Navepegritide Injection

Navepegritide injection is used to increase growth (height) in certain children who have achondroplasia (a type of dwarfism that results in short arms and legs). Navepegritide is in a class of medications called C-type natriuretic peptide (CNP) analog. It works by increasing cartilage cell growth which results in increased bone growth.

Navepegritide injection comes as a powder to be mixed with a liquid to inject subcutaneously (under the skin) once a week. Use navepegritide injection on the same day every week.

Use navepegritide injection exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your healthcare provider will monitor your child's growth carefully during treatment with navepegritide injection and will adjust the dose and the length of treatment based on your child's response to this medication.

You or a caregiver will be shown how to prepare and inject the medicine before your first dose. You will also be given the instructions for use. Read these carefully. Talk to your doctor or pharmacist if you have any questions on how to use the medicine.

Before you inject navepegritide injection, look at the solution closely. The medication should be clear and colorless and free of floating particles. If the medication is cloudy, discolored, or contains particles, do not use it.

You can inject navepegritide injection anywhere on the front of your thighs (upper leg) or stomach area except your navel (belly button) and the area 2 inches (5 centimeters) around it. If another person is injecting your medication, the outer area of the upper arm or the buttocks also may be used. Do not inject into an area where the skin is tender, bruised, red, or swollen or where you have scars. Choose a different site for each injection.

Use each syringe and needle only once. Dispose of used syringes and needles in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using navepegritide injection,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had low blood pressure or kidney problems.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using navepegritide injection, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

If it is 2 days or less after you miss a dose of navepegritide injection, inject the dose as soon as you remember it. However, if it is more than 2 days after the missed dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

To avoid missed doses, navepegritide injection can be injected 2 days before or 2 days after the scheduled dosing day. Make sure that there are at least 5 days between doses.

Navepegritide injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• redness, itching, discoloration, bleeding, bruising, swelling, blistering, or pain at the injection site
• vomiting
• nausea
• leg or arm pain
• unusual hair growth on the arms, legs, back, shoulders, or at the injection site

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• dizziness, feeling tired, and nausea

Navepegritide injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in the refrigrator and protect it from light. Do not freeze. Before use, unmixed medication can be stored at room temperature for up to 6 months and can be returned to the refrigerator within the 6 months. After mixing, navepegritide injection can be stored at room temperature for up to 4 hours. If not used with 4 hours, dispose of the medication.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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