Patient Medication Information: uses, side effects, how to take - Idhifa
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.
For the following indication IDHIFA 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.
IDHIFA is used to treat Acute Myeloid Leukemia (AML) in adults with a particular change (mutation) in the enzyme “IDH2”. AML is a form of cancer which affects your bone marrow and can cause problems with producing normal blood cells.
IDHIFA is used when your AML:
- has come back (relapsed) or,
- has not improved with another treatment (refractory).
How does IDHIFA work?
Normal “IDH2” enzyme plays an important role in making energy for cells. Changes (mutations) in the enzyme in the bone marrow can cause cancers such as AML. These changes cause the bone marrow to stop producing normal blood cells that fight infection or stop bleeding. IDHIFA blocks the mutated “IDH2” enzyme. This increases the number of normal blood cells.
This medicine should only be used to treat AML with the “IDH2” mutation. Therefore, before starting treatment your doctor will test for this mutation.
It may take up to six months to see the full effect of IDHIFA on your AML.
Talk to your healthcare professional if you have any questions about how IDHIFA works or why this medicine has been prescribed for you.
What are the ingredients in IDHIFA?
Medicinal ingredients: enasidenib (as enasidenib mesylate)
Non-medicinal ingredients: colloidal silicone dioxide, hydroxypropyl cellulose, hypromellose acetate succinate, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, sodium starch glycolate, talc and titanium dioxide
Serious Warnings and Precautions
Differentiation Syndrome Differentiation syndrome is a condition that affects your blood cells which may be life threatening or lead to death if not treated. Differentiation syndrome has happened within 1 day and up to 5 months after starting IDHIFA. Call your healthcare professional or go to the nearest hospital emergency room right away if you develop any of the following symptoms of differentiation syndrome while taking IDHIFA:
If you develop any of these symptoms of differentiation syndrome, your healthcare professional may start you on a medicine called corticosteroids and may monitor you in the hospital. You will be given a Patient Wallet Card and a Companion Wallet Card in the IDHIFA carton. The cards include space to record contact information for your healthcare professional and/or hospital/centre and lists Differentiation Syndrome signs and symptoms and treatment guidance. Keep the Patient Wallet Card with you at all times and share the Companion Card with a caregiver. You or your caregiver should show this card to any new healthcare professionals you see. |
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IDHIFA comes in the following dosage forms:
tablets: 50 mg or 100 mg
Do not use IDHIFA if:
You are allergic to enasidenib or any of the other ingredients of this medicine.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take IDHIFA. Talk about any health conditions or problems you may have, including if you:
are pregnant, or you or your partner are planning on becoming pregnant;
- are breastfeeding or planning to breastfeed. You should not breastfeed while taking IDHIFA and for 8 weeks after your last dose.
Your healthcare professional will do blood tests before you start taking IDHIFA and then every 2 weeks for at least the first 3 months to check for side effects.
Other warnings you should know about:
Pregnancy
You should not use IDHIFA during pregnancy. IDHIFA can cause harm to an unborn baby.
- If you are pregnant, think you may be pregnant or are planning to have a baby, ask your healthcare professional for advice before taking IDHIFA.
If you are female and of an age where you could get pregnant, your healthcare professional will have you take a pregnancy test before you start treatment with IDHIFA.
Birth Control
If you are a woman:
- Do not become pregnant while you are taking IDHIFA and for 8 weeks after your last dose. This is because IDHIFA may cause harm to an unborn baby.
- You must use an effective method of birth control during treatment with IDHIFA and for 8 weeks after your last dose.
- IDHIFA may affect how hormonal birth control methods work and may cause them not to work as well. Talk to your healthcare professional about birth control methods that may be right for you while you are taking IDHIFA.
If you are a man:
- Your partner(s) must not become pregnant while you are taking IDHIFA and for 8 weeks after your last dose. This is because IDHIFA may cause harm to an unborn baby.
- You must use an effective method of birth control during treatment and for 8 weeks after your last dose.
Talk to your healthcare professional about birth control methods that may be right for you while you are taking IDHIFA.
Fertility
IDHIFA may decrease your ability to have children. Talk to your healthcare professional for advice before taking it.
Driving and using machines
IDHIFA is not likely to affect you being able to drive, cycle or use any tools or machines. However, use caution until you know how IDHIFA affects you.
Tell your healthcare professional about all the medicines you take, including any drugs, vitmains, minerals, natural supplements or alternative medicines.
How to take IDHIFA:
- Take this medicine by mouth.
- Do not chew, split or crush the tablets.
- Swallow the tablets whole with water.
Take with or without food.
Usual adult dose: The recommended dose is 100 mg once a day.
Overdose:
| If you think you have taken too much IDHIFA, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
If you forget a dose of IDHIFA or vomit after taking a dose of IDHIFA, take the dose of IDHIFA as soon as posible on the same day then take your next dose the next day at your regularly scheduled time. Do not take 2 doses at the same time to make up for the missed dose.
What are possible side effects from using IDHIFA?
These are not all the possible side effects you may feel when taking IDHIFA. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- Decreased appetite
- Diarrhea
- Fatigue
- Nausea
- Vomiting
- Persistent, unpleasant, abnormal, or altered taste sensation
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 | |||
| Differentiation Syndrome: fever, cough, shortness of breath, swelling of arms and legs, swelling around neck, | √ | ||
| groin, or underarm area, fast weight gain (greater than 10 pounds within a week), bone pain, dizziness, feeling lightheaded | |||
| COMMON | |||
| Decrease in red blood cells (anemia): tiredness, fatigue | √ | ||
| Decrease in white blood cells (febrile neutropenia): fever, chills or sweating, sore mouth, infections | √ | ||
| Increase in the number of white cells (leukocytosis): fever | √ | ||
| Decrease in platelets that help with blood clotting (thrombocytopenia): easy bruising, bleeding from gums or nose, prolonged bleeding from cuts | √ | ||
Tumor lysis syndrome: lack of urination, severe muscle weakness, irregular heartbeat, seizures | √ | ||
| Dyspnea: shortness of breath at rest, labored breathing | √ | ||
| Low oxygen in your tissues (hypoxia): changes in the color of your skin, confusion, cough, fast heart rate, rapid breathing, shortness of breath, sweating, wheezing | √ | ||
| Excess fluid in the lungs (pulmonary edema): difficulty breathing at rest or that worsens when lying down, chest pain, pink/red frothy mouth mucus | √ | ||
| UNCOMMON | |||
| Jaundice (elevated blood bilirubin): yellowing of the skin or whites of the eyes | √ | ||
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 health 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 - 25°C). Keep the bottle tightly closed. Store in the original package in order to protect from moisture.
Keep out of reach and sight of children.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.
If you want more information about IDHIFA:
- 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 (http://www.canada.ca/en/health-canada.html); the manufacturer’s website www.celgene.ca, or by calling 1-877-923-5436.
- The information in this document is current as of the last revision date shown below.
® IDHIFA is a registered trademark of Celgene Corporation used under license by Celgene Inc.
Licensed from:
Agios Pharmaceuticals