Instruction for use: Suprefakt depot

ATX Code L02AE01 Buserelin

Pharmacological group

Antineoplastic hormonal agents and hormone antagonists

Nosological classification (ICD-10)

C61 Malignant neoplasm of prostate

Adenocarcinoma of the prostate, Hormone-dependent prostate cancer, Hormone-Resistant Prostate Cancer, Malignant tumor of prostate, Malignant neoplasm of prostate, Carcinoma of the prostate, Locally-distributed non-metastatic prostate cancer, Locally advanced prostate cancer, Locally spread prostate cancer, Metastatic prostatic carcinoma, Metastatic prostate cancer, Metastatic hormone-resistant prostate cancer, Non-metastatic prostate cancer, Incompatible prostate cancer, Prostate Cancer, Prostate cancer, Common prostate cancer, Testosterone-Depot Prostate Cancer

Composition

A sterile single-use applicator with an implant in the form of two identical carrier supports contains buzerelin acetate 6.6 mg, equivalent to 6.3 mg buserelin; In the box 1 pc.

pharmachologic effect

Pharmacological action - antiandrogenic.

Suppresses the secretion of LH and the synthesis of testosterone.

Clinical Pharmacology

The concentration of testosterone increases at the beginning of therapy, then decreases within 2 weeks and reaches the required level for drug castration after 2-4 weeks, keeping the last until the end of treatment.

Prescription of Suprefakt Depot

Prostate cancer (hormone-dependent).

Contraindications

Hypersensitivity, castration.

Side effects

From the side of the musculoskeletal system: the emergence or intensification of pain in the bones of patients with bone metastases, pain and discomfort in the back and joints, swelling in the ankles, feet.

From the side of the nervous system: neurological symptoms due to tumor compression (eg, muscle weakness in the limbs), headache, nervousness, sleep disturbance, weakness, drowsiness, memory impairment and ability to concentrate, emotional lability, agitation, depression.

On the part of the genitourinary system: violation of urination, hydronephrosis, hot flashes, a violation of potency, decreased libido, painless gynecomastia.

From the cardiovascular system: thrombosis with pulmonary embolism, increased blood pressure in patients with hypertension, tachycardia.

Allergic reactions: redness of the skin, rashes, itching, attacks of bronchial asthma, allergic shock.

From the blood: increased serum transaminases, bilirubin, thrombocytopenia, leukopenia.

From the senses: dizziness, noise in the ears, hearing and vision impairment, a feeling of pressure on the eyeball.

On the part of the intestine: nausea, diarrhea, constipation, a violation of appetite.

Other: weakening or strengthening hair growth on the head and body, reducing glucose tolerance, increasing or decreasing body weight.

Local reactions: irritation and redness of the skin at the injection site.

Interaction

Weaken the effect of hypoglycemic agents.

Dosing and Administration

The content of the applicator (equivalent to 6.3 mg buserelin) is injected into the side of the stomach every 2 months (the interval between injections may vary). Before injection, the use of a local anesthetic is allowed. Treatment is long, duration is determined by the doctor.

Precautionary measures

The correctness of the treatment is checked by monitoring the serum levels of testosterone, acid phosphatase and a specific antigen of the prostate. During treatment, it is necessary to monitor blood pressure in patients with hypertension, the level of sugar in diabetics, patients with depressive conditions. It is necessary to take into account the possibility of reducing the concentration of attention and response in the management of vehicles and mechanisms.

special instructions

For 5 days before the start of therapy, it is recommended to start taking antiandrogen (cyproterone acetate, flutamide, nilutamide), which is continued for 3-4 weeks after inclusion in therapy of Buserelin.

Storage conditions

At a temperature not exceeding 30 ° C.

Keep out of the reach of children.

Shelf life

3 years.

Do not use after the expiry date printed on the package.