DIPHERELINE P.R. POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION 11.25 MG/VIAL [SIN14635P]

Product Info

DIPHERELINE P.R. POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION 11.25 MG/VIAL

[SIN14635P]

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

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

4.2 Posology and method of administration

Posology

• Prostate cancer

One intramuscular or subcutaneous injection of Diphereline P.R. 11.25 mg every 3 months.

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 P.R. 11.25 mg every 3 months.
The subcutaneous administration has not been studied in women.

The treatment must be initiated in the first five days of the menstrual cycle.

Duration of the 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 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.

• 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 over 20 kg in body weight: One intramuscular injection of Diphereline P.R. 11.25 mg administered every 3 months.

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 – 14 years.

Diphereline P.R. 11.25 mg must not be injected intravascularly. The subcutaneous administration has not been studied in children.

Method of administration

See above in Posology section.

For reconstitution of Diphereline before use, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

NB: The prolonged release form must be injected in strict compliance with the instructions given in the package insert. Any incomplete injections resulting in the loss of suspension volumes greater than the volume generally remaining in the injection syringe must be reported.

4. 3 Contraindications

Hypersensitivity to active substance, to GnRH, its analogues or to any of the excipients (see section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Pregnancy and breast feeding.