![]() Dimethyl fumarate delayed-release capsules can be taken with or without food.ĥ.2 Progressive Multifocal Leukoencephalopathy ![]() Dimethyl fumarate delayed-release capsules should not be crushed or chewed, and the capsule contents should not be sprinkled on food. ![]() Dimethyl 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 capsule 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. FULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Dosing Information 2.2 Blood 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 5.6 Flushing 6 ADVERSE REACTIONS 6.1Ĝlinical Trials Experience 6.2 Post Marketing Experience 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 10 OVERDOSE 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.
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