What is the dosage of Adcetris?

Adcetris is available in 1 dosages, including 50 mg Injection

What does Adcetris treat?

Adcetris treats Hodgkin Disease and Lymphoma, Large-Cell, Immunoblastic

What is Adcetris made of?

Adcetris contains brentuximab vedotin which is a CD30-directed Immunoconjugate

How is Adcetris administered?

Adcetris is administered as a Injectable

What is Adcetris mechanism of action?

Adcetris mechanism of action is CD30-directed Antibody Interactions

Adcetris

(brentuximab vedotin)

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Dosage & Administration

* Administer only as an intravenous infusion over 30 minutes .
* The recommended dosage as monotherapy for adult patients is 1.8 mg/kg up to a maximum of 180 mg every 3 weeks .
* The recommended dosage in combination with chemotherapy for adult patients with previously untreated Stage III or IV cHL is 1.2 mg/kg up to a maximum of 120 mg every 2 weeks for a maximum of 12 doses .
* The recommended dosage in combination with chemotherapy for pediatric patients 2 years and older with previously untreated high risk cHL is 1.8 mg/kg up to a maximum of 180 mg every 3 weeks for a maximum of 5 doses .
* The recommended dosage in combination with chemotherapy for adult patients with previously untreated PTCL is 1.8 mg/kg up to a maximum of 180 mg every 3 weeks for 6 to 8 doses .
* The recommended dosage in combination with lenalidomide and a rituximab product for adult patients with relapsed or refractory LBCL is 1.2 mg/kg up to a maximum of 120 mg every 3 weeks .
* Avoid use in patients with severe renal impairment
* Reduce dose in patients with mild hepatic impairment; avoid use in patients with moderate or severe hepatic impairment .

Adcetris Prescribing Information

Previously Untreated Stage III or IV Classical Hodgkin Lymphoma (cHL), in Combination with Chemotherapy

ADCETRIS is indicated for the treatment of adult patients with previously untreated Stage III or IV cHL, in combination with doxorubicin, vinblastine, and dacarbazine.

Previously Untreated High Risk Classical Hodgkin Lymphoma (cHL), in Combination with Chemotherapy

ADCETRIS is indicated for the treatment of pediatric patients 2 years and older with previously untreated high risk cHL, in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide.

Classical Hodgkin Lymphoma (cHL) Consolidation

ADCETRIS is indicated for the treatment of adult patients with cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.

Relapsed Classical Hodgkin Lymphoma (cHL)

ADCETRIS is indicated for the treatment of adult patients with cHL after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates.

Previously Untreated Systemic Anaplastic Large Cell Lymphoma (sALCL) or Other CD30-Expressing Peripheral T-cell Lymphomas (PTCL), in Combination with Chemotherapy

ADCETRIS is indicated for the treatment of adult patients with previously untreated sALCL or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified (NOS), in combination with cyclophosphamide, doxorubicin, and prednisone.

Relapsed Systemic Anaplastic Large Cell Lymphoma (sALCL)

ADCETRIS is indicated for the treatment of adult patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen.

Relapsed Primary Cutaneous Anaplastic Large Cell Lymphoma (pcALCL) or CD30-Expressing Mycosis Fungoides (MF)

ADCETRIS is indicated for the treatment of adult patients with pcALCL or CD30-expressing MF who have received prior systemic therapy.

Relapsed or Refractory Large B-Cell Lymphoma (LBCL)

ADCETRIS in combination with lenalidomide and a rituximab product is indicated for the treatment of adult patients with relapsed or refractory LBCL, including diffuse large B-cell lymphoma (DLBCL) NOS, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for auto-HSCT or chimeric antigen receptor (CAR) T-cell therapy.

Recommended Dosage

The recommended ADCETRIS dosage is provided in Table 1. Administer ADCETRIS as a 30-minute intravenous infusion.

For recommended dosage for patients with renal or hepatic impairment, see Dosage and Administration (2.2 and 2.3).

