Dosing & Uses
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 50mg/vial
Classical Hodgkin Lymphoma (cHL)
Previously untreated cHL
- First-line therapy for previously untreated Stage III or IV cHL in combination with doxorubicin, vinblastine, and dacarbazine (AVD)
- 1.2 mg/kg IV q2Weeks (in combination with AVD); not to exceed 120 mg/dose
- Continue until a maximum of 12 doses, disease progression, or unacceptable toxicity
cHL consolidation
- Indicated for cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation
- Initiate within 4–6 weeks post-auto-HSCT or upon recovery from auto-HSCT
- 1.8 mg/kg IV q3Weeks; not to exceed 180 mg/dose
- Continue until a maximum of 16 cycles, disease progression, or unacceptable toxicity
Relapsed cHL
- Indicated for cHL after failure of auto-HSCT or after failure of at least 2 prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates
- 1.8 mg/kg IV q3Weeks; not to exceed 180 mg/dose
- Continue until disease progression or unacceptable toxicity
Systemic Anaplastic Large Cell Lymphoma
Previously-untreated systemic anaplastic large cell lymphoma (sALCL)
- Indicated for treatment of previously-untreated sALCL
- 1.8 mg/kg IV q3Weeks for 6-8 doses; not to exceed 180 mg/dose
Relapsed sALCL
- Indicated for treatment of systemic anaplastic large cell lymphoma (sALCL) after failure of at least 1 prior multiagent chemotherapy regimen
- 1.8 mg/kg IV q3Weeks; not to exceed 180 mg/dose
- Continue until disease progression or unacceptable toxicity
Primary Cutaneous Anaplastic Large Cell Lymphoma
Indicated for primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30 expressing mycosis fungoides (MF) who have received prior systemic therapy
1.8 mg/kg IV q3Weeks; not to exceed 180 mg/dose
Continue until a maximum of 16 cycles, disease progression, or unacceptable toxicity
CD30-expressing Peripheral T-cell Lymphomas
Indicated in 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 (CHP)
1.8 mg/kg IV q3Weeks for 6-8 doses; not to exceed 180 mg/dose
Dosage Modifications
Renal impairment
- 1.2 mg/kg q2Weeks or 1.8 mg/kg q3Weeks
- Mild or moderate (CrCl 30-80 mL/min): No dosage adjustment required
- Severe (CrCl <30 mL/min): Avoid use
Hepatic impairment
Mild (Child-Pugh A)
- 1.2 mg/kg q2Weeks: 0.9 mg/kg q2Weeks; not to exceed 90 mg/dose
- 1.8 mg/kg q3Weeks: 1.2 mg/kg q3Weeks; not to exceed 120 mg/dose
- Moderate or severe (Child-Pugh B or C): Avoid use
Peripheral neuropathy
Monotherapy (1.8 mg/kg q3Weeks)
- New or worsening Grade 2 or 3: Hold dose until neuropathy improves to Grade 1 or baseline; restart at 1.2 mg/kg (not to exceed 120 mg/dose)
- Grade 4: Discontinue brentuximab
Combination therapy (1.2 mg/kg q2Weeks)
- Grade 2: Reduce dose to 0.9 mg/kg/dose q2Weeks; not to exceed 90 mg/dose
- Grade 3: Hold dose until neuropathy improves to Grade ≤2; restart at 0.9 mg/kg q2Weeks (not to exceed 90 mg/dose); consider modifying dose of other neurotoxic chemotherapy
- Grade 4: Discontinue brentuximab
Combination therapy (1.8 mg/kg q3Weeks)
- Grade 2 sensory neuropathy: No dosage adjustment required
- Grade 2 motor neuropathy or Grade 3 sensory neuropathy: Reduce to 1.2 mg/kg q3Weeks (not to exceed 120 mg/dose)
- Grade 3 motor neuropathy or Grade 4 peripheral neuropathy: Discontinue brentuximab
Neutropenia
Combination therapy (1.8 mg/kg q3Weeks or 1.2 mg/kg q2Weeks)
- Grade ≥3: Administer G-CSF prophylaxis for subsequent cycles for patients not receiving primary G-CSF prophylaxis
Monotherapy (1.8 mg/kg q3Weeks)
- Grade ≥3 neutropenia: Hold dose until resolution to baseline or Grade ≤2 ; consider G-CSF prophylaxis for subsequent cycles
- Recurrent Grade 4 (despite use of G-CSF prophylaxis): Consider discontinuing brentuximab or reduce to 1.2 mg/kg q3Weeks (not to exceed 120 mg/dose)
Dosing Considerations
Patients weighing >100 kg should be calculated based on a weight of 100 kg
Orphan Designations
Angioimmunoblastic T-cell lymphoma
Cutaneous T-cell lymphoma
Diffuse large B-cell lymphoma
Adult T-cell leukemia/lymphoma
Enteropathy-associated T-cell lymphoma
Extranodal NK/T-cell lymphoma (ENKTL)
