Medicinal Products

DECAPEPTYL LP 22.5 mg

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
All forms

Indication

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.

Against indications

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

Very common

Frequent

Rare

Rare

After marketing

Not known frequency

Infections and infestations

nasopharyngitis

Blood and lymphatic system disorders

purpura

Immune system disorders

Anaphylactic reaction

hypersensitivity

Endocrine disorders

Diabetic sugar

Metabolism and nutrition disorders

Anorexia

Drop

Increased appetite

Psychiatric disorders

Decreased libido

Depression*

Mood changes *

Insomnia

Irritability

Confusional state

Decrease in activity

Euphoric mood

Anxiety

The nervous system

Paresthesia of the lower limb

cephalalgia

Dizzying sensations

paresthesia

Memory disorders

Eye disorders

Abnormal feeling in the eyes

Visual disturbance

Blurry vision

Affections of the ear and labyrinth

tinnitus

Fear of heights

Vascular disorders

Hot flashes

Hypertension

hypotension

Respiratory, thoracic and mediastinal disorders

Dyspnea

orthopnea

Epistaxis

Gastrointestinal disorders

Nausea

Abdominal pain

Constipation

Diarrhea

vomiting

Abdominal distention

Dry mouth

dysgeusia

Flatulence

Skin and subcutaneous tissue disorders

Hyperhidrosis

Acne

Alopecia

itching

Skin rash

Cutaneous vesicle

Angioneurotic edema

Urticaria

Musculoskeletal and systemic disorders

Back pain

Musculoskeletal pain

Painful extremities

arthralgia

Muscle cramp

Muscular weakness

myalgia

Joint stiffness

Joint swelling

Musculoskeletal stiffness

osteoarthritis

Bone pain

Disorders of reproductive organs and breast

erectile dysfunction

gynecomastia

mastodynia

Testicular atrophy

Testicular pain

anejaculation

General disorders and administration site conditions

Asthenia

Tired

Erythema at the injection site

Inflammation at the injection site

Pain at the injection site

Reaction at the injection site

Edema

Lethargy

Pain

Chills

Drowsiness

Chest pain

Dystasie

Flu-like syndrome

Fever

Discomfort

investigations

Alanine aminotransferase increased

Aspartate aminotransferase increased

Increased creatinine

Increased uremia

Increased weight

Increased alkaline phosphatase

Increased body temperature

Decreased weight

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.

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