Diphereline PR

Diphereline PR

triptorelin

Manufacturer:

Ipsen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per 3.75 mg PR powd for inj Triptorelin acetate. Per 11.25 mg PR powd for inj Triptorelin pamoate
Indications/Uses
Locally advanced or metastatic, hormone-dependent prostate cancer. Endometriosis & central precocious puberty (before 8 yr in girls & 10 yr in boys). Adjuvant treatment to radiotherapy 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 completion of chemotherapy.
Dosage/Direction for Use
3.75 IM inj Prostate cancer 1 inj every 4 wk. Endometriosis 3.75 mg/vial: 1 inj every 4 wk initiated in the 1st 5 days of the menstrual cycle. Max duration: 6 mth. Central precocious puberty Childn >30 kg 1 inj every 4 wk. Childn 20-30 kg ⅔ dose every 4 wk. Childn <20 kg ½ dose every 4 wk. 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 an 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. 11.25 mg IM/SC inj Prostate cancer 1 IM/SC inj every 3 mth. Recommended duration: 2-3 yr. Endometriosis 1 IM inj every 3 mth initiated in the 1st 5 days of the menstrual cycle. Max duration: 6 mth. Central precocious puberty Childn >20 kg 1 IM inj every 3 wk.
Contraindications
Hypersensitivity to GnRH & its analogues. Pregnancy & lactation.
Special Precautions
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. 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 hypogonadotrophic amenorrhoea. Measure plasma oestradiol levels. Periodically check blood testosterone levels. Concomitant use w/ anticoagulants & drugs known to prolong QT interval. Dizziness, somnolence & visual disturbances may impair ability to drive & use machines. Not to be used during pregnancy & lactation. Childn w/ progressive brain tumours. Pseudo-precocious & gonadotropin-independent precocious puberty, mild to moderate vag bleeding, slipped capital femoral epiphysis. Not to be given in girls >12 yr & boys 13-14 yr w/ bone maturation. Assess bone mineral density before starting treatment especially in women who have multiple risk factors for osteoporosis. Regular monitoring of CV risk factors & BP in premonopausal women w/ breast cancer receiving triptorelin in combination w/ either exemestane or tamoxifen. Plasma oestradiol levels should be measured if genital haemorrhage occurs after the 1st mth. If menstruation persists, a non-hormonal method of contraception should be used throughout including for 2 mth (3.75 mg/vial), 3 mth (11.25 mg/vial) after last inj. May impair the ability to drive & use machines. 11.75 mg/vial: Slipped capital femoral epiphysis.
Adverse Reactions
Men: Decreased libido; paraestesia 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 & bleeding including spotting). Hypersensitivity; headache; hot flushes; abdominal pain; acne; inj site reaction (including site reaction painm erythema & inflammation); increased wt. Breast cancer: Sleep disorder, mood changes; headache; hot flush; hyperhidrosis; dyspareunia, dysmenorrhea, genital haemorrhage (including menorrhagia, metrorrhagia), decreased libido, ovarian hyperstimulation syndrome, ovarian hypertrophy, pelvic pain, vulvovaginal dryness. Nausea, abdominal pain & discomfort; arthralgia, muscle spasms; breast pain; inj site erythema, inflammation & pain; increased wt.
Drug Interactions
Monitor hormone assays in combination w/ drugs that modify the secretion of pituitary gonadotropin secretion. Concomitant use w/ drugs known to prolong QT interval or induce Torsades de pointes eg, class IA (eg, quinidine, disopyramide) or class III (eg, aminodarone, sotalol, dofetilide, ibutilide) antiarrhythmics, methadone, moxifloxacin, antipsychotics.
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
(+ 2 mL solvent amp) 1's
Form
Diphereline PR powd for susp for inj 3.75 mg
Packing/Price
(+ 1 solvent amp + 1 syringe + 2 needles) 1's
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