Patient Medication Information: uses, side effects, how to take - Iqirvo
What is IQIRVO used for?
What is a Notice of Compliance with Conditions (NOC/c)?
A Notice of Compliance with Conditions (NOC/c) is a type of approval to sell a drug in Canada.
Health Canada only gives an NOC/c to a drug that treats, prevents, or helps identify a serious or life-threatening illness. The drug must show promising proof that it works well, is of high quality, and is reasonably safe. Also, the drug must either respond to a serious medical need in Canada, or be much safer than existing treatments.
Drug makers must agree in writing to clearly state on the label that the drug was given an NOC/c, to complete more testing to make sure the drug works the way it should, to actively monitor the drug’s performance after it has been sold, and to report their findings to Health Canada.
How does IQIRVO work?
IQIRVO, used to treat primary biliary cholangitis (PBC), contains the active substance elafibranor. Elafibranor is a medicine that targets the liver. This medicine helps to improve how your liver works by reducing the amount of bile acid produced by the liver and reducing the build-up of bile. It also acts by reducing inflammation of the liver. This may slow or prevent progression of the disease.
What are the ingredients in IQIRVO?
Medicinal ingredients: elafibranor
Non-medicinal ingredients: Anhydrous colloidal silica, Croscarmellose sodium, Iron oxide red,
For the following indication IQIRVO has been approved with conditions (NOC/c). This means it has passed Health Canada’s review and can be bought and sold in Canada, but the manufacturer has agreed to complete more studies to make sure the drug works the way it should. For more information, talk to your healthcare professional.
- IQIRVO is used to treat adult patients with a liver disease called primary biliary cholangitis (PBC). It is used along with another medicine, ursodeoxycholic acid (UDCA), in patients who have not responded well to UDCA. Or, it is used alone in patients who are not able to tolerate UDCA.
Iron oxide yellow, Macrogol, Magnesium stearate, Microcrystalline cellulose, Polyvinyl alcohol-part hydrolyzed, Povidone, Talc, Titanium dioxide
IQIRVO comes in the following dosage forms:
Tablets; 80mg.
Do not use IQIRVO if:
- You are allergic to elafibranor.
- You are allergic to any of the other ingredients in IQIRVO or to any part of the container.
- You are pregnant or plan to become pregnant.
- You could become pregnant and are not using effective birth control. See “Other warnings you should know about, Pregnancy” for more information.
- You have advanced liver disease called decompensated cirrhosis.
IQIRVO is not approved for use in patients 17 years of age and younger. It is not known if IQIRVO is safe and effective in these patients.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take IQIRVO. Talk about any health conditions or problems you may have, including if you:
- Have a blockage of bile flow called a complete biliary obstruction.
- Have received a liver transplant.
Other warnings you should know about:
Birth Control
IQIRVO may affect how well ethinylestradiol-containing birth control works. If you are taking IQIRVO and you are able to get pregnant, use effective non-hormonal birth control or hormonal birth control that does not contain ethinylestradiol.
Pregnancy
You must not take IQIRVO if you are pregnant or are planning to become pregnant. This is because IQIRVO may harm your unborn baby. Your healthcare professional will make sure you are not pregnant before you start taking IQIRVO. You must use effective birth control while you are taking IQIRVO and for 3 weeks after you stop taking it. You must use a non-hormonal birth control method like a condom. If you take hormonal birth control you must also use a non-hormonal birth control method. Talk to your healthcare provider about effective birth control methods. Tell your healthcare professional right away if you do get pregnant while you are taking IQIRVO.
Breastfeeding
You must not breastfeed your baby while you are taking IQIRVO and for 3 weeks after you stop taking it. It is not known if IQIRVO passes into breastmilk. Talk with your healthcare provider about the best way to feed your baby while you are taking IQIRVO.
