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Crysvita Start Guide

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Crysvita Start Guide CRYSVITA START GUIDE Ultragenyx is committed to supporting patients, caregivers, and healthcare providers along the CRYSVITA journey INDICATION CRYSVITA® (burosumab-twza) is a fibroblast growth factor 23 (FGF23) blocking antibody indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older. CONTRAINDICATIONS CRYSVITA is contraindicated: • In concomitant use with oral phosphate and/or active vitamin D analogs (e.g., calcitriol, paricalcitol, doxercalciferol, calcifediol) due to the risk of hyperphosphatemia. • When serum phosphorus is within or above the normal range for age. • In patients with severe renal impairment or end stage renal disease because these conditions are associated with abnormal mineral metabolism. Please see Important Safety Information, on pages 14 and 15, and full Prescribing Information in the pocket. THE CRYSVITA JOURNEY TEAM UP TO 1 MANAGE XLH DISCONTINUE PRIOR The relationship between patients with 42 XLH and their healthcare providers is XLH THERAPY lifelong. As patients begin the CRYSVITA Oral phosphate and/or active vitamin journey, maintaining an ongoing D analogs (e.g., calcitriol, paricalcitol, dialogue can help address questions MEASURE FASTING doxercalciferol, calcifediol) should that may come up during therapy. 25 be discontinued 1 week prior to SERUM PHOSPHORUS initiation of CRYSVITA treatment. Fasting serum phosphorus levels are Pediatric patients (6 months to <18 years of age): CRYSVITA increases phosphorus measured to ensure levels are below dosing occurs every 2 weeks and vitamin D levels in the blood. the reference range for age prior to starting CRYSVITA. The dose of CRYSVITA will be adjusted as needed to help keep 2 4 6 8 phosphorus levels in a normal range. WEEKS WEEKS WEEKS WEEKS X Plan CRYSVITA 27 ADMINISTRATION 2 COMPLETE THE ULTRACARE® START FORM Completing the UltraCare Start Form allows patients and their 23 ENROLL IN ULTRACARE PLAN FOR CRYSVITA 4 8 12 16 26 WEEKS WEEKS WEEKS WEEKS healthcare providers to connect Patients who enroll in UltraCare can get help TREATMENT with an UltraCare Guide who can navigating access to treatment. UltraCare CRYSVITA is administered by help provide information regarding Adult patients (18 years of age or older): Guides reach out to patients to help them: subcutaneous injection and should be access to treatment. It DOES NOT dosing occurs every 4 weeks • Understand their insurance coverage administered by a healthcare provider. commit healthcare providers to prescribe CRYSVITA or patients to • Determine if they are eligible for financial If a dose of CRYSVITA is missed, patients initiate it. Patients and healthcare assistance and patient assistance programs should contact their healthcare provider right providers should complete the form • Get access to patient support resources away to resume treatment at the prescribed dose as soon as possible. To avoid missed together and return it to UltraCare and programs doses, treatments may be administered 3 days Patient Services. Download the form For additional enrollment support, call either side of the scheduled treatment date. at UltraCareSupport.com. UltraCare at 1-888-756-8657. Travel plans? Patients should inform their UltraCare enrollment is optional and not healthcare provider of their plans, as they may required to receive CRYSVITA treatment. be able to receive their scheduled CRYSVITA dose from another healthcare provider. Start with UltraCare Patient Services for CRYSVITA at UltraCareSupport.com or call 1-888-756-8657 2 Please see Important Safety Information, on pages 14 3 and 15, and full Prescribing Information in the pocket. CRYSVITA DOSING SCHEDULE DOSE ADJUSTMENTS FOR PEDIATRIC PATIENTS FOR PEDIATRIC PATIENTS All patients should discontinue oral phosphate and/or active vitamin D analogs (e.g., calcitriol, If serum phosphorus is paricalcitol, doxercalciferol, calcifediol) 1 week prior to initiation of CRYSVITA treatment. below the reference PEDIATRIC DOSE SCHEDULE Fasting serum phosphorus concentration should be below the reference range for age prior 2 MG/KG range for age: FOR STEPWISE DOSE INCREASE FOR PATIENTS WEIGHING 10 kg OR MORE to initiation of treatment. Starting First Dose Second Dose Body Weight (kg) For patients who weigh less than 10 kg, Dose (mg) Increase to (mg) Increase to (mg) the CRYSVITA dose may be increased to 1.5 mg/kg, rounded to the nearest 1 mg, 10-14 10 15 20 Dosing in pediatric patients (6 months to <18 years of age) administered every 2 weeks. If additional 15-18 10 20 30 2 dose increases are needed, the dose 19-31 20 30 40 WEEKS is every 2 weeks* may be increased to the maximum dose of 2 mg/kg, rounded to the nearest 1 mg. 32-43 30 40 60 44-56 40 60 80 Recommended starting dose: For patients who weigh 10 kg or greater, the CRYSVITA dose may be increased 57-68 50 70 90 10 • For patients who weigh less than 10 kg, starting dose regimen is 1 mg/kg of body 7 13 stepwise up to approximately 2 mg/kg, weight, rounded to the nearest 1 mg 69-80 60 90 90 1 administered every 2 weeks (maximum NEAREST 81-93 70 90 90 1 OR 10 MG • For patients who weigh 10 kg and greater, starting dose regimen is 0.8 mg/kg of body dose of 90 mg) according to the weight, rounded to the nearest 10 mg; minimum dose: 10 mg; maximum dose: 90 mg pediatric dosing schedule to the right. 