Eligard, lyophilizate 45 mg syringes 2 pcs

Hormone-dependent prostate cancer.

Active ingredient

Composition

1 syringe A contains:

the active ingredient:

no

excipients:

solvent consisting of:

–
–
217 mg

1 syringe B contains:
active ingredient: leuprorelin acetate*
7.5 mg dose: 10.6 mg
22.5 mg dose: 29.2 mg
45 mg dose: 59.2 mg
excipients: none

*The excess leuprorelin acetate compensates for losses in the syringe and needle. The reconstituted solution (administered dose) contains 7.5 mg, 22.5 mg or 45 mg of leuprorelin acetate.

How to take, the dosage

Interaction

Special Instructions

Contraindications

Side effects

Adverse events caused by taking Eligard are mainly due to the specific pharmacological action of leuprorelin, which causes increases and decreases in hormone levels. The most common side effects were “hot flashes”, malaise, nausea and weakness, and local irritation at the injection site. Mild to moderate “flushes” were observed in approximately 58% of patients.

The following adverse events have been reported during clinical trials of Eligard in patients with advanced prostate cancer. The frequency of adverse reactions listed below is stated according to the following grading: very common (>1/10), common (>1/100, <1/10); infrequent (>1/1000, <1/100); rare (>1/10000, <1/1000); very rare (<1/10000), unknown (cannot be estimated based on available data).

Table 1:

Unwanted events in clinical trials of Eligard

Infectious and parasitic diseases

Not known

very often

very often

often

infrequently

often

often

Reproductive and mammary system disorders

often

infrequent

Systemic disorders and complications at the site of administration

very common

often

malaise, pain at the injection site, bruising, burning, muscle stiffness, weakness

infrequent

itching at the injection site, lethargy, pain, pyrexia

rarely

Blood and lymphatic system disorders

hematologic changes (abnormal blood cell count, abnormal INR (international normalized ratio)

infrequent

increased alanine aminotransferase activity, hypertriglyceridemia, increased prothrombin time, weight gain

Other adverse events when taking leuprorelin acetate include: Peripheral edema, pulmonary embolism, palpitations, myalgia, muscle weakness, impaired skin sensitivity, chills, dizziness, pruritus, amnesia and visual disturbances. Rarely, cases of pituitary apoplexy-induced infarction have been reported after taking short- and long-acting GnRH antagonists. Cases of thrombocytopenia and leukopenia and changes in glucose tolerance have also been reported.

The local reactions after administration of the drug Eligard are the same as those of subcutaneous administration of other drugs.

In general, local reactions after administration of the drug are moderate and short-lived.

Changes in bone density

Publications have noted decreased bone density in men after orchiectomy or GnRH analogue therapy. It can be assumed that long-term leuprorelin therapy leads to increased symptoms of osteoporosis, which increases the risk of fractures.

Worsening of symptoms and signs of disease

The therapy with leuprorelin acetate may lead to worsening of disease symptoms during the first weeks of treatment. In diseases with spinal metastases and/or urinary tract obstruction or hematuria, neurological complications such as weakness and/or paresthesias of the lower extremities or worsening symptoms of urinary dysfunction may occur.

Overdose