JC virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death can occur in patients receiving brentuximab vedotin.
Hodgkin lymphoma, advanced, previously untreated: IV: 1.2 mg/kg (maximum dose: 120 mg) every 2 weeks (in combination with doxorubicin, vinblastine, and dacarbazine [AVD]; begin brentuximab within ~1 hour after completion of AVD) until a maximum of 12 doses, disease progression, or unacceptable toxicity (Connors 2018). Administer primary prophylaxis with G-CSF (filgrastim) beginning with cycle 1.
Hodgkin lymphoma, relapsed or refractory: IV: 1.8 mg/kg (maximum dose: 180 mg) every 3 weeks, continue until disease progression or unacceptable toxicities (Younes 2012)
Hodgkin lymphoma, consolidation therapy after autologous hematopoietic stem cell transplantation (HSCT): IV: 1.8 mg/kg (maximum dose: 180 mg) every 3 weeks, continue until a maximum of 16 cycles, disease progression, or unacceptable toxicity (Moskowitz 2015). Begin therapy within 4 to 6 weeks post HSCT or upon recovery from HSCT.
Mycosis fungoides (CD-30 expressing), relapsed: IV: 1.8 mg/kg (maximum dose: 180 mg) every 3 weeks, continue until a maximum of 16 cycles, disease progression, or unacceptable toxicity (Prince 2017)
Peripheral T-cell lymphoma (CD30-expressing), previously untreated: IV: 1.8 mg/kg (maximum dose: 180 mg) every 3 weeks for 6 to 8 doses (in combination with cyclophosphamide, doxorubicin, and prednisone) (Horwitz 2019). Administer primary prophylaxis with G-CSF (filgrastim) beginning with cycle 1.
Primary cutaneous anaplastic large cell lymphoma, relapsed (pcALCL): IV: 1.8 mg/kg (maximum dose: 180 mg) every 3 weeks, continue until a maximum of 16 cycles, disease progression, or unacceptable toxicity (Prince 2017)
Systemic anaplastic large cell lymphoma (sALCL), previously untreated: IV: 1.8 mg/kg (maximum dose: 180 mg) every 3 weeks for 6 to 8 doses (in combination with cyclophosphamide, doxorubicin, and prednisone)
Systemic anaplastic large cell lymphoma, relapsed: IV: 1.8 mg/kg (maximum dose: 180 mg) every 3 weeks, continue until disease progression or unacceptable toxicities (Pro 2012)
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
CrCl ≥30 mL/minute: Initial: No dosage adjustment necessary.
CrCl <30 mL/minute: Avoid use.
Hepatic impairment at treatment initiation:
Usual dose 1.2 mg/kg every 2 weeks:
Mild impairment (Child-Pugh class A): Initial: 0.9 mg/kg (maximum dose: 90 mg) every 2 weeks.
Moderate to severe impairment (Child-Pugh class B or C): Avoid use.
Usual dose 1.8 mg/kg every 3 weeks:
Mild impairment (Child-Pugh class A): Initial: 1.2 mg/kg (maximum dose: 120 mg) every 3 weeks.
Moderate to severe impairment (Child-Pugh class B or C): Avoid use.
Hepatotoxicity during treatment:
New, worsening, or recurrent hepatotoxicity: May require brentuximab vedotin treatment delay, dose modification, or discontinuation.
Refer to adult dosing.
Hematologic toxicity:
Combination therapy (usual dose 1.2 mg/kg every 2 weeks or 1.8 mg/kg every 3 weeks):
Grade 3 or 4 neutropenia: Administer G-CSF prophylaxis for subsequent cycles for patients not receiving primary prophylaxis.
Single agent therapy (usual dose 1.8 mg/kg every 3 weeks):
Grade 3 or 4 neutropenia: Withhold treatment until resolves to baseline or ≤ grade 2, consider growth factor support in subsequent cycles.
Recurrent grade 4 neutropenia (despite the use of growth factor prophylaxis): Consider reducing the dose to 1.2 mg/kg (maximum dose: 120 mg) every 3 weeks or discontinuing treatment.
Nonhematologic toxicities:
Anaphylaxis: Discontinue brentuximab vedotin immediately and permanently (and administer appropriate medical intervention).
