Medicinal Products

DOXORUBICIN DAKOTA PH 10 mg 2 mg / mL

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 10 mg
All forms

Indication

· 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 10 mg 2 mg / mL Lyophilisate for parenteral use Box of 10 vials of 10 mg

Dosage

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.

Administration mode

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 perform a long infusion, it can be started shortly before the administration of doxorubicin and stopped a few minutes later.

WARNING

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.

Against indications

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 10 MG

· General side effects:

o nausea and vomiting

o stomatitis,

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 ).

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