SARILUMAB AUTO-INJECTOR

Clinical Criteria Summary

Uncontrolled, active, severe infection (including undrained abscess)
Untreated latent or active tuberculosis infection
Hepatitis B surface antigen (HBsAg)-positive without antiviral prophylaxis
Untreated HIV infection
Concomitant live or live-attenuated vaccines, or administration of such vaccines less than 2 weeks prior to initiation
Concomitant immunosuppressive biologic, immunosuppressive targeted synthetic drug (e.g., tofacitinib or other JAK inhibitors), cyclophosphamide, or alkylating agents
Active hepatic disease or hepatic impairment
Baseline absolute neutrophil count (ANC) < 2000/mm3 (unless associated with Duffy-null Associated Neutrophil Count)
Baseline platelet count < 150,000/mm3
Baseline alanine transaminase (ALT) and/or aspartate transaminase (AST) > 1.5x the upper limit of normal (ULN)

Diagnosis of polymyalgia rheumatica (PMR)
Prescribed and monitored by a VA/VA Community Care rheumatologist or locally-designated expert
Completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay (IGRA)
Completed hepatitis B screening (HBsAg, total antibody-to-hepatitis-B-core-antigen [anti-HBc], and antibody to hepatitis B surface antigen [anti-HBs])
Current or past completion of hepatitis C screening
Initiated concurrently with or after glucocorticoid therapy (unless glucocorticoids are medically inadvisable)

For HBsAg-negative, anti-HBc-positive patients where consult is indicated: E-consult with GI/liver or infectious diseases expert for advice on antiviral prophylaxis or preemptive monitoring for HBV reactivation
Patients capable of pregnancy: Counseling provided on treatment risks vs benefits and requirement for effective contraception during therapy
Lactating patients/providing breastmilk: Counseling provided on potential risks and benefits of treatment

Antiviral prophylaxis for hepatitis B should utilize agents with a high genetic barrier to resistance (e.g., entecavir or tenofovir)
Vaccinations should be updated prior to initiation; recombinant zoster vaccine should be completed or initiated by the end of the first year, preferably when dosage is low or disease is stable
Routine rescreening for hepatitis B or C is not required for prescription renewals; retesting in high-risk patients should be considered

Uncontrolled active infection (may start/restart once treatment for infection has been initiated)
Untreated latent or active tuberculosis infection
Hepatitis B surface antigen (HBsAg)-positive and not on antiviral prophylaxis (may initiate after starting antiviral prophylaxis)
Untreated HIV infection (treated, well-controlled, asymptomatic HIV-positive patients may be treated)
Congenital or acquired immunodeficiency
Concomitant live or live-attenuated vaccines, or administration of inactivated, live, or live-attenuated vaccines less than 2 weeks before initiation
Concomitant immunosuppressive biologic, immunosuppressive targeted synthetic drug (e.g., tofacitinib or other JAK inhibitors), cyclophosphamide, or alkylating agents
Active hepatic disease or hepatic impairment
Baseline absolute neutrophil count (ANC) < 2000/mm3 unless associated with Duffy-null Associated Neutrophil Count
Baseline platelet count <150,000/mm3
Baseline ALT and/or AST > 1.5x the upper limit of normal (ULN)

Diagnosis of moderate to severe rheumatoid arthritis
Prescribed and monitored by a VA/VA Community Care rheumatologist or locally-designated expert
Offered all age-appropriate vaccinations prior to initiating therapy
Completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay [IGRA]
Completed hepatitis B screening (HBsAg, total antibody to hepatitis B core antigen [anti-HBc], and antibody to hepatitis B surface antigen [anti-HBs])
Current or past completion of hepatitis C screening (may initiate while waiting for test results)
Tumor necrosis factor inhibitor (TNFI) therapy is medically inadvisable, not tolerated, not adequate (no response to one TNFI after 3 months, partial response to 3-month trials of two TNFIs totaling 6 months), or lost response

If HBsAg-negative but anti-HBc-positive and consult is indicated: GI/liver or infectious diseases expert consulted for advice on antiviral prophylaxis or preemptive monitoring for HBV reactivation
Females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and use of effective contraception during therapy
Females who are lactating/providing breastmilk: Counseling provided on potential risks and benefits of treatment
Antiviral prophylaxis for hepatitis B virus should utilize agents with a high genetic barrier to resistance (e.g., entecavir or tenofovir)
Vaccinations should be updated prior to initiation; recombinant zoster vaccine should be completed or initiated by end of first year, preferably when dosage is low, disease is stable, or immune response is robust
May be used with methotrexate, other nonbiologic DMARDs, mycophenolate, hydroxychloroquine, or glucocorticoids; concomitant use of potent immunosuppressives should generally be avoided
Routine rescreening for hepatitis B or C is not required for prescription renewals; retesting in high-risk patients should be considered