DECAPEPTYL CR FOR INJECTION 3.75 MG/SYRINGE [SIN09105P]

Product Info

DECAPEPTYL CR FOR INJECTION 3.75 MG/SYRINGE

[SIN09105P]

4.1 Therapeutic Indications
DECAPEPTYL® CR is indicated in situations where lowering of sex steroid serum levels to castrate level is desired, such as prostate cancer, endometriosis or uterine myoma, or assisted reproduction techniques, e.g. IVF.

Treatment of confirmed central precocious puberty (preterm sexual development) (girls under 9 years, boys under 10 years of age).

4.2 Posology and method of administration

Men
Once every four weeks an injection with one syringe, equivalent to 3.75 mg triptorelin.
Therapy of prostate carcinoma: It is important that the 4-week cycle be observed.
As a diagnostic: It can be generally clarified after 3 months treatment whether the prostate cancer is androgen dependent or not. If so, administration can be continued.

Women - Uterine myoma and endometriosis
Once every four weeks an injection with one syringe, equivalent to 3.75 mg triptorelin.
In view of the possible effect on bone density, therapy should not exceed a 6-month period.

Women - Assisted reproduction techniques (ART)
Single administration on cycle days 2 or 3 (follicular phase) or cycle day 22 (luteal phase).

Children – Precocious Puberty
Treatment starts with the injection of one syringe each, equivalent to 3.75 mg triptorelin, on days 0, 14, and 28. Thereafter one injection follows every 4 weeks. Should the effect be insufficient, the injections may be given every 3 weeks. Dosing should be based on body weight. Children weighing less than 20 kg receive 1.875 mg (half dose), children between 20 and 30 kg receive 2.5 mg (2/3 dose), and children with more than 30 kg body weight are given 3.75 mg triptorelin (full dose).

Treatment should be stopped if a bone maturation of older than 12 years in girls and older than 13 years in boys has been achieved.

General
In view of the possible effect on bone density, DECAPEPTYL® CR therapy without add-back therapy should not exceed a duration of 6 months (see section 4.4 Warnings and Precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Special populations
Elderly
There is no need to adjust the dose for the elderly.

Patients with renal or hepatic impairment
According to current data, dose reduction or prolongation of the dosage interval in patients with impaired renal or hepatic function is not necessary (see section 5.2 Pharmacokinetic data – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration
The product should only be used under the supervision of an appropriate specialist having requisite facilities for regular monitoring of response.

It is important that the injection of the sustained release form be performed strictly in accordance with the instructions given in section 6.7 Instructions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information}.

The dosage of one syringe, equivalent to 3.75 mg triptorelin, is injected either subcutaneously (e.g. into the skin of the abdomen, the buttock or thigh) or deep intramuscularly. The injection site should be changed each time.

4.3 Contraindications
General

• Hypersensitivity to the active substance or to any of the excipients.

• Hypersensitivity to gonadotrophin-releasing hormone (GnRH) or any other GnRH analogue.

Women – ART, Uterine Myoma and Endometriosis

• Pregnancy or Lactation