LUPRON DEPOT (leuprolide acetate)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Pregnancy

There are 10 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Acute myocardial infarction
Cerebrovascular accident
Chronic heart failure
Congenital long QT syndrome
Hypokalemia
Hypomagnesemia
Lower seizure threshold
Osteopenia
Prolonged QT interval
Seizure disorder

There are 11 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Alcohol use disorder
Diabetes mellitus
Disease of liver
Hypercholesterolemia
Hypertension
Obesity
Osteopenia
Seizure disorder
Tobacco smoker
Urinary tract obstruction
Vertebral metastases

There are 54 severe adverse reactions.

More Frequent	Less Frequent
None.	Arthralgia Female hirsutism Infection Myalgia Tumor flare reaction

Rare/Very Rare

Abnormal hepatic function tests Acute generalized exanthematous pustulosis Acute myocardial infarction Anaphylaxis Anemia Angina Asthma Bullous dermatitis Cellulitis Cerebrovascular accident Chronic heart failure Diabetes mellitus DRESS syndrome Drug-induced hepatitis Epididymitis Erythema multiforme Exfoliative dermatitis Fracture Granulocytopenic disorder Hemoptysis Hepatocellular damage Hepatomegaly Hypertension Hypogonadotropic hypogonadism Hypotension Idiopathic intracranial hypertension Injection site infection Interstitial lung disease Leukopenia Lymphadenopathy Neutropenic disorder Ophthalmoplegia Osteopenia Paralysis Peptic ulcer Pituitary apoplexy Pulmonary edema Pulmonary emphysema Pulmonary thromboembolism Pyelonephritis Seizure disorder Skin rash Steatosis of liver Stevens-johnson syndrome Suicidal ideation Syncope Toxic epidermal necrolysis Transient cerebral ischemia Urticaria

There are 65 less severe adverse reactions.

More Frequent	Less Frequent
Abnormal vaginal bleeding Amenorrhea Depression Dizziness Drug-induced hot flash Dyspepsia Edema Fatigue Headache disorder Hyperhidrosis Malaise Nausea Pain Stinging of skin Testicular atrophy Upper respiratory infection Vaginitis Vomiting Weight gain	Acne vulgaris Constipation Erectile dysfunction General weakness Gynecomastia Hypercholesterolemia Hypersensitivity drug reaction Hypertriglyceridemia Injection site sequelae Insomnia Libido changes Mastalgia Mood changes Nervousness Paresthesia

Rare/Very Rare

Aggressive behavior Agitation Alopecia Anorexia Balanitis Deep venous thrombosis Dysphagia Dyspnea Ecchymosis Epistaxis Eructation Fever Glossitis Hostility Hyperglycemia Hyperkinesis Hypoesthesia Induration of skin Irritability Lethargy Melanosis Muscle atrophy Non-cardiac chest pain Peripheral neuropathy Pharyngitis Skin hypertrophy Skin photosensitivity Tenosynovitis Testicular pain Urinary incontinence Urinary tract infection

Leuprolide acetate injection may cause fetal harm when administered to a pregnant female based on findings from animal studies and the drug's mechanism of action. Discontinue leuprolide if pregnancy occurs during treatment and inform patients of potential risk to the fetus. Leuprolide is contraindicated in pregnant females.

Based on animal reproduction studies, leuprolide may be associated with an increased risk of pregnancy complications, including early pregnancy loss and fetal harm. In animal reproduction studies, subcutaneous administration of leuprolide acetate to rabbits during the period of organogenesis caused embryofetal toxicity, decreased fetal weights, and a dose-dependent increase in major fetal abnormalities in animals at doses less than the recommended human dose based on body surface area using an estimated daily dose. Similarstudiesin ratsshowed increased fetal mortality and decreased fetal weights but no increase infetal malformations at doses less than the recommended human dose based on body surface area using an estimated daily dose.

There are no data on the presence of leuprolide in either animal or human milk, the effects on breastfed infants, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for leuprolide and any potential adverse effects on the breastfed infant from the drug or underlying maternal condition.

Safety and efficacy of leuprolide were established in older adult male patients for the treatment of prostate cancer; in clinical trials; 69-80% of patients were >=65 years of age. Leuprolide is not indicated in postmenopausal women and has not been studied in this population.