For dosing instructions of combination agents administered with ADCETRIS, see Clinical Studies (14.1, 14.2, and 14.5) and the manufacturer’s prescribing information.

Table 1: Recommended ADCETRIS Dosage
* The dose for patients weighing greater than 100 kg should be calculated based on a weight of 100 kg. † Starting with cycle 2, rituximab intravenous treatment could be substituted with rituximab and hyaluronidase human via subcutaneous injection every 3 weeks.
Indication	Recommended Dose *	Frequency and Duration
Adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma	1.2 mg/kg up to a maximum of 120 mg in combination with chemotherapy	Administer every 2 weeks until a maximum of 12 doses, disease progression, or unacceptable toxicity
Pediatric patients with previously untreated high risk classical Hodgkin lymphoma	1.8 mg/kg up to a maximum of 180 mg in combination with chemotherapy	Administer every 3 weeks with each cycle of chemotherapy for a maximum of 5 doses
Adult patients with classical Hodgkin lymphoma consolidation	1.8 mg/kg up to a maximum of 180 mg	Initiate ADCETRIS treatment within 4‑6 weeks post-auto-HSCT or upon recovery from auto-HSCT Administer every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity
Adult patients with relapsed classical Hodgkin lymphoma	1.8 mg/kg up to a maximum of 180 mg	Administer every 3 weeks until disease progression or unacceptable toxicity
Adult patients with previously untreated systemic ALCL or other CD30-expressing peripheral T-cell lymphomas	1.8 mg/kg up to a maximum of 180 mg in combination with chemotherapy	Administer every 3 weeks with each cycle of chemotherapy for 6 to 8 doses
Adult patients with relapsed Systemic ALCL	1.8 mg/kg up to a maximum of 180 mg	Administer every 3 weeks until disease progression or unacceptable toxicity
Adult patients with relapsed primary cutaneous ALCL or CD30-expressing mycosis fungoides	1.8 mg/kg up to a maximum of 180 mg	Administer every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity
Adult patients with relapsed or refractory LBCL	1.2 mg/kg up to a maximum of 120 mg in combination with lenalidomide and rituximab †	Administer every 3 weeks until disease progression, or unacceptable toxicity

Recommended Dosage in Patients with Renal Impairment

No dosage adjustment is required for mild renal impairment (CrCL greater than 50‑80 mL/min) and moderate renal impairment (CrCL 30-50 mL/min).

Avoid use in patients with severe (CrCL less than 30 mL/min) renal impairment [see Warnings and Precautions (5.6)].

Recommended Dosage in Patients with Hepatic Impairment

Adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma

Reduce the dosage of ADCETRIS to 0.9 mg/kg up to a maximum of 90 mg every 2 weeks for patients with mild hepatic impairment (Child-Pugh A).

Avoid use in patients with moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment [see Warnings and Precautions (5.7)].

Adult patients with relapsed or refractory LBCL

Reduce the dosage of ADCETRIS to 0.9 mg/kg up to a maximum of 90 mg every 3 weeks for patients with mild hepatic impairment (total bilirubin ≤ upper limit of normal [ULN] and aspartate transaminase [AST] > ULN, or total bilirubin >1 to 1.5 × ULN and any AST).

Avoid use in patients with moderate and severe hepatic impairment (total bilirubin >1.5 × ULN) [see Warnings and Precautions (5.7)].

Hepatic impairment is defined per the National Cancer Institute Organ Dysfunction Working Group.

All other indications

Reduce the dosage of ADCETRIS to 1.2 mg/kg up to a maximum of 120 mg every 3 weeks for patients with mild hepatic impairment (Child-Pugh A).

Avoid use in patients with moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment [see Warnings and Precautions (5.7)].

Recommended Prophylactic Medications

In adult patients with previously untreated Stage III or IV cHL who are treated with ADCETRIS + doxorubicin, vinblastine, and dacarbazine (AVD), administer G‑CSF beginning with Cycle 1.

In pediatric patients with previously untreated high risk cHL who are treated with ADCETRIS + doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide (AVEPC), administer G-CSF beginning with Cycle 1.

