Version July 2025
JC virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death can occur in patients receiving brentuximab vedotin.
Hodgkin lymphoma, classic; high risk:
Children ≥2 years and Adolescents: IV: 1.8 mg/kg/dose; maximum dose: 180 mg/dose; administer every 3 weeks with each cycle of chemotherapy up to 5 doses total. For use in previously untreated patients and administered in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide along with filgrastim. For patients weighing >100 kg, calculate dose based on a weight of 100 kg (Ref).
Dosing adjustment for toxicity:
Hodgkin lymphoma
Children ≥2 years and Adolescents: IV: Note: Adjustment to the vincristine dose may be necessary in some instances; refer to Vincristine monograph for details.
|
Hematologic toxicity | |
|
Neutropenia, grade 3 or 4 |
In patients unable to start a cycle >5 weeks after the initiation of the previous cycle due to neutropenia (ie, >2-week treatment delay), reduce brentuximab dose to 1.2 mg/kg (maximum dose: 120 mg/dose) every 3 weeks. |
|
Nonhematologic toxicity | |
|
Peripheral neuropathy: Grade 2 |
Continue brentuximab at current dose. |
|
Peripheral neuropathy: Grade 3 |
First occurrence: Hold brentuximab until improvement to ≤ grade 2; restart at reduced dose of 1.2 mg/kg (maximum dose: 120 mg/dose). Second occurrence: Hold brentuximab until improvement to ≤ grade 2; restart at reduced dose of 0.8 mg/kg (maximum dose: 80 mg/dose). Third occurrence: Discontinue brentuximab treatment. |
|
Peripheral neuropathy: Grade 4 |
Discontinue brentuximab treatment. |
Children ≥2 years and Adolescents: IV:
CrCl ≥30 mL/minute: Initial: No dosage adjustment necessary.
CrCl <30 mL/minute: Avoid use.
Children ≥2 years and Adolescents: IV:
Hepatic impairment at treatment initiation:
Mild impairment: Reduce initial dose to 1.2 mg/kg (maximum dose: 120 mg/dose) every 3 weeks.
Moderate to severe impairment: Avoid use.
Hepatotoxicity during treatment:
New, worsening, or recurrent hepatotoxicity: May require brentuximab vedotin treatment delay, dose modification, or discontinuation.
(For additional information see "Brentuximab vedotin: Drug information")
Dosage guidance:
Safety: Administer premedications (eg, acetaminophen, antihistamine, and a corticosteroid) prior to subsequent infusions in patients with a prior brentuximab vedotin infusion-related reaction.
Anaplastic large cell lymphoma, primary cutaneous, relapsed: IV: 1.8 mg/kg (maximum dose: 180 mg) once every 3 weeks; continue until a maximum of 16 cycles, disease progression, or unacceptable toxicity (Ref).
Anaplastic large cell lymphoma, systemic, previously untreated: IV: 1.8 mg/kg (maximum dose: 180 mg) once every 3 weeks (in combination with cyclophosphamide, doxorubicin, and prednisone [CHP]) for 6 to 8 doses (Ref). Administer primary prophylaxis with G-CSF beginning with cycle 1.
Anaplastic large cell lymphoma, systemic, relapsed: IV: 1.8 mg/kg (maximum dose: 180 mg) once every 3 weeks; continue until disease progression or unacceptable toxicities (Ref).
Diffuse large B- cell lymphoma and high-grade B-cell lymphoma, relapsed or refractory: IV: 1.2 mg/kg (maximum dose: 120 mg) once every 3 weeks (in combination with lenalidomide and rituximab [may substitute with rituximab and hyaluronidase beginning with cycle 2]); continue until disease progression or unacceptable toxicity (Ref). Administer primary prophylaxis with G-CSF beginning with cycle 1.
Hodgkin lymphoma, classical, stage III or IV, previously untreated: IV: 1.2 mg/kg (maximum dose: 120 mg) once every 2 weeks (in combination with doxorubicin, vinblastine, and dacarbazine [AVD]); continue until a maximum of 12 doses, disease progression, or unacceptable toxicity (Ref). Administer primary prophylaxis with G-CSF beginning with cycle 1.
Hodgkin lymphoma, classical, relapsed or refractory: IV: 1.8 mg/kg (maximum dose: 180 mg) once every 3 weeks; continue until disease progression or unacceptable toxicity (Ref).
