HIGHLIGHTS OF PRESCRIBING INFORMATION DOSAGE …

1 HIGHLIGHTS OF PRESCRIBING INFORMATION _____ DOSAGE FORMS AND STRENGTHS _____. These HIGHLIGHTS do not include all the INFORMATION needed to use ADCETRIS safely and For injection: 50 mg lyophilized powder in a single-dose vial (3). effectively. See full PRESCRIBING INFORMATION for ADCETRIS. _____ CONTRAINDICATIONS _____. ADCETRIS (brentuximab vedotin) for injection, for intravenous use Concomitant use with bleomycin due to pulmonary toxicity (4). Initial approval: 2011 _____ WARNINGS AND PRECAUTIONS _____. WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) Peripheral neuropathy: Monitor patients for neuropathy and institute dose modifications See full PRESCRIBING INFORMATION for complete boxed warning. accordingly ( ). JC virus infection resulting in PML and death can occur in patients receiving Anaphylaxis and infusion reactions: If an infusion reaction occurs, interrupt the infusion.

2 ADCETRIS ( , ