WARNING

Denileukin diftitox is a medication used primarily to treat certain types of lymphoma. While it can be effective, it carries several risks and potential side effects. Key risks include:

• Infusion Reactions: Common during or shortly after administration, symptoms can range from mild (fever, chills) to severe (difficulty breathing, low blood pressure).
• Capillary Leak Syndrome: This serious condition involves fluid and proteins leaking from small blood vessels into surrounding tissues, potentially leading to low blood pressure, swelling, and organ failure.
• Visual Changes: Patients may experience vision problems, which can include blurred vision or other eye-related issues.
• Infections: The immune system can be weakened, making patients more susceptible to infections.
• Electrolyte Imbalance: It can cause abnormalities in electrolytes, such as low levels of albumin, calcium, or magnesium.
• Hepatotoxicity: Liver function may be impaired, indicated by elevated liver enzymes in blood tests.

Given these risks, it’s essential for patients to be closely monitored by healthcare professionals during and after treatment with denileukin diftitox.

Why is this medication prescribed?

Denileukin Diftitox Injection, marketed under the brand name Ontak, is prescribed for the treatment of certain types of cancer, particularly cutaneous T-cell lymphoma (CTCL). CTCL is a rare type of non-Hodgkin lymphoma that affects the skin.

Denileukin Diftitox works by targeting certain cells in the body called CD25-positive malignant T-cells, which are commonly found in CTCL. It contains two components: denileukin, which is a genetically engineered protein that specifically targets these CD25-positive cells, and diphtheria toxin, which is a bacterial toxin that kills cells. By combining these components, Denileukin Diftitox can selectively target and destroy cancerous cells while sparing healthy cells.

How should this medicine be used?

Denileukin diftitox should be administered under the supervision of a healthcare professional experienced in the use of cancer chemotherapeutic agents. Here are the general guidelines for its use:

• Preparation and Dosage: The drug is typically prepared by mixing the powder form with a sterile solution. The exact dosage depends on the patient’s body surface area, which is calculated based on height and weight.
• Administration: It is given as an intravenous (IV) infusion. The infusion is usually administered over a 30-60 minute period. It is typically given once daily for five consecutive days, which constitutes one treatment cycle. This cycle may be repeated every 21 days, depending on the patient’s response and tolerance to the medication.
• Pre-medication: Patients are often given medications such as antihistamines, acetaminophen, and corticosteroids before the infusion to reduce the risk of infusion reactions and other side effects.
• Monitoring: Patients should be closely monitored during and after the infusion for any adverse reactions. Regular blood tests are necessary to check liver function, kidney function, and electrolyte levels.
• Hydration: Adequate hydration is important before, during, and after the treatment to help prevent kidney damage and other complications.

Due to the potential for severe side effects, it is crucial that denileukin diftitox is administered in a clinical setting where appropriate medical support is available.

Other uses for this medicine

• Other Cancers: Investigations are ongoing to determine its efficacy against other types of cancers that express the IL-2 receptor.
• Autoimmune Diseases: There is some research into its use for autoimmune diseases, leveraging its ability to target immune cells.

What special precautions should I follow?

When using denileukin diftitox, it is crucial to follow certain precautions to minimize risks and manage potential side effects effectively:

• Medical History: Inform your doctor about any allergies, especially to diphtheria toxin or interleukin-2. Disclose your complete medical history, particularly if you have liver disease, heart disease, lung disease, or kidney issues.
• Pre-medication: Follow the prescribed regimen of pre-medications to help prevent infusion reactions, which may include antihistamines, acetaminophen, and corticosteroids.
• Monitoring: Regular monitoring is essential. Attend all scheduled appointments for blood tests and other evaluations to check your body’s response to the treatment. Be vigilant for signs of infusion reactions, such as fever, chills, rash, or difficulty breathing, and report them immediately to your healthcare provider.
• Hydration: Ensure adequate hydration before, during, and after treatment to help prevent kidney damage and other complications.
• Electrolyte Balance: Maintain a balanced diet and possibly supplements as advised by your doctor to manage electrolyte levels, as the treatment can cause imbalances.
• Infection Prevention: Practice good hygiene and avoid contact with sick individuals, as your immune system may be weakened, increasing the risk of infections.
• Pregnancy and Breastfeeding: Denileukin diftitox can harm an unborn baby. Inform your doctor if you are pregnant or plan to become pregnant. Do not breastfeed while using this medication and for some time after the last dose, as it may pass into breast milk and harm the nursing baby.
• Other Medications: Provide your healthcare provider with a list of all medications you are taking, including over-the-counter drugs, supplements, and herbal products, to avoid potential interactions.
• Side Effects Management: Be aware of potential side effects, such as vision problems, signs of capillary leak syndrome (e.g., swelling, weight gain, dizziness), and liver issues (e.g., jaundice, dark urine). Report these immediately to your doctor.

