Vosoritide
Vosoritide (VOXZOGO) is a synthetic peptide that helps children with achondroplasia grow taller by supporting bone growth at the growth plates.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Vosoritide: Patient Information Guide
A plain-language walkthrough of Vosoritide — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Vosoritide (VOXZOGO) is approved for one indication in children:
- VOXZOGO is used to increase linear growth (height) in pediatric patients with achondroplasia — a genetic bone growth disorder — whose growth plates (epiphyses) are still open, meaning they still have growth potential.
- This approval is under accelerated approval, based on improvement in how fast children grew (annualized growth velocity). Confirmation of long-term clinical benefit is pending from ongoing trials.
⚙️How it works▾
Achondroplasia is caused by a mutation that makes a protein called FGFR3 overactive. FGFR3 normally limits how fast cartilage cells (chondrocytes) grow, but in achondroplasia it applies too strong a brake, slowing limb and spinal bone growth. Vosoritide is a synthetic copy of a naturally occurring hormone called CNP (C-type natriuretic peptide). It binds to a receptor called NPR-B on growth plate cells, which blocks the downstream signal that FGFR3 sends — specifically a cellular pathway involving ERK1/2 and RAF-1. This allows chondrocytes to divide and mature more normally, widening the growth plate and supporting longer bone growth.
💊How it's taken▾
VOXZOGO is given as a once-daily subcutaneous injection (a small shot under the skin). The dose is calculated based on the child's actual body weight and is adjusted as the child grows — so regular weight checks every 3 to 6 months are important. Before each injection, the child should eat a full meal and drink about a cup (240–300 mL) of fluid. Caregivers can give the injection at home after proper training from a healthcare professional.
- Rotate injection sites each day (thighs, abdomen, buttocks, or upper arms) — do not use the same spot two days in a row
- Inject at roughly the same time each day if possible
- If a dose is missed: give it within 12 hours; if more than 12 hours have passed, skip it and resume the regular schedule the next day
- Stop treatment permanently once growth plates are confirmed closed
🤒Side effects — in detail▾
The most common side effects with VOXZOGO in clinical trials included:
- Injection site reactions — redness, swelling, or hives at the injection spot (very common)
- Temporary drop in blood pressure — dizziness, fatigue, or nausea shortly after dosing
- Vomiting
- Diarrhea
- Joint pain (arthralgia)
- Stomach bug (gastroenteritis)
- Dizziness or lightheadedness
- Ear pain, fatigue, or seasonal allergy symptoms
The most important reaction to watch for is a blood pressure drop within about 30 minutes of the injection — call your doctor if your child feels faint, very dizzy, or unusually tired after dosing.
⚠️Warnings & precautions▾
- Low blood pressure: Temporary drops in blood pressure were seen in about 13% of VOXZOGO-treated children in trials. Symptoms include dizziness, fatigue, and nausea. Always ensure your child eats and drinks well before each dose. Children with significant heart or blood vessel disease, or those on blood pressure medications, need extra caution.
- Injection site reactions: Most children (85%) experienced injection site reactions; while common, watch for signs of infection (warmth, pus, worsening redness) and tell your doctor if reactions are severe.
- Growth monitoring: The prescriber should check your child's weight and growth every 3 to 6 months and adjust the dose accordingly. Treatment must be permanently stopped once growth plates close.
- Kidney function: VOXZOGO is not recommended for children with significant kidney impairment (eGFR below 60 mL/min/1.73 m²).
🔀What it interacts with▾
Based on laboratory studies, vosoritide is not expected to meaningfully interact with most other medications. However, one clinical concern exists:
- Blood pressure-lowering medications (antihypertensives): Children on these drugs were excluded from VOXZOGO trials; combining them with VOXZOGO may increase the risk of a blood pressure drop and should be discussed with the prescriber.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Kidney problems: VOXZOGO is not recommended if the child has significant kidney impairment (eGFR below 60 mL/min/1.73 m²).
- Heart or blood vessel disease: Children with significant cardiac or vascular conditions were not studied — discuss with your doctor before starting.
- Blood pressure medications: There is added risk of low blood pressure if VOXZOGO is used alongside antihypertensive drugs.
- Pregnancy: There are no human data on vosoritide use during pregnancy. Animal studies did not show harm to developing fetuses, but the background risk of birth defects is higher in the achondroplasia population than the general population.