Orphan sponsor
- Seattle Genetics, Inc; 21823 30th Drive Southeast, Bothell, WA 98021
Classical Hodgkin Lymphoma
Indicated in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide (AVEPC), for previously untreated high risk classical Hodgkin lymphoma (cHL) in pediatric patients aged ≥2 years
Each cycle is 21 days
Day 1: Brentuximab 1.8 mg/mg (not to exceed 180 mg/dose) IV with each cycle of chemotherapy for up to 5 doses
Calculate patients weighing >100 kg based on a weight of 100 kg
AVEPC regimen
- Days 1-2: Doxorubicin 25 mg/m2 IV qDay
- Days 1-3: Etoposide 125 mg/m2 IV qDay
- Days 1-2: Cyclophosphamide 600 mg/m2 IV qDay
- Day 8: Vincristine 1.4 mg/m2 (not to exceed 2.8 mg/dose) IV once
- Days 1-7: Prednisone 20 mg/m2 PO BID
Dosage Modifications
Peripheral neuropathy
- Assessed using Balis scale
-
Grade 2
- Reduce dose of vincristine {monograph link} based in prescribing information
- Continue brentuximab dose
- If neuropathy resolves to Grade ≤1 by day 8 of next cycle, then resume vincristine at full dose
-
Grade 3
- Discontinue vincristine
- First occurrence: Hold until resolves to Grade ≤2, then restart at 1.2 mg/kg (not to exceed 120 mg/dose) IV q3Weeks
- Second occurrence: Hold until resolves to Grade ≤2, then restart at 0.8 mg/kg (not to exceed 80 mg/dose) IV q3Weeks
-
Discontinue brentuximab
- Third occurrence of Grade 3 peripheral neuropathy
- Grade 4 neuropathy
Neutropenia
- Grade 3 or 4: Reduce to 1.2 mg/kg (not to exceed 120 mg/dose) q3Weeks if unable to start a cycle >5 weeks after start of previous cycle (>2-week delay)
Renal impairment
- Mild-to-moderate (CrCl 30-80 mL/min): No dosage adjustment necessary
- Severe (CrCl <30 mL/min): Avoid use
Hepatic impairment
- Mild (Child-Pugh A): Reduce dose to 1.2 mg/kg (not to exceed 120 mg/dose) IV q3Weeks
- Moderate or severe (Child-Pugh B or C): Avoid use
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- bleomycin
brentuximab vedotin and bleomycin both increase Other (see comment). Contraindicated. Contraindicated because of increased risk of pulmonary toxicity.
Serious - Use Alternative (14)
- abametapir
abametapir will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.
- apalutamide
apalutamide will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.
- erdafitinib
erdafitinib will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If coadministration unavoidable, separate administration by at least 6 hr before or after administration of P-gp substrates with narrow therapeutic index.
- fexinidazole
fexinidazole will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.
- idelalisib
idelalisib will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates
- ivosidenib
ivosidenib will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternate therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.
- lasmiditan
lasmiditan increases levels of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.
- lonafarnib
lonafarnib will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling.
- palifermin
palifermin increases toxicity of brentuximab vedotin by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.
- selinexor
selinexor, brentuximab vedotin. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.
- sotorasib
sotorasib will decrease the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications.
- tepotinib
tepotinib will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If concomitant use unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.
- tucatinib
tucatinib will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.
- voxelotor
voxelotor will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.
Monitor Closely (61)
- atazanavir
atazanavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor patients for adverse reactions. .
- belzutifan
belzutifan will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. If unable to avoid coadministration of belzutifan with sensitive CYP3A4 substrates, consider increasing the sensitive CYP3A4 substrate dose in accordance with its prescribing information.
