Idarubicin Hydrochloride Injection - Consumer Medicine Information
|Manufacture:||Fresenius Kabi USA, LLC|
|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
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;
- 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.
If you think you are given more Idarubicin Hydrochloride Injection than you should, contact your doctor, nurse, or poison control centre immediately.
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
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.
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