rituximab-hyaluronidase (Rx)

Brand and Other Names:Rituxan Hycela
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

rituximab/hyaluronidase

injectable solution

  • (120mg/2,000 units)/mL
  • Ready-to-use SC solution contains rituximab and hyaluronidase human

Follicular Lymphoma

All patients must receive at least 1 full dose of rituximab IV infusion before starting rituximab/hyaluronidase SC

Relapse or refractory follicular lymphoma

  • Indicated for relapsed or refractory follicular lymphoma (FL) as a single agent
  • Rituximab 1,400/hyaluronidase 23,400 units SC qWeek for 3 or 7 weeks following a full dose of rituximab IV at Week 1 (ie, 4 or 8 weeks total)
  • Retreatment relapse/refractory FL
    • Rituximab 1,400/hyaluronidase 23,400 units SC qWeek for 3 weeks following a full dose of a rituximab by IV infusion at Week 1 (ie, 4 weeks in total)

Previously untreated FL

  • Indicated for previously untreated FL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy
  • Rituximab 1,400/hyaluronidase 23,400 units SC on day 1 of a 21-day cycle in cycles 2-8, for up to 7 cycles, following a full IV rituximab dose on Day 1 of cycle 1 of chemotherapy (ie, up to 8 cycles in total)
  • Maintenance after complete or partial response
    • Single agent maintenance: Rituximab 1,400/hyaluronidase 23,400 SC q8Weeks x 12 doses
    • Initiate 8 weeks after complete or partial response to rituximab in combination with chemotherapy

Nonprogressing FL

  • Indicated for nonprogressing (eg, stable disease) FL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy
  • Following completion of 6-8 cycles of CVP chemotherapy and a full dose of a rituximab by IV infusion at Week 1, rituximab 1,400 mg/hyaluronidase 23,400 units SC qWeek for 3 weeks (ie, 4 weeks in total) at 6-month intervals for maximum of 16 doses

Diffuse Large B-Cell Lymphoma

Indicated for previously untreated diffuse large B-cell lymphoma (DLBCL) in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens

Rituximab 1,400 mg/hyaluronidase 23,400 on Day 1 of cycles 2-8 in combination with CHOP for up to 7 cycles, following a full IV rituximab dose (Day 1, cycle 1) of CHOP (up to 6-8 cycles)

Chronic Lymphocytic Leukemia

Indicated, in combination with fludarabine and cyclophosphamide (FC), for treatment of adults with previously untreated and previously treated CLL

Rituximab 1,600 mg/hyaluronidase 26,800 units SC on Day 1 of a 28-day cycle in cycles 2-6 (in combination with FC) for a total of 5 cycles, following a full IV rituximab dose (Day 1 of cycle 1) of FC (ie, 6 cycles in total)

Dosing Considerations

Initiate treatment only after patients have received at least 1 full dose of rituximab IV infusion

Not indicated for nonmalignant conditions

Safety and efficacy not established

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Interactions

Interaction Checker

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              Serious - Use Alternative (15)

              • adenovirus types 4 and 7 live, oral

                rituximab-hyaluronidase, adenovirus types 4 and 7 live, oral. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.

              • baricitinib

                baricitinib, rituximab-hyaluronidase. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.

              • certolizumab pegol

                rituximab-hyaluronidase and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid combination because of an increased risk of serious infection.

              • influenza virus vaccine quadrivalent, intranasal

                rituximab-hyaluronidase, influenza virus vaccine quadrivalent, intranasal. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.

              • measles (rubeola) vaccine

                rituximab-hyaluronidase, measles (rubeola) vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.

              • measles mumps and rubella vaccine, live

                rituximab-hyaluronidase, measles mumps and rubella vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.

              • measles, mumps, rubella and varicella vaccine, live

                rituximab-hyaluronidase, measles, mumps, rubella and varicella vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.

              • palifermin

                palifermin increases toxicity of rituximab-hyaluronidase by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

              • poliovirus vaccine live oral trivalent

                rituximab-hyaluronidase, poliovirus vaccine live oral trivalent. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.

              • rotavirus oral vaccine, live

                rituximab-hyaluronidase, rotavirus oral vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.

