Generic drug of the therapeutic class: Oncology and Hematology
active ingredients: Triptorelin
laboratory: Ipsen Pharma
Powder and solvent for injectable suspension for sustained release
Box of 1 Bottle of powder + 2 ml solvent ampoule
DECAPEPTYL LP 22.5 mg is indicated for the treatment of locally advanced or metastatic hormone-dependent prostate cancer.
DECAPEPTYL LP 22.5 mg is indicated for concomitant therapy and adjuvant to radiotherapy for locally advanced hormone-dependent prostate cancer
Dosage DECAPEPTYL LP 22.5 mg Powder and solvent for prolonged-release suspension for injection Box of 1 vial of powder + 2 ml solvent ampoule
The recommended dose of DECAPEPTYL LP 22.5 mg is 22.5 mg triptorelin (1 vial) administered every 6 months (24 weeks) by single intramuscular injection.
In concomitant and adjuvant radiotherapy for locally advanced prostate cancer, clinical data have shown that radiotherapy followed by 3-year androgen deprivation is preferable to radiotherapy followed by androgenic deprivation for 6 months (see section Pharmacodynamic properties ). The duration of the androgen suppression recommended in the guidelines of good medical practice, for the patients of the T3 and T4 stages treated by radiotherapy, is 2 to 3 years.
As with any drug administered by injection, it is necessary to change the injection site regularly.
DECAPEPTYL LP 22.5 mg is a suspension of microgranules, its accidental injection by the intravascular route must absolutely be avoided.
DECAPEPTYL LP 22.5 mg should be administered under medical supervision.
No dosage adjustment is necessary in patients with renal or hepatic impairment.
The safety and efficacy of DECAPEPTYL LP 22.5 mg have not been established in neonates, infants, children, and adolescents, which is why DECAPEPTYL 22.5 mg not indicated in these populations.
Hypersensitivity to GnRH, GnRH analogues, or any of the excipients (see section 4.8 ).
Decapeptyl LP side effects
Since patients with locally advanced or metastatic hormone-dependent prostate cancer are generally elderly and have other diseases frequently encountered in this elderly population, adverse events have been reported in more than 90% of patients included in clinical studies, the cause being difficult to determine. As was observed with other GnRH agonists or after surgical castration, the most commonly observed adverse effects during treatment with triptorelin were due to its expected pharmacological effects. These effects include hot flashes (50%), erectile dysfunction (4%) and decreased libido (3%). With the exception of immunoallergic (rare) and injection site (<5%) reactions, all adverse effects are known to be related to changes in testosterone levels.
The following side effects have been reported and are considered to be at least possibly related to treatment with triptorelin. Most of these effects are known to be related to biochemical or surgical castration.
The frequency of these adverse reactions can be categorized as follows: very common (≥1 / 10); frequent (≥1 / 100, <1/10); uncommon (≥1 / 1, 000, <1/100), rare (≥1 / 10, 000, <1/1000).
Classes of organ systems
Not known frequency
Infections and infestations
Blood and lymphatic system disorders
Immune system disorders
Metabolism and nutrition disorders
Mood changes *
Decrease in activity
The nervous system
Paresthesia of the lower limb
Abnormal feeling in the eyes
Affections of the ear and labyrinth
Fear of heights
Respiratory, thoracic and mediastinal disorders
Skin and subcutaneous tissue disorders
Musculoskeletal and systemic disorders
Disorders of reproductive organs and breast
General disorders and administration site conditions
Erythema at the injection site
Inflammation at the injection site
Pain at the injection site
Reaction at the injection site
Alanine aminotransferase increased
Aspartate aminotransferase increased
Increased alkaline phosphatase
Increased body temperature
Increased blood pressure
* The frequency of these class effects is based on the frequency common to GnRH agonists.
Triptorelin causes a transient increase in circulating levels of testosterone during the first week after the first injection of the sustained-release formulation. Following the initial increase in circulating levels of testosterone, a small percentage of patients (≤5%) may experience a transient worsening of the signs and symptoms of their prostate cancer (exacerbation of the tumor), usually manifesting themselves by an increase in urinary symptoms (<2%) and metastatic pain (5%), which can be treated symptomatically. These symptoms are transient and usually go away in 1-2 weeks.
Isolated cases of exacerbation of disease-related symptoms such as obstruction of the urethra or spinal cord compression by metastases may occur. Therefore, patients with vertebral metastatic lesions and / or obstruction of the urinary system should be closely monitored during the first weeks of treatment (see Warnings and Precautions ). .
The use of GnRH agonists in the treatment of prostate cancer may be associated with bone loss that can lead to osteoporosis and increase the risk of fracture. It can also lead to an erroneous diagnosis of bone metastases.
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.