Key warnings and precautions

• Lab Monitoring
• Patient Monitoring
• • Lipids

    4–8 WEEKS FOLLOWING INITIATION; EVERY 6 MONTHS THEREAFTER

    WARNINGS Treatment with ACTEMRA was associated with increases in lipid parameters such as total cholesterol, triglycerides, LDL cholesterol, and/or HDL cholesterol.

    LAB VALUE	RECOMMENDATION
    See National Cholesterol Education Program	Patients should be managed according to clinical guidelines for the management of hyperlipidemia (PI 5.3) Prescribers should exercise caution when ACTEMRA is coadministered with CYP3A4 substrate drugs where decrease in effectiveness is undesirable (eg, lovastatin, atorvastatin) (PI 7.2)

  • Liver function tests
    (ALT/AST)

    EVERY 4–8 WEEKS

    WARNINGS Treatment with ACTEMRA was associated with a higher incidence of transaminase elevations. Increased frequency and magnitude of these elevations was observed when potentially hepatotoxic drugs (eg, methotrexate) were used in combination with ACTEMRA.

    It is not recommended to initiate ACTEMRA treatment in patients with elevated transaminases ALT or AST > 1.5x ULN.

    When clinically indicated, other liver function tests such as bilirubin should be considered.

    Treatment with ACTEMRA is not recommended in patients with active hepatic disease or hepatic impairment.

    LAB VALUE	RECOMMENDATION
    > 1 to 3x ULN	If appropriate, modify concomitant DMARD(s) dose For persistent increases in this range, reduce ACTEMRA dose to 4 mg/kg or interrupt ACTEMRA until ALT or AST have normalized
    > 3 to 5x ULN (confirmed by repeat testing)	Interrupt ACTEMRA dosing until < 3x ULN and follow recommendations above for lab value > 1 to 3x ULN For persistent increases > 3x ULN, discontinue ACTEMRA
    > 5x ULN	Discontinue ACTEMRA (PI 2.4)

  • Neutrophils

    EVERY 4–8 WEEKS

    WARNINGS Treatment with ACTEMRA was associated with a higher incidence of neutropenia.

    It is not recommended to initiate ACTEMRA treatment in patients with an absolute neutrophil count

    (ANC) < 2000/mm³. In patients who develop an ANC < 500/mm³ treatment is not recommended.

    LAB VALUE	RECOMMENDATION
    ANC > 1000	Maintain ACTEMRA dosing
    500 to 1000	Interrupt ACTEMRA dosing When ANC > 1000 cells per mm3, resume ACTEMRA at 4 mg/kg and increase to 8 mg/kg as clinically appropriate
    ANC < 500	Discontinue ACTEMRA (PI 2.4)

  • Platelets

    EVERY 4–8 WEEKS

    WARNINGS Treatment with ACTEMRA was associated with a reduction in platelet counts.

    It is not recommended to initiate ACTEMRA treatment in patients with a platelet count < 100,000/mm³.

    LAB VALUE	RECOMMENDATION
    50,000 to 100,000	Interrupt ACTEMRA dosing When platelet count is > 100,000 cells per mm3, resume ACTEMRA at 4 mg/kg and increase to 8 mg/kg as clinically appropriate
    < 50,000	Discontinue ACTEMRA (PI 2.4)

• Serious or opportunistic infections
  • Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, protozoal, or other opportunistic pathogens have been reported in patients receiving immunosuppressive agents including ACTEMRA
  • ACTEMRA should not be administered in patients with an active infection, including localized infections
  • Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ACTEMRA
  • ACTEMRA should be interrupted if a patient develops a serious infection, an opportunistic infection, or sepsis
  (PI 5.1)
  Malignancies
  • The impact of treatment with ACTEMRA on the development of malignancies is not known but malignancies were observed in clinical studies
  • ACTEMRA is an immunosuppressant, and treatment with immunosuppressants may result in an increased risk of malignancies
  (PI 5.4)
  Demyelination
  • The impact of treatment with ACTEMRA on demyelinating disorders is not known, but multiple sclerosis and chronic inflammatory demyelinating polyneuropathy were reported rarely in RA clinical studies
  • Patients should be closely monitored for signs and symptoms potentially indicative of demyelinating disorders
  • Prescribers should exercise caution in considering the use of ACTEMRA in patients with preexisting or recent onset demyelinating disorders
  (PI 5.6)
  Gastrointestinal perforations
  • Events of gastrointestinal perforation have been reported in clinical trials, primarily as complications of diverticulitis
  • ACTEMRA should be used with caution in patients who may be at increased risk for gastrointestinal perforation
  • Patients presenting with new onset abdominal symptoms should be evaluated promptly for early identification of gastrointestinal perforation
  (PI 5.2)
  Hypersensitivity reactions, including anaphylaxis
  • Hypersensitivity reactions, including anaphylaxis and death, have been reported in association with infusion of ACTEMRA
  • If anaphylaxis or other clinically significant hypersensitivity reaction occurs, administration of ACTEMRA should be stopped immediately and ACTEMRA should be permanently discontinued
  • Do not administer ACTEMRA to patients with known hypersensitivity to ACTEMRA
  • See full PI for contraindications
  (PI 5.5)
  Vaccinations
  • Live vaccines should not be given concurrently with ACTEMRA
  • No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving ACTEMRA or on the effectiveness of vaccination in patients receiving ACTEMRA
  (PI 5.8)

• ULN=upper limit of normal; ANC=absolute neutrophil count.

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