Complete dosing information for VALOCTOCOGENE ROXAPARVOVEC-RVOX
Medical guidance required: Dosing information here is for educational purposes. Your healthcare provider will determine the appropriate dose based on your specific condition, kidney function, other medications, and medical history. Never adjust your dose without consulting your doctor or pharmacist.
2 DOSAGE AND ADMINISTRATION For one-time single-dose intravenous use only. Treatment with ROCTAVIAN should be under the supervision of a physician experienced in the treatment of hemophilia and/or bleeding disorders. For one-time single-dose intravenous use only. ( 2 ) Perform baseline testing to select patients, including testing for pre-existing antibodies to adeno-associated virus serotype 5 (AAV5), factor VIII inhibitor presence, and liver health assessments. ( 2 ) The recommended dose of ROCTAVIAN is 6 × 10 13 vector genomes (vg) per kg of body weight. ( 2.1 ) Start the infusion at 1 mL/min. If tolerated, the rate may be increased every 30 minutes by 1 mL/min up to a maximum rate of 4 mL/min. ( 2.1 ) For Patient Selection Perform testing for pre-existing antibodies to AAV5 using the FDA approved companion diagnostic. DO NOT administer ROCTAVIAN to patients with a positive test for antibodies to AAV5. Information on FDA-approved tests for the detection of antibodies to AAV5 is avai