Generic Name: ponatinib (poe-NA-ti-nib)
Brand Name: Iclusig
Serious and sometimes fatal blood clots or blocked blood vessels (including heart attack and stroke) have occurred in patients taking Iclusig. Some people have needed emergency surgery or treatment in a hospital. These effects can happen in people with and without risk factors (including people 50 years old or younger). Contact your doctor right away if you experience chest pain or pressure; jaw, arm, leg, back, or neck pain; confusion; fast, slow, or irregular heartbeat; fainting; numbness or weakness on one side of your body; shortness of breath; trouble talking; unusual dizziness, headache, or stomach pain; or vision problems.
Serious and sometimes fatal heart failure and liver problems have occurred in patients taking Iclusig. You will need to have your heart and liver function checked before treatment and while you take Iclusig. Contact your doctor right away if you experience symptoms of heart failure (eg, shortness of breath, a big weight gain, swelling in the arms or legs) or symptoms of liver problems (eg, dark urine; drowsiness; pale stools; persistent loss of appetite; unusual nausea, vomiting, or stomach pain; yellowing of the skin or eyes).
Iclusig is used for:
Treating certain types of leukemia in certain patients. It may also be used for other conditions as determined by your doctor.
Iclusig is a kinase inhibitor. It works by preventing the growth of cancer cells.
Do NOT use Iclusig if:
- you are allergic to any ingredient in Iclusig
Contact your doctor or health care provider right away if any of these apply to you.
Before using Iclusig:
Some medical conditions may interact with Iclusig. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are able to become pregnant
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you are lactose intolerant
- if you have a history of heart problems (eg, heart failure, irregular or slow heartbeat), a heart attack, stroke, "mini-stroke" or transient ischemic attack, blood vessel problems (eg, those in the brain or heart), or blood clots
- if you have high blood pressure, high blood cholesterol or lipid levels, diabetes, or bleeding problems
- if you have a history of liver or kidney problems, pancreas inflammation (pancreatitis), eye or vision problems, stomach or bowel problems (eg, tears, fistula), or alcohol abuse
- if you have bone marrow problems, low white blood cell levels, low blood platelet levels, or anemia
- if you plan to have surgery or if you have had recent surgery
Some MEDICINES MAY INTERACT with Iclusig. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Azole antifungals (eg, itraconazole, ketoconazole, voriconazole), cobicistat, conivaptan, macrolide antibiotics (eg, clarithromycin), mifepristone, nefazodone, protease inhibitors (eg, boceprevir, ritonavir), or telithromycin because they may increase the risk of Iclusig's side effects
- Antacids, carbamazepine, enzalutamide, H2 blockers (eg, famotidine, ranitidine), hydantoins (eg, phenytoin), phenobarbital, primidone, proton pump inhibitors (eg, omeprazole), rifamycins (eg, rifampin), or St. John's wort because they may decrease Iclusig's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Iclusig may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Iclusig:
Use Iclusig as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Iclusig comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Iclusig refilled.
- Take Iclusig by mouth with or without food.
- Swallow Iclusig whole. Do not break, crush, chew, or dissolve before swallowing.
- Check with your doctor before you eat grapefruit or drink grapefruit juice while you use Iclusig.
- Continue to take Iclusig even if you feel well. Do not miss any doses.
- If you miss a dose of Iclusig, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Iclusig.
Important safety information:
- Iclusig may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Iclusig with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do NOT change your dose or stop taking Iclusig without checking with your doctor.
- Tell your doctor or dentist that you take Iclusig before you receive any medical or dental care, emergency care, or surgery. You may need to stop Iclusig for a period of time before planned surgery as directed by your doctor. Your doctor will decide when you should start to take it again.
- Iclusig may cause serious eye or vision problems such as blurred vision or loss of vision. Tell your doctor if you develop flashes of light, floaters in your vision, sensitivity to light, dry or itchy eyes, or eye pain.
- Iclusig may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Severe and sometimes fatal bleeding has been reported in patients taking Iclusig. Avoid activities that may cause bruising or bleeding. Contact your doctor right away if you develop blood in the urine; coughing or spitting up blood; dark, tarry, or bloody stools; menstrual bleeding that is heavier than normal; nosebleeds that happen often; pink or brown urine; unusual vaginal bleeding; other unusual bruising or bleeding; or vomiting blood or vomit that looks like coffee grounds.
- A serious and possibly fatal condition called tumor lysis syndrome has been reported in certain patients taking Iclusig. Contact your doctor right away if you develop symptoms such as fast or irregular heartbeat; fainting; decreased urination; muscle weakness or cramps; nausea, vomiting, diarrhea, or loss of appetite; or sluggishness. Discuss any questions or concerns with your doctor.
- If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
- If you may become pregnant, you must use an effective form of birth control while taking Iclusig. If you have questions about effective birth control, talk with your doctor.
- Lab tests, including blood pressure, heart function, liver function, pancreas function, complete blood cell counts, and eye exams, may be performed while you use Iclusig. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Iclusig with caution in the ELDERLY; they may be more sensitive to its effects, especially blocked blood vessels; loss of appetite; muscle spasms; shortness of breath; swelling of the hands, feet, ankles, or legs; unusual bruising or bleeding; or weakness.
- Iclusig should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Iclusig may cause harm to the fetus. Do not become pregnant while you are taking it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Iclusig while you are pregnant. It is not known if Iclusig is found in breast milk. Do not breast-feed while taking Iclusig.
Possible side effects of Iclusig:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; diarrhea; dry skin; headache; joint pain; mild muscle pain or spasms; mild stomach pain; nausea; tiredness; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; bone pain; calf or leg pain, redness, swelling, or tenderness; chest, jaw, arm, back, or neck pain; confusion; difficult or painful urination; dizziness; drooping eyelids or parts of the face; drowsiness; fainting; fast, slow, or irregular heartbeat; fever, chills, or cough, or sore throat; light-headedness; mouth or tongue swelling or soreness; muscle weakness, tingling, burning, or pain or loss of feeling in your hands or feet; one-sided numbness or weakness; severe or persistent headache; severe or persistent stomach or back pain (with or without nausea or vomiting); shortness of breath; speech problems (eg, slurred speech); stomach swelling; sudden, severe nausea or vomiting; sudden, unusual weight gain; swelling of the hands, feet, or ankles, or all over your body; symptoms of liver problems (eg, dark urine; drowsiness; pale stools; persistent loss of appetite; unusual stomach pain; yellowing of the skin or eyes); trouble moving the eye; unusual sweating, tiredness, or weakness; vision problems (eg, blurred or double vision; loss of vision); vomiting blood or vomit that looks like coffee grounds.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Iclusig:
Store Iclusig at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Iclusig out of the reach of children and away from pets.
- If you have any questions about Iclusig, please talk with your doctor, pharmacist, or other health care provider.
- Iclusig is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Iclusig or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Iclusig. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Iclusig. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Iclusig.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.