Medicinal Products

DECAPEPTYL 0.1 mg

Generic drug of the therapeutic class: Oncology and Hematology
active ingredients: Triptorelin
laboratory: Ipsen Pharma

Powder and solvent for SC solution for injection
Box of 7 vials of powder + 1 mL solvent ampoules
All forms

Indication

- Prostate cancer with metastases (attack treatment, before use of the sustained-release form).
A favorable effect of the drug is all the more clear and more frequent than the patient has not previously received another hormonal treatment.
- Female infertility as complementary treatment, in combination with gonadotropins (hMG, FSH, hCG) during induction of ovulation for in vitro fertilization followed by embryo transfer (FIVETE).

Dosage DECAPEPTYL 0.1 mg Powder and solvent for solution for injection SC Box of 7 Vials of powder + 1 mL solvent ampoules

- Prostate cancer :
One injection per day of 0.1 mg triptorelin subcutaneously J1 to J7 before taking over with the sustained release form.
- Female infertility: in association with gonadotropins.
One injection per day subcutaneously to be administered from the second day of the menstrual cycle (together with the beginning of ovarian stimulation) until the day before the day fixed for the onset, ie an average duration of 10-12 days per day. attempt.

Against indications

Hypersensitivity to GnRH, GnRH analogues, or any of the excipients (see section 4.8 ).

Pregnancy and breast feeding.

Decapeptyl side effects

Data collected during clinical trials

The adult population enrolled in the clinical trials and treated with an immediate-release form of triptorelin was 127 men with prostate cancer treated daily for 3 months and approximately 1000 women undergoing a prostate cancer protocol. in vitro fertilization. Additional detailed safety data obtained in clinical studies with the 1 month and 3 month formulations of triptorelin in both men and women were also included.

The overall analysis of safety data collected in clinical trials included pharmacologic adverse events resulting from hypogonadotropic hypogonadism or sometimes initial pituitary-gonadal stimulation.

The frequency of adverse reactions is classified as follows: very common (≥ 1/10), common (≥ 1/100 to <1/10); uncommon (≥ 1/1, 000 to <1/100); rare (≥ 1 / 10, 000 to <1/1, 000), very rare ((<1/10, 000).

General tolerance in adults

Very common

Mild to severe flushes and hyperhidrosis that do not usually require treatment discontinuation.

General tolerance in humans

Very common at the beginning of treatment (see Warnings and Precautions section )

An exacerbation of urinary symptoms, bone pain of metastatic origin or symptoms related to vertebral metastases medullary compression (back pain, asthenia, paresthesia of the lower limbs), is sometimes observed during the initial and transient increase in plasma levels testosterone at the beginning of treatment. These symptoms are transient and usually go away in one to two weeks.

Frequent during treatment

Decreased libido, erectile dysfunction associated with lower plasma levels of testosterone, a consequence of the pharmacological action of the product, and are similar to those seen with other GnRH analogues.

General tolerance in women

Very common at the beginning of treatment

In female infertility, association with gonadotropins may lead to ovarian hyperstimulation syndrome. Ovarian hypertrophy, dyspnea, pelvic and / or abdominal pain may be observed (see Warnings and Precautions ).

Very common at the beginning of treatment with formulations 1 month and 3 months

Genital haemorrhages including menorrhagia or metrorrhagia that may occur within one month of the first injection.

Very common during treatment with formulations 1 month and 3 months

There is a general tendency for hypo - oestrogenic events related to pituitary - ovarian blockage such as sleep disorders, mood disorder, headache, vaginal dryness, decreased libido, and dyspareunia.

Frequent during treatment with 1 month formulations

Mastodynia, muscle spasm, arthralgia, increased weight, nausea, pain / abdominal discomfort, asthenia.

Local tolerance

Very rare.

Pain, erythema and inflammation at the injection site.

Post-market data

· In women:

Additional adverse reactions have been reported post-marketing in women treated with in vitro fertilization. They are classified by organ system and in descending order of frequency of notification:

Skin and subcutaneous tissue disorders

Hypersensitivity reactions including pruritus, urticaria, rash, angioneurotic edema (see section 4.3 ).

Nervous system disorders

Headache.

Eye disorders

Episodes of blurred vision or visual disturbances.

· In humans:

An increase in lymphocytes has been reported in patients treated with GnRH analogues. This secondary lymphocytosis is apparently related to GnRH-induced castration and suggests that gonadal hormones are involved in thymic involution.

· In both sexes:

Prolonged use of GnRH analogues may induce bone loss, a risk factor for possible osteoporosis. These effects are not observed during treatment with DECAPEPTYL 0.1 mg short-term.

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