              • rubella vaccine

                rituximab-hyaluronidase, rubella vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.

              • smallpox (vaccinia) vaccine, live

                rituximab-hyaluronidase, smallpox (vaccinia) vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.

              • varicella virus vaccine live

                rituximab-hyaluronidase, varicella virus vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.

              • yellow fever vaccine

                rituximab-hyaluronidase, yellow fever vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.

              • zoster vaccine live

                rituximab-hyaluronidase, zoster vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.

              Monitor Closely (33)

              • amphotericin B deoxycholate

                amphotericin B deoxycholate and rituximab-hyaluronidase both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor. Caution should be exercised when concurrent therapy is used. Patients should be monitored for signs of renal failure.

              • belatacept

                belatacept and rituximab-hyaluronidase both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • cholera vaccine

                rituximab-hyaluronidase, cholera vaccine. immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

              • cisplatin

                cisplatin and rituximab-hyaluronidase both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor. Potential for renal toxicity when used in combination with cisplatin.

              • dengue vaccine

                rituximab-hyaluronidase decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

              • denosumab

                rituximab-hyaluronidase, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • fingolimod

                rituximab-hyaluronidase increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

              • hepatitis A vaccine inactivated

                rituximab-hyaluronidase, hepatitis A vaccine inactivated. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • hepatitis a/b vaccine

                rituximab-hyaluronidase, hepatitis a/b vaccine. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • hepatitis b vaccine

                rituximab-hyaluronidase, hepatitis b vaccine. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • HIV vaccine

                rituximab-hyaluronidase, HIV vaccine. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • human papillomavirus vaccine, bivalent

                rituximab-hyaluronidase, human papillomavirus vaccine, bivalent. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • human papillomavirus vaccine, nonavalent

                rituximab-hyaluronidase, human papillomavirus vaccine, nonavalent. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • human papillomavirus vaccine, quadrivalent

                rituximab-hyaluronidase, human papillomavirus vaccine, quadrivalent. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • influenza A (H5N1) vaccine

                rituximab-hyaluronidase, influenza A (H5N1) vaccine. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • influenza virus vaccine (H5N1), adjuvanted

                rituximab-hyaluronidase, influenza virus vaccine (H5N1), adjuvanted. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • influenza virus vaccine quadrivalent

                rituximab-hyaluronidase, influenza virus vaccine quadrivalent. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • influenza virus vaccine quadrivalent, adjuvanted

                rituximab-hyaluronidase, influenza virus vaccine quadrivalent, adjuvanted. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • influenza virus vaccine quadrivalent, cell-cultured

                rituximab-hyaluronidase, influenza virus vaccine quadrivalent, cell-cultured. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • influenza virus vaccine trivalent

                rituximab-hyaluronidase, influenza virus vaccine trivalent. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • influenza virus vaccine trivalent, adjuvanted

                rituximab-hyaluronidase, influenza virus vaccine trivalent, adjuvanted. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • ioversol

                ioversol and rituximab-hyaluronidase both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely.

              • Japanese encephalitis virus vaccine

                rituximab-hyaluronidase, Japanese encephalitis virus vaccine. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • mechlorethamine

                mechlorethamine, rituximab-hyaluronidase. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration with mechlorethamine may increase the risk of immunosuppression and myelosuppression.

              • poliovirus vaccine inactivated

                rituximab-hyaluronidase decreases effects of poliovirus vaccine inactivated by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response may be suboptimal. Patients on chemotherapy with anti-B cell antibodies should wait =6 months after therapy before being vaccinated with inactivated vaccines.

              • ponesimod

                ponesimod and rituximab-hyaluronidase both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • rabies vaccine

                rituximab-hyaluronidase, rabies vaccine. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • rabies vaccine chick embryo cell derived

                rituximab-hyaluronidase, rabies vaccine chick embryo cell derived. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • siponimod

                siponimod and rituximab-hyaluronidase both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • sipuleucel-T

                rituximab-hyaluronidase decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • trastuzumab

                trastuzumab, rituximab-hyaluronidase. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

              • trastuzumab deruxtecan

                trastuzumab deruxtecan, rituximab-hyaluronidase. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

              • zoster vaccine recombinant

                rituximab-hyaluronidase, zoster vaccine recombinant. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              Minor (1)

              • methotrexate

                methotrexate and rituximab-hyaluronidase both increase nephrotoxicity and/or ototoxicity. Minor/Significance Unknown.

