DIMETHYL FUMARATE capsule, delayed release

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Solco Healthcare US, LLC

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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.

Tuoteyhteenveto:

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.

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

Solco Healthcare US, LLC
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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

Valmisteyhteenveto

DIMETHYL FUMARATE- DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE
SOLCO HEALTHCARE US, 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
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