Obinutuzumab Brand Name– GAZYVA
What is Obinutuzumab
Obinutuzumab is a monoclonal antibody that binds to the CD20 molecule found on pre B- and mature B-lymphocytes.
It is indicated for the treatment of previously untreated chronic lymphocytic leukemia in combination with chlorambucil; relapsed or refractory follicular lymphoma (FL) in combination with bendamustine; and previously untreated bulky stage II, stage III, or IV FL in combination with chemotherapy.
Patients with FL who respond to combination therapy may receive up to 2 years of obinutuzumab monotherapy.
Hepatitis B virus reactivation resulting in fulminant hepatitis, hepatic failure, and death has been reported
Indications
- chronic lymphocytic leukemia (CLL)
- non-Hodgkin’s lymphoma (NHL)
- small lymphocytic lymphoma (SLL)
For the treatment of chronic lymphocytic leukemia (CLL)
NOTE: The FDA has designated obinutuzumab as an orphan drug for the treatment of CLL.
for the treatment of previously untreated CLL, in combination with chlorambucil
Side Effects
- agranulocytosis
- anemia
- anemia
- anorexia
- anorexia
- antibody formation
- arthralgia
- arthralgia
- asthenia
- back pain
- back pain
- bone pain
- bronchospasm
- cardiotoxicity
- chest pain (unspecified)
- chills
- constipation
- constipation
- cough
- cough
- diarrhea
- diarrhea
- dizziness
- dyspnea
- elevated hepatic enzymes
- elevated hepatic enzymes
- fatigue
- fatigue
- fever
- fever
- flushing
- GI perforation
- headache
- headache
- hepatitis B exacerbation
- hyperbilirubinemia
- hyperbilirubinemia
- hyperkalemia
- hyperkalemia
- hypernatremia
- hypernatremia
- hypertension
- hyperthermia
- hyperuricemia
- hypoalbuminemia
- hypoalbuminemia
- hypocalcemia
- hypocalcemia
- hypokalemia
- hypokalemia
- hyponatremia
- hyponatremia
- hypophosphatemia
- hypophosphatemia
- hypotension
- infection
- infection
- infusion-related reactions
- infusion-related reactions
- insomnia
- insomnia
- laryngeal edema
- lethargy
- leukopenia
- leukopenia
- lymphopenia
- lymphopenia
- migraine
- musculoskeletal pain
- musculoskeletal pain
- nausea
- neutropenia
- neutropenia
- pharyngitis
- pharyngitis
- progressive multifocal leukoencephalopathy
- pruritus
- pruritus
- rash
- rash
- rhinitis
- serum sickness
- sinus tachycardia
- sinusitis
- throat irritation
- thrombocytopenia
- thrombocytopenia
- tumor lysis syndrome (TLS)
- urticaria
- vomiting
- wheezing
Monitoring Parameters
- CBC with differential
- hepatitis B serology
- LFTs
- serum creatinine
- serum electrolytes
- serum uric acid
Contraindications
- anticoagulant therapy
- bleeding
- breast-feeding
- cardiac disease
- contraception requirements
- fungal infection
- hepatitis
- hepatitis B exacerbation
- hepatotoxicity
- hypertension
- infection
- infusion-related reactions
- neonates
- neutropenia
- pregnancy
- progressive multifocal leukoencephalopathy
- pulmonary disease
- reproductive risk
- thrombocytopenia
- tumor lysis syndrome (TLS)
- vaccination
- viral infection
Interactions
- Abciximab
- Anagrelide
- Anticoagulants
- Antithrombin III
- Apixaban
- Argatroban
- Aspirin, ASA; Dipyridamole
- Betrixaban
- Bivalirudin
- Cilostazol
- Clopidogrel
- Clozapine
- Dabigatran
- Dalteparin
- Danaparoid
- Desirudin
- Dipyridamole
- Edoxaban
- Enoxaparin
- Eptifibatide
- Fondaparinux
- Heparin
- Lepirudin
- Live Vaccines
- Palifermin
- Penicillamine
- Pentosan
- Platelet Inhibitors
- Prasugrel
- Rivaroxaban
- Ticagrelor
- Ticlopidine
- Tinzaparin
- Tirofiban
- Tuberculin Purified Protein Derivative, PPD
- Vorapaxar
- Warfarin
