Medicinal Products

DECAPEPTYL LP 3 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

· Prostate cancer

Treatment of locally advanced prostate cancer, alone or in concomitant treatment and adjuvant to radiotherapy.

· Treatment of metastatic prostate cancer

A favorable effect of the drug is all the more clear and more frequent than the patient has not previously received another hormonal treatment.

· Early puberty (before 8 years at the girl, before 10 years at the boy).

· Genital and extragenital endometriosis (stage I to stage IV)

The duration of treatment is limited to 6 months (see section 4.8 ). It is not desirable to take a second course of treatment with triptorelin or another GnRH analogue.

· Female infertility

Complementary treatment, in combination with gonadotropins (hMG, FSH, hCG), during induction of ovulation for in vitro fertilization followed by embryo transfer (FIVETE).

· Preoperative treatment of uterine fibroids:

o associated with anemia (with a hemoglobin level less than or equal to 8 g / dl),

o in the case where a reduction in the size of the fibroid is necessary to facilitate or modify the operative technique: endoscopic surgery, transvaginal surgery.

The duration of treatment is limited to 3 months.

Dosage DECAPEPTYL LP 3 mg Powder and solvent for prolonged-release suspension for injection Box of 1 vial of powder + 2 ml solvent ampoule

· Prostate cancer:

Two treatment regimens can be used:

Subcutaneous daily injection of DECAPEPTYL 0.1 mg immediate release for seven days, then intramuscular injection of DECAPEPTYL LP 3 mg on day 8; this injection is repeated every 4 weeks, or immediately, an intramuscular injection of DECAPEPTYL LP 3 mg prolonged release which will be renewed every 4 weeks.

Duration of treatment see section Pharmacodynamic properties .

· Early puberty:

Treatment should be supervised by a pediatric endocrinologist, pediatrician or endocrinologist who specializes in the treatment of central precocious puberty.

Children under 20 kg: intramuscular injection every 4 weeks (28 days) of ½ (half) dose (ie half the volume of the reconstituted suspension).

Children 20 to 30 kg: intramuscular injection every 4 weeks (28 days) 2/3 (two thirds) of the dose (ie 2/3 of the volume of the reconstituted suspension).

Children over 30 kg: intramuscular injection every 4 weeks (28 days) of the entire dose (ie the entire volume of the reconstituted suspension).

· Endometriosis:

An intramuscular injection of DECAPEPTYL LP 3 mg renewed every 4 weeks.

Treatment should be started within the first 5 days of the cycle.

Duration of treatment: it depends on the initial severity of endometriosis and the evolution under treatment of its clinical manifestations (functional and anatomical). In principle, it is at least 4 months and 6 months at most. It is not desirable to undertake a second course of treatment with triptorelin or other GnRH analogues.

· Female infertility:

The usual regimen is based on the intramuscular injection of a vial of DECAPEPTYL LP 3 mg from day 2 of the cycle.

The combination with gonadotropins begins after obtaining the pituitary desensitization (plasma estrogen level less than 50 pg / ml), generally about fifteen days after the injection of DECAPEPTYL LP 3 mg.

· Preoperative treatment of uterine fibroids:

An intramuscular injection of DECAPEPTYL LP 3 mg renewed every 4 weeks.

Intramuscular use only.

Treatment should begin within the first 5 days of the cycle.

The duration of treatment is limited to 3 months.

NB It is important that the injection of the sustained-release form be practiced strictly according to the instructions in the package leaflet. Any defective injection leading to the loss of an amount of the suspension greater than that which normally remains in the device used for the injection, must be reported.

Against indications

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

Pregnancy and breast feeding.

Decapeptyl LP side effects

General tolerance in humans (see section Warnings and precautions for use )

As 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: initial increase in testosterone levels, followed by almost complete suppression of testosterone. These effects included hot flashes (50%), erectile dysfunction (4%) and decreased libido (3%).

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). No frequency can be applied to post-marketing adverse reactions. They are therefore reported with the words "indeterminate frequency".

