Learn more about starting your patients on VOXZOGO1
Dedicated BioMarin representatives can help answer questions about treatment.
Eve, 3 years old, on VOXZOGO since 16 months old as part of a clinical trial
Get to know Eve and hear her mom, Julie, talk about why she decided to start VOXZOGO as early as possible.
Shawn, 8 years old, on VOXZOGO since 4 years old as part of a clinical trial
Meet Shawn and hear from his mom, Patty, as she discusses how important their BioMarin Clinical Coordinator was to helping their family understand, start, and feel supported throughout treatment.
Miller, 13 years old, on VOXZOGO since 10 years old as part of a clinical trial
Hear Miller and his parents describe how they got their family used to an injection routine.
Annika, 14 years old, on VOXZOGO since 9 years old as part of a clinical trial
See Annika and her mom, Krista, share their story about how they decided to start and stay on VOXZOGO.
Ahmin, 17 years old, completed treatment with VOXZOGO
Learn how Ahmin built a routine over time that helped him stay the course throughout his treatment experience.
Munira, Ahmin’s mom
Munira shares how she became a strong advocate for her son since his birth, including throughout his VOXZOGO journey.
Vivan, 18 years old, completed treatment with VOXZOGO
Watch Vivan discuss his passion for playing basketball and describe how he stayed dedicated to his treatment routine.
Satya, Vivan’s dad
Hear Satya share why his family decided VOXZOGO was the right choice for Vivan and why they feel it’s important to start as early as possible.
Dedicated BioMarin representatives can help answer questions about treatment.
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.