Medicinal Products

ENANTONE LP 3.75 mg

Generic drug of the therapeutic class: Oncology and Hematology
active ingredients: Leuprorelin
laboratory: Takeda France

Powder and solvent for injectable suspension for sustained release
Box of 1 Bottle of powder + device + 2 ml solvent ampoule
All forms

Indication

· Prostate cancer

Treatment of locally advanced or metastatic prostate cancer.

Concomitant therapy and adjuvant to external radiotherapy in locally advanced prostate cancer (T3-T4 stage of the TNM classification or stage C of the AUA classification)

· Treatment of the precocious puberty (before 8 years at the girl, before 10 years at the boy).

· Treatment of genital and extragenital endometriosis (stage I to stage IV).

Clinical experience with the treatment of endometriosis is limited to women aged 18 and over.

Duration of treatment: see section Posology and method of administration .

· Treatment of hormone-dependent metastatic breast cancer in pre-menopausal women when suppression of ovarian function is required.

· 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 ENANTONE LP 3.75 mg Powder and solvent for suspension for injection for prolonged release Box of 1 vial of powder + device + ampoule of solvent of 2 ml

Prostate cancer

A subcutaneous injection that will be repeated every four weeks.

In the indication "Concomitant treatment and adjuvant to external radiotherapy in locally advanced prostate cancer (stage T3-T4 of the TNM classification or stage C of the AUA classification)", it is recommended to continue the treatment for 3 years .

Early puberty

A subcutaneous injection that will be repeated every four weeks (for children weighing less than 20 kg, the dose administered will be only 1.88 mg, ie half the volume of the suspension reconstituted from microcapsules contained in a flask and the 2 ml of solvent).

endometriosis

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

A subcutaneous or intramuscular injection that will be repeated every four weeks.

Duration: endometriosis, whatever the stage, will be treated maximum during 6 months.

However, in cases associated with chronic pelvic symptomatology and in the absence of immediate desire for pregnancy, the duration of treatment may be extended to one year by combining ENANTONE with hormone replacement therapy ("add-back therapy") from 3rd month.

The approved treatment regimen is: ENANTONE in combination with micronized oral estradiol valerate 2 mg per day orally and promegestone 0.5 mg per day administered orally.

It is not desirable to take a second course of treatment with ENANTONE or another GnRH analogue.

Metastatic breast cancer

A subcutaneous or intramuscular injection that will be repeated every four weeks.

Preoperative treatment of uterine fibroids

A subcutaneous or intramuscular injection that will be repeated every four weeks.

Duration: the treatment will be limited to 3 months.

Against indications

Hypersensitivity to GnRH, GnRH analogues or any of the ingredients.

· Genital haemorrhage of undetermined cause.

· In the case of endometriosis treatment with ENANTONE and hormone replacement therapy, the contraindications for the use of estroprogestratives should be respected.

Adverse effects Enantone LP

In all cases :

Altered mood, depression were frequently observed during long-term treatments and infrequently during short-term treatments

Local intolerance such as inflammatory reaction or subcutaneous nodule at the injection site has been reported, particularly in children where it may be important. It occurs in 4% of children (3-13% according to clinical studies). If this persists, treatment with ENANTONE LP 3.75 mg should be discontinued.

As with other GnRH agonists, very rare cases of pituitary apoplexy have been reported during the first administration in patients with pituitary adenoma.

Very rare cases of development of pituitary adenomas have been described during treatment with LH-RH agonists.

Very rare cases of anaphylactic reactions have been reported (urticaria, angioedema and exceptionally anaphylactic shock) in both adults and children treated with leuprorelin.

Prostate cancer:

Adverse reactions reported with a frequency greater than or equal to 0.5% in patients receiving leuprorelin are listed below according to the MedDRA classification (by organ class and absolute frequency). Frequencies are defined as follows: very common (> 1/10), common (> 1/100, 1/1000, 1/10 000, <1/1000), very rare (<10 000), isolated cases, not known (can not be estimated from the available data).

investigations:

Very common: weight gain.

