Generic drug of the therapeutic class: Oncology and Hematology
Active ingredients: Doxorubicin
laboratory: Sanofi-Aventis France
Lyophilisate for parenteral use
Box of 10 vials of 50 mg
· Breast cancers
· Sarcomas of bones and soft tissues
· Hodgkin's disease and non-Hodgkin's lymphoma
· Solid tumors of the child
· Lung Cancers
· Acute and chronic leukemia
· Cancers of the bladder, ovary, stomach.
Dosing Dosage DOXORUBICINE DAKOTA PH 50 mg 2 mg / mL Lyophilisate for parenteral use Box of 10 vials of 50 mg
Strict intravenous route.
The average dosage is 40 to 75 mg / m 2 per cycle, each cycle being separated from the previous one by an interval of 3 to 4 weeks. The cycles are repeated up to a maximum total dose of 550 mg / m 2 .
Sometimes weekly administrations (15 to 30 mg / m 2 per injection) or continuous administrations over 72 to 144 hours (9 to 20 mg / m 2 / day) are used.
After introducing the solvent into the bottle containing doxorubicin, it is essential to shake the bottle until a perfectly clear solution is obtained.
The dose of doxorubicin is administered within 3 to 5 minutes in the tubing of an intravenous infusion of isotonic sodium chloride solution or 5% glucose solution:
· In one go,
· Be spread over 2 or 3 days.
It is not necessary to carry out a long infusion, which can be started shortly before the administration of doxorubicin and stopped a few minutes later.
It is extremely important to ensure that the administration is well endovenous. Any extravasation may produce necrosis of the surrounding tissues: in this case, the injection should be stopped immediately and the techniques indicated below should be used.
This medicine is contraindicated in the following situations:
· pregnancy and breast feeding,
· Cardiac toxicity induced by another anthracycline or maximum cumulative doses obtained for another anthracycline,
· Association with:
o the yellow fever vaccine,
o Phenytoin for prophylaxis (see section Interactions with other medicinal products and other forms of interaction ).
This medicine is generally not recommended:
· In subjects with cardiac disease with proven heart failure.
Coronary insufficiency is not a contraindication if it is controlled and is not complicated by a clear impairment of left ventricular function,
· In combination with live attenuated vaccines.
Adverse effects Doxorubicin Dakota PH 50 MG
· General side effects:
o nausea and vomiting
o medullary hypoplasia in about 2/3 of patients,
o alopecia in 90% of cases, but reversible at the end of treatment,
o amenorrhea, azoospermia.
Febrile bouts, abdominal pain and diarrhea have also been reported. But these manifestations are transient and do not pose a serious therapeutic problem.
· Local adverse effects:
Two types of local reactions are described:
o Extravasation with risk of necrosis: it is necessary to interrupt the infusion, to aspire the maximum of infiltrated product, to make a cold bandage, to inject possibly a steroids, to apply possibly locally of DMSO; daily monitoring is necessary. The use of catheters or implantable chambers reduces this risk.
o The "booster" reaction in irradiated areas of pain and erythema lasting up to several days
· Cardiac toxicity
o Acute toxicity:
§ It occurs within 48 hours
§ Some modifications of the ECG may appear: rhythm disorders, QT prolongation in particular, most often without clinical translation; they do not contraindicate continued treatment. Potential associated electrolyte disturbances (hypokalemia, hyponatremia) should be corrected.
§ Rare is acute myopericarditis of early onset.
o Chronic toxicity
§ This is a cardiomyopathy that can progress to congestive heart failure requiring specialized care but may lead to death.
§ It is correlated to the cumulative dose administered (the incidence is 10% for cumulative doses greater than 450 mg / m 2 )
§ 96-hour slow infusions would reduce its incidence
o Prevention: cardiac toxicity can be prevented by
§ clinical supervision
§ regular monitoring of cardiac function by ultrasound or isotopic ventricular performance measurement: these examinations must be performed before the first injection and repeated regularly; a significant alteration will cause the treatment to be interrupted
§ certain cardioprotective products would limit the risks of toxicity
As with other DNA-damaging anticancer agents, myelodysplastic syndromes and acute myeloid leukemias have been observed following combination therapy including doxorubicin.
With the topoisomerase II inhibitors, there has been reported a higher than expected incidence of secondary leukaemias presenting as de novo leukemias LAM2, LAM3, LAM4. Such forms may have a short latency period (from 1 to 3 years). These forms, accessible to a curative treatment, require early diagnosis and treatment adapted to curative purpose (see section Warnings and precautions for use ).