By following these precautions and maintaining open communication with your healthcare team, you can help ensure the safe and effective use of denileukin diftitox.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with denileukin diftitox itself. However, maintaining a balanced diet can support overall health and help manage side effects.

What should I do if I forget a dose?

• Inform Your Healthcare Provider: Contact your healthcare provider immediately if you miss a dose. They will provide guidance on the next steps.
• Do Not Self-Administer: Do not attempt to make up the missed dose by self-administering the medication. It must be given by a healthcare professional.
• Follow Professional Advice: Follow the advice given by your healthcare provider regarding the scheduling of the next dose or any adjustments to the treatment plan.

What side effects can this medication cause?

Denileukin diftitox injection can cause a range of side effects, from mild to severe. It is important for patients to be aware of these potential side effects and to communicate with their healthcare provider if they experience any of them.

Common Side Effects:

• Infusion Reactions:
  • Fever
  • Chills
  • Nausea
  • Vomiting
  • Fatigue
  • Headache
  • Muscle or joint pain
• Skin Reactions:
  • Rash
  • Itching
  • Redness at the injection site
• Gastrointestinal Issues:
  • Diarrhea
  • Abdominal pain
• Flu-like Symptoms:
  • General malaise
  • Sweating

Serious Side Effects:

• Capillary Leak Syndrome:
  • Rapid weight gain
  • Swelling of the arms, legs, or face
  • Low blood pressure
  • Dizziness or fainting
  • Difficulty breathing
• Visual Changes:
  • Blurred vision
  • Other vision disturbances
• Liver Problems:
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine
  • Severe nausea or vomiting
  • Pain in the upper right side of the abdomen
• Kidney Problems:
  • Changes in urine output
  • Swelling in the legs or ankles
• Electrolyte Imbalances:
  • Symptoms of low calcium, magnesium, or potassium (muscle cramps, weakness, irregular heartbeat)
• Severe Allergic Reactions:
  • Anaphylaxis (difficulty breathing, swelling of the throat or tongue, severe rash)
  • Hives
• Infections:
  • Increased susceptibility to infections
  • Fever, chills, sore throat, or other signs of infection

Less Common but Serious Side Effects:

• Heart Problems:
  • Irregular heartbeat
  • Chest pain
• Neurological Symptoms:
  • Confusion
  • Seizures

Management of Side Effects:

• Pre-medication: Using antihistamines, acetaminophen, and corticosteroids before treatment can reduce the risk of infusion reactions.
• Close Monitoring: Regular blood tests and clinical evaluations to monitor for early signs of serious side effects.
• Hydration: Adequate hydration can help prevent kidney damage and manage capillary leak syndrome.
• Prompt Reporting: Patients should immediately report any unusual or severe symptoms to their healthcare provider for timely management.

Due to the potential severity of some of these side effects, denileukin diftitox should be administered in a clinical setting where healthcare professionals can provide immediate care if needed.

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

Storage and disposal of denileukin diftitox:

Storage:

• Proper Temperature: Store denileukin diftitox in the refrigerator at a temperature between 2°C and 8°C (36°F and 46°F). Do not freeze.
• Light Protection: Keep the medication in its original packaging to protect it from light.
• Handling: Handle the medication with care, ensuring that it is kept away from children and pets.

Disposal:

• Unused Medication: Do not dispose of denileukin diftitox in household trash or wastewater (e.g., down the sink or toilet).
• Professional Disposal: Return unused or expired medication to a pharmacy or a specialized disposal service for proper disposal. Your healthcare provider or pharmacist can provide information on local disposal programs.

In case of emergency/overdose

• Immediate Action: If you suspect an overdose or experience severe side effects (e.g., difficulty breathing, severe allergic reaction, rapid weight gain, extreme dizziness), seek emergency medical attention immediately. Call emergency services or go to the nearest emergency room.
• Poison Control Center: Contact your local poison control center for guidance if an overdose is suspected. In the U.S., the Poison Help hotline is 1-800-222-1222.

What other information should I know?

• Before using Denileukin Diftitox Injection, inform your healthcare provider about any allergies, medical conditions, and medications you are currently taking, including over-the-counter drugs and supplements.
• Follow your healthcare provider’s instructions carefully regarding the dosage and administration schedule of Denileukin Diftitox Injection.
• Attend all scheduled appointments for monitoring and follow-up with your healthcare provider during treatment.
• Report any side effects or adverse reactions to your healthcare provider promptly.
• Avoid coming into contact with people who have infections while using Denileukin Diftitox Injection, as it may lower your body’s ability to fight infections.
• Use effective contraception during treatment and for at least 30 days after the last dose if you are of reproductive age and sexually active.

Always consult your healthcare provider or pharmacist if you have any questions or concerns regarding the storage, disposal, administration, or side effects of Denileukin Diftitox Injection.