WARNING

Caprelsa (vandetanib) is a medication used primarily for the treatment of thyroid cancer. Like all medications, it carries certain risks and side effects that patients should be aware of:

• Cardiac Risks: Caprelsa can cause QT prolongation, which is an abnormality in the heart’s electrical activity that can lead to dangerous arrhythmias (irregular heartbeats). Patients with a history of QT prolongation or certain heart conditions may be at higher risk.
• Hypothyroidism: It can lead to decreased thyroid hormone levels (hypothyroidism), which may require monitoring and thyroid hormone replacement therapy.
• Pulmonary Toxicity: Some patients may experience interstitial lung disease or pneumonitis, which can cause symptoms like cough, difficulty breathing, and chest pain.
• Hypertension: Caprelsa can increase blood pressure, requiring monitoring and possibly medication to control.
• Gastrointestinal Effects: Common side effects include diarrhea, nausea, and abdominal pain.
• Skin Reactions: Rash and acne are common, and in rare cases, severe skin reactions may occur.
• Liver Function: There can be abnormalities in liver function tests, necessitating monitoring.
• Other Adverse Effects: Fatigue, headache, and anorexia (loss of appetite) are also reported side effects.

Patients taking Caprelsa should be closely monitored by healthcare professionals for these potential risks. It’s crucial to discuss any concerns or side effects with a doctor promptly.

Why is this medication prescribed?

Caprelsa (vandetanib) is a medication primarily used for the treatment of medullary thyroid cancer (MTC), a type of thyroid cancer that originates in the thyroid gland’s C cells. It works by inhibiting several molecular pathways involved in cancer growth and progression, including the RET (rearranged during transfection) protein tyrosine kinase.

How should this medicine be used?

How Caprelsa Should be Used:

• Dosage: The typical starting dose of Caprelsa is 300 mg taken orally once daily. The dosage may be adjusted based on individual patient response and tolerability.
• Administration: Caprelsa tablets should be taken at approximately the same time each day, preferably in the morning. They can be taken with or without food.
• Monitoring: Regular monitoring is essential during Caprelsa treatment. This includes assessing cardiac function (ECG for QT prolongation), thyroid function (TSH, T4 levels), blood pressure, and liver function tests (ALT, AST).
• Duration: Treatment with Caprelsa is generally continued as long as it is providing clinical benefit and tolerated by the patient. The duration of treatment will be determined by the treating physician based on individual response and disease progression.
• Special Considerations: Patients should avoid taking medications that can prolong the QT interval or medications known to interact with Caprelsa. If a dose is missed, the missed dose should be skipped and the next dose taken at the regular time.
• Side Effects: Patients should be aware of potential side effects such as QT prolongation (which can lead to abnormal heart rhythms), hypertension, diarrhea, rash, fatigue, and others. Any concerning side effects should be promptly reported to the healthcare provider.
• Contraindications: Caprelsa is contraindicated in patients with congenital long QT syndrome or those with hypersensitivity to vandetanib or any of its components.

Caprelsa is a targeted therapy designed to specifically inhibit pathways that promote cancer cell growth in MTC. Its use is closely monitored to balance therapeutic benefit with potential risks and side effects.

Other uses for this medicine

Here are some other uses that have been explored or are under investigation:

• Non-Small Cell Lung Cancer (NSCLC): Caprelsa has been studied in combination with chemotherapy for the treatment of advanced NSCLC, particularly in patients with EGFR mutation-positive tumors.
• Other Solid Tumors: There have been investigations into the efficacy of Caprelsa in other types of solid tumors, including colorectal cancer and glioblastoma multiforme (a type of brain cancer).
• RET Fusion-Positive Tumors: Caprelsa targets the RET protein kinase, which is involved in various cancers where it is mutated or fused. It has shown potential in treating cancers with RET mutations or fusions, beyond MTC.

What special precautions should I follow?

Special Precautions for Caprelsa:

• Cardiac Monitoring: Regular monitoring of cardiac function is crucial due to the risk of QT prolongation, which can lead to serious arrhythmias. Electrocardiograms (ECGs) should be performed before starting treatment, periodically during treatment, and as clinically indicated.
• Thyroid Function: Since Caprelsa can affect thyroid hormone levels, thyroid function should be monitored regularly with blood tests (TSH, T4 levels). Thyroid hormone replacement therapy may be necessary if hypothyroidism develops.
• Blood Pressure: Monitoring of blood pressure is essential during Caprelsa treatment, as hypertension can occur. Blood pressure should be managed and controlled with medications if necessary.
• Liver Function: Liver function tests (ALT, AST) should be monitored regularly to detect any abnormalities in liver function.
• Pulmonary Function: Patients should be monitored for signs and symptoms of interstitial lung disease or pneumonitis, such as cough, dyspnea (shortness of breath), or chest pain.
• Pregnancy and Contraception: Caprelsa can cause fetal harm if used during pregnancy. Effective contraception should be used during treatment and for a period after discontinuation of Caprelsa.
• Drug Interactions: Caprelsa can interact with other medications, particularly those that affect QT interval or liver function. Inform healthcare providers about all medications, including over-the-counter drugs and supplements.
• Dose Adjustments: Dose adjustments may be necessary based on individual patient response and tolerability, as guided by healthcare providers.

Patients and healthcare providers should maintain open communication about any concerns or side effects experienced during Caprelsa treatment. Prompt reporting and management of side effects are essential for optimizing treatment outcomes.