94-105 80 90 90 Reassess fasting serum phosphorus 106 and greater 90 90 90 After initiating CRYSVITA, measure fasting serum phosphorus every level 4 weeks after dose adjustment. 4 weeks for the first 3 months of treatment and thereafter, as appropriate. If serum phosphorus is above the lower limit of the reference range for If serum phosphorus is age and below 5 mg/dL, continue with the same dose. above 5 mg/dL, withhold PEDIATRIC DOSE SCHEDULE the next dose and reassess FOR REINITIATION OF THERAPY FOR PATIENTS WEIGHING 10 kg OR MORE fasting serum phosphorus level in 4 weeks. Previous Dose (mg) Reinitiation Dose (mg) 10 5 Sample Starting Dose Calculation: Serum phosphorus must be below the 15 10 Pediatric patient weighing more than 10 kg (6 months to <18 years of age) reference range for age to reinitiate CRYSVITA. Once serum phosphorus is 20 10 Patient weight (kg) x Recommended starting dose (0.8 mg/kg) below the normal range, treatment with 30 10 CRYSVITA may be restarted. Example: 23 kg x 0.8 mg/kg = 18.4 mg (Round to nearest 10 mg) 40 20 Starting dose CRYSVITA = 20 mg For patients who weigh less than 10 kg, 50 20 restart CRYSVITA at 0.5 mg/kg of body weight, rounded to the nearest 1 mg, 60 30 administered every 2 weeks. 70 30 Sample Starting Dose Calculation: For patients who weigh 10 kg or more, 80 40 Pediatric patient weighing less than 10 kg (6 months to <18 years of age) restart CRYSVITA according to the dose 90 40 schedule to the right. Patient weight (kg) x Recommended starting dose (1 mg/kg) After a dose decrease, reassess fasting serum phosphorus level 4 weeks after the dose adjustment. Example: 8.2 kg x 1 mg/kg = 8.2 mg (Round to nearest 1 mg) If the level remains below the reference range for age after the reinitiation dose, the dose can be Starting dose CRYSVITA = 8 mg adjusted according to the pediatric dosing schedule above. Do not adjust CRYSVITA more frequently than every 4 weeks. * Effectiveness in patients aged 6 months to 1 year and adolescents is supported by evidence from the studies in pediatric patients aged 1 year to <13 years with additional modeling and simulation of adult and pediatric pharmacokinetic (PK) and pharmacodynamic (PD) data to inform dosing. Missed Dose If a patient misses a dose, resume CRYSVITA as soon as possible at the prescribed dose. To avoid missed doses, treatments may be administered 3 days either side of the scheduled treatment date. 25-Hydroxy Vitamin D Supplementation Monitor 25-hydroxy vitamin D levels. Supplement with cholecalciferol or ergocalciferol to maintain 25-hydroxy vitamin D levels in the normal range for age. Do not administer active vitamin D 4 Please see Important Safety Information, on pages 14 5 analogs during CRYSVITA treatment. and 15, and full Prescribing Information in the pocket. STARTING AND STAYING ON TRACK WITH Use the information below to help your patients understand CRYSVITA IN PEDIATRIC PATIENTS what to expect and keep track of appointments. HEALTHCARE PROVIDER GUIDANCE FOR YOUR PEDIATRIC PATIENT AND THEIR CAREGIVER Patients should discontinue oral phosphate and/or active vitamin D analogs (e.g., calcitriol, paricalcitol, Pediatric patients will need to receive CRYSVITA every 2 weeks. Patients should discontinue oral doxercalciferol, calcifediol) 1 week prior to initiation of CRYSVITA treatment. Fasting serum phosphorus phosphate and/or active vitamin D analogs 1 week prior to initiation of CRYSVITA treatment. level should be below the reference range for age prior to initiation of treatment. WEEK 0/ WEEK 0/ • First CRYSVITA dose • Administer first dose DAY 1 DAY 1 • Mark the next injection (2 weeks out) WEEK 2 • Administer next dose. Maintain dosage WEEK 2 • Mark the next injection (2 weeks out) WEEK 4 • Measure fasting serum phosphorus level • Mark the next fasting serum phosphorus test (2 weeks out). A fasting serum phosphorus level at Week 4 is needed before administering CRYSVITA at Week 4 WITHIN range: BELOW range: ABOVE range: • Administer next • Increase dose • Withhold doses at Week 4 and Week 6 WEEK 4 If the patient did receive CRYSVITA: If the patient did NOT receive CRYSVITA: dose. Maintain stepwise, as • Schedule a fasting serum phosphorus test dosage recommended to reassess level in 4 weeks • Mark the next injection (2 weeks out) • Mark the next injection (4 weeks out) (see page 5) • Mark the next fasting serum • Mark the next fasting serum phosphorus test phosphorus test WEEK 6 If dose was administered at Week 4: If dose was NOT administered at Week 4: (4 weeks out) (4 weeks out) • Administer next dose.
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