Patient Medication Information: uses, side effects, how to take - Amvuttra
What AMVUTTRA is used for:
AMVUTTRA is used to treat:
- stage 1 or 2 polyneuropathy (damage to peripheral nerves) in adults with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis).
- cardiomyopathy (damage to the heart muscle) in adults with hATTR amyloidosis or non-hereditary (so-called “wild-type”) transthyretin amyloidosis (wtATTR amyloidosis).
How AMVUTTRA works:
ATTR amyloidosis is caused by problems with a protein in the body called ‘transthyretin’ (TTR). AMVUTTRA works by rapidly lowering the amount of TTR protein in the body. This can help to reduce the symptoms of ATTR amyloidosis.
The ingredients in AMVUTTRA are:
Medicinal ingredient: vutrisiran (as vutrisiran sodium)
Non-medicinal ingredients: sodium chloride, sodium phosphate dibasic dihydrate, sodium phosphate monobasic dihydrate, water for injections. Sodium hydroxide and phosphoric acid may be used to adjust the pH.
AMVUTTRA comes in the following dosage forms:
Solution for injection: 25 mg/0.5 mL
Do not use AMVUTTRA if:
- You have ever had a severe allergic reaction to vutrisiran, or any of the other ingredients of this medicine. If you are not sure, talk to your healthcare professional before you are given AMVUTTRA.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you start using AMVUTTRA. Talk about any health conditions or problems you may have.
Other warnings you should know about:
Lowered vitamin A levels in the blood and vitamin A supplements: Treatment with AMVUTTRA lowers the amount of vitamin A in your blood. Your healthcare professional will ask you to take a vitamin A supplement every day. Your healthcare professional will tell you the dose of vitamin A that is right for you. Signs of low vitamin A may include:
- sight problems especially at night,
- dry eyes,
- poor vision,
- hazy or cloudy vision.
If you notice a change in your vision or any other eye problems while on AMVUTTRA, talk to your healthcare professional. Your healthcare professional may send you to an eye specialist for a check-up.
Fertility: AMVUTTRA lowers the amount of vitamin A in your blood, which may have an effect on fertility. Talk to your healthcare professional if this is a concern for you.
Pregnancy and birth control: Before starting treatment with AMVUTTRA, tell your healthcare professional if you are pregnant, think you may be pregnant or are planning on becoming pregnant. Your healthcare professional may have you take a pregnancy test before starting treatment with AMVUTTRA. You should not take AMVUTTRA if you are pregnant. AMVUTTRA affects your levels of vitamin A, and low or high levels of vitamin A may harm the baby. If you become pregnant while being treated with AMVUTTRA, tell your healthcare professional right away.
If you are able to become pregnant, you should use effective birth control while taking AMVUTTRA. Talk to your healthcare professional about suitable methods of birth control.
Breastfeeding: Before starting treatment with AMVUTTRA, tell your healthcare professional if you are breastfeeding or are planning to breastfeed. You and your healthcare professional should decide if the benefit of breastfeeding is greater than the risk to your baby. This is because this medicine may pass into the breast milk, and it is not known how it will affect the baby.
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 AMVUTTRA:
Interactions with other drugs are not known.
How AMVUTTRA is given:
- AMVUTTRA will be given to you by a healthcare professional.
- AMVUTTRA is given as an injection under the skin (subcutaneous injection) into your stomach area (abdomen), your upper arm, or thigh.
Usual dose:
The usual dose of AMVUTTRA is 25 mg once every 3 months.
Overdose:
This medicine will be given to you by a healthcare professional. In the unlikely event that you are given too much AMVUTTRA (an overdose) your healthcare professional will check you for side effects.
If you think you, or a person you are caring for, have been given too much AMVUTTRA, 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 symptoms.
Missed Dose:
If you miss an appointment for your AMVUTTRA injection, contact your healthcare professional as soon as you can to arrange to have the injection you missed.
Possible side effects from using AMVUTTRA:
These are not all the possible side effects you may have when taking AMVUTTRA. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- Pain in the joints (arthralgia)
- Pain in the arms, hands, feet, and legs
- Shortness of breath (dyspnea)
- Redness, pain, itching, bruising, or warmth where the injection was given (injection site reaction)
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 2 °C to 30 °C in the original carton, until ready for use. Do not freeze.
- Keep out of reach and sight of children.
- Do not use this medicine after the expiry date which is stated on the label and carton after ‘EXP’. The expiry date refers to the last day of that month.
- Do not throw away any medicines via wastewater or household waste. Ask your healthcare professional how to throw away medicines you no longer use. These measures will help protect the environment.
If you want more information about AMVUTTRA:
- 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 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.alnylam.ca) or by calling 1-877-256-9526.
Date of Authorization: 2025-12-12