Generic drug of the therapeutic class: Oncology and Hematology
active ingredients: Buserelin
laboratory: Sanofi-Aventis France
Injectable implant for the subcutaneous route
Box of 1 pre-filled syringe (+ needle)
Prostate cancer with metastases.
Dosage BIGONIST 6.3 mg Injectable implant for subcutaneous injection Box of 1 pre-filled syringe (+ needle)
A BIGONIST implant will be injected subcutaneously into the anterior abdominal wall every two months. Before injection, local anesthesia can be performed if necessary.
It should be ensured that the implants are visible in the transparent part of the needle. The syringe should be held horizontally before injection. The piston should not be removed when the needle is in place. It is important to push it all the way to inject the implant into the subcutaneous tissue.
Five days before the start of treatment, an anti-androgen will be administered and continued for the first three to four weeks of treatment, when the testosterone usually reaches the castration level.
It is important to follow a regular administration schedule of two months; this interval can be shortened or increased by a few days.
Hypersensitivity to LHRH, LHRH analogues or any of its excipients.
- Orchiectomy or pulpectomy.
- Clinically proven tumor resistance to LHRH analogues.
Bigonist side effects
- Initial stimulation of androgen secretion may result in transient activation of the tumor. In 2 to 3% of cases, urination problems or urine retention have been reported; they regressed spontaneously despite continued treatment. Such symptoms can be avoided by the administration of an anti-androgen (see dosage and instructions for use). However, in 1% of cases, mild exacerbation of pain and / or deterioration of the general condition was noted transiently.
Exceptionally, venous thrombosis with pulmonary embolism or neurological disorders (eg weakness, paresthesia of the lower limbs) have been reported.
- Due to pharmacological effects, hot flashes, erectile dysfunction or libido occur in most patients. Exceptionally, depression may occur or worsen. Gynecomastia was observed in less than 1% of cases. Hypertensive pressure was observed in 10% of hypertensive patients. Discrete edema of the lower extremities was reported in 2% of cases; he regresses under symptomatic treatment. Aggravation of diabetes was observed in one isolated case.
- The following adverse effects have also been reported: headache (10%) and more rarely:
. sleep disorders, dizziness, shortness of breath, palpitation,
. erythema, urticarial rash, change in hairiness,
. nausea, vomiting, diarrhea, constipation, change in weight,
. elevated liver enzymes (transaminases),
. thrombocytopenia, leukopenia,
. feeling of retro-ocular tension, dry eyes,
. myalgia and osteo-articular pain can be observed.
- Rare cases of anaphylactic reactions that may progress to bronchospasm or dyspnea and exceptionally anaphylactic shock (and likely to require surgical removal of the implant) have been observed. Pain or injection site reaction was reported by 3% of patients.
Very rare cases of development of pituitary adenomas have been described during treatment with LHRH agonists, including with buserelin.