Table 8.

Stelara (ustekinumab) [25]

Initial Visit:

History and Physical

·        History of malignancy or serious infections (hepatitis, TB, HIV, other)?

·        Total body skin exam for skin cancer

·        Check for HSM, cervical/axillary/inguinal lymphadenopathy

·        Active infection?  Hold dose for infection or sepsis

·        Coronary artery disease or stroke?

·        Have you lived in Southwest (risk of coccidiomycosis) or Southeast – Ohio and Mississippi River Valleys (risk of histoplasmosis or blastomycosis)?

·        Travel to area endemic for TB?

·        Live vaccine within past month – you or household member?

·        Medications:  warfarin; cyclosporine (can alter blood levels)

·        Major surgery in next month?

·        Latex allergy?

Labs

·        CBC, CMP

·        TB test (for PPD, consider >5mm as positive)

·        Hepatitis B screen:  Hepatitis B sAg, Hepatitis B sAb, Hepatitis B cAb

·        Influenza vaccine (if flu season)

·        HIV (optional) – especially with erythrodermic psoriasis

·        Cardiovascular risk panel:  CRP, homocysteine, HbA1C, lipid profile (if screening for psoriasis) (optional)

·        Pneumovax (optional)

Counseling/Other

·        Injections under supervision of health care professional

·        Can worsen existing malignancies

·        Increased risk of malignancy (non-melanoma skin cancer, breast, colon, head and neck, kidney, prostate, and thyroid cancers)

o    History of prior phototherapy - increased risk for non-melanoma skin cancer

·        Risk of bacterial, mycobacterial, fungal, and viral infections

·        Risk of coronary artery thrombosis/ischemic heart disease

·        Theoretical risk for infection from:  mycobacteria, salmonella, Bacillus Calmette-Guerin vaccinations

·        Risk of reactivation of latent infection (i.e., TB or Hepatitis B)

·        No BCG vaccine one year prior to first dose or before one year after last dose

·        Reversible Posterior Leukoencephalopathy Syndrome (headache, seizure, confusion, visual disturbance)

·        Avoid live vaccines – self and household members

·        Pediatric Patients:  Up to date on vaccines before starting?

·        Needle cap of the prefilled syringe and the autoinjector contain a latex derivative

·        Formation of anti-Stelara antibodies that can cause decreased efficacy over time

Follow-up Visit:

History and Physical

·        Every six months:  Total body skin exam for skin cancer

·        Every six months:  Check for HSM, cervical/axillary/inguinal lymphadenopathy

·        Any new infection – hold dose for active infection or sepsis

·        Major surgery in next month?

·        Is there sustained clinical efficacy in the treatment interval?  Skin?  Joints?

·        Any live vaccines in past month?

·        Any household members getting live vaccine?

·        Other interval history

Labs

·        Prior to each injection:  CBC, CMP

·        Every year:  TB test (consider induration of >5mm as positive)

·        Influenza vaccine annually (in flu season)

·        In HBV carriers, check liver panel for laboratory signs of hepatitis B reactivation