WARNING

Iclusig (ponatinib) is a medication used for the treatment of certain types of leukemia, specifically chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). While Iclusig can be effective in managing these conditions, it also carries certain risks that need to be considered. Here are some of the potential risks associated with taking Iclusig:

• Blood Clots: Iclusig has been associated with an increased risk of blood clots, including serious or life-threatening conditions such as heart attack or stroke. Patients with a history of blood clots or cardiovascular problems may be at a higher risk.
• Liver Toxicity: Iclusig can cause liver problems, including liver failure. Regular monitoring of liver function is important while taking this medication.
• High Blood Pressure: Some patients may experience an increase in blood pressure while taking Iclusig. Regular monitoring and appropriate management of blood pressure are essential.
• Pancreatitis: Iclusig may cause inflammation of the pancreas (pancreatitis), which can be severe and require immediate medical attention.
• Bleeding: Iclusig may increase the risk of bleeding, including serious or life-threatening bleeding events. Patients with a history of bleeding disorders or who are taking blood-thinning medications may be at a higher risk.
• Fluid Retention: Some individuals may experience fluid retention while taking Iclusig, leading to swelling, weight gain, or shortness of breath. Close monitoring is necessary, especially in patients with a history of heart failure.
• Birth Defects: Iclusig can be harmful to unborn babies. Pregnant women or those planning to become pregnant should avoid taking this medication.

It is important to note that the risks and benefits of Iclusig should be carefully evaluated by a healthcare professional, considering an individual’s specific medical history and condition. Patients should communicate any concerns or symptoms they experience to their healthcare provider promptly to ensure appropriate management.

Why is this medication prescribed?

Iclusig (ponatinib) is prescribed for the treatment of certain types of leukemia, specifically chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). These conditions involve abnormal and uncontrolled growth of certain white blood cells.

Iclusig belongs to a class of medications known as tyrosine kinase inhibitors (TKIs). It works by inhibiting the activity of an abnormal protein called BCR-ABL, which is produced by a genetic mutation known as the Philadelphia chromosome. BCR-ABL is responsible for the uncontrolled growth and division of white blood cells in these types of leukemia.

Iclusig is typically prescribed in the following situations:

• Chronic Myeloid Leukemia (CML): Iclusig is used in the treatment of chronic phase, accelerated phase, or blast phase CML in patients who have not responded to or have developed resistance to other TKIs, such as imatinib, dasatinib, or nilotinib.
• Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL): Iclusig is used for the treatment of Ph+ ALL in patients who have not responded to or have developed resistance to other TKIs.

How should this medicine be used?

Here are some general guidelines for the use of Iclusig:

• Dosage: Take Iclusig according to the prescribed dosage. Do not take more or less than the recommended amount unless directed by your doctor.
• Timing: Take Iclusig at the same time every day. You can take it with or without food, but try to be consistent in your approach.
• Swallowing: Swallow the tablet whole with a glass of water. Do not crush, chew, or break the tablet before swallowing.
• Follow-up appointments: Regularly visit your doctor for check-ups and laboratory tests to monitor your response to the medication and assess any potential side effects.
• Adherence: It is crucial to take Iclusig consistently and as prescribed. Skipping doses or stopping the medication without consulting your doctor can affect its effectiveness in managing your condition.
• Special instructions: If you miss a dose, take it as soon as you remember, unless it is close to the time for your next scheduled dose. Do not take a double dose to make up for a missed one. If you accidentally take more than the prescribed dose, seek immediate medical attention.
• Pregnancy and breastfeeding: Iclusig can cause harm to unborn babies, so it is important to avoid pregnancy while taking this medication. It is also not recommended to breastfeed while on Iclusig, as it may pass into breast milk and harm the nursing infant.

Remember to consult your healthcare professional for detailed instructions and any specific guidance regarding the use of Iclusig. They will provide you with the most accurate information tailored to your condition.

Other uses for this medicine

Iclusig (ponatinib) is primarily approved for the treatment of chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). However, it’s important to note that healthcare professionals may sometimes prescribe medications off-label, meaning for uses not specifically approved by regulatory authorities. In such cases, the decision to use Iclusig for other conditions would be based on the healthcare provider’s judgment and the available scientific evidence.

What special precautions should I follow?

Regarding special precautions for Iclusig, here are some important points to consider:

• Cardiovascular Effects: Iclusig has been associated with an increased risk of cardiovascular events, including blood clots, heart attack, and stroke. Patients with a history of cardiovascular disease or risk factors should be closely monitored. It is important to discuss any pre-existing heart conditions or concerns with your doctor before starting Iclusig.
• Liver Toxicity: Iclusig can cause liver problems, including liver failure. Regular monitoring of liver function through blood tests is necessary during treatment. Inform your doctor about any history of liver disease or abnormalities.
• Hypertension (High Blood Pressure): Iclusig may increase blood pressure in some patients. Blood pressure should be monitored regularly, and appropriate management strategies may be employed.
• Pancreatitis: Iclusig use has been associated with pancreatitis, which can be severe. Patients should be vigilant for symptoms such as persistent abdominal pain, nausea, and vomiting, and promptly report them to their healthcare provider.
• Bleeding: Iclusig may increase the risk of bleeding, including serious or life-threatening bleeding events. Patients with a history of bleeding disorders or taking blood-thinning medications should exercise caution.
• Fluid Retention: Some patients may experience fluid retention, which can lead to swelling and other symptoms. Close monitoring is necessary, especially in individuals with a history of heart failure or who are at higher risk for fluid retention.
• Pregnancy and Contraception: Iclusig can cause harm to unborn babies, and effective contraception should be used by both males and females during treatment. Discuss with your doctor about appropriate contraceptive methods.
• Drug Interactions: Inform your healthcare provider about all the medications, supplements, and herbal products you are taking, as certain drugs may interact with Iclusig and affect its effectiveness or increase the risk of side effects.

