Iclusig

The recommended starting dose of Iclusig (Ponatinib) is 45 mg taken by mouth once daily. Your doctor may lower your dose depending on the side effects you experience. Iclusig (Ponatinib) may be taken with food or on an empty stomach, but the tablets must be swallowed whole with fluids. Do not crush, chew, or dissolve the tablets when taking them.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Iclusig (Ponatinib) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

15 mg
Each white, biconvex, round, film-coated tablet, approximately 6 mm in diameter, with “A5” debossed on one side, contains 15 mg of Iclusig (Ponatinib) as Iclusig (Ponatinib) hydrochloride. Nonmedicinal ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, colloidal anhydrous silica, and magnesium stearate; coating: talc, polyethylene glycol, polyvinyl alcohol, and titanium dioxide (E171).

45 mg
Each white, biconvex, round, film-coated tablet, approximately 9 mm in diameter, with “AP4” debossed on one side, contains 45 mg Iclusig (Ponatinib) as Iclusig (Ponatinib) hydrochloride. Nonmedicinal ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, colloidal anhydrous silica, and magnesium stearate; coating: talc, polyethylene glycol, polyvinyl alcohol, and titanium dioxide (E171).

Do not take Iclusig (Ponatinib) if you:

• are allergic to Iclusig (Ponatinib) or any ingredients of the medication
• have any risk factors for heart disease that are not controlled, such as high blood pressure
• have untreated, high levels of uric acid in the blood
• are dehydrated

There may be an interaction between Iclusig (Ponatinib) and any of the following:

• Apalutamide
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• bacillus Calmette-Guérin (BCG) (intravesical)
• birth control pills
• Carbamazepine
• Clozapine
• Cobicistat
• Deferiprone
• Enzalutamide
• grapefruit juice
• HIV protease inhibitors (atazanavir, darunavir, lopinavir, ritonavir)
• Idelalisib
• lumacaftor
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• mifepristone
• Mitotane
• Phenobarbital
• Phenytoin
• primidone
• rifabutin
• rifampin
• St. John's wort

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Iclusig (Ponatinib). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Iclusig (Ponatinib).

Anemia: Iclusig (Ponatinib) may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Bleeding: Iclusig (Ponatinib) can reduce the number of platelet cells in the blood. Platelets help the blood to clot, and a shortage could make you bleed more easily. Tell your doctor about any signs that your blood is not clotting as quickly as usual. Such symptoms may include black and tarry stools, blood in the urine, easy bruising, or cuts that won't stop bleeding. Uncontrolled bleeding in the brain can be a cause of stroke. If you experience symptoms of a stroke such as slurred speech, sudden blurred vision, lack of coordination, or difficulty speaking, get medical help immediately.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including platelets, in your blood.

Blood Clots: Iclusig (Ponatinib) may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities. The most serious conditions that can be caused by blood clots are stroke, heart attack, and pulmonary Embolism (blood clot in the lung).

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, or sudden blurred vision, get medical help immediately.

If you have risk factors for experiencing blood clots, such as angina, high blood pressure, Diabetes, or high levels of blood cholesterol, discuss with your doctor how Iclusig (Ponatinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Iclusig (Ponatinib), and whether any special monitoring is needed.

Fluid retention: Excess fluid may build up in the body as a result of taking Iclusig (Ponatinib). Swelling in the feet, legs, or ankles or difficulty breathing may be signs of this happening. Contact your doctor if you experience this.

Gastrointestinal problems: Rarely, Iclusig (Ponatinib) can cause perforation of the stomach or intestines. If you experience severe abdominal pain, fever, vomiting, or nausea, contact your doctor immediately.

Grapefruit, grapefruit juice, starfruit, pomegranate, Seville oranges: These fruits affect how Iclusig (Ponatinib) is removed from the body and may cause too much of the medication to build up in the body and cause possibly harmful side effects. They should not be eaten at any time while taking Iclusig (Ponatinib) for treatment.