Off- label combination: IV: 1.8 mg/kg once every 3 weeks (in combination with bendamustine) for up to 6 cycles (Ref); followed by optional autologous hematopoietic cell transplantation (at any time after cycle 2) and brentuximab vedotin (as a single agent) for up to 14 additional cycles (maximum: 16 cycles of brentuximab vedotin) (Ref).
Hodgkin lymphoma, classical, consolidation therapy after autologous hematopoietic cell transplantation (HCT): IV: 1.8 mg/kg (maximum dose: 180 mg) once every 3 weeks; continue until a maximum of 16 cycles, disease progression, or unacceptable toxicity (Ref). Begin brentuximab vedotin within 4 to 6 weeks post HCT or upon recovery from HCT.
Mycosis fungoides, CD30 expressing, relapsed: IV: 1.8 mg/kg (maximum dose: 180 mg) once every 3 weeks; continue until a maximum of 16 cycles, disease progression, or unacceptable toxicity (Ref).
Peripheral T-cell lymphoma, CD30 expressing, previously untreated: IV: 1.8 mg/kg (maximum dose: 180 mg) once every 3 weeks (in combination with cyclophosphamide, doxorubicin, and prednisone [CHP]) for 6 to 8 doses (Ref). Administer primary prophylaxis with G-CSF beginning with cycle 1.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Kidney impairment prior to treatment initiation:
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute: Avoid use. Due to higher exposure of monomethylauristatin E (MMAE; the microtubule disrupting agent component), the incidence of ≥ grade 3 adverse reactions may be increased in patients with severe kidney impairment (compared to patients with normal kidney function).
Hepatic impairment prior to treatment initiation:
Diffuse large B- cell lymphoma and high-grade B-cell lymphoma, relapsed or refractory (usual dose 1.2 mg/kg every 3 weeks; in combination with lenalidomide and rituximab):
Mild impairment (total bilirubin ≤ ULN and AST > ULN or total bilirubin >1 to 1.5 times ULN and any AST): Reduce dose to 0.9 mg/kg (maximum dose: 90 mg) once every 3 weeks.
Moderate or severe impairment (total bilirubin >1.5 times ULN): Avoid use. The incidence of ≥ grade 3 adverse reactions was increased in patients with moderate or severe impairment (compared to patients with normal hepatic function).
Hodgkin lymphoma, classical, stage III or IV (usual dose: 1.2 mg/kg every 2 weeks; in combination with doxorubicin, vinblastine, and dacarbazine):
Mild impairment (Child-Turcotte-Pugh class A): Reduce dose to 0.9 mg/kg (maximum dose: 90 mg) once every 2 weeks.
Moderate to severe impairment (Child-Turcotte-Pugh class B or C): Avoid use. The incidence of ≥ grade 3 adverse reactions was increased in patients with moderate or severe impairment (compared to patients with normal hepatic function).
All other indications (usual dose 1.8 mg/kg every 3 weeks):
Mild impairment (Child-Turcotte-Pugh class A): Reduce dose to 1.2 mg/kg (maximum dose: 120 mg) once every 3 weeks.
Moderate to severe impairment (Child-Turcotte-Pugh class B or C): Avoid use. The incidence of ≥ grade 3 adverse reactions may be increased in patients with moderate or severe impairment (compared to patients with normal hepatic function).
Acute hepatotoxicity during treatment:
New, worsening, or recurrent hepatotoxicity: May require brentuximab vedotin treatment delay, dose modification, or discontinuation.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults on monotherapy regimens, unless otherwise noted.
