Idamycin PFS

DRUG DESCRIPTION

IDAMYCIN PFS Injection contains idarubicin hydrochloride and is a sterile, semi-synthetic, preservative-free solution (PFS) antineoplastic anthracycline for intravenous use. Chemically, idarubicin hydrochloride is 5, 12-Naphthacenedione, 9-acetyl-7-[(3-amino-2,3,6-trideoxy-?-L-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,9,11-trihydroxyhydrochloride, (7S-cis). The structural formula is as follows:

Idamycin PFS  (idarubicin hydrochloride) Structural Formula Illustration

C26H27NO9Hcl M.W 533.96

IDAMYCIN PFS (idarubicin hydrochloride injection) is a sterile, red-orange, isotonic parenteral preservative-free solution, available in 5 mL (5 mg), 10 mL (10 mg) and 20 mL (20 mg) single-use-only vials.

Each mL contains Idarubicin HCL, USP 1 mg and the following inactive ingredients: Glycerin, USP 25 mg and Water for Injection, USP q.s. Hydrochloric Acid, NF is used to adjust the pH to a target of 3.5.

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...

Read All Potential Side Effects and See Pictures of Idamycin PFS

What are the precautions when taking idarubicin hydrochloride injection (Idamycin PFS)?

Before using idarubicin, tell your doctor or pharmacist if you are allergic to it; or to other anthracyclines (e.g., doxorubicin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bleeding disorders (e.g., anemia, low blood cell counts), gout, heart disease (e.g., congestive heart failure, irregular heartbeat), kidney disease, liver disease, radiation treatment (especially to chest area).

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu...

Read All Potential Precautions of Idamycin PFS


Idamycin PFS Consumer (continued)

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.

PRECAUTIONS: Before using idarubicin, tell your doctor or pharmacist if you are allergic to it; or to other anthracyclines (e.g., doxorubicin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bleeding disorders (e.g., anemia, low blood cell counts), gout, heart disease (e.g., congestive heart failure, irregular heartbeat), kidney disease, liver disease, radiation treatment (especially to chest area).

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist that you are using this medication.

Caution is advised when using this medication in the elderly because they may be more sensitive to the effects of the drug, especially the effects on the heart.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. To avoid pregnancy, both males and females using this drug should use reliable form(s) of birth control (e.g., birth control pills, condoms) during treatment. Consult your doctor for details and to discuss effective forms of birth control.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Idamycin PFS Patient Information Including Side Effects

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.

Related Drug Centers
  • Idamycin-PFS


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