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Denileukin diftitox intraven.
DENILEUKIN DIFTITOX - INJECTABLE

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

DENILEUKIN DIFTITOX - INJECTABLE

(den-ih-LEW-kin DIFF-teh-tox)

COMMON BRAND NAME(S): Ontak

WARNING: Denileukin is a potent medication that should only be given in a proper facility (e.g., hospital, clinic) with the recommended safety/monitoring equipment available. Consult your doctor.

Uses

Denileukin diftitox is used to treat a certain type of cancer (recurrent or persistent cutaneous T-cell lymphoma/CTCL).

How To Use

This medication has very specific directions for use. Follow all instructions for proper handling (e.g., thawing and swirling the vials), mixing, and diluting with the correct IV fluids. If you have any questions regarding the use of this medication, consult your pharmacist. Do not shake the container/vial. Give this medication by vein (IV) over at least 15 minutes in a preservative-free saline solution. Usually this drug is given once daily for 5 days only, or as directed by your doctor. The dosage and length of treatment is based on your weight, medical condition, and response to therapy. The dose cycle (every day for 5 days) is usually repeated every 3 weeks, or as determined by your doctor. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. When used for an extended period, this medication may not work as well and may require different dosing. Consult your doctor. Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.

Side Effects

Flu-like symptoms (e.g., fever, chills, sore throat, unusual weakness, muscle aches), nausea, vomiting, diarrhea, constipation, dizziness, nervousness, lightheadedness, cough, runny nose, or headache may occur. If any of these effects persist or worsen, notify your doctor. Tell your doctor immediately if any of these serious side effects occur: swelling (edema), loss of appetite, weight loss, muscle pain/cramps, pain/swelling/redness at the injection site, rash, itching, trouble breathing, chest pain. Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual sweating/flushing, unusually fast/irregular heartbeat, joint pain, back pain, confusion, trouble sleeping, trouble swallowing. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: easy bleeding or bruising, persistent sore throat and fever, red or pink-colored urine, severe stomach pain, change in amount of urine, pain in the lower legs. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Tell your doctor your medical history, especially of: heart or blood vessel problems (cardiovascular disease), liver problems, kidney problems, other cancer, any allergies (especially to diphtheria vaccines). Because this medication can lower your body's ability to fight an infection, do not touch your eyes or the inside of your nose without first washing your hands. Do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received live vaccines (e.g., oral polio vaccine). Use caution with sharp objects like safety razors or nail cutters and avoid activities that may put you at risk of getting cut, bruised, or injured. To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of this drug. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Drug Interactions

Tell your doctor of all prescription and nonprescription medication you may use, especially: other cancer chemotherapy drugs. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately.

Notes

Laboratory and/or medical tests (e.g., albumin levels, blood counts, liver function tests) will be performed to monitor your progress and/or the occurrence of side effects.

Missed Dose

If you miss a dose, contact your doctor to establish a new dosing schedule.

Storage

Store frozen at, or below 14 degrees F (-10 degrees C). Before using, thaw the vial/solution in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C) for not more than 24 hours or at room temperature (77 degrees F or 25 degrees C) for 1 to 2 hours. Do not heat the solution and do not re-freeze the solution. Discard any unused portion of the vial.

Medical Alert

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).