Description
Navepegritide injection is used to increase linear growth in children with a genetic disorder called achondroplasia with open epiphyses (bones are still growing).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of navepegritide injection in children younger than 2 years of age. Safety and efficacy have not been established.
Geriatric
Navepegritide injection is not indicated for use in geriatric patients.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Kidney disease, moderate to severe—Use is not recommended in patients with this condition.
Proper Use
A nurse or other trained health professional will give you this medicine. It is given as a shot under the skin, usually in the buttocks, stomach, thighs, or upper arms. This medicine may also be given at home to patients who do not need to be in a hospital or clinic. Your caregiver may be trained to prepare and inject this medicine at home. Be sure that you understand all instructions before giving your child an injection.
This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
If you use navepegritide at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems. Do not inject into skin areas that are red, swollen, or scarred.
If refrigerated, allow the medicine to warm to room temperature for 30 minutes before using it.
To use the vial:
- Wash your hands with soap and water before and after using this medicine.
- Remove the cap from the vial. Do not touch the rubber top of the vial.
- Break off the white cap of the prefilled diluent syringe. Do not push the plunger. Open the preparation needle and screw it on the syringe. Pull back the safety shield and remove the needle cap. Use a new kit if the safety shield locks or if the diluent spills.
- Insert the needle into the center on top of the vial. Push all the diluent and pull the needle out of the vial. Push the safety shield over the needle with one hand or press the shield against a hard surface after use until you hear it click and it locks.
- Shake the vial up and down for 15 seconds. Do not swirl or roll as it will not be fully mixed. Put the vial down and leave it for 5 minutes to let the medicine settle.
- Check the liquid in the vial. It should be clear and colorless. Do not use it if it is cloudy, discolored, or has particles in it.
- Screw a new needle onto the syringe. Pull back the safety shield and remove the needle cap. Do not remove the cap until you are ready to inject.
- Pull the plunger to the line that matches the prescribed dose. Insert the syringe into the vial. Turn the vial upside down and inject the air into the vial. Pull back the syringe plunger. The plunger has 2 rings. Your dose should be in line with the top ring of the black part of the plunger. Make sure to remove large air bubbles or an air gap. Pull the needle out of the vial. Lock the safety shield.
- Twist and pull off the short needle cap. Pull off the long needle cap. Insert the needle at 45 degree angle. Push the plunger all way down. Pull the needle out from the skin. Do not recap the needle.
Use a new needle and syringe each time you inject your medicine.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form (powder for solution):
- For linear growth in children with achondroplasia and open epiphyses:
- Children—Dose is based on body weight and must be determined by your doctor.
- Weighing 73.6 kilograms (kg) to 90 kg—8.8 milligrams (mg) or 1.6 milliliters (mL) (use 2 kits, 0.8 mL from each kit) injected under the skin once a week.
- Weighing 56 kg to 73.5 kg—6.6 mg or 1.2 mL (use 2 kits, 0.6 mL from each kit) injected under the skin once a week.
- Weighing 41.3 kg to 55.9 kg—5 mg or 0.9 mL injected under the skin once a week.
- Weighing 30.6 kg to 41.2 kg—3.6 mg or 0.65 mL injected under the skin once a week.
- Weighing 23.1 kg to 30.5 kg—2.8 mg or 0.6 mL injected under the skin once a week.
- Weighing 17.6 kg to 23 kg—2.1 mg or 0.45 mL injected under the skin once a week.
- Weighing 13.5 kg to 17.5 kg—1.6 mg or 0.35 mL injected under the skin once a week.
- Weighing 10 kg to 13.4 kg—1.2 mg or 0.55 mL injected under the skin once a week.
- Weighing 8 kg to 9.9 kg—0.88 mg or 0.4 mL injected under the skin once a week.
- Children—Dose is based on body weight and must be determined by your doctor.
- For linear growth in children with achondroplasia and open epiphyses:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose, use it as soon as possible but not more that 2 days after the missed dose. If it is more than 2 days, skip the missed dose and go back to your regular dosing schedule. To avoid missed doses, this medicine can be used 2 days before or 2 days after the scheduled dose. At least 5 days should pass between doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
You may store the medicine at room temperature for up to 6 months and can be returned to the refrigerator within 6 months. Throw away unused medicine if it is expired or 6 months after it was first removed from the refrigerator, whichever comes first.
After mixing, you may store the mixture at room temperature and must be used within 4 hours. Throw away unused medicine 4 hours after mixing.
Throw away used needles in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may increase risk of low blood pressure. Check with your doctor right away if your child have blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, sweating, or unusual tiredness or weakness.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Incidence not known
- Arm or leg pain
- bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- blurred vision
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- nausea
- sweating
- unusual tiredness or weakness
- vomiting
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Increased hair growth on the forehead, back, arms, and legs
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-80010351
