CPP Definition and Related Medical Terms

Central precocious puberty (CPP) is a treatable condition that causes puberty-inducing hormones to release too soon. If your child has recently been diagnosed with CPP, you likely (and understandably) have a lot of questions. That’s why we’ve assembled a comprehensive list of central precocious puberty definitions and related CPP medical terms. Use these definitions to help boost your understanding of this condition so you can advocate for your child.

A

Adolescence: The phase of life during which children transition into adults.

Androgen: A male sex hormone (like testosterone, for example).

B

Bone age X-ray: An X-ray of the left hand/wrist that helps determine how a patient’s skeleton is maturing compared to their chronological age.

Breast bud: When the breast develops into a small mound and areola (pigmented area around nipple) diameter increases, signifying puberty.

С

Central precocious puberty (CPP): A rare, treatable condition where the brain releases the puberty-inducing hormone (GnRH) too soon. This results in puberty before the age of eight in girls and nine in boys.

E

Estrogen: The sex hormone responsible for the development and regulation of feminine body characteristics and the female reproductive system.

F

Follicle-stimulating hormone (FSH): A hormone secreted by the brain’s pituitary gland that controls menstrual cycles and egg formation in females and promotes the production of sperm in males. FSH release is triggered by GnRH.

G

Gonadotropin-releasing hormone (GnRH): A hormone that, when secreted from the brain’s pituitary gland, triggers the release of follicle-stimulating hormone and luteinizing hormone, causing puberty.

Gonadarche: The first instance of gonadal puberty symptoms, which entails the development of ovaries and increased estradiol production in females, and the development of testes and testosterone in males.

H

Histrelin: A GnRH agonist that treats CPP by suppressing the release of gonadotropin hormones, pausing puberty.

Hormone: Chemical substances in the body that serve as messenger molecules, telling other cells and organs how to function.

Hypothalamus: The region of the brain beneath the thalamus that coordinates the pituitary gland, controlling sexual development and basic body functions.

I

Idiopathic: When the cause of a medical condition is unknown, as is often the case with CPP.

L

Leuprolide acetate: A drug used to block the release of GnRH, and subsequently pause puberty.

Luteinizing hormone: A hormone secreted by the brain’s pituitary gland that stimulates ovulation in females and testosterone release in males. Luteinizing hormone release is triggered by GnRH.

M

Menarche: A girl’s first occurrence of menstruation.

P

Pediatric Endocrinologist: A doctor who specializes in the diagnosis and treatment of children with endocrine (hormone) conditions such as diabetes, growth disorders, and precocious puberty.

Peripheral precocious puberty (aka precocious pseudopuberty): One of two types of precocious puberty, occurring due to the excess production of estrogen or testosterone.

Pituitary gland: A pea-sized gland in the base of the brain that helps control the growth and function of other endocrine glands.

S

Sex hormone: A hormone, such as estrogen, progesterone, and testosterone, that affects the growth and/or function of the reproductive organs.

T

Testosterone: The sex hormone responsible for the development and regulation of masculine body characteristics and the male reproductive system.

Triptorelin: A type of GnRH agonist that treats CPP by blocking the release of gonadotropin-releasing hormone, pausing puberty.

We hope this glossary helps you feel more confident understanding and communicating about CPP. After all, the better you know your CPP terminology, the better you can support your child!

For more information on how Fensolvi can help you throughout this medical journey, reach out to your child’s pediatric endocrinologist today.

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.