Acellbia Special Precautions

Infusion/administration-related reactions: Rituximab is associated with infusion/administration-related reactions, which may be related to release of cytokines and/or other chemical mediators. Cytokine release syndrome may be clinically indistinguishable from acute hypersensitivity reactions.
Hypersensitivity reactions/Anaphylaxis: Anaphylactic and other hypersensitivity reactions have been reported following the intravenous administration of proteins to patients. Epinephrine, antihistamines, and glucocorticoids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.
Cardiovascular: Since hypotension may occur during Rituximab administration consideration should be given to withholding antihypertensive medications 12 hours prior to and throughout Rituximab administration.
Monitoring of blood counts: Although Rituximab is not myelosuppressive in monotherapy, caution should be exercised when considering treatment of patients with neutrophil counts of <1.5 x 10⁹/L and/or platelet counts <75 x 10⁹/L, as clinical experience with such patients is limited. Rituximab IV has been used in patients who underwent autologous bone marrow transplantation and in other risk groups with a presumable reduced bone marrow function without inducing myelotoxicity.
Infections: Rituximab treatment should not be initiated in patients with severe active infections.
Hepatitis B infections: Cases of hepatitis B reactivation, including reports of fulminant hepatitis, some of which were fatal, have been reported in subjects receiving Rituximab, although the majority of these subjects were also exposed to cytotoxic chemotherapy.
Progressive multifocal leukoencephalopathy: Cases of progressive multifocal leukoencephalopathy (PML) have been reported during use of Rituximab in NHL and CLL.
Skin reactions: Severe skin reactions such as toxic epidermal necrolysis and Stevens-Johnson syndrome, some with fatal outcomes, have been reported.
Immunization: The safety of immunization with live viral vaccines following Rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.
Driving and Using other machines: It is not known whether Rituximab has an effect on the ability to drive or use any tools or machines.
This medicine contains 2.3 mmol (or 52.6 mg) sodium per 10 mL vial. Take this into account if the patient is on low-sodium diet.