Medicinal Products

DOXORUBICINE ACTAVIS 2 mg / mL

Generic medicinal product of Adriblastine 50 MG
Therapeutic class: Oncology and hematology
Active ingredients: Doxorubicin
laboratory: Actavis

Powder for IV infusion solution
Box of 1 vial of 50 mg
All forms

Indication

· Breast carcinoma

· 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.

Dosage DOXORUBICINE ACTAVIS 2 mg / mL Powder for solution for infusion IV Box of 1 vial of 50 mg

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 .

Reconstitute the solution with 5 ml (10 mg doxorubicin hydrochloride bottle) or 25 ml (50 mg doxorubicin hydrochloride bottle) of water for injection or isotonic sodium chloride solution. Reconstitution of the product is usually rapid (less than 60 seconds) and does not require agitation.

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,

· In 2 times during the day,

· 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.

Handling modalities

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

No 98/188 of 24 March 1998) in collaboration with any suitable and qualifying structure.

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,

· Combination with the yellow fever vaccine.

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 association with :

o live attenuated vaccines

o and phenytoin or fosphenytoin (see section Interactions with other medicinal products and other forms of interaction).

Adverse effects Doxorubicin Actavis

General side effects:

Stomatitis,

· Medullary hypoplasia in about 2/3 of patients,

· Rapidly regressive immuno-depression,

· Alopecia in 90% of the cases, but reversible at the end of the treatment,

· Amenorrhea, azoospermia.

Febrile bouts, nausea, vomiting, abdominal pain and diarrhea have also been reported. But these manifestations are transient and do not pose a serious therapeutic problem.

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.

Potential associated electrolyte disturbances (hypokalemia, hyponatremia) should be corrected.

In some cases, severe heart failure, which is resistant to usual treatments, may occur. These reactions are rare in patients who received a total dose less than 550 mg / m 2, they are more frequent beyond this dose and can in this case reach 27% of patients.

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 curative treatment, require early diagnosis and treatment adapted to curative purposes (see section Special warnings and precautions for use).

Due to the presence of methyl parahydroxybenzoate, risk of contact eczema; exceptionally, immediate reactions with urticaria and bronchospasm.

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