Patient Medication Information: uses, side effects, how to take - AJ-Idarubicin
ABOUT THIS MEDICATION
What the medication is used for:
AJ-IDARUBICIN 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:
AJ-IDARUBICIN is cancer drug (chemotherapy drug) which works 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:
Glycerol USP/Ph.Eur. , Hydrochloric acid used to adjust pH, Water for Injection USP
What dosage forms it comes in:
AJ-IDARUBICIN is a clear red-orange sterile solution to be given intravenously.
WARNINGS AND PRECAUTIONS
PRECAUTIONS
AJ-IDARUBICIN should be given under the supervision of a doctor experienced with the use of anticancer drugs.
AJ-IDARUBICIN 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 AJ-IDARUBICIN 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 AJ-
IDARUBICIN or other anti-cancer drugs, including anthracyclines (cardiotoxic drugs).
As AJ-IDARUBICIN 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 AJ-IDARUBICIN. Ask your baby’s doctor to recommend a formula that would be best for your
baby.
As AJ-IDARUBICIN may cause fertility impairment and damage chromosomes in sperm, men undergoing treatment with AJ-IDARUBICIN, 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 AJ-IDARUBICIN include: cytarabine, other anthracyclines, anthracenediones and calcium channel blockers such amlodipine, diltiazem or verapamil.
Other drugs that may be used in therapy with AJ-IDARUBICIN may increase the chance of toxic effects include: cyclophosphamide, fludarabine, etoposide, paclitaxel.
Talk to your doctor before you receive a vaccine while treated with AJ-IDARUBICIN, 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 is AJ-IDARUBICIN given?
You may receive AJ-IDARUBICIN 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 AJ-IDARUBICIN?
It usually takes about 5-10 minutes to inject AJ-IDARUBICIN. However, you may get other medicines before or after Idarubicin Hydrochloride Injection, 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. AJ-IDARUBICIN is usually given once a day for 3 consecutive days.
Overdose
If you think you are given AJ-IDARUBICIN 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
E EFFCTS AND WHAT TO DO ABOUT THEM Like all medicines, AJ-IDARUBICIN 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 AJ-IDARUBICIN 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 AJ-IDARUBICIN, contact your doctor or pharmacist.
HOW TO STORE IT
AJ-IDARUBICIN should be stored at 2-8°C. Protect from light.
Keep out of reach of children.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
Report online at
www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program Health Canada
Postal Locator 0701E
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of the side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Agila Jamp Canada Inc. at 1-866-399-9091.