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Dósis y administración

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WINREVAIR is administered once every
3 weeks by subcutaneous injection according to patient weight

The recommended STARTING DOSE in adults is 0.3 mg/kg

PRIOR TO THE FIRST DOSE

  • Obtain Hgb and platelet count prior to the first dose of WINREVAIR.
  • Rapid increases in Hgb of more than 2 g/dL have been observed after initiating treatment.
  • It is not recommended to initiate treatment if platelet count is <50,000/mm3 (<50.0 x 109/L).

Note to countries: [For countries who register the kit presentation, include the “Option A” column. For countries who register the vial only presentation, include the “Option B” column.]

The recommended TARGET DOSE in adults is 0.7 mg/kg

PRIOR TO THE FIRST RECOMMENDED TARGET DOSE

  • Obtain and review Hgb and platelet count prior to increasing to the target dose.
  • Continue treatment at 0.7 mg/kg every 3 weeks unless dosage adjustments are required.
  • It is not recommended to initiate treatment if platelet count is <50,000/mm3 (<50.0 x 109/L).

Note to countries: [For countries who register the kit presentation, include the “Option A” column. For countries who register the vial only presentation, include the “Option B” column.]

Note to countries: [Include text for countries registering kit presentation.]

Missed dose, overdose, or underdose

  • If a dose of WINREVAIR is missed, administer as soon as possible.
    • If the missed dose of WINREVAIR is not taken within 3 days of the scheduled date, adjust the schedule to maintain 3-week dosing intervals.
  • In case of an overdose or underdose, consider retraining the patient or caregiver on proper administration as appropriate.
    • In case of an overdose, monitor for erythrocytosis.

Note to countries: [Include text for countries registering vial only presentation.]

Missed dose or overdose

  • If a dose of WINREVAIR is missed, administer as soon as possible.
    • If the missed dose of WINREVAIR is not taken within 3 days of the scheduled date, adjust the schedule to maintain 3-week dosing intervals.
  • In case of an overdose, monitor for erythrocytosis.

Dosage modifications in adults due to hemoglobin increase or platelet count decrease

  • Check Hgb count before each dose until Hgb is stable. Thereafter, monitor Hgb and platelet count periodically.
  • Consider assessment of benefit-risk for the individual patient in determining whether dose modification is appropriate.
  • Hgb increases >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 <50,000/mm3 (<50.0 x 109/L)

For treatment delays lasting >9 weeks, restart treatment at 0.3 mg/kg.

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Preparation and administration

Note to countries: [For countries who register the kit presentation, choose “Option A” text. For countries who register the vial only presentation, choose “Option B” text.]
Option A:

WINREVAIR is intended for use under the guidance of a health care professional. Patients and caregivers may administer WINREVAIR when considered appropriate and when they receive training and follow-up from the doctor in how to reconstitute, prepare, measure, and inject WINREVAIR.

Consider confirming at subsequent visits that the patient or caregiver can prepare and administer WINREVAIR correctly:

  • If the dose changes or the patient requires a different kit.
  • If the patient develops erythrocytosis.

Refer to the Instructions for Use for detailed instructions on the proper preparation and administration of WINREVAIR. 

Selecting the appropriate product kit

If a patient’s weight requires the use of two 45 mg vials or two 60 mg vials of lyophilized product, a 2-vial kit should be used 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.

Reconstitution instructions

  1. 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.
  2. Check the vial to ensure the product is not expired. The powder should be white to off-white and may look like a whole or fragmented cake.
  3. Remove the lid from the vial containing the WINREVAIR lyophilized powder and swab the rubber stopper with an alcohol wipe.
  4. Attach the vial adapter to the vial.
  5. Visually inspect the pre-filled syringe for any damage or leaks and the sterile water inside to ensure there are no visible particles.
  6. Snap off the cap of the pre-filled syringe and attach the syringe to the vial adapter.
  7. Inject all of the sterile water from the attached syringe into the vial containing the lyophilized powder. This will provide a final concentration of 50 mg/mL.
  8. Gently swirl the vial to reconstitute the drug product. Turn the vial upside-down as needed to mix powder stuck to the sides or top of the vial. DO NOT shake or vigorously agitate.
  9. Allow the vial to stand for up to 3 minutes to allow bubbles to disappear.
  10. Visually inspect the reconstituted solution. When properly mixed, WINREVAIR should be clear and colorless and does not have clumps or powder.
  11. Unscrew the syringe from the vial adapter and discard the emptied syringe into a sharps container.
  12. If prescribed a 2-vial presentation, repeat the steps within this section to prepare the second vial.
  13. Use the reconstituted solution as soon as possible, but no later than 4 hours after reconstitution.

Syringe preparations

  1. Swab the vial adapter with an alcohol wipe.
  2. Remove dosing syringe from packaging and attach the syringe to the vial adapter.
  3. 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.
  4. If necessary, push plunger in to remove excess drug product or air from the syringe.
  5. Remove the syringe from the vial and attach the needle.

Administration instructions

WINREVAIR is for subcutaneous injection.

  1. Select the injection site on the abdomen (at least 2 inches away from navel), upper thigh, or upper arm, and swab with an alcohol wipe. Select a new site for each injection that is not scarred, tender, or bruised.
    • For administration by the patient or caregiver, use only the abdomen and upper thigh
      (see Instructions for Use).
  2. Perform subcutaneous injection.
  3. Discard the emptied syringe into a sharps container. Do not reuse the syringe.

Option B:

WINREVAIR lyophilized powder should be prepared and administered by a health care professional. Step-by-step preparation and administration instructions are provided below.

Reconstitution instructions

  1. Remove the vial(s) from the refrigerator and wait 15 minutes to allow the drug product to come to room temperature prior to preparation.
  2. Check the vial to ensure the product is not expired. The powder should be white to off-white and may look like a whole or fragmented cake.
  3. Remove the lid from the vial containing the WINREVAIR lyophilized powder and swab the rubber stopper with an alcohol wipe.
  4. Reconstitute the content of the vial with sterile water:
    • For each vial of WINREVAIR 45 mg, inject 1.0 mL of sterile water
    • For each vial of WINREVAIR 60 mg, inject 1.3 mL of sterile water
    This will provide a final concentration of 50 mg/mL
  5. Gently swirl the vial to reconstitute the drug product. Turn the vial upside-down as needed to mix powder stuck to the sides or top of the vial. DO NOT shake or vigorously agitate.
  6. Allow the vial to stand for up to 3 minutes to allow bubbles to disappear.
  7. Visually inspect the reconstituted solution. When properly mixed, WINREVAIR should be clear and colorless and does not have clumps or powder.
  8. If prescribed a 2-vial presentation, repeat the steps within this section to prepare the second vial.
  9. Use the reconstituted solution as soon as possible, but no later than 4 hours after reconstitution.

Administration instructions

  1. Withdraw the appropriate dose of WINREVAIR from one or two vials, depending on the volume to inject, using a 3 mL syringe with 0.1 mL graduation.
  2. Select the injection site on the abdomen (at least 2 inches away from navel), upper thigh, or upper arm, and swab with an alcohol wipe. For each injection, select a new site that is not scarred, tender, or bruised.
  3. Perform subcutaneous injection.
  4. Discard the emptied syringe into a sharps container. Do not reuse the syringe.

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