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Crysvita

side effects drug center crysvita (burosumab-twza injection, for subcutaneous use) drug - patient side effects and images

 

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CONSUMER

SIDE EFFECTS

Crysvita Patient Information Including Side Effects

Brand Names: Crysvita

Generic Name: burosumab

What is burosumab (Crysvita)?

Burosumab is a monoclonal antibody that targets and blocks the activity of a blood protein called FGF23. In a genetic condition called X-linked hypophosphatemia (HYE-poe-fos-fa-TEEM-ee-a), low phosphate levels in blood are caused by abnormally high levels of FGF23 protein, which causes the kidneys to stop reabsorbing phosphate into the bloodstream.

Blocking the FGF23 protein allows the kidneys to restore and maintain normal phosphate levels. Phosphate is important for the strength of your bones and teeth. Low phosphate levels can lead to bone deformities and growth problems.

Burosumab is used to normalize phosphate levels in adults and children who are at least 1 year old and have X-linked hypophosphatemia.

Burosumab may also be used for purposes not listed in this medication guide.

What are the possible side effects of burosumab (Crysvita)?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects may include:

  • headache, dizziness;
  • pain in your arms, legs, or back;
  • vomiting, constipation;
  • a restless feeling in your legs;
  • fever;
  • tooth infection;
  • decreased vitamin D levels;
  • increased phosphorous levels; or
  • pain, redness, itching, swelling, bruising, or a hard lump where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about burosumab (Crysvita)?

You should not use burosumab if you have severe kidney disease, or if you currently take phosphate or vitamin D by mouth.

Crysvita Patient Information including How Should I Take

What should I discuss with my healthcare provider before using burosumab (Crysvita)?

You should not use burosumab if you are allergic to it, or if you have:

  • severe or end-stage kidney disease; or
  • if you currently take phosphate or vitamin D by mouth.

Tell your doctor if you have ever had:

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or if you become pregnant while using burosumab.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Burosumab is not approved for use by anyone younger than 1 year old.

How is burosumab given (Crysvita)?

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using burosumab.

At least 1 week before your first injection, stop using oral phosphate and vitamin D medications.

Burosumab is injected under the skin, once every 2 weeks in children and once every 4 weeks in adults.

A healthcare provider will give you this injection.

Burosumab doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight.

You may need frequent medical tests. Even if you have no symptoms, tests can help your doctor determine if this medicine is effective.

Crysvita Patient Information including If I Miss a Dose

What happens if I miss a dose (Crysvita)?

Call your doctor for instructions if you miss an appointment for your burosumab injection.

What happens if I overdose (Crysvita)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using burosumab (Crysvita)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect burosumab (Crysvita)?

Other drugs may affect burosumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information (Crysvita)?

Your pharmacist can provide more information about burosumab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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