NDC: 50090-5288-0 1 CAPSULE, DELAYED RELEASE in a KIT
Advise the patient to read the FDA-approved patient labeling (Patient Information)
Inform patients that they will be provided two strengths of dimethyl fumarate delayed-release capsules when starting treatment: 120 mg capsules for the 7 day starter dose and 240 mg capsules for the maintenance dose, both to be taken twice daily. Inform patients to swallow dimethyl fumarate delayed-release capsules whole and intact. Inform patients to not crush, chew, or sprinkle capsule contents on food. Inform patients that dimethyl fumarate delayed-release capsules can be taken with or without food [see Dosage and Administration (2.1)].
Anaphylaxis and Angioedema
Advise patients to discontinue dimethyl fumarate delayed-release capsules and seek medical care if they develop signs and symptoms of anaphylaxis or angioedema [see Warnings and Precautions (5.1)].
Progressive Multifocal Leukoencephalopathy
Inform patients that progressive multifocal leukoencephalopathy (PML) has occurred in patients who received dimethyl fumarate delayed-release capsules. Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months. Instruct the patient of the importance of contacting their doctor if they develop any symptoms suggestive of PML. Inform the patient that typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes [see Warnings and Precautions (5.2)].
Herpes Zoster and Other Serious Opportunistic Infections
Inform patients that herpes zoster and other serious opportunistic infections have occurred in patients who received dimethyl fumarate delayed-release capsules. Instruct the patient of the importance of contacting their doctor if they develop any signs or symptoms associated with herpes zoster or other serious opportunistic infections [see Warnings and Precautions (5.3)].
Inform patients that dimethyl fumarate delayed-release capsules may decrease lymphocyte counts. A blood test should be obtained before they start therapy. Blood tests are also recommended after 6 months of treatment, every 6 to 12 months thereafter, and as clinically indicated [see Warnings and Precautions (5.4), Adverse Reactions (6.1)].
Inform patients that dimethyl fumarate delayed-release capsules may cause liver injury. Instruct patients treated with dimethyl fumarate delayed-release capsules to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. A blood test should be obtained before patients start therapy and during treatment, as clinically indicated [see Warnings and Precautions (5.5)].
Flushing and Gastrointestinal (GI) Reactions
Flushing and GI reactions (abdominal pain, diarrhea, and nausea) are the most common reactions, especially at the initiation of therapy, and may decrease over time. Advise patients to contact their healthcare provider if they experience persistent and/or severe flushing or GI reactions. Advise patients experiencing flushing that taking dimethyl fumarate delayed-release capsules with food or taking a non-enteric coated aspirin prior to taking dimethyl fumarate delayed-release capsules may help [see Adverse Reactions (6.1)].
Instruct patients that if they are pregnant or plan to become pregnant while taking dimethyl fumarate delayed-release capsules they should inform their physician.
Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854
Hetero Labs Limited
Jeedimetla, Hyderabad – 500 055, India. Revised: 05/2020
|Patient Information Dimethyl Fumarate (dye meth il FYOO ma rate)Delayed-Release Capsules|
|What are dimethyl fumarate delayed-release capsules ? |
|Who should not take dimethyl fumarate delayed-release capsules ? |
|Before taking and while you take dimethyl fumarate delayed-release capsules , tell your doctor if you have or have had: |
|How should I take dimethyl fumarate delayed-release capsules ? |
|What are the possible side effects of dimethyl fumarate delayed-release capsules ? Dimethyl fumarate delayed-release capsules may cause serious side effects including: |
|General Information about the safe and effective use of dimethyl fumarate delayed-release capsules |
|What are the ingredients in dimethyl fumarate delayed-release capsules ? Active ingredient: dimethyl fumarate Inactive ingredients: calcium silicate, colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, methacrylic acid and methyl methacrylate copolymer, poloxamer, polysorbate 80, silicified microcrystalline cellulose, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. In addition, the 120 mg capsules also contain FD&C Blue 1, iron oxide black and iron oxide yellow.The imprinting ink contains the following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.|
|Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854By: HETEROTM Hetero Labs LimitedJeedimetla, Hyderabad – 500 055, India.|
This Patient Information has been approved by the U.S. Food and Drug Administration.
Patient Information available at http://camberpharma.com/medication-guides
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