Medicinal Products

ENANTONE LP 3.75 mg Powder and solvent for injectable suspension LP (IM or SC) Box of 1 vial of powder + 2 ml solvent ampoule

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

Powder and solvent for injectable suspension for sustained release
All forms

Indication

- Treatment of prostate cancer with metastases.
- 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 dosage and method of administration.
- Treatment of hormone-dependent metastatic breast cancer in premenopausal women when suppression of ovarian function is necessary.
- Preoperative treatment of uterine fibroids:
. associated with anemia (with a hemoglobin level less than or equal to 8 g / dl),
. in the case where a reduction of 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 injectable suspension LP (IM or SC) Box of 1 vial of powder + ampoule of solvent of 2 ml

- Prostate cancer :
A subcutaneous injection that will be repeated every four weeks.
- 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 or half the volume of the suspension reconstituted from microcapsules contained in a vial and 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 can 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 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 constituents.
- Genital haemorrhage of undetermined cause.
- In the case of endometriosis treatment combining Enantone and hormone replacement therapy, the contraindications for the use of estrogen / progestin should be respected.
- Pregnancy: in animals, the studies carried out did not reveal any teratogenic effect. In the absence of teratogenic effect in animals, a malformative effect in the human species is not expected. Indeed, to date, the substances responsible for malformations in the human species have proved teratogenic in animals in well conducted studies on two species. Clinically, the inadvertent use of GnRH analogues in limited numbers of exposed pregnancies has not revealed any particular malformative or foetotoxic effect to date. However, further studies are needed to verify the consequences of exposure during pregnancy.
- Breast-feeding: In the absence of data regarding the passage of this drug in the milk and the possible effects on the breastfed child, Enantone should not be used when breastfeeding.

Adverse effects Enantone LP

- In all cases :
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.
- Prostate cancer :
. 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, 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 side effects are hot flushes. Also noted were impotence, decreased testicular size, nausea, vomiting, limb edema, generalized pain.
. With other GnRH agonists other adverse effects have been observed: fever, nausea, vomiting, skin rash, itching (on the order of 3 to 4 percent), weakness of the lower limbs, vertigo and dyspnea (less 2 percent); headache, palpitations, diarrhea, constipation, vision problems, depression, anorexia, night sweats, cold sweats, hair loss, drowsiness (less than 1 percent).
- Early puberty :
The possible occurrence of small haemorrhages after the first injection in girls justifies the addition of a treatment braking if they continue beyond the first month of treatment.
- Endometriosis and pre-operative treatment of uterine fibroids:
Adverse reactions related to the mode of action of the product and hypo-estrogen-induced 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 hormone replacement therapy ("add-back therapy"), there are also metrorrhagia.
- Metastatic breast cancer:
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.

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