Diphereline PR

Triptorelin

Locally advanced or metastatic, hormone-dependent prostate cancer. Endometriosis & central precocious puberty (before 8 yr in girls & 10 yr in boys). Adjuvant treatment to RT in patients w/ high-risk localised or locally advanced prostate cancer. 3.75 mg: Uterine fibromyomas prior to surgery. Adjuvant treatment in combination w/ tamoxifen or an aromatase inhibitor of endocrine responsive early stage breast cancer in women at high risk of recurrence who are confirmed as premenopausal after chemotherapy completion.

3.75 IM Prostate cancer 1 inj every 4 wk. Endometriosis 1 inj every 4 wk initiated in the 1st 5 days of menstrual cycle. Max duration: 6 mth. Uterine fibromyomas prior to surgery 1 inj every 4 wk initiated in 1st 5 days of menstrual cycle. Duration: 3-4 mth. Breast cancer 1 inj every 4 wk in combination w/ tamoxifen or aromatase inhibitor. Treatment must be initiated at least 6-8 wk before starting aromatase inhibitor treatment. Duration: Up to 5 yr for adjuvant treatment in combination w/ other hormonotherapy. Central precocious puberty Childn >30 kg 1 inj every 4 wk. Childn 20-30 kg ²/₃ dose every 4 wk. Childn <20 kg ½ dose every 4 wk. 11.25 mg IM/SC Prostate cancer 1 inj every 3 mth. Patient w/ high-risk localised/locally advanced prostate cancer receiving RT Recommended duration: 2-3 yr. Endometriosis 1 inj every 3 mth initiated in the 1st 5 days of menstrual cycle. Max duration: 6 mth. Central precocious puberty Childn >20 kg 1 inj every 3 mth.

Hypersensitivity to GnRH & its analogues. Pregnancy & lactation.

Not to be inj intravascularly. Patients w/ additional risk factors for osteoporosis eg, chronic alcohol abuse, smoking, long-term therapy w/ drugs that reduce bone mineral density (eg, anticonvulsants or corticoids), family history of osteoporosis, malnutrition. Previously unknown gonadotroph cell pituitary adenoma. Closely monitor patients w/ known depression during therapy. Haematoma may potentially appear at inj site in patients treated w/ anticoagulants. Transient increase in serum testosterone levels. May experience temporary worsening of signs & symptoms of prostate cancer (tumor flare) & temporary increase in cancer related pain. Patients suffering from vertebral metastasis, at risk of spinal cord compression & in those w/ urinary tract obstruction. Increased risk of bone loss & fracture; CV diseases. Androgen deprivation therapy may prolong QT interval. Assess benefit-risk ratio including potential for Torsade de Pointes in patients w/ history or risk factors for QT prolongation & in those receiving concomitant QT-prolonging medications. Patients may experience metabolic changes (eg, glucose intolerance, fatty liver). Constant hypogonadotrophic amenorrhoea. Measure plasma oestradiol levels if genital haemorrhage occurs after the 1st mth; investigate for organic lesions if levels are <50 pg/mL. Pseudo-precocious & gonadotropin-independent precocious puberty should be precluded. Possible mild to moderate vag bleeding. Bone mineral density may decrease during GnRH therapy for central precocious puberty. Slipped capital femoral epiphysis after w/drawal of GnRH treatment. Contains Na <1 mmol/dose. Dizziness, somnolence & visual disturbances may impair ability to drive & use machines. Not to be used during pregnancy & lactation. Childn w/ progressive brain tumours. Not to be given in girls >12-13 yr & boys 13-14 yr of bone maturation. Possible idiopathic intracranial HTN in paed patients. 3.75 mg: Ensure adequate ovarian suppression in premenopausal women; administer triptorelin for at least 6-8 wk prior to commencement of aromatase inhibitor. High risk of osteoporosis when combined w/ tamoxifen or aromatase inhibitor. Assess bone mineral density before starting treatment especially in women who have multiple risk factors for osteoporosis. Risk of musculoskeletal disorders. Regularly monitor CV risk factors & BP; risk factors for diabetes w/ blood glucose monitoring.

Men: Decreased libido; paraesthesia in lower limbs; hot flush; hyperhidrosis; back pain; erectile dysfunction (including ejaculation failure & disorder); asthenia. Anaemia; hypersensitivity; depression, libido loss, mood changes; dizziness, headache; HTN; nausea, dry mouth; musculoskeletal pain, pain in extremity; pelvic pain; inj site reaction (including erythema, inflammation & pain), oedema; increased wt. Women: Sleep disorder (including insomnia), altered mood, decreased libido; headache; hot flush; acne, hyperhidrosis, seborrhoea; breast disorder, dyspareunia, genital bleeding (including vag bleeding, privation haemorrhage), ovarian hyperstimulation syndrome, ovarian hypertrophy, pelvic pain, vulvovaginal dryness; asthenia. Hypersensitivity; depression, nervousness; dizziness; nausea, abdominal pain & discomfort; arthralgia, muscle spasms, extremities pain; breast pain; inj site reaction (including pain, swelling, erythema & inflammation), peripheral oedema; increased wt. Childn: Vag bleeding (including vag haemorrhage), w/drawal bleed, uterine haemorrhage, vag discharge. Hypersensitivity; headache; hot flushes; abdominal pain; acne; inj site reaction (including inj site pain, erythema & inflammation); increased wt. Breast cancer: Nausea; fatigue; musculoskeletal disorder, osteoporosis; insomnia, decreased libido, depression; urinary incontinence; dyspareunia, vulvovaginal dryness; hyperhidrosis; hot flushes, HTN. DM (glucose intolerance), hyperglycaemia; inj site reaction; hypersensitivity; fracture; embolism.

Concomitant use w/ drugs that modify the secretion of pituitary gonadotropins; drugs known to prolong QT interval or induce Torsades de Pointes eg, class IA (eg, quinidine, disopyramide) or class III (eg, amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmics, methadone, moxifloxacin, antipsychotics.

Cancer Hormone Therapy / Trophic Hormones & Related Synthetic Drugs

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

POM