Table 10.

Initial Visit:

History and Physical

·        History of malignancy, especially leukemia or lymphoma?

·        History of 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

·        History of angina or cardiac arrhythmia? (requires cardiac monitoring)

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

·        Medications:  cisplatin (renal toxicity)

·        Major surgery in next month?

Labs

·        CBC with differential, CMP, uric acid, phosphorus

·        Baseline CD19 count

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

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

·        Hepatitis C ELISA screen

·        Baseline EKG; cardiac monitoring during infusion if history of arrhythmia

·        Influenza vaccine (if flu season)

·        HIV (optional)

·        Pneumovax (optional)

Administration Considerations

·        First infusion in the hospital with crash cart available (Mount Sinai policy)

·        Premedicate with acetaminophen 650mg po, diphenhydramine 50mg po, and methylprednisolone 100mg i.v. 30 minutes prior to infusion

·        PCP and HSV prophylaxis if CLL during and for 12 months following treatment

Counseling/Other

·        Fatal infusion reaction, esp. first infusion 

·        Risk of infection, especially:

o    progressive multifocal leukoencephalopathy from JC virus (a fatal infection);

o    new or reactivated CMV, HSV, parvo B19, VZV, West Nile, hep B, hep C

·        Hepatitis B reactivation

·        Cardiac arrhythmia and angina worsening

·        Cytopenias

·        Risk of hypophosphatemia, esp. with steroids, and hyperuricemia

·        Avoid live vaccines – self and household members for one month prior to Rituxan and until CD19 count recovers

·        Tumor lysis syndrome (acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, hyperphosphatemia) if preexisting non-Hodgkin's lymphoma

·        Risk of hepatotoxicity and liver failure

·        Severe mucocutaneous reactions (paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesicobullous dermatitis, toxic epidermal necrolysis)

·        Bowel obstruction and perforation (in combination with chemotherapy)

·        In NHL, risk of cytopenias:  lymphopenia, neutropenia, leukopenia, anemia, thrombocytopenia

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 – for blistering diseases, expect effects at three weeks after second dose (more immediate effects likely due to premedication with methylprednisolone)?

·        Any live vaccines in past month?

·        Any household members getting live vaccine?

·        Other interval history

Labs

·        Premedicate with acetaminophen 650mg po, diphenhydramine 50mg po, and methylprednisolone 100mg i.v. 30 minutes prior to infusion

·        Prior to every infusion:  CMP, CBC, uric acid, phosphorus

·        One month after last infusion:  CBC

·        Every six months:  CD19 (CD19 < 1 indicates efficacy)

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

·        Influenza vaccine annually (in flu season)

·        If cytopenias develop, then weekly CBC

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

·        Repeat EKG with each infusion if history of arrhythmia

·        PCP and HSV prophylaxis if CLL during and for 12 months following treatment