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Fensolvi Generic Name & Formulations
Legal Class
Rx
General Description
Leuprolide acetate 45mg; per kit; lyophilized pwd for SC inj after reconstitution.
Pharmacological Class
GnRH analogue.
How Supplied
Kit—1 (Syringe A: prefilled w. diluent + Syringe B: prefilled w. lyophilized pwd + safety needle)
Manufacturer
Generic Availability
NO
Fensolvi Indications
Indications
Central precocious puberty.
Fensolvi Dosage and Administration
Adult
Not applicable.
Children
<2yrs: not established. Give by SC inj on the abdomen, upper buttocks, or another location with adequate amounts of SC tissue; rotate inj sites. Avoid areas with brawny or fibrous tissue or locations that could be rubbed or compressed. ≥2yrs: 45mg once every 6 months. If inadequate response, consider alternative treatments.
Fensolvi Contraindications
Contraindications
Pregnancy.
Fensolvi Boxed Warnings
Not Applicable
Fensolvi Warnings/Precautions
Warnings/Precautions
Use aseptic technique. Must administer under physician supervision. Initial transient rise in gonadotropins and sex steroids may result in increased signs/symptoms of puberty. Monitor LH and sex steroid levels at 1–2 months after treatment initiation and as needed during treatment. Measure height every 3–6 months and monitor bone age periodically. Monitor for pseudotumor cerebri or psychiatric symptoms. History of seizures/epilepsy, cerebrovascular disorders, CNS anomalies or tumors: risk of convulsions. Exclude pregnancy prior to initiation. Advise females of reproductive potential to use non-hormonal method of contraception during treatment. Nursing mothers.
Fensolvi Pharmacokinetics
See Literature
Fensolvi Interactions
Interactions
Caution with concomitant drugs that are associated with convulsions (eg, bupropion, SSRIs).
Fensolvi Adverse Reactions
Adverse Reactions
Inj site pain, nasopharyngitis, pyrexia, headache, cough, abdominal pain, inj site erythema, nausea, constipation, vomiting, upper respiratory tract infection, bronchospasm, productive cough, hot flush.
Fensolvi Clinical Trials
See Literature
Fensolvi Note
Not Applicable
Fensolvi Patient Counseling
See Literature
