Consumer Information for: PMS-DIMETHYL FUMARATE

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

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

The exact way that pms-DIMETHYL FUMARATE works is not known. However, pms-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.

Medicinal ingredient: Dimethyl fumarate

Non-medicinal ingredients: Ammonium Hydroxide. Colloidal Anhydrous Silica, Croscarmellose

Sodium, Glycerol Monostearate, Iron Oxide Black, Methacrylic Acid – Ethyl Acrylate Copolymer, Methacrylic Acid – Methyl Methacrylate Copolymer (1:1), Polysorbate 80, Shellac, Sodium Lauryl Sulfate, Sodium Stearyl Fumarate, Talc, Triethyl Citrate, Propyle Glycol.

The capsule shell contains: Brilliant Blue FCF, Gelatin, Titanium Dioxide, Yellow Iron Oxide

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

• 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 pms-DIMETHYL FUMARATE.

Gastrointestinal (GI) problems: Treatment with pms-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 pms-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 pms-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 delayed-release capsules. Infections could be serious and sometimes life-threatening.

• Before you start taking pms-DIMETHYL FUMARATE, your healthcare professional will make sure you have enough white blood cells (lymphocytes) in your blood. This is because pms-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 pms-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 might do an MRI scan to check for this condition. Your healthcare professional will decide whether you need to stop taking pms-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 pms-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: pms-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 pms-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 pms-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 pms-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.

• Fumaric acid. pms-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. pms-DIMETHYL FUMARATE should not be started while you are on other MS medications. If you stop taking one of these medicines to switch to pms-DIMETHYL FUMARATE you may be required to wait before starting pms-DIMETHYL FUMARATE. The amount of time you may need to wait will vary, depending on the treatment. Your 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.

• Always follow your healthcare professional’s instructions for taking pms-DIMETHYL FUMARATE. You should check with your healthcare professional if you are not sure.

• Swallow the whole pms-DIMETHYL FUMARATE capsule. Do not divide, crush, dissolve, suck, or chew the capsule.

• pms-DIMETHYL FUMARATE can be taken with or without food. Taking pms-DIMETHYL FUMARATE with food may help reduce the chances of certain side effects (flushing and gastrointestinal).

• pms-DIMETHYL FUMARATE capsules are packaged in a folding 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.

Your healthcare professional will tell you how much and how often to take pms-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.

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.

These are not all the possible side effects you may have when taking pms-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

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.

Store pms-DIMETHYL FUMARATE at room temperature between 15°C to 25°C.

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 wastewater or household garbage. Ask your pharmacist how to dispose of medicines you no longer need.

• Talk to your healthcare professional

• Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), or by contacting the sponsor Pharmascience Inc. at: 1-888-550-6060.

This leaflet was prepared by:

Pharmascience Inc.

Montréal, Québec

H4P 2T4

Last revised: NOV 8, 2023