Hyperglycemia: Administer antihyperglycemics as clinically indicated.
Infusion reaction: Interrupt brentuximab vedotin infusion and administer appropriate medical intervention. Premedicate subsequent infusions with acetaminophen, an antihistamine, and/or a corticosteroid.
Peripheral neuropathy:
Combination therapy (usual dose 1.2 mg/kg every 2 weeks):
Grade 2: Reduce brentuximab vedotin dose to 0.9 mg/kg (maximum dose: 90 mg) every 2 weeks.
Grade 3: Withhold treatment until improves or returns to grade 2 or lower; then resume with dose reduced to 0.9 mg/kg (maximum dose: 90 mg) every 2 weeks. Also consider modifying the dose of other neurotoxic chemotherapy agents.
Grade 4: Discontinue treatment.
Combination therapy (usual dose 1.8 mg/kg every 3 weeks):
Grade 2: For grade 2 sensory neuropathy, continue treatment at the same dose. For grade 2 motor neuropathy, reduce brentuximab vedotin dose to 1.2 mg/kg (maximum dose: 120 mg) every 3 weeks.
Grade 3: For grade 3 sensory neuropathy, reduce brentuximab vedotin dose to 1.2 mg/kg (maximum dose: 120 mg) every 3 weeks. For grade 3 motor neuropathy, discontinue brentuximab vedotin.
Grade 4: Discontinue treatment.
Single agent therapy (usual dose 1.8 mg/kg every 3 weeks):
New or worsening grade 2 or 3: Withhold treatment until improves or returns to grade 1 or baseline; then resume with dose reduced to 1.2 mg/kg (maximum dose: 120 mg) every 3 weeks.
Grade 4: Discontinue treatment.
Progressive multifocal leukoencephalopathy (PML): Withhold treatment with new-onset symptoms suggestive of PML; discontinue brentuximab vedotin if PML diagnosis confirmed.
Pulmonary toxicity ( new-onset or worsening pulmonary symptoms ): Withhold treatment until symptomatic improvement; perform prompt diagnostic evaluation and management.
Stevens-Johnson syndrome or toxic epidermal necrolysis: Discontinue brentuximab vedotin and administer appropriate medical intervention.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous [preservative free]:
Adcetris: 50 mg (1 ea) [contains polysorbate 80]
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous:
Adcetris: 50 mg (1 ea) [contains polysorbate 80]
IV: Infuse over 30 minutes. Do not administer as IV push or bolus; do not mix or infuse with other medications.
Hodgkin lymphoma (previously untreated): When administering in combination with doxorubicin, vinblastine, and dacarbazine [AVD], begin brentuximab within ~1 hour after completion of AVD (Connors 2018).
Hazardous agent (NIOSH 2016 [group 1]).
Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).
Anaplastic large cell lymphoma (primary cutaneous), relapsed: Treatment of primary cutaneous anaplastic large cell lymphoma in patients who have received prior systemic therapy
Anaplastic large cell lymphoma (systemic), previously untreated: Treatment of previously untreated systemic anaplastic large cell lymphoma (in combination with cyclophosphamide, doxorubicin, and prednisone)
Anaplastic large cell lymphoma (systemic), relapsed: Treatment of systemic anaplastic large cell lymphoma after failure of at least 1 prior multiagent chemotherapy regimen
Hodgkin lymphoma, previously untreated: Treatment of previously untreated stage III or IV classical Hodgkin lymphoma (in combination with doxorubicin, vinblastine, and dacarbazine)
Hodgkin lymphoma, relapsed or refractory: Treatment of classical Hodgkin lymphoma after failure of at least 2 prior multiagent chemotherapy regimens (in patients who are not autologous hematopoietic stem cell transplant [HSCT] candidates) or after failure of autologous HSCT
Hodgkin lymphoma, consolidation (post-autologous hematopoietic stem cell transplantation): Treatment of classical Hodgkin lymphoma in patients at high risk of relapse or progression as post–autologous HSCT consolidation
Mycosis fungoides, relapsed: Treatment of CD30-expressing mycosis fungoides in patients who have received prior systemic therapy