Frequent: increase of alanine aminotransferase, increase of gamma glutamyl transferase, increase of lactico dehydrogenase.

Uncommon: increased alkaline phosphatase.

Hematological and lymphatic system disorders:

Frequent: anemia.

Nervous system disorders:

Frequent: headache.

Uncommon: dizziness, paresthesia.

Respiratory, thoracic and mediastinal disorders:

Common: dyspnoea

Gastrointestinal disorders:

Common: nausea, constipation

Uncommon: vomiting, diarrhea.

Renal and urinary disorders:

Very common: nocturia, dysuria.

Frequency: pollakiuria, hematuria.

Skin and subcutaneous tissue disorders:

Very common: sweating.

Frequency: pruritus.

Uncommon: eruption.

Musculoskeletal and systemic disorders:

Very common: bone pain, muscle weakness.

Common: back pain, arthralgia

Uncommon: myalgia, pain of the extremities.

Metabolism and nutrition disorders:

Frequent: anorexia, decreased appetite.

Infections and infestations:

Common: urinary tract infection

Vascular disorders:

Very common: hot flashes.

Common: lymphedema

General disorders and administration site defects:

Very common: tiredness.

Common: injection site reaction, pain, peripheral edema, injection site pain.

Uncommon: chest pain, asthenia, edema at the injection site.

Hepatobiliary disorders:

Common: abnormal liver function

Reproductive and breast disorders:

Very common: impotence, testicular atrophy, testicular disorder.

Frequent: Gynecomastia.

Psychiatric disorders:

Very common: decreased libido.

Common: Altered mood , depression, long-term treatment, sleep disorder.

Start treatment (see Warnings): it is sometimes accompanied by an accentuation of clinical signs and symptoms (especially bone pain).

Some cases of worsening of pre-existing hematuria or urinary obstruction, sensations of weakness or paresthesia of the lower extremities have been reported with GnRH analogues.

These manifestations are usually transient, disappearing in 1 to 2 weeks when continuing treatment. Nevertheless, the possibility of a temporary exacerbation of symptoms during the first weeks of treatment should be taken into account in patients threatened by the occurrence of neurological disorders or in those with urinary obstruction.

During treatment: The most common undesirable effects related to the pharmacological activity of the product are: hot flushes, sweating, impotence, decreased libido and decreased testicular size.

With other GnRH agonists, other undesirable effects have been observed: fever (around 3 to 4%), palpitations, visual disturbances, hair loss, changes in glucose tolerance, leukopenia and thrombocytopenia (less than 1%).

Variations in bone density:

A decrease in bone density has been reported in the medical literature in men who have had an orchiectomy or who have been treated with a GnRH agonist. It is likely that long-term treatment with leuprorelin reveals signs of worsening osteoporosis, with regard to increased risk of osteoporotic fracture.

Endometriosis and preoperative treatment of uterine fibroids:

Adverse reactions reported with a frequency greater than or equal to 0.5% in patients receiving leuprorelin are listed below according to the MedDRA classification (by organ class and absolute frequency). Frequencies are defined as follows: very common (> 1/10), frequent (> 1/100, 1/1000, 1/10 000, <1/1000), very rare (<1 / 10, 000), isolated cases, unknown (can not be estimated from the available data).

Investigations:

Frequent: weight gain, weight loss.

Uncommon: increased alanine aminotransferase, increased lactic dehydrogenase, increased blood phosphorus, increased triglycerides.

Heart conditions:

Uncommon: palpitation.

Nervous system disorders:

Very common: headache.

Common: dizziness, paresthesia, hypertonia

Uncommon: hypoaesthesia.

Eye disorders:

Uncommon: visual disturbance, amblyopia

Gastrointestinal disorders:

Common: nausea, abdominal pain, constipation

Uncommon: flatulence, dry mouth, vomiting, diarrhea.

Renal and urinary disorders:

Uncommon: dysuria.

