Patient Medication Information: uses, side effects, how to take - Iclusig
What is ICLUSIG used for?
ICLUSIG is used to treat adults with chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). These patients will have leukemia that no longer benefits from treatment with other medicines.
How does ICLUSIG work?
ICLUSIG belongs to a group of medicines called tyrosine kinase inhibitors. In patients with CML and Ph+ ALL, the body produces abnormal white blood cells. ICLUSIG blocks a signal and stops the production of these abnormal white blood cells.
What are the ingredients in ICLUSIG?
Medicinal ingredients: Ponatinib
Non-medicinal ingredients: Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, talc, titanium dioxide
ICLUSIG comes in the following dosage forms:
Tablets; 15 mg and 45 mg ponatinib (as ponatinib hydrochloride)
Serious Warnings and Precautions
ICLUSIG should only be given under the supervision of a doctor experienced in the:
Serious side effects with ICLUSIG include the following:
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Do not use ICLUSIG if:
- you are allergic to ponatinib or to any other ingredient in this medicine or part of the container
- your doctor thinks you are at risk of heart problems
- you have high blood pressure that is not controlled by medication
- you are dehydrated or have severe vomiting, diarrhea, or sweating. This is more important if you have high uric acid in your blood.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ICLUSIG. Talk about any health conditions or problems you may have, including if you:
- have a liver or pancreas disorder, diabetes, or reduced kidney function
- have a history of alcohol abuse
- had a heart attack or stroke before, or surgery to restore blood supply after a blockage
- had a recent surgery or plan to have a medical procedure
- have a history of bleeding issues
- have a history of blood clots in your blood vessels or heart problems, including heart failure, angina or irregular heartbeats
- have high blood pressure
- have a history of high cholesterol or fats in your blood (called hypertriglyceridemia)
- have a history of narrowing of the blood vessels to one or both kidneys
are intolerant to milk sugar, or have one of the following rare hereditary diseases:
- Galactose intolerance
- Lapp lactase deficiency
- Glucose-galactose malabsorption
This is because lactose is a non-medicinal ingredient in ICLUSIG.
- have ever had or might now have a hepatitis B virus infection (a viral infection of the liver). This is because during treatment with ICLUSIG, hepatitis B virus may become active again, which can be fatal in some cases. Your doctor will check for signs of this infection before and during treatment with ICLUSIG.
- are over 65 years of age, as you may be more likely to have side effects.
Other warnings you should know about:
- Eye problems can occur while you are taking ICLUSIG. Tell your doctor without delay if you experience any blurred vision, dry eye, eye pain, or any other eye problem during treatment. You may need tests performed by an eye specialist (ophthalmologist).
Driving and using machines
Before doing tasks that require special attention, wait until you know how you respond to ICLUSIG. Blurred vision, visual disturbance, dizziness, mental status changes, and confusion can occur.
Pregnancy and Breast-Feeding:
Female patients:
- If you are pregnant, planning to get pregnant, or think you are pregnant, there are specific risks you should discuss with your healthcare professional.
- Avoid getting pregnant while you are taking ICLUSIG. It may harm your unborn baby.
Use effective birth control during your treatment with ICLUSIG. It is not known if ICLUSIG affects how birth control pills work. They may not work as well to prevent pregnancy when taken at the
- . Use a different or additional method of birth control during your treatment with ICLUSIG.
- It is not known if ICLUSIG passes into breast milk. Stop breast-feeding during your treatment.
Male patients:
- You should not father a child during your treatment with ICLUSIG.
- Use effective birth control during your treatment.
Fertility (ability to have a child) for women: ICLUSIG may make it harder to get pregnant. This has not been tested in humans.
Tests and check-ups: Before you start ICLUSIG, your healthcare professional will do blood tests and other assessments to check your eyes, heart and blood pressure. They will also test you for hepatitis B virus. If you test positive for hepatitis B virus, you may need to see a liver specialist before you start ICLUSIG.
During your treatment, you will have blood tests. These will be done every 2 weeks for the first few months of treatment or as directed by your doctor. Thereafter, the blood tests will be done about once per month or as directed by your doctor. These tests will tell your healthcare professional how your treatment is affecting your blood, liver and pancreas. Your healthcare professional will also monitor your blood pressure and check you for signs of swelling, blood clots and heart or eye problems.
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 ICLUSIG:
- medicines to treat fungal, viral (including HIV infection) or bacterial infections such as ketoconazole, itraconazole, voriconazole, posaconazole, nelfinavir, ritonavir, clarithromycin
- an herbal product used to treat depression called St. John’s Wort
- a medicine to treat epilepsy, euphoric/depressive stages and certain pain conditions called carbamazepine
- medicines to treat seizures such as phenobarbital, phenytoin
- medicines to treat tuberculosis or certain other infections such as rifabutin, rifampicin
- a medicine to treat heart weakness called digoxin
- a medicine to prevent blood clots called dabigatran
- a medicine to treat gout called colchicine
- medicines to lower high cholesterol levels such as pravastatin, rosuvastatin
- a medicine to treat severe joint inflammation (rheumatoid arthritis), cancer and the skin disease psoriasis called methotrexate
- a medicine to treat severe bowel and rheumatic joint inflammation called sulfasalazine
Avoid eating or drinking any products or juices that contain grapefruit, star fruit, pomegranate, Seville oranges or other similar fruit. They may interact with ICLUSIG.
