Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
DIMETHYL FUMARATE (UNII: FO2303MNI2) (MONOMETHYL FUMARATE - UNII:45IUB1PX8R)
Solco Healthcare US, LLC
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 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. 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.
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 caramel and white 120 mg capsules are printed with “612” in black ink on the cap and “120 mg” in black ink on the body. The caramel 240 mg capsules are printed with “613” in black ink on the cap and “240 mg” in black ink on the body. Dimethyl fumarate delayed-release capsules are available as follows: 120 mg capsules: 240 mg capsules: Store at 20o C to 25o C (68o F to 77o F); excursions permitted between 15o C and 30o C (59o F and 86o F) [see USP Controlled Room Temperature]. Protect the capsules from light. Store in original container.
Abbreviated New Drug Application
Solco Healthcare US, LLC ---------- PATIENT INFORMATION Dispense with Patient Information available at: www.solcohealthcare.com/druglabeling/dimethyl-fumarate-dr-capsules.pdf Dimethyl Fumarate Delayed-Release Capsules (dye-METH-il FUE-ma-rate) What are dimethyl fumarate delayed-release capsules? • Dimethyl fumarate delayed-release capsules are a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. • It is not known if dimethyl fumarate delayed-release capsules are safe and effective in children under 18 years of age Who should not take dimethyl fumarate delayed-release capsules? • Do not use dimethyl fumarate delayed-release capsules if you have had an allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing) to dimethyl fumarate delayed-release capsules or any of its ingredients. See below for a complete list of ingredients. Before taking and while you take dimethyl fumarate delayed-release capsules, tell your doctor if you have or have had: • low white blood cell counts or an infection • any other medical conditions Tell your doctor if you are: • pregnant or plan to become pregnant. It is not known if dimethyl fumarate delayed-release capsules will harm your unborn baby. • breastfeeding or plan to breastfeed. It is not known if dimethyl fumarate passes into your breast milk. You and your doctor should decide if you will take dimethyl fumarate delayed-release capsules or breastfeed. • taking prescription or over-the-counter medicines, vitamins, or herbal supplements How should I take dimethyl fumarate delayed-release capsules? • Take dimethyl fumarate delayed-release capsules exactly as your doctor tells you to take it • The recommended starting dose is one 120 mg capsule taken by mouth 2 times a day for 7 days • The recommended dose after 7 days is one 240 mg capsule taken by mouth 2 times Prečítajte si celý dokument
DIMETHYL FUMARATE- DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE SOLCO HEALTHCARE US, LLC ---------- 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 • • • • 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 • • • • • ADVERSE REACTIONS Most common adverse reactions (incidence ≥10% and ≥2% placebo) were flushing, abdominal pain, diarrhea, and nausea. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SOLCO HEALTHCARE US, LLC AT 1-866-257- 2597 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. (8.1) SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE. REVISED: 2/2024 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) Anaphylaxis and Angioedema: Discontinue and do not restart dimethyl fumarate delayed-release capsules if the Prečítajte si celý dokument