Usual Pediatric Dose for Achondroplasia

Administer by subcutaneous injection once daily.

5 years or older:

• Weight 10 to 11 kg: 0.24 mg subcutaneously once a day
• Weight 12 to 16 kg: 0.28 mg subcutaneously once a day
• Weight 17 to 21 kg: 0.32 mg subcutaneously once a day
• Weight 22 to 32 kg: 0.4 mg subcutaneously once a day
• Weight 33 to 43 kg: 0.5 mg subcutaneously once a day
• Weight 44 to 59 kg: 0.6 mg subcutaneously once a day
• Weight 60 to 89 kg: 0.7 mg subcutaneously once a day
• Weight at least 90 kg: 0.8 mg subcutaneously once a day

• The recommended dosage is based on the patient's actual body weight.
• This drug should be administered at about the same time each day, if possible.
• Patient body weight, growth, and physical development should be monitored and assessed regularly every 3 to 6 months; dosage should be adjusted according to patient's actual body weight.
• This drug should be permanently discontinued upon confirmation of no further growth potential, indicated by closure of epiphyses.

Renal Dose Adjustments

Estimated GFR less than 60 mL/min/1.73 m2: Not recommended

Comment:

• The influence of renal dysfunction on the pharmacokinetics of this drug has not been evaluated.

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 5 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Drug should be administered subcutaneously within 3 hours after reconstitution.
• Caregivers should be instructed on the proper preparation and subcutaneous administration.
• Inform patients that this drug may lower blood pressure after administration. Patients should have an adequate food intake within the hour before administration and should drink 8 to 10 ounces of fluid.
• Dispose syringe and needle properly in a puncture-resistant container. Do not reuse these items.
• If a dose is missed, it can be administered within 12 hours of the scheduled time of administration. Beyond 12 hours, skip the missed dose and administer the next daily scheduled dose.

• Refrigerate vials and prefilled diluent syringes at 2C to 8C (36F to 46F). Do not freeze.
• Store in the original package to protect from light.
• Can be stored at room temperature 20C to 25C (68F to 77F); for 90 days. Do not return the vials to the refrigerator once stored at room temperature.
• After reconstitution, this drug can be held in the vial at room temperature 20C to 25C (68F to 77F) for a maximum of 3 hours.

• This drug should be reconstituted before administration.
• The manufacturer product information should be consulted.

• The concentration of this drug in reconstituted 0.4 mg vial and 0.56 mg vial is 0.8 mg/mL; the concentration in reconstituted 1.2 mg vial is 2 mg/mL.
• This indication is approved under accelerated approval based on an improvement in annualized growth velocity. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

• Cardiovascular: Monitor blood pressure after administration.
• General: Monitor patient's body weight, growth, and physical development regularly every 3-6 months.

• Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
• Have an adequate meal and drink 8 to 10 ounces of liquid within the hour before administration.