Gonapeptyl 3.75mg. 104mg / ml Injection

Posology
Prostate carcinoma: One injection, equivalent to 3,75 mg triptorelin, every four weeks (28 days).
Uterine myomas and endometriosis: One injection, equivalent to 3,75 mg triptorelin, every four weeks (28 days). The treatment should be initiated in the first 5 days of the cycle. The duration of the treatment depends on the initial degree of severity of endometriosis, on the evolution of its clinical manifestations and on the evolution of the volume of the uterine myomas, determined by ultrasonography during the course of treatment. Normally, the maximum attainable result is achieved after 3 u2013 4 injections. In view of the possible effect on bone density, therapy should not exceed a duration of 6 months. Menstruation will resume 7-12 weeks after the final injection, but may vary in individual cases.
Central Precocious Puberty: Initially: One injection on days 0, 14 and 28. Maintenance dose: One injection every 4 weeks (28 days). Should the effect be insufficient, the injections may be given every three weeks. Dosage should be based on body weight. Children weighing less than 20 kg to be injected with 1,875 mg (half dose), children between 20 and 30 kg to receive 2,5 mg (2/3 dose) and children with more than 30 kg body weight to be injected with 3,75 mg triptorelin (full dose). Treatment should be stopped if a bone maturation of older than 12 years in girls has been achieved.
Method of administration
Note: It is important that the directions for administering the injection be followed rigorously as per separate instruction card. Any incomplete injection kit must be reported. One syringe to be injected once every 28 days either subcutaneously (e.g. into the skin of the abdomen, the buttock or thigh) or deep intramuscularly. The injection site should be changed each time. Appearance after reconstitution: Homogenous milky white to faintly yellow suspension. After reconstitution of the suspension, the injection should be administered immediately. Any unused portion must be discarded.

Men: Prostatic carcinoma: The initial transient increase of serum testosterone has been associated with a temporary aggravation of symptoms of the disease (in particular bone pains). This requires careful medical supervision during the first week of treatment especially in patients presenting with urinary tract obstruction due to metastases and/or spinal metastases. These effects are usually transient, disappearing in one to two weeks with continued treatment. However, the possibility of a temporary exacerbation of the symptoms during the first weeks of treatment must be borne in mind with patients presenting a risk of neurological disorder or urinary obstruction. Administration of an anti-androgen one week before and up to four weeks after GONAPEPTYL u00ae Depot Powder for injection treatment may help to prevent side-effects. The prostate-specific antigen (PSA) and the testosterone plasma levels should be regularly monitored during treatment. Testosterone levels should not exceed 1 ng/ml (1 nmol/l).
Women: GONAPEPTYL u00ae should be prescribed only after careful diagnosis (e.g. laparoscopy). A supervening metrorrhagia in the course of the treatment is abnormal (except in the first month) and should lead to verification of plasma oestrogen level. Should this level be less than 50 pg/ml, possible associated organic lesions should be sought. Non-hormonal methods of contraception should be employed during therapy and must be continued until menses are resumed. Oestrogen-containing products may not be used during treatment with GONAPEPTYL u00ae. During treatment of uterine myomas, the size of the uterus and myoma should be determined regularly, e.g. by means of ultrasonography. Disproportional fast reduction of uterus size in comparison with the reduction of myoma tissue has in isolated cases led to bleeding and sepsis. Treatment should not exceed a duration of 6 months due to a decrease in bone density. After withdrawal of treatment, the bone loss is generally reversible within 6 u2013 9 months.
Children: The chronological age at the beginning of therapy should be under 8 years in girls. Pseudo-precocious puberty (gonadal or adrenal tumour or hyperplasia) should be precluded.

Oestrogen containing medicinal products should not be used during treatment with GONAPEPTYL u00ae.

Pregnancy
GONAPEPTYL u00ae should not be used during pregnancy (see section 4.3).
Lactation
GONAPEPTYL u00ae should not be used during lactation (see section 4.3).
Fertility
No data on fertility is currently available.

No studies on the effects on the ability to drive and use machines have been performed. However, the ability to drive and use machines may be impaired if the patient experiences dizziness, somnolence and visual disturbances which could be possible undesirable effects of treatment or resulting from the underlying disease.

a) Summary of safety profile
In men the initiation of treatment is followed by a transient accentuation of clinical signs and symptoms (in particular bone pains). These effects are usually transient, disappearing in one to two weeks with continued treatment. The most frequent adverse reactions reported in men and women are temporary pain at the injection site, depressive mood and irritation, fatigue, sleep disturbances, hot flushes, nausea, myalgia and arthralgia. In men the most frequently reported adverse reactions include gynecomastia; loss of libido and impotence, perspiration; paraesthesia; asthenia; compression of the spinal cord.
b) List of adverse reactions
Men and women:

• Immune system disorders
• Less frequent: Hypersensitivity reaction, e.g. itching, skin rash, fever and anaphylaxis may occur. These reactions may include both local injection site reactions and systemic symptoms.
• General disorders and administration site conditions
• Frequent: Temporary pain at the injection site may occur.
• Less frequent: After subcutaneous injection, some patients may notice foreign body reactions at the injection site.
• Metabolism disorders
• Less frequent: Elevated enzyme levels (LDH, u03b3 GT, AST, ALT).
• Nervous system disorders
• Frequent: Depressive mood and irritation; fatigue; sleep disturbances; hot flushes.
• Gastrointestinal disorders
• Frequent: Nausea.
• Musculoskeletal disorders
• Frequent: Myalgia and arthralgia.

Men:

• Blood disorders
• Less frequent: Thrombophlebitis.
• Reproductive system and breast disorders
• Frequent: Gynecomastia; loss of libido and impotence.
• Less frequent: Testicular atrophy.
• Nervous system disorders
• Frequent: Perspiration; paraesthesia; asthenia; compression of the spinal cord.
• Vascular disorders
• Less frequent: Hypertension; lymphatic oedema of the legs.
• Metabolism disorders
• Less frequent: Loss of appetite and weight changes.
• Skin disorders
• Less frequent: Reduced growth of beard and hair loss on chest, arms and legs.
• Renal and urinary disorders
• Less frequent: Urinary obstruction with decreased kidney function.
• Musculoskeletal disorders
• Less frequent: Skeletal pain and muscular fatigue.

Women:

• Blood disorders
• Less frequent: Decrease in plasma oestrogen levels; slightly elevated serum cholesterol.
• Reproductive system disorders
• Less frequent: Vaginal dryness and/or dyspareunia; withdrawal bleeding, spotting, loss of libido.
• Nervous system disorders
• Less frequent: Nervousness and mood swings; paraesthesia.
• Musculoskeletal and bone disorders
• Less frequent: Backache; trabecular bone loss may occur which is usually reversible within 6 u2013 9 months after withdrawal of therapy.
• Eye disorders
• Less frequent: Visual disturbance.

Children:

• Reproductive system disorders
• Less frequent: Vaginal bleeding and discharge may occur.
• Gastrointestinal disorders
• Less frequent: Vomiting and nausea.
• Nervous system disorders
• Less frequent: Headache.

c) Description of selected adverse reactions
Due to increased testosterone levels in men the first week of treatment, worsening of symptoms and complaints may occur.

Treatment is symptomatic and supportive.