Medicinal Products

ENANTONE LP 30 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 pre-filled syringe with 2 compartments of 1 mL
All forms

Indication

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.

Against indications

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).

Psychiatric disorders

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.

Vascular disorders

Very common : hot flashes.

Rare : change in blood pressure (hypertension or hypotension).

Gastrointestinal disorders

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.

Other observations

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.

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