Ocrevus

Ocrelizumab

Adult patients w/ relapsing forms of multiple sclerosis (RMS) w/ active disease defined by clinical or imaging features; early primary progressive multiple sclerosis (PPMS) in terms of disease duration & level of disability, & w/ imaging features inflammatory-activity characteristic.

IV Adult Premed for infusion-related reaction (IRR): Methylprednisolone (or an equiv) 100 mg IV, approx 30 min prior to each infusion; antihistamine approx 30-60 min prior to each infusion. May consider an antipyretic approx 30-60 min prior to each infusion. Initial dose: 600 mg as 2 separate IV infusions (1st as 300 mg in 250 mL soln for infusion at a rate of 30 mL/hr for 30 min; 2nd, 2 wk later, by 300 mg in 250 mL soln for infusion at a rate of 30 mL/hr for 30 min). May increase infusion rate to 30 mL/hr increments every 30 min to a max of 180 mL/hr. Give each infusion over approx 2.5 hr. Subsequent doses: 600 mg IV infusion administered as single dose every 6 mth, 6 mth after the initial dose (min interval: 5 mth between each dose). (Option 1) 600 mg in 500 mL soln for infusion at a rate of 40 mL/hr for 30 min. May increase infusion rate to 40 mL/hr increments every 30 min to a max of 200 mL/hr. Give each infusion over approx 3.5 hr. (Option 2) 600 mg in 500 mL soln for infusion at a rate of 100 mL/hr for the 1st 15 min. Increase infusion rate to 200 mL/hr for the next 15 min, to 250 mL/hr for the next 30 min & to 300 mL/hr for the remaining 60 min. Give each infusion over approx 2 hr. Patient experiencing mild to moderate IRR Reduce rate to ½ at the onset of the reaction & maintain reduced rate for at least 30 min. Increase the infusion rate according to the patient's tolerance.

Hypersensitivity. Current active infection. Patients in a severely immunocompromised state. Known active malignancies.

Not to be administered as an IV push or bolus. IRRs may occur w/in 24 hr of the infusion; appropriate resources for the management of severe reactions (eg, serious IRR, hypersensitivity reactions &/or anaphylactic reactions) must be available. Observe patient for at least 1 hr after infusion completion for any IRR symptom. Hypotension may occur during infusions; consider w/holding antihypertensives for 12 hr prior to & throughout each infusion. Patients w/ a history of CHF (NYHA III & IV). Interrupt infusion immediately & permanently in patients who experience severe pulmonary symptoms (eg, bronchospasm or asthma exacerbation) during the infusion & must be administered w/ symptomatic treatment & monitored until the pulmonary symptoms have resolved. Monitor for possible IRR w/in 24 hr. IgE-mediated hypersensitivity reactions can occur; do not treat patients w/ known IgE-mediated hypersensitivity. Delay administration in patients w/ active infection until the infection is resolved. Verify the patient's immune status before dosing; not to be administered in severely immunocompromised patients (eg, w/ lymphopenia, neutropenia, hypogammaglobulinemia). Reported increased risk of severe pneumonia in patients w/ swallowing difficulties; take prompt action for patients presenting w/ pneumonia. Monitor for early signs & symptoms of progressive multifocal leukoencephalopathy (PML); w/hold dosing if PML is suspected & permanently discontinue treatment if PML is confirmed. Reported HBV reactivation; perform HBV screening before treatment initiation. Possible late-onset neutropenia at least 4 wk after the latest infusion; measure blood neutrophils in patients w/ signs & symptoms of infection. Not to be used in patients w/ known active malignancy. Patients w/ known risk factors for malignancies & who are being actively monitored for recurrence of malignancy. Concomitant use w immunosuppressants; consider potential for overlapping pharmacodynamic effects when initiating ocrelizumab after an immunosuppressive therapy or initiating an immunosuppressive therapy after ocrelizumab. Not recommended for concomitant live-attenuated or live vaccines. Patients who require vaccination should complete immunisation at least 6 wk prior to treatment initiation. Delay vaccination w/ live or live-attenuated vaccines until B-cell levels have recovered in infants of mothers exposed to ocrelizumab during pregnancy. Contains Na <23 mg/dose. Moderate & severe renal & hepatic impairment. Women of childbearing potential should use contraception during treatment & for 12 mth after the last infusion. Avoid use during pregnancy. Discontinue breastfeeding during therapy. Childn 0-18 yr.

URTI, nasopharyngitis, flu; decreased blood Ig M; IRRs. Sinusitis, bronchitis, oral herpes, gastroenteritis, resp tract & viral infection, herpes zoster, conjunctivitis, cellulitis; neutropenia; cough, catarrh; decreased blood Ig G.

Not recommended to be used w/ other immunosuppressive therapies except corticosteroids for symptomatic treatment of relapses. Increased result of serious infections, including opportunistic infections when used concomitantly w/ immunosuppressants (eg, chronic corticosteroids, non-biologic & biologic DMARDS, mycophenolate mofetil, cyclophosphamide, azathioprine).

Immunosuppressants

L04AG08 - ocrelizumab ; Belongs to the class of monoclonal antibodies. Used as immunosuppressants.

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