How to take ICLUSIG:
Take ICLUSIG:
- exactly as your healthcare professional has told you. Ask your doctor, nurse or pharmacist if you are not sure.
once per day, with or without food.
- Swallow tablet(s) whole, with a glass of water.
- Do NOT crush or dissolve tablet(s).
This is a long-term treatment. Take ICLUSIG daily for as long as it is prescribed. Do not change your dose, unless your healthcare professional tells you to do so.
Usual starting dose: 45 mg once a day. Your starting dose might be lower if you have liver problems.
To make this dose, you may take either one 45 mg tablet or three 15 mg tablets.
Your doctor may reduce your dose or tell you to stop taking this medicine if you experience certain side effects. Your doctor may also adjust your dose based on your response to treatment. Other possible doses are:
30 mg a day: to make this dose, take two 15 mg tablets
15 mg a day: to make this dose, take one 15 mg tablet
Overdose:
| If you think you, or a person you are caring for, have taken too much ICLUSIG, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
Do not take two doses at the same time or take an extra dose to make up for a forgotten dose. Take your next dose at your usual time.
What are possible side effects from using ICLUSIG?
These are not all the possible side effects you may have when taking ICLUSIG. If you experience any side effects not listed here, tell your healthcare professional.
- headache, dizziness or spinning feeling, ringing in the ears, state of confusion
- inflammation of hair follicles, hair loss
- skin that is red, abnormally darkened, dry, itchy, blistered, peeling, scaly, rash
- fatigue, sleeplessness, lack of energy, weakness, general feeling of being unwell, either emotionally or physically, or a combination of the two (malaise)
- vomiting, diarrhea, abdominal distension, discomfort, indigestion, decreased appetite, weight loss, dehydration, unpleasant taste, dry mouth, inflammation in the mouth, stomach acid reflux, nausea, constipation
- cough, upper airway infection, difficulty producing voice sounds, breathing difficulties, chills, flu-like illness, fever
- dry or inflamed eyes
- hot flush, flushing, night sweats, increased sweating
- pain in bones, arms or legs, back, chest, neck, skeletal system, pain in joint, muscles
- pain in one or both legs when walking or exercising. This pain disappears after some rest.
- muscle spasms
- fluid retention in arms and/or legs
- inability to develop and maintain an erection
ICLUSIG can cause abnormal blood and urine test results. Your doctor will decide when to perform blood and urine tests and will interpret the results.
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 | |||
| Abdominal pain | √ | ||
| Thrombocytopenia (decreased number of blood cells called platelets): bleeding or easy bruising | √ | ||
| Anemia (decreased number of red blood cells): tiredness and lack of energy, shortness of breath, noticeable heartbeats, a pale complexion | √ | ||
| Neutropenia (low white blood cell count): fever, often with signs of infection | √ | ||
| Hypertension (increase or worsening of existing blood pressure): headache, dizziness, chest pain, or shortness of breath | √ | ||
| Hemorrhage (unusual bleeding or bruising of the skin): unusual nose bleed, eye bleeding, coughing or vomiting blood, unusual vaginal bleeding, pink or brown-coloured urine, red or black stools, drowsiness, confusion, headache, change in speech | √ | ||
| COMMON | |||
| Heart failure/Left ventricular dysfunction (heart does not pump blood as well as it should): swelling in ankles and legs, shortness of breath, cough, fluid retention, fatigue, lack of appetite, nausea | √ | ||
| Pericardial effusion (abnormal accumulation of fluid around the heart): difficult or painful breathing, chest pain, cough, dizziness, rapid heart rate | √ | ||
| Heart weakness, heart attack: pain or discomfort in chest, arms, back, neck, jaw or stomach, shortness of breath | √ | ||
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 | ||
| Pulmonary hypertension (high blood pressure that affects the blood vessels in the lungs and the right side of your heart): shortness of breath, fatigue, cough, chest pain, fainting and swelling of ankles and feet | √ | ||
| Coronary artery disease (narrowing of the heart blood vessels): uncomfortable pressure, fullness, squeezing or pain in your chest (angina) | √ | ||
| Pleural effusion (fluid in the chest): chest pain, cough, fever, hiccups, rapid breathing, shortness of breath | √ | ||
| Pancreatitis (inflammation of the pancreas): severe stomach and back pain, nausea and vomiting | √ | ||
| Arterial occlusive events (condition where arteries are narrowed or blocked): blood circulation problems, blood clot, chest pain, shortness of breath, weakness on one side of the body, speech problems, leg pain or swelling, pain, cold or numbness in the affected limb, limb may be pale or bluish, may result in amputations or need for surgery to restore blood supply by way of a blood vessel graft | √ | ||
