Usual Adult Dose for Neuromyelitis Optica

120 mg subcutaneously at Weeks 0, 2, and 4, followed by 120 mg subcutaneously every 4 weeks

Use: For the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

See dose adjustments.

Dose Adjustments

MISSED DOSE;

• Last dose administered less than 8 weeks ago during the maintenance period or missed a loading dose: Administer 120 mg subcutaneously as soon as possible; do not wait until the next planned dose:
• Maintenance period After the delayed or missed dose is administered: Reset the dose schedule to every 4 weeks.
• Loading period If the second loading dose is delayed or missed: Administer as soon as possible and administer the 3rd and final loading dose 2 weeks later.
• If the third loading dose is delayed or missed, administer as soon as possible and administer the 1st maintenance dose 4 weeks later.
• Last dose administered 8 weeks to less than 12 weeks ago: Administer 120 mg subcutaneously at 0 and 2 weeks, followed by 120 mg subcutaneously every 4 weeks.
• Last dose administered 12 weeks ago or longer: Administer 120 mg subcutaneously at 0, 2, and 4 weeks, followed by 120 mg subcutaneously every 4 weeks.

• If associated with any bilirubin elevation, discontinue this drug, and do not reinitiate.
• If not associated with any bilirubin elevation above the ULN, when the ALT or AST level has returned to the normal range and following assessment of the patient, therapy can be restarted per this schedule:
• Last dose administered less than 12 weeks ago: Restart at 120 mg subcutaneously every 4 weeks.
• Last dose administered 12 weeks ago or longer: Restart therapy at 120 mg subcutaneously at Weeks 0, 2, and 4 followed by 120 mg subcutaneously every 4 weeks.

• Monitor neutrophils 4 to 8 weeks after initiation of therapy and thereafter at regular intervals.
• If the neutrophil count is below 1 x 10(9)/L and confirmed by repeat testing, therapy should be interrupted until the neutrophil count is greater than 1 x 10(9)/L.

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients
• Active Hepatitis B infection
• Active or untreated latent tuberculosis (TB)

Dialysis

Data not available

Other Comments

Administration advice:

• Inject into the abdomen or thigh.
• Rotate injection sites with each administration.
• Do not inject into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact.

• Refrigerate at 2C to 8C (36F to 46F) in original carton to protect from light. Do not freeze. Do not shake.
• Prior to administration, if unopened, can be removed from and returned to the

• The total combined time out of refrigeration should not exceed 8 days at a temperature that does not exceed 30C (86F).

• This drug injection is available as a sterile, preservative-free, clear, colorless to slightly yellow solution in single-dose prefilled syringe (PFS) with needle safety device.
• The manufacturer product information should be consulted.

• Perform Hepatitis B virus (HBV) screening prior to the first dose; this drug is contraindicated in patients with active HBV.
• 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 therapy.
• Evaluate for active tuberculosis (TB) and test for latent infection.
• For patients with active TB or positive TB screening without a history of treatment, consult infectious disease experts before initiating therapy.
• Liver transaminases and serum bilirubin should be assessed prior to initiation of therapy; caution should be exercised when considering initiation of therapy in patients whose aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels are greater than 1.5 times the upper limit of normal (ULN).
• Because vaccination with live-attenuated or live vaccines is not recommended during therapy, administer all immunizations at least 4 weeks prior to initiation of therapy for live or live-attenuated vaccines and, if possible, at least 2 weeks prior to initiation of therapy for non-live vaccines.

• Monitor ALT and AST levels every 4 weeks for the first 3 months of therapy, followed by every 3 months for one year, and thereafter as necessary.

• After training the patient/caregiver may inject this drug.
• Seek immediate medical attention for a serious allergic reaction and do not administer further doses until evaluated.
• Prior to use, remove the prefilled syringe from the refrigerator and allow to sit at room temperature outside of the carton for 30 minutes; do not warm this drug.
• Inspect visually for particulate matter and discoloration prior to administration; solution should be clear and colorless to slightly yellow; do not use if the solution is cloudy, discolored, or contains particles, or if any part of the prefilled syringe appears to be damaged.
• Inject the full amount in the syringe.
• Administer subcutaneously in the abdomen or thigh; rotate injection sites with each administration.