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Drug overview for FENSOLVI (leuprolide acetate):
Generic name: leuprolide acetate (LOO-proe-lide)
Drug class: LHrH(GNrH) Agonist Analog Pituitary Suppressants
Therapeutic class: Endocrine
Leuprolide, a synthetic nonapeptide analog of naturally occurring porcine or ovine gonadotropin-releasing hormone (GnRH, luteinizing hormone-releasing hormone, gonadorelin), is used as an antineoplastic agent and for its endocrine effects.
No enhanced Uses information available for this drug.
Generic name: leuprolide acetate (LOO-proe-lide)
Drug class: LHrH(GNrH) Agonist Analog Pituitary Suppressants
Therapeutic class: Endocrine
Leuprolide, a synthetic nonapeptide analog of naturally occurring porcine or ovine gonadotropin-releasing hormone (GnRH, luteinizing hormone-releasing hormone, gonadorelin), is used as an antineoplastic agent and for its endocrine effects.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for FENSOLVI (leuprolide acetate) have been approved by the FDA:
Indications:
Precocious puberty
Professional Synonyms:
Accelerated sexual maturity
Indications:
Precocious puberty
Professional Synonyms:
Accelerated sexual maturity
The following dosing information is available for FENSOLVI (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.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for FENSOLVI (leuprolide acetate):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for FENSOLVI (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 3 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Lower seizure threshold |
| Osteopenia |
| Seizure disorder |
There are 3 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 |
| Hypercholesterolemia |
| Tobacco smoker |
The following adverse reaction information is available for FENSOLVI (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 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 |
The following precautions are available for FENSOLVI (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 FENSOLVI (leuprolide acetate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for FENSOLVI (leuprolide acetate)'s list of indications:
| Precocious puberty | |
| E30.1 | Precocious puberty |
Formulary Reference Tool