WARNING

Ontak (denileukin diftitox) is a medication used for the treatment of cutaneous T-cell lymphoma (CTCL), a type of skin cancer. While Ontak can be effective in managing the condition, like any medication, it carries certain risks and potential side effects. Here are some of the risks associated with taking Ontak:

• Infusion reactions: Ontak is administered through intravenous infusion, and some individuals may experience infusion reactions, which can include symptoms like fever, chills, nausea, vomiting, headache, and difficulty breathing. These reactions typically occur during or shortly after the infusion.
• Capillary leak syndrome: Capillary leak syndrome is a potentially serious condition characterized by the leakage of fluid from blood vessels into surrounding tissues. It can cause symptoms such as low blood pressure, fluid retention, swelling, and shortness of breath. Ontak has been associated with an increased risk of capillary leak syndrome.
• Allergic reactions: Some individuals may develop allergic reactions to Ontak, which can range from mild to severe. Symptoms may include rash, itching, swelling, dizziness, and difficulty breathing. Severe allergic reactions can be life-threatening and require immediate medical attention.
• Liver toxicity: Ontak has been reported to cause liver damage in some patients. Monitoring liver function is important during treatment to detect any signs of liver toxicity, which may include yellowing of the skin or eyes (jaundice), abdominal pain, dark urine, and fatigue.
• Decreased blood cell counts: Ontak can lead to a decrease in the number of blood cells, including white blood cells, red blood cells, and platelets. This can increase the risk of infections, anemia, and bleeding. Regular blood tests are typically conducted to monitor blood cell counts.
• Other side effects: Additional common side effects of Ontak may include fatigue, nausea, vomiting, diarrhea, muscle and joint pain, fever, and dizziness. These side effects can vary in severity and individual tolerance.

It is essential to discuss the potential risks and benefits of Ontak with your healthcare provider before starting treatment. They can provide detailed information about your specific situation and help monitor and manage any potential risks throughout the course of treatment.

Why is this medication prescribed?

Ontak is a medication that was used for the treatment of certain types of cancer, specifically cutaneous T-cell lymphoma (CTCL) and persistent or recurrent CTCL in patients who have not responded adequately to other treatments.

CTCL is a type of non-Hodgkin lymphoma that primarily affects the skin. It occurs when certain immune cells called T-cells become cancerous and accumulate in the skin. CTCL can be challenging to treat, and in some cases, other treatments such as topical therapies, phototherapy, or systemic chemotherapy may not provide sufficient benefit.

Ontak is a targeted therapy that works by combining two different proteins. It consists of a genetically engineered portion of the diphtheria toxin, which is a toxin that can kill cells, and the interleukin-2 (IL-2) protein, which is a substance that stimulates the immune system. By combining these two components, Ontak can bind to specific receptors on cancerous T-cells, enter them, and release the toxin, thereby killing the cancer cells.

The use of Ontak is generally considered when other treatments have not been effective or if the CTCL has relapsed or become resistant to previous therapies. It is typically prescribed by a healthcare professional with expertise in the treatment of CTCL and administered in a healthcare setting under close medical supervision.

How should this medicine be used?

Ontak (denileukin diftitox) is a prescription medication used for the treatment of cutaneous T-cell lymphoma (CTCL), a type of skin cancer. It is important to follow the instructions provided by your healthcare provider regarding the appropriate use of Ontak. Here are some general guidelines:

• Administration: Ontak is administered as an intravenous infusion, which means it is given directly into a vein. It is typically administered by a healthcare professional in a clinic or hospital setting.
• Dosing: The dosage of Ontak and the treatment schedule will be determined by your healthcare provider based on your individual condition and response to the medication. It is important to strictly adhere to the prescribed dosage and schedule.
• Duration of treatment: The duration of Ontak treatment can vary depending on the specific circumstances. Your healthcare provider will determine the appropriate length of treatment, which may involve multiple cycles of therapy.
• Precautions: It is important to inform your healthcare provider about any existing medical conditions, allergies, or medications you are currently taking before starting Ontak. Certain conditions or medications may interact with Ontak or increase the risk of adverse effects.
• Monitoring: During treatment with Ontak, regular monitoring of your health and blood tests will be conducted to assess the response to the medication and to check for any potential side effects or complications.
• Adverse reactions: If you experience any severe or concerning side effects while receiving Ontak, such as infusion reactions, allergic reactions, or signs of liver toxicity, it is important to notify your healthcare provider immediately.

It is crucial to have open communication with your healthcare provider throughout the treatment process. They will provide you with specific instructions on how to use Ontak, monitor your progress, and address any concerns or questions you may have.

Other uses for this medicine

Regarding alternative uses for Ontak, it is crucial to note that medications are typically prescribed for specific conditions based on clinical evidence and regulatory approvals. Off-label uses (uses not approved by regulatory authorities) may exist, but they should only be considered under the guidance and supervision of a qualified healthcare professional. It is always recommended to consult with a healthcare provider for information on alternative uses of medications or to explore other treatment options for specific medical conditions.

What special precautions should I follow?

