WINREVAIR

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE WINREVAIR™ is indicated for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 pulmonary hypertension) to improve exercise capacity and World Health Organization (WHO) functional class (FC), and reduce the risk of clinical worsening events including hospitalization for PAH, lung transplantation and death [see Clinical Studies (14.1) ] . WINREVAIR is an activin signaling inhibitor indicated for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1 pulmonary hypertension) to improve exercise capacity and WHO functional class (FC), and reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION The recommended starting dose is 0.3 mg/kg by subcutaneous injection. ( 2.1 ) The recommended target dose is 0.7 mg/kg every 3 weeks by subcutaneous injection. ( 2.2 ) Dosage modifications due to increased hemoglobin (Hgb) and decreased platelets may be necessary. Check Hgb and platelets before each dose for the first 5 doses, or longer if values are unstable, and monitor periodically thereafter. ( 2.3 ) See full prescribing information for preparation and administration instructions. ( 2.4 ) 2.1 Recommended Starting Dosage WINREVAIR is administered once every 3 weeks by subcutaneous injection according to patient body weight. The starting dose of WINREVAIR is 0.3 mg/kg. Obtain hemoglobin (Hgb) and platelet count prior to the first dose of WINREVAIR. Do not initiate treatment if platelet count is 2.0 g/dL from the previous dose and is above ULN. Hgb increases >4.0 g/dL from baseline. Hgb increases >2.0 g/dL above ULN. Platelet count decreases to 9 weeks, restart treatment at 0.3 mg/kg, and escalate to 0.7 mg/kg after verifying acceptable Hgb and platelet count. 2.4 Preparation and Administration Administration is subject to monitoring of hemoglobin and platelet count [see Dosage and Administration (2.3) , Warnings and Precautions (5.1 , 5.2) ] . WINREVAIR is intended for use under the guidance of a healthcare professional. Patients and caregivers may administer WINREVAIR when considered appropriate and when they receive training and follow-up from the healthcare provider (HCP) on how to reconstitute, prepare, measure, and inject WINREVAIR [see Patient Counseling Information (17) ] . Confirm at subsequent visits that the patient and/or caregiver can correctly prepare and administer WINREVAIR, particularly if the dose changes or the patient requires a different kit [see Warnings and Precautions (5.1) ] . Refer to the Instructions for Use (IFU) for detailed instructions on the proper preparation and administration of WINREVAIR. Selecting the Appropriate Product Kit If a patient’s body weight requires the use of two 45 mg vials or two 60 mg vials of lyophilized product, use a 2-vial kit instead of two individual 1-vial kits. A 2-vial kit includes instructions to combine the contents of two vials, which aids in measuring the proper dosage and eliminates the need for multiple injections [see How Supplied/Storage and Handling (16.1) ] . Reconstitution Instructions Remove the injection kit from the refrigerator and wait 15 minutes to allow the prefilled syringe(s) and drug product to come to room temperature prior to preparation. Attach the vial adapter to the vial. Visually inspect the pre-filled syringe for any damage or leaks and the Sterile Water for Injection inside to ensure there are no visible particles. Snap off the cap of the pre-filled syringe and attach the syringe to the vial adapter. Inject all of the Sterile Water for Injection from the attached syringe into the vial containing the lyophilized powder. This will provide a final concentration of 50 mg/mL. Gently swirl the vial to reconstitute the drug product. DO NOT shake or vigorously agitate. Allow the vial to stand for up to 3 minutes to allow bubbles to disappear. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. When properly mixed, WINREVAIR should be clear to opalescent and colorless to slightly brownish-yellow and does not have clumps or powder. If prescribed a 2-vial presentation, repeat the steps within this section to prepare the second vial. Use the reconstituted solution as soon as possible, but no later than 4 hours after reconstitution. Discard unused reconstituted solution. Syringe Preparation Turn the syringe and vial upside-down and withdraw the appropriate volume for injection, based on the patient’s weight. If the dose amount requires the use of two vials, withdraw the entire contents of the first vial and slowly transfer full contents into the second vial. Turn the syringe and vial upside-down and withdraw the required amount of drug product. If necessary, remove excess drug product. If necessary, remove excess air from the syring