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Brand Names: Idamycin PFS

Generic Name: idarubicin (Pronunciation: EYE da ROO bi sin)

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

What is idarubicin (Idamycin PFS)?

Idarubicin is a cancer (antineoplastic) medication. Idarubicin interferes with the growth of cancer cells and slows their growth and spread in the body.

Idarubicin is used to treat a type of blood cancer (acute myeloid leukemia -AML) in adults .

Idarubicin may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of idarubicin (Idamycin PFS)?

If you experience any of the following serious side effects from idarubicin, contact your doctor immediately:

• an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
• decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);
• congestive heart failure (difficulty breathing, fluid retention, chest pain);
• irregular heartbeats;
• tissue or vein reactions near the site of administration;
• liver damage (abdominal pain, yellowing of the skin or eyes);
• severe nausea, vomiting, diarrhea, and loss of appetite;
• inflamation and sores inside the mouth, throat, or intestines;
• fever, chills, or other signs of infection;
• numbness, tingling, or difficult movement of a body part;
• seizures; or
• increased levels of uric acid in the body (joint pain and stiffness).

Other, less serious side effects may be more likely to occur. Continue taking idarubicin and talk to your doctor if you experience:

• facial flushing during administration;
• eye irritation or tearing;
• darkening of the nail beds and skin folds;
• temporary hair loss; or
• red colored urine for 1 or 2 days following a dose.

Some breast cancer patients developed a second cancer (leukemia) after treatment with idarubicin. Idarubicin may cause premature menopause.

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 idarubicin (Idamycin PFS)?

Idarubicin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of idarubicin including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); severe heart damage with prolonged use; decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection); severe nausea, vomiting, diarrhea, and loss of appetite; and others.Talk to your doctor about the possible side effects from treatment with idarubicin.