>10%:
Cardiovascular: Peripheral edema (11%)
Dermatologic: Alopecia (15%), maculopapular rash (11%), pruritus (11% to 17%)
Endocrine & metabolic: Weight loss (19%)
Gastrointestinal: Abdominal pain (14%), constipation (13%), decreased appetite (12% to 15%), diarrhea (20% to 29%; grade 3: 2% to 3%), nausea (22% to 36%; grade 3: 2% to 3%), vomiting (16% to 17%; grade 3: 2%)
Hematologic & oncologic: Anemia (27% to 62%; grade 3: 4%), neutropenia (21% to 78%; grades 3/4: 2% to 30%), thrombocytopenia (15% to 41%; grades 3/4: 2% to 4%)
Hypersensitivity: Infusion-related relation (≤13%)
Nervous system: Asthenia (11%), fatigue (24% to 29%), headache (11%), peripheral neuropathy (≤62%; grade 3: 4%; including peripheral motor neuropathy [23%; grade 3: 6%], peripheral sensory neuropathy [45% to 56%; grade 3: 5% to 10%])
Neuromuscular & skeletal: Arthralgia (12% to 18%), muscle spasm (11%), myalgia (11% to 12%)
Respiratory: Cough (21%), dyspnea (11% to 13%), upper respiratory tract infection (26%)
Miscellaneous: Fever (17% to 19%)
1% to 10%:
Dermatologic: Cellulitis (serious: 3%)
Endocrine & metabolic: Hyperglycemia (≤8%)
Hepatic: Hepatotoxicity (severe: 2%; including increased serum bilirubin, increased serum transaminases)
Nervous system: Chills (10%)
Respiratory: Pneumonia (serious: 4%), pulmonary toxicity (5%; including acute respiratory distress syndrome, interstitial lung disease, pneumonitis)
Frequency not defined:
Hypersensitivity: Anaphylaxis
Immunologic: Antibody development (can be neutralizing)
Nervous system: Paresthesia
Postmarketing (monotherapy or combination therapy):
Dermatologic: Stevens-Johnson syndrome, toxic epidermal necrolysis
Endocrine & metabolic: Exacerbation of diabetes mellitus, ketoacidosis
Gastrointestinal: Acute pancreatitis, enterocolitis, gastrointestinal erosion, gastrointestinal hemorrhage, gastrointestinal perforation, gastrointestinal ulcer, intestinal obstruction, neutropenic enterocolitis
Hematologic & oncologic: Febrile neutropenia
Infection: Bacteremia, JC virus infection (resulting in progressive multifocal leukoencephalopathy), opportunistic infection, sepsis, septic shock, serious infection
Concurrent use with bleomycin (due to pulmonary toxicity [eg, interstitial infiltration and/or inflammation]).
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
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 (eg, perforation) may be increased in patients with lymphoma with preexisting GI involvement.
• Hepatotoxicity: Serious hepatotoxicity, including fatalities, has occurred; cases were consistent with hepatocellular injury, with elevations of transaminases and/or bilirubin. Cases 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 hepatotoxic 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; grades 1 to 4 neuropathy have been reported. Neuropathy is usually sensory, although motor neuropathy has also been observed. Neuropathy completely resolved in almost two-thirds of patients receiving brentuximab vedotin (as a single agent); almost one-quarter had partial improvement. Neuropathy did not improve in some patients. In patients receiving brentuximab vedotin (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 vedotin in combination with chemotherapy (all indications), the median time to onset of neuropathy (any grade) was 2 to 3 months (range: up to 10 months). The median time from onset to resolution or improvement of any grade was 2 to ~7 months (range: up to 67 months). Of patients with ongoing neuropathy (following treatment with brentuximab as a single agent or in combination with chemotherapy), most cases were grade 1; grade 2 to 4 neuropathy were also observed. 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.
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:
• Older adult: 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, when compared to patients <65 years of age.
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.
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
Solution (reconstituted) (Adcetris Intravenous)
50 mg (per each): $14,640.00
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.
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. Refer to protocol regarding timing of brentuximab dose in relation to chemotherapy.
IV: Infuse over 30 minutes. Do not administer as IV push or bolus; do not mix or infuse with other medications.
Monitor for infusion-related reactions. Interrupt brentuximab vedotin infusion and administer appropriate medical management if infusion-related infusion occurs. Premedication (eg, acetaminophen, antihistamine, and a corticosteroid) should be administered prior to subsequent infusions in patients with a prior infusion-related reaction.
Administration sequence (for combination therapy):
In combination with bendamustine (off-label combination): When administered in combination with bendamustine, administer brentuximab vedotin prior to bendamustine when administered on the same day (Ref).
In combination with cyclophosphamide, doxorubicin, and prednisone (CHP regimen): When administered in combination with cyclophosphamide, doxorubicin, and prednisone [CHP], administer brentuximab vedotin after completion of CHP chemotherapy (Ref).
In combination with doxorubicin, vinblastine, and dacarbazine (AVD regimen): When administered in combination with doxorubicin, vinblastine, and dacarbazine [AVD], begin brentuximab within ~1 hour after completion of AVD (Ref).
