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MYLOTARG
GEMTUZUMAB OZOGAMICIN - 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.

GEMTUZUMAB OZOGAMICIN - INJECTABLE

(gem-TOOZ-oo-mab oh-zoh-GAM-ih-sin)

COMMON BRAND NAME(S): Mylotarg

WARNING: This is a potent medication that can lower the body's ability to fight infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat. Avoid having immunizations/vaccinations and contact with people who are ill during your treatment. This drug may also cause severe, rarely fatal, allergic-type reactions and liver problems. Seek immediate medical attention if you experience any of the following allergic-type symptoms during your treatment with this drug: rash, severe itching, swelling, dizziness, trouble breathing. Also, tell your doctor immediately if you experience any of the following symptoms of severe liver problems during, or anytime after your treatment with this drug: unusual weight gain, stomach pain/swelling.

Uses

Gemtuzumab ozogamicin is used to treat a certain form of leukemia called acute myeloid leukemia (AML). Leukemia is a form of cancer that affects the white blood cells. This medication works by combining an antibody that is specific for this form of leukemia with a potent anti-cancer antibiotic. It is recommended only for people with AML who are older than 60 years of age or who should not receive other forms of cancer chemotherapy.

How To Use

Follow all instructions for proper mixing and dilution with the correct IV fluids. If you have questions regarding the use of this medication, consult your pharmacist. This medication must be protected from light (sunlight or fluorescent indoor light) at all times. Exposure of this drug to light may make it ineffective. Consult your pharmacist for details. Give this medication by vein (IV) over 2 hours in a saline solution (NS), usually once every 14 days for a total of 2 doses only; or as directed by your doctor. The dosage is based on your body size, medical condition, and response to therapy. It is recommended that other medications (acetaminophen, diphenhydramine) be given before, and up to 12 hours after this drug has been given to decrease the risk of certain allergic-like side effects (e.g., chills, fever). This medication may contain small particles after it is added to the IV solution. It is very important to use an IV filter (in- line filter) when giving this medication. Consult your pharmacist for the proper use of the filter. Before using, check this product visually for unusual particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.

Side Effects

Temporary chills or fever (lasting up to 24 hours), nausea, vomiting, headache, rash, fatigue, dizziness, diarrhea, or constipation may occur. If any of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these serious side effects occur: cough, persistent sore throat or fever, easy bruising or bleeding, trouble breathing, sores on the mouth or genitals. Tell your doctor immediately if any of these unlikely but serious side effects occur: change in amount of urine, pink or red-colored urine, unusual increase in thirst, one-sided weakness, slurred speech, irregular heartbeat. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: swelling of the mouth/tongue, yellowing eyes or skin, stomach pain, dark urine, swelling, pain. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Tell your doctor your medical history, especially of: liver problems, blood problems (e.g., low blood counts), any allergies (especially to antibiotics similar to calicheamicin). Because this medication can decrease your immune system function, 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 increase the chance of getting cut, bruised, or injured. This medication is not recommended for use during pregnancy. Consult your doctor for more details. 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.

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., blood counts, uric acid levels, liver function tests) may be performed to monitor your progress or check for side effects.

Missed Dose

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

Storage

Store the unmixed powder/vials in a refrigerator between 36 and 46 degrees F (2 and 8 degrees C) away from light. Once mixed, the vial is good for up to 8 hours if protected from light and stored in the refrigerator. After mixing and subsequent dilution with IV fluids, this product must be used immediately after dilution. Discard any unused portion of the vial(s).

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).