Deaths have occurred within 24 hours of rituximab infusion, an essential component of the ibritumomab tiuxetan therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion. Discontinue rituximab and Y-90 ibritumomab tiuxetan infusions in patients who develop severe infusion reactions.
Y-90 ibritumomab tiuxetan administration results in severe and prolonged cytopenias in most patients. Do not administer the ibritumomab tiuxetan therapeutic regimen to patients with ≥25% lymphoma marrow involvement and/or impaired bone marrow reserve.
Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the ibritumomab tiuxetan therapeutic regimen. Discontinue rituximab and Y-90 ibritumomab tiuxetan infusions in patients experiencing severe cutaneous or mucocutaneous reactions.
The dose of Y-90 ibritumomab tiuxetan should not exceed 32 mCi (1,184 MBq).
Note: Premedicate with oral acetaminophen 650 mg and oral diphenhydramine 50 mg prior to each rituximab infusion. Allow at least 6 weeks, but no more than 12 weeks following first-line chemotherapy before treatment initiation; platelets should recover to ≥150,000/mm3 prior to initiation of treatment regimen. Do not administer to patients with ≥25% lymphoma marrow involvement and/or impaired bone marrow reserve.
Non-Hodgkin lymphomas: Ibritumomab is administered only as part of the Zevalin therapeutic regimen (a combined treatment regimen with rituximab). The regimen consists of two steps:
Day 1:
Rituximab: IV: 250 mg/m2 at an initial rate of 50 mg/hour. If hypersensitivity or infusion-related events do not occur, increase infusion in increments of 50 mg/hour every 30 minutes, to a maximum of 400 mg/hour. Stop rituximab and discontinue regimen for severe infusion reaction. For less severe infusion reactions, temporarily slow or interrupt; the infusion may be resumed at one-half the previous rate upon improvement of symptoms.
Day 7, 8, or 9 of treatment:
Rituximab: IV: 250 mg/m2 at an initial rate of 100 mg/hour (50 mg/hour if infusion-related events occurred with the day 1 infusion). If hypersensitivity or infusion-related events do not occur, increase infusion in increments of 100 mg/hour every 30 minutes, to a maximum of 400 mg/hour, as tolerated (increase in 50 mg/hour increments every 30 minutes if initial infusion rate was 50 mg/hour).
Y-90 ibritumomab (within 4 hours after completion of the rituximab infusion):
Platelet count ≥150,000 cells/mm3: IV: 0.4 mCi/kg (14.8 MBq/kg) actual body weight over 10 minutes; maximum dose: 32 mCi (1184 MBq).
Platelet count between 100,000 to 149,000 cells/mm3 (in relapsed or refractory patients): IV: 0.3 mCi/kg (11.1 MBq/kg) actual body weight over 10 minutes; maximum dose: 32 mCi (1184 MBq).
Platelet count <100,000 cells/mm3: Do not administer.
Maximum dose: The prescribed, measured, and administered dose of Y-90 ibritumomab must not exceed 32 mCi (1184 MBq), regardless of the patient's body weight.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Cutaneous or mucocutaneous skin reactions, severe: Discontinue rituximab and ibritumomab tiuxetan.
Infusion reactions:
Severe infusion reaction: Immediately stop rituximab infusion and discontinue ibritumomab tiuxetan therapeutic regimen.
Less severe reactions: Temporarily slow or interrupt rituximab infusion; if symptoms improve, the rituximab infusion may be resumed/continued at one-half the previous rate.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults and include the use of concomitant rituximab.
>10%:
Gastrointestinal: Abdominal pain (17%), diarrhea (11%), nausea (18%)
Hematologic & oncologic: Anemia (22% to 61%; grades 3/4: 5% to 17%), leukopenia (43%; grades 3/4: 36%), lymphocytopenia (26%; grades 3/4: 18%), malignant neoplasm (secondary) (13%), neutropenia (45% to 77%; grades 3/4: 41% to 60%), thrombocytopenia (62% to 95%; grades 3/4: 51% to 63%)
Infection: Infection (within first 3 months: 29%; serious infection: 1% to 3%; 3 months to 4 years after treatment: 6%)
Nervous system: Asthenia (15%), fatigue (33%)
Respiratory: Cough (11%), nasopharyngitis (19%)
1% to 10%:
Cardiovascular: Hypertension (7%)
Dermatologic: Ecchymosis (7%), night sweats (8%), pruritus (7%), skin rash (7%)
Gastrointestinal: Anorexia (8%)
Genitourinary: Urinary tract infection (7%)
Hematologic & oncologic: Acute myelocytic leukemia (≤5%), myelodysplastic syndrome (≤5%), petechia (8%)
Immunologic: Antibody development (HAMA/HACA: 1% to 3%)
Nervous system: Dizziness (7%)
Neuromuscular & skeletal: Myalgia (9%)
Respiratory: Bronchitis (8%), epistaxis (5%), flu-like symptoms (8%), pharyngolaryngeal pain (7%), rhinitis (8%), sinusitis (7%)
Miscellaneous: Fever (10%)
Frequency not defined:
Hematologic & oncologic: Febrile neutropenia
Hypersensitivity: Infusion-related reaction
Infection: Sepsis
Postmarketing:
Dermatologic: Bullous dermatitis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis
Miscellaneous: Radiation injury (delayed [~1 month]; in tissues in or near areas of lymphomatous involvement)
There are no contraindications listed within the manufacturer's US labeling.
