Diphereline PR

Per 3.75 mg PR powd for inj Triptorelin acetate. Per 11.25 mg PR powd for inj Triptorelin pamoate

Locally advanced prostate cancer when used alone or as concomitant & adjuvant to RT. Metastatic prostate cancer. Genital & extragenital stage I-IV endometriosis. Precocious puberty (<8 yr in girls & <10 yr in boys). 3.75 mg: Uterine fibromyomas prior to surgery. Adjuvant treatment in combination w/ tamoxifen or aromatase inhibitor for endocrine responsive early stage breast cancer in premenopausal women.

3.75 mg IM inj Prostate cancer 1 inj every 4 wk. Endometriosis 1 inj every 4 wk initiated in 1st 5 days of menstrual cycle for at least 4 mth. Max duration: 6 mth. Uterine fibromyomas prior to surgery 1 inj every 4 wk initiated in 1st 5 days of menstrual cycle. Duration: Not to exceed 3 mth. Breast cancer 1 inj every 4 wk in combination w/ tamoxifen or aromatase inhibitor, initiated at least 6-8 wk prior to aromatase inhibitor treatment. Duration: Up to 5 yr. Precocious puberty Childn >30 kg 1 inj every 4 wk, 20-30 kg ²/₃ dose every 4 wk, <20 kg ½ dose every 4 wk. 11.25 mg IM inj Prostate cancer & precocious puberty 1 inj every 3 mth. Endometriosis 1 inj every 3 mth initiated in 1st 5 days of menstrual cycle for at least 3 mth. Max duration: 6 mth. 11.25 mg SC inj Prostate cancer 1 inj every mth.

Hypersensitivity to GnRH & its analogues. Not to be used during pregnancy & lactation.

Patients w/ additional osteoporosis risk factors eg, chronic alcohol abuse, smokers, long-term therapy w/ drugs reducing bone mineral density eg, anticonvulsants or corticoids, family history of osteoporosis, malnutrition. Previously unknown gonadotroph cell pituitary adenoma; QT prolongation. Closely monitor patients w/ known depression during therapy. Patients suffering from vertebral metastasis, at risk of spinal cord compression, w/ urinary tract obstruction. Increased risk of bone loss & fracture, metabolic changes or CV diseases. Constant hypogonadotrophin amenorrhea. Periodically check blood testosterone & measure plasma oestradiol levels. Concomitant use w/ drugs modifying pituitary gonadotropin secretion & drugs prolonging QT interval. May affect ability to drive & use machines. Not to be used during pregnancy & lactation. Childn w/ progressive brain tumours. Mild to moderate vag bleeding, pseudo- & gonadotrophin-independent precocious puberty, slipped capital femoral epiphysis. Not to be given in girls >12 yr & boys 13-14 yr w/ bone maturation. 3.75 mg: Measure oestradiol & FSH prior to & every 3 mth during therapy. Increased risk of musculoskeletal disorders eg, joint or musculoskeletal pain. Regularly monitor CV risk factors, BP & blood glucose levels. 11.25 mg: Not indicated in transient precocious puberty & premature thelarche, pubarche & menarche.

Hot flushes; depression, mood changes; headache; inj site erythema, inflammation & pain. Men & women: Hyperhidrosis; decreased/loss of libido; dizziness, nausea. Women & childn: Genital haemorrhage; abdominal pain; increased wt. Men, women & 3.75 mg inj: Fatigue. Men: Lower limb paraesthesia; back pain; erectile dysfunction; asthenia; musculoskeletal pain, pain in extremity; oedema. Women: Dyspareunia; vulvovag dryness; sleep disorder; dysmenorrhea, ovarian hyperstimulation syndrome & hypertrophy, pelvic pain; abdominal pain & discomfort; arthralgia, muscle spasms; breast pain; increased wt. Childn: Vag bleeding; pain, erythema; hypersensitivity reaction.

Closely monitor hormone assays in combination w/ drugs modifying pituitary gonadotropins secretion. Concomitant use w/ drugs prolonging QT interval or inducing Torsade de pointes eg, class IA (eg, quinidine, disopyramide) or class III (eg, amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmics, methadone, moxifloxacin, antipsychotics.

Trophic Hormones & Related Synthetic Drugs / Cancer Hormone Therapy

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

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