HUMATROPE Somatropin Kit — NDC 0002-8149-01 (Billing 00002-8149-01)

1 INDICATIONS AND USAGE HUMATROPE is a recombinant human growth hormone indicated for: Pediatric Patients: growth failure due to inadequate secretion of endogenous growth hormone (GH); short stature associated with Turner syndrome; Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range; short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency; short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age.

( 1.1 ) Adult Patients: replacement of endogenous GH in adults with GH deficiency. ( 1.2 )

1.1Pediatric Patients HUMATROPE is indicated for the treatment of pediatric patients with: growth failure due to inadequate secretion of endogenous growth hormone (GH), short stature associated with Turner syndrome, Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency, short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age.

1.2Adult Patients HUMATROPE is indicated for the replacement of endogenous GH in adults with GH deficiency.

2 DOSAGE AND ADMINISTRATION Administer by subcutaneous injection to the back of upper arm, abdomen, buttock, or thigh with regular rotation of injection sites. ( 2.1 ) Pediatric Dosage - divide the calculated weekly dosage into equal doses given either 6, or 7 days per week. GHD: 0.18 mg/kg/week to 0.3 mg/kg/week.

( 2.2 ) Turner Syndrome: Up to 0.375 mg/kg/week. ( 2.2 ) ISS: Up to 0.37 mg/kg/week. ( 2.2 ) SHOX Deficiency: 0.35 mg/kg/week.

( 2.2 ) SGA: Up to 0.47 mg/kg/week. ( 2.2 ) Adult Dosage - Either of the following two dosing regimens may be used: Non-weight based dosing: Initiate with a dose of approximately 0.2 mg/day (range: 0.15 mg/day-0.3 mg/day) and increase the dose every 1-2 months by increments of approximately 0.1 mg/day-0.2 mg/day, according to individual patient requirements ( 2.3 ) Weight-based dosing (Not recommended for obese patients): Initiate at 0.006 mg/kg daily and increase the dose according to individual patient requirements to a maximum of 0.0125 mg/kg daily ( 2.3 ) See Full Prescribing Information for reconstitution instructions.

( 2.4 )

2.1Administration and Use Instructions Therapy with HUMATROPE should be supervised by a physician who is experienced in the diagnosis and management of patients with the conditions for which HUMATROPE is indicated [see Indications and Usage ( 1 )] . Fundoscopic examination should be performed routinely before initiating treatment with HUMATROPE to exclude preexisting papilledema, and periodically thereafter [see Warnings and Precautions ( 5.5 )] . Leave HUMATROPE at room temperature for 10 minutes prior to administration.

Administer HUMATROPE by subcutaneous injection to the back of the upper arm, abdomen, buttock, or thigh with regular rotation of injection sites to avoid lipoatrophy.

2.2Pediatric Dosage Individualize dosage for each patient based on the growth response. Divide the calculated weekly HUMATROPE dosage into equal doses given either 6 or 7 days per week. The recommended weekly dose in milligrams (mg) per kilogram (kg) of body weight for pediatric patients is: Pediatric GH Deficiency: 0.18 mg/kg/week to 0.3 mg/kg/week (0.026 to 0.043 mg/kg/day) Turner Syndrome: Up to 0.375 mg/kg/week (up to.054 mg/kg/day) Idiopathic Short Stature: Up to 0.37 mg/kg/week (up to 0.053 mg/kg/day) SHOX Deficiency: 0.35 mg/kg/week (0.05 mg/kg/day) Small for Gestational Age (SGA): Up to 0.47 mg/kg/week (up to 0.067 mg/kg/day) In very short pediatric patients, height SDS less than -3, and older pubertal pediatric patients consider initiating treatment with a larger dose of HUMATROPE (up to 0.067 mg/kg/day).

