What Idarubicin Hydrochloride Injection is used for and how to use it
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Idarubicin Hydrochloride Injection - Consumer Medicine Information

Manufacture: Fresenius Kabi USA, LLC
Country: Canada
Condition: Acute Myeloid Leukemia
Class: Antineoplastic detoxifying agents, Antineoplastics
Form: Liquid solution, Intravenous (IV)
Ingredients: Idarubicin hydrochloride, Glycerin, Hydrochloric acid, Water for Injection

About This Medication

What the Medication is Used For

Idarubicin Hydrochloride Injection alone or in combination with other anticancer drugs is used in the treatment of:

  • acute non-lymphocytic leukemia (ANLL) as a firstline in adult patients;
  • acute lymphocytic leukemia (ALL) as a second-line in adults and children.

What it Does

Idarubicin hydrochloride is a cancer drug (chemotherapy drug) which work by killing rapidly dividing cells, such as cancer cells. This action can affect normal cells as well.

In people with leukemia, the bone marrow produces abnormal white blood cells. The abnormal white cells are leukemia cells (cancer cells).

When it Should not be Used

Do not use the drugs if you:

  • are allergic to idarubicin or any of the ingredients of the drug or its container (see What the important non-medicinal ingredients are);
  • are allergic to other anthracyclines or anthracenediones such as epirubicin, daunorubicin, mitoxantrone or mitomycin;
  • have persistent low blood count (myelosuppression);
  • have severe liver, renal or heart disease;
  • have recent heart attack;
  • have severe irregular heartbeat;
  • have history of severe cardiac disease;
  • have uncontrolled infections;
  • have been treated with a maximum cumulative dose of idarubicin, doxorubicin, daunorubicin, epirubicin or other anthracyclines or anthracenediones.

What the Medicinal Ingredient Is

Idarubicin hydrochloride, USP is the active ingredient.

What the Important Non-medicinal Ingredients Are

Glycerin, USP
Hydrochloric acid, NF
Water for Injection, USP

What Dosage Forms it Comes In

Idarubicin Hydrochloride Injection, 1 mg/mL is a clear red-orange sterile solution to be given intravenously.

Warning and Precautions

Idarubicin Hydrochloride Injection should be given under the supervision of a doctor experienced with the use of anticancer drugs.

Idarubicin Hydrochloride Injection should not be given to patients with the following conditions:
- A low blood count (bone marrow suppression induced by previous drug therapy or radiotherapy);
- A heart disease and/or previous treatment with anthracyclines (cardiotoxic drugs).

BEFORE you use Idarubicin Hydrochloride Injection, talk to your doctor if you have:

  • low blood cell counts;
  • heart disease, recent heart attack or irregular heartbeat;
  • infection;
  • had radiotherapy to chest area;
  • if you are taking calcium channel blockers, such as amlodipine, diltiazem, verapamil;
  • you are pregnant or planning to become pregnant;
  • you are breast-feeding or planning to breast-feed
  • if you have been previously treated with Idarubicin Hydrochloride Injection or other anti-cancer drugs, including anthracyclines (cardiotoxic drugs).

As idarubicin hydrochloride may be harmful to an unborn child, women should be advised to avoid becoming pregnant. Effective contraceptive methods should be used.

Tell your doctor right away if you become pregnant during treatment. If you have been nursing, you should stop before starting treatment with idarubicin hydrochloride injection. Ask your baby’s doctor to recommend a formula that would be best for your baby.

As idarubicin hydrochloride may cause fertility impairment and damage chromosomes in sperm, men undergoing treatment with idarubicin hydrochloride should use effective contraceptive methods.

Interactions With This Medication

Tell your doctor or pharmacist if you have or recently have taken any other medicines including medicines bought without prescription.

Drugs that may interact with idarubicin hydrochloride include: cytarabine, other anthracyclines, anthracenediones and calcium channel blockers such amlodipine, diltiazem or verapamil.

Other drugs that may be used in therapy with idarubicin hydrochloride may increase the chance of toxic effects include: cyclophosphamide, fludarabine, etoposide, paclitaxel.

