FENSOLVI- leuprolide acetate 
TOLMAR PHARMACEUTICALS INC.

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Medication Guide

Medication Guide
FENSOLVI® (fen-SOL-vee)
(leuprolide acetate)
injectable suspension, for subcutaneous use

What is the most important information I should know about FENSOLVI?

 

FENSOLVI may cause serious side effects, including:

  • In the first few weeks after your child receives their first FENSOLVI injection, FENSOLVI can cause an increase in some hormones. During this time, you may notice more signs of puberty in your child including vaginal bleeding. Call your child’s healthcare provider if signs of puberty continue after 2 months of receiving FENSOLVI.
  • Some people taking gonadotropin releasing hormone (GnRH) agonists like FENSOLVI have had new or worsened mental (psychiatric) problems. Mental (psychiatric) problems may include emotional symptoms such as:
    • crying
    • irritability
    • restlessness (impatience)
    • anger
    • acting aggressively

Call your child’s healthcare provider right away if your child has any new or worsening emotional symptoms while taking FENSOLVI.

  • Some people taking GnRH agonists like FENSOLVI have had seizures. The risk of seizures may be higher in people who:
    • have a history of seizures
    • have a history of epilepsy
    • have a history of brain tumors or brain vessel (cerebrovascular) problems
    • are taking a medicine that has been associated with seizures such as bupropion or selective serotonin reuptake inhibitors (SSRIs)

Seizures have also happened in people who have not had any of these problems.

Call your child’s healthcare provider right away if your child has a seizure while taking FENSOLVI.

  • Increased pressure in the fluid around the brain can happen in children taking GnRH agonists medicines including FENSOLVI. Call your child’s doctor right away if your child has any of the following symptoms during treatment with FENSOLVI:
  • headache • ringing in the ears
  • eye problems, including blurred vision, double vision and decreased eyesight • dizziness
  • eye pain • nausea

 What is FENSOLVI?

  • FENSOLVI is a prescription gonadotropin releasing hormone (GnRH) medicine used for the treatment of children with central precocious puberty (CPP).
  • It is not known if FENSOLVI is safe and effective in children younger than 2 years of age.
 FENSOLVI should not be received if your child is:
  • allergic to GnRH, GnRH agonist medicines, or any ingredients in FENSOLVI. See the end of this Medication Guide for a complete list of ingredients in FENSOLVI.
         
    Call your child’s healthcare provider or get emergency medical help right away if your child gets any of the following symptoms of a serious allergic reaction:
              •  skin rashes, redness, or swelling •  swelling of face, mouth, and tongue
              •  trouble breathing or swallowing •  hives
              •  throat tightness, hoarseness •  sweating
              •  severe itching •  dizziness or fainting
              •  fast heartbeat 
  • pregnant or becomes pregnant. FENSOLVI can cause birth defects or loss of the baby. If your child becomes pregnant, call your healthcare provider.

Before your child receives FENSOLVI, tell your child’s healthcare provider about all of your child’s medical conditions, including if they:

  • have a history of mental (psychiatric) problems.
  • have a history of seizures.
  • have a history of epilepsy.
  • have a history of brain vessel (cerebrovascular) problems.
  • have a history of brain or spinal cord (central nervous system) problems or tumors.
  • are breastfeeding or plan to breastfeed. It is not known if FENSOLVI passes into breastmilk.

Tell your healthcare provider about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

 

How will your child receive FENSOLVI?

  • FENSOLVI will be given to your child by a healthcare provider.
  • FENSOLVI is injected under the skin (subcutaneous) every 6 months.
  • Keep all scheduled visits to the healthcare provider. If you miss a scheduled dose, your child may start having signs of puberty again. The healthcare provider will do regular exams and blood tests to check for signs of puberty.
What are the possible side effects of FENSOLVI?
FENSOLVI may cause serious side effects. See “What is the most important information I should know about FENSOLVI?”

The most common side effects of FENSOLVI include:

 •  injection site pain •  abdominal pain • sudden shortness of breath
   or wheezing (bronchospasm) 
 •  nasal congestion, sore throat,
    and runny nose (nasopharyngitis)
 •  nausea •  productive cough
 •  fever (pyrexia) •  constipation •  sudden strong feelings of heat and sweating (hot flush)
 •  headache •  vomiting 
 •  cough •  upper respiratory tract infection 

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


General information about the safe and effective use of FENSOLVI.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. 
You can ask your pharmacist or healthcare provider for information about FENSOLVI that is written for health professionals.

 

What are the ingredients in FENSOLVI?
Active ingredient: leuprolide acetate.
Inactive ingredients: poly (DL-lactide-co-glycolide) and N-methyl-2-pyrrolidone.              


Manufactured by: Tolmar, Inc.
Fort Collins, CO 80526 for
Tolmar International Ltd.
Dublin 2, Ireland D02 T380

Distributed by: Tolmar Pharmaceuticals, Inc.
Fort Collins, CO 80526

©2020 Tolmar Pharmaceuticals, Inc. For more information, go to www.fensolvi.com or call 1-888-FENSOLVI (1-888-336-7658).

04006141 Rev. 2 04/22

This Medication Guide has been approved by the U.S. Food and Drug Administration                              Issued:04/2022


Revised: 4/2022
TOLMAR PHARMACEUTICALS INC.