Iclusig

Generic Name: ponatinib (poe NA ti nib)
Brand Name: Iclusig

What is 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).

Ponatinib 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 know about Iclusig

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

Before you take Iclusig, tell your doctor if you have heart disease, high blood pressure, a history of stroke or blood clot, liver disease, a bleeding disorder, a history of pancreatitis, or a history of stomach or intestinal bleeding.

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

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

You may need frequent medical tests at your doctor's office to be sure this medication is not causing harmful effects. If you need surgery, tell the surgeon ahead of time that you are using Iclusig. You may need to stop using the medicine for a short time. Do not stop taking Iclusig or change your medication dose without your doctor's advice.

Call your doctor at once if you have chest pain spreading to your arm or shoulder, sudden numbness or weakness, problems with vision or speech, warmth or pain in one or both legs, easy bruising, unusual bleeding, blood in your urine or stools, fever, flu symptoms, mouth sores, upper stomach pain, dark urine, jaundice (yellowing of the skin or eyes), lower back pain, severe headache, buzzing in your ears, or feeling like you might pass out.

Before taking Iclusig

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: Iclusig 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 Iclusig 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 a Iclusig 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 at your doctor's office to be sure Iclusig 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 for a short time.

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 while taking Iclusig?

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.

Call your doctor at once if you have:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, sweating, general ill feeling;

• sudden numbness or weakness (especially on one side of the body), problems with vision, speech, or balance;

• sudden cough, wheezing, rapid breathing, coughing up blood;

• pain, swelling, warmth, or redness in one or both legs;

• bloody or tarry stools, pink or brown urine;

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

• heavy menstrual periods;

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

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• uneven or irregular heart rate;

• feeling short of breath (even with mild exertion), swelling, rapid weight gain;

• itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• severe pain in your upper stomach spreading to your back, nausea and vomiting;

• lower back pain, blood in your urine, little or no urinating, numbness or tingly feeling around your mouth, muscle weakness, tightness, or contraction, overactive reflexes, weak pulse, fainting; 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: Iclusig 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 Iclusig, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

• Your pharmacist can provide more information about Iclusig.