Diphereline PR

Triptorelin

3.75 mg-, 11.25 mg-, & 22.5 mg-vial: Locally advanced or metastatic prostate cancer. 3.75 mg- & 11.25 mg-vial: Genital & extragenital endometriosis (Stage I-IV). 3.75 mg-vial only: Precocious puberty (before 8 yr in girls & 10 yr in boys). Uterine fibromyomas prior to surgery, associated w/ anaemia (Hb ≤8 g/dL), when a reduction in the size of fibromyoma is necessary to facilitate or modify the surgical techniques: endoscopic surgery, transvaginal surgery. Supplementary treatment in combination w/ gonadotrophins (hMG, FSH, hCG) to induce ovulation w/ a view to in vitro fertilization & embryo transfer (I.V.F.E.T.).

IM 3.75-mg vial Prostate cancer 1 SC inj of immediate release Diphereline 0.1 mg for 7 days, then 1 IM inj of Diphereline PR 3.75 mg on day 8, repeated every 4 wk. Or from the outset, 1 IM inj every 4 wk. Precocious puberty Childn >20 kg 1 inj every 4 wk (28 days), <20 kg ½ dose every 4 wk (28 days). Endometriosis 1 inj every 4 wk (start in the 1st 5 days of the menstrual cycle). Max duration: 6 mth. Treatment of uterine fibromyoma prior to surgery 1 inj every 4 wk (start in the 1st 5 days of the menstrual cycle). Max duration: 3 mth. Female infertility 1 vial on the 2nd day of the cycle. 11.25-mg vial Prostate cancer 1 inj every 3 mth. Endometriosis 1 inj every 3 mth (start in the 1st 5 days of the menstrual cycle) for at least 3 mth. Max duration: 6 mth. 22.5-mg vial Locally advanced or metastatic, hormone-dependent prostate cancer 1 vial every 6 mth.

Hypersensitivity to GnRH & its analogues. Pregnancy.

Avoid inadvertent intravascular inj. May reduce bone mineral density, increasing the risk of osteoporosis. Rarely, treatment w/ GnRH agonists may reveal the presence of a previously unknown gonadotroph cell pituitary adenoma. Reports of mood changes including depression; closely monitor patients w/ known depression during therapy. Potential risk of haematoma; caution in patients treated w/ anticoagulants. In men: May cause transient increase in serum testosterone levels & transient worsening of signs & symptoms of prostate cancer during the 1st wk of treatment. Isolated cases of spinal cord compression or urethral obstruction. Risk of pituitary gonadal system suppression; transient increase in acid phosphatases. Increased risk of diabetes & certain CV diseases. Carefully assess before commencing treatment & monitor during androgen deprivation therapy patients at high risk for metabolic or CV diseases. Periodically check blood testosterone levels. In women: Occurrence of constant hypogonadotropic amenorrhoea. Check plasma oestradiol levels in case of metrorrhagia; if <50 pg/mL, possible associated organic lesions should be sought. Contraception may be required following treatment withdrawal as ovarian function resumes. Female infertility: Follicular retrieval induced by triptorelin inj combined w/ gonadotrophins may increase markedly in some predisposed patients, particularly in cases of polycystic ovarian disease. Induced ovulation should be monitored under rigorous medical supervision w/ strict & regular biological & clinical controls: fast plasma oestrogen assay & ultrasonography. In childn: May cause minor vag bleeding in the initial stimulation of the ovaries. 22.5-mg vial: Safety & efficacy has not been established in neonates, infants, childn & adolescents, therefore it is not indicated for the use in these population.

Allergic reactions eg, urticaria, rash, pruritus & very occasionally, Quincke's oedema. Few cases of nausea, vomiting, wt gain, HTN, mood disorders, fever, visual disturbances, inj site pain. In men: 3.75 mg & 11.25 mg-vial: At the start of treatment: Urinary symptoms, bone pain of metastatic origin & symptoms associated w/ medullary compression from spinal metastases. During treatment: Hot flushes, decreased libido, impotence. In women: At the start of treatment: Endometriosis symptoms (pelvic pain, dysmenorrhoea); metrorrhagia. During treatment: Hot flushes, vag dryness, decreased libido & dyspareunia. Rarely, headache, arthralgia & myalgia. In childn: Minor vag bleeding. 22.5-mg vial: Paraesthesia in lower limbs; hot flushes; hyperhidrosis; back pain; asthenia. Libido loss; dizziness, headache; nausea; musculoskeletal pain, pain in extremity; erectile dysfunction; fatigue, inj site reaction (including erythema, inflammation & pain), oedema.

Close monitoring w/ hormone assays when triptorelin is used in combination w/ drugs that modify pituitary gonadotropins secretion.

Cancer Hormone Therapy / Trophic Hormones & Related Synthetic Drugs

L02AE04 - triptorelin ; Belongs to the class of gonadotropin releasing hormone analogues. Used in endocrine therapy.

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