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              Adverse Effects

              Percentages are for all grades of toxicity unless otherwise noted

              >10% (FL)

              Neutropenia (32%)

              Nausea (31%)

              Constipation (25%)

              Cough (23%)

              Fatigue (20%)

              Diarrhea (18%)

              Asthenia (17%)

              Pyrexia (15%)

              Anemia (15%)

              Abdominal pain (14%)

              Vomiting (14%)

              Alopecia (14%)

              Paresthesia (16%)

              Injection site erythema (13%)

              Arthralgia (13%)

              Peripheral neuropathy (12%)

              Dyspnea (11%)

              Pneumonia (11%)

              >10% (DLBCL)

              Neutropenia (31%)

              lopecia (24%)

              Anemia (23%)

              Nausea (22%)

              Fatigue (19%)

              Constipation (15%)

              Diarrhea (14%)

              Febrile neutropenia (14%)

              Decreased neutrophil count (14%)

              Pyrexia (13%)

              Peripheral neuropathy (12%)

              Cough (11%)

              Asthenia (11%)

              Vomiting (11%)

              >10% (CLL)

              Neutropenia (65%)

              Nausea (38%)

              Pyrexia (32%)

              Injection site erythema (26%)

              Thrombocytopenia (24%)

              Vomiting (21%)

              Leukopenia (19%)

              Injection site pain (16%)

              Erythema (15%)

              Anemia (13%)

              Chills (13%)

              Cough (13%)

              Upper respiratory tract infection (13%)

              Rash (12%)

              Diarrhea (12%)

              Fatigue (11%)

              Febrile neutropenia (11%)

              1-10% (FL)

              Bone pain (10%)

              Extremity pain (10%)

              Pruritus (10%)

              Rash (10%)

              Erythema (9%)

              Back pain (9%)

              Oropharyngeal pain (9%)

              Insomnia (9%)

              Dyspepsia (8%)

              Chills (8%)

              Injection site pain (8%)

              Chills (8%)

              Bronchitis (8%)

              Urinary tract infection (8%)

              Muscle spasms (8%)

              Myalgia (8%)

              Sinusitis (7%)

              Dizziness (7%)

              Insomnia (7%)

              Stomatitis (6%)

              Hypertension (6%)

              Conjunctivitis (5%)

              Upper abdominal pain (5%)

              Peripheral edema (5%)

              Mucosal inflammation (5%)

              Influenza (4%)

              Influenza-like illness (3%)

              Peripheral neuropathy, Grade 3-4 (2%)

              Diarrhea, Grade 3-4 (2%)

              Asthenia, Grade 3-4 (1%)

              Chest pain, Grade 3-4 (1%)

              Dyspnea, Grade 3-4 (1%)

              Hypertension, Grade 3-4 (1%)

              1-10% (DLBCL)

              Paresthesia (9%)

              Mucosal inflammation (8%)

              Peripheral edema (8%)

              Decreased weight (8%)

              Decreased appetite (8%)

              Abdominal pain (7%)

              Pneumonia (7%)

              Leukopenia (7%)

              Decreased WBC count (7%)

              Insomnia (7%)

              Stomatitis (6%)

              Headache (6%)

              Dyspnea (6%)

              Dyspepsia (5%)

              Lymphopenia (5%)

              Decreased lymphocyte count (5%)

              1-10% (CLL)

              Abdominal pain (9%)

              Arthralgia (9%)

              Constipation (8%)

              Asthenia (8%)

              Respiratory tract infection (8%)

              Pruritus (8%)

              Bronchitis (7%)

              Extremity pain (7%)

              Headache (7%)

              Bone pain (6%)

              Oropharyngeal pain (6%)

              Dyspnea (4%)

              Urinary tract infection (2%)