• Allergic reactions: Ontak contains a fusion protein that can potentially cause severe allergic reactions. Patients should be closely monitored during treatment for signs of allergic reactions, such as difficulty breathing, chest pain, rash, or swelling. If any such symptoms occur, immediate medical attention should be sought.
• Capillary leak syndrome: Ontak has been associated with capillary leak syndrome, a condition characterized by fluid and protein leakage from blood vessels into surrounding tissues. Symptoms may include swelling, weight gain, hypotension, and hypoalbuminemia. Healthcare providers should monitor patients for signs of capillary leak syndrome and manage it appropriately.
• Liver toxicity: Ontak may cause liver toxicity, leading to liver function abnormalities. Regular monitoring of liver function tests is necessary during treatment to detect any potential liver damage.
• Fluid retention: Ontak can cause fluid retention, which may manifest as weight gain, swelling, or edema. Monitoring of body weight and fluid status is important, and appropriate measures should be taken to manage fluid retention.
• Immunogenicity: Some patients treated with Ontak may develop antibodies against the drug, which can affect its effectiveness. Periodic monitoring for the development of anti-Ontak antibodies may be necessary.
• Pregnancy and breastfeeding: The use of Ontak during pregnancy or breastfeeding is not recommended due to the limited data available on its safety in these situations. It is important to discuss the potential risks and benefits with a healthcare professional.

It is crucial to consult with a healthcare professional for comprehensive information about Ontak, its uses, and the specific precautions that should be taken based on an individual’s medical condition and other factors.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Ontak. However, it is always advisable to maintain a healthy and balanced diet to support overall well-being during treatment.

What should I do if I forget a dose?

If you forget to take a scheduled dose of Ontak, it is essential to contact your healthcare provider or follow the specific instructions provided by your medical team. They will be able to provide guidance on the best course of action based on your treatment plan and the time elapsed since the missed dose. It is not recommended to make up for a missed dose without medical advice, as altering the treatment schedule may affect its effectiveness.

What side effects can this medication cause?

Ontak (denileukin diftitox) can cause several side effects. It is important to note that not all individuals will experience these side effects, and their severity can vary. It is always recommended to consult a healthcare professional for the most accurate and up-to-date information. Here are some common side effects associated with Ontak:

• Flu-like symptoms: These may include fever, chills, body aches, fatigue, and headache.
• Skin reactions: Ontak can cause skin reactions such as rash, itching, redness, and swelling.
• Nausea and vomiting: Some individuals may experience gastrointestinal symptoms like nausea, vomiting, or diarrhea.
• Fatigue: Ontak can cause fatigue or general weakness.
• Fluid retention: Fluid retention may manifest as swelling or edema in various parts of the body, including the hands, feet, and ankles.
• Difficulty breathing: Ontak can potentially cause difficulty breathing or shortness of breath, which may indicate an allergic reaction or other respiratory complications.
• Hypotension: Low blood pressure (hypotension) may occur as a side effect of Ontak.
• Liver toxicity: Ontak can affect liver function and may lead to liver abnormalities. Monitoring of liver function is important during treatment.
• Capillary leak syndrome: In rare cases, Ontak has been associated with capillary leak syndrome, which involves fluid and protein leakage from blood vessels into surrounding tissues. Symptoms may include swelling, weight gain, hypotension, and hypoalbuminemia.
• Immunogenicity: Some patients treated with Ontak may develop antibodies against the drug, which can impact its effectiveness.

These are not all the possible side effects of Ontak. Other side effects may occur. It is important to promptly report any new or worsening symptoms to your healthcare provider.

It is crucial to consult with a healthcare professional for comprehensive information about the potential side effects of Ontak, as they can provide individualized guidance and address any concerns you may have.

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

Storage and disposal of Ontak:

• Ontak should be stored in the refrigerator at a temperature between 36°F (2°C) and 46°F (8°C). Do not freeze the medication.
• Keep Ontak in its original packaging to protect it from light.
• Do not use Ontak if it has been frozen or exposed to temperatures above 86°F (30°C).
• Do not use Ontak beyond the expiration date mentioned on the packaging.
• Keep Ontak out of the reach of children and pets.

In case of emergency/overdose

• In case of an emergency or suspected overdose, immediately contact your local emergency services or the nearest poison control center.
• It is advisable to have the product packaging or label available for quick reference.

What other information should I know?

• Before starting Ontak, inform your healthcare provider about any existing medical conditions, allergies, or medications you are taking (including prescription, over-the-counter, or herbal supplements).
• Regular follow-up visits and medical tests may be necessary to monitor your response to Ontak and check for any potential side effects or complications.
• Inform all healthcare professionals involved in your care that you are receiving Ontak, as it may interact with certain medications or affect the interpretation of certain laboratory tests.
• It is important to attend all scheduled appointments and laboratory tests as recommended by your healthcare provider.
• Do not receive any live vaccines while undergoing treatment with Ontak without consulting your healthcare provider first.
• If you have any questions or concerns about Ontak, its administration, or its effects, consult your healthcare provider for clarification.

It is important to consult your healthcare provider or refer to the latest information for the most accurate and up-to-date guidance regarding storage, disposal, emergencies, and any other specific instructions related to Ontak.