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Important Safety Information
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.
Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) has been reported in pediatric patients treated with GnRH agonists. Patients should be monitored for headache, papilledema and blurred vision.
The most common adverse reactions 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.
Important Safety Information
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.
Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) has been reported in pediatric patients treated with GnRH agonists. Patients should be monitored for headache, papilledema and blurred vision.
The most common adverse reactions 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.
FENSOLVI TOTALSOLUTIONS COPAY PROGRAM TERMS AND CONDITIONS
The Fensolvi® Co-pay Assistance Program (“Program”) is valid ONLY for patients who are prescribed Fensolvi® and are reimbursed exclusively by commercial insurance. This Program is valid only in the United States; but, void where prohibited by law or by the patient’s health insurance provider. This Program is non-transferable, limited to one per person, and cannot be combined with any other coupon, free trial, discount, prescription savings card, or other offer. Restrictions or limits may apply.
Medicare, Medicaid, Tricare and other federal health care program beneficiaries may not participate in this Program. This Program also is neither available for cash paying patients nor where your commercial plan reimburses you for the entire cost of your prescription drug. Patients cannot seek reimbursement from health insurance or any third party for any part of the assistance received through this Program. The patient or his/her guardian is responsible for reporting the receipt of all benefits or reimbursement received under the Program to any insurer, health plan, or other third party, as may be required. This Program is not insurance and is not intended as a substitute for insurance.
With the Program, you pay as little as $5 of your co-pay or co-insurance for Fensolvi®, per prescription. The remainder of your co-pay or co-insurance is covered, up to two prescriptions per calendar year. The Program assists with the cost of Fensolvi only. It does not assist with the cost of other administrations, medicines, procedures or office visit fees.
Tolmar, Inc. (“Tolmar”) reserves the right to terminate, rescind, revoke, or modify this Program at any time without notice. This Program expires at the end of the current calendar year, at which time you must re-enroll. For complete information about the terms and conditions of this Program, including the limitations on use and the amount of assistance call 1-866-FENSOLVI (336-7658).
Program managed by Scripts Rx on behalf of Tolmar.