              Pneumonia (2%)

              Insomnia (1%)

              Hypotension (1%)

              Postmarketing Reports

              Skin: Severe mucocutaneous reactions, pyoderma gangrenosum (including genital presentation)

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              Warnings

              Black Box Warnings

              Severe mucocutaneous reactions

              • Severe, including fatal, mucocutaneous reactions reported including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis
              • Discontinue drug if severe mucocutaneous reaction occurs

              Progressive multifocal leukoencephalopathy

              • Progressive multifocal leukoencephalopathy (PML), including fatal PML, reported

              Reactivation of hepatitis B

              • Reactivation of hepatitis B virus (HBV) infection reported, including deaths
              • Screen all patients for HBV infection before initiating drug by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc)
              • Consult with hepatitis experts regarding monitoring and use of HBV antiviral therapy when screening identifies patients at risk of HBV reactivation due to evidence of prior HBV infection
              • Monitor patients with evidence of prior HBV infection for clinical and laboratory signs of hepatitis B or HBV reactivation during therapy and for several months thereafter, since reactivations have occurred several months following completion of therapy
              • If HBV reactivation develops, discontinue drug immediately and start HBV treatment; also discontinue any chemotherapy until the HBV infection controlled/resolved
              • Because of insufficient data, no recommendation can be made regarding the resumption of the drug in patients who develop HBV reactivation hepatitis

              Contraindications

              None

              Cautions

              Tumor lysis syndrome (TLS) can occur within 12-24 hr after administration; administer aggressive IV hydration and antihyperuricemic therapy in patients at high risk for TLS; correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated

              Cardiac adverse reactions (eg, ventricular fibrillation, myocardial infarction, cardiogenic shock) may occur; discontinue treatment for serious or life-threatening cardiac arrhythmias; perform cardiac monitoring during and after all administrations for patients who develop clinically significant arrhythmias, or who have a history of arrhythmia or angina

              Severe, including fatal, renal toxicity can occur after administration; closely monitor for signs of renal failure and discontinue treatment in patients with a rising serum creatinine or oliguria

              Abdominal pain, bowel obstruction, and bowel perforation can occur in patients receiving rituximab-containing products, in combination with chemotherapy; in postmarketing reports, the mean time to documented gastrointestinal perforation was 6 days; evaluate if symptoms of obstruction such as abdominal pain or repeated vomiting occur

              Safety of immunization with live viral vaccines following rituximab-containing chemotherapy has not been studied, and vaccination with live virus vaccines is not recommended before or during treatment

              Based on human data, rituximab-containing products can cause fetal harm due to B-cell lymphocytopenia in infants exposed to rituximab in utero (see Pregnancy)

              Infections

              • Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of rituximab
              • Infections reported in some patients with prolonged hypogammaglobulinemia (defined as hypogammaglobulinemia >11 months after rituximab exposure)
              • New or reactivated viral infections included cytomegalovirus, herpes simplex virus, parvovirus B19, varicella-zoster virus, West Nile virus, and hepatitis B and C viruses
              • Discontinue treatment for serious infections and institute appropriate anti-infective therapy

              Hypersensitivity

              • Rituximab-containing products are associated with hypersensitivity and other administration reactions (eg, cytokine release syndrome, TLS, anaphylactic reactions)
              • Severe infusion-related reactions (eg, pulmonary events, fever, chills, rigors, hypotension, urticaria, angioedema) with fatal outcome reported with IV use of rituximab, with an onset ranging within 30-120 minutes after starting the first IV infusion
              • Cytokine release syndrome may occur within 1-2 hr of initiating infusion; severe cytokine release syndrome is characterized by severe dyspnea, often accompanied by bronchospasm and hypoxia, in addition to fever, chills, rigors, urticaria, and angioedema
              • Local cutaneous reactions may occur more than 24 hr after administration
              • During administration, interrupt treatment immediately when observing signs of a severe reaction, and initiate aggressive symptomatic treatment; closely monitor the following patients: those with preexisting cardiac or pulmonary conditions, those who experienced prior cardiopulmonary adverse reactions, and those with high numbers of circulating malignant cells (≥25,000/mm³ )
              • Premedicate patients with an antihistamine and acetaminophen prior to each administration; also consider glucocorticoids
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              Pregnancy & Lactation

