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FENSOLVI (leuprolide acetate)
- puberty at an earlier age than would be expected
45 mg subcutaneous syringe
- Dosage information is not available
- None
Contraindicated
- None
Severe
Moderate
- None
- Pregnancy
Contraindicated
- Lower seizure threshold
- Osteopenia
- Seizure disorder
Severe
Moderate
- Alcohol use disorder
- Hypercholesterolemia
- Tobacco smoker
FENSOLVI (leuprolide acetate)
- puberty at an earlier age than would be expected
- None
- 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
More Frequent
Severe
Less Severe
- Arthralgia
- Female hirsutism
- Infection
- Myalgia
- Tumor flare reaction
- Acne vulgaris
- Constipation
- Erectile dysfunction
- General weakness
- Gynecomastia
- Injection site sequelae
- Insomnia
- Libido changes
- Mastalgia
- Mood changes
- Nervousness
- Paresthesia
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Abnormal hepatic function tests
- Acute myocardial infarction
- Anaphylaxis
- Angina
- Asthma
- Cellulitis
- Cerebrovascular accident
- Chronic heart failure
- Diabetes mellitus
- Drug-induced hepatitis
- Epididymitis
- Fracture
- Granulocytopenic disorder
- Hemoptysis
- Hepatocellular damage
- Hepatomegaly
- Hypertension
- Hypotension
- Idiopathic intracranial hypertension
- Injection site infection
- Interstitial lung disease
- Leukopenia
- Lymphadenopathy
- Ophthalmoplegia
- Osteopenia
- Paralysis
- Peptic ulcer
- Pituitary apoplexy
- Prolonged QT interval
- Pulmonary edema
- Pulmonary emphysema
- Pulmonary thromboembolism
- Pyelonephritis
- Seizure disorder
- Skin rash
- Suicidal ideation
- Syncope
- Transient cerebral ischemia
- Urticaria
- Visual changes
Less Severe
- Aggressive behavior
- Agitation
- Alopecia
- Anorexia
- Balanitis
- Deep venous thrombosis
- Dysphagia
- Dyspnea
- Ecchymosis
- Epistaxis
- Eructation
- Fever
- Glossitis
- Hyperglycemia
- Hyperkinesis
- Hypoesthesia
- Induration of skin
- Irritability
- Lethargy
- Melanosis
- Muscle atrophy
- Peripheral neuropathy
- Pharyngitis
- Skin hypertrophy
- Skin photosensitivity
- Tenosynovitis
- Testicular pain
- Urinary incontinence
- Urinary tract infection
Contraindicated
None
Severe Precaution
Leuprolide (45 mg preco. puberty)
For precocious puberty: not indicated age < 1 year.
For precocious puberty: not indicated > age 12 years. Reports of psychiatric symptoms and convulsions, post-marketing reports of pseudotumor cerebri (PTC)/idiopathic intracranial hypertension: monitor for development or worsening psychiatric symptoms including emotional lability, crying, irritability, anger, for signs or symptoms of seizure activity, and for headache, papilledema, vision changes, tinnitus, dizziness, and nausea.
- 1 Day – 364 Days
- For precocious puberty: not indicated age < 1 year.
- 12 Years – 18 Years
- For precocious puberty: not indicated age < 1 year.
Leuprolide (precocious puberty)
For precocious puberty: not indicated age < 1 year.
For precocious puberty: not indicated > age 12 years. Reports of psychiatric symptoms and convulsions, post-marketing reports of pseudotumor cerebri (PTC)/idiopathic intracranial hypertension: monitor for development or worsening psychiatric symptoms including emotional lability, crying, irritability, anger, for signs or symptoms of seizure activity, and for headache, papilledema, vision changes, tinnitus, dizziness, and nausea.
- 1 Day – 364 Days
- For precocious puberty: not indicated > age 12 years. Reports of psychiatric symptoms and convulsions, post-marketing reports of pseudotumor cerebri (PTC)/idiopathic intracranial hypertension: monitor for development or worsening psychiatric symptoms including emotional lability, crying, irritability, anger, for signs or symptoms of seizure activity, and for headache, papilledema, vision changes, tinnitus, dizziness, and nausea.
- 12 Years – 18 Years
- For precocious puberty: not indicated > age 12 years. Reports of psychiatric symptoms and convulsions, post-marketing reports of pseudotumor cerebri (PTC)/idiopathic intracranial hypertension: monitor for development or worsening psychiatric symptoms including emotional lability, crying, irritability, anger, for signs or symptoms of seizure activity, and for headache, papilledema, vision changes, tinnitus, dizziness, and nausea.
Management or Monitoring Precaution
Leuprolide (45mg precoc, puberty)
Reports of psychiatric symptoms and convulsions, post-marketing reports of pseudotumor cerebri/ idiopathic intracranial hypertension: monitor for development or worsening psychiatric symptoms including emotional lability, crying, irritability, anger, for signs or symptoms of seizure activity, and for headache, papilledema, vision changes, tinnitus, dizziness, and nausea.
- 1 Years – 12 Years
- Reports of psychiatric symptoms and convulsions, post-marketing reports of pseudotumor cerebri/ idiopathic intracranial hypertension: monitor for development or worsening psychiatric symptoms including emotional lability, crying, irritability, anger, for signs or symptoms of seizure activity, and for headache, papilledema, vision changes, tinnitus, dizziness, and nausea.
Leuprolide
- Severity Level:
1
- Additional Notes: Based on drug pharmacology developmental toxicity is possible.
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Leuprolide
Insufficient human data available
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Insufficient human data available |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- None
| Precocious puberty | |
| E30.1 | Precocious puberty |
| 0-9 | A-Z |
|---|---|
| E30.1 | Precocious puberty |
Formulary Reference Tool