Patient Medication Information: uses, side effects, how to take - Vyndamax
What VYNDAMAX is used for:
VYNDAMAX is used to treat adults with cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM). Cardiomyopathy is a disease of the heart muscle that makes it harder for your heart to pump blood to the rest of your body. VYNDAMAX reduces death and hospitalization related to heart problems.
VYNDAMAX is not for use in patients less than 18 years of age.
How VYNDAMAX works:
VYNDAMAX is used to treat a disease called transthyretin amyloid cardiomyopathy (also known as ATTR-CM). In ATTR-CM, a protein called transthyretin (TTR) breaks up and may form fibrils called amyloid. Amyloid can build up between cells in your heart preventing your heart from working normally. This can cause heart-related symptoms and problems. VYNDAMAX is used to prevent the TTR protein from breaking up and slows the deposit of amyloid fibrils in the heart.
The ingredients in VYNDAMAX are:
Medicinal ingredient: tafamidis.
Non-medicinal ingredients: ammonium hydroxide 28%, butylated hydroxytoluene, gelatin, glycerin, iron oxide (red), polyethylene glycol 400, polysorbate 20, povidone (K value 90), polyvinyl acetate phthalate, propylene glycol, sorbitol, and titanium dioxide.
VYNDAMAX comes in the following dosage form:
Capsules: 61 mg.
Do not use VYNDAMAX if:
- You are allergic to tafamidis or any of the ingredients in this medicine, including non-medicinal ingredients, or component of the container.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take VYNDAMAX. Talk about any health conditions or problems you may have, including if you:
- have liver problems
- have severe kidney problems
- had an organ transplant
are pregnant or plan to become pregnant. VYNDAMAX may harm your unborn baby. Tell your healthcare professional right away if you become pregnant or think you may be pregnant during treatment with VYNDAMAX. If you are a woman of childbearing potential, you should use appropriate contraception during treatment with VYNDAMAX. You should also continue to use appropriate contraception for one month after stopping treatment.
- are breast-feeding or plan to breast-feed. It is not known if VYNDAMAX passes into breast milk. You should not breast-feed during treatment with VYNDAMAX. Talk to your healthcare professional about the best way to feed your baby during treatment with VYNDAMAX.
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 VYNDAMAX:
- midazolam and triazolam, sedative drugs
- methotrexate and imatinib, drugs used to treat cancer
- rosuvastatin, atorvastatin and pravastatin, drugs used to lower cholesterol
- olmesartan, used to treat high blood pressure
- acetylsalicylic acid, ibuprofen, naproxen, and other non-steroidal anti-inflammatory drugs
- drugs used to treat HIV/AIDS
- diuretics or water pills, used to treat high blood pressure
- apixaban and rivaroxaban, used to treat and prevent blood clots
How to take VYNDAMAX:
- Take VYNDAMAX exactly as your healthcare professional tells you to.
- VYNDAMAX capsules should be swallowed whole and not crushed or cut open.
Usual dose:
Take one (1) VYNDAMAX 61 mg capsule once a day, with or without food.
- Your healthcare professional may reduce your dose to one capsule of 20 mg VYNDAQEL (tafamidis meglumine) if you can’t tolerate the usual VYNDAMAX dose (for information on tafamidis meglumine 20 mg, see Product Monograph for VYNDAQEL, Patient Medication Information).
Overdose:
If you think you, or a person you are caring for, have taken too much VYNDAMAX, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed dose:
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regularly scheduled time. Do not take 2 doses at the same time.
Possible side effects from using VYNDAMAX:
These are not all the possible side effects you may have when taking VYNDAMAX. If you experience any side effects not listed here, tell your healthcare professional.
- fall
- sinusitis (congested nose)
- asthenia (feeling weak or a lack of energy)
- feeling unbalanced when standing or walking
- cataract (clouding of the lens in your eye)
- abdominal discomfort (unpleasant sensation in the stomach)
- abdominal pain (stomachache)
- constipation
- diarrhea
- pruritis: itching or itchy skin
- rash
VYNDAMAX may cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help |
|---|---|---|
| Only if severe | In all cases | |
| Common | ||
| Cystitis (bladder infection): increased need to urinate, pain in the pelvis or lower back, frequent urination during the night, cloudy urine that may contain blood, burning sensation when passing urine. | ||
| x | ||
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.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store at room temperature (15°C to 25°C).
Keep out of reach and sight of children.
If you want more information about VYNDAMAX:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.pfizer.ca; or by calling 1-800-463-6001.
Date of Authorization: 2026-05-07