What special dietary instructions should I follow?

There are no specific dietary restrictions for Caprelsa. However, it’s generally recommended to maintain a healthy and balanced diet while undergoing cancer treatment. If you experience diarrhea or other gastrointestinal side effects, your doctor may recommend dietary adjustments such as avoiding spicy or greasy foods and increasing fluid intake.

What should I do if I forget a dose?

If you forget to take your dose of Caprelsa at the scheduled time, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and take your next dose at the regular time. Do not double the dose to catch up.

What side effects can this medication cause?

Caprelsa (vandetanib) can cause a range of side effects, some of which can be serious. It’s important for patients to be aware of these potential side effects and to promptly report any concerning symptoms to their healthcare provider. Here are the common side effects and some of the more serious ones associated with Caprelsa:

Common Side Effects:

• Diarrhea: This is one of the most common side effects of Caprelsa. It can range from mild to severe.
• Rash and Skin Reactions: Skin rash, acne, and dry skin are commonly reported. In some cases, severe skin reactions may occur, although this is rare.
• Nausea and Vomiting: Gastrointestinal symptoms like nausea, vomiting, and abdominal pain can occur.
• Headache: Headaches are a common side effect.
• Fatigue: Feelings of tiredness or fatigue may occur.
• High Blood Pressure (Hypertension: Caprelsa can cause an increase in blood pressure. Regular monitoring and management may be necessary.
• Decreased Appetite: Some patients may experience a loss of appetite.
• Hoarseness or Voice Changes: This can occur due to inflammation or irritation of the vocal cords.
• Disturbances in Liver Function Tests: Elevated liver enzymes (ALT, AST) may occur, indicating potential liver toxicity.

Serious Side Effects:

• QT Prolongation: Caprelsa can affect the electrical activity of the heart, leading to QT prolongation, which can cause abnormal heart rhythms (arrhythmias). This is a potentially serious side effect that requires monitoring with ECGs.
• Interstitial Lung Disease/Pneumonitis: Rare but serious, these conditions can cause cough, difficulty breathing, or chest pain. Immediate medical attention is necessary if these symptoms occur.
• Thyroid Hormone Changes: Caprelsa can lower thyroid hormone levels (hypothyroidism), which may require monitoring and thyroid hormone replacement therapy.
• Gastrointestinal Perforation: Though rare, gastrointestinal perforation has been reported with Caprelsa. Symptoms may include severe abdominal pain.
• Bleeding: Some patients may experience bleeding events, such as gastrointestinal bleeding or bleeding in other parts of the body.
• Severe Skin Reactions: Rarely, severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis can occur.
• Kidney Problems: Caprelsa may affect kidney function, leading to changes in urine output or kidney function tests.
• Fetal Harm: Caprelsa can cause harm to unborn babies if used during pregnancy.

It’s important for patients to discuss any concerns or side effects with their healthcare provider. Depending on the severity of side effects, dose adjustments, supportive care, or discontinuation of Caprelsa may be necessary. Regular monitoring and communication with healthcare providers are crucial for managing these potential side effects effectively.

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

Storage and Disposal of Caprelsa:

• Storage: Caprelsa should be stored at room temperature between 20-25°C (68-77°F). It should be kept in its original container and protected from light and moisture. Do not store Caprelsa in the bathroom.
• Disposal: Unused or expired Caprelsa should be disposed of properly to prevent accidental ingestion by children, pets, or others. Follow any specific disposal instructions provided by your healthcare provider or local waste disposal regulations. Do not flush medications down the toilet unless instructed to do so.

In case of emergency/overdose

In case of an overdose or if you suspect someone has taken more than the prescribed dose of Caprelsa, seek immediate medical attention or contact a poison control center (such as 1-800-222-1222 in the United States). Symptoms of overdose may include severe diarrhea, nausea, vomiting, QT prolongation (heart rhythm problems), and other serious side effects. Be prepared to provide information about the amount of Caprelsa taken and any symptoms experienced.

What other information should I know?

• Regular Monitoring: During treatment with Caprelsa, your healthcare provider will conduct regular monitoring to check for side effects, assess cardiac function with ECGs, monitor thyroid and liver function, and manage any other potential complications.
• Follow-Up Visits: Attend all scheduled appointments with your healthcare provider for follow-up assessments and monitoring. These visits are essential for evaluating treatment effectiveness and managing any side effects or complications.
• Medication Adherence: Take Caprelsa exactly as prescribed by your healthcare provider. Do not adjust your dose or stop taking the medication without consulting your doctor first.
• Pregnancy and Breastfeeding: Caprelsa can cause harm to unborn babies if used during pregnancy. Effective contraception should be used during treatment and for a period after discontinuation of Caprelsa. It is not recommended for use while breastfeeding.
• Drug Interactions: Inform your healthcare provider about all medications, supplements, and herbal products you are taking to avoid potential drug interactions.
• Handling Precautions: Wash hands thoroughly after handling Caprelsa tablets. Avoid direct contact with broken or crushed tablets as they may pose a risk of exposure.
• Support Services: Consider accessing support services or resources available through your healthcare provider or cancer treatment center to assist with managing the emotional and practical aspects of treatment.

By being informed about storage, disposal, emergency procedures, and other important aspects of Caprelsa treatment, you can effectively manage your medication regimen and maximize the benefits while minimizing potential risks. Always consult your healthcare provider if you have any questions or concerns about your treatment with Caprelsa.