Peripheral T- cell lymphoma, CD30-expressing, previously untreated: Treatment of previously untreated CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified (in combination with cyclophosphamide, doxorubicin, and prednisone)
Brentuximab may be confused with bendamustine, bevacizumab, bezlotoxumab, rituximab
This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Cardiovascular: Peripheral edema (11%)
Central nervous system: Neuropathy (62%), peripheral sensory neuropathy (45% to 56%; grade 3: 5% to 10%), fatigue (24% to 29%), peripheral motor neuropathy (23%; grade 3: 6%), headache (11%)
Dermatologic: Pruritus (11% to 17%; infusion-related: 2% to 5%), alopecia (15%), maculopapular rash (11%)
Endocrine & metabolic: Weight loss (19%)
Gastrointestinal: Nausea (22% to 36%; infusion-related: 3% to 4%), diarrhea (20% to 29%), vomiting (16% to 17%), decreased appetite (12% to 15%), abdominal pain (14%), constipation (13%)
Hematologic & oncologic: Neutropenia (21% to 78%; grade 3: 3% to 30%; grade 4: 2% to 9%), anemia (27% to 62%; grade 3: 4%), thrombocytopenia (15% to 41%; grade 3: 2%; grade 4: 2% to 4%)
Immunologic: Antibody development (7% to 30%)
Neuromuscular & skeletal: Arthralgia (12% to 18%), myalgia (11% to 12%), asthenia (11%), muscle spasm (11%)
Respiratory: Upper respiratory tract infection (26%), cough (21%; infusion-related: 2%), dyspnea (11% to 13%; infusion-related: 2% to 3%)
Miscellaneous: Fever (17% to 19%; infusion-related: 2%)
1% to 10%:
Central nervous system: Chills (10%; infusion-related: 4%)
Dermatologic: Cellulitis (3%)
Endocrine & metabolic: Hyperglycemia (8%)
Hepatic: Hepatotoxicity (2%)
Respiratory: Pulmonary toxicity (5%), pneumonia (4%)
Frequency not defined:
Immunologic: Antibody development (neutralizing)
<1%, postmarketing, and/or case reports: Acute pancreatitis, acute respiratory distress syndrome, anaphylaxis, bacteremia, enterocolitis, exacerbation of diabetes mellitus, febrile neutropenia, gastrointestinal erosion, gastrointestinal hemorrhage, gastrointestinal perforation, gastrointestinal ulcer, increased serum bilirubin, increased serum transaminases, interstitial pulmonary disease, intestinal obstruction, JC virus infection, ketoacidosis, neutropenic enterocolitis, opportunistic infection, pancreatitis, pneumonitis, progressive multifocal leukoencephalopathy, sepsis, septic shock, serious infection, severe hepatotoxicity, Stevens-Johnson syndrome, toxic epidermal necrolysis
Concurrent use with bleomycin (due to pulmonary toxicity).
Canadian labeling (additional contraindications not in the US labeling): Hypersensitivity to brentuximab or any component of the formulation; patients who have or have had progressive multifocal leukoencephalopathy
Concerns related to adverse effects:
• Bone marrow suppression: Grade 3 or 4 neutropenia, thrombocytopenia, and anemia may occur. Neutropenia may be severe and/or prolonged (≥1 week). Neutropenic fever (sometimes fatal) also has been reported.
• Dermatologic toxicity: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported (some fatal).
• GI toxicity: Acute pancreatitis (some fatal) has been observed. Other serious and fatal GI complications (including hemorrhage, obstruction, perforation, erosion, ulcer, enterocolitis, neutropenic colitis, and ileus) have also been reported. The risk for GI complications may be increased in patients with lymphoma with preexisting GI involvement. Prompt diagnostic evaluation and management should be performed if new or worsening GI symptoms (including severe abdominal pain) occur.
• Hepatotoxicity: Serious hepatotoxicity, including fatalities, has occurred; cases were consistent with hepatocellular injury, with elevations of transaminases and/or bilirubin. Some have occurred after the initial dose or after rechallenge. The risk for hepatotoxicity may be increased with preexisting liver disease, elevated baseline liver enzymes, and concurrent medications.
