Additional heart side effects included heart failure and an accumulation of fluid in the body.
Severe liver injury also occurred in some people who took Iclusig.
TKIs are a type of targeted therapy often used in cancer treatment. Iclusig works by targeting and blocking the activity of several tyrosine kinases, which are proteins that promote cell growth, on the surface of cancer cells.
Iclusig comes in tablet form for oral use.
What Is Iclusig Used For?
The Food and Drug Administration (FDA) approved Iclusig for use in adults for four indications:
Brand Name(s): Iclusig
Drug Availability: Prescription
Therapeutic Classification: Tyrosine kinase inhibitor (TKI)
Available Generically: No
Controlled Substance: N/A
Administration Route: Oral
Active Ingredient: Ponatinib
Dosage Form(s): Tablets
Chronic phase CML in which at least two other TKIs have become resistant or were not tolerated Accelerated or blast phase CML or Philadephia chromosome-positive (Ph+) CML where no other TKIs are appropriate for use T315I-positive CML T315I-positive Ph+ ALL
Iclusig is not approved to treat newly diagnosed chronic phase CML.
How to Take Iclusig
Iclusig is usually taken once a day around the same time each day. You can take it with or without food, but do not crush, chew, or break the tablets. Swallow the tablet whole. Avoid taking grapefruit products, such as grapefruit juice, while taking Iclusig. Grapefruit may increase exposure to the medication, which can result in side effects.
Storage
Store Iclusig at room temperature (68 F to 77 F) and keep the tablets in their original packaging.
What Are the Side Effects of Iclusig?
This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.
Common Side Effects
The most common side effects experienced when taking Iclusig include:
Joint pain Rash or dry skin Headache Constipation Feeling tired Nausea Elevated blood pressure (hypertension) Swelling in the hands, ankles, or body Bleeding Blood clots Liver problems Inflammation of the pancreas (pancreatitis)
The most common lab abnormalities associated with Iclusig include low red blood cell (anemia), low platelet, and low white blood cell counts.
Severe Side Effects
More serious or severe side effects can happen when taking Iclusig. Call your healthcare provider immediately if you’re having serious side effects, or call 911 if you feel your symptoms are life-threatening. Serious side effects and symptoms can include the following:
Blood clots: Chest pain, stroke symptoms, leg swelling, and severe abdominal pain Heart failure or irregular heart rate: Swelling, shortness of breath, and palpitations Liver problems: Yellowing of the eyes or skin (jaundice), bleeding, bruising, and abdominal pain High blood pressure: Dizziness, headaches, chest pain, and confusion Pancreas inflammation: Stomach pain, nausea, and vomiting Neuropathy (nerve damage or impairment): Numbness or tingling in the hands or feet, vision problems, drooping of the face or eyelid, and taste changes Eye problems: Bleeding in the eye, blurred vision, dryness, light flashes, itchiness, pain, and swelling Bleeding: Vomiting or coughing up blood, significant bruising, frequent nose bleeds, blood in the urine or stool, and heavy menstrual bleeding Fluid retention (edema): Swollen arms, legs, or face; shortness of breath; and cough Irregular heartbeat: Palpitations, chest pain, and dizziness Wound healing problems Tear in stomach or intestine wall: Abdominal pain or swelling and fever Reversible posterior leukoencephalopathy syndrome: Confusion, seizures, headaches, and vision changes
Dosage: How Much Iclusig Should I Take?
Modifications
Dosage adjustments may be necessary for:
If you experience a serious side effect, you or your healthcare provider may send a report to the FDA’s MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For oral dosage form (tablets): For treatment of leukemia: Adults—At first, 45 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated. Children—Use and dose must be determined by your doctor.
Side effects: If you experience side effects, your healthcare provider may adjust your dose of the medication, depending on the severity of the side effect. Liver impairment: If you have pre-existing liver disease, your healthcare provider may reduce the starting dose of Iclusig. Breastfeeding: Do not breastfeed during treatment with ponatinib. Wait for six days following the last dose to start breastfeeding. Interacting medications: The dose may also need to be modified if you take other medications that can interact with Iclusib.
