Luprolex Adverse Reactions

Post-marketing Experience: The following adverse reactions have been identified during post approval use of leuprorelin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
During post-marketing surveillance, the following adverse events were reported. Like other drugs in this class, mood swings, including depression, have been reported. There have been rare reports of suicidal ideation and attempt. Many, but not all, of these patients had a history of depression or other psychiatric illness. Patients should be counselled on the possibility of development or worsening of depression during treatment with leuprorelin.
Symptoms consistent with an anaphylactoid or asthmatic process have been rarely reported. Rash, urticaria and photosensitivity reactions have also been reported.
Localized reactions including induration and abscess have been reported at the site of injection.
Symptoms consistent with fibromyalgia (eg. joint and muscle pain, headaches, sleep disorders, gastrointestinal distress, and shortness of breath) have been reported individually and collectively.
Other events reported are: Gastrointestinal Disorders: Abdominal pain.
General Disorders and Administration Site Conditions: Chest pain.
Respiratory, thoracic and mediastinal disorder: Interstitial lung disease.
Hepato-biliary disorder: Rarely reported serious liver injury.
Injury, poisoning and procedural complications: Spinal fracture.
Investigations: Decreased white blood cells (WBC), weight increased.
Metabolism and Nutrition Disorders: Diabetes mellitus.
Musculoskeletal and Connective tissue disorder: Tenosynovitis-like symptoms, severe muscle pain.
Nervous System Disorder: Convulsions, peripheral neuropathy, paralysis.
Vascular Disorder: Hypertension, hypotension.
Cases of serious venous and arterial thromboembolism have been reported, including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke and transient ischemic attack.
Although a temporal relationship was reported in some cases, most cases were confounded by risk factors or concomitant medication use. It is unknown if there is a causal association between the use of GnRH analogs and these events.
Pituitary Apoplexy: During post-marketing surveillance, rare cases of pituitary apoplexy (a clinical syndrome secondary to infarction of the pituitary gland) have been reported after the administration of gonadotropin-releasing hormone agonists. In a majority of these cases, a pituitary adenoma was diagnosed, with a majority of pituitary apoplexy cases occurring within 2 weeks of the first dose, and some within the first hour. In these cases, pituitary apoplexy has presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status and sometimes, cardiovascular collapse. Immediate medical attention has been required.
General: Endometriosis, Uterine fibroids, Premenopausal Breast Cancer (for 3.75 mg and 11.25 mg): Hypoestrogenism-related symptoms: Skin & appendages disorder: Hair loss.
Musculo-skeletal system disorder: Arthralgia, myalgia, decreased bone mass.
Central & peripheral nervous system disorders: Headache, Dizziness and Paresthesia.
Autonomic nervous system disorder: Increased sweating.
Vision disorder: Visual disturbance.
Psychiatric disorders: Decreased libido, emotional lability, depression and sleep disorders.
Reproductive disorders, Female: Breast size decrease, dry vagina/vaginitis.
Body as a whole: General disorders: Hot flushes, edema and weight changes.
Hypersensitivity: Anaphylactic reaction, rash and pruritus.
Gastrointestinal: Nausea, Vomiting and Anorexia.
Liver: Abnormal liver function test values, usually transient.
Administration site: Injection site reactions.
Prostate Cancer (3.75 mg and 11.25 mg): Flare phenomenon: Bone pain, urinary tract obstruction and hematuria (as urinary symptoms), Weakness of lower extremity/paresthesia (as neurologic symptoms).
Hypersensitivity: Anaphylactic reaction, rash and pruritus.
Endocrine: Hot flushes, diaphoresis, decreased libido, impotence, orchiatrophy and gynecomastia.
Gastrointestinal: Nausea, vomiting, anorexia and diarrhea.
Musculo-skeletal system disorder: Decreased bone mass.
Liver: Abnormal liver function test values, usually transient.
Administration site: Injection site reaction.
Others: Headache, edema, dizziness and depression.
Cardiovascular: QT prolongation.
Central Precocious Puberty: In children: In the initial phase of therapy, a short-term increase as flare-up of the sex hormone level occurs, followed by a decrease to values within the pre-pubertal range. Due to pharmacological effect, adverse events may occur particularly at the beginning of treatment.
Immune system disorders: general allergic reactions (fever, rash, e.g. itching, anaphylactic reactions).
Psychiatric disorders: emotional lability (e.g. crying, irritability, impatience, anger, and aggression).
Nervous system disorders: headache, pituitary haemorrhage following initial administration in patients with pituitary adenoma, seizure, Pseudotumor cerebri/idiopathic intracranial hypertension.
Gastrointestinal disorders: abdominal pain/abdominal cramps, nausea/vomiting.
Skin and subcutaneous tissue disorders: acne.
Musculoskeletal and connective tissue disorders: myalgia.
Reproductive system and breast disorders: vaginal bleeding, spotting, discharge.
General disorders and administration site conditions: injection site reactions.
Note: In general, the occurrence of vaginal spotting with continued treatment (subsequent to possible withdrawal bleeding in the first month of treatment) should be assessed as a sign of potential underdosage. The pituitary suppression should then be determined by an LHRH test.