In combination with lenalidomide and rituximab: When administered in combination with lenalidomide and rituximab, brentuximab vedotin may be given either before or after rituximab. If brentuximab vedotin is administered prior to rituximab, administer rituximab within 60 to 90 minutes after completion of brentuximab vedotin; interval may be shortened to 30 minutes after cycle 1 if both medications are tolerated (Ref).
Hazardous agent (NIOSH 2024 [table 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 2023; NIOSH 2024; USP-NF 2020).
Store intact vials at 2°C to 8°C (36°F to 46°F). Store in the original carton to protect from light. If not diluted immediately, reconstituted solution may be stored at 2°C to 8°C (36°F to 46°F) for up to 24 hours; do not freeze. If not used immediately, solutions diluted for infusion may be stored for 24 hours (from initial reconstitution) at 2°C to 8°C (36°F to 46°F); do not freeze.
Indications including pediatric patients: Treatment of previously untreated high-risk classical Hodgkin lymphoma (in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide) (FDA approved in pediatric patients ≥2 years).
Indications approved only in adults: Treatment of relapsed primary cutaneous anaplastic large cell lymphoma in patients who have received prior systemic therapy; treatment of previously untreated systemic anaplastic large cell lymphoma (in combination with cyclophosphamide, doxorubicin, and prednisone); treatment of systemic anaplastic large cell lymphoma after failure of at least 1 prior multiagent chemotherapy regimen; treatment of previously untreated stage III or IV classical Hodgkin lymphoma (in combination with doxorubicin, vinblastine, and dacarbazine); treatment of relapsed or refractory 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; treatment of classical Hodgkin lymphoma in patients at high risk of relapse or progression as post–autologous HSCT consolidation; treatment of CD30-expressing mycosis fungoides in patients who have received prior systemic therapy; 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) (All indications: FDA approved in adults).
Brentuximab vedotin may be confused with belantamab mafodotin, bendamustine, bevacizumab, bezlotoxumab, brexucabtagene autoleucel, cetuximab, dinutuximab, enfortumab vedotin, isatuximab, locastuximab tesirine, margetuximab, mirvetuximab soravtansine, polatuzumab vedotin, rituximab, siltuximab, tisotumab vedotin, zolbetuximab.
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).
Substrate of CYP3A4 (Major), P-glycoprotein (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;
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.
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
5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor
Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid
BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Bleomycin: Brentuximab Vedotin may increase adverse/toxic effects of Bleomycin. Specifically, the risk for pulmonary toxicity may be increased. Risk X: Avoid
Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid
Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor
Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid
Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
Clofazimine: May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor
CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor
Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Miscellaneous Oncologic Agents) and Coccidioides immitis Skin Test may alter diagnostic results. 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 (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor
COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
CYP3A4 Inducers (Strong): May decrease serum concentration of Brentuximab Vedotin. Specifically, concentrations of the active monomethyl auristatin E (MMAE) component may be decreased. Risk C: Monitor
CYP3A4 Inhibitors (Strong): May increase serum concentration of Brentuximab Vedotin. Specifically, concentrations of the active monomethyl auristatin E (MMAE) component may be increased. Risk C: Monitor
Deferiprone: Myelosuppressive Agents may increase neutropenic effects 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 decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Denosumab: May increase immunosuppressive effects 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 increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid
Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification
Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects 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
Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects 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 increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Mumps- Rubella- or Varicella-Containing Live Vaccines may increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor
Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may increase hypersensitivity effects of 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 increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects 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 increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects 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 decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects 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 Modulators: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor
Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects 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
Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid
Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor
Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid
Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification
Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
Evaluate pregnancy status prior to use in patients who could become pregnant. Patients who could become pregnant should use effective contraception during treatment and for 2 months after the last brentuximab vedotin dose. Patients with partners who could become pregnant should use effective contraception during treatment and for 4 months after the last brentuximab vedotin dose. Brentuximab vedotin treatment may compromise fertility.
Based on the mechanism of action and on animal data, in utero exposure to brentuximab vedotin may cause fetal harm.
CBC with differential prior to each dose (more frequently if clinically indicated). Monitor for infusion reaction, tumor lysis syndrome, signs of infection, and for signs of neuropathy (hypoesthesia, hyperesthesia, paresthesia, discomfort, burning sensation, or neuropathic pain or weakness).
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: 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.
Altered kidney function: The exposure (AUC) of MMAE, a brentuximab vedotin component, was increased ~2-fold in patients with severe kidney impairment receiving a 1.2 mg/kg dose compared to patients with normal kidney 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.
