vosoritide 0.4 mg subcutaneous solution

Generic name:
Vosoritide - subcutaneous injection

Pronunciation
(voe-SOR-i-tide)

Brand name(s)
Voxzogo

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.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist when you get this medication and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin as directed by your doctor, usually once daily. The injection is given in the thigh, buttock, upper arm, or abdomen (except for a 2-inch area around your belly button). 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.

Before mixing the medication, take it out of the refrigerator to allow it to reach room temperature. Do not warm up this medication any other way (for example, do not heat it in the microwave or place it in hot water). Do not shake the medication. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is red, swollen, or tender. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

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.

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

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.

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 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.

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.

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.

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.

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.

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.