Apo-Dimethyl Fumarate: Uses, Side Effects and Dosage

What is APO-DIMETHYL FUMARATE used for?

APO-DIMETHYL FUMARATE is used in adults to treat relapsing remitting multiple sclerosis (MS). APO-DIMETHYL FUMARATE helps to:

• reduce the number of flare-ups (relapses) that occur, and
• delay physical problems due to MS (disability progression).

How does APO-DIMETHYL FUMARATE work?

The exact way that APO-DIMETHYL FUMARATE works is not known. However, APO-DIMETHYL FUMARATE is thought to work by changing the way the body’s immune system works, to help keep MS from further damaging your brain and spinal cord.

What are the ingredients in APO-DIMETHYL FUMARATE?

Medicinal ingredient: dimethyl fumarate

Nonmedicinal ingredients: Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methacrylic acid and methyl methacrylate copolymer, microcrystalline cellulose, talc and triethyl citrate. The capsule shell contains black iron oxide, FD&C Blue 1, gelatin, titanium dioxide and yellow iron oxide. The black ink contains ammonia solution, iron oxide black, potassium hydroxide, propylene glycol and shellac.

APO-DIMETHYL FUMARATE comes in the following dosage forms:

Delayed-release capsules: 120 mg and 240 mg of dimethyl fumarate.

Do not use APO-DIMETHYL FUMARATE if:

• you are allergic to dimethyl fumarate or to any other ingredients in APO-DIMETHYL FUMARATE.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-DIMETHYL FUMARATE. Talk about any health conditions or problems you may have, including if you:

• have or have had low white blood cell counts (low lymphocytes).
• have a weakened immune system (immunocompromised) due to diseases (immunodeficiency syndrome), medicines, or treatments that suppress the immune system (e.g., medicines used to treat cancer or bone marrow transplantation).
• have an infection.
• have a herpes zoster infection (shingles).
• have liver problems.
• have kidney problems.
• have gastrointestinal (GI) problems (e.g., stomach or bowel problems).

• are pregnant or planning to become pregnant.

• are breast-feeding or planning to breast-feed.
• are taking other medications known as fumaric acid derivatives.
• are taking certain medications that can affect your kidney function (nephrotoxic medications).
• are planning on getting certain types of vaccines known as live attenuated vaccines. Check with your healthcare professional before receiving any vaccination during treatment or after stopping APO-DIMETHYL FUMARATE.

Other warnings you should know about:

Gastrointestinal (GI) problems: Treatment with APO-DIMETHYL FUMARATE can cause GI problems, especially in the first month. Some symptoms of GI problems include nausea, vomiting, diarrhea, and abdominal pain. Most people have mild to moderate symptoms and they tend to go away over time. You should take APO-DIMETHYL FUMARATE with food to help reduce the chances of GI problems. If this does not help, talk to your healthcare professional. They may also temporarily reduce your dose. Do not reduce your dose unless your healthcare professional tells you to.

Infections: If you have an infection before you start taking APO-DIMETHYL FUMARATE, tell your healthcare professional. Any infection that you already have may get worse. Other infections, including shingles, have occurred when taking dimethyl fumarate. Infections could be serious and sometimes life-threatening.

• Before you start taking APO-DIMETHYL FUMARATE, your healthcare professional will make sure you have enough white blood cells (lymphocytes) in your blood. This is because APO-DIMETHYL FUMARATE may cause low white blood cell count (lymphopenia). Blood measurements are done throughout treatment and afterwards, to monitor your lymphocyte count.
• While you are taking APO-DIMETHYL FUMARATE if you think you have an infection, have a fever, chills or feel like you have the flu, tell your healthcare professional right away. These may be the symptoms of infection.

• If you believe your MS is getting worse (e.g. weakness, clumsiness, or visual changes) or if you notice any new or unusual symptoms, talk to your healthcare professional as soon as possible. These may be the symptoms of a rare brain disorder caused by infection called progressive multifocal leukoencephalopathy (PML). Your healthcare

  • professional will decide whether you need to stop taking APO-DIMETHYL FUMARATE.
• If you need to receive medications and treatments that suppress or change how the immune system works, talk to your healthcare professional about the potential increased risk of infections.

Liver problems: Treatment with APO-DIMETHYL FUMARATE may cause liver problems, including increasing certain types of liver enzymes (i.e., liver transaminases) in your body. This usually happens during the first 6 months of treatment. Your healthcare professional will monitor your liver enzyme levels before, during, and after your treatment. They may stop your treatment if you have liver problems, or if liver problems are suspected.

