Iclusig (Ponatinib Hydrochloride)
Complete patient guide for uses, dosage, side effects, and safety information
Prescription RequiredQuick Facts
What Is Iclusig Used For?
Iclusig is a targeted cancer medication that treats specific types of blood cancers in adults who are no longer responding to other treatments.
Primary Uses
Iclusig treats adults with chronic myeloid leukemia (CML) – a blood cancer with too many abnormal white blood cells in the blood and bone marrow, and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) – a type of leukemia with too many immature white blood cells. Both conditions involve DNA changes that create an abnormal chromosome called the Philadelphia chromosome.
How It Works
Iclusig blocks the signal that tells your body to produce abnormal white blood cells. In patients with CML and Ph+ ALL, DNA changes trigger signals for abnormal white blood cell production. By blocking these signals, Iclusig stops the production of these harmful cells.
Prescription Only: This medicine is only available with a prescription from a doctor experienced with leukemia treatment.
How to Take Iclusig
Take Iclusig exactly as prescribed by your doctor. Follow all directions carefully and ask your doctor or pharmacist if you have questions.
Dosage Instructions
The recommended starting dose is one 45 mg tablet once daily. Take at about the same time each day for best results. Swallow tablets whole with water – do not crush or dissolve them. You can take with or without food. Your doctor may reduce your dose or temporarily stop treatment if you develop side effects or if your blood cell counts become too low.
What If You Miss a Dose?
If you miss a dose, take it as soon as you remember, then return to your normal schedule. If it’s less than 12 hours before your next dose, skip the missed dose and take your next dose at the regular time. Continue taking your medicine for as long as your doctor tells you, even if you feel well.
Important: Never take a double dose to make up for a missed dose. This may increase your chance of side effects.
Available Tablet Strengths
Side Effects
Like all medications, this medicine can cause side effects. Most are mild and temporary, but some require medical attention.
Common Side Effects
These side effects occur relatively frequently and usually don’t require emergency care:
- Upper respiratory tract infection
- Anemia and changes in blood cell levels
- Decreased appetite
- Sleeplessness
- Headache
- Dizziness
- Cough and shortness of breath
- Stomach pain, constipation, nausea, diarrhea, vomiting
- Rash, dry skin, itching
- Pain in bones, joints, muscles, or back
- Muscle spasms
- Tiredness, fever, weakness
- Swelling of legs or arms
- Hot flushes, night sweats
- Hair loss
- Dry mouth, mouth inflammation
Seek immediate medical attention if you experience:
- Lung infection (pneumonia)
- Sudden severe headache, seizures
- Lethargy, confusion, problems thinking
- Eye or vision changes (blurred vision, vision loss, dry eye, eye pain)
- Eyelid or face swelling
- Speech changes or difficulty talking
- Dizziness, feeling faint, decreased alertness
- Chest pain or pressure
- Heart rate changes, blood clots
- Breathing difficulties
- Weakness on one side of body
- Numbness or loss of fine motor skills
- Unusual bleeding (blood in stool, vomiting blood, easy bruising, nosebleeds)
- Fever with infection signs, chills
- Yellow skin and/or eyes
- Severe stomach pain, fluid buildup around stomach
- Dark-colored urine
- Leg, ankle, or foot swelling
- Painful rash, blistering, mouth sores
- Aneurysm or artery tear symptoms
Important Warnings
Iclusig has serious risks that require careful monitoring. Your doctor will discuss these risks and monitor you closely during treatment.
Who Should Not Take Iclusig
Do not take Iclusig if you are allergic to ponatinib or any ingredients in the tablets. Always check the ingredient list to make sure you can safely use this medicine.
Medical Conditions to Discuss
Tell your doctor if you have: history of blood clots in blood vessels, heart problems (heart failure, irregular heartbeats, QT prolongation, prior heart attack), history of stroke, history of aneurysm or blood vessel wall tear, high blood pressure, diabetes, high cholesterol, bleeding problems, liver disease, kidney problems (including narrowed blood vessels to kidneys), pancreas disorder, history of alcohol abuse, or ever had hepatitis B (it may become active again during treatment).
