TECFIDERA- dimethyl fumarate kit TECFIDERA- dimethyl fumarate capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

dimethyl fumarate (UNII: FO2303MNI2) (monomethyl fumarate - UNII:45IUB1PX8R)

Available from:

Biogen Inc.

INN (International Name):

dimethyl fumarate

Composition:

dimethyl fumarate 120 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

TECFIDERA is 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. TECFIDERA is contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of TECFIDERA. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.1)]. Risk Summary Available data from the TECFIDERA 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 TECFIDERA 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 TECFIDERA 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 TECFIDERA did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

Product summary:

TECFIDERA is 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 “BG-12 120 mg” in black ink. The green 240 mg capsules are printed with “BG-12 240 mg” in black ink. TECFIDERA is available as follows: 30-day Starter Pack, (NDC 64406-007-03): 120 mg capsules: 240 mg capsules: Store at 15°C to 30°C (59 to 86°F). Protect the capsules from light. Store in original container.

Authorization status:

New Drug Application

Summary of Product characteristics

TECFIDERA- DIMETHYL FUMARATE
TECFIDERA- DIMETHYL FUMARATE CAPSULE
BIOGEN INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TECFIDERA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TECFIDERA.
TECFIDERA (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
TECFIDERA is 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 TECFIDERA capsules whole and intact. Do not crush, chew, or
sprinkle capsule contents on food
(2.1)
Take TECFIDERA 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 TECFIDERA. (4)
WARNINGS AND PRECAUTIONS
Anaphylaxis and Angioedema: Discontinue and do not restart TECFIDERA
if these occur. (5.1)
Progressive Multifocal Leukoencephalopathy (PML): Withhold TECFIDERA
at the first sign or symptom
suggestive of PML. (5.2)
Herpes Zoster and Other Serious Opportunistic Infections: Consider
withholding TECFIDERA in cases of
serious infection until the infection has resolved. (5.3)
Lymphopenia: Obtain a CBC including lymphocyte count before initiating
TECFIDERA, after 6 months,
and every 6 to 12 months thereafter. Consider interruption of
TECFIDERA if lymphocyte counts <0.5 x
10 /L persist for more than six months. (5.4)
Liver Injury: Obtain serum aminotransferase, alkaline phosphatase, and
total bilirubin levels before
initiating TECFIDERA and during treatment, as clinically indicated.
Discontinue TECFIDERA if clinically
significant li