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Idamycin-PFS

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Idamycin PFS

Idamycin-PFS Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Idamycin PFS (idarubicin hydrochloride) Injection is a cancer (antineoplastic) medication used to treat a type of blood cancer (acute myeloid leukemia -AML) in adults. This medication is available in generic form. Common side effects include nausea, vomiting, abdominal cramps, diarrhea, and headache. Temporary hair loss is a common side effect. Normal hair growth should return after treatment has ended.

For induction therapy in adult patients with AML the following dose schedule is recommended: Idamycin PFS Injection 12 mg/mē daily for 3 days by slow (10 to 15 min) intravenous injection in combination with cytarabine. Idamycin PFS may interact with paclitaxel, cimetidine, progesterone, verapamil, cyclosporine, cyclophosphamide, phenobarbital, phenytoin, streptozocin, or "live" vaccines. Tell your doctor if you have previously been treated with doxorubicin, daunorubicin, idarubicin, or mitoxantrone. There is a maximum amount of these medications that should be administered to an individual, and you may not be able to use idarubicin. Tell your doctor all medications and supplements you use and all vaccines you recently received. Idamycin PFS is not recommended for use during pregnancy. It may harm a fetus. If you become pregnant or think you may be pregnant, tell your doctor. Males and females using this drug should use birth control (e.g., birth control pills, condoms) during treatment; consult your doctor. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug is not recommended.

Our Idamycin PFS (idarubicin hydrochloride) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Idamycin-PFS in Detail - Patient Information: Side Effects

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.

Read the entire detailed patient monograph for Idamycin-PFS (Idarubicin Hydrochloride Injection) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Idamycin-PFS Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, abdominal cramps, diarrhea, and headache may occur. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Temporary hair loss is a common side effect. Normal hair growth should return after treatment has ended.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: severe abdominal pain, mental/mood changes (e.g., confusion), numbness/tingling of arms/legs, rash/blisters on palms of hands/soles of feet, unusual bleeding/bruising (e.g., small red spots on the skin, black/bloody stools, bloody urine, vomit that looks like coffee grounds).

Pain or sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.

Get medical help right away if this rare but very serious side effect occurs: seizure.

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

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.

Read the entire patient information overview for Idamycin-PFS (Idarubicin Hydrochloride Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Idamycin-PFS FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Approximately 550 patients with AML have received idarubicin in combination with cytarabine in controlled clinical trials worldwide. In addition, over 550 patients with acute leukemia have been treated in uncontrolled trials utilizing idarubicin as a single agent or in combination. The table below lists the adverse experiences reported in U.S.

Study 2 (see Clinical Studies) and is representative of the experiences in other studies. These adverse experiences constitute all reported or observed experiences, including those not considered to be drug related. Patients undergoing induction therapy for AML are seriously ill due to their disease, are receiving multiple transfusions, and concomitant medications including potentially toxic antibiotics and antifungal agents. The contribution of the study drug to the adverse experience profile is difficult to establish.

Induction Phase
Adverse Experiences
Percentage of Patients
IDR
(N=110)
DNR
(N=118)
Infection 95% 97%
Nausea & Vomiting 82% 80%
Hair Loss 77% 72%
Abdominal Cramps/Diarrhea 73% 68%
Hemorrhage 63% 65%
Mucositis 50% 55%
Dermatologic 46% 40%
Mental Status 41% 34%
Pulmonary-Clinical 39% 39%
Fever (not elsewhere classified) 26% 28%
Headache 20% 24%
Cardiac-Clinical 16% 24%
Neurologic-Peripheral Nerves 7% 9%
Pulmonary Allergy 2% 4%
Seizure 4% 5%
Cerebellar 4% 4%

The duration of aplasia and incidence of mucositis were greater on the IDR arm than the DNR arm, especially during consolidation in some U.S. controlled trials (see Clinical Studies).

The following information reflects experience based on U.S. controlled clinical trials.

Myelosuppression

Severe myelosuppression is the major toxicity associated with idarubicin therapy, but this effect of the drug is required in order to eradicate the leukemic clone. During the period of myelosuppression, patients are at risk of developing infection and bleeding which may be life-threatening or fatal.

Gastrointestinal

Nausea and/or vomiting, mucositis, abdominal pain and diarrhea were reported frequently, but were severe (equivalent to WHO Grade 4) in less than 5% of patients. Severe enterocolitis with perforation has been reported rarely. The risk of perforation may be increased by instrumental intervention. The possibility of perforation should be considered in patients who develop severe abdominal pain and appropriate steps for diagnosis and management should be taken.

Dermatologic

Alopecia was reported frequently and dermatologic reactions including generalized rash, urticaria and a bullous erythrodermatous rash of the palms and soles have occurred. The dermatologic reactions were usually attributed to concomitant antibiotic therapy. Local reactions including hives at the injection site have been reported. Recall of skin reaction due to prior radiotherapy has occurred with idarubicin administration.

Hepatic and Renal

Changes in hepatic and renal function tests have been observed. These changes were usually transient and occurred in the setting of sepsis and while patients were receiving potentially hepatotoxic and nephrotoxic antibiotics and antifungal agents. Severe changes in renal function (equivalent to WHO Grade 4) occurred in no more than 1% of patients, while severe changes in hepatic function (equivalent to WHO Grade 4) occurred in less than 5% of patients.

Cardiac

Congestive heart failure (frequently attributed to fluid overload), serious arrhythmias including atrial fibrillation, chest pain, myocardial infarction and asymptomatic declines in LVEF have been reported in patients undergoing induction therapy for AML. Myocardial insufficiency and arrhythmias were usually reversible and occurred in the setting of sepsis, anemia and aggressive intravenous fluid administration. The events were reported more frequently in patients over age 60 years and in those with pre-existing cardiac disease.

Read the entire FDA prescribing information for Idamycin-PFS (Idarubicin Hydrochloride Injection) »

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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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