Ofatumumab Brand Name– Arzerra
What is Ofatumumab
Ofatumumab is a fully human monoclonal antibody that binds specifically to the CD20 molecule expressed on normal B lymphocytes and on B-cell chronic lymphocytic leukemia (CLL), which causes B-cell lysis and death.
The epitope that ofatumumab binds is different from the binding sites targeted by other CD20 antibodies that are currently available such as rituximab. Also, ofatumumab appears to have a slower off-rate and more stable CD20 binding as compared with rituximab.
The slower off-rate and more stable binding may be responsible for ofatumumab’s efficacy against cells with low CD20-antigen density and high expression of complement inhibitory molecules.
It is approved for the treatment of patients with CLL refractory to fludarabine and alemtuzumab, in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL, in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate, and for extended treatment in patients who have a complete or partial response after at least 2 lines of therapy for recurrent or progressive CLL.
In a phase II study (median follow-up of 24 months), treatment with ofatumumab resulted in an objective response rate of 49% and 43%, median progression-free survival (PFS) times of 4.6 months and 5.5 months, and median overall survival (OS) times of 13.9 months and 17.4 months, in CLL patients with fludarabine-refractory and alemtuzumab-refractory disease (n = 95) or bulky disease not suitable for alemtuzumab treatment (n = 112), respectively
Indications
- chronic lymphocytic leukemia (CLL)
- non-Hodgkin’s lymphoma (NHL)
For the treatment of chronic lymphocytic leukemia (CLL)
NOTE: The FDA has designated ofatumumab as an orphan drug for the treatment of CLL.
Side Effects
- abdominal pain
- agranulocytosis
- anaphylactic shock
- anaphylactoid reactions
- anemia
- anemia
- angioedema
- antibody formation
- arthralgia
- arthralgia
- asthenia
- asthenia
- back pain
- back pain
- bradycardia
- bronchospasm
- chills
- cough
- diarrhea
- dyspnea
- dyspnea
- elevated hepatic enzymes
- fatigue
- fever
- fever
- flushing
- headache
- headache
- hepatic failure
- hepatitis
- hepatitis B exacerbation
- hyperbilirubinemia
- hyperhidrosis
- hypertension
- hypotension
- infection
- infection
- influenza
- infusion-related reactions
- infusion-related reactions
- insomnia
- insomnia
- laryngeal edema
- leukopenia
- leukopenia
- lymphopenia
- lymphopenia
- myocardial infarction
- nausea
- neutropenia
- neutropenia
- pancytopenia
- peripheral edema
- peripheral edema
- pharyngitis
- porphyria
- progressive multifocal leukoencephalopathy
- pulmonary edema
- rash
- rash
- sinus tachycardia
- sinus tachycardia
- sinusitis
- sinusitis
- Stevens-Johnson syndrome
- syncope
- thrombocytopenia
- tumor lysis syndrome (TLS)
- urticaria
Monitoring Parameters
- CBC with differential
- hepatitis B serology
- LFTs
- serum bilirubin
- serum creatinine/BUN
- serum electrolytes
- serum uric acid
Contraindications
- agranulocytosis
- anemia
- breast-feeding
- geriatric
- hepatitis
- hepatitis B exacerbation
- infants
- infusion-related reactions
- neonates
- neutropenia
- pregnancy
- progressive multifocal leukoencephalopathy
- sepsis
- thrombocytopenia
- tumor lysis syndrome (TLS)
- vaccination
Interactions
- Belimumab
- Clozapine
- Live Vaccines
- Natalizumab
- Palifermin
- Penicillamine
- Sarilumab
- Tocilizumab
- Tuberculin Purified Protein Derivative, PPD
