iclusig

Iclusig (ponatinib) interferes with the growth of some cancer cells.

Iclusig is used to treat a type of blood cancer called chronic myeloid leukemia (CML), or Philadelphia chromosome positive acute lymphoblastic leukemia (ALL). It is usually given after other similar medications have been tried without success.

Iclusig may also be used for purposes not listed in this medication guide.

Important information

Iclusig may cause heart or blood vessel problems that could lead to heart attack or stroke.

Call your doctor at once if you have chest pain spreading to your jaw or shoulder, shortness of breath, sudden numbness or weakness, severe headache, severe dizziness, or problems with vision or speech.

Iclusig may also cause harm to your liver.

Call your doctor right away if you have upper stomach pain with loss of appetite, dark urine, or jaundice (yellowing of the skin or eyes).

Before taking this medicine

You should not use Iclusig if you are allergic to ponatinib.

To make sure Iclusig is safe for you, tell your doctor if you have:

• heart disease, high blood pressure;

• a history of stroke or blood clot;

• liver disease;

• a bleeding or blood-clotting disorder;

• a history of pancreatitis; or

• a history of stomach or intestinal bleeding.

FDA pregnancy category D. Do not use Iclusig if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

It is not known whether ponatinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medication to anyone under 18 years old without medical advice.

How should I take Iclusig?

Iclusig is usually taken once daily. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Iclusig with or without food.

Do not crush, break, or dissolve the tablet. Swallow it whole.

Do not share this medication with another person, even if they have the same symptoms you have.

You may need frequent medical tests to be sure this medication is not causing harmful effects. Your cancer treatments may be delayed based on the results of these tests.

If you need surgery, tell the surgeon ahead of time that you are using Iclusig. You may need to stop using the medicine at least 1 week before a surgery.

Do not stop taking Iclusig or change your medication dose without your doctor"s advice.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

Do not receive a "live" vaccine while using Iclusig, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Grapefruit and grapefruit juice may interact with ponatinib and lead to unwanted side effects. Avoid drinking grapefruit juice while taking this medication.

Iclusig side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Iclusig: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Iclusig may cause heart or blood vessel problems that could lead to heart attack or stroke.

Call your doctor at once if you have:

• nosebleeds, bloody or tarry stools, pink or brown urine, heavy menstrual periods, vomit that is bloody or looks like coffee grounds;

• severe stomach pain and bloating;

• liver problems--upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot in the lung--sudden cough, wheezing, rapid breathing, coughing up blood;

• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• heart problems--shortness of breath, swelling or rapid weight gain, chest pain and severe dizziness, fainting, uneven or irregular heart rate, fast or pounding heartbeats;

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• pale skin, confusion, severe drowsiness, feeling like you might pass out;

• signs of tumor cell breakdown--lower back pain, blood in your urine, little or no urinating; numbness or tingly feeling around your mouth; muscle weakness or tightness; fast or slow heart rate, weak pulse, confusion;

• low blood cell counts--fever, chills, flu symptoms, sores in your mouth and throat, pale skin, severe drowsiness, easy bruising, purple or red pinpoint spots under your skin;

• pancreas problems--severe pain in your upper stomach spreading to your back, nausea and vomiting; or

• dangerously high blood pressure--severe headache, blurred vision, buzzing in your ears, anxiety, seizure.

Common Iclusig side effects may include:

• dry skin, mild skin rash;

• stomach pain, constipation;

• headache, tired feeling; or

• joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Iclusig?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Iclusig, especially:

• conivaptan;

• imatinib;

• isoniazid;

• nefazodone;

• heart or blood pressure medicine--nicardipine, quinidine;

• an antibiotic--clarithromycin, telithromycin;

• antifungal medicine--itraconazole, ketoconazole, posaconazole, voriconazole;

• the hepatitis C medications boceprevir or telaprevir; or

• HIV or AIDS medications--atazanavir, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir.

This list is not complete. Other drugs may interact with ponatinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.