Description
Diroximel fumarate is used to treat the relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. This medicine will not cure MS, but it may slow some disabling effects and decrease the number of relapses of the disease.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule, Delayed Release
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of diroximel fumarate in the pediatric population. Safety and efficacy have not been established.
Geriatric
Although appropriate studies on the relationship of age to the effects of diroximel fumarate have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of dimethyl fumarate in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Dimethyl Fumarate
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Infection or
- Lymphopenia (low white blood cells) or
- Weak immune system—May decrease your body's ability to fight infections.
- Kidney disease, moderate to severe—Use is not recommended in patients with this condition.
- Stomach or bowel problems or
- Liver disease—Use with caution. May make these conditions worse.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Swallow the delayed-release capsule whole. Do not crush or chew it. Do not sprinkle the contents of the capsule on food.
If you take this medicine with food, avoid a high-fat, high-calorie meal or snack. The meal or snack should contain no more than 700 calories and no more than 30 g fat.
Your doctor may want you to take some medicine (eg, non-enteric coated aspirin) 30 minutes before taking this medicine to prevent flushing.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (delayed-release capsules):
- For multiple sclerosis:
- Adults—At first, 231 milligrams (mg) 2 times a day. After 7 days, your doctor will increase your dose to 462 mg 2 times a day.
- Children—Use and dose must be determined by your doctor.
- For multiple sclerosis:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Do not use this medicine together with dimethyl fumarate (Tecfidera®). Using these medicines together may cause serious side effects.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection (including herpes). Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often. Tell your doctor if you have any kind of infection before you start using this medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.
Check with your doctor right away if you think you are getting an infection or if you get a fever, chills, cough, hoarseness, lower back or side pain, painful or difficult urination, burning or stinging of the skin, painful cold sores or blisters on the lips, nose, eyes, genitals, or trunk of body, chest pain, coughing or spitting up blood, sore throat, muscle aches, night sweats, trouble breathing, or unusual tiredness.
This medicine may increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you have vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, or weak legs.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause skin flushing. Tell your doctor right away if you have warmth, redness, itching, or a burning sensation in your face, neck, arms, or upper chest while using this medicine.
Do not drink alcohol while you are using this medicine.
Make sure your doctor know if you are pregnant or planning to become pregnant before using this medicine.
This medicine may cause serious stomach or bowel problems (eg, bleeding, blockage, perforation, or ulcers). Check with your doctor right away if you have black, tarry stools, constipation, diarrhea, fever, heartburn, indigestion, nausea, stomach pain, cramps, or burns, or vomiting of blood or material that looks like coffee grounds.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Cough or hoarseness
- fever or chills
- lower back or side pain
- painful or difficult urination
Incidence not known
- Back pain
- black, tarry stools
- bloating of the stomach
- blurred vision
- chest tightness
- confusion
- constipation
- dark urine
- diarrhea
- difficulty with swallowing
- dizziness
- drowsiness
- fast heartbeat
- fever
- headache
- heartburn
- hives, itching, or skin rash
- indigestion
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light-colored stools
- nausea
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- seizures
- stomach pain, cramps, or burn
- unusual tiredness or weakness
- vomiting of blood or material that looks like coffee grounds
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Feeling of warmth
- redness of the face, neck, arms and occasionally, upper chest
Less common
- Acid or sour stomach
- belching
- stomach discomfort or upset
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
