internal comparator cohort. 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 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 did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
Dimethyl fumarate delayed-release capsules, 120mg are white to off white colored mini tablets filled in size '0' empty hard gelatin capsule shell with opaque green colored cap and opaque white body imprinted 'CIPLA 322' on cap with black ink. Dimethyl fumarate delayed-release capsules, 240mg are white to off white colored mini tablets filled in size '0' empty hard gelatin capsule shell with opaque green colored cap and body imprinted 'CIPLA 323' on cap with black ink.: 30-day Starter Pack, (NDC 69097-552-03): 7-day bottle 120 mg capsules, quantity 14 – NDC 69097-322-28 23-day bottle 240 mg capsules, quantity 46 – NDC 69097-323-88 120 mg capsules: 7-day bottle of 14 capsules (NDC 69097-322-89) 240 mg capsules: 30-day bottle of 60 capsules (NDC 69097-323-03) Store at 15°C to 30°C (59 to 86°F). Protect the capsules from light. Store in original container.
Abbreviated New Drug Application
DIMETHYL FUMARATE- DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE DIMETHYL FUMARATE- DIMETHYL FUMARATE CIPLA USA 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 RECENT MAJOR CHANGES 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 lymphocyte count before initiating dimethyl fumarate delayed- release capsules, after 6 months, and every 6 to 12 Læs hele dokumentet