- berotralstat
berotralstat will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor or titrate P-gp substrate dose if coadministered.
- carbamazepine
carbamazepine decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- cenobamate
cenobamate will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.
- ceritinib
ceritinib will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- cholera vaccine
brentuximab vedotin decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.
- clarithromycin
clarithromycin increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor patients for adverse reactions. .
- cobicistat
cobicistat will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- darunavir
darunavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor patients for adverse reactions. .
- dengue vaccine
brentuximab vedotin decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- dexamethasone
dexamethasone decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- efavirenz
efavirenz will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- efgartigimod alfa
efgartigimod alfa will decrease the level or effect of brentuximab vedotin by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- elagolix
elagolix will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
elagolix will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed. - encorafenib
encorafenib, brentuximab vedotin. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.
- enzalutamide
enzalutamide will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- eslicarbazepine acetate
eslicarbazepine acetate will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- fedratinib
fedratinib will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.
- fosamprenavir
fosamprenavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor patients for adverse reactions. .
- fosphenytoin
fosphenytoin decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- imatinib
imatinib increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor patients for adverse reactions. .
- indinavir
indinavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor patients for adverse reactions. .
- isavuconazonium sulfate
brentuximab vedotin and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.
- isoniazid
isoniazid increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor patients for adverse reactions. .
- istradefylline
istradefylline will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.
istradefylline will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of P-gp substrates in clinical trials. Consider dose reduction of sensitive P-gp substrates. - itraconazole
itraconazole increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor patients for adverse reactions. .
- ketoconazole
ketoconazole increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor patients for adverse reactions. .
- lenacapavir
lenacapavir will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Lencapavir (a moderate CYP3A4 inhibitor) may increase CYP3A4 substrates initiated within 9 months after last SC dose of lenacapavir, which may increase potential risk of adverse reactions of CYP3A4 substrates.
- levoketoconazole
levoketoconazole increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor patients for adverse reactions. .
- lopinavir
lopinavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor patients for adverse reactions. .
- mifepristone
mifepristone will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- mitotane
mitotane decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.
- nefazodone
nefazodone increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor patients for adverse reactions. .
- nelfinavir
nelfinavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor patients for adverse reactions. .
- nicardipine
nicardipine increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor patients for adverse reactions. .
- ofatumumab SC
ofatumumab SC, brentuximab vedotin. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.
- oxcarbazepine
oxcarbazepine decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- phenobarbital
phenobarbital decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- phenytoin
phenytoin decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- posaconazole
posaconazole increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor patients for adverse reactions. .
- primidone
primidone will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- ribociclib
ribociclib will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- rifabutin
rifabutin decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- rifampin
rifampin decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- rifapentine
rifapentine decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- ritonavir
ritonavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor patients for adverse reactions. .
- rucaparib
rucaparib will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.
- saquinavir
saquinavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor patients for adverse reactions. .
- sarecycline
sarecycline will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor for toxicities of P-gp substrates that may require dosage reduction when coadministered with P-gp inhibitors.
- siponimod
siponimod and brentuximab vedotin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- St John's Wort
St John's Wort decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- stiripentol
stiripentol, brentuximab vedotin. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.
stiripentol will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing the dose of P-glycoprotein (P-gp) substrates, if adverse reactions are experienced when administered concomitantly with stiripentol. - tazemetostat
tazemetostat will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- tecovirimat
tecovirimat will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.
- tipranavir
tipranavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor patients for adverse reactions. .
- trastuzumab
trastuzumab, brentuximab vedotin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trastuzumab deruxtecan
trastuzumab deruxtecan, brentuximab vedotin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- tucatinib
tucatinib will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.
- ublituximab
ublituximab and brentuximab vedotin both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
- voriconazole
voriconazole increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor patients for adverse reactions. .