Canadian labeling: Known type I hypersensitivity or anaphylactic reaction to ibritumomab tiuxetan, murine proteins, or any component of the formulation, including yttrium chloride and rituximab; pregnancy; breastfeeding.
Concerns related to adverse effects:
• Bone marrow suppression: Severe, delayed, and prolonged cytopenias (thrombocytopenia and neutropenia) commonly occur. The median platelet, ANC, and hemoglobin nadir occurred at 49 to 53 days, 61 to 62 days, and 68 to 69 days, respectively. Cytopenias may persist beyond 12 weeks. The median duration of thrombocytopenia and neutropenia was 24 to 35 days and 22 to 29 days respectively, and the median time to platelet and ANC recovery was 13 to 14 days and 12 to 15 days, respectively. Patients with mild baseline thrombocytopenia (100,000 to 149,000/mm3) may experience higher incidences of severe neutropenia and thrombocytopenia. Hemorrhage may occur due to thrombocytopenia; avoid concomitant use of medications interfering with coagulation or platelet function.
• Cutaneous/mucocutaneous reactions: Severe cutaneous and mucocutaneous skin reactions may occur with ibritumomab tiuxetan (some fatal). Reactions include erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous dermatitis, and exfoliative dermatitis. Onset may occur within days to 4 months following infusion. Discontinue rituximab and ibritumomab tiuxetan in patients experiencing severe cutaneous or mucocutaneous skin reactions.
• Extravasation/radiation necrosis: Irritant with vesicant-like properties; avoid extravasation. Infusion site erythema and ulceration have been reported following extravasation; monitor infusion site; promptly terminate infusion with symptoms/signs of extravasation (restart in another limb). There is a case report of (delayed) erythema and ulceration, which is described as radiation necrosis following yttrium-90-ibritumomab extravasation (Williams 2006).
• Infusion reactions: Deaths have occurred within 24 hours of rituximab infusion, an essential component of the ibritumomab tiuxetan therapeutic regimen; these fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most fatalities occurred with the initial rituximab infusion (onset within 30 to 120 minutes). Other reactions may include hypotension, angioedema, bronchospasm, and urticaria. Administer in a facility with immediate access to resuscitative measures.
• Radiation injury: Delayed (up to 1 month) radiation injury has occurred in or near areas of lymphomatous involvement.
• Secondary malignancies: Malignancies due to the radiation dose from therapeutic exposure may occur. Secondary malignancies (acute myelogenous leukemia and/or myelodysplastic syndrome) have been reported; the median time to secondary malignancy diagnosis following ibritumomab treatment was 1.9 years with a range of 0.4 to 6.3 years (Czuczman 2007).
Dosage form specific issues:
• Albumin: Product contains albumin, which confers a theoretical risk of transmission of viral disease or Creutzfeldt-Jakob disease.
Special handling:
• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients and health care personnel. Use only under supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority. The contents of the kit are not radioactive until radiolabeling occurs. During and after radiolabeling, adequate shielding should be used with this product, minimize radiation exposure (to patient and health care professionals) in accordance with institutional radiation safety practices.
Other warnings/precautions:
• Immunizations: Do not administer live viral vaccines to patients who have recently received ibritumomab treatment. The safety of immunization with live vaccines following ibritumomab therapy has not been studied; the ability to generate a response to any vaccine after receiving treatment has not been studied.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Kit, Intravenous [preservative free]:
Zevalin Y-90: 3.2 mg/2 mL [contains albumin human]
No
Kit (Zevalin Y-90 Intravenous)
3.2 mg/2 mL (per each): $74,124.43
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Kit, Intravenous:
Zevalin: 3.2 mg/2 mL [contains albumin human]
IV:
Rituximab: Administer the first infusion of rituximab at an initial rate of 50 mg/hour. If hypersensitivity or infusion-related events do not occur, escalate the infusion rate in 50 mg/hour increments every 30 minutes, to a maximum of 400 mg/hour. Immediately stop infusion for severe infusion reaction (discontinue ibritumomab regimen); less severe reactions may be managed by slowing or interrupting infusion. For less severe reactions, infusion may continue at one-half the previous rate upon improvement of patient symptoms. If infusion reaction did not occur in initial rituximab infusion, subsequent rituximab infusion can be administered at an initial rate of 100 mg/hour and increased in 100 mg/hour increments at 30-minute intervals, to a maximum of 400 mg/hour as tolerated. If infusion reaction occurred with initial rituximab infusion, initiate at 50 mg/hour with increases of 50 mg/hour increments every 30 minutes.
Y-90 ibritumomab: Begin within 4 hours of completion of rituximab infusion. Inject slowly, over 10 minutes through a 0.22 micron low protein binding in-line filter (filter placed between syringe and infusion port) into a free-flowing IV line. After injection, flush line with at least 10 mL normal saline.
