部份中文奥法木单抗处方资料（仅供参考）
英文名称：ofatumumab
商品名：Arzerra
中文名：奥法木单抗
国外上市：美国（2014）日本（2013）欧洲（2015）
适应症：Ofatumumab用于治疗慢性淋巴细胞白血病（CLL
使用剂量：第1天300毫克，接着：第1天1 周后1000毫克，随后：7周后1000毫克，此后每8周较多2年
药品副作用：
见说明书
ARZERRA（ofatumumab）用于治疗难治型慢性淋巴细胞性白血病（CLL）难治型慢性淋巴细胞性白血病患者
完整说明书附件：https://www.medicines.org.uk/emc/product/520/smpc
Arzerra 100mg/1000mg concentrate for solution for infusion
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 2  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 eva luation 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 antihyperuricemics and hydration prior to infusion of ARZERRA
For treatment of TLS, administer aggressive intravenous hydration and antihyperuricemic 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%)
Extended treatment therapy in CLL: Common adverse reactions (≥10%) were infusion reactions, neutropenia, and upper respiratory infection
Relapsed CLL: Common adverse reactions (≥10%) were infusion reactions, neutropenia, febrile neutropenia, and leukopenia
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, postbaseline 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%)