![]() ĭimethyl fumarate delayed-release capsules should be swallowed whole and intact. Alternatively, administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to dimethyl fumarate delayed-release capsules dosing may reduce the incidence or severity of flushing. The incidence of flushing may be reduced by administration of dimethyl fumarate delayed-release capsules with food. Discontinuation of dimethyl fumarate delayed-release capsules should be considered for patients unable to tolerate return to the maintenance dose. Within 4 weeks, the recommended dose of 240 mg twice a day should be resumed. Temporary dose reductions to 120 mg twice a day may be considered for individuals who do not tolerate the maintenance dose. After 7 days, the dose should be increased to the maintenance dose of 240 mg twice a day orally. The starting dose for dimethyl fumarate delayed-release capsules is 120 mg twice a day orally. ( 5.5)įULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1ĝosing Information 2.2ělood Tests Prior to Initiation of Therapy 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1Ěnaphylaxis and Angioedema 5.2 Progressive Multifocal Leukoencephalopathy 5.3 Herpes Zoster and Other Serious Opportunistic Infections 5.4 Lymphopenia 5.5 Liver Injury 5.6ğlushing 6 ADVERSE REACTIONS 6.1Ĝlinical Trials Experience 6.2 Postmarketing Experience 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Toxicology and/or Pharmacology 14 CLINICAL STUDIES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. Discontinue dimethyl fumarate delayed-release capsules if clinically significant liver injury induced by dimethyl fumarate delayed-release capsules is suspected. Liver injury: Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels before initiating dimethyl fumarate delayed-release capsules and during treatment, as clinically indicated.Consider interruption of dimethyl fumarate delayed-release capsules if lymphocyte counts < 0.5 x 10 9/L persist for more than 6 months. Lymphopenia: Obtain a CBC including lymphocyte count before initiating dimethyl fumarate delayed-release capsules, after 6 months, and every 6 to 12 months thereafter.Herpes zoster and other serious opportunistic infections: Consider withholding dimethyl fumarate delayed-release capsules in cases of serious infection until the infection has resolved. ![]() Progressive multifocal leukoencephalopathy (PML): Withhold dimethyl fumarate delayed-release capsules at the first sign or symptom suggestive of PML.Anaphylaxis and angioedema: Discontinue and do not restart dimethyl fumarate delayed-release capsules if these occur. ![]()
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