              Pregnancy

              Based on human data, rituximab can cause adverse developmental outcomes including B-cell lymphocytopenia in infants exposed to rituximab in utero

              There are no available data on use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage

              Verify pregnancy status in females of reproductive potential prior to initiating therapy

              Animal data

              • In animal reproduction studies, IV administration of a rituximab to pregnant cynomolgus monkeys during organogenesis caused lymphoid B-cell depletion in newborn offspring at doses resulting in 80% of the exposure (based on AUC) of those achieved following a dose of 2 g in humans
              • Reduced fetal weight and increased fetal lethality were observed following SC administration of hyaluronidase human in mice at a dose >2700 times higher than the human dose

              Contraception

              • Females of childbearing potential should use effective contraception during treatment and for 12 months following treatment

              Lactation

              There are no data on the presence of rituximab or hyaluronidase human in human milk, the effect on the breastfed infant, or the effect on milk production

              However, rituximab is detected in the milk of lactating cynomolgus monkeys, and IgG is present in human milk

              Rituximab reported to be excreted at low concentrations in human breast milk; advise a lactating woman not to breastfeed during treatment and for at least 6 months after last dose due to potential for serious adverse reactions in breastfed children

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Monoclonal antibody targets CD20 antigen expressed on pre-B and mature B-lymphocytes’ surfaces

              Upon binding to CD20, mediates B-cell lysis

              Hyaluronidase human increases permeability of SC tissue by temporarily depolymerizing hyaluronan

              In doses administered, hyaluronidase human acts locally; effects of hyaluronidase human are reversible and permeability of SC tissue is restored within 24-48 hr

              Absorption

              Bioavailability: 0.646 (FL); 0.634 (CLL)

              Peak plasma concentration

              • FL: 237 mcg/mL (cycle 7); 156 mcg/mL (cycle 18)
              • CLL: 202 mcg/mL (cycle 6)

              Peak trough concentration

              • FL: 122.2 mcg/mL (cycle 7); 45.5 mcg/mL (cycle 18)
              • CLL: 97.5 mcg/mL (cycle 6)

              AUC

              • FL: 3,779 mcg·d/mL (cycle 7); 5,000 mcg·d/mL (cycle 18)
              • CLL: 4088 mcg·d/mL (cycle 5)

              Distribution

              Vd (steady-state): 8.09 L (FL); 8.52 (CLL)

              Elimination

              Half-life: 34.1 days (FL); 32 days (CLL)

              Clearance: 0.18 L/day (FL); 0.204 (CLL)

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              Administration

              SC Preparation

              Solution for SC is ready to use

              Visually inspect solution for particulates; solution should appear as a clear-to-opalescent and colorless-to-yellowish liquid

              SC Administration

              Consider premedication (ie, acetaminophen, diphenhydramine, and/or glucocorticoids)

              Premedication with acetaminophen and diphenhydramine may attenuate infusion-related reactions

              Observe patients for 15 minutes after SC administration

              If administration is interrupted, administer at the same site or at a different site along the abdomen

              Avoid coadministering other SC medications at the same site

              Avoid injections into areas where skin appears red, bruised, tender, or hard

              Avoid injections in areas where there are moles or scars No data available on other injection sites

              SC injection rate

              • Inject SC in abdomen
              • 1,400 mg/23,400 IU/vial (1,400 mg rituximab and 23,400 Units hyaluronidase human): SC over ~5 minutes
              • 1,600 mg/26,800 IU/vial (1,600 mg rituximab and 26,800 Units hyaluronidase human): SC over ~7 minutes

              Storage

              Unused vials: Refrigerate at 2-8°C (36-46°F)

              Solution for SC injection: Refrigerate at 2-8°C (36-46°F) up to 48 hr and subsequently for 8 hr at room temperature up to 30°C (86°F)

              Protect vials and solution from light

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              Images

              No images available for this drug.
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              Patient Handout

              A Patient Handout is not currently available for this monograph.
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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.