• Hyperglycemia: Hyperglycemia, including new-onset hyperglycemia, exacerbation of pre-existing diabetes mellitus, and ketoacidosis (including fatalities) have been reported, including grade 3 and 4 events. The median time to hyperglycemia onset was 1 month (range: up to 10 months). Hyperglycemia occurred more frequently in patients with increased body mass or diabetes.
• Infection: Serious infection, including opportunistic infections (eg, pneumonia, bacteremia, sepsis/septic shock) have been reported (some fatal).
• Infusion reactions/anaphylaxis: Infusion reactions, including anaphylaxis have been reported.
• Peripheral neuropathy: Peripheral neuropathy is common and is generally cumulative. Neuropathy is usually sensory, although motor neuropathy has also been observed. Neuropathy completely resolved in over half of patients receiving brentuximab vedotin as monotherapy; almost one-quarter had partial improvement. Neuropathy did not improve in some patients. In patients receiving brentuximab as a single agent, the median time to onset of neuropathy (any grade) was 3 months (range: up to 12 months), and the median time from onset to resolution or improvement of any grade was 5 months (range: up to 45 months). In patients receiving brentuximab in combination with chemotherapy, the median time to onset of neuropathy (any grade) was 2 months (range: up to 7 months), and the median time from onset to resolution or improvement of any grade was 2 to 4 months (range: up to 45 months). Neuropathy completely resolved in approximately one-half of patients receiving brentuximab in combination with chemotherapy; ~12% to 24% had partial improvement. Symptoms of neuropathy include hypoesthesia, hyperesthesia, paresthesia, discomfort, burning sensation, neuropathic pain, or weakness.
• Progressive multifocal leukoencephalopathy: Cases of progressive multifocal leukoencephalopathy (PML) and death due to JC virus infection have been reported. Immunosuppression due to prior chemotherapy treatments or underlying disease may also contribute to PML development. New-onset signs/symptoms of central nervous system abnormalities include changes in mood, memory, cognition, motor incoordination and/or weakness, speech and/or visual disturbances. The time to initial symptom onset varies from treatment initiation, with some cases occurring within 3 months of initial drug exposure.
• Pulmonary toxicity: Noninfectious pulmonary toxicity (eg, pneumonitis, interstitial lung disease, acute respiratory distress syndrome), some fatal, has been reported in patients receiving brentuximab vedotin.
• Tumor lysis syndrome: Tumor lysis syndrome (TLS) may occur; risk of TLS is higher in patients with a high tumor burden or with rapid tumor proliferation.
Disease-related concerns:
• Hepatic impairment: The frequency of grade 3/4 toxicities (and deaths) was increased in patients with moderate or severe impairment (compared to patients with normal hepatic function). A component of brentuximab vedotin, the microtubule-disrupting agent monomethylauristatin E (MMAE) is excreted hepatically. MMAE exposure is increased ~2.2-fold in patients with hepatic impairment.
• Renal impairment: The frequency of grade 3/4 toxicities (and deaths) was increased in patients with severe impairment (compared to patients with normal renal function). A component of brentuximab vedotin, the microtubule-disrupting agent MMAE is excreted renally; MMAE exposure is increased in patients with severe impairment.
Concurrent drug therapy issues:
• Bleomycin: Due to the risk for pulmonary injury, concurrent use with bleomycin is contraindicated. In a study comparing brentuximab combined with ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) to brentuximab combined with AVD (doxorubicin, vinblastine, and dacarbazine), the occurrence of pulmonary toxicity was higher in the brentuximab/ABVD group. Pulmonary symptoms/toxicities reported with brentuximab in combination with ABVD consisted of cough, dyspnea, and interstitial infiltration/inflammation; most patients responded to corticosteroids.