Irritant with vesicant-like properties; avoid extravasation. Ensure proper needle or catheter position prior to administration. Closely monitor infusion site. If signs or symptoms of extravasation occur, stop infusion and restart in another limb.
Radiopharmaceutical; use appropriate precautions for handling and disposal.
Non-Hodgkin lymphomas: Treatment of relapsed or refractory, low-grade or follicular B-cell non-Hodgkin lymphoma (NHL) in adults; treatment of previously untreated follicular NHL in adults who achieve a partial or complete response to first-line chemotherapy.
Ibritumomab tiuxetan may be confused with ibrutinib and inotuzumab ozogamicin.
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).
Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use under supervision of experienced personnel. Should be stored in original lead container or adequate radiation shield.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the adverse/toxic effect of Ibritumomab Tiuxetan. Both agents may contribute to impaired platelet function and an increased risk of bleeding. Risk C: Monitor therapy
Anticoagulants: May enhance the adverse/toxic effect of Ibritumomab Tiuxetan. Both agents may contribute to an increased risk of bleeding. Risk C: Monitor therapy
Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy
Antithymocyte Globulin (Equine): Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of anti-CD20 B-cell depleting therapy is reduced. Anti-CD20 B-Cell Depleting Therapies may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy
Antithyroid Agents: Myelosuppressive Agents may enhance the neutropenic effect of Antithyroid Agents. Risk C: Monitor therapy
Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG Products: Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Chikungunya Vaccine (Live): Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy
Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination
Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy
Coccidioides immitis Skin Test: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification
COVID-19 Vaccines: Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of COVID-19 Vaccines. Management: Administer COVID-19 vaccine 2 to 4 weeks prior to the next scheduled dose of anti-CD20 therapy, if used chronically for the treatment of autoimmune disease. Revaccinate 6 months after completion of anti-CD20 therapy if used over a limited period. Risk D: Consider therapy modification
Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider therapy modification
Dengue Tetravalent Vaccine (Live): Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider therapy modification
Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines 2 weeks prior to starting anti-CD20 B-cell depleting therapies. Vaccination of patients treated with these agents in the past 6 months is not recommended. Risk D: Consider therapy modification
Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification
Linezolid: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Mumps- Rubella- or Varicella-Containing Live Vaccines: Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination
Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Poliovirus Vaccine (Live/Trivalent/Oral): Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification
Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Rabies Vaccine: Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification
Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination
Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification
Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor therapy
Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination
Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination
Typhoid Vaccine: Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Live): Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Vaccines (Non-Live/Inactivated/Non-Replicating): Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation or 6 months after anti-CD20 B-cell depleting therapies. If vaccinated prior to B cell recovery, consider assessing immune response to vaccination. Risk D: Consider therapy modification
Yellow Fever Vaccine: Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Evaluate pregnancy status prior to therapy in patients who could become pregnant. Patients who could become pregnant and patients with partners who could become pregnant should use effective contraception during therapy and for 12 months following the last ibritumomab tiuxetan dose.
Based on the radioactivity, Y-90 ibritumomab may cause fetal harm if administered during pregnancy. In addition, ibritumomab tiuxetan is a humanized monoclonal antibody (IgG1). Potential placental transfer of human IgG is dependent upon the IgG subclass and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).
It is not known if ibritumomab is present in breast milk.
Because many immunoglobulins are present in milk, excretion of ibritumomab tiuxetan is expected. Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends that lactating patients avoid breastfeeding during therapy and for 6 months following the last ibritumomab tiuxetan dose.
CBC with differential and platelet counts weekly until recovery, or as clinically indicated. Platelet count must be obtained prior to day 7, 8, or 9; monitor for cytopenias (and related complications such as febrile neutropenia or hemorrhage) for up to 3 months after use.
Monitor for signs of active hepatitis B infection (during and for up to 12 months after therapy completion). Monitor for infusion-related allergic reactions (typically within 30 to 120 minutes of administration), for extravasation during ibritumomab infusion; and for severe cutaneous and mucocutaneous reactions.
The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.
Ibritumomab is a monoclonal antibody directed against the CD20 antigen found on pre-B and mature B lymphocytes (normal and malignant). Ibritumomab binding induces apoptosis in B lymphocytes in vitro. It is combined with the chelator tiuxetan, which acts as a specific chelation site for Yttrium-90 (Y-90). The monoclonal antibody acts as a delivery system to direct the radioactive isotope to the targeted cells, however, binding has been observed in lymphoid cells throughout the body and in lymphoid nodules in organs such as the large and small intestines. Beta-emission induces cellular damage through the formation of free radicals (in both target cells and surrounding cells).
Duration: B cell recovery begins in ~12 weeks; generally in normal range within 9 months.
Distribution: To lymphoid cells throughout the body and in lymphoid nodules in organs such as the large and small intestines, spleen, testes, and liver.
Half-life elimination: Y-90 ibritumomab: 30 hours; Yttrium-90 decays with a physical half-life of 64 hours.
Excretion: A median of 7.2% of the radiolabeled activity was excreted in urine over 7 days.
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