Diphereline PR

Diphereline PR

triptorelin

Manufacturer:

Ipsen Pharma

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 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 for responsive early stage breast cancer in premenopausal women.
Dosage/Direction for Use
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.
Contraindications
Hypersensitivity to GnRH & its analogues. Not to be used during pregnancy & lactation.
Special Precautions
Patients w/ additional osteoporosis risk factors eg, chronic alcohol abuse, smokers, long-term therapy w/ drugs known to reduce 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 that modify pituitary gonadotropin secretion & drugs known to prolong 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.
Adverse Reactions
Hypersensitivity; hot flushes; depression; headache; inj site erythema, inflammation & pain. Men & women: Hyperhidrosis; decreased/loss of libido; dizziness, nausea. Men & childn: Mood changes. Women & childn: Genital haemorrhage. Women & 3.75 mg inj: Dyspareunia; vulvovag dryness. Men, women & 3.75 mg inj: Fatigue. Men: Lower limb paraesthesia; back pain; erectile dysfunction; asthenia; musculoskeletal pain, pain in extremity; oedema. Women: Sleep disorder; dysmenorrhea, ovarian hyperstimulation syndrome & hypertrophy, pelvic pain; abdominal pain & discomfort; arthralgia, muscle spasms; breast pain; increased wt. Childn: Vag bleeding; pain, erythema. 3.75 mg inj: Insomnia, HTN; nausea; musculoskeletal disorder, osteoporosis; urinary incontinence; DM, hyperglycaemia; embolism; fracture.
Drug Interactions
Closely monitor hormone assays in combination w/ drugs that modify pituitary gonadotropins secretion. Concomitant use w/ drugs known to prolong QT interval or induce Torsade de pointes eg, class IA (eg, quinidine, disopyramide) or class III (eg, amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmics, methadone, moxifloxacin, antipsychotics.
ATC Classification
L02AE04 - triptorelin ; Belongs to the class of gonadotropin releasing hormone analogues. Used in endocrine therapy.
Presentation/Packing
Form
Diphereline P.R. powd for inj 3.75 mg
Packing/Price
1's
Form
Diphereline P.R. powd for inj 11.25 mg
Packing/Price
1's
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