Crysvita
Crysvita (burosumab or burosumab-twza) is a monoclonal antibody. It helps keep phosphate levels in the blood from getting too low in people with tumor-induced osteomalacia (TIO) or a genetic condition called X-linked hypophosphatemia (XLH). This medication is given as an injection under the skin every 2 or every 4 weeks by a trained healthcare professional. Side effects can be different depending on your dose, but they generally include headache, pain, and injection-site reactions (e.g., itching, redness, swelling).
What is Crysvita (burosumab)?
What is Crysvita (burosumab) used for?
X-linked hypophosphatemia (XLH) in people ages 6 months and older
Tumor-induced osteomalacia (TIO) in certain people ages 2 years and older
How Crysvita (burosumab) works
Crysvita (burosumab) is a monoclonal antibody that's known as an FGF23-blocking antibody. It stops the actions of a protein called fibroblast growth factor 23 (FGF23), which normally tells your kidneys to get rid of phosphorous from the body.
By stopping FGF23 from working, Crysvita (burosumab) lessens the amount of phosphate that gets removed from the body. As a result, the medication helps keep your phosphate levels from getting too low. This is important for your bone health.
Drug Facts
What are the side effects of Crysvita (burosumab)?
Common Side Effects
- Fever (55%)
- Injection-site reaction (52%)
- Cough (52%)
- Vomiting (41%)
- Pain in arm or leg (38%)
- Headache (34%)
- Tooth infection or toothache (34%)
- Diarrhea (24%)
- Low vitamin D levels (24%)
- Back pain (15%)
- Headache (13%)
- Tooth infection (13%)
- Injection-site reaction (12%)
- Restless leg syndrome (12%)
- Low vitamin D levels (12%)
- Dizziness (10%)
- Tooth infection or toothache (19%)
- Muscle spasms (19%)
- Dizziness (15%)
- Constipation (15%)
- Injection-site reaction (15%)
- Rash (15%)
- Headache (11%)
Other Side Effects
- Dizziness
- Allergic reaction
- High blood phosphorus levels
Serious Side Effects
- Serious allergic reaction: trouble breathing, tightness in the throat, hives, itching, fast heartbeat, nausea, stomach pain, dizziness, lightheadedness, swelling in the face or tongue
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Kidney stones—blood in the urine, pain or trouble passing urine, pain in the lower back or sides
- High phosphorus level—muscle pain or cramps, bone or joint pain, numbness and tingling around the mouth
- Restless leg syndrome—tingling, crawling, pulling, or other unusual feelings in the legs, restlessness, uncontrolled urge to move
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Crysvita (burosumab)
Pros
Works well to raise blood phosphorus levels in people with XLH or TIO
Given every 2 weeks or every 4 weeks, depending on your age
Can use in children as young as 6 months (for XLH) or as young as 2 years (for TIO)
Cons
Must be give as an injection under the skin by a healthcare professional
Doesn't cure XLH or TIO
Not clear how safe the medication is during pregnancy or while breastfeeding
Pharmacist tips for Crysvita (burosumab)
Mark your appointments on your calendar to get your Crysvita (burosumab) injections at the medical office. It's important to get your injections on time so you don't miss any doses. Be sure to follow up with your care team to discuss how treatment is going for you.
Your care team will order blood tests to measure your phosphorus level. This helps check how well Crysvita (burosumab) is working for you.
It's possible to get a reaction at the injection site within a day of your Crysvita (burosumab) injection. These reactions can include pain, swelling, redness, itchiness, rash, hives, bleeding, or bruising. They're typically mild, last a few days, and go away on their own.
Don't take phosphate supplements, vitamin D supplements, or vitamin D analogues (e.g., calcitriol (Rocaltrol)) at least 1 week before you start Crysvita (burosumab). Also don't take these medications or products during treatment. They can cause your phosphate level to get dangerously high while you're taking Crysvita (burosumab).
Discuss with your healthcare team about nutrition and your treatment with Crysvita (burosumab). Since Crysvita (burosumab) can raise your phosphorous levels, make sure to be mindful about how much foods that are high in phosphorous you eat. Having phosphorous levels that are too high can be harmful.
Some people who take Crysvita (burosumab) might start to have restless leg syndrome, which is a condition that causes an irresistible urge to move your legs because of an uncomfortable sensation, typically when you're trying to sleep. Talk to your care team if you start to notice this while you're taking this medication.