Minor (4)
- acetazolamide
acetazolamide will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- anastrozole
anastrozole will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- cyclophosphamide
cyclophosphamide will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- larotrectinib
larotrectinib will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
Adverse Effects
>10% (Untreated cHL, Any Grade)
Anemia (98%)
Neutropenia (91%)
Peripheral sensory neuropathy (65%)
Constipation (42%)
Vomiting (33%)
Diarrhea (27%)
Pyrexia (27%)
Decreased weight (22%)
Stomatitis (21%)
Abdominal pain (21%)
Febrile neutropenia (19%)
Bone pain (19%)
Insomnia (19%)
Decreased appetite (18%)
Back pain (13%)
Rashes, eruptions, exanthems (13%)
Dyspnea (12%)
Peripheral motor neuropathy (11%)
>10% (Untreated cHL, Grade 3 or 4)
Neutropenia (20-62%)
Febrile neutropenia (6-13%)
Anemia (1-11%)
>10% (pcALCA or MF, Any Grade)
Anemia (62%)
Peripheral sensory neuropathy (45%)
Nausea (36%)
Diarrhea (29%)
Fatigue (29%)
Neutropenia (21%)
Vomiting (17%)
Pruritus (17%)
Pyrexia (17%)
Alopecia (15%)
Thrombocytopenia (15%)
Decreased appetite (15%)
Arthralgia (12%)
Myalgia (12%)
Peripheral edema (11%)
Maculopapular rash (11%)
Generalized pruritus (11%)
Asthenia (11%)
Dyspnea (11%)
1-10% (Untreated cHL)
Increased ALT, all grades (10%)
Grades 3 or 4
- Peripheral sensory neuropathy (10%)
- Vomiting (3%)
- Diarrhea (3%)
- Abdominal pain (3%)
- Increased ALT (3%)
- Pyrexia (3%)
- Constipation (2%)
- Stomatitis (2%)
- Peripheral motor neuropathy (2%)
- Dyspnea (1%)
1-10% (Other Indications)
Extremity pain (10%)
Muscle spasms (9-10%)
Dry skin (4-10%)
Chills (4%)
Nausea (3–4%)
Dyspnea (2–3%)
Pruritus (2–5%)
Pyrexia (2%)
Cough (2%)
Grade 3 or 4 (pcALCL or MF)
- Peripheral sensory neuropathy (5%)
- Fatigue (5%)
- Diarrhea (3%)
- Neutropenia (2-3%)
- Asthenia (2%)
- Maculopapular rash (2%)
- Generalized pruritus (2%)
- Nausea (2%)
- Vomiting (2%)
- Thrombocytopenia (2%)
Postmarketing reports
Blood and lymphatic system disorders: Febrile neutropenia
Gastrointestinal disorders: Acute pancreatitis and gastrointestinal complications (including fatal outcomes)
Hepatobiliary disorders: Hepatotoxicity
Infections: PML, serious infections and opportunistic infections
Metabolism and nutrition disorders: Hyperglycemia
Respiratory, thoracic and mediastinal disorders: Noninfectious pulmonary toxicity including pneumonitis, interstitial lung disease, and ARDS (some with fatal outcomes)
Skin and subcutaneous tissue disorders: Toxic epidermal necrolysis, including fatal outcomes
Warnings
Black Box Warnings
Progressive multifocal leukoencephalopathy
- JC virus infection resulting in PML and death can occur; cases of progressive multifocal leukoencephalopathy (PML) reported
- PML is a rare, but serious brain infection that can result in death
- Signs and symptoms of PML may develop over several weeks or months and may include mood changes, unusual behavior, confusion, thinking problems, memory loss, changes in vision, speech, or walking, and a unilateral decrease in strength or weakness
Contraindications
Concomitant use of brentuximab with bleomycin because of pulmonary toxicity
Cautions
Peripheral neuropathy (predominately sensory neuropathy) and motor neuropathy reported; drug-induced peripheral neuropathy is cumulative; monitor for symptoms of neuropathy (eg, hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, weakness)
Fatal and serious cases of febrile neutropenia reported; monitor complete blood counts (CBC) prior to each dose; start primary prophylaxis with G-CSF beginning with Cycle 1 for patients who receive drug with chemotherapy for previously untreated Stage III or IV cHL or previously untreated PTCL and pediatric patients who receive this medication in combination with chemotherapy for previously untreated high risk cHL
Grade 3 or 4 thrombocytopenia or anemia can occur
Frequency of Grade 3 adverse reactions and deaths reported to be greater in patients with severe renal or hepatic impairment compared to patients with normal renal/hepatic function
Serious cases of hepatotoxicity, including fatal outcomes reported after first dose or after rechallenge; serious cases of hepatotoxicity, including fatal outcomes; preexisting liver disease, elevated baseline liver enzymes, and concomitant medications may increase risk; monitor liver enzymes and bilirubin; patients experiencing new, worsening, or recurrent hepatotoxicity may require a delay, change in dose, or discontinuation of therapy
JC virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death reported (see Black Box Warnings)
Closely monitor for emergence of bacterial, fungal or viral infections
Events of noninfectious pulmonary toxicity (eg, pneumonitis, interstitial lung disease, acute respiratory distress syndrome [ARDS]), some with fatal outcomes, reported
