Usual Adult Dose for Myasthenia Gravis

10 mg/kg IV once weekly for 4 weeks

• Weight greater than 120 kg: 1200 mg IV once weekly for 4 weeks

• Subsequent treatment cycles should be based on clinical evaluation.
• The safety of initiating a cycle sooner than 50 days from the start of the prior cycle has not been established.
• Evaluate the need for age-appropriate immunizations prior to therapy initiation.

Renal Dose Adjustments

Mild renal dysfunction (estimated GFR [eGFR] 60 to 89 mL/min/1.73 m2): No adjustment recommended.
Moderate to severe renal dysfunction (eGFR less than 6059 mL/min/1.73 m2): Data not available

Liver Dose Adjustments

No adjustment recommended

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer as an IV infusion over 1 hour; use a 0.2 micron in-line filter and flush line after administration.
• Administration should be performed by a healthcare professional.
• If a hypersensitivity reaction occurs during administration, discontinue infusion and institute appropriate supportive measures.

• Prior to use: Store vials in refrigerator (36F to 46F [2C to 8C]) in the original carton to protect from light; do not freeze; do not shake.
• Once diluted, complete infusion within 4 hours.
• If immediate use is not possible, may store diluted solution in refrigerator for up to 8 hours; do not freeze, protect from light.
• Once diluted solution has been refrigerated, allow to reach room temperature via ambient air (do not heat in any other manner); complete infusion within 4 hours of removing from the refrigerator.

• Prescribed dose should be gently withdrawn from vials and diluted with 0.9% sodium chloride to make a total volume of 125 mL for IV infusion.
• The diluted solution should be gently inverted without shaking to ensure thorough mixing.
• The diluted solution can be administered using polyethylene (PE), polyvinyl chloride (PVC), ethylene vinyl acetate (EVA), or ethylene/polypropylene copolymer bags (polyolefins bags), and with PE, PVC, EVA, or polyurethane/polypropylene infusion lines.

• Should not be mixed with other drugs

• Subsequent treatment cycles should be based on clinical evaluation; the safety of initiating subsequent cycles sooner than 50 days from the start of the previous treatment cycle has not been established.

• Monitor patients for hypersensitivity reactions during administration and for 1 hour after.
• Monitor for infections.

• Patients should be instructed to contact their healthcare provider if they develop an infection or any signs or symptoms of a hypersensitivity reaction.
• Patients are advised to discuss vaccination status with their healthcare provider.