Patient Medication Information: uses, side effects, how to take - Idamycin Powder -10mg/Vial
ABOUT THIS MEDICATION
What the medication is used for:
IDAMYCIN and IDAMYCIN PFS alone or in combination with other anticancer drugs are used in the treatment of:
$ Acute non-lymphocytic leukemia (ANLL) as a first line in
adult patients
$ Acute lymphocytic leukemia (ALL) as a second line in
adults and children.
What it does:
IDAMYCIN and IDAMYCIN PFS are cancer drugs (chemotherapy drugs) 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 cancer cells (leukemia 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, mitoxanthrone 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 is the active ingredient.
What the important non-medicinal ingredients are: IDAMYCIN PFS 1mg/mL (idarubicin hydrochloride injection):
Glycerol USP/Ph.Eur.
Hydrochloric acid
Water for Injection USP
IDAMYCIN (idarubicin hydrochloride for injection, house std.):
Lactose NF
What dosage forms it comes in:
IDAMYCIN PFS 1mg/mL (idarubicin hydrochloride injection) is a clear red-orange sterile solution to be given intravenously.
IDAMYCIN (idarubicin hydrochloride for injection, house std.) is a red-orange sterile powder to be given intravenously after reconstitution with sterile water for injection.
WARNINGS AND PRECAUTIONS
BEFORE you use IDAMYCIN or IDAMYCIN PFS 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 IDAMYCIN or
IDAMYCIN PFS or other anti-cancer drugs, including anthracyclines (cardiotoxic drugs).
IDAMYCIN and IDAMYCIN PFS should be given under the supervision of a doctor experienced with the use of anticancer drugs.
IDAMYCIN and IDAMYCIN PFS 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)
As IDAMYCIN and IDAMYCIN PFS 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 IDAMYCIN or IDAMYCIN PFS. Ask your baby’s doctor to recommend a formula that would be best for your baby.
As IDAMYCIN and IDAMYCIN PFS may cause fertility impairment and damage chromosomes in sperm, men undergoing treatment with IDAMYCIN or IDAMYCIN PFS, 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 IDAMYCIN or IDAMYCIN PFS include: cytarabine, other anthracyclines, anthracenediones and calcium channel blockers such amlodipine, diltiazem or verapamil.
Other drugs that may be used in therapy with IDAMYCIN or IDAMYCIN PFS may increase the chance of toxic effects include: cyclophosphamide, fludarabine, etoposide, paclitaxel.
Talk to your doctor before you receive a vaccine while treated with IDAMYCIN or IDAMYCIN PFS, as the combination may result in a serious infection in patients with a compromised immunity (ie patients taking oral corticosteroids, transplanted patients, elderly patients).
PROPER USE OF THIS MEDICATION
How are IDAMYCIN and IDAMYCIN PFS given? You may receive IDAMYCIN or IDAMYCIN PFS 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 IDAMYCIN?
It usually takes about 5-10 minutes to inject IDAMYCIN or IDAMYCIN PFS. However, you may get other medicines before or after IDAMYCIN or IDAMYCIN PFS, 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. IDAMYCIN and IDAMYCIN PFS are usually given once a day for 3 consecutive days.
Overdose
If you think you are given more IDAMYCIN or IDAMYCIN PFS 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, IDAMYCIN and IDAMYCIN PFS 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 IDAMYCIN or IDAMYCIN PFS 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 | |
| T T T T T T | |
This is not a complete list of side effects. For any unexpected effects while taking IDAMYCIN or IDAMYCIN PFS, contact your doctor or pharmacist.
HOW TO STORE IT
IDAMYCIN PFS (idarubicin hydrochloride injection) should be stored at 2-8°C and protected from light.
IDAMYCIN (idarubicin hydrochloride for injection, house std) should be stored at 15-30°C and protected from light.
Keep out of the reach of children.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:
By toll-free telephone: 866-234-2345
By toll-free fax: 866-678-6789
Online: www.healthcanada.gc.ca/medeffect By email: CanadaVigilance@hc-sc.gc.ca
By regular mail:
Canada Vigilance National Office
Marketed Health Products Safety and Effectiveness Information Bureau
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full Product Monograph, prepared for health professionals, can be found at: http://www.pfizer.ca or by contacting the sponsor, Pfizer Canada Inc., at: 1-800-463-6001.