Classes of organ systems

Very common

Frequent

Rare

Rare

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

Depression

Insomnia

Irritability

Mood swings

Confusional state

Decrease in activity

Euphoric mood

Anxiety

Nervous system disorders

Paresthesia of the lower limb

Dizzying sensations

cephalalgia

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

Epistaxis

hypotension

Respiratory, thoracic and mediastinal disorders

Dyspnea

orthopnea

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

Decreased libido

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 aminotransferases increased

Increased creatinine

Increased uremia

Increased weight

Increased alkaline phosphatase

Increased body temperature

Decreased weight

Increased blood pressure

Triptorelin causes a transient increase in circulating levels of testosterone during the first week after the first injection of the sustained-release formulation. As a result of the initial increase in circulating testosterone levels, a small percentage of patients (≤5%) may experience a temporary 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 disappear after 1 to 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 synthetic GnRH analogues in the treatment of prostate cancer may be associated with bone loss that can lead to osteoporosis and increase the risk of fracture.

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.

Patients treated with long-term GnRH analogue in combination with radiotherapy may have more side effects especially gastrointestinal, related to radiotherapy.

General tolerance in women (see section Warnings and precautions for use )

The most common side effects (≥ 10% of patients) are the result of decreased estrogen levels. These include headache, low libido, sleep disorders, mood disorders, dyspareunia, dysmenorrhea, genital hemorrhage, ovarian hyperstimulation syndrome, ovarian hypertrophy, pelvic pain, vulvovaginal dryness, hyperhidrosis, hot flushes.

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). No frequency can be applied to post-marketing adverse reactions. They are therefore reported with the words "indeterminate frequency".

Classes of organ systems

Very common

Frequent

Not known frequency

Immune system disorders

Hypersensitivity reactions

Psychiatric disorders

Sleeping troubles

Mood disorders

Depression

Anxiety

Confusional state

Nervous system disorders

cephalalgia

Dizzying sensations

Eye disorders

Blurry vision

Visual disturbance

Affections of the ear and labyrinth

Fear of heights

Vascular disorders

Hot flashes

Respiratory, thoracic and mediastinal disorders

Dyspnea

Gastrointestinal disorders

Nausea

Abdominal pain

Abdominal discomfort

Diarrhea

Vomiting

Skin and subcutaneous tissue disorders

Hyperhidrosis

Angioneurotic edema

itching

Skin rash

Urticaria

Musculoskeletal disorders

arthralgia

Muscle spasm

myalgia

Muscular weakness

Disorders of reproductive organs and breast

dyspareunia

Dysmenorrhea

Genital haemorrhage (including menorrhagia and metrorrhagia)

Decreased libido

Ovarian hyperstimulation syndrome

Ovarian hypertrophy

Pelvic pain

Vulvovaginal dryness

mastodynia

Amenorrhea

General disorders and administration site conditions

Erythema at the injection site

Inflammation at the injection site

Pain at the injection site

Fever

Discomfort

investigations

Increased weight

Increased blood pressure

An exacerbation of the symptoms of endometriosis (pelvic pain, dysmenorrhea) can be observed very frequently (≥ 10%) during the initial and transient increase in the plasma estradiol level and disappears in one to two weeks.

The occurrence of genital haemorrhage including bleeding and menorrhagia can be observed in the month following the first injection.

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

Prolonged use of GnRH analogues may induce bone loss, a risk factor for possible osteoporosis.

General tolerance in children (see section Warnings and precautions for use )

The frequency of these adverse reactions can be categorized as follows: very common (≥1 / 10); frequent (≥1 / 100, <1/10). No frequency can be applied to post-marketing adverse reactions. They are therefore reported with the words "indeterminate frequency".

Classes of organ systems

Very common

Frequent

Not known frequency

Immune system disorders

Hypersensitivity reaction

Psychiatric disorders

Emotional lability

Nervousness

Nervous system disorders

cephalalgia

Eye disorders

Blurry vision

Visual disturbance

Vascular disorders

Hot flashes

Respiratory, thoracic and mediastinal disorders

Epistaxis

Gastrointestinal disorders

Vomiting

Abdominal pain

Abdominal discomfort

Skin and subcutaneous tissue disorders

Angioneurotic edema

Skin rash

Urticaria

Musculoskeletal and systemic disorders

myalgia

Disorders of reproductive organs and breast

Genital haemorrhage

Vaginal bleeding

General disorders and administration site conditions

Pain

Erythema

Erythema at the injection site

Inflammation at the injection site

Pain at the injection site

Discomfort

investigations

Increased blood pressure

Increased weight

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