Supprelin LA histrelin acetate 50 mg Implant, 1 implant — NDC 67979-002-01 (Billing 67979-0002-01)

1 INDICATIONS AND USAGE SUPPRELIN LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP). Children with CPP (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). They also show a significantly advanced bone age that can result in diminished adult height attainment.

Prior to initiation of treatment a clinical diagnosis of CPP should be confirmed by measurement of blood concentrations of total sex steroids, luteinizing hormone (LH) and follicle stimulating hormone (FSH) following stimulation with a GnRH analog, and assessment of bone age versus chronological age. Baseline evaluations should include height and weight measurements, diagnostic imaging of the brain (to rule out intracranial tumor), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumors), human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumor), and adrenal steroids to exclude congenital adrenal hyperplasia.

SUPPRELIN LA is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of children with central precocious puberty (CPP) ( 1 ).

2 DOSAGE AND ADMINISTRATION The recommended dose of SUPPRELIN LA is one implant every 12 months. The implant is inserted subcutaneously in the inner aspect of the upper arm and provides continuous release of histrelin for 12 months of hormonal therapy ( 2 ).

2.1Recommended Dose The recommended dose of SUPPRELIN LA is one implant every 12 months. Each implant contains 50 mg histrelin acetate. The implant is inserted subcutaneously in the inner aspect of the upper arm and provides continuous release of histrelin acetate (65 mcg/day) for 12 months of hormonal therapy.

SUPPRELIN LA should be removed after 12 months of therapy (the implant has been designed to allow for a few additional weeks of histrelin acetate release, in order to allow flexibility of medical appointments). At the time an implant is removed, another implant may be inserted to continue therapy. Discontinuation of SUPPRELIN LA should be considered at the discretion of the physician and at the appropriate time point for the onset of puberty (approximately 11 years for females and 12 years for males).

2.2Recommended Procedure for Implant Insertion and Removal This procedure section is intended to provide guidance for the insertion and removal of SUPPRELIN LA. The actual procedure used, however, is at the discretion of the qualified healthcare provider performing the procedure. Insertion of a new implant can proceed using the following Suggested Insertion Procedure .

If a previous SUPPRELIN LA implant must first be removed, please see the Suggested Removal Procedure instructions below. Suggested Insertion Procedure The supplies necessary to insert the implant, including the Insertion Tool and local anesthetic, are provided in a separate Implantation Kit that is shipped along with the implant. Please note that the implant should be kept refrigerated (2-8°C) in its sealed vial, pouch, and carton, until needed for the procedure.

Once removed from refrigeration, the vial containing the implant (still in its unopened pouch and carton) may remain at room temperature for up to 7 days, if necessary, before being used. If not used in that time, the packaged implant may again be properly refrigerated until the expiration date on the carton. NOTE: The Implantation Kit is to be stored at room temperature and should not be refrigerated.

Insertion of the SUPPRELIN LA implant is a surgical procedure. Sterile gloves and aseptic technique must be used to minimize any chance of infection. Setting up the Sterile Field Using proper aseptic technique, the sterilized components of the Implantation Kit needed for the insertion procedure, including the Insertion Tool, are to be carefully dispensed from their packaging onto the Sterile Field drape ( non -fenestrated) provided.

NOTE THAT THE KIT BOX AND ALL PACKAGING ARE NOT STERILE and should be kept off of the Sterile Field drape. DO NOT PLACE THE VIAL OF LOCAL ANESTHETIC OR THE VIAL CONTAINING THE IMPLANT ONTO THE DRAPE as the exterior surface of these vials is not sterile. The implant vial should not be opened until just before the time of insertion.

Open the vial by removing the metal band and carefully pour the sterile contents (implant and sterile saline) onto the Sterile Field drape. The implant can then be handled with sterile gloves or with the sterile mosquito clamp provided. AVOID bending or pinching the implant .

Preparing the Patient and the Insertion Site The patient should be on his/her back, ideally with the arm least used (e.g., left arm for a right-handed person) positioned, either bent or extended, so that the physician has ready access to the inner aspect of the upper arm. Propping the arm with pillows may help the patient more easily hold the position. The suggested optimum site for subcutaneous insertion is approximately half-way between the shoulder and the elbow, in line with the crease between the biceps and triceps muscles.

Antiseptic Swab the insertion area with topical antiseptic, then overlay with the fenestrat… [Excerpted — this section continues on DailyMed.]

3 DOSAGE FORMS AND STRENGTHS SUPPRELIN LA is a sterile, nonbiodegradable, diffusion-controlled, hydrogel polymer reservoir drug delivery system designed to deliver histrelin acetate continuously for 12 months after subcutaneous implantation. The sterile implant contains 50 mg histrelin acetate and delivers approximately 65 mcg histrelin acetate per day over 12 months. SUPPRELIN LA is available as a 50 mg histrelin acetate subcutaneous implant which delivers approximately 65 mcg histrelin acetate per day over 12 months ( 3 ).

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-Approved patient labeling ( Medication Guide ). Initial Agonistic Action Patients should be advised that a transient worsening of symptoms of puberty or onset of new symptoms may occur initially. However, within 4 weeks of histrelin therapy, complete suppression of gonadal steroids occurs and manifestations of puberty decrease [ see Warnings and Precautions ( 5.1 )].

