DIPHERELINE P.R. POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION 3.75 MG/VIAL [SIN14634P]

Product Info

DIPHERELINE P.R. POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION 3.75 MG/VIAL

[SIN14634P]

4.1 Therapeutic indications

• Prostate cancer
  Treatment of locally advanced or metastatic, hormone-dependent prostate cancer.
  As adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced prostate cancer.

• Endometriosis

• Treatment of uterine fibromyomas prior to surgery

• Central precocious puberty (before 8 years in girls and 10 years in boys).

• Breast cancer
  As adjuvant treatment in combination with tamoxifen or an aromatase inhibitor, of endocrine responsive early stage breast cancer in women at high risk of recurrence who are confirmed as pre-menopausal after completion of chemotherapy.

4.2 Posology and method of administration

Posology

• Prostate cancer

One intramuscular injection of Diphereline P.R. 3.75 mg every 4 weeks.

Duration of the treatment: In high-risk localised or ‘locally advanced hormone-dependent prostate cancer as concomitant to and following radiation therapy’ clinical data have shown that radiotherapy followed by long-term androgen deprivation therapy is preferable to radiotherapy followed by short-term androgen deprivation therapy (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The treatment duration of androgen deprivation therapy recommended by medical guidances for patients with high-risk localised or locally advanced prostate cancer receiving radiotherapy is 2 – 3 years.

In patients who are not surgically castrated and treated with GnRH analogues for metastatic prostate cancer, treatment is usually continued upon development of castrate-resistant prostate cancer.

• Endometriosis

One intramuscular injection of Diphereline PR 3.75 mg every 4 weeks. The treatment must be initiated in the first five days of the menstrual cycle.

Duration of treatment: This depends on the initial severity of the endometriosis and the changes observed in the clinical features (functional and anatomical) during treatment. The treatment should not be administered for more than 6 months (see section 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). It is not recommended to undertake a second course of treatment by triptorelin or by another GnRH analogue. In patients treated with GnRH analogues for endometriosis, the addition of hormone replacement therapy an add-back therapy (ABT – an estrogen and progestogen) has been shown to reduce bone mineral density loss and vasomotor symptoms. Therefore, if appropriate, ABT should be co-administered with GnRH analogue taking into account the risks and benefits of each treatment.

• Treatment of uterine fibromyomas prior to surgery

One intramuscular injection of Diphereline PR 3.75 mg every 4 weeks. The treatment must be initiated in the first five days of the menstrual cycle. Clinical studies were conducted for durations between 3 to 4 months.

• Central precocious puberty

The treatment of children with triptorelin should be under the overall supervision of the paediatric endocrinologist or of a paediatrician or endocrinologist with expertise in the treatment of central precocious puberty.

• Children under 20 kg in body weight: half (1/2) a dose by intramuscular route, every 4 weeks (28 days), i.e. administer half the volume of the reconstituted suspension.

• Children between 20 and 30 kg in body weight: two-thirds (2/3) of the dose by intramuscular route, every 4 weeks (28 days), i.e. administer two-thirds of the volume of the reconstituted suspension.

• Children over 30 kg in body weight: one intramuscular injection every 4 weeks (28 days), i.e. administer the full volume of reconstituted suspension.

Treatment should be stopped around the physiological age of puberty in boys and girls and it is recommended that treatment is not continued in girls with bone maturation of more than 12 to 13 years. There are limited data available in boys relating to the optimum time to stop treatment based on bone age, however it is advised that treatment is stopped in boys with a bone maturation age of 13 to 14 years.

• Breast cancer

One intramuscular injection every 4 weeks in combination with tamoxifen or an aromatase inhibitor.

Triptorelin should be commenced after completion of chemotherapy, once pre-menopausal status has been confirmed.

The treatment with triptorelin must be initiated at least 6 – 8 weeks before starting aromatase inhibitor treatment. A minimum of two injections of triptorelin (with an interval of 4 weeks between injections) should be administered before commencement of aromatase inhibitor treatment.

During treatment with an aromatase inhibitor, triptorelin must not be interrupted to avoid rebound increases in circulating oestrogens in premenopausal women.

The recommended treatment duration for adjuvant treatment in combination with other hormonotherapy is up to 5 years.

Method of administration

See above in Posology section.

Since Diphereline P.R. 3.75 mg is a suspension of microparticles, inadvertent intravascular injection must be strictly avoided.

NB: The sustained release form must be injected in strict compliance with the instructions given in the package leaflet. Any incomplete injection resulting in the loss of suspension volume greater than the volume generally remaining in the injection device must be reported.

4.3 Contraindications

Hypersensitivity to GnRH, its analogues or to any of the excipients (see section 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Pregnancy and breast feeding.
In the pre-menopausal breast cancer setting: Initiation of aromatase inhibitor treatment before adequate ovarian suppression with triptorelin has been achieved (see sections 4.2 and 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).