Medically reviewed by Drugs.com. Last updated on Aug 10, 2021.
Recommended Vaccination and Prophylaxis
Vaccinate patients against encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B at least 2 weeks prior to initiation of EMPAVELI therapy according to current ACIP guidelines [see Warnings and Precautions (5.1)].
Provide 2 weeks of antibacterial drug prophylaxis to patients if EMPAVELI must be initiated immediately and vaccines are administered less than 2 weeks before starting therapy with EMPAVELI.
Healthcare professionals who prescribe EMPAVELI must enroll in the REMS for EMPAVELI [see Warnings and Precautions (5.2)].
The recommended dose of EMPAVELI is 1,080 mg by subcutaneous infusion twice weekly via a commercially available infusion pump with a reservoir of at least 20 mL.
Dosage for patients switching to EMPAVELI from C5 inhibitors
To reduce the risk of hemolysis with abrupt treatment discontinuation:
- For patients switching from eculizumab, initiate EMPAVELI while continuing eculizumab at its current dose. After 4 weeks, discontinue eculizumab before continuing on monotherapy with EMPAVELI.
- For patients switching from ravulizumab, initiate EMPAVELI no more than 4 weeks after the last dose of ravulizumab.
- For lactate dehydrogenase (LDH) levels greater than 2 × the upper limit of normal (ULN), adjust the dosing regimen to 1,080 mg every three days.
- In the event of a dose increase, monitor LDH twice weekly for at least 4 weeks.
EMPAVELI is for subcutaneous infusion using an infusion pump.
EMPAVELI is intended for use under the guidance of a healthcare professional. After proper training in subcutaneous infusion, a patient may self-administer, or the patient's caregiver may administer EMPAVELI, if a healthcare provider determines that it is appropriate.
- Refer to the EMPAVELI Instructions for Use and the infusion pump manufacturer's instructions for full preparation and administration information.
- Use aseptic technique when preparing and administering EMPAVELI.
- Prior to use‚ allow EMPAVELI to reach room temperature for approximately 30 minutes. Keep the vial in the carton until ready for use to protect from light.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. EMPAVELI is a clear, colorless to slightly yellowish solution. Do not use if the liquid looks cloudy, contains particles, or is dark yellow.
- Use a needleless transfer device (such as a vial adapter) or a transfer needle to fill the syringe.
- Rotate infusion sites (i.e., abdomen, thighs, hips, upper arms) from one infusion to the next. Do not infuse where the skin is tender, bruised, red, or hard. Avoid infusing into tattoos, scars, or stretch marks.
- If multi-infusion sets are needed, ensure the infusion sites are at least 3 inches apart.
- The typical infusion time is approximately 30 minutes (if using two infusion sites) or approximately 60 minutes (if using one infusion site).
- Discard any unused portion.
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