Muscle Problems
IQIRVO can cause an increase in an enzyme in your blood called creatine phosphokinase (CPK). It can also cause a condition called rhabdomyolysis. Your healthcare professional will monitor your CPK levels before you take IQIRVO and while you are taking it. Before you take
IQIRVO, tell your healthcare professional if you are taking a medicine called a statin, used to lower cholesterol. Taking a statin along with IQIRVO can increase your risk of getting rhabdomyolysis. Talk to your healthcare professional if you get any of the following symptoms: muscle pain / soreness, weakness, swelling, dark tea-coloured (brown) urine, fatigue. Your healthcare professional may ask you to interrupt or stop taking IQIRVO. Stop taking IQIRVO and get immediate medical help if rhabdomyolysis is suspected.
Liver Problems
IQIRVO can cause liver problems. Your healthcare professional will monitor your liver function before you start taking IQIRVO and while you are taking it. Talk to your healthcare professional if you get any of the following symptoms: nausea, vomiting, weight loss, abdominal pain, fatigue, itching. Your healthcare professional may ask you to interrupt or stop taking IQIRVO. Stop taking IQIRVO and get immediate medical help if you get yellowing of the skin or eyes, or dark urine.
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 IQIRVO:
- Rifampin, used to treat bacterial infections.
- Bile acid sequestrants, used to lower cholesterol levels.
How to take IQIRVO:
- Take IQIRVO exactly as your healthcare professional tells you to.
You can take IQIRVO with or without food.
- Swallow tablets whole with water. Do not crush the tablets.
- If you also take a medicine called a bile acid sequestrant, take IQIRVO at least 4 hours before or 4 hours after taking the bile acid sequestrant. If this is not possible, space the time between taking IQIRVO and your bile acid sequestrant as far apart as possible.
- Follow all instruction given to you by your healthcare professional.
Usual dose:
The usual adult dose is one tablet taken once a day, at about the same time each day.
Overdose:
| If you think you, or a person you are caring for, have taken too much IQIRVO, 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 forget to take a dose, skip the missed dose. Take your next dose at its scheduled time. Never take a double dose to make up for a missed dose.
What are possible side effects from using IQIRVO?
These are not all the possible side effects you may feel when taking IQIRVO. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- Heartburn
- Regurgitation
- Abdominal pain
- Dry mouth
- Joint pain
- Weight gain or weight loss
- Dizziness
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 | ||
| COMMON | |||
| Fracture (a break or crack in a bone) | X | ||
| Gallstones: abdominal pain, nausea, vomiting. | X | ||
| Liver problems: nausea, vomiting, weight loss, abdominal pain, fatigue, yellowing of the skin or eyes, dark urine, itching. | X | ||
| Increased creatine phosphokinase (CPK) (higher level of enzyme in blood that is usually found in your muscles): muscle weakness, swelling, fatigue. | X | ||
| Myalgia (muscle pain): muscle aches, pains or soreness, stiffness, muscle weakness, cramping. | X | ||
| UNCOMMON | |||
| Allergic reaction: swelling of the face, tongue or throat, shortness of breath, difficulty breathing, chest tightness, flushing, nausea, headache, skin rash, hives, itching. | X | ||
| Anemia (decreased number of red blood cells): fatigue, loss of energy or weakness, looking pale, shortness of breath. | X | ||
| Rash | X | ||
| RARE | |||
| Kidney Problems: reduced urine output, swelling, fatigue, nausea, vomiting, confusion, back or abdominal pain. | X | ||
| Rhabdomyolysis (breakdown of damaged muscle): muscle pain / soreness, muscle weakness, swelling, dark-coloured urine, fatigue. | X | ||
| VERY RARE | |||
| Biliary obstruction (blockage of bile ducts): abdominal pain, yellowing of the skin or eyes, dark urine, pale stools, nausea, vomiting, fever, itching, loss of appetite. | 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, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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 - 30°C). Keep out of reach and sight of children.
If you want more information about IQIRVO:
- 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 www.ipsen.ca, or by calling 1-855-215-2288.