- Breastfeeding: It is unknown whether vosoritide passes into human milk. The benefits of breastfeeding should be weighed against any potential risk; discuss with your doctor.
- Growth plate status: Treatment should only continue while the child's growth plates remain open. Once closure is confirmed, VOXZOGO must be stopped permanently.
📡Pharmacodynamics — effects in the body▾
After a VOXZOGO injection, a marker called urinary cGMP — which reflects how well the drug is binding to its target receptor (NPR-B) — rises within 4 hours and peaks at about 2 hours post-dose. With daily use, a bone growth marker called collagen type X (CXM), which reflects activity at the growth plate, also rises from baseline and remains elevated beyond 24 months of treatment. At the approved once-daily dose, VOXZOGO does not cause any meaningful change in heart rhythm (QT interval).
🔬Pharmacokinetics — how your body processes it▾
VOXZOGO is absorbed quickly after a subcutaneous injection, with peak blood levels reached in about 15 minutes. Its half-life (the time for the body to clear half the drug) is very short — roughly 21 to 28 minutes — so it does not accumulate in the body with daily dosing. The drug is broken down via normal protein-degradation pathways into small peptide fragments and amino acids, similar to how the body breaks down natural proteins. Body weight significantly affects how the drug is distributed and cleared, which is why dosing is adjusted by weight.
📦How to store it▾
Refrigerate VOXZOGO vials and prefilled diluent syringes at 2°C to 8°C (36°F to 46°F). Do not freeze. stored at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) for 90 days.
📄 Written from Vosoritide’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Vosoritide — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly does VOXZOGO do, and will it make my child grow to a normal height? ▾
How do I give this injection at home, and does it hurt my child? ▾
Why does my child need to eat and drink before the shot? ▾
What side effects should I watch for closely? ▾
How long will my child need to stay on this medication? ▾
Is it safe to miss a dose, and can I give two doses at once to make up for it? ▾
Is Vosoritide available over the counter? ▾
When was Vosoritide first available? ▾
Who makes Vosoritide? ▾
💬 Answers drafted from Vosoritide’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Vosoritide comes
Vosoritide is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- VOXZOGO injection is used to increase linear growth in pediatric patients with achondroplasia whose growth plates (epiphyses) are still open
- VOXZOGO injection is approved under accelerated approval based on improved annualized growth velocity in clinical trials
- VOXZOGO injection must be reconstituted (mixed with the provided sterile water) before each use and inspected for clarity before injecting
- VOXZOGO injection is given as a subcutaneous (under-the-skin) injection once daily, rotating sites among the thighs, abdomen, buttocks, and upper arms
- Ensure your child has eaten and drunk about a cup of fluid in the hour before each VOXZOGO injection to help prevent a blood pressure drop
- After reconstitution, VOXZOGO injection must be used within 3 hours; discard any unused portion and never pool or reuse from the same vial
📊 Vosoritide across the U.S. market
How Vosoritide appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Kit (9) · Powder (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Vosoritide is used
A general measure of how commonly Vosoritide is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Vosoritide is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Vosoritide prescribed? Of the 1,596 medications we measure, Vosoritide ranks #1,247 by Medicaid prescriptions — more than 22% of them.
Utilization by Vosoritide product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
vosoritide 0.56 MG Injection Most dispensed
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2586371
vosoritide 0.4 MG Injection
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2586364
vosoritide 1.2 MG Injection
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2586375
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Vosoritide, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 6 listed Vosoritide NDCs with Medicaid activity.
🔍 Compare Vosoritide products
A representative set of FDA-listed product records for Vosoritide — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|
| 💊Injection | |||
| 8 g/kg | BioMarin Pharmaceutical Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 💊Kits | |||
| — | BioMarin Pharmaceutical Inc. × 9 listings | NDA | View NDC → |
| 💊Bulk drug substance | |||
| 1 kg/kg | Apicore Pharmaceuticals private Limited | BULK INGREDIENT | View NDC → |
Showing 11 of 11 products — FDA National Drug Code Directory. See every product, package size and price: browse all 11 Vosoritide NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Vosoritide — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Vosoritide in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Vosoritide went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2586354 1 dose form · 3 strengths
-
Dose form (SCDF) Injection RxCUI 2586363In current FDA listings
Look up RxCUI 2586354 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Vosoritide is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Vosoritide belongs to the C-type Natriuretic Peptide Analog class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. BioMarin Pharmaceutical Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.