Sophie’s Story

What central precocious puberty treatment can look like for active kids.

Sophie* is a young girl who loves playing soccer, doodling in her sketchbook, and playing outside with her siblings. But after she turned seven years old, her and her mother started to notice signs of early puberty—body odor, breast buds, growth spurts, pubic hair, and even terrible acne.

Sophie and her mother visited her pediatrician to get an opinion on what Sophie was experiencing. Sophie’s symptoms led her pediatrician to believe that Sophie had central precocious puberty (CPP)—a condition that causes early puberty and height acceleration in children. They recommended Sophie and her mother consult with a pediatric endocrinologist to figure out how to treat Sophie’s condition. Left untreated, CPP could have negative life-long physical and mental consequences for Sophie.

Sophie was nervous, but the pediatric endocrinologist was incredibly encouraging and informative. They told Sophie how CPP is actually a more common condition than some think (1 in 5,000–10,000 girls experience CPP). They also explained she needs a treatment that blocks GnRH, which is the cause of early puberty.

While the pediatric endocrinologist mentioned several different treatment paths, Sophie’s mother had some preferences to help narrow down the options. First, Sophie needed a treatment for early puberty that didn’t require frequent visits to the doctor’s office so that she could maintain her active and athletic lifestyle. Enrollment for her treatment and visits should also be easy so that Sophie can stay focused on being a kid and her mom can easily navigate the process. Second, Sophie’s treatment ideally shouldn’t have any day-after muscle pain that often comes with injections into muscle. This muscle pain would not only hurt Sophie, but could impact her ability to play sports, dance or play with her friends. It goes without saying that mothers want their child to avoid as much pain as possible. ^{(12, 13, 14)}

With the preferences listed above, the treatment path revealed the choice that fulfilled these requests: Fensolvi. With Fensolvi, Sophie would only need to visit the doctor twice a year for a short needle injection. The drug slowly releases for six months to put a pause on puberty, letting Sophie enjoy her childhood.

With Fensolvi, Sophie plays soccer and enjoys her art projects as much as she did before her CPP symptoms started to show up in her life. And with Fensolvi’s easy enrollment plan, Sophie and her mother had an easier time getting her prescriptions and scheduling her biannual doctor visits.

If you like the sound of Sophie’s less invasive CPP treatment, you can learn more today by asking your healthcare provider about Fensolvi.

*Not an actual patient.

Learn About Fensolvi

IMPORTANT SAFETY INFORMATION

FENSOLVI is a type of medicine known as a gonadotropin releasing hormone (“GnRH”) agonist. It is used to treat central precocious puberty (CPP) in children 2 years of age and older and is administered as an injection under the skin (subcutaneously) by your child’s healthcare provider.

FENSOLVI should not be given to children:

Who are sensitive to GnRH, GnRH agonists or any of the ingredients in FENSOLVI (your child’s doctor can help you know this)
- Call your child’s doctor or get emergency medical help right away if your child gets any symptoms of a serious allergic reaction
Who are pregnant. FENSOLVI can cause birth defects or loss of the baby

During the first few weeks of treatment, an increase in signs and symptoms of puberty, including vaginal bleeding in girls, may occur.

Some children may have emotional changes with FENSOLVI, including crying, irritability, impatience, anger, or aggression. Call your child’s doctor right away if your child has any new or worsening emotional symptoms while taking FENSOLVI.

There have been reports of convulsions (uncontrolled movements due to rapid contraction and relaxation of muscles) in children taking GnRH agonists. Convulsions may occur in children who have not had them before. If your child has a convulsion, call your child’s doctor, or get emergency help right away.

Idiopathic Intracranial Hypertension (unexplained elevated pressure in the brain) has been reported in pediatric patients receiving GnRH agonists. Call your child’s doctor right away if your child has headaches and/or vision issues.

The most common side effects seen in studies with FENSOLVI were injection site pain/redness, colds/sore throat, fever, headache, cough, stomach pain, nausea, constipation, vomiting, wheezing, wet cough and hot flush. Tell your child’s doctor about any side effects.

These are not all the possible side effects of FENSOLVI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see Full Prescribing Information for additional Important Safety Information.

IMPORTANT SAFETY INFORMATION

FENSOLVI should not be given to children:

Who are sensitive to GnRH, GnRH agonists or any of the ingredients in FENSOLVI (your child’s doctor can help you know this)
- Call your child’s doctor or get emergency medical help right away if your child gets any symptoms of a serious allergic reaction
Who are pregnant. FENSOLVI can cause birth defects or loss of the baby

During the first few weeks of treatment, an increase in signs and symptoms of puberty, including vaginal bleeding in girls, may occur.

These are not all the possible side effects of FENSOLVI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see Full Prescribing Information for additional Important Safety Information.

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.