PONATINIB

(poe NA ti nib) Brand: Iclusig

What is the most significant information I must know about ponatinib?

• You must not use ponatinib if you are allergic to it.

• Till you take ponatinib, speak your doctor if you have heart malady, tall blood pressure, a history of stroke or blood clot, liver malady, a bleeding mess, a history of pancreatitis, or a history of stomach or intestinal bleeding.

• Speak your doctor about all medicines you use, and those you start or stop using during your treatment with ponatinib.

• 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 trials at your doctor's office to be certain this medicine is not causing deleterious effects. If you need surgery, speak the surgeon onward of time that you are using ponatinib. You may need to stop using the medication for a short time. Do not stop taking ponatinib or change your medicine doze without your doctor's advice.

• Call your doctor at once if you have chest pain spreading to your hand or shoulder, sudden numbness or weakness, problems with vision or speech, warmth or pain in one or both legs, light 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.

What is ponatinib?

• Ponatinib interferes with the growth of some cancer cells.

• Ponatinib is used to treat a type of blood cancer called chronic myeloid leukemia (CML), or Philadelphia chromosome positive acute lymphoblastic leukemia (ALL).

• Ponatinib is generally given after another similar medications have been tried without success.

• Ponatinib may also be used for purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till taking ponatinib?

• You must not use ponatinib if you are allergic to it.

• To create certain ponatinib is safety for you, speak your doctor if you have:

· heart malady, tall blood pressure;

· a history of stroke or blood clot;

· liver malady;

· 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 ponatinib if you are pregnant. It could harm the unborn child. Use effective birth control, and speak your doctor if you become pregnant during treatment.

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

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

How must I take ponatinib?

• Ponatinib is generally taken once daily. Follow all directions on your prescription label. Do not take this medication in larger or less amounts or for longer than recommended.

• You may take ponatinib with or without food.

• Do not crush, interrupt, or dissolve a ponatinib tablet. Swallow it intact.

• Do not share this medicine with other person, even if they have the same symptoms you have.

• You may need frequent medical trials at your doctor's office to be certain this medicine is not causing deleterious effects. Your cancer treatments may be delayed based on the results of these tests.

• If you need surgery, speak the surgeon onward of time that you are using ponatinib. You may need to stop using the medication for a short time.

• Do not stop taking ponatinib or change your medicine doze without your doctor's advice.

• Store at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must I avoid while taking ponatinib?

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

What are the possible side effects of ponatinib?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, lips, tongue, or throat.

• Call your doctor at once if you have:

· chest pain or hard feeling, pain spreading to the hand or shoulder, sweating, common 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;

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

· hard 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, few or no urinating, numbness or tingly feeling near your mouth, muscle weakness, tightness, or contraction, overactive reflexes, weak pulse, fainting; or

· dangerously tall blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, seizure).

• General side effects may include:

· dry skin, mild skin rash;

· stomach pain, constipation;

· headache, weary 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 message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect ponatinib?

• Speak your doctor about all medicines you use, and those you start or stop using during your treatment with ponatinib, 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. Another drugs may interact with ponatinib, including prescription and over-the-counter medicines, vitamins, and herbal commodity. Not all possible interactions are listed in this medicine manual.

Where can I get more information?

• Your pharmacist can provide more information about ponatinib.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.