Talk with your healthcare team if you're pregnant or thinking about getting pregnant. Crysvita (burosumab) hasn't been studied during pregnancy, so it's not known how safe it is for unborn babies. Call 1-844-768-3544 to report to the manufacturer if you become pregnant while you're taking this medication.
Make sure to ask your healthcare team whether it's safe for you to breastfeed while you're taking Crysvita (burosumab). There haven't been any studies done to know whether it's safe to nurse while you're taking this medication.
Frequently asked questions about Crysvita (burosumab)
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What are the risks and warnings for Crysvita (burosumab)?
Crysvita (burosumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Allergic reactions
Allergic reactions to Crysvita (burosumab) are possible. The most common allergic reactions that people reported during clinical studies were rash and hives. Get medical attention right away if you notice trouble breathing; a choking sensation; dizziness; sweating; nausea; rash; or swelling around your eyes, lips, or tongue at any time during treatment with Crysvita (burosumab).
Injection-site reactions
Crysvita (burosumab) can cause injection-site reactions, such as pain, swelling, redness, itchiness, rash, hives, bleeding, and bruising. These reactions are typically mild, last about 1 to 3 days, and usually go away on their own. Contact your healthcare team if you have a more severe reaction.
High phosphorous levels, leading to calcium buildup in the kidneys
Risk factors: High blood phosphorus levels | Eating foods or taking other medications that raise phosphorus levels
Crysvita (burosumab) raises your blood phosphorus levels. When the phosphorous levels get too high, there's a risk for calcium to build up in your kidneys. Your healthcare team will monitor for this risk throughout treatment by checking your blood phosphorous levels.
Your risk for this problem might be higher if you take medications that raise phosphorus levels (phosphate supplements or vitamin D analogues) or eat too much food that contains phosphorus. Make sure to tell your healthcare team about all of the medications, vitamins, and supplements that you're taking or planning to take during treatment with Crysvita (burosumab).
Contact your healthcare team if you notice blood in the urine. Also speak with your care team if you have fever; chills; nausea; or severe pain in the belly, back, or groin area. These might be signs of calcium buildup in the kidneys.
Crysvita (burosumab) dosage forms
Typical dosing for Crysvita (burosumab)
Crysvita (burosumab) is given as an injection under the skin in the upper arm, upper thigh, buttock, or stomach. The injection is given by a trained healthcare professional.
The dose depends on the medical condition you have and is calculated based on your age and weight. And how often you need to get Crysvita (burosumab) injections depends on your age.
Children younger than 18 years old: Crysvita (burosumab) is typically given every 2 weeks.
Adults: Crysvita (burosumab) is typically given every 4 weeks.
Your healthcare team will adjust your dose based on how your blood phosphate levels are responding to the medication and whether you're having side effects.
Crysvita (burosumab) contraindications
Take vitamin D analogues or medications with phosphate in them
Normal or high blood phosphorus levels
Severe kidney problems
Crysvita (burosumab) images
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References
Best studies we foundBrandi, M. L., et al. (2022). Efficacy of burosumab in adults with X-linked hypophosphatemia (XLH): A post hoc subgroup analysis of a randomized double-blind placebo-controlled phase 3 study. Calcified Tissue International.
Drugs and Lactation Database (LactMed®). (2023). Burosumab. National Institute of Child Health and Human Development.
Goretti Penido, M., et al. (2012). Phosphate homeostasis and its role in bone health. Pediatric Nephrology.
Harvey, N., et al. (2022). Tumor-induced osteomalacia (TIO) in adults. International Osteoporosis Foundation.
Imanishi, Y., et al. (2021). Interim analysis of a phase 2 open-label trial assessing burosumab efficacy and safety in patients with tumor-induced osteomalacia. Journal of Bone and Mineral Research.
Imel, E. A., et al. (2019). Burosumab versus conventional therapy in children with X-linked hypophosphataemia: A randomised, active-controlled, open-label, phase 3 trial. The Lancet.
Kyowa Kirin. (n.d.). Now may be the right time to talk to your doctor about Crysvita.
Kyowa Kirin. (n.d.). Starting your child on Crysvita.
Kyowa Kirin. (2023). Crysvita- burosumab injection [package insert]. DailyMed.
Lyseng-Williamson, K. A. (2018). Burosumab in X-linked hypophosphatemia: A profile of its use in the USA. Drugs & Therapy Perspectives.
MedlinePlus. (2012). FGF23 gene.
MedlinePlus. (2023). Nephrocalcinosis.
MedlinePlus. (2023). Phosphate in blood.
U.S. Food and Drug Administration. (2018). FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia.
XLH Link. (n.d.). What is XLH.
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