Medicinal Products

ADRIBLASTINE 10 mg / 5 ml 2 mg / mL

Generic drug of the therapeutic class: Oncology and Hematology
Active ingredients: Doxorubicin
laboratory: Pfizer Holding France

Injection solution for IV infusion
Box of 1 Bottle (polypropylene) of 5 ml
All forms

Indication

· Breast carcinomas.

· Sarcomas of bones and soft tissues.

· Hodgkin's disease, non-Hodgkin lymphoma.

· Solid tumors of the child.

· Lung cancers.

· Acute and chronic leukemias.

· Cancers of the bladder, ovary, stomach.

Dosage ADRIBLASTINE 10 mg / 5 ml 2 mg / mL Solution for IV infusion Pack of 1 vial (polypropylene) 5 ml

The average dosage is 40 to 75 mg / m 2 per cycle.

Each cycle is 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 .

The dose of Adriblastine should be injected within 3 to 5 minutes into the tubing of a venous infusion of 0.9% 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 installed shortly before the administration of Adriblastine and stopped a few minutes later.

WARNING

It is extremely important to ensure that the administration is endovenous. 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 may be envisaged within the framework of the oncology network (circular DGS / DH / 98 N ° 98/188 of 24 March 1998) in collaboration with any suitable and qualified structure.

Against indications

· Prescription should be avoided in subjects with cardiac disease with myocardial insufficiency.

· Pregnancy

· Breastfeeding

· Yellow fever vaccine: risk of fatal generalized vaccine disease.

Adverse effects Adriblastine 10 MG / 5 ML

ADRIBLASTINE may give rise to side effects:

Stomatitis,

· Medullary hypoplasia in about 2/3 of patients,

· Rapidly regressive immuno-depression,

· Alopecia in 90% of cases, but reversible when treatment is stopped.

· 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 methods) should allow to clarify the meaning.

Potential associated electrolyte disturbances (hypokalemia, hyponatremia) should be corrected. In some cases, severe heart failure, which is resistant to usual treatment, 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 a curative treatment, require early diagnosis and treatment adapted to curative purpose (see section Warnings and precautions for use ).

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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