DECAPEPTYL INJECTION 0.1 MG/ML [SIN08697P]

Product Info

DECAPEPTYL INJECTION 0.1 MG/ML

[SIN08697P]

4.1 Therapeutic indications

Women – ART
DECAPEPTYL® is indicated for downregulation and prevention of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation for assisted reproductive technologies (ART).

4.2 Posology and method of administration
General
The dosage regimen of DECAPEPTYL® is 0.1 mg given once daily as a 1 mL subcutaneous injection.

Women – ART
Treatment with DECAPEPTYL® should be initiated under the supervision of a physician experienced in the treatment of infertility. Treatment can be started in the early follicular phase (day 2 or 3 of the menstrual cycle) or in the mid-luteal phase (day 21–23 of the menstrual cycle or 5–7 days before expected start of menses). Controlled ovarian hyperstimulation with gonadotrophins should be started after approximately 2–4 weeks of DECAPEPTYL® treatment. Ovarian response should be monitored clinically (including ovarian ultrasound alone or preferably in combination with measurement of oestradiol levels) and the dose of gonadotrophins adjusted accordingly. When a suitable number of follicles have reached an appropriate size, treatment with DECAPEPTYL® and gonadotrophin is stopped and a single injection of human chorionic gonadotrophin (hCG) is administered to induce the final follicular maturation. If downregulation is not confirmed after 4 weeks (determined by ultrasound documentation of a shedded endometrium alone or preferably in combination with measurement of oestradiol levels), discontinuation of DECAPEPTYL® should be considered. The total duration of treatment is usually 4–7 weeks.

When using DECAPEPTYL®, luteal phase support should be provided. Luteal phase support should be given according to the reproductive medical centre's practice.

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

Patients with renal or hepatic impairment
No specific dose recommendations are given for subjects with renal or hepatic impairment. A clinical study indicated that the risk of accumulation of triptorelin in patients with severe liver and renal impairment is small (see section 5.2 Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population
There is no relevant use of DECAPEPTYL® in the paediatric population.

Method of administration
DECAPEPTYL® is intended for subcutaneous injection once daily into the lower abdominal wall. Following the first administration, it is advised that the patient be kept under medical supervision for 30 minutes to ensure there is no allergic/pseudo-allergic reaction to the injection.

Facilities for the treatment for such reactions should be immediately available. The following injections may be self-administered as long as the patient is made aware of the signs and symptoms that may indicate hypersensitivity, the consequences of such a reaction and the need for immediate medical intervention. The injection site should be varied to prevent lipoatrophy. For instructions for use and handling, see section 6.7 Other handling information – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications
General

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

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

Women – ART

• Pregnancy or lactation.