Fensolvi Generic Name & Formulations
Leuprolide acetate 45mg; per kit; lyophilized pwd for SC inj after reconstitution.
Kit—1 (Syringe A: prefilled w. diluent + Syringe B: prefilled w. lyophilized pwd + safety needle)
Central precocious puberty.
Fensolvi Dosage and Administration
<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 Boxed Warnings
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.
Caution with concomitant drugs that are associated with convulsions (eg, bupropion, SSRIs).
Fensolvi 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
Fensolvi Patient Counseling