Talk to your doctor before you receive a vaccine while treated with Idarubicin Hydrochloride Injection, as the combination may result in a serious infection in patients with a compromised immunity (i.e., patients taking oral corticosteroids, transplanted patients, elderly patients).

Proper use of This Medication

How is Idarubicin Hydrochloride Given

You may receive idarubicin hydrochloride through a vein in the arm (“intravenously” or “IV”) by your doctor or nurse, usually in the hospital, outpatient department or clinic.

If you are getting many injections, for your convenience, your doctor may insert a catheter (thin tube) or port into a large vein in your body that is placed there as long as it is needed. Medicines get injected through the catheter or port rather than directly into a vein.

How Much Time Does it Take to get a Treatment With Idarubicin Hydrochloride

It usually takes about 5-10 minutes to inject idarubicin hydrochloride. However, you may get other medicines before or after idarubicin hydrochloride, so your entire treatment may last an hour or longer.

How Long Will I Need Treatment

Your doctor will determine the length of your treatment based on your treatment goals, the medicines you receive, and how your body responds to those medicines.

Your treatment cycle will depend on your medical condition and the other chemotherapy medicines you are getting. Idarubicin hydrochloride is usually given once a day for 3 consecutive days.

Overdose

If you think you are given more Idarubicin Hydrochloride Injection than you should, contact your doctor, nurse, or poison control centre immediately.

Missed Dose

If you miss your scheduled treatment with the drug, contact your doctor as soon as possible to schedule your next treatment.

Side Effects and What to do About Them

Like all medicines, idarubicin hydrochloride can have side effects.

Common side effects include:

  • Hair loss, which is temporary and usually starts to grow back within 2 or 3 months after you have finished your treatments;
  • Infection, as a result of low white blood cell count. The signs of infection include fever over 38 °C (100 °F), chills or sweating, sore throat or coughing, redness or swelling around a cut, wound or a catheter site, a burning feeling when you urinate, unusual vaginal itching or discharge;
  • Nausea and vomiting;
  • Fatigue, or feeling tired;
  • Mouth sores;
  • Anemia, or low red blood cell count;
  • Red coloration of your urine for 1 to 2 days after administration during active therapy;
  • Diarrhea with dehydration and symptoms such as skin flushed, dry and pale, less urination;
  • Sensitivity of irradiated skin;
  • Hot flashes;
  • Skin and nail changes or colouration, tingling sensation;
  • Rash/itch/redness skin allergy.

Rare side effects include:

  • Severe adverse events such as local tissue damages due to leakage of idarubicin hydrochloride from your vein into surrounding tissues with intravenous injection might be observed;
  • Serious heart problems in a small percentage of patients;
  • Urticaria (hives).

Serious Side Effects and What to do About Them

Symptom/effect Talk with your doctor or pharmacist
Only if severe In all cases
Low white blood cell count and symptoms such as increased infection, fever > 38 °C, chills or sweating, sore throat, mouth sores, burning feeling when urinating, unusual vaginal itching or discharge  
Anemia (reduced red blood cell) and symptoms such as feeling weak, dizzy, shortness of breath  
Injection site reactions such as pain, sores, burning  
Increased bleeding with symptoms such as dark urine or dark/bloody stool, unexplained bruising  
Cardiovascular problems with symptoms such as irregular heartbeat, chest pain, swelling of the ankles, shortness of breath/cardiac problems  
Bowel inflammation (colitis) or, digestive tract bleeding and symptoms such as bloody stools, bloody vomit  

This is not a complete list of side effects. For any unexpected effects while taking idarubicin hydrochloride, contact your doctor or pharmacist.

How to Store It

Idarubicin hydrochloride injection should be stored between 2 °C and 8 °C and protected from light.

Keep out of the reach of children.

Reporting Side Effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:

  • Online at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Consumer Side Effect Reporting
    Form and sending it by:
    • Fax to 1-866-678-6789 (toll-free), or
    • Mail to: Canada Vigilance Program
      Health Canada, Postal Locator 0701E
      Ottawa, ON
      K1A 0K9

      Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide advice.

More Information

This document plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Fresenius Kabi Canada Ltd. at: 1-877-821-7724