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DIN (Drug Identification Number)
02437333 Iclusig 15 mg Tablet
02437341 Iclusig 45 mg Tablet
How does this medication work? What will it do for me?
Ponatinib belongs to a group of cancer fighting medications called antineoplastics, and more specifically to a group of medications called protein kinase inhibitors. Ponatinib is used to treat adults who have chronic phase (long-lasting), accelerated phase (fast-growing), or blast phase forms of chronic myeloid leukemia (CML). It is also used to treat adults with Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) when other medications in the tyrosine kinase inhibitor family are not appropriate. It is used when other therapies have been tried and not produced a response, or other therapies have produced unacceptable levels of side effects.
Ponatinib works by recognizing certain types of cancer cells and blocking the action of chemicals that cause them to divide and grow. In CML and ALL, the body produces abnormal white blood cells. Ponatinib works by blocking the signal that triggers the production of these abnormal white blood cells. This may slow down or stop cancers from growing and dividing.
The effectiveness of this medication is usually seen within one month. If there has not been any improvement after 3 months, your doctor may decide to discontinue the medication.
Ponatinib has been granted a notice of compliance with conditions (NOC/c) by Health Canada. This means that Health Canada has approved this medication to be marketed based on promising evidence of effectiveness, but additional results of studies are needed to verify its effectiveness. An NOC/c is used to allow access to products that are used to treat or prevent serious, life-threatening, or severely debilitating illness.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each white, biconvex, round, film-coated tablet, approximately 6 mm in diameter, with “A5” debossed on one side, contains 15 mg of ponatinib as 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).
Each white, biconvex, round, film-coated tablet, approximately 9 mm in diameter, with “AP4” debossed on one side, contains 45 mg ponatinib as 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).
How should I use this medication?
The recommended starting dose of this medication is 45 mg taken by mouth once daily. Your doctor may lower your dose depending on the side effects you experience. 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 this medication 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.
Who should NOT take this medication?
- are allergic to 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
Do not take this medication if you:
What side effects are possible with this medication?
- appetite loss
- changed sense of touch
- decreased sexual ability
- dry mouth
- general feeling of being unwell
- hair loss
- inflamed hair follicles
- lack of energy
- mouth inflammation
- muscle and joint pain
- muscle spasms
- night sweats
- skin problems (dry, itchy, blistered, peeling, darkened)
- increased sweating
- trouble sleeping
- weight loss
- abnormal heart beat
- angina (e.g., uncomfortable pressure, fullness or chest pain that happens at rest, in the centre or left side)
- bone pain
- fluid in the chest (e.g., chest pain, cough, fever, hiccups, rapid breathing, shortness of breath)
- fluid retention in the arms or legs
- prickling, tingling, numbness, or pain in the hands and feet
- signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
- signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
- signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worst when breathing in, coughing, coughing up blood, sweating, or passing out)
- signs of heart failure (e.g., shortness of breath, fatigue, swelling in legs, ankles, feet)
- signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
- signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
- symptoms of pneumonia (e.g., fever or chills, shortness of breath, fatigue, chest pain, cough)
- vision or eye problems (blurred vision, inflamed, red or dry eyes, blindness)
- signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds)
- signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
- signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
- signs of stroke (e.g., sudden slurring of speech, unexplained weakness, numbness, or pain in arm or leg)
- signs of tumour lysis syndrome (e.g., nausea, difficulty breathing, cloudy urine, joint pain)
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Stop taking the medication and seek immediate medical attention if any of the following occur:
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
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 this medication.
HEALTH CANADA ADVISORY
May 4, 2016
Health Canada has issued new restrictions concerning the use of Iclusig (ponatinib). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Anemia: 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: This medication 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 of 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: This medication 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Fluid retention: Excess fluid may build up in the body as a result of taking 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, 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 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 this medication for treatment.
Heart problems: This medication may worsen symptoms of heart disease. If you have heart disease such as angina, congestive heart failure, or arrhythmia, discuss with your doctor how this medication may affect the medical condition, how the medical condition may affect the dosing and effectiveness of this medication, 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: 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience symptoms of irregular heartbeat such as fainting, dizziness, chest pain, pounding heart beat, or fast or slowed heart beat, contact your doctor immediately.
Infection: As well as killing cancer cells, 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: This medication contains lactose. If you have galactose intolerance (galactosemia, glucose-galactose malabsorption, or Lapp lactase deficiency) you should not take this medication.
Liver function: Ponatinib is broken down by the liver. Liver disease or reduced liver function may cause this medication 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.
Pancreatitis: Ponatinib can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, 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.
Tumour lysis syndrome: 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, shortness of breath, 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: This medication may cause harm to an unborn fetus and should not be used during pregnancy. If you or your partner become pregnant while taking this medication, contact your doctor immediately. Both men and women of childbearing age who are taking ponatinib should use an effective method of birth control (e.g., birth control pill, condoms) during treatment and for at least 4 weeks after finishing treatment. 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 ponatinib passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.
Seniors: When compared to younger adults, seniors are more likely to experience side effects of this medication and may require lower doses.
What other drugs could interact with this medication?
- "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
- bacillus Calmette-Guérin (BCG) (intravesical)
- birth control pills
- grapefruit juice
- HIV protease inhibitors (atazanavir, darunavir, lopinavir, ritonavir)
- macrolide antibiotics (e.g., clarithromycin, erythromycin)
- St. John's wort
- 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.
There may be an interaction between ponatinib and any of the following:
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:
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 this medication. 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.
All material copyright MediResource Inc. 1996 – 2019. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Iclusig
All material © 1996-2019 MediResource Inc. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.
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