Diphereline PR

Diphereline PR

triptorelin

Manufacturer:

Ipsen

Distributor:

DCH Auriga - Healthcare
Concise Prescribing Info
Contents
Triptorelin
Indications/Uses
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. 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.).
Dosage/Direction for Use
IM 3.75-mg vial Prostate cancer 1 inj every 4 wk. Alternatively, 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. Precocious puberty Childn >20 kg 1 inj every 28 days, <20 kg ½ dose every 28 days. Endometriosis 1 inj every 4 wk (start in the 1st 5 days of the menstrual cycle) for at least 4 mth. 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 inj 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 inj every 6 mth.
Contraindications
Special Precautions
Prostate cancer: Clinical symptoms (eg, bone pain) may worsen on treatment initiation, notably in patients presenting obstructed urinary tracts & those w/ spinal metastases. Patients w/ premonitory signs of medullary compression. Transitory increase in acid phosphatases at the start of treatment. Increased risk of diabetes & certain CV diseases. Check blood testosterone level periodically; should not exceed 1 ng/mL. Endometriosis & uterine fibromyomas: Constant hypogonadotropic amenorrhoea w/ treatment administration. Verify plasma oestradiol levels in case of onset of metrorrhagia. Ovarian function resumes after treatment is withdrawn. Female infertility: Follicular retrieval induced by the inj of triptorelin combined w/ gonadotrophins may increase markedly in some predisposed patients, particularly in cases of polycystic ovarian disease. Monitor induced ovulation under rigorous medical supervision w/ strict & regular biological & clinical controls; fast plasma oestrogen assay & ultrasonography.
Adverse Reactions
Men: At the start of treatment: Urinary symptoms, bone pain of metastatic origin & symptoms associated w/ medullary compression from spinal metastases may be exacerbated. During treatment: Hot flushes, decreased libido, impotence. Women: At the start of treatment: Symptoms of endometriosis (pelvic pain, dysmenorrhoea) may be exacerbated. Metrorrhagia. During treatment: Hot flushes, vag dryness, decrease libido, dyspareunia. Men & women: Allergic reactions (eg, urticaria, rash, pruritus); Quincke's oedema; nausea, vomiting, wt gain, HTN, mood disorders, visual disturbances, pain at the inj site, fever; bone loss (prolonged use). Childn: Minor genital bleeding in girls. Allergic reations (eg, urticaria, pruritus); Quincke's oedema; nausea, vomiting, wt gain, HTN, mood disorders, fever, visual disturbances, pain at the inj site.
MIMS Class
Cancer Hormone Therapy / Trophic Hormones & Related Synthetic Drugs
ATC Classification
L02AE04 - triptorelin ; Belongs to the class of gonadotropin releasing hormone analogues. Used in endocrine therapy.
Presentation/Packing
Form
Diphereline PR powd for inj 11.25 mg
Packing/Price
1's
Form
Diphereline PR powd for inj 22.5 mg
Packing/Price
1's
Form
Diphereline PR powd for inj 3.75 mg
Packing/Price
1's
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