Fatal and serious cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) reported; if SJS or TEN occurs, discontinue treatment and administer appropriate medical therapy
Acute pancreatitis, including fatal outcomes, reported
Fatal and serious gastrointestinal (GI) complications (eg, perforation, hemorrhage, erosion, ulcer, intestinal obstruction, enterocolitis, neutropenic colitis, and ileus) reported; lymphoma with preexisting GI involvement may increase risk of perforation; promptly evaluate for any new or worsening GI symptoms, and treat appropriately
Fetal harm can occur (see Pregnancy)
Patients with rapidly proliferating tumor and high tumor burden are at risk of tumor lysis syndrome; closely monitor and treat appropriately
Serious events of hyperglycemia (eg, new-onset hyperglycemia), exacerbation ofpreexisting diabetes mellitus, and ketoacidosis (including fatal outcomes) have beenreported; occurred more frequently in patients with high body mass index or diabetes;monitor serum glucose and if hyperglycemia develops, administer antihyperglycemicmedications as clinically indicated
Infusion-related reactions
- Infusion-related reactions (eg, anaphylaxis), may occur
- If anaphylaxis occurs, immediately and permanently discontinue treatment
- If an infusion-related reaction occurs, interrupt infusion
- After interrupting or discontinuing treatment, institute appropriate medical management
- Premedicate patients who previously experienced infusion-related reactions for subsequent infusions
- Premedication may include acetaminophen, an antihistamine, and a corticosteroid
Drug interactions overview
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Strong CYP3A4 Inhibitors
- Coadministration with ketoconazole, a potent CYP3A4 inhibitor, increased exposure to MMAE which may increase the risk of adverse reaction
- Closely monitor adverse reactions when concomitantly used with strong CYP3A4 inhibitors
Pregnancy & Lactation
Pregnancy
Based on the findings from animal studies and mechanism of action, brentuximab may cause fetal harm
Available data from case reports in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes
Animal data
- In animal reproduction studies, administration of brentuximab vedotin to pregnant rats during organogenesis at doses similar to the clinical dose (1.8 mg/kg q3weeks) caused embryo-fetal toxicities, including congenital malformation
Contraception
- Verify pregnancy status of females of reproductive potential prior to initiation
- Advise females of reproductive potential to avoid pregnancy during treatment and for at least 6 months after final dose; immediately report pregnancy
- May damage spermatozoa and testicular tissue, resulting in possible genetic abnormalities
- Use effective contraception in males with female sexual partners of reproductive potential during treatment and for at least 6 months after final dose
Fertility
- Based on findings in rats, male fertility may be compromised by brentuximab
Lactation
There is no information related to the presence of brentuximab vedotin in human milk, the effects on the breastfed child, or the effects on milk production
Owing to the potential for serious adverse reactions in a breastfed child from brentuximab, including cytopenias and neurologic or gastrointestinal toxicities, breastfeeding is not recommended during treatment
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
CD30-directed antibody-drug conjugate (ADC) consisting of chimeric IgG1 antibody cAC10, specific for human CD30 and the microtubule disrupting agent, monomethyl auristatin E (MMAE, or vedotin)
Conjugate binds to cell expressing the CD30 antigen and forms a complex that is internalized within the cell and MMAE is released; MMAE induces cell cycle (G2/M phase) arrest by binding to tubules and disrupting cellular microtubule network
Absorption
Peak plasma time: 20-30 min (ADC); 1-3 days (MMAE)
Steady-state: 21 days (1.8 mg/kg q3Weeks); 56 days (1.2 mg/kg q2Weeks)
Distribution
Protein Bound: 68-82% (MMAE)
Vd: 6-10 L (ADC)
Metabolism
Data indicated MMAE metabolism occurs primarily via oxidation by CYP3A4/5
Excretion
Half-life: 4-6 days
Excretion: Feces and urine (24% of the total MMAE [72% unchanged and recovered in feces])
Administration
IV Incompatibilities
Do not mix or administer with other medicinal products
IV Compatibilities
0.9% NaCl
D5W
Lactated Ringer’s (LR)
IV Preparation
Adhere to proper handling, dispensing, and administration of anticancer drugs
Reconstitution
- Reconstitute with 10.5 mL sterile water for injection to yield 5 mg/mL
- Direct stream toward vial wall and not directly at cake or powder to prevent foaming
- Do not shake vial; gently swirl vial to aid dissolution
