Ontak

DRUG DESCRIPTION

Ontak (denileukin diftitox), is a recombinant DNA-derived cytotoxic protein composed of the amino acid sequences for diphtheria toxin fragments A and B (Met1-Thr387)-His and the sequences for human interleukin-2 (IL-2; Ala1-Thr133). It is produced in an E. coli expression system and has a molecular weight of 58 kD. Neomycin is used in the fermentation process but is undetectable in the final product. Ontak (denileukin diftitox) is supplied in single use vials as a sterile, frozen solution intended for intravenous (IV) administration. Each 2 mL vial of Ontak contains 300 mcg of recombinant denileukin diftitox in a sterile solution of citric acid (20 mM), EDTA (0.05 mM) and polysorbate 20 ( < 1%) in Water for Injection, USP. The solution has a pH range of 6.9 to 7.2.

What are the possible side effects of denileukin diftitox (Ontak)?

You may have a reaction from a denileukin diftitox injection within hours or days after receiving the injection. Call your doctor promptly if you have one or more of these symptoms: fever, chills, weakness, muscle or joint pain, nausea, vomiting, or stomach upset.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • blurred vision,...

Read All Potential Side Effects and See Pictures of Ontak

What are the precautions when taking denileukin diftitox (Ontak)?

Before receiving denileukin diftitox, tell your doctor or pharmacist if you are allergic to it; or to diphtheria toxin/vaccines; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart/blood vessel disease, any current infections.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

Do not have...

Read All Potential Precautions of Ontak


Ontak Consumer (continued)

SIDE EFFECTS: See also Warning section.

Dizziness, back pain, mild rash/itching, flushing, fever, chills, muscle/joint pain, nausea, vomiting, or diarrhea may occur during or after the infusion. Tell your doctor or pharmacist immediately if any of these effects occur, persist, or worsen. Your doctor may stop/slow down the infusion, and/or prescribe additional medications to help control these symptoms. Headache, loss of appetite, sweating, or trouble sleeping may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor immediately if any of these serious side effects occur: extreme thirst, very dry mouth, decreased urination, weakness, muscle cramps, chest pain/tightness, shortness of breath, fast/slow/irregular heartbeat, trouble swallowing, confusion, pain/redness/swelling of arms/legs/injection site, numbness/tingling of arms/legs.

This medication may cause very serious blood disorders (low number of blood cells such as red cells, white cells, and platelets). This effect can cause anemia, decrease your body's ability to fight an infection, or cause your body to bruise or bleed more easily. Tell your doctor immediately if you develop any of the following symptoms: signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, unusual tiredness, fast/pounding heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before receiving denileukin diftitox, tell your doctor or pharmacist if you are allergic to it; or to diphtheria toxin/vaccines; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart/blood vessel disease, any current infections.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk and the effect on a nursing infant is unknown. Discuss the risks and benefits with your doctor before breast-feeding.


Ontak Patient Information Including Side Effects

Brand Names: Ontak

Generic Name: denileukin diftitox (Pronunciation: de ni LOO kin DIF ti tox)

  • What is denileukin diftitox (Ontak)?
  • What are the possible side effects of denileukin diftitox (Ontak)?
  • What is the most important information I should know about denileukin diftitox (Ontak)?
  • What should I discuss with my health care provider before using denileukin diftitox (Ontak)?
  • How should I use denileukin diftitox (Ontak)?
  • What happens if I miss a dose (Ontak)?
  • What happens if I overdose (Ontak)?
  • What should I avoid while receiving denileukin diftitox (Ontak)?
  • What other drugs will affect denileukin diftitox (Ontak)?
  • Where can I get more information?

What is denileukin diftitox (Ontak)?

Denileukin diftitox is a designed protein containing toxins that attach themselves to certain types of malignant cells in the body. Denileukin diftitox works by destroying these malignant cells to slow the progression of cancer.

Denileukin diftitox is used to treat leukemia and lymphomas, including cutaneous (of the skin) T-cell lymphoma.

Denileukin diftitox may also be used for other purposes not listed in this medication guide.

What are the possible side effects of denileukin diftitox (Ontak)?

You may have a reaction from a denileukin diftitox injection within hours or days after receiving the injection. Call your doctor promptly if you have one or more of these symptoms: fever, chills, weakness, muscle or joint pain, nausea, vomiting, or stomach upset.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • blurred vision, changes in color vision;
  • swelling in your hands, ankles, or feet;
  • easy bruising or bleeding, unusual weakness;
  • fever, chills, body aches, cough, flu symptoms;
  • fast heart rate;
  • feeling light-headed, fainting;
  • back pain, trouble breathing, chest pain or tightness;
  • trouble swallowing, tight feeling in your throat; or
  • warmth or redness in your face, neck, or chest.

Less serious side effects may include:

  • headache, dizziness, or nervousness;
  • numbness or tingling;
  • runny or stuffy nose;
  • skin itching or rash;
  • weight gain or loss;
  • mild diarrhea or constipation; or
  • nausea, vomiting, loss of appetite.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about denileukin diftitox (Ontak)?

You should not use denileukin diftitox if you have ever had an allergic reaction to a diphtheria vaccine or to medicines containing interleukin-2 (IL-2).

Denileukin diftitox is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection in a hospital or clinic setting. The injection normally takes about 15 minutes or longer. During this time you will be observed for side effects.

You may have a reaction from a denileukin diftitox injection within hours or days after receiving the injection. Call your doctor promptly if you have one or more of these symptoms: fever, chills, weakness, muscle or joint pain, nausea, vomiting, or stomach upset.

Some patients receiving denileukin diftitox have had permanent changes in their vision or ability to see colors. Talk with your doctor about your individual risk. Tell your doctor if you have any vision changes during your treatment.

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