Generic Name and Formulations:
Burosumab-twza 10mg/mL, 20mg/mL, 30mg/mL; soln for SC inj; preservative-free.
Ultragenyx Pharmaceutical Inc.
Indications for CRYSVITA:
Treatment of X-linked hypophosphatemia in patients aged ≥1 year.
Discontinue oral phosphate and active vitamin D analogs 1 week prior to treatment start. Give as SC inj (eg, upper arms, upper thighs, buttocks, abdomen quadrant); rotate sites. Round to nearest 10mg; max 1.5mL per inj site. ≥18yrs: 1mg/kg every 4 weeks; max 90mg. Assess fasting serum phosphorus every 4 weeks, measured 2 weeks post-dose, for the first 3 months, 2 weeks after a dose adjustment, then thereafter as needed. Interrupt or reduce dose based on serum phosphorus level; do not adjust sooner than every 4 weeks (see full labeling).
<1yr: not established. Discontinue oral phosphate and active vitamin D analogs 1 week prior to treatment start. Give as SC inj (eg, upper arms, upper thighs, buttocks, abdomen quadrant); rotate sites. Round to nearest 10mg; max 1.5mL per inj site. 1–<18yrs: initially 0.8mg/kg every 2 weeks; max 90mg. Assess fasting serum phosphorus every 4 weeks for the first 3 months, 4 weeks after a dose adjustment, then thereafter as needed. Adjust dose based on serum phosphorus level, but not sooner than every 4 weeks (see full labeling).
Concomitant oral phosphate and active vitamin D analogs. Serum phosphorus within or above normal range for age: do not initiate. Severe renal impairment or ESRD.
Prior to initiation, confirm fasting serum phosphorus concentration below reference range for age. Discontinue if serious hypersensitivity or severe inj site reactions occur. Elderly. Pregnancy. Nursing mothers.
Fibroblast growth factor 23 (FGF23) blocking antibody.
Headache, inj site reaction, vomiting, pyrexia, extremity pain, vitamin D decreased, back pain, tooth infection, restless leg syndrome, dizziness, constipation, blood phosphorus increased; hypersensitivity, hyperphosphatemia, nephrocalcinosis.
Sign Up for Free e-newsletters
Psychiatry Advisor Articles
- Link Identified Between Cured Meat and Mania in Bipolar Disorder
- Early Risk Factors for Bipolar Disorder Found in Offspring of BD Parents
- First-Episode Delusional Disorder vs Schizophrenia: Assessment of Outcomes
- Daily Drinking Associated With Increased Mortality Risk
- Probiotics, Depression, and the Role of Inflammation
- The Opioid System: The Foundation for Social Risk and Reward
- Correctional Psychiatry: Challenges and Rewards
- Those Left Behind: Working With Suicide-Bereaved Families
- Is Mandatory Reporting of Child Maltreatment in the Best Interests of the Child?
- The Impact of Deafness on Hallucinations and Delusions
- High Risk for Anxiety, Depression, and Stress Observed Among Single Mothers
- Self-Harm, Suicidality Among Adolescents Associated With Poor Outcomes, Recurrent Clinical Care
- Moderate Association Between Sociocognitive Functioning and Thought Disorder in Schizophrenia
- Psychotropic Medications May Improve Pregnancy Outcomes in Bipolar Disorder
- Schizophrenia Polygenetic Risk Score as a Predictor of Bipolar Disorder With Psychosis