What to Expect When Starting Fensolvi for Central Precocious Puberty

Making CPP treatment smoother for children and caregivers

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Has your child been recently diagnosed with central precocious puberty (CPP)? If you’ve received this news, or you’ve been recommended Fensolvi as a treatment, you’re sure to have a lot of questions. We hope to answer at least a few of these questions today to help you move forward with confidence and conviction in your child’s Fensolvi treatment.

But first, let’s clarify the relationship between CPP and Fensolvi.

What Is Central Precocious Puberty?

CPP is a medical condition characterized by early onset of puberty in children. To treat CPP, you need a medication that inhibits the release of gonadotropin-releasing hormones (GnRH) from the brain—the hormone responsible for initiating puberty.

What Is Fensolvi?

Fensolvi is a treatment that prevents the progression of CPP. A single injection of Fensolvi stays in a child’s system for 6 months, blocking puberty-inducing hormones from making changes to your child’s body.

What Should I Ask Our Pediatric Endocrinologist?

There are a few questions you should ask your pediatric endocrinologist when looking at next steps after a CPP diagnosis:

  • What are the treatment options? The most common treatment option for CPP are GnRH agonists, or drugs that block GnRH hormones. 
  • What can you tell us about Fensolvi? Your pediatric endocrinologist may have some insight about Fensolvi, whether it’s from the experiences of previous CPP patients or reading material about Fensolvi treatments. They will help set an expectation of what your Fensolvi experience could include.
  • Based on my child’s activity level what therapy would best suit them? Each injection may affect your child’s activity level differently.

How Is Fensolvi Administered?

Fensolvi is a shot that is injected into a thin layer of fat just under the skin, also known as a subcutaneous (SC) injection. A short needle is used and a local anesthetic can be requested when administering the shot. The procedure doesn’t require surgery or muscle injections, which could make the treatment more comfortable for your child.

The Fensolvi medicine will remain in that layer of fat and slowly release for six months, giving your child just enough of the drug to stabilize their GnRH levels and pause early puberty.

With Fensolvi, you will only need to receive an injection twice a year. Every six months, your child will get a new injection until it is the right time to begin puberty.

Does Fensolvi Work Right Away?

Your child’s puberty symptoms may worsen before they improve. Fensolvi can take up to three weeks to stop the waves of GnRH. Fortunately, you should start to notice your child’s symptoms improving after the initial three week period or even sooner.

What Kind of Support Is Provided with Fensolvi?

Fensolvi offers the following support programs and information that can simplify the CPP treatment process for you and your child:

  • Educational resources: Whether you want to learn more about Fensolvi or want to learn about potential side effects, we’ve got you covered.
  • Refill reminders: Need a reminder when it’s time to refill your child’s medicine? We’ll alert you when their next treatment is due so you can know when it’s time to go back to the doctor’s office.
  • Fensolvi copay assistance: The financial aspect of CPP treatment can be challenging. That’s why we’ve established Fensolvi TotalSolutions, a program that helps you pay as little as $5 for your prescription (through the assistance of your insurance provider). Your healthcare provider can help you enroll in this program.

Read the terms and conditions here.

Please note: If you do choose the Fensolvi treatment for CPP, expect a call from a specialty pharmacy to authorize and confirm your child’s Fensolvi prescription.

Hold Onto Childhood with Fensolvi

What can you expect with Fensolvi? Simple treatment, fewer visits to the doctor’s office, and greater support for both you and your child. As you continue with your child through this journey, we hope our resources and programs give you the support you need to continue with confidence. Talk to your child’s doctor today about using Fensolvi for CPP treatment.

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 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.

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.