In adult patients with previously untreated PTCL who are treated with ADCETRIS + cyclophosphamide, doxorubicin, and prednisone (CHP), administer G-CSF beginning with Cycle 1.

In adult patients with relapsed or refractory LBCL who are treated with ADCETRIS + lenalidomide + rituximab, administer G-CSF beginning with Cycle 1.

Dosage Modifications for Adverse Reactions

Table 2: Dosage Modifications for Peripheral Neuropathy or Neutropenia in Adult Patients [see Warnings and Precautions (5.1, 5.3)]
* The dose for patients weighing greater than 100 kg should be calculated based on a weight of 100 kg. † Grades based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.
Recommended ADCETRIS Dosage from Table 1 *	Monotherapy or Combination Therapy	Severity †	Dosage Modification
Peripheral Neuropathy
1.2 mg/kg up to a maximum of 120 mg every 2 weeks	In combination with chemotherapy	Grade 2	Reduce dose to 0.9 mg/kg up to a maximum of 90 mg every 2 weeks.
		Grade 3	Hold ADCETRIS dosing until improvement to Grade 2 or lower. Restart at 0.9 mg/kg up to a maximum of 90 mg every 2 weeks. Consider modifying the dose of other neurotoxic chemotherapy agents.
		Grade 4	Discontinue dosing.
1.2 mg/kg up to a maximum of 120 mg every 3 weeks	In combination with lenalidomide and rituximab	Grade 2	Sensory neuropathy: If resolves to Grade 1 or lower before the next scheduled dose, resume at the same dose level. If Grade 2 persists at the next scheduled dose, reduce one dose level. Motor neuropathy: Reduce dosage to 0.9 mg/kg up to a maximum of 90 mg every 3 weeks.
		Grade 3	Sensory neuropathy: Hold ADCETRIS dosing until improvement to Grade 2 or lower, then restart treatment at a reduced dosage of 0.9 mg/kg up to a maximum of 90 mg every 3 weeks. Motor neuropathy: Discontinue dosing.
		Grade 4	Discontinue dosing.
1.8 mg/kg up to a maximum of 180 mg every 3 weeks	As monotherapy	New or worsening Grade 2 or 3	Hold dosing until improvement to baseline or Grade 1. Restart at 1.2 mg/kg up to a maximum of 120 mg every 3 weeks.
	As monotherapy	Grade 4	Discontinue dosing.
	In combination with chemotherapy	Grade 2	Sensory neuropathy: Continue treatment at same dose. Motor neuropathy: Reduce dose to 1.2 mg/kg up to a maximum of 120 mg every 3 weeks.
		Grade 3	Sensory neuropathy: Reduce dose to 1.2 mg/kg, up to a maximum of 120 mg every 3 weeks. Motor neuropathy: Discontinue dosing.
		Grade 4	Discontinue dosing.
Neutropenia
1.2 mg/kg up to a maximum of 120 mg every 2 weeks	In combination with chemotherapy	Grade 3 or 4	Administer G‑CSF prophylaxis for subsequent cycles for patients not receiving primary G‑CSF prophylaxis.
1.2 mg/kg up to a maximum of 120 mg every 3 weeks	In combination with lenalidomide and rituximab	Grade 3 or 4	Hold dosing until improvement to baseline or Grade 2 or lower. Reduce/discontinue lenalidomide dose per prescribing information. Administer G-CSF prophylaxis for subsequent cycles for patients not receiving primary G-CSF prophylaxis.
1.8 mg/kg up to a maximum of 180 mg every 3 weeks	In combination with chemotherapy	Grade 3 or 4	Administer G-CSF prophylaxis in subsequent cycles for patients not receiving primary G-CSF prophylaxis.
1.8 mg/kg up to a maximum of 180 mg every 3 weeks	As monotherapy	Grade 3 or 4	Hold dosing until improvement to baseline or Grade 2 or lower. Consider G-CSF prophylaxis for subsequent cycles.
1.8 mg/kg up to a maximum of 180 mg every 3 weeks	As monotherapy	Recurrent Grade 4 despite G‑CSF prophylaxis	Consider discontinuation or dose reduction to 1.2 mg/kg up to a maximum of 120 mg every 3 weeks.

