Important Safety Information

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FENSOLVI (leuprolide acetate) for injectable suspension is a gonadotropin releasing hormone (GnRH) agonist used to treat patients 2 years of age and older with central precocious puberty (CPP). CPP may be diagnosed when signs of sexual maturity begin to develop in girls under the age of 8 or boys under the age of 9.

FENSOLVI is contraindicated in individuals with hypersensitivity to any drug that is in the same class as FENSOLVI, or in individuals who are allergic to any of the ingredients in FENSOLVI.

During the first few weeks of treatment, increases in gonadotropins and sex steroids above baseline may result in an increase in signs and symptoms of puberty including vaginal bleeding in girls.

Psychiatric events have been reported in patients taking GnRH agonists. Events include emotional lability, such as crying, irritability, impatience, anger, and aggression. Patients should be monitored for development or worsening of psychiatric symptoms.

Convulsions have been observed in patients treated with GnRH agonists with or without a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs.

The most common adverse events seen with FENSOLVI were: injection site pain, nasopharyngitis, pyrexia, headache, cough, abdominal pain, injection site erythema, nausea, constipation, vomiting, upper respiratory tract infection, bronchospasm, productive cough and hot flush.

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References

  1. Fensolvi® (leuprolide acetate) for injectable suspension 45 mg Prescribing Information. Dublin 2, Ireland: Tolmar International, Ltd.; 2020
  2. Prettyman J. Urologic Nursing 2019

Keep childhood

Fensolvi® delivers an all-in-one treatment experience for central precocious puberty.

Fensolvi® is the first and only 6-month, subcutaneous injection of leuprolide acetate for CPP1

Indication

FENSOLVI (leuprolide acetate) for injectable suspension is a gonadotropin releasing hormone (GnRH) agonist used to treat patients 2 years of age and older with central precocious puberty (CPP). CPP may be diagnosed when signs of sexual maturity begin to develop in girls under the age of 8 or in boys under the age of 9.

Important Safety Information

FENSOLVI is contraindicated in individuals with hypersensitivity to any drug that is in the same class as FENSOLVI, in individuals who are allergic to any of the ingredients in FENSOLVI, or in individuals who are pregnant. FENSOLVI may cause fetal harm when administered to a pregnant patient.

During the first few weeks of treatment, increases in gonadotropins and sex steroids above baseline may result in an increase in signs and symptoms of puberty including vaginal bleeding in girls.

Psychiatric events have been reported in patients taking GnRH agonists. Events include emotional lability, such as crying, irritability, impatience, anger, and aggression. Patients should be monitored for development or worsening of psychiatric symptoms.

Convulsions have been observed in patients treated with GnRH agonists with or without a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs.

The most common adverse events seen with FENSOLVI were: injection site pain, nasopharyngitis, pyrexia, headache, cough, abdominal pain, injection site erythema, nausea, constipation, vomiting, upper respiratory tract infection, bronchospasm, productive cough and hot flush.

Click for Full Prescribing Information

REFERENCES:

  1. Fensolvi® (leuprolide acetate) for injectable suspension 45 mg Prescribing Information. Dublin 2, Ireland: Tolmar International, Ltd.; 2020.
  2. Data on file. Tolmar Pharmaceuticals, Inc.

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