Flushing: APO-DIMETHYL FUMARATE may cause flushing, especially at the start of your treatment. Flushing can include hot flush, warmth, redness, itching, and burning sensation. Most people have mild to moderate symptoms early in the treatment and they tend to go away over time. Your healthcare professional may temporarily reduce your dose or recommend taking an over-the-counter pain and fever medication, such as aspirin, for a few days 30 minutes before your APO-DIMETHYL FUMARATE dose. Do not reduce your dose unless your healthcare professional tells you to.

If you become flushed and get swelling of the face, lips, mouth or tongue, wheezing, difficulty breathing or shortness of breath, stop taking APO-DIMETHYL FUMARATE and seek emergency medical assistance.

See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.

Monitoring and testing: Your healthcare professional will monitor and assess your health by doing various tests. These tests may be performed before, during, and after your treatment. This will tell your healthcare professional about your blood, urine, and liver. They will use this information to determine if APO-DIMETHYL FUMARATE is right for you and how it is affecting you.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with APO-DIMETHYL FUMARATE:

• Fumaric acid. APO-DIMETHYL FUMARATE should not be used with other types of fumaric acid. Ask your healthcare professional if you are not sure what other products may contain fumaric acids or its derivatives.

• Medicines that affect the immune system. This can include some commonly used cancer treatments and other medicines used to treat MS, such as, beta-interferons, glatiramer acetate, natalizumab, fingolimod, or mitoxantrone. APO-DIMETHYL FUMARATE should not be started while you are on other MS medications. If you stop taking one of these medicines to switch to APO-DIMETHYL FUMARATE you may be required to wait before starting APO-DIMETHYL FUMARATE. The amount of time you

  • healthcare professional will know how long you may need to wait.
• Medicines that can affect the kidneys. This can include antibiotics from the aminoglycoside class, non-steroidal anti-inflammatory drugs (NSAIDs), diuretics, or lithium.
• Vaccines. If you need to receive a vaccine, talk to your healthcare professional first. The administration of vaccines containing live virus (attenuated vaccines) is not recommended.
• Corticosteroids. If you need to receive corticosteroids, talk to your healthcare professional about the potential increased risk of infections.
• Acetylsalicylic acid. Long-term use of acetylsalicylic acid (e.g., aspirin) is not recommended.

How to take APO-DIMETHYL FUMARATE:

• Always follow your healthcare professional’s instructions for taking APO-DIMETHYL FUMARATE. You should check with your healthcare professional if you are not sure.
• Swallow the whole APO-DIMETHYL FUMARATE capsule. Do not divide, crush, dissolve, suck, or chew the capsule.
• APO-DIMETHYL FUMARATE can be taken with or without food. Taking APO-DIMETHYL FUMARATE with food may help reduce the chances of certain side effects (flushing and gastrointestinal).
• APO-DIMETHYL FUMARATE capsules are packaged in a blister card inside a carton. Remove the capsules from the blister by pushing them through the foil.
• Your healthcare professional may reduce your dose if you have certain side effects. Do not reduce your dose unless your healthcare professional tells you to.

Usual dose:

Your healthcare professional will tell you how much and how often to take APO-DIMETHYL FUMARATE each day. This will depend on your condition, other medications you are taking, and how you respond to the treatment.

The usual starting and regular doses are as follows:

• Starting dose: One 120 mg capsule two times a day (one in the morning and one in the evening). For a total starting daily dose of 240 mg a day. Take this starting dose for the first 7 days, and then take the regular dose.
• Regular dose: One 240 mg capsule two times a day (one in the morning and one in the evening). For a total regular daily dose of 480 mg a day.

Overdose:

Missed Dose:

If you forget or miss a dose, take it as soon as you remember if there is at least 4 hours between the morning and evening doses. If there is less than 4 hours, wait and take your next dose as planned. Do not try to make up for the missed dose by taking two doses at the same time.

What are possible side effects from using APO-DIMETHYL FUMARATE?

These are not all the possible side effects you may have when taking APO-DIMETHYL FUMARATE. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• Very Common - may affect more than 1 in 10 people

  urinary tract infection

• Common - may affect up to 1 in 10 people

  dry mouth

  feeling hot

  weight loss

  ear infection

  itchiness

  skin rash

  burning sensation

  • Unknown frequency

    runny nose

    hair loss or thinning

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Serious side effects and what to do about them

Reporting Side Effects

Storage:

Store APO-DIMETHYL FUMARATE at room temperature (between 15°C to 30°C). Protect APO-DIMETHYL FUMARATE from light. Store the capsules in their original packaging. Do not take your medicine after the expiry date shown on the carton. Keep out of reach and sight of children.

Medicines should not be disposed of in waste water or household garbage. Ask your pharmacist how to dispose of medicines you no longer need.

If you want more information about APO-DIMETHYL FUMARATE:

Last Revised: MAY 30, 2024