Medicinal Products

DOXORUBICIN TEVA 10 mg / 5 ml 2 mg / mL

Generic drug of the therapeutic class: Oncology and Hematology
Active ingredients: Doxorubicin
laboratory: Teva Sante

Injectable solution
Box of 1 bottle of 5 ml
All forms

Indication

- Breast cancers.
- Sarcomas of the bones and soft parts.
- Hodgkin's disease and non-Hodgkin's lymphoma.
- solid tumors of the child.
- lung cancer.
- Acute and chronic leukemias. - Cancers of the bladder, ovary, stomach.

Dosage DOXORUBICINE TEVA 10 mg / 5 ml 2 mg / mL Solution for injection Box of 1 vial of 5 ml

Dosage:
The average dosage is 40 to 75 mg / m² 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 / m².
The dosage should be reduced when combined with other cytostatics in case of hyperbilirubinemia.
- Dosage in children:
. The recommended dose in monotherapy is 75 to 90 mg / m². Predictors of myelotoxicity occur, with nadir cell counts 10 to 12 days after initiation of treatment, but the large medullary reserve of the child relative to the adult usually allows for rapid recovery as a result of these phenomena.
. Doxorubicin is given as an intravenous bolus or continuous infusion. Bolus shots result in higher peak plasma concentrations and are therefore probably more cardiotoxic than infusions. The risk of cardiomyopathy increases when the cumulative dose exceeds 550 mg / m² and in young children the administration of doxorubicin by echocardiography should be monitored.
. In case of pre-existing cardiac disease or history of cardiac radiotherapy, a cumulative dose of 400 mg / m² should not be exceeded.
. In combination with oncolytics, the dose of doxorubicin is 50 to 75 mg / m². Medullary depression may be more pronounced due to the additive effects of the various products.
- Superficial cancer of the bladder and cancer in situ:
. The recommended dose in monotherapy is 50 mg in 50 ml of saline, administered by means of a sterile catheter. This dose is initially weekly, to become monthly thereafter. The optimal duration of treatment has not yet been determined; it is between 6 and 12 months.
. Cumulative maximum intravenous dose restrictions do not apply to the intravesical route because of the negligible systemic absorption of doxorubicin.
Administration mode :
IV infusion.
- The dose of doxorubicin is administered at least 3 to 5 minutes into the tubing of an intravenous infusion of isotonic sodium chloride solution or 5% glucose solution:
. in one go,
. in 2 times during the day,
. be spread over 2 or 3 days.
- It is not necessary to carry out a long infusion, it can be started shortly before the administration of doxorubicin and stopped a few minutes later.
- In patients with increased cardiotoxic risk, a 24-hour continuous infusion rather than a bolus injection will be preferred to minimize the frequency of cardiotoxicity events without decreasing the therapeutic efficacy of the product. In this type of patient, the systolic ejection fraction should be measured before each treatment.
ATTENTION :
- It is extremely important to ensure that the administration is well intravenous.
- Any extravasation may produce necrosis of the surrounding tissues: in this case, the injection should be stopped immediately.
- In case of extravasation, immediately stop the injection of the drug and start again by choosing another vein. Treat the infiltrated area.
How to handle:
- The preparation of injectable cytotoxic solutions must be carried out by specialized and trained personnel with knowledge of the drugs used, under conditions ensuring the protection of the environment and especially the protection of the personnel handling. It requires a preparation room reserved for this purpose. It is forbidden to smoke, eat, drink in this room. Manipulators must have a set of equipment suitable for handling, including long-sleeved gowns, face masks, hood, safety goggles, sterile disposable gloves, worktop protection fields, containers and collection bags. waste. Excreta and vomit must be handled with care. Pregnant women should be warned and avoid manipulation of cytotoxics. Any broken container must be treated with the same precautions and considered as contaminated waste. Disposal of contaminated waste is by incineration in rigid containers labeled for this purpose .
- These provisions can be envisaged within the framework of the oncology network (circular DGS / DH / 98 N ° 98/188 of March 24, 1998) in collaboration with any suitable and fulfilling the required conditions.

Against indications

CONTRAINDICATED:
This medicine is contraindicated in the following situations:
- Cardiac toxicity induced by another anthracycline or maximum cumulative doses obtained for another anthracycline.
- Cardiopathy with myocardial insufficiency, previous treatments with complete cumulative doses of doxorubicin or other anthracyclines. Coronary artery disease is not a contraindication if it is controlled and is not complicated by a clear alteration of left ventricular function.
- Medullary depression.
Pregnancy and lactation: in animals, doxorubicin is embryotoxic and teratogenic. Doxorubicin passes into breast milk.
- Association with the vaccine against yellow fever.
NOT RECOMMENDED :
Associations advised against : phenytoin (and fosphenytoin extrapolation), live attenuated vaccines (except yellow fever); other anthracyclines.

Adverse effects Doxorubicin Teva 10 MG / 5 ML

- The medullary depression and the cardiotoxicity are toxic factors limiting the dose:
. stomatitis,
. medullary hypoplasia in about 2/3 of patients,
. rapidly decreasing immunodepression,
. alopecia in 90% of the cases, but reversible at the end of the treatment,
. amenorrhea, azoospermia.
. Some changes in the ECG may appear: rhythm disturbances, QT prolongation in particular; Acute rhythm disturbances can occur within hours of the injection. Frequent ECG checks, possibly supplemented by a 24-hour recording (Holter method) should help to clarify the meaning.
- Possible associated electrolyte disorders (hypokalemia, hyponatremia) must be corrected.
- In some cases, severe heart failure, rebellious to usual treatment, may occur. These reactions are rare in patients who received a total dose of less than 550 mg / m², they are more frequent beyond this dose and can in this case reach 27% of patients.
- Febrile attacks, nausea, vomiting, abdominal pain and diarrhea have also been reported. But these manifestations are transient and do not pose a serious therapeutic problem.
- As with other DNA-damaging anticancer agents, myelodysplastic syndromes and acute myeloid leukemias have been observed after combination therapy including doxorubicin.
- With 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 warnings and precautions for use).
- Intravesical administration has been associated with the following reactions: hematuria, bladder and urethral irritation, pollakiuria. These reactions are usually of moderate intensity and short duration. Hemorrhagic cystitis may be responsible for a possible decrease in bladder capacity.

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