Iclusic can cause fetal harm if taken during pregnancy. If you are of reproductive potential, using effective contraception during treatment is recommended. Contact your healthcare provider immediately if you become pregnant.
Missed Dose
If a dose of Iclusig is missed, it needs to be skipped and taken the next day at the usual scheduled time. The dose should never be doubled to make up for a missed dose.
Overdose: What Happens If I Take Too Much Iclusig?
If you take too much Iclusig, notify your healthcare provider and seek medical attention immediately. You may need to be monitored by a medical professional and receive supportive treatment.
Precautions
What Are Reasons I Shouldn’t Take Iclusig?
Do not take Iclusig if you:
If someone collapses or isn’t breathing after taking Iclusig, call 911 immediately.
Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use a highly effective form of birth control to keep from getting pregnant during treatment and for 3 weeks after your last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine may cause blood clotting problems. Check with your doctor right away if you have chest pain, numbness or weakness in your arm, leg, or on one side of your body, trouble breathing, speech problems, or leg pain or swelling.
Check with your doctor right away if you have stomach pain, pale stools or dark urine, a loss of appetite, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause fluid retention and heart failure. Check with your doctor if you are rapidly gaining weight, have chest pain or discomfort, extreme tiredness or weakness, trouble breathing, or swelling of the hands, wrist, ankles, or feet. These may be symptoms of heart problems or too much water in your body.
Pancreatitis may occur with this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
Check with your doctor immediately if you have vision changes, such as blurred vision, difficulty reading, or eye pain, dryness, irritation, or swelling, during treatment. Your doctor may want you to have your eyes checked by an eye doctor.
Check with your doctor right away if you are having decreased or increased sensitivity to pain or touch, or burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a nerve problem (eg, cranial or peripheral neuropathy).
Ponatinib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination. Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin. Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done. Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime. Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters. Avoid contact sports or other situations where bruising or injury could occur.
This medicine may increase your chance of having blood clots or a brain condition called reversible posterior leukoencephalopathy syndrome (RPLS). Tell your doctor right away if you develop sudden and severe headaches, fainting spells, seizures, unusual drowsiness, confusion, or problems with vision, speech, or walking while you are using this medicine.
This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.
This medicine may affect the way your body heals from cuts and wounds. Make sure any doctor who treats you knows that you are using this medicine. You might need to stop using this medicine several weeks before having surgery. If you have questions about this, talk to your doctor.
If you plan to have children, talk with your doctor before using this medicine. Some women using this medicine have become infertile (unable to have children).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Are pregnant or breastfeeding Are lactose intolerant, as it contains lactose Surgery is planned within the same week
What Other Medications Interact With Iclusig?
When taken together, other medications may affect how Iclusig works and vice versa.
Drugs known as strong cytochrome P450 3A (CYP3A) inhibitors can increase concentrations of Iclusig in the blood, which may result in adverse reactions. Ketoconazole and grapefruit juice are examples of potent CYP3A inhibitors.
Additionally, strong CYP3A inducers can decrease concentrations of Iclusig, thereby reducing the Iclusig’s efficacy. These include:
Rifampin Tegretol (carbamazepine) Dilantin (phenytoin) St. John’s Wort Dexamethasone
This is not a complete list of drug interactions that can occur with Iclusig. Share all your medications, including OTC and prescription products, vitamins, and herbal supplements, with your healthcare provider.
What Medications Are Similar?
There are other medications in the same class as Iclusig, which are used to treat CML. These medications include:
Gleevec (imatinib)Tasigna (nilotinib)Bosulif (bosutinib)Sprycel (dasatinib)
How Can I Stay Healthy While Taking Iclusig?
Taking care of yourself when you have CML or ALL is very important. Taking Iclusig as prescribed is a critical component of your treatment.
FatigueSkin rash or dry skinNauseaHeart problemsConstipationHigh blood pressureInflammation of the pancreasBlood clotsLiver problems
While taking this medication, follow all the instructions given to you by your healthcare provider. It can be scary or overwhelming to start a new cancer treatment, especially due to the potential side effects. Talk to your oncology team about what to expect and contact them if you start experiencing any adverse effects.
