Important Safety Information, Including Boxed WARNING


WARNING: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

Hepatitis B virus (HBV) reactivation can occur in patients receiving CD20-directed cytolytic antibodies, +

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INDICATIONS for ARZERRA® (ofatumumab)

  • In combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate
  • In combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL
  • For extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL
  • For the treatment of patients with CLL refractory to fludarabine and alemtuzumab

IMPORTANT SAFETY INFORMATION for ARZERRA® (ofatumumab)

WARNING: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

  • Hepatitis B virus (HBV) reactivation can occur in patients receiving CD20-directed cytolytic antibodies, including ARZERRA, in some cases resulting in fulminant hepatitis, hepatic failure, and death

  • Progressive multifocal leukoencephalopathy (PML) resulting in death can occur in patients receiving CD20-directed cytolytic antibodies, including ARZERRA

 

Infusion Reactions

  • ARZERRA can cause serious, including fatal, infusion reactions manifesting as bronchospasm, dyspnea, laryngeal edema, pulmonary edema, flushing, hypertension, hypotension, syncope, cardiac events, back pain, abdominal pain, pyrexia, rash, urticaria, angioedema, cytokine release syndrome, and anaphylactoid/anaphylactic reactions
  • Administer ARZERRA in an environment where facilities to adequately monitor and treat infusion reactions are available. Premedicate with acetaminophen, an antihistamine, and a corticosteroid. Infusion reactions may occur despite premedication
  • Interrupt ARZERRA for infusion reactions of any severity and initiate appropriate medical treatment. If an anaphylactic reaction occurs, immediately and permanently discontinue ARZERRA

Hepatitis B Virus Reactivation

  • Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, has occurred in patients treated with ARZERRA 
  • Screen all patients for HBV infection before initiating ARZERRA
  • Monitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following treatment with ARZERRA. HBV reactivation has been reported for at least 12 months following completion of therapy
  • In ARZERRA-treated patients who develop reactivation of HBV, immediately discontinue ARZERRA and any concomitant chemotherapy, and institute appropriate treatment

HBV Infection

  • Fatal infection due to hepatitis B in patients who have not been previously infected has been observed with ARZERRA. Monitor patients for clinical and laboratory signs of hepatitis

Progressive Multifocal Leukoencephalopathy

  • Progressive multifocal leukoencephalopathy (PML) resulting in death has occurred with ARZERRA. Consider PML in any patient with new onset of or changes in pre-existing neurological signs or symptoms
  • If PML is suspected, discontinue ARZERRA and initiate evaluation for PML, including neurology consultation

Tumor Lysis Syndrome

  • Tumor lysis syndrome (TLS), including the need for hospitalization, has occurred in patients treated with ARZERRA. Patients with high tumor burden and/or high circulating lymphocyte counts (>25 x 109/L) are at greater risk
  • Consider TLS prophylaxis with anti-hyperuricemics and hydration prior to infusion of ARZERRA
  • For treatment of TLS, administer aggressive intravenous hydration and anti-hyperuricemic agents, correct electrolyte abnormalities, and monitor renal function

Cytopenias

  • Severe cytopenias, including neutropenia, thrombocytopenia, and anemia, can occur with ARZERRA. Pancytopenia, agranulocytosis, and fatal neutropenic sepsis have occurred in patients who received ARZERRA in combination with chlorambucil. Grade 3/4 late-onset neutropenia and/or prolonged neutropenia were reported in ARZERRA-treated patients
  • Monitor complete blood counts at regular intervals during and after conclusion of therapy, and increase the frequency of monitoring in patients who develop Grade 3/4 cytopenias

Immunizations

  • Do not administer live viral vaccines to patients who have recently received ARZERRA

Most Common Adverse Reactions

  • Previously untreated CLL: (≥10%, all grades) were infusion reactions (67% for ARZERRA plus chlorambucil vs 0% for chlorambucil) and neutropenia (27% vs 18%)
  • Relapsed CLL: Common adverse reactions (≥10%) were infusion reactions, neutropenia, febrile neutropenia, and leukopenia
  • Extended treatment therapy in CLL: Common adverse reactions (≥10%) were infusion reactions, neutropenia, and upper respiratory infection 
  • In the single-arm refractory CLL clinical trial, the most common adverse reactions (≥10%, all grades) were neutropenia, pneumonia, pyrexia, cough, diarrhea, anemia, fatigue, dyspnea, rash, nausea, bronchitis, and upper respiratory tract infections. The most common serious adverse reactions were infections (including pneumonia and sepsis), neutropenia, and pyrexia

Laboratory Abnormalities

  • In the previously untreated CLL clinical trial, post-baseline hematologic laboratory abnormalities (all grades) occurring with ≥5% incidence in patients receiving ARZERRA plus chlorambucil, and also ≥2% more than patients receiving chlorambucil, were leukopenia (67% for ARZERRA plus chlorambucil vs 28% for chlorambucil), neutropenia (66% vs 56%), and lymphopenia (52% vs 20%)

Please see full Prescribing Information, including Boxed WARNING, for ARZERRA.