Medicinal Products

ELIGARD 75 mg

Generic drug of the therapeutic class: Oncology and Hematology
active ingredients: Leuprorelin
laboratory: Astellas Pharma Sas

Powder and solvent for solution for injection
750 mg powder syringe (+ solvent syringe)
All forms

Indication

ELIGARD 7.5 mg is indicated for the treatment of advanced hormone-dependent prostate cancer and in combination with radiation therapy for the treatment of locally-based, high-risk, locally advanced hormone-dependent prostate cancer.

Dosage ELIGARD 75 mg powder and solvent for solution for injection 750 mg powder syringe (+ solvent syringe)

ELIGARD 7.5 mg is indicated for the treatment of advanced hormone-dependent prostate cancer and in combination with radiation therapy for the treatment of locally-based, high-risk, locally advanced hormone-dependent prostate cancer.

Against indications

ELIGARD 7.5 mg is contraindicated in women and children.

Hypersensitivity to leuprorelin acetate, other GnRH agonists, or any of the excipients listed under Composition .

In patients who have previously undergone orchiectomy (as with other GnRH agonists, ELIGARD 7.5 mg does not result in an additional decrease in serum testosterone levels in the case of surgical castration).

ELIGARD 7.5 mg should not be used in monotherapy in patients with prostate cancer with spinal compression or vertebral metastases (see Warnings and Precautions ).

Eligard side effects

The adverse effects observed with ELIGARD are mainly due to the specific pharmacological action of leuprorelin, ie elevations and decreases in the levels of certain circulating hormones. The most commonly reported adverse reactions are hot flushes, malaise, nausea and fatigue, and transient local irritation at the injection site. Mild to moderate hot flashes occur in approximately 58% of patients.

Tabulated list of adverse effects

The following adverse reactions have been reported in clinical trials in patients with advanced prostate carcinoma treated with ELIGARD. Adverse reactions are classified by frequency: very common (≥1 / 10), common (≥1 / 100, <1/10), uncommon (≥1 / 1, 000, <1/100), rare (≥1) / 10, 000, <1/1000) and very rare (<1 / 10, 000), not known (can not be estimated from the available data).

Table 1: Undesirable effects in clinical studies with Eligard

Infections and infestations

Frequent

nasopharyngitis.

Rare

urinary tract infection, local skin infection.

Metabolism and nutrition disorders

Rare

severe diabetes.

Psychiatric disorders

Rare

nightmares, depression, decreased libido.

Nervous system disorders

Rare

dizziness, headache, hypoesthesia, insomnia, disturbances of taste

and smell.

Rare

abnormal and involuntary movements.

Heart conditions

Not known frequency

QT prolongation (see sections Warnings and precautions for use and Interactions with other medicinal products and other forms of interaction )

Vascular disorders

Very common

hot flashes.

Rare

hypertension, hypotension.

Rare

syncope, collapse.

Respiratory, thoracic and mediastinal disorders

Rare

rhinorrhea, dyspnea.

Gastrointestinal disorders

Frequent

nausea, diarrhea.

Rare

constipation, dry mouth, dyspepsia, vomiting.

Rare

flatulence, belching.

Skin and subcutaneous tissue disorders

Very common

bruises, erythema.

Frequent

pruritus, night sweating.

Rare

cold sweat, sweating.

Rare

alopecia, rash.

Musculoskeletal and systemic disorders

Frequent

arthralgia, limb pain, myalgia.

Rare

dorsalgia, muscle cramp.

Renal and urinary disorders

Frequent

decreased frequency of urination, difficult urination, dysuria, nocturia, oliguria.

Rare

bladder spasms, hematuria, aggravation of urinary frequency, urinary retention.

Disorders of reproductive organs and breast

Frequent

breast tenderness, testicular atrophy, testicular pain, infertility, breast hypertrophy.

Rare

gynecomastia, impotence, testicular disorders.

Rare

breast pain.

General disorders and administration site conditions

Very common

fatigue, burning at the injection site, paresthesia at the injection site.

Frequent

Malaise, pain at the injection site, hematoma at the injection site, tingling at the injection site, stiffness, weakness.

Rare

pruritus at the injection site, lethargy, pain, fever.

Rare

ulceration at the injection site.

Very rare

necrosis at the injection site.

Blood and lymphatic system disorders

Frequent

haematological disturbances.

investigations

Frequent

increased blood creatinine phosphokinase, prolonged clotting time.

Rare

increased alanine aminotransferase, increased blood triglycerides, increased prothrombin time, weight gain.

Other adverse events have generally been reported with leuprorelin acetate, including peripheral edema, pulmonary embolism, palpitations, myalgia, muscle hypotonia, impaired skin sensation, chills, vertigo peripheral origin, skin rash, amnesia and vision problems. Infarction of preexisting pituitary apoplexy has been rarely reported following immediate or prolonged GnRH agonist therapy. Rare cases of leukopenia and thrombocytopenia have been reported. Changes in glucose tolerance have been reported.

Local adverse events reported after injection of ELIGARD are similar to those associated with similar products injected subcutaneously.

Generally, these localized adverse events occurring after a subcutaneous injection are mild and described as being of short duration.

Variations in bone density

A decrease in bone density has been reported in the medical literature in men who have had an orchiectomy or those who have been treated with a GnRH agonist. Long-term treatment with leuprorelin may be indicative of worsening osteoporosis with respect to increased risk of osteoporotic fracture (see Warnings and Precautions section ).

Accentuation of the signs and symptoms of the disease

Treatment with leuprorelin acetate may increase the signs and symptoms of the disease during the first few weeks of treatment. Worsening of conditions such as vertebral metastases and / or urinary obstruction or hematuria may result in neurological problems such as weakness and / or paresthesia of the lower limbs or increased urinary symptoms.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

Popular Posts

Category Medicinal Products, Next Article