Vosoritide

Vosoritide is a prescription medication used to increase linear growth in pediatric patients aged 5 years and older who have achondroplasia with open epiphyses.

• Vosoritide is available under the following different brand names: Voxzogo

Common side effects of Vosoritide include:

• injection site reactions (redness, swelling, hives)
• vomiting
• joint pain
• decreased blood pressure
• gastroenteritis

Serious side effects of Vosoritide include:

• hives
• difficult breathing
• swelling of the face, lips, tongue, or throat

Rare side effects of Vosoritide include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Pediatric dosage

• Injection, lyophilized powder for reconstitution
• 0.4 mg/vial
• 0.56 mg/vial
• 1.2 mg/vial

Achondroplasia

Pediatric dosage

• Children aged 5 years and older
• Recommended dosage based on actual body weight (ABW)
  • 10–11 kg: 0.24 mg SC once a day
  • 12–16 kg: 0.28 mg SC once a day
  • 17–21 kg: 0.32 mg SC once a day
  • 22–32 kg: 0.4 mg SC once a day
  • 33–43 kg: 0.5 mg SC once a day
  • 44–59 kg: 0.6 mg SC once a day
  • 60–89 kg: 0.7 mg SC once a day
  • 90 kg and more: 0.8 mg SC once a day

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Vosoritide has no noted severe interactions with any other drugs
• Vosoritide has no noted serious interactions with any other drugs
• Vosoritide has no noted moderate interactions with any other drugs
• Vosoritide has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Vosoritide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Vosoritide?”

Cautions

• Risk of low blood pressure
• Transient decreases in blood pressure were observed
• Subjects with significant cardiac or vascular disease and patients on antihypertensive medicinal products were excluded from participation in clinical trials
• To reduce the risk of a decrease in blood pressure and associated symptoms (dizziness, fatigue, and/or nausea), instruct the patient to be well hydrated (approximately 240–300 mL within an hour before SC injection) and have adequate food intake before administration

Pregnancy and Lactation

• No data are available on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Lactation
  • There is no information regarding the presence of vosoritide in human milk, its effects on the breastfed infant, or milk production
  • Vosoritide is present in rat milk
  • When a drug is present in animal milk, it will likely be present in human milk