Diphereline PR

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 aromatase inhibitor of endocrine responsive early stage breast cancer in women at high risk of recurrence who are confirmed as pre-menopausal after chemotherapy completion.

3.75 mg IM Prostate cancer 1 inj every 4 wk. Endometriosis 1 inj every 4 wk initiated in 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. Initiate treatment at least 6-8 wk before starting aromatase inhibitor. Duration: Up to 5 yr for adjuvant treatment in combination w/ other hormonotherapy. Central precocious puberty Childn weighing >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/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 IM inj every 3 mth initiated in 1st 5 days of menstrual cycle. Max duration: 6 mth. Central precocious puberty Childn weighing >20 kg 1 IM inj every 3 mth.

Hypersensitivity to triptorelin, GnRH & its analogues. Pregnancy & lactation. 3.75 mg: Initiation of aromatase inhibitor treatment before adequate ovarian suppression w/ triptorelin has been achieved in pre-menopausal breast cancer setting.

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/ anti-coagulants. Transient increase in serum testosterone levels. May experience temporary worsening of signs & symptoms of prostate cancer (tumor flare) & temporary increase in cancer related pain. Careful monitoring during the 1st wk of treatment in patients suffering from vertebral metastasis, at risk of spinal cord compression & in those w/ urinary tract obstruction. Increased risk of bone loss & fracture. 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 interval-prolonging medicinal products. Patients may experience metabolic changes (eg, glucose intolerance, fatty liver). Increased risk of CV diseases during androgen deprivation therapy. Possible transitory increase in acid phosphatases at the beginning of treatment. 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. Possible slipped capital femoral epiphysis after w/drawal of GnRH treatment. Contains Na <1 mmol/dose. Possible dizziness, somnolence & visual disturbances may impair ability to drive & use machines. Not to be used during pregnancy & lactation. Not recommended for patients <18 yr for endometriosis & pre-surgery treatment of uterine fibromyomas. Adolescents & young women especially <16 yr who may not have reached max bone density. 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; discontinue use if idiopathic intracranial HTN occurs. 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. 11.25 mg: SC administration for childn.

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 & pelvic pain, pain in extremity; 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, vulvovag dryness; asthenia. Hypersensitivity; depression, nervousness; dizziness; nausea, abdominal pain & discomfort; arthralgia, muscle spasms, extremities & 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, vulvovag dryness; hyperhidrosis; hot flushes, HTN. DM (glucose intolerance), hyperglycaemia; inj site reaction; hypersensitivity; fracture; embolism.

Concomitant use w/ drugs that modify secretion of pituitary gonadotropins; medicinal products 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