vosoritide 0.4 mg subcutaneous solution

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Medication name

Generic name:
Vosoritide - subcutaneous injection

Pronunciation
(voe-SOR-i-tide)

Brand name(s)
Voxzogo

Uses

This medication is used to treat children with achondroplasia. Achondroplasia is a condition that affects bone growth, making them shorter than usual, especially the arms and legs. Vosoritide works by promoting bone growth in children who are still growing.

How to use

Read the Patient Information Leaflet and Instructions for Use Leaflet provided by your pharmacist when you get this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the Patient Instructions for Use leaflet.

Before use, take vosoritide out of the refrigerator and let it warm up to room temperature before mixing the dose. Do not heat this medication any other way, such as by heating in the microwave or placing in hot water. If needed this medication may be kept in the original package at room temperature for up to 90 days.

Do not shake this medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into any areas of skin that are red, swollen, or tender.

Inject this medication under the skin of the thigh, buttock, upper arm, or abdomen, at least 2 inches from the belly button as directed by your doctor, usually once daily. The dosage is based on your medical condition, weight, and response to treatment.

Monitor your child's weight and growth periodically. Tell your doctor about any weight changes. Your doctor will need to adjust the dose based on the weight change.

To reduce the risk of low blood pressure, your child should eat a meal and drink 8 to 10 ounces (240 to 300 milliliters) of fluids (such as water, milk, or juice) within 1 hour before injecting this medication. Tell your doctor right away if your child has symptoms of low blood pressure including dizziness, tiredness, or nausea.

Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

Side effects

See also How to Use section.

Joint pain, diarrhea, ear pain, flu-like symptoms (such as sore throat, cough, body aches), dry skin, or redness/swelling/bruising/pain at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may cause low blood pressure. Tell your doctor right away if any of these serious side effects occur:

  • dizziness
  • tiredness
  • nausea

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using vosoritide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your child's medical history, especially of:

  • child's bones no longer growing (closed growth plates)

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Notes

Do not share this medication with others.

Lab tests (such as alkaline phosphatase levels) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed dose

If you miss a dose, use it as soon as you remember. If it is more than 12 hours after the missed dose, skip the missed dose. Use your next dose at the regular time on the next day. Do not double the dose to catch up.

Storage

Store in the refrigerator. Do not freeze. Keep the medication in the original carton to protect from light. This medication may also be stored at room temperature if needed. If the medication is stored at room temperature, do not put it back in the refrigerator and discard after 90 days. Discard any unused portion after use. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised July 2024.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.