Lupron Depot (leuprolide acetate)

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Leuprolide acetate is administered by subcutaneous or IM injection depending on the formulation and indication. Leuprolide acetate depot suspension (e.g., LupronDepot(R), LupronDepot-Ped(R)) is administered by IM injection. Leuprolide acetate injectable suspension (Eligard(R), Fensolvi(R)) and leuprolide acetate injection are administered by subcutaneous injection.

Leuprolide mesylate emulsion (Camcevi(R)) is administered by subcutaneous injection.

Extended-release or depot formulations of leuprolide have different release characteristics. Do not use partial syringes, a combination of syringes, or substitute other extended-release products to achieve a particular dose.

Some formulations of leuprolide are not intended for self-administration and should be administered by a healthcare professional only (e.g., Camcevi(R), Eligard(R), Fensolvi(R), Lupron(R), Lupron Depot-Ped(R)); consult the manufacturer's prescribing information for details.

Store leuprolide acetate injection at a temperature of less than 25degreesC in carton until time of use and protect from light; avoid freezing.

Store leuprolide acetate powder for injectable suspension (Lupron Depot(R), Lupron Depot-Ped(R)) and its diluent at a controlled room temperature of 25degreesC; excursions permitted to temperatures ranging from 15-30degreesC. It is not necessary to store the drug or its diluent under refrigeration;avoid freezing.

Store leuprolide acetate injectable suspension (Eligard(R) and Fensolvi(R)) at 2-8degreesC. Once outside the refrigerator,Eligard(R) and Fensolvi(R) may both be stored at 15-30degreesC in their original packaging for up to 8 weeks prior to reconstitution and administration.

Store leuprolide mesylate injectable emlusion (Camcevi(R)) at 2-8degreesC in carton until time of use and protect from light; do not freeze or shake.

No dosing information is available for this tab.

No formal drug interaction studies have been performed to date with leuprolide.

Metabolism of leuprolide does not involve cytochrome P-450 (CYP) isoenzymes; pharmacokinetic interactionsassociated with CYP isoenzymesare therefore unlikely to occurwith leuprolide.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Known hypersensitivity to gonadotropin-releasing hormone (GnRH), GnRH analogs, or any ingredient in the respective leuprolide formulation.

*Pregnancy.

*Women with abnormal vaginal bleeding of unknown etiology.

• Pregnancy

• Atherosclerotic cardiovascular disease
• Cerebrovascular accident
• Chronic heart failure
• Congenital long QT syndrome
• Hypokalemia
• Hypomagnesemia
• Lower seizure threshold
• Osteopenia
• Prolonged QT interval
• Seizure disorder

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

Common adverse reactions occurring in >10% of males receiving leuprolide for the treatment of prostate cancer include hot flashes/sweats, general pain, hypertension, testicular atrophy, injection site reaction, GI disorders, joint disorders, musculoskeletal pain, urinary disorder, and lethargy/fatigue.

Common adverse reactions occurring in >10% of females receiving leuprolide for the treatment of endometriosis and uterine leiomyomata include hot flashes/sweats, headache, vaginitis, depression/emotional lability, general pain, asthenia, weight gain/loss, nausea/vomiting, decreased libido, dizziness, constipation, diarrhea, acne, and skin reactions.

Common adverse reactions occurring in >=10% or more of pediatric patients receiving leuprolide for the treatment of centralprecocious pubertyinclude injection site reactions (includingpain), nasopharyngitis, pyrexia, headache, psychiatric events,and cough.

Less Frequent

• Infection

Rare or 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
• Deep venous thrombosis
• 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
• Injection site necrosis
• Interstitial lung disease
• Leukopenia
• Lymphadenopathy
• Neutropenic disorder
• Ophthalmoplegia
• Paralysis
• Pituitary apoplexy
• Pulmonary edema
• Pulmonary emphysema
• Pulmonary thromboembolism
• Pyelonephritis
• Seizure disorder
• Steatosis of liver
• Stevens-johnson syndrome
• Suicidal
• Suicidal ideation
• Toxic epidermal necrolysis
• Transient cerebral ischemia

More 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

Less Frequent

• Acne vulgaris
• Arthralgia
• Constipation
• Erectile dysfunction
• Female hirsutism
• General weakness
• Gynecomastia
• Hypercholesterolemia
• Hypersensitivity drug reaction
• Hypertriglyceridemia
• Injection site sequelae
• Insomnia
• Libido changes
• Mastalgia
• Mood changes
• Myalgia
• Nervousness
• Paresthesia
• Tumor flare reaction

Rare or Very Rare

• Aggressive behavior
• Agitation
• Alopecia
• Anorexia
• Balanitis
• Dysphagia
• Dyspnea
• Ecchymosis
• Epistaxis
• Eructation
• Fever
• Glossitis
• Hostility
• Hyperglycemia
• Hyperkinesis
• Hypoesthesia
• Induration of skin
• Injection site abscess
• Irritability
• Lethargy
• Melanosis
• Muscle atrophy
• Non-cardiac chest pain
• Osteopenia
• Peptic ulcer
• Peripheral neuropathy
• Pharyngitis
• Skin hypertrophy
• Skin photosensitivity
• Skin rash
• Syncope
• Tenosynovitis
• Testicular pain
• Urinary incontinence
• Urinary tract infection
• Urticaria

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Safety and effectiveness of leuprolide acetate depot suspension for treatment of central precocious puberty (Lupron Depot-Ped(R)) have been established in pediatric patients >=1 year of age. Safety and effectiveness of leuprolide acetate forinjectable suspension for treatment of central precocious puberty (Fensolvi(R)) have been established in pediatric patients >=2 years of age.

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.