Navepegritide

Navepegritide is used to help children with achondroplasia (a rare genetic bone disorder) who are 2 years and older and whose bones are still growing (open epiphyses) to increase their growth.

Navepegritide may also be used for other reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Navepegritide is injected under the skin, usually once every week. A healthcare provider will teach you how to properly give this medicine to a child.

Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand how to use an injection.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.

Do not inject within 2 inches of your navel (belly button) or areas where the skin is red, swollen, or has scars. Do not inject into the same place two times in a row. Your healthcare provider will show you where to inject navepegritide.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Your child's doctor will check your child's growth on a regular basis to determine how long your child should use navepegritide. Follow your doctor's instructions.

Store this medicine in the original carton in the refrigerator. Protect from light and do not freeze.

You may store navepegritide (before mixing) at room temperature and can be returned to the refrigerator within the 6 months. Throw away any unused medicine 6 months after you first removed it from the refrigerator or use until the expiration date (whichever comes first).

Take the medicine out of the refrigerator and allow it to reach room temperature for 30 minutes before mixing your dose.

The mixed medicine may be kept at room temperature for up to 4 hours. Throw away any unused mixed medicine after 4 hours.

Use only as directed. Inform your doctor if your child is taking other medicines, has other medical conditions, or has allergies.

Tell your doctor if your child has or has ever had:

• heart problems; or
• kidney problems.

It is not known if navepegritide will harm an unborn baby. Tell the doctor if your teenage child is pregnant or plans to become pregnant.

Ask a doctor if it is safe to breastfeed while using navepegritide.

Get emergency medical help if your child shows signs of an allergic reaction: hives, trouble breathing, swelling of the face, lips, tongue, or throat.

Call your doctor right away if your child experiences:

• dizziness, feeling tired, or nausea.

Common side effects of navepegritide may include:

• pain, bruising, swelling, or irritation at the injection site;
• nausea, vomiting; or
• pain in the arms or legs.

This is not a complete list of side effects and others may happen. Call your doctor for medical advice regarding side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Usual Pediatric Dose for Achondroplasia:

2 years and older:-Weight 8 to 9.9 kg: 0.88 mg subcutaneously once a week-Weight 10 to 13.4 kg: 1.2 mg subcutaneously once a week-Weight 13.5 to 17.5 kg: 1.6 mg subcutaneously once a week-Weight 17.6 to 23 kg: 2.1 mg subcutaneously once a week-Weight 23.1 to 30.5 kg: 2.8 mg subcutaneously once a week-Weight 30.6 to 41.2 kg: 3.6 mg subcutaneously once a week-Weight 41.3 to 55.9 kg: 5 mg subcutaneously once a week-Weight 56 to 73.5 kg: 6.6 mg subcutaneously once a week-Weight 73.6 to 90 kg: 8.8 mg subcutaneously once a weekComments:-Dosage is based on actual body weight.-For patients weighing at least 56 kg, use 2 kits to administer the complete dose.-When switching from daily C-type natriuretic peptide (CNP) therapy: Start this drug the day after completing the last dose of daily CNP therapy.-Periodically monitor growth and adjust dosage according to actual body weight.-Discontinue treatment when no further growth potential is confirmed, as indicated by epiphyseal closure.Use: To increase linear growth in patients with achondroplasia with open epiphyses

If you miss a dose, take it as soon as you remember. If more than 2 days have gone by, skip the missed dose and go back to your regular schedule for the next dose. Do not take two doses within 5 days of each other or at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may affect navepegritide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines your child is using.