| Pneumonia (lung infection): fever, cough, shortness of breath, chills, chest pain, fatigue | √ | ||
| Sepsis / septic shock (infection in blood): fever, rapid heart rate and breathing | √ | ||
| Arrhythmia (abnormal heart beat): rapid, irregular or slow | √ | ||
| Deep vein thrombosis (blood clot in a deep vein): swelling or pain in leg, ankle or foot, warmth or changes in skin color, such as turning pale, red or blue over affected area | √ | ||
| Pulmonary embolism (blood clot in a lung artery): chest pain, shortness of breath, cough, rapid breathing | √ | ||
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 | ||
| Stroke (bleeding in the brain due to a burst blood vessel, or a blockage in blood vessels supplying blood to the brain): trouble with speaking and understanding, weakness or numbness of face, arm or leg, trouble with seeing in one or both eyes, dizziness, severe headache, trouble with walking and loss of balance | √ | ||
| Neuropathy (damage to nerves): increased or reduced sense of touch, prickling, tingling, itching, numbness and pain in the hands and feet, muscle weakness, difficulty walking, convulsions | √ | ||
| UNCOMMON | |||
| Tumour lysis syndrome (the sudden, rapid death of cancer cells due to the treatment): nausea, shortness of breath, abnormal heartbeat, lack of urination, cloudy urine, muscle spasms or twitching, muscle weakness, joint pain, tiredness | √ | ||
| Eye disorder: blocked eye veins, dry eye, eye pain, blurred vision, visual disturbance, blindness, or cataract | √ | ||
| Stomach bleeding: blood in stool, vomiting blood, dark or tarry stool | √ | ||
| Liver damage: yellow skin and whites of eyes, nausea, tiredness, loss of appetite, fever, skin rash, joint pain and inflammation, pain in the upper right abdomen, pale stools and dark or tea-coloured urine | √ | ||
| Renal artery stenosis (narrowing of blood vessels supplying blood to the kidneys): high blood pressure, swelling | √ | ||
| Acute kidney injury (kidneys stop working): decreased urine, swelling of legs, ankles and/or eyes | √ | ||
| RARE | |||
| Artery dissection (tearing in an artery): sudden severe pain in the back, chest or abdomen | √ | ||
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 | ||
| Artery aneurysm (a bulge in the wall of any artery including in the chest, arms, legs, heart, and brain): Symptoms will differ by the site. There can be cough, coughing up blood. Strong pain high in your neck or in your back when you didn't hurt yourself. Problems swallowing. Hoarse voice. Unusual pulsing in your chest or abdomen. | √ | ||
| Gastrointestinal perforation or fistula (a hole in the wall of the gastrointestinal tract and/or leaking of stomach contents): severe abdominal pain, tenderness, diarrhea, nausea or vomiting, heartburn, bleeding | √ | ||
| Poor wound healing | √ | ||
| UNKNOWN FREQUENCY | |||
| Hepatitis B Virus Reactivation (a previous viral infection of the liver becomes active again): yellow skin and whites of eyes, nausea, tiredness, loss of appetite, fever, skin rash, joint pain and inflammation, pain in the upper right abdomen, pale stools and dark-coloured urine | √ | ||
| Posterior Reversible Encephalopathy Syndrome, PRES – also known as Reversible Posterior Leukoencephalopathy Syndrome, RPLS (a rare neurological disorder): headaches, seizures, confusion, changes in vision or problems thinking | √ | ||
| Erythema multiforme (an allergic skin reaction): raised red or purple skin patches, possibly with blister or crust in the center. Possibly swollen lips. Mild itching or burning. | √ | ||
| Stevens Johnson syndrome (severe skin reaction): rash, red skin, red or purple skin patches possibly with blister or crust in the center, pus-filled rash, peeling skin, blisters on the lips, eyes, skin or in the mouth, itching, burning, flu-like feeling, fever. | √ | ||
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 | ||
| Squamous cell carcinoma (a form of cancer): red bump on the skin, red or scaly patch of skin, a sore that doesn’t heal, wart-like sores | √ | ||
| Panniculitis (inflammation of fatty tissue under the skin): painful red lumps, skin pain, skin reddening | √ | ||
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:
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 ICLUSIG at room temperature between 15° to 30°C in the original container.
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the bottle label after EXP. The expiry date refers to the last day of that month.
If you want more information about ICLUSIG:
- 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.takeda.com/en-ca, or by calling 1-800-268-2772 (English and French).
ICLUSIG® is a registered trademark of ARIAD Pharmaceuticals, Inc.
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Imported and distributed by: Takeda Canada Inc., Toronto, ON M5H 4E3