- Reconstituted solution should be clear to slightly opalescent, colorless, and free of visible particulates
- Discard any unused portion left in vial
Dilution
- Calculate dosage volume (mL) and withdraw dose from vial(s)
- Patients weighing >100 kg should be calculated for 100 kg
- Dilute reconstituted solution in at least 100 mL of 0.9% NaCl, D5W, or LR (final concentration: 0.4-1.8 mg/mL)
- Gently invert bag to mix solution
- Contains no bacteriostatic preservatives, use immediately or refrigerate solution and use within 24 hr
IV Administration
Infuse over 30 minutes
Do not administer as an IV push or bolus
Administer G-CSF beginning with Cycle 1 for the following:
- Adults with previously untreated Stage III or IV cHL who are treated with brentuximab + AVD
- Adults with previously untreated PTCL who are treated with brentuximab + CHP
- Pediatric patients with previously untreated high risk cHL who are treated with brentuximab + AVEPC
Storage
Unopened vials: Refrigerate at 2-8°C (36-46°F) in original carton to protect from light
Diluted solutions or reconstituted vials: Refrigerate at 2-8°C (36-46°F) for up to 24 hr
Do not freeze
Images
Patient Handout
brentuximab vedotin intravenous
BRENTUXIMAB - INJECTION
(bren-TUX-i-mab)
COMMON BRAND NAME(S): Adcetris
WARNING: Rarely, a serious (sometimes fatal) brain infection (Progressive Multifocal Leukoencephalopathy-PML) has occurred in people receiving this medication. Get medical help right away if you develop any signs of PML, including changes in mood, unusual behavior, confusion, difficulty concentrating, changes in vision/speech/walking, decreased strength or weakness on one side of the body.
USES: Brentuximab is used to treat certain types of cancers (Hodgkin's lymphoma, systemic anaplastic large cell lymphoma, peripheral T-cell lymphoma, primary cutaneous anaplastic large cell lymphoma, CD30-expressing mycosis fungoides). It works by slowing or stopping the growth of cancer cells.
HOW TO USE: This medication is given by injection into a vein over 30 minutes by a health care professional. It is given as directed by your doctor, usually once every 2 or 3 weeks.The dosage is based on your medical condition, weight, and response to treatment.Your health care professional will monitor you during the infusion in case you develop a reaction to brentuximab. If a rare but severe allergic reaction occurs, the infusion will be stopped and you should never receive brentuximab again. If a less serious reaction occurs, the infusion will be interrupted, you will be treated for the reaction, and the infusion will be continued. If you develop a less serious infusion reaction, you will be directed by your doctor to take certain medications (such as acetaminophen, antihistamines, corticosteroids) before each future brentuximab infusion to lessen the chance of symptoms. Consult your doctor for more details. Get medical help right away if you have symptoms such as fever, chills, rash, itching, cough, or trouble breathing within 24 hours of the infusion.
SIDE EFFECTS: See also Warning and How to Use sections.Nausea, vomiting, diarrhea, dizziness, headache, or unusual tiredness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar, such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.Tell your doctor right away if you have any serious side effects, including: numbness/tingling/weakness/pain of the hands/feet/arms/legs, muscle weakness, signs of infection (such as sore throat that doesn't go away, fever, chills, cough), shortness of breath, easy bruising/bleeding, signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), severe diarrhea, severe constipation, black stools, vomit that looks like coffee grounds.Brentuximab sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using brentuximab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, diabetes.Brentuximab can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using brentuximab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the side effects of this drug.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using brentuximab. Brentuximab may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Men and women using this medication should ask about reliable forms of birth control during treatment and for 6 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this medication passes into breast milk. Because of the possible risk to a nursing infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: bleomycin, other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Lab and/or medical tests (such as complete blood counts, kidney/liver function, blood sugar) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.
STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised February 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