Heart problems: Iclusig (Ponatinib) may worsen symptoms of heart disease. If you have heart disease such as angina, Congestive Heart Failure, or arrhythmia, discuss with your doctor how Iclusig (Ponatinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Iclusig (Ponatinib), and whether any special monitoring is needed. Contact your doctor as soon as possible if you develop symptoms of heart problems such as shortness of breath, chest pain, rapid heartbeat, or swollen ankles.

Heart rhythm: Iclusig (Ponatinib) can cause changes to the normal rhythm of the heart. If you are at risk for heart rhythm problems (e.g., people with heart failure, angina, low potassium or magnesium levels), discuss with your doctor how Iclusig (Ponatinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Iclusig (Ponatinib), and whether any special monitoring is needed. If you experience symptoms of irregular heartbeat such as fainting, dizziness, chest pain, pounding heartbeat, or fast or slowed heartbeat, contact your doctor immediately.

Hepatitis B reactivation: People who have hepatitis B infection that is dormant may experience a return of the infection, causing further liver dysfunction or liver failure. If you have a history of hepatitis B infection, discuss with your doctor how Iclusig (Ponatinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this mediation, and whether any special monitoring is needed.

If you experience symptoms of worsening liver function, such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Infection: As well as killing cancer cells, Iclusig (Ponatinib) can reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Lactose intolerance: Iclusig (Ponatinib) contains lactose. If you have galactose intolerance (galactosemia, glucose-galactose malabsorption, or Lapp lactase deficiency) you should not take Iclusig (Ponatinib).

Liver function: Iclusig (Ponatinib) is broken down by the liver. Liver disease or reduced liver function may cause Iclusig (Ponatinib) to build up in the body, causing side effects. It has also been reported to cause decreased liver function and possibly liver failure, which can lead to death. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

If you have liver problems, discuss with your doctor how Iclusig (Ponatinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Iclusig (Ponatinib), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Iclusig (Ponatinib).

Pancreatitis: Iclusig (Ponatinib) can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how Iclusig (Ponatinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Iclusig (Ponatinib), and whether any special monitoring is needed.

Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.

If you have a history of pancreatitis, gallstones, Alcoholism, or high triglycerides, you may be more at risk of experiencing this.

Posterior Reversible Encephalopathy Syndrome (PRES): This is a rare disease of the brain that may occur when using medications like Iclusig (Ponatinib). If you have had a previous episode of PRES, Iclusig (Ponatinib) may not be an appropriate medication for you. Make sure your doctor knows you have experienced this before. If you experience signs and symptoms of PRES, such as headache, seizures, change in awareness or consciousness, or vision changes, contact your doctor immediately.

Tumour lysis syndrome: Iclusig (Ponatinib), like many other cancer medications, causes many cancer cells to be suddenly killed when treatment is first started. This can overwhelm the body with waste products from the cells. As a result, the body may not be able to keep up with getting rid of all the waste. When this happens, you may experience nausea or shortness of breath, or notice cloudy urine or joint pain. This is called tumour lysis syndrome. Your doctor may prescribe some medications to help your body get rid of the waste products. Make sure you understand how to use these medications and report any of these signs or symptoms to your doctor immediately.

Pregnancy: Iclusig (Ponatinib) may cause harm to an unborn fetus and should not be used during pregnancy. If you or your partner become pregnant while taking Iclusig (Ponatinib), contact your doctor immediately. Both men and women of childbearing age who are taking Iclusig (Ponatinib) should use an effective method of birth control (e.g., birth control pill, condoms) during treatment. Iclusig (Ponatinib) may affect how well birth control pills work, so an alternative or additional method of birth control should be used.

Breast-feeding: It is not known if Iclusig (Ponatinib) passes into breast milk. If you are a breast-feeding mother and are taking Iclusig (Ponatinib), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Iclusig (Ponatinib) have not been established for children.

Seniors: When compared to younger adults, seniors are more likely to experience side effects of Iclusig (Ponatinib) and may require lower doses.