Skin and subcutaneous tissue disorders:

Frequent: sweating, acne, rash, dry skin.

Uncommon: seborrhea, alopecia, hair disorder, bruising.

Musculoskeletal and systemic disorders:

Common: arthralgia, stiffness of the shoulders, back pain.

Uncommon: neck pain, myalgia, stiff neck, arthropathy

Metabolism and nutrition disorders:

Uncommon: hypercholesterolemia, anorexia.

Vascular disorders:

Very common: hot flashes.

General disorders and administration site defects:

Frequent: asthenia, pain, peripheral edema, injection site pain, injection site induration, chest pain.

Uncommon: chills, fatigue, redness at the injection site.

Reproductive and breast disorders:

Very common: vaginitis.

Frequent: vaginal dryness, breast pain.

Uncommon: pelvic pain, breast atrophy, leucorrhea.

Psychiatric disorders:

Very common: sleep disorder.

Common: Altered mood, depression, long-term treatment, emotional instability,

decreased libido, nervousness.

Uncommon: anxiety, confusion

Adverse reactions related to the mode of action of the product and induced hypoestrogenesis are: hot flushes, headache, changes in libido, vaginal dryness, dyspareunia, mood disorders, asthenia (these manifestations are generally well tolerated and rarely lead to discontinuation of treatment), myalgia, decreased breast volume, changes in bone density (prolonged use leads to a decrease in bone density, a risk factor for possible osteoporosis).

As part of a treatment of endometriosis combining ENANTONE with hormone replacement therapy ("add-back therapy"), there are also metrorrhagia.

Metastatic breast cancer:

Adverse reactions reported with a frequency greater than or equal to 0.5% in patients receiving leuprorelin are listed below according to the MedDRA classification (by organ class and absolute frequency). Frequencies are defined as follows: very common (> 1/10), common (> 1/100, 1/1000, 1/10 000, <1/1000), very rare (<10 000), isolated cases, not known, can not be estimated from the available data).

investigations:

Frequent: weight gain

Nervous system disorders:

Very common: headache.

Common: dizziness

Gastrointestinal disorders:

Very common: nausea.

Skin and subcutaneous tissue disorders:

Very common: sweats.

Musculoskeletal and systemic disorders:

Very common: bone pain.

Frequent: stiffness of the shoulders, lumbar pain.

Vascular disorders:

Very common: hot flashes.

General disorders and administration site defects:

Very common: tiredness.

Frequent: pain, reaction at the injection site.

Reproductive and breast disorders:

Very common: metrorrhagia.

Psychiatric disorders:

Very common: decreased libido.

Common: Altered mood, depression, long-term treatment, insomnia.

The most common adverse effects are related to the pharmacological activity of the product: notably hot flushes and sweat attacks.

Rarely, as with other GnRH agonists, hypercalcemia may occur at treatment initiation in patients with bone metastases.

Early puberty :

Adverse reactions reported with a frequency greater than or equal to 0.5% in patients receiving leuprorelin are listed below according to the MedDRA classification (by organ class and absolute frequency). Frequencies are defined as follows: very common (> 1/10), common (> 1/100, 1/1000, 1/10 000, <1/1000), very rare (<10 000), isolated cases, not known, can not be estimated from the available data).

Nervous system disorders:

Frequent: headache.

Gastrointestinal disorders:

Common: abdominal pain

Uncommon: vomiting.

Skin and subcutaneous tissue disorders:

Frequent: acne.

Uncommon: eruption.

Vascular disorders:

Frequent: hot flashes

General disorders and administration site defects:

Common: injection site reaction, injection site inflammation, injection site pain.

Uncommon: induration at the injection site.

Reproductive and breast disorders:

Frequent: vaginitis, metrorrhagia.

Uncommon: leucorrhea

Psychiatric disorders:

Frequent: emotional instability, mood impairment, depression during long-term treatment.

The possible occurrence of small haemorrhages after the first injection in girls justifies the addition of a treatment brake if they continue beyond the first month of treatment.

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