Medicinal Products

ADRIBLASTINE 200 mg / 100 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
Bottle (polypropylene) of 120 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 200 mg / 100 ml 2 mg / mL Solution for IV infusion 120 ml bottle (polypropylene)

Dosage

Intravenous administration:

The total dose of doxorubicin per cycle may vary depending on the therapeutic protocol (monotherapy or combination with other cytotoxic drugs) and the therapeutic indication.

Recommended initial dose:

In monotherapy, the recommended starting dose per cycle in adults is 60 to 90 mg / m 2 body surface area.

The total dose per cycle can be administered as a single dose or over 3 days or alternatively on D1 and D8. Under conditions where the patient normally regains treatment-induced toxicity (including bone marrow depression and stomatitis), each cycle may be repeated every 3 to 4 weeks. The administration of doxorubicin weekly cycle of 10 to 20mg / m 2 has also shown its effectiveness. If doxorubicin is used in combination with other cytotoxics whose toxicity may be superadded, the recommended dose per cycle is 30 to 60 mg / m 2 .

Dosage adjustment:

Achievement of liver function:

The bilirubin level should be monitored before each treatment. In cases of impaired hepatic function (see Warnings and Precautions ), dose reductions are recommended according to:

Serum biochemistry parameters

Dose to administer

(as a percentage of the theoretical dose)

Bilirubin: 20-51 μmol / l

Or

ASAT: 2 to 4 times the upper limit of normal

50

Bilirubin> 51 μmol / l

Or

ASAT> 4 times the upper limit of normal

25

Doxorubicin should not be administered to patients with severe impairment of liver function (see section 4.3 ).

Other special populations: lower initial doses or greater spacing of treatment cycles should be considered in heavily pretreated patients, children, the elderly, obese patients, or patients with spinal cord invasion (see section 5.2). care and precautions for use ).

Administration mode

Intravenous administration:

The dose of Adriblastine should be injected within 3 to 5 minutes and in 10 minutes maximum (to reduce the risk of thrombosis or extravasation) in the tubing of an intravenous infusion of isotonic sodium chloride solution at 0, 9% or 5% glucose solution.

A direct bolus injection is not recommended because of the risk of extravasation, which can occur even in the presence of adequate blood return to aspiration.

WARNING

It is extremely important to make sure the administration is intravenous. Extravasation may produce necrosis of the surrounding tissues. In case of extravasation, the administration will be interrupted 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

This medicine is contraindicated in the following cases:

Hypersensitivity to doxorubicin or any of the excipients, or to other anthracyclines or anthracediones.

Persistent myelosuppression,

· Severe liver failure,

· Severe myocardial insufficiency,

· Recent myocardial infarction (less than 6 months),

· Severe arrhythmia

· Prior treatments with doxorubicin, daunorubicin, epirubicin, idarubicin and / or other anthracyclines or anthracenediones at the maximum cumulative dose (see section 4.4 ).

In combination with yellow fever vaccine (see section Interactions with other medicinal products and other forms of interaction ),

· Breastfeeding (see section on Pregnancy and breastfeeding ).

Adverse effects Adriblastine 200 MG / 100 ML

The following side effects have been reported following treatment with doxorubicin:

Infections and infestations:

Infection, sepsis / sepsis.

Benign, malignant tumors:

Acute lymphoid leukemia, acute myeloid leukemia.

Hematological and lymphatic system disorders:

Leukopenia, neutropenia, anemia, thrombocytopenia.

Immune system disorders:

Anaphylaxis.

Metabolism and nutrition disorders:

Anorexia, dehydration, hyperuricemia.

Eye disorders:

Conjunctivitis / keratitis, tearing.

Heart conditions:

Sinus tachycardia, tachyarrhythmia, atrioventricular block and branch block, congestive heart failure.

Vascular disorders:

Haemorrhage, flushing, phlebitis, thrombophlebitis, thromboembolism, shock.

Gastrointestinal disorders:

Nausea / vomiting, mucositis / stomatitis, hyperpigmentation of the oral mucosa, esophagitis, abdominal pain, gastric erosions, gastrointestinal tract bleeding, diarrhea, colitis.

Skin and subcutaneous tissue disorders

Alopecia, local toxicity, rash / itching, cutaneous changes, skin and nail hyperpigmentation, photosensitivity, hypersensitivity of irradiated skin (booster reaction in irradiated area), urticaria, acral erythema, palmoplantar erythrodysaesthesia.

Renal and urinary disorders:

Urine staining 1 to 2 days after administration.

Disorders of the reproductive organs and the breast:

Amenorrhea, oligospermia, azoospermia.

General disorders and administration site defects:

Malaise / asthenia, fever, chills.

Investigations:

ECG abnormalities, asymptomatic left ventricular ejection fraction decline, transaminase level change.

In the NSABP B-15 study in patients treated with doxorubicin in adjuvant breast cancer, the most relevant adverse events reported were similar to the toxicity profile of doxorubicin. An additional side effect has been reported:

Investigations: weight gain.

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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