Drug Interaction:
None reported
Indication:
Treatment of AML in adults in combination with other approved antileukemic drugs
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Idarubicin Hcl Anti-cancer Drug May 1991
Adverse Reaction:
Nausea and vomiting, hair loss, abdominal cramps, hemorrhage, mucositis, fever, headache, seizure, pulmonary allergy.
IDR DNR IDR - Idarubicin DNR - Daunorubicin Infection 95% 97% Nausea and vomiting 82% 80% Hair loss 77% 72% abdominal cramps 73% 68% haemorrhage 63% 65% mucositis 50% 55% dermatologic 46% 40% mental status 41% 34% pulmonary -clinical 39% 39% fever 26% 28% headache 20% 24% cardiac -clinical 16% 24% neurological - peripheral nerves 7% 9% seizure 4% 5% cerebellar 4% 4% pulmonary allergy 2%
Contra-Indications:
None reported
Special precuations:
Monitoring- Laboratory monitoring, hyperuricemia. Administer slowly. frequent complete blood counts and monitoring of heparin and renal function tests recommend
Heperuricema- Ttake appropiate measures to prevent hyperuricemia and to control any systemic infection before beginning surgery
Admininster- Slowly ( over 10 t0 15 minutes ) into tubing of a freely running IV infusion of 0.9% sodium chloride injection, USP or 5% dextrose injection USP
Warnings
Bone marrow suppression- Do not give to patients with pre-existing bone marrow suppresion induced by previous drug therapy or radiotherapy unless the benefits warrant risk
Severe myelosuppression- Will occur in all patients given a therapeutic dose of the agent for induction, consolidation or maintenance. Careful monitoring is required
Cardiotoxicity- Carefully monitor cardiac function during treatment in order to minimise risk of cardiac toxicity Pregnancy Advice women of child bearing potential to avoid pregnancy
Lactation- Mothers should discontinue nursing prior to taking this drug
Dosages/ Overdosage Etc:
Treatment of AML in adults in combination with other approved antileukmic drugs AML - 12mg/m2 daily for 3 days by slow ( 10 to 15min ) IV injection in combination with Ara-C 100mg/m2 daily by continuous infusion for 7 days or as a 25mg/m2 IV bolus followed by 200mg/m2 for 5 days by cintinous infusion
Patient Information:
Ref - USP PDI Vol II 17th Edition (1997)
1.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to
Idarubicin.
2.Pregnancy-
There is a chance that this medicine may cause birth dfects if the male or
female us receiving this medicine at the time of conception.
Before receiving idarubicin, make sure your doctor knows if you are pregnant
or if you become pregnant.
3. Breast-feeding-
Because idarubicin may cause serious side effects, breast feeding is not
recommended while you are receiving it.
4.Children-
There is no specific information comparing Idarubicin in children with use
in other age groups.
5.Older adults-
Heart problems are more likely to occur occur in elderly, who are generally
more sensitive to the effects of Idarubin.
6. Other medicines-
Tell your doctor if you are using any of the following-
Amphotericin by injection or
Antithyroid agents or
Azathioprine or
Chloramphenicol or
Colchicine or
Flucytosine or
Ganciclovir or
Zidovudine - Idarubicin may increase the effects of radiation therapy
7. Other medical problems-
The presence of other medical problems may affect the use of Idarubicin.
Make sure you tell your doctor if you have any other medical problems
especially-
Chicken pox including recent exposure or
Herpes Zoster - risk of severe disease affecting the other parts of the body
Gout or
Kidney stones - Idarubicin may increaese levels of uric acid, which can cause
gout or kidney stones
Heart disease - heart problems increases
Kidney disease or
Liver disease - effects of idarubicin increased because of slow removal
from the body
Pharmacology/ Pharmacokinetics:
Pharmacology:
Idarubicin hcl is a synthetic antineoplastic anthracycline for IV use. It is a DNA -intercallating analog of daunorubicin which has an inhibitory effect on nucleic acid synthesis and intercats with the enzyme topoisomerase II.
Pharmacokinetics:
The drug is eliminated predominantly by biliary and to a lesser extent by renal excretion, mostly in the form of primary metabolite 13-dihydroxydarubicin (idarubinol).
Pregnancy and lactation:
Pregnancy:
Use caution and advise women of child bearing potential to avoid pregnancy
Lactation: Advise mothers to discontinue nursing prior to taking this drug.
Manufacturer Details