Post-insertion Care Patients should be instructed to refrain from getting the inserted arm wet for 24 hours and from strenuous exertion of the inserted arm for 7 days after implant insertion to allow the incision to fully close. The adhesive elastic bandage can be removed at that time. The patient should not remove the surgical strips; rather, the strips should be allowed to fall off on their own after several days.

Psychiatric Adverse Events Inform caregivers that symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression, have been observed in patients receiving GnRH agonists, including SUPPRELIN LA. Alert caregivers to the possibility of development or worsening of psychiatric symptoms, including depression, during treatment with SUPPRELIN LA [ see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.3 ) ]. Convulsions Inform caregivers that reports of convulsions have been observed in patients receiving GnRH agonists, including SUPPRELIN LA.

Patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions may be at risk [ see Warnings and Precautions ( 5.4 ) ]. Severe Cutaneous Adverse Reactions Inform patients and/or caregivers that severe cutaneous adverse reactions may occur during treatment with SUPPRELIN LA. Advise patients and/or caregivers to stop SUPPRELIN LA and immediately contact their healthcare provider if they experience signs or symptoms of severe cutaneous adverse reactions [see Warnings and Precautions ( 5.5 )] .

Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) Inform patients and caregivers that reports of pseudotumor cerebri (idiopathic intracranial hypertension) have been observed in pediatric patients receiving GnRH agonists. Advise patients and caregivers to monitor for headache, and vision issues such as blurred vision, double vision, loss of vision, pain behind the eye or pain with eye movement, ringing in the ears, dizziness, and nausea. Advise patients and caregivers to contact their healthcare provider if the patient develops any of these symptoms. [ see Warnings and Precautions ( 5.6 ) ].

Common Adverse Reactions Patients should be advised to report to their physician any severe pain, redness, or swelling in and around the implant site. Infrequently, SUPPRELIN LA may be expelled from the body through the original incision site, rarely without the patient noticing. The patient should be instructed to monitor the incision site until it is healed.

The patient should also return for routine checks of their condition and to ensure that SUPPRELIN LA is present and functioning in his/her body [ see Adverse Reactions ( 6.1 ) ]. For more information, call 1-800-462-3636 or visit www.supprelinla.com . Manufactured for: Endo USA Malvern, PA 19355 © 2025 Endo, Inc. or one of its affiliates.

Revised: 09/2025

Medication Guide SUPPRELIN ® LA [Suh-Preh-Lin El-Ay] (histrelin acetate) subcutaneous implant What is the most important information I should know about SUPPRELIN LA? In the first week of treatment, SUPPRELIN LA can cause an increase in some hormones. During this time you may notice more signs of puberty in your child, including light vaginal bleeding and breast enlargement in girls.

Within 4 weeks of treatment, you should see signs in your child that puberty is stopping. Some people who had SUPPRELIN LA placed in their arm have had the implant come through the skin (extrusion). Call your child’s doctor right away if the SUPPRELIN LA implant comes through the skin.

Some people taking GnRH agonists like SUPPRELIN LA have had new or worsening mental (psychiatric) problems. Mental (psychiatric) problems may include emotional symptoms such as: crying irritability restlessness (impatience) anger acting aggressive Call your child’s doctor right away if your child has any new or worsening mental symptoms or problems while taking SUPPRELIN LA . Some people taking GnRH agonists like SUPPRELIN LA 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 or brain vessel (cerebrovascular) problems or tumors are taking a medicine that has been connected to 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 doctor right away if your child has a seizure while taking SUPPRELIN LA . Severe cutaneous (skin) adverse reactions can happen during treatment with GnRH agonists like SUPPRELIN LA.

Stop SUPPRELIN LA and call your child's doctor right away if your child has any of the following signs or symptoms during treatment with SUPPRELIN LA: skin rash or acne blisters or sores in your mouth dry skin peeling of your skin itching fever blisters on your skin muscle or joint aches redness or swelling of your face, hands, or soles of your feet swollen glands Increased pressure in the fluid around the brain can happen in children taking GnRH agonist medicines including SUPPRELIN LA. Call your child’s doctor right away if your child has any of the following symptoms during treatment with SUPPRELIN LA: headache ringing in the ears eye problems, including blurred vision, double vision, and decreased eyesight dizziness nausea eye pain What is SUPPRELIN LA?

SUPPRELIN LA is an implanted gonadotropin releasing hormone (GnRH) medicine used for the treatment of children with central precocious puberty (CPP). It is not known if SUPPRELIN LA is safe and effective in children under 2 years of age. SUPPRELIN LA should not be taken if your child is: allergic to gonadotropin releasing hormone (GnRH), GnRH agonist medicines, or any ingredients in the SUPPRELIN LA implant.

See the end of this Medication Guide for a complete list of ingredients in SUPPRELIN LA. pregnant or becomes pregnant. SUPPRELIN LA can cause birth defects or loss of the baby. If your child becomes pregnant call your doctor.

Before your child receives SUPPRELIN LA, tell the doctor 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 or brain vessel (cerebrovascular) problems or tumors. are taking a medicine that has been connected to seizures such as bupropion or selective serotonin reuptake inhibitors (SSRIs). Tell your doctor about all the medicines your child takes , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will your child receive SUPPRELIN LA? Your child’s doctor should do tests to make sure your child has CPP before treating with SUPPRELIN LA. SUPPRELIN LA lasts for 12 months.

One implant will give the medicine for 12 months. After 12 months, the SUPPRELIN LA implant must be removed. The doctor may… [Excerpted — this section continues on DailyMed.]