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 pre-filled syringe with 2 compartments of 1 mL
Treatment of locally advanced and advanced prostate cancer requiring androgen suppression, as a relay of another sustained release formulation of the GnRH agonist.
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).
Dosage ENANTONE LP 30 mg Powder and solvent for prolonged-release suspension for injection 1-ml pre-filled syringe with 2 compartments of 1 mL
A subcutaneous injection to be repeated every 6 months (26 weeks).
As with other subcutaneous specialties, the injection site must be modified periodically.
Duration of treatment :
The need to continue treatment with ENANTONE LP 30 mg will be assessed by the attending physician.
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 .
Measurement of testosterone should be performed at least every six months during treatment with ENANTONE LP 30 mg.
This drug should not be prescribed in case of hypersensitivity to GnRH, GnRH analogues or any of the components.
Adverse effects Enantone LP
They are partly due to the pharmacological activity of the product, ie hormonal deprivation. The frequency of observation of adverse events in clinical trials with ENANTONE LP 30 mg is defined as follows: very common (> 1/10), common (> 1/100, 1/1000, 1/10 000, < 1/1 000), very rare (<10 000)
Immune system disorders
Uncommon : generalized allergic reactions (fever, pruritus, eosinophilia and skin rash).
Metabolic and nutritional system disorders
Common : loss of appetite
Rare : change in glucose metabolism (decrease or increase).
Frequent : Mood swings, depression have been commonly observed during long-term treatment and infrequently during short-term treatment.
Nervous system disorders
Frequent : headache.
Rare : feeling of discomfort, transient alterations of taste.
Very rare : As with other GnRH agonists, cases of pituitary apoplexy have been reported after initial administration of leuprorelin in patients with pituitary adenoma.
Very common : hot flashes.
Rare : change in blood pressure (hypertension or hypotension).
Frequent : nausea.
Uncommon : diarrhea
Skin and subcutaneous tissue disorders
Uncommon : skin dryness or mucous membranes.
Rare : alopecia.
Bone disorders, musculoskeletal tissue
Very common : bone pain.
Common : joint pain, muscle weakness
Reproductive and breast system disorders
Very common : disorders of libido, impotence, reduction of the size of the testicles.
Frequent : Gynecomastia.
Uncommon : testicular pain.
Renal and urinary disorders
Very common : nocturia, dysuria.
General disorders and local conditions of administration
Very common : injection site reactions, including erythema, pain, edema, pruritus. These events usually decrease with continued treatment; isolated cases of abscess have been observed.
Very common : sweats.
Frequent : fatigue, peripheral edema, paresthesia, sleep disorders.
Very common : weight gain.
Uncommon : weight loss.
Alteration of biological parameters
Frequent : Cases of elevated blood levels of LDH, transaminases, gamma-GT and alkaline phosphatase have been noted that may be related to the underlying disease; decrease in blood hemoglobin level.