Special populations:
• Elderly: Patients ≥65 years of age may be at higher risk for grade 3 or higher adverse events and neutropenic fever when brentuximab vedotin is used in combination with chemotherapy.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
Substrate of CYP3A4 (major), P-glycoprotein/ABCB1 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
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
Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Bleomycin: Brentuximab Vedotin may enhance the adverse/toxic effect of Bleomycin. Specifically, the risk for pulmonary toxicity may be increased. Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy
Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination
Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
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 Vaccine (Adenovirus Vector): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Risk C: Monitor therapy
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Consider administration of a 3rd dose of COVID-19 vaccine, at least 28 days after completion of the primary 2-dose series, in patients 5 years of age and older taking immunosuppressive therapies. Risk D: Consider therapy modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
CYP3A4 Inducers (Strong): May decrease the serum concentration of Brentuximab Vedotin. Specifically, concentrations of the active monomethyl auristatin E (MMAE) component may be decreased. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Brentuximab Vedotin. Specifically, concentrations of the active monomethyl auristatin E (MMAE) component may be increased. Risk C: Monitor therapy
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): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) 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
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination
Echinacea: May diminish the therapeutic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider avoiding echinacea in patients receiving therapeutic immunosuppressants, such as the oncology agents listed in this monograph. If coadministered, monitor for reduced efficacy of the immunosuppressant during concomitant use. Risk D: Consider therapy modification
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Erdafitinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy
Erdafitinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification
Ivosidenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy
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
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
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
Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) 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: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If post-exposure rabies vaccination is required during immunosuppressant therapy, administer a 5th dose of vaccine and check for rabies antibodies. Risk D: Consider therapy modification
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
Rubella- or Varicella-Containing Live Vaccines: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
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: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Inactivated). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification
Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Evaluate pregnancy status prior to use in females of reproductive potential. Females of reproductive potential and males with female partners of reproductive potential should avoid pregnancy during treatment and for at least 6 months after the final dose. Brentuximab vedotin treatment may compromise fertility in males.
Based on the mechanism of action and on animal data, brentuximab vedotin may cause fetal harm if administered to a pregnant woman.
It is not known if brentuximab vedotin is present in breast milk. Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer does not recommend breastfeeding during treatment.
CBC with differential prior to each dose (monitor more frequently in patients with grade 3 or 4 neutropenia); liver and renal function tests. Verify pregnancy status (in females of reproductive potential) prior to treatment initiation. Monitor for infusion reaction. Monitor for signs/symptoms of progressive multifocal leukoencephalopathy (evaluate with MRI, and lumbar puncture or brain biopsy), neuropathy (hypoesthesia, hyperesthesia, paresthesia, discomfort, burning sensation, or neuropathic pain or weakness), dermatologic toxicity, pulmonary toxicity (new or worsening symptoms such as cough or dyspnea), GI toxicity, tumor lysis syndrome, and/or infection (bacterial, fungal, or viral).
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.
Brentuximab vedotin is an antibody drug conjugate (ADC) directed at CD30 consisting of 3 components: 1) a CD30-specific chimeric IgG1 antibody cAC10; 2) a microtubule-disrupting agent, monomethylauristatin E (MMAE); and 3) a protease cleavable dipeptide linker (which covalently conjugates MMAE to cAC10). The conjugate binds to cells which express CD30, and forms a complex which is internalized within the cell and releases MMAE. MMAE binds to the tubules and disrupts the cellular microtubule network, inducing cell cycle arrest (G2/M phase) and apoptosis.
Distribution: Vdss: ADC: ~6 to 10 L
Protein binding: MMAE: 68% to 82%
Metabolism: MMAE: Minimal, primarily via oxidation by CYP3A4/5
Half-life elimination: Terminal: ADC: ~4 to 6 days; MMAE: ~3 to 4 days
Time to peak: ADC: At end of infusion; MMAE: ~1 to 3 days after the end of infusion
Excretion: MMAE: Feces (~72% [of recovered MMAE], primarily unchanged); urine
Renal function impairment: The exposure (AUC) of MMAE, a brentuximab vedotin component, was increased ~2-fold in patients with severe renal impairment receiving a 1.2 mg/kg dose compared to patients with normal renal function.
Hepatic function impairment: The exposure (AUC) of MMAE, a brentuximab vedotin component, was increased ~2.3-fold in patients with hepatic impairment receiving a 1.2 mg/kg dose compared to patients with normal hepatic function.
Solution (reconstituted) (Adcetris Intravenous)
50 mg (per each): $11,640.00
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