Table 3: Dosage Modifications for Peripheral Neuropathy or Neutropenia in Pediatric Patients
* The dose for patients weighing greater than 100 kg should be calculated based on a weight of 100 kg. † Peripheral neuropathy was assessed using the Balis scale.
Recommended ADCETRIS Dosage from Table 1 *	Severity	Dosage Modification
Peripheral Neuropathy †
1.8 mg/kg up to a maximum of 180 mg every 3 weeks	Grade 2 †	Reduce dose of vincristine per prescribing information. Continue dosing with ADCETRIS. If neuropathy improves to Grade ≤1 by day 8 of next cycle, then resume vincristine at full dose.
	Grade 3 †	Discontinue vincristine. First Occurrence: Hold ADCETRIS dosing until improvement to ≤ Grade 2 then restart at 1.2 mg/kg up to a maximum of 120 mg. Second Occurrence: Hold until improvement to ≤ Grade 2 then restart at 0.8 mg/kg up to a maximum of 80 mg. Third Occurrence: Discontinue ADCETRIS.
	Grade 4 †	Discontinue ADCETRIS and vincristine.
Neutropenia
1.8 mg/kg up to a maximum of 180 mg every 3 weeks	Grade 3 or 4	Reduce dose to 1.2 mg/kg up to a maximum of 120 mg every 3 weeks in patients who are unable to start a cycle >5 weeks after the start of the previous cycle (>2-week delay) due to neutropenia.

Instructions for Preparation and Administration

Administration

•: Administer ADCETRIS as an intravenous infusion only.
•: Do not mix ADCETRIS with, or administer as an infusion with, other medicinal products.

Reconstitution

•: Follow procedures for proper handling and disposal of hazardous drugs1.
•: Use appropriate aseptic technique for reconstitution and preparation of dosing solutions.
•: Determine the number of 50 mg vials needed based on the patient’s weight and the prescribed dose [see Dosage and Administration (2.1)].
•: Reconstitute each 50 mg vial of ADCETRIS with 10.5 mL of Sterile Water for Injection to yield a single-dose solution containing 5 mg/mL brentuximab vedotin.
•: Direct the stream toward the wall of vial and not directly at the cake or powder.
•: Gently swirl the vial to aid dissolution. DO NOT SHAKE.
•: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted solution should be clear to slightly opalescent, colorless, and free of visible particulates.
•: Following reconstitution, dilute immediately into an infusion bag. If not diluted immediately, store the solution refrigerated at 2°C to 8°C (36°F to 46°F) and use within 24 hours of reconstitution. DO NOT FREEZE.
•: Discard any unused portion left in the vial.

Dilution

•: Calculate the required volume of 5 mg/mL reconstituted ADCETRIS solution needed.
•: Withdraw this amount from the vial and immediately add it to an infusion bag containing 0.9% Sodium Chloride Injection, USP, 5% Dextrose Injection or Lactated Ringer's Injection to achieve a final concentration of 0.4 mg/mL to 1.8 mg/mL brentuximab vedotin.
•: Gently invert the bag to mix the solution.
•: Following dilution, infuse the ADCETRIS solution immediately. If not used immediately, store the solution refrigerated at 2°C to 8°C (36°F to 46°F) and use within 24 hours of reconstitution. DO NOT FREEZE.