Pregnancy and Breastfeeding
Women of childbearing age should avoid becoming pregnant during treatment as risks exist for the unborn child. Men should avoid fathering a child during treatment. You and your partner must use effective contraception. Contraceptive pills may not work as well with Iclusig, so use additional contraception methods. Do not breastfeed during treatment as it’s unknown if Iclusig passes into breast milk.
Serious Cardiovascular Risks: Iclusig can cause life-threatening blood vessel problems including heart attack, stroke, severe circulation problems (sometimes requiring amputation), vision loss, and events requiring emergency surgery. Some of these events have been fatal. It can also cause blood clots, heart failure, high blood pressure, and liver toxicity including liver failure.
Drug Interactions
Many medications can interact with Iclusig and affect how it works. Tell your doctor about all medicines, vitamins, and supplements you take.
Grapefruit Interaction: Avoid grapefruit, star fruit, pomegranate, Seville oranges, and similar fruits or their juices. These can alter how your body processes Iclusig.
- Antifungal medicines (ketoconazole, itraconazole, voriconazole)
- HIV medicines (atazanavir, indinavir, nelfinavir, ritonavir, saquinavir)
- Antibiotics (clarithromycin and similar antibiotics)
- Depression medicines including St. John’s Wort
- Epilepsy medicines (carbamazepine, phenobarbital, phenytoin)
- Tuberculosis medicines (rifabutin, rifampicin)
- Stomach acid medicines (omeprazole, pantoprazole, lansoprazole, ranitidine, cimetidine, famotidine, aluminum and magnesium hydroxides)
- Heart medicine (digoxin)
- Blood clot prevention medicine (dabigatran)
- Gout medicine (colchicine)
- Cholesterol medicines (pravastatin, rosuvastatin)
- Arthritis/cancer medicine (methotrexate)
- Bowel inflammation medicine (sulfasalazine)
Alcohol & Driving
Use caution with alcohol and when driving or operating machinery while taking Iclusig.
Alcohol
Tell your doctor if you have a history of alcohol abuse, as this is important information for your treatment plan.
Driving and Operating Machinery
Be careful driving or operating machinery until you know how Iclusig affects you. This medicine may cause dizziness, tiredness, blurred vision, visual impairment, mental status changes, or confusion in some people.
Storage
Store tablets in the original container to protect from light. Keep in a cool, dry place where temperature stays below 30°C. Do not store in the bathroom, near a sink, on a windowsill, or in a car, as heat and dampness can destroy the medicine. Keep out of reach of children. Do not use after the expiry date.
Overdose Information
If you think you have taken too much Iclusig, seek urgent medical attention immediately. Phone the Poisons Information Centre (13 11 26), contact your doctor, or go to the Emergency Department at your nearest hospital, even if you have no symptoms of discomfort or poisoning.
Frequently Asked Questions
Your doctor will monitor your progress with regular blood tests and check-ups to see how well Iclusig is working. Blood counts are checked every 2 weeks for the first 3 months, then monthly. The timeline for response varies by individual and condition.
Yes, you can take Iclusig with or without food. It doesn’t matter if you take it before or after eating.
Do not stop taking Iclusig without talking to your doctor first. It’s important to keep taking your medicine even if you feel well, as stopping suddenly could allow your leukemia to progress.
Tell your doctor if you have a history of alcohol abuse. While the medication information doesn’t specifically prohibit alcohol, it’s important to discuss your alcohol use with your doctor.
Take the missed dose as soon as you remember, then return to your normal schedule. If it’s less than 12 hours before your next dose, skip the missed dose. Never take a double dose to make up for a missed one.
If you are over 65 years of age, you may have an increased chance of getting side effects. Your doctor will monitor you closely and may adjust your treatment as needed.
Your doctor will perform regular tests including blood counts every 2 weeks for 3 months then monthly, heart function checks, liver function tests, blood pressure monitoring at every visit, and lipase level measurements every 2 weeks for 2 months then regularly.
Important Disclaimer
This information is intended for general educational purposes only and should not be considered medical advice. Always consult your healthcare provider or pharmacist before starting, stopping, or changing any medication.
If you think you may have a medical emergency, call your doctor or emergency services immediately.