This dosing calculator can help you determine the appropriate dose based on your patients’ body weight and the concentration of reconstituted VOXZOGO.
Recommended vial strength for reconstitution should show mg on the label.
Vial should have a white, magenta, or gray colored cap.
After reconstitution, mL should be injected.
| Body Weight | Vial Strength for Reconstitution* | Dose | Injection Volume |
|---|---|---|---|
| 3 kg | 0.4 mg | 0.096 mg | 0.12 mL |
| 4 kg | 0.12 mg | 0.15 mL | |
| 5 kg | 0.16 mg | 0.2 mL | |
| 6-7 kg | 0.2 mg | 0.25 mL | |
| 8-11 kg | 0.24 mg | 0.3 mL | |
| 12-16 kg | 0.56 mg | 0.28 mg | 0.35 mL |
| 17-21 kg | 0.32 mg | 0.40 mL | |
| 22-32 kg | 0.40 mg | 0.50 mL | |
| 33-43 kg | 1.2 mg | 0.50 mg | 0.25 mL |
| 44-59 kg | 0.60 mg | 0.30 mL | |
| 60-89 kg | 0.70 mg | 0.35 mL | |
| ≥ 90 kg | 0.80 mg | 0.4 mL |
*Intermediate body weights that fall within these weight bands should be rounded to the nearest whole number.
†The concentration of vosoritide in reconstituted 0.4 mg vial and 0.56 mg vial is 0.8 mg/mL. The concentration of vosoritide in reconstituted 1.2 mg vial is 2 mg/mL.
By using this resource, you agree to the following: This Dosing Calculator is being provided as is and is intended for use only by qualified healthcare providers. All calculations should be confirmed before use. BioMarin Pharmaceutical Inc. makes no claims as to the accuracy of the information contained herein. This calculator does not replace the need for independent clinical judgment. Neither BioMarin Pharmaceutical Inc., nor any other party involved in the preparation of this site, shall be liable to you or others for any decisions made or action taken by you or others in reliance on this information.
Please also refer to the VOXZOGO Instructions for Use.
Body weight affects VOXZOGO clearance and volume of distribution. When treating with VOXZOGO, it’s important to monitor growth every 3 to 6 months, including:
Warnings and Precautions for Risk of Low Blood Pressure
Transient decreases in blood pressure were observed in clinical studies. Patients with significant cardiac or vascular disease and patients on anti-hypertensive medicinal products were excluded from participation in VOXZOGO clinical trials. To reduce the risk of a decrease in blood pressure and associated symptoms (dizziness, fatigue, and/or nausea), patients should be well hydrated, have adequate food intake, and drink approximately 8-10 ounces of fluid in the hour prior to VOXZOGO administration.
In a 52-week, randomized, double-blind, placebo-controlled trial in 121 subjects with achondroplasia, subjects aged from 5.1 to 14.9 years, (Study 1) eight (13%) of 60 patients treated with VOXZOGO had a total of 11 events of transient decrease in blood pressure, compared to 3 (5%) of 61 patients on placebo, over a 52-week treatment period. The median time to onset from injection was 31 (18 to 120) minutes, with resolution within 31 (5 to 90) minutes in VOXZOGO-treated subjects. Two out of 60 (3%) VOXZOGO-treated patients each had one symptomatic episode of decreased blood pressure with vomiting and/or dizziness compared to 0 of 61 (0%) patients on placebo.
Adverse Reactions:
Adverse reactions that occurred in ≥5% of patients treated with VOXZOGO and at a rate greater than that of placebo in the phase 3 study are injection site reactions (including erythema, swelling, urticaria, pain, bruising, pruritus, hemorrhage, discoloration, and induration), vomiting, arthralgia, decrease in blood pressure, gastroenteritis, diarrhea, dizziness, ear pain, influenza, fatigue, seasonal allergy, and dry skin. VOXZOGO-treated patients had an increase in alkaline phosphatase levels (17%), and was noted as a laboratory abnormality.
Injection site reactions:In Study 1, injection site reactions occurred in 51 (85%) subjects receiving VOXZOGO and 50 (82%) subjects receiving placebo over a 52-week period of treatment. Patients receiving VOXZOGO experienced a total of 6983 events of injection site reactions, while patients receiving placebo experienced a total of 1776 events of injection site reactions, over a 52-week period, representing 120.4 events per patient/year exposure and 29.2 events per patient/year exposure, respectively. Two patients in the VOXZOGO arm discontinued treatment due to adverse events of pain and anxiety with injections.
Pediatric Patients 0 to <5 Years:The safety of VOXZOGO in pediatric patients 0 to <5 years with achondroplasia was evaluated in a 52-week randomized, double-blind, placebo-controlled study (Study 2). In this study, 64 patients from birth to <5 years of age were randomized to receive either a daily vosoritide dose with similar exposure to that characterized to be safe and effective in children with ACH aged ≥5 years old, or placebo. An additional 11 patients received open-label treatment as part of this study. The most common adverse reactions (>10%) reported in pediatric patients 0 to <5 years were injection site reactions (86%) and rash (28%). The overall safety profile of VOXZOGO in pediatric patients 0 to <5 years was similar to that seen in older pediatric patients.
Administration and Monitoring:
VOXZOGO is administered as a daily subcutaneous injection. Prior to use, instruct caregivers on proper preparation and administration of VOXZOGO, and ensure caregivers have demonstrated the ability to perform a subcutaneous injection.
Monitor and assess patient body weight, growth, and physical development regularly every 3-6 months. Adjust dosage according to the patient’s actual body weight. Permanently discontinue treatment with VOXZOGO upon confirmation of no further growth potential, indicated by closure of epiphyses.
Special Populations:
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to BioMarin at 1-866-906-6100.
Please see additional safety information in the full Prescribing Information.
VOXZOGO® (vosoritide) is indicated to increase linear growth in pediatric patients with achondroplasia and open growth plates.