Pregnancy

Risk Summary

ADCETRIS can cause fetal harm based on the findings from animal studies and the drug’s mechanism of action [see Clinical Pharmacology (12.1)]. In animal reproduction studies, administration of brentuximab vedotin to pregnant rats during organogenesis at doses similar to the clinical dose of 1.8 mg/kg every three weeks caused embryo-fetal toxicities, including congenital malformations (see Data). The available data from case reports on ADCETRIS use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. Advise a pregnant woman of the potential risk to a fetus.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

Data

Animal Data

In an embryo-fetal developmental study, pregnant rats received 2 intravenous doses of 0.3, 1, 3, or 10 mg/kg brentuximab vedotin during the period of organogenesis (once each on Pregnancy Days 6 and 13). Drug-induced embryo-fetal toxicities were seen mainly in animals treated with 3 and 10 mg/kg of the drug and included increased early resorption (≥99%), post-implantation loss (≥99%), decreased numbers of live fetuses, and external malformations (i.e., umbilical hernias and malrotated hindlimbs). Systemic exposure in animals at the brentuximab vedotin dose of 3 mg/kg is approximately the same exposure in patients with cHL or sALCL who received the recommended dose of 1.8 mg/kg every three weeks.

Lactation

Risk Summary

There is no information regarding the presence of brentuximab vedotin in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child from ADCETRIS, including cytopenias and neurologic or gastrointestinal toxicities, advise patients that breastfeeding is not recommended during ADCETRIS treatment.

Females and Males of Reproductive Potential

ADCETRIS can cause fetal harm based on the findings from animal studies and the drug’s mechanism of action [see Use in Specific Populations (8.1)].

Pregnancy Testing

Verify the pregnancy status of females of reproductive potential prior to initiating ADCETRIS therapy.

Contraception

Females

Advise females of reproductive potential to use effective contraception during ADCETRIS treatment and for 2 months after the last dose of ADCETRIS. Advise females to immediately report pregnancy [see Use in Specific Populations (8.1)].

Males

ADCETRIS may damage spermatozoa and testicular tissue, resulting in possible genetic abnormalities. Males with female sexual partners of reproductive potential should use effective contraception during ADCETRIS treatment and for 4 months after the last dose of ADCETRIS [see Nonclinical Toxicology (13.1)].

Infertility

Females

Based on findings in animal studies with MMAE-containing antibody-drug conjugates (ADCs), ADCETRIS may impair female fertility. The effect on fertility is reversible [see Nonclinical Toxicology (13.1)].

Males

Based on findings in rats, male fertility may be compromised by treatment with ADCETRIS [see Nonclinical Toxicology (13.1)].

Pediatric Use

The safety and effectiveness of ADCETRIS have been established in pediatric patients age 2 years and older with previously untreated high risk classical Hodgkin lymphoma in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide. The safety and effectiveness of ADCETRIS have not been established for all other indications [see Indications and Usage (1)].

Previously Untreated, High Risk Classical Hodgkin Lymphoma (cHL) in Combination with Doxorubicin, Vincristine, Etoposide, Prednisone, and Cyclophosphamide

The safety and effectiveness of ADCETRIS have been established in pediatric patients 2 years and older with previously untreated high risk cHL in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide chemotherapy.

Use of ADCETRIS for this indication is supported by evidence from Study 7: AHOD1331, a randomized study which included pediatric patients with previously untreated high risk cHL, including patients in the following age groups: 9 patients 3 to less than 6 years of age, 81 patients 6 to less than 12 years of age, and 345 patients 12 to less than 17 years of age [see Adverse Reactions (6.1) and Clinical Studies (14.1)].

The safety and efficacy of ADCETRIS have not been established for this indication in patients younger than 2 years.

Previously Untreated High Risk Classical Hodgkin Lymphoma (cHL) in Combination with Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Prednisone, and Dacarbazine

The safety and effectiveness of ADCETRIS in combination with etoposide (E), prednisone (P), and doxorubicin (A)/cyclophosphamide (C), prednisone (P), and dacarbazine (Dac) (AEPA/CAPDac) were assessed but have not been established based on a single arm, open-label trial (NCT01920932) in 77 patients, which included 48 pediatric patients age 6 to less than 17 with previously untreated high risk (IIB, IIIB, IVA, or IVB) cHL. No new safety signals were identified in this study.

Relapsed or Refractory Classical HL (cHL)

ADCETRIS in Combination with Gemcitabine

The safety and effectiveness of ADCETRIS in combination with gemcitabine were assessed but have not been established based on a study (NCT01780662) in 45 patients, which included 18 pediatric patients age 5 to less than 17 with relapsed or refractory cHL. No new safety signals were identified in this study.

