Usual Adult Dose for Neuromyelitis Optica

Initial dose: 300 mg intravenous infusion followed 2 weeks later by a second 300 mg intravenous infusion.
Maintenance dose: Single 300 mg intravenous infusion every 6 months (starting 6 months from the first infusion).

Comments:

• Determine whether there is an active, clinically significant infection before each infusion and do not administer in the presence of an active infection.
• Pre-medicate with a corticosteroid (methylprednisolone or equivalent), antihistamine (diphenhydramine or equivalent), and an anti-pyretic (acetaminophen or equivalent) before each infusion.
• Observe the patient for at least one hour after the completion of the infusion

Renal Dose Adjustments

Data not available. No formal clinical studies have been conducted.

Based on population pharmacokinetic analysis, clearance was comparable in NMOSD patients with normal and mild/moderate impaired renal function.

Liver Dose Adjustments

Data not available. No formal clinical studies have been conducted.

Based on population pharmacokinetic analysis, clearance was comparable in NMOSD patients with normal and mild/moderate impaired hepatic function.

Precautions

CONTRAINDICATIONS:

• A history of a life-threatening infusion reaction to this drug.
• Active hepatitis B infection
• Active or untreated latent tuberculosis

Dialysis

Data not available

Other Comments

Administration advice:
Determine whether there is an active, clinically significant infection before each infusion and do not administer in the presence of an active infection.

• Pre-medicate with a corticosteroid (methylprednisolone or equivalent), antihistamine (diphenhydramine or equivalent), and an anti-pyretic (acetaminophen or equivalent) before each infusion.
• Administer under the close supervision of an experienced healthcare professional with access to appropriate medical support to manage potential severe reactions such as serious infusion reactions.
• Prior to the start of the intravenous infusion, the prepared infusion solution should be at room temperature.
• Administer drug in 250 mL bag via an IV infusion pump over 90 minutes; IV line should contain a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.
• Recommended IV Infusion Rate: 0 to 30 minutes: Infuse at 42 mL/hr; 31 to 60 minutes: Infuse at 125 mL/hr; 61 minutes to completion: Infuse at 333 mL/hr
• Observe the patient for at least one hour after the completion of the infusion.

• Store in a refrigerator at 2C to 8C (36F to 46F) in original carton to protect from light; do not freeze; do not shake; store vials upright
• Administer the prepared infusion solution immediately.
• If immediate administration is not possible, may store up to 24 hours in the refrigerator at 2C to 8C (36F to 46F) or 4 hours at room temperature prior to the start of the infusion.

• Dilute in 250 mL of 0.9% Sodium Chloride
• Mix diluted solution by gentle inversion; do not shake the solution

• Data not available

• Perform Hepatitis B virus (HBV) screening; contraindicated in patients with active HBV confirmed by positive results for surface antigen [HBsAg] and anti-HBV tests; For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment.
• Evaluate for active tuberculosis and test for latent infection; For patients with active tuberculosis or positive tuberculosis screening without a history of appropriate treatment, consult infectious disease experts before initiating.
• Perform testing for quantitative serum immunoglobulins. For patients with low serum immunoglobulins, consult immunology experts before initiating treatment.
• Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of therapy.

• Determine whether there is an active infection. In case of active infection, delay infusion until infection resolves.
• Premedicate with methylprednisolone 80 mg to 125 mg intravenously 30 minutes prior to infusion and diphenhydramine 25 mg to 50 mg orally and acetaminophen 500 mg to 650 mg orally 30 to 60 minutes prior to infusion.

• Observe the patient for at least one hour after the completion of the infusion.

• Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).