Patient Medication Information: uses, side effects, how to take - Onpattro
What is ONPATTRO used for?
- ONPATTRO is a medicine that treats the nervous system problems due to an illness which runs in families called hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis).
- ONPATTRO is used in adults only.
How does ONPATTRO work?
hATTR amyloidosis is caused by problems with a protein in the body called ‘transthyretin’ (TTR). ONPATTRO works by lowering the amount of TTR protein in the body.
This can help to reduce the symptoms of hATTR amyloidosis.
What are the ingredients in ONPATTRO?
Medicinal ingredient: patisiran
Non-medicinal ingredients: cholesterol; DLin-MC3-DMA ((6Z,9Z,28Z,31Z)-heptatriaconta-6,9,28,31-tetraen-19-yl-4-(dimethylamino) butanoate); DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine); PEG2000-C-DMG (α-(3’-{[1,2-di(myristyloxy)propanoxy]carbonylamino}propyl)-ω-methoxy, polyoxyethylene); potassium phosphate monobasic anhydrous; sodium chloride; sodium phosphate dibasic heptahydrate and water for injection.
ONPATTRO comes in the following dosage forms:
Lipid complex solution for injection: 2 mg/mL patisiran (as patisiran sodium).
Do not use ONPATTRO if:
- You have ever had a severe allergic reaction to patisiran, or any of the other ingredients of this medicine. If you are not sure, talk to your healthcare professional before you are given ONPATTRO.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you receive ONPATTRO. Talk about any health conditions or problems you may have.
Other warnings you should know about:
Infusion-related reactions
ONPATTRO is given as a drip into a vein (called an ‘intravenous infusion’). You may have an infusion-related reaction during treatment with ONPATTRO. To help lower the chance of this, you will be given medicines before each infusion.
Tell your healthcare professional right away if you get any signs of an infusion-related reaction.
If you have an infusion-related reaction, your healthcare professional may slow down or stop your infusion, and you may need to take other medicines. When these reactions stop, or get better, your healthcare professional may decide to start the infusion again. See the Serious side effects and what to do about them table for more information on this and other serious side effects.
Lowered vitamin A levels in the blood and vitamin A supplements
Treatment with ONPATTRO lowers the amount of vitamin A in your blood. Your healthcare professional will tell you to take a vitamin A supplement every day. Talk to your healthcare professional if you notice a change in your vision.
Pregnancy
Before starting treatment with ONPATTRO, tell your healthcare professional if you are pregnant, think you may be pregnant, or are planning to have a baby.
You should not take ONPATTRO if you are pregnant. If you become pregnant while being treated with this medicine, tell your healthcare professional right away.
Breastfeeding
Before starting treatment with ONPATTRO, tell your healthcare professional if you are breastfeeding. You and your healthcare professional will decide if the benefit of breastfeeding is greater than the risk to your baby. This is because the medicine may pass into the mother’s milk and it is not known how it will affect the baby.
Birth Control
If you are a woman who is able to become pregnant, you should use effective birth control:
- During treatment with ONPATTRO and
- For 12 weeks after your last treatment.
Talk to your healthcare professional about suitable methods of birth control.
Driving and using machines
It is not known if ONPATTRO may affect your ability to drive or use machinery. Therefore, be careful when driving or doing any tasks that require you to be alert during your treatment with ONPATTRO.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
There are no known relevant drug interactions with ONPATTRO.
How ONPATTRO is given:
- ONPATTRO will be given to you by a healthcare professional.
- It is given as a drip into a vein (‘intravenous infusion’) over about 80 minutes.
- You will take other medicines at least 60 minutes before each infusion. They will help to lower the chance that you will have an infusion-related reaction. These medicines include a pain reliever, allergy medicines and a type of steroid (corticosteroid).
- Your healthcare professional will tell you how long you need to receive ONPATTRO. Do not stop treatment with ONPATTRO unless your healthcare professional tells you to.
Usual dose:
- Your healthcare professional will work out how much ONPATTRO to give you – this will depend on your body weight.
- The usual dose of ONPATTRO is 0.3 milligrams (mg) per kilogram (kg) of body weight given once every 3 weeks. The maximum dose is 30 mg.
Overdose:
This medicine will be given to you by your healthcare professional. In the unlikely event that you are given too much (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 ONPATTRO, contact your healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
If you miss an appointment to have ONPATTRO, ask your healthcare professional when to schedule your next treatment.
What are possible side effects from using ONPATTRO?
These are not all the possible side effects you may feel when receiving ONPATTRO. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- Pain in the joints
- Muscle spasms
- Indigestion
- Redness of the skin
- Stuffy or runny nose
- Irritation or infection of the airways
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
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Peripheral edema (swelling of the legs or hands caused by fluid retention): swollen or puffy legs or hands, feeling heavy, achy or stiff | ✓ | ||
| Infusion-related reactions: stomach pain, nausea, body aches or pain (including pain in the back, neck, or joints), headache, feeling tired, chills, dizziness, cough, feeling short of breath, or other breathing problems, reddening of the face or body, warm skin, rash, or itching, chest discomfort or chest pain, rapid heart rate, low or high blood pressure, fainting, pain, redness, burning sensation, or swelling at or near the infusion site, swelling of the face | ✓ | ||
| COMMON | |||
| Dyspnea (shortness of breath) | ✓ | ||
| Vertigo (a false sense that you or your surroundings are spinning or moving): dizziness, feeling faint, unsteadiness, nausea, vomiting | ✓ | ||
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
- Store in a refrigerator (2 °C to 8 °C). Do not freeze.
- If refrigeration is not available, ONPATTRO can be stored at room temperature (up to 25 °C for up to 14 days).
- Do not use this medicine after the expiration date, which is stated on the carton after ‘EXP’. The expiration date refers to the last day of that month.
- Keep out of reach and sight of children.
- Medicines should not be disposed of via wastewater or household waste. Your healthcare professional will throw away any medicines that are no longer being used. These measures will help protect the environment.
If you want more information about ONPATTRO:
- 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); the manufacturer’s website (Alnylam.ca/onpattro-monograph-en; Alnylam.ca/onpattro-monograph-fr) or by calling 1-877-256-9526.