ADCETRIS Monotherapy

The safety and effectiveness of ADCETRIS monotherapy was assessed but have not been established based on a study (NCT01492088) in 36 patients, which included 15 pediatric patients age 8 to less than 17 with relapsed or refractory cHL. No new safety signals were identified in this study.

Relapsed or Refractory Systemic ALCL (sALCL)

ADCETRIS monotherapy

The safety and effectiveness of ADCETRIS monotherapy was assessed but have not been established based on a study (NCT01492088) in 36 patients, which included 16 pediatric patients age 7 to less than 17 with sALCL. No new safety signals were identified in this study.

Newly Diagnosed ALK+ ALCL

The safety and effectiveness of ADCETRIS in combination with alternating chemotherapy Courses A (dexamethasone, ifosfamide, methotrexate, etoposide, cytarabine) and B (dexamethasone, methotrexate, cyclophosphamide, doxorubicin) administered every 21 days for a total of 6 cycles was assessed but have not been established based on a study (NCT01979536) in 67 patients, which included 61 pediatric patients age 2 to less than 17 years with newly diagnosed ALK+ ALCL. No new safety signals were identified in this study.

Geriatric Use

In the clinical trial of ADCETRIS in combination with AVD for patients with previously untreated Stage III or IV cHL (Study 5: ECHELON-1), 9% of ADCETRIS + AVD-treated patients were age 65 and older. Older age was a risk factor for febrile neutropenia, occurring in 39% of patients who were age 65 and older versus 17% of patients less than age 65, who received ADCETRIS + AVD [see Dosage and Administration (2.3)]. The ECHELON-1 trial did not contain sufficient information on patients age 65 and older to determine whether they respond differently from younger patients [see Clinical Studies (14.1)].

In the clinical trial of ADCETRIS in combination with CHP for patients with previously untreated, CD30-expressing PTCL (Study 6: ECHELON-2), 31% of ADCETRIS + CHP-treated patients were age 65 and older [see Clinical Studies (14.2)]. Among older patients, 74% had adverse reactions ≥ Grade 3 and 49% had serious adverse reactions. Among patients younger than age 65, 62% had adverse reactions ≥ Grade 3 and 33% had serious adverse reactions. Older age was a risk factor for febrile neutropenia, occurring in 29% of patients who were age 65 and older versus 14% of patients less than age 65.

Other clinical trials of ADCETRIS in cHL (Study 1; Study 3: AETHERA) and sALCL (Study 2) did not include sufficient numbers of patients who were age 65 and older to determine whether they respond differently from younger patients [see Clinical Studies (14.1, 14.3)].

In the clinical trial of ADCETRIS in pcALCL or CD30-expressing MF (Study 4: ALCANZA), 42% of ADCETRIS-treated patients were age 65 and older [see Clinical Studies (14.4)]. No meaningful differences in safety or efficacy were observed between these patients and younger patients.

In the clinical trial of ADCETRIS in relapsed or refractory LBCL (Study 8: ECHELON-3) [see Clinical Studies (14.5)], 79 (71%) of ADCETRIS-treated patients were age 65 and older. No meaningful differences in safety or efficacy were observed between these patients and younger patients.

Renal Impairment

Avoid the use of ADCETRIS in patients with severe renal impairment (CrCL <30 mL/min) [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.3)]. No dosage adjustment is required for mild (CrCL >50–80 mL/min) or moderate (CrCL 30–50 mL/min) renal impairment.

Hepatic Impairment

Avoid the use of ADCETRIS in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment [see Warnings and Precautions (5.7) and Clinical Pharmacology (12.3)]. Dosage reduction is required in patients with mild (Child-Pugh A) hepatic impairment [see Dosage and Administration (2.3)].

Hepatic impairment for patients with relapsed or refractory large B-cell lymphoma is defined per the National Cancer Institute Organ Dysfunction Working Group.