Usual Adult Dose for Hemolytic Anemia

Recommended dosage is based on body weight:
39 to less than 75 kg: 6500 mg IV
75 kg or more: 7500 mg IV

Comments:

• Is recommended to administer treatment weekly for the first 2 weeks, and every 2 weeks thereafter.
• It is recommended to administer treatment at specified dosage time points, or within 2 days of these time points.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Known hypersensitivity to the active component or any of the ingredients

Dialysis

Data not available

Other Comments

Administration advice:

• Vaccinate patients against encapsulated bacteria at least 2 weeks prior to initiation of therapy. If urgent therapy is indicated in an unvaccinated patient, administer vaccine(s) as soon as possible.
• This drug is for IV infusion only.
• In-line infusion warmers may be used; do not exceed a temperature of 40C (104F).
• Total time from preparation, refrigeration, adjustment to room temperature, and infusion time should not exceed 36 hours.
• Administer infusion over 1 or 2 hours depending on body weight.
• Administer the infusion solution only through a 0.2 micron in-line filter with a polyethersulfone (PES) membrane.
• If a dose is missed, administer as soon as possible and thereafter resume every 2 weeks. If the duration since last dose exceeds 17 days, administer weekly for 2 weeks and then every 2 weeks thereafter.
• The manufacturer product information should be consulted for recommended infusion rates.

• If the infusion solution is not used immediately once prepared, store refrigerated between 2C and 8C (36F to 46F). Once removed from refrigeration, allow solution to adjust to room temperature at 20C to 25C (68F to 77F) and administer within 8 hours.

• Each vial is intended for a single dose.
• Inspect visually for particulate matter and discoloration prior to administration. Solution is clear and colorless to slightly yellow.
• Use aseptic technique to prepare. Do not shake to minimize foaming.
• The manufacturer product information should be consulted.

• This IV drug is compatible with 0.9% Sodium Chloride Injection.
• No incompatibilities have been observed between this infusion solution and infusion bags made of Di-(2-ethylhexyl)phthalate (DEHP) plasticized polyvinyl chloride (PVC), Ethyl Vinyl Acetate (EVA) and polyolefin (PO); administration sets made of DEHP-plasticized PVC, DEHP-free polypropylene (PP) and polyethylene (PE); and vial adapters made of polycarbonate (PC) and acrylonitrile-butadiene-styrene (ABS).

• It is recommended to monitor patients for at least 2 hours after completion of the initial administration for signs or symptoms of any infusion and/or hypersensitivity reaction, and for 1 hour following completion of subsequent infusions.
• Monitor patients for signs or symptoms of recurrent hemolysis after discontinuation of treatment, and consider restarting treatment if signs or symptoms of hemolysis occur.

• Read the US FDA-approved patient labeling (Medication Guide).
• Seek immediate medical attention if any new symptoms of infection occur.
• Seek medical attention if any new symptoms of infusion-related reactions occur.
• Report any new symptoms of SLE and seek medical attention.