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The following indications for VABRINTY (leuprolide acetate) have been approved by the FDA:
Indications:
Advanced prostatic carcinoma
Professional Synonyms:
Advanced cancer of prostate gland
Advanced malignant neoplasm of prostate
Advanced prostate cancer
Advanced prostate malignancy
Advanced prostatic cancer
Indications:
Advanced prostatic carcinoma
Professional Synonyms:
Advanced cancer of prostate gland
Advanced malignant neoplasm of prostate
Advanced prostate cancer
Advanced prostate malignancy
Advanced prostatic cancer
The following dosing information is available for VABRINTY (leuprolide acetate):
No enhanced Dosing information available for this drug.
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.
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.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| VABRINTY 22.5 MG SYRINGE KIT | Maintenance | Adults inject 22.5 mg by subcutaneous route every 3 months |
| VABRINTY 30 MG SYRINGE KIT | Maintenance | Adults inject 30 mg by subcutaneous route every 4 months |
| VABRINTY 45 MG SYRINGE KIT | Maintenance | Adults inject 45 mg by subcutaneous route every 6 months |
No generic dosing information available.
The following drug interaction information is available for VABRINTY (leuprolide acetate):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for VABRINTY (leuprolide acetate):
Drug contraindication overview.
*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.
*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.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Pregnancy |
There are 7 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 |
| Prolonged QT interval |
There are 10 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Diabetes mellitus |
| Disease of liver |
| Hypercholesterolemia |
| Hypertension |
| Obesity |
| Osteopenia |
| Seizure disorder |
| Tobacco smoker |
| Urinary tract obstruction |
| Vertebral metastases |
The following adverse reaction information is available for VABRINTY (leuprolide acetate):
Adverse reaction overview.
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.
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.
There are 47 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Infection |
| 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 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 ideation Toxic epidermal necrolysis Transient cerebral ischemia |
There are 74 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 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/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 |
The following precautions are available for VABRINTY (leuprolide acetate):
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.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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.
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.
The following prioritized warning is available for VABRINTY (leuprolide acetate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for VABRINTY (leuprolide acetate)'s list of indications:
| Advanced prostatic carcinoma | |
| C61 | Malignant neoplasm of prostate |
Formulary Reference Tool