gemtuzumab ozogamicin - injection, Mylotarg (cont.)

USES: This medication is used to treat a certain type of leukemia (acute myeloid leukemia-AML). It is recommended for use in patients whose AML has returned for the first time and who are 60 years or older and cannot use other forms of cancer chemotherapy. This medication works by stopping the growth of cancer cells.

HOW TO USE: This medication is given by injection into a vein by a health care professional. Follow all instructions for proper mixing and dilution with the correct IV fluid. The medication may appear cloudy, which is normal. Before using, check this product visually for large/unusual particles or discoloration. If either is present, do not use the liquid. Do not mix gemtuzumab ozogamicin with other medications in the same IV bag or give together with other medications through the same IV line. Protect the medication from light while it is prepared and given. If you have any questions about the preparation or use of this medication, consult your pharmacist.Dosage is based on your body size. This medication is usually given over 2 hours with another dose given 14 days later for a total of 2 doses. You will be given other medications (e.g., acetaminophen, diphenhydramine) before the infusion to help prevent side effects.To get the most benefit from this medication, do not miss any doses. To help you remember, mark the days on the calendar when you need to receive the medication.

SIDE EFFECTS: See also Warning section.Fever, chills, dizziness, headache, nausea, vomiting, or pain/swelling at injection site may occur during or after the infusion. Tell your doctor or pharmacist promptly if any of these effects occur, persist, or worsen. You may be given additional medications to help control these symptoms. Mouth sores, a mild rash, constipation, or diarrhea may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Many people using this medication may 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 unlikely but serious side effects occur: increased thirst/urination, change in the amount of urine, muscle spasm/weakness, seizures, fast/irregular heartbeat, black/bloody stools.Seek immediate medical attention if any of these rare but very serious side effects occur: slurred speech, weakness on one side of the body, confusion, pain/redness/swelling of arms or legs.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.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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