Dimethyl Fumarate (Page 5 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-5288

NDC: 50090-5288-0 1 CAPSULE, DELAYED RELEASE in a KIT

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information)
Dosage
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)].
Lymphocyte Counts
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)].
Liver Injury
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)].
Pregnancy
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

Manufactured for:
Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854
By: HETEROTM
Hetero Labs Limited
Jeedimetla, Hyderabad – 500 055, India. Revised: 05/2020

Patient Information

Patient Information Dimethyl Fumarate (dye meth il FYOO ma rate)Delayed-Release Capsules
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 them
  • 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 a day
  • Dimethyl fumarate delayed-release capsules can be taken with or without food
  • Swallow dimethyl fumarate delayed-release capsules whole. Do not crush, chew, or sprinkle capsule contents on food.
  • Protect dimethyl fumarate delayed-release capsules from light. You can do this by storing the capsules in their original container.
  • If you take too much dimethyl fumarate delayed-release capsules, call your doctor or go to the nearest hospital emergency room right away.
What are the possible side effects of dimethyl fumarate delayed-release capsules ? Dimethyl fumarate delayed-release capsules may cause serious side effects including:
  • allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing)
  • PML a rare brain infection that usually leads to death or severe disability
  • decreases in your white blood cell count Your doctor should do a blood test before you start treatment with dimethyl fumarate delayed-release capsules and while on therapy.
  • liver problems. Your doctor should do blood tests to check your liver function before you start taking dimethyl fumarate delayed-release capsules and during treatment if needed. Tell your doctor right away if you get any of these symptoms of a liver problem during treatment.
    • severe tiredness
    • loss of appetite
    • pain on the right side of your stomach
    • have dark or brown (tea color) urine
    • yellowing of your skin or the white part of your eyes
    herpes zoster infections (shingles), including central nervous system infections • other serious infections
The most common side effects of dimethyl fumarate delayed-release capsules include:
  • flushing, redness, itching, or rash
  • nausea, vomiting, diarrhea, stomach pain, or indigestion
  • Flushing and stomach problems are the most common reactions, especially at the start of therapy, and may decrease over time. Taking dimethyl fumarate delayed-release capsules with food may help reduce flushing. Call your doctor if you have any of these symptoms and they bother you or do not go away. Ask your doctor if taking aspirin before taking dimethyl fumarate delayed-release capsules may reduce flushing.
These are not all the possible side effects of dimethyl fumarate delayed-release capsules. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov. For more information, call Hetero Labs Limited at 1-866-495-1995.
General Information about the safe and effective use of dimethyl fumarate delayed-release capsules
  • Medicines are sometimes prescribed for purposes other than those listed in this Patient Information. Do not use dimethyl fumarate delayed-release capsules for a condition for which it was not prescribed. Do not give dimethyl fumarate delayed-release capsules to other people, even if they have the same symptoms that you have. It may harm them.
  • If you would like more information, talk to your doctor or pharmacist. You can ask your doctor or pharmacist for information about dimethyl fumarate delayed-release capsules that is written for healthcare professionals.
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.
camber2Manufactured 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

Revised: 05/2020

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