Tolmar Pharmaceuticals, Inc. issued the following announcement on Aug. 18.
Tolmar Pharmaceuticals, Inc., a specialty pharmaceutical company, today affirmed the full availability of FENSOLVI® (leuprolide acetate) for injectable suspension in its six-month dose (45mg) for pediatric patients with central precocious puberty (CPP). The company confirmed a complete inventory of product supply and also announced a production increase in response to reports of a shortage in the United States for a different leuprolide acetate injection product. Tolmar has a demonstrated record of providing consistent supply of its leuprolide acetate products in the U.S. and globally across approximately 89 countries, with no shortages to date.
On July 24, 2020 and re-verified on August 3, 2020, the U.S. Food and Drug Administration (FDA) listed the Lupron Depot PED, 3 Months, 30mg as not available and on backorder in its database of Current and Resolved Drug Shortages and Discontinuations Reported to FDA. The listing indicates the estimated duration of this shortage is currently unknown.
"Tolmar is pleased to step up production in our state-of-the-art cGMP facilities to help ensure that children with CPP and their parents are able to access their treatment on schedule," said Anil D'Souza, Chief Executive Officer, Tolmar. "Fensolvi is manufactured to the highest quality standards in our Northern Colorado plants, and we are able to fill any short- or long-term gaps in the supply of this drug for those who need it."
Fensolvi is the only six-month, subcutaneously administered leuprolide acetate approved for the treatment of pediatric patients two years of age and older with central precocious puberty. Fensolvi utilizes an innovative proprietary polymeric gel technology that forms an in-situ solid after injection and releases leuprolide acetate in a sustained and controlled manner over time. This polymeric gel technology enables the subcutaneous injection of a small volume of only 0.375mL, with a short 5/8-inch needle, and a twice-yearly dosing cycle.
"During the global COVID-19 pandemic parents and patients should be able to remain focused on keeping childhood simple instead of worrying about a missed treatment or an extra office visit," continued Mr. D'Souza. "Tolmar has a full inventory of API and the other components of Fensolvi, and the capacity to manufacture sufficient supply of the drug for the pediatric endocrinology community and patients at this time."
For more information about product availability or any questions about reported leuprolide acetate product shortages in the U.S. market, please contact Tolmar at 1-888-FENSOLVI (1-888-336-7658).
About Central Precocious Puberty (CPP)
Gonadotropin releasing hormone (GnRH)-dependent central precocious puberty (CPP) is the premature development of signs of sexual maturation occurring in girls younger than eight and in boys younger than nine years of age. CPP patients are at risk of having significantly short stature as adults in addition to social, psychological and emotional issues, including lower self-esteem, stress, anxiety and depression. CPP is believed to have a five- to twenty-fold higher incidence in girls than in boys and is estimated to occur in one in 5,000-10,000 children.
About FENSOLVI® (leuprolide acetate) for injectable suspension
FENSOLVI (leuprolide acetate) for injectable suspension is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients two years of age and older with CPP. It is a prescription drug, given by injection.
Fensolvi is the first and only six-month, subcutaneous leuprolide acetate with a small injection volume that allows flexibility in selection of injection site and enables administration in an office setting. Fensolvi represents an effective, safe and convenient treatment option for this vulnerable patient group, and its profile aligns with twice-yearly visits to the pediatric endocrinologist's office.
Information about FENSOLVI is available at fensolvi.com.
Important Safety Information for Fensolvi® (leuprolide acetate) for injectable suspension
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.
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.
Please see Full Prescribing Information for FENSOLVI for additional important safety information.
To report suspected adverse reactions contact Tolmar at 1-844-4TOLMAR (486-5627) or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
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