Consider a gradual reduction in dosage if substantial catch-up growth is observed during the first few years of therapy. In pediatric patients less than 4 years of age with less severe short stature, baseline height SDS values between -2 and -3, consider initiating treatment at 0.033 mg/kg/day and titrate the dose as needed. Assess compliance and evaluate other causes of poor growth such as hypothyroidism, under-nutrition, advanced bone age and antibodies to recombinant human GH if patients experience failure to increase height velocity, particularly during the first year of treatment.

Discontinue HUMATROPE for stimulation of linear growth once epiphyseal fusion has occurred [see Contraindications ( 4 )] .

2.3Adult Dosage Patients who were treated with somatropin for GH deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin for GH deficient adults. Consider using a lower starting dose and smaller dose increment increases for geriatric patients as they may be at increased risk for adverse reactions with HUMATROPE than younger individuals [see Use in Specific Populations ( 8.5 )] . Women may require higher doses and patients receiving oral estrogen may require higher doses [see Drug Interactions ( 7 )] .

Administer the prescribed dose daily. Either of two HUMATROPE dosing regimens may be used: Non-weight based: Initia… [Excerpted — this section continues on DailyMed.]

3 DOSAGE FORMS AND STRENGTHS Each single-patient-use HUMATROPE cartridge is designed for use only with the appropriate corresponding HumatroPen ® supplied separately. HUMATROPE is a white lyophilized powder available as follows: For injection: 6 mg in a single-patient-use cartridge (gold) For injection: 12 mg in a single-patient-use cartridge (teal) For injection: 24 mg in a single-patient-use cartridge (purple) For injection: 6 mg, 12 mg, or 24 mg lyophilized powder in a single-patient-use cartridge for reconstitution.

( 3 )

17 PATIENT COUNSELING INFORMATION Each single-patient-use HUMATROPE cartridge is designed for use only with the appropriate corresponding HumatroPen ® supplied separately. Advise the patient to read the FDA-approved patient labeling (Instructions for Use). Neoplasms – Advise childhood cancer survivors/caregivers that individuals treated with brain/head radiation are at increased risk of secondary neoplasms and as a precaution need to be monitored for recurrence.

Advise patients/caregivers to report marked changes in behavior, onset of headaches, vision disturbances and/or changes in skin pigmentation or changes in the appearance of pre-existing nevi. Fluid Retention - Advise patients that fluid retention during HUMATROPE replacement therapy in adults may frequently occur. Inform patients of the clinical manifestations of fluid retention (e.g. edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paraesthesias) and to report to their healthcare provider any of these signs or symptoms that occur during treatment with HUMATROPE.

Pancreatitis - Advise patients/caregivers that pancreatitis may develop and to report to their healthcare provider any new onset of abdominal pain. Hypoadrenalism - Advise patients/caregivers who have or who are at risk for pituitary hormone deficiency(s) that hypoadrenalism may develop and to report to their healthcare provider if they experience hyperpigmentation, extreme fatigue, dizziness, weakness, or weight loss. Hypothyroidism - Advise patients/caregivers that undiagnosed/untreated hypothyroidism may prevent an optimal response to HUMATROPE.

Advise patients/caregivers they may require periodic thyroid function tests. Intracranial Hypertension - Advise patients/caregivers to report to their healthcare provider any visual changes, headache, and nausea and/or vomiting. Hypersensitivity Reactions – Advise patients/caregivers that serious systemic hypersensitivity reactions (anaphylaxis and angioedema) are possible and that prompt medical attention should be sought if an allergic reaction occurs.

Glucose Intolerance/ Diabetes Mellitus – Advise patients/caregivers that new onset impaired glucose intolerance/diabetes mellitus or exacerbation of preexisting diabetes mellitus can occur and monitoring of blood glucose during treatment with HUMATROPE may be needed. Administration – Counsel patients and parents that they should never share a HumatroPen with another person, even if the needle is changed. Sharing of the pen between patients may pose a risk of transmission of infection.