These are just some of the special precautions associated with Iclusig. It is essential to consult with your healthcare professional for a comprehensive understanding of the risks, benefits, and precautions specific to your situation. They will consider your medical history and individual circumstances to ensure safe and effective use of the medication.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with taking Iclusig (ponatinib). However, it is generally recommended to maintain a healthy and balanced diet while on any medication. It is important to follow your healthcare professional’s advice regarding overall dietary guidelines and any specific recommendations they may provide based on your individual health status.

What should I do if I forget a dose?

If you forget to take a dose of Iclusig, you should take it as soon as you remember, unless it is close to the time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed one.

What side effects can this medication cause?

Here are some of the potential side effects associated with Iclusig:

• Cardiovascular Effects: Iclusig can increase the risk of cardiovascular events, including heart attack, stroke, and peripheral arterial disease. Symptoms may include chest pain, shortness of breath, sudden numbness or weakness, or problems with speech or vision.
• Blood Clots: There is an increased risk of blood clots, including deep vein thrombosis (DVT) and pulmonary embolism (PE). Signs of blood clots may include swelling, pain, or tenderness in the legs, chest pain, or difficulty breathing.
• Liver Toxicity: Iclusig can cause liver problems, such as elevated liver enzyme levels or liver failure. Symptoms may include yellowing of the skin or eyes (jaundice), dark urine, abdominal pain, or persistent nausea.
• Pancreatitis: Inflammation of the pancreas (pancreatitis) can occur, leading to severe abdominal pain, nausea, and vomiting.
• Hypertension (High Blood Pressure): Some patients may experience an increase in blood pressure while taking Iclusig.
• Bleeding: Iclusig may increase the risk of bleeding events, including gastrointestinal bleeding, intracranial bleeding, or epistaxis (nosebleeds).
• Fluid Retention: Fluid retention can occur, leading to swelling (edema) and weight gain. This may be accompanied by shortness of breath or other signs of fluid overload.
• Skin Reactions: Skin-related side effects, such as rash, itching, or dry skin, may occur.
• Gastrointestinal Effects: Common gastrointestinal side effects may include diarrhea, nausea, vomiting, abdominal pain, or constipation.
• Fatigue: Some patients may experience fatigue or weakness while taking Iclusig.
• Headache: Headaches, including migraines, have been reported as a side effect.
• Joint and Muscle Pain: Musculoskeletal pain, including joint pain and muscle pain, may occur.

It is important to promptly report any side effects or concerns to your healthcare provider. They can provide guidance on managing side effects and determine if any further evaluation or adjustments to your treatment plan are necessary.

What should I know about storage and disposal of this medication?

• Storage: Store Iclusig tablets at room temperature, typically between 20°C to 25°C (68°F to 77°F). Keep the medication in its original container, tightly closed, and away from moisture and direct sunlight. Do not freeze Iclusig.
• Disposal: Properly dispose of any unused or expired Iclusig tablets. Do not flush them down the toilet or throw them in the trash. Contact your local pharmacy or healthcare facility to inquire about the appropriate disposal methods in your area. They can provide guidance on safe disposal to protect the environment and prevent accidental ingestion.

In case of emergency/overdose

In case of emergency or overdose, it is important to seek immediate medical assistance. Contact your local emergency services or go to the nearest emergency room. Be sure to bring the medication packaging or inform the medical professionals about the specific medication you have taken.

What other information should I know?

• Regular Monitoring: Your healthcare provider will monitor your response to Iclusig treatment through periodic blood tests and other medical evaluations. This monitoring helps assess the effectiveness of the medication and detect any potential side effects or complications.
• Drug Interactions: Inform your healthcare provider about all the medications, supplements, and herbal products you are taking to avoid any potential drug interactions. Certain medications may interact with Iclusig and affect its efficacy or increase the risk of side effects.
• Compliance: It is important to adhere to your prescribed dosing schedule and take Iclusig exactly as directed by your healthcare provider. Do not skip doses or change the dosage without consulting your doctor.
• Pregnancy and Contraception: Iclusig can harm unborn babies. Effective contraception should be used during treatment, and it is important to discuss family planning with your healthcare provider. If you become pregnant while taking Iclusig, inform your doctor immediately.
• Follow-up Appointments: Regularly attend follow-up appointments with your healthcare provider. These visits are important for monitoring your condition, assessing treatment response, and adjusting the treatment plan if needed.

Always consult your healthcare provider or pharmacist for specific instructions and additional information regarding the safe use, storage, and disposal of Iclusig. They can provide you with personalized guidance based on your individual circumstances and needs.