Eli Lilly and Company, Indianapolis, IN 46285, USA US License Number 1891 Copyright ©, 1987, 2025, Eli Lilly and Company. All rights reserved. HTR-0007-USPI-20251125

Humatrope Cartrige Kit Instuctions for Use Instructions for Use HUMATROPE ® (HU-ma-trope) (somatropin) For injection, for subcutaneous use Single-Patient-Use Cartridge Kit HUMATROPE cartridges are only to be used with the appropriate corresponding HumatroPen ® injection devices supplied separately. Read this Instructions for Use before you start using HUMATROPE Cartridge Kit and each time you get a refill. There may be new information.

This information does not take the place of talking to your healthcare provider about your or your child's medical condition or treatment. Your healthcare provider should show you how to prepare, mix, measure, and inject HUMATROPE the right way before you use it for the first time. Ask your healthcare provider if you have any questions.

How should I store HUMATROPE? Store HUMATROPE in the refrigerator between 36°F to 46°F (2°C to 8°C) before and after mixing. Do not freeze.

Store HUMATROPE in the original carton to protect from light. HUMATROPE that has been mixed and is in liquid form must be used within 28 days. Throw away any mixed HUMATROPE left over after 28 days.

Before giving an injection, check the expiration date on the Cartridge. Do not use the Cartridge if it has expired (See Figure A ). Important: HUMATROPE Cartridges should not be used if you are allergic to metacresol or glycerin.

The HUMATROPE Cartridge is not recommended for use by blind or visually impaired individuals without the help of a sighted individual trained on how to use it. If your healthcare provider changes the prescribed cartridge strength you will need to get a new HumatroPen to match the new cartridge strength. Only use the following HUMATROPE cartridges with the following HumatroPen: 6 mg cartridge with HumatroPen 6 mg 12 mg cartridge with HumatroPen 12 mg 24 mg cartridge with HumatroPen 24 mg HUMATROPE Cartridge Kit (See Figure A ) 1 Cartridge with 6 mg, 12 mg, or 24 mg of powdered HUMATROPE 1 prefilled syringe with Diluent (the liquid used to mix the powdered HUMATROPE) Note: There are 3 strengths of HUMATROPE Cartridges that have different amounts of HUMATROPE (6 mg, 12 mg, or 24 mg).

Make sure that you have the Cartridge that your healthcare provider prescribed. Mixing the HUMATROPE in the Cartridge Only use the prefilled Diluent Syringe that comes with your HUMATROPE Cartridge Kit to mix the HUMATROPE in the Cartridge. Do not use the diluent that comes in the HUMATROPE vial box, or any other liquid.

HUMATROPE Cartridge Kit mixing Instructions Parts (Figure A) Only use a HUMATROPE Cartridge Kit to prepare the HUMATROPE Cartridge. * Note : The liquid (Diluent) should be clear, colorless, and free of particles and is shown as blue in the figure (See Figure A ). Preparing Your New HUMATROPE Cartridge Start by thoroughly washing your hands. Remove all contents from the tray.

Note: The HUMATROPE Cartridge is made for left or right handed use so you may handle it the way that is most comfortable for you. Hold the gray needle cover at the bottom of the Diluent Syringe. Pull the needle cover straight down to remove from the Diluent Syringe and throw it away.

Do not push the plunger yet. It is okay if a drop of Diluent is seen. You do not have to release air from the Diluent Syringe.

Hold the Cartridge, with the black triangles up toward the Diluent Syringe. Make sure the Cartridge and Diluent Syringe are facing each other in a straight line. Do not insert the Cartridge at an angle.

Push the Cartridge straight into the Diluent Syringe until it stops and the black triangles are covered inside the Diluent Syringe. You may hear or feel a click. Do not twist the Cartridge.

Hold the Diluent Syringe and the Cartridge together with both hands . Push and release the plunger 2 or 3 times until the Diluent is in the Cartridge. Remove your thumb from the plunger and check that the Diluent Syringe is empty.

It is normal for small drops of Diluent to remain in the Diluent Syringe. With your thumb off the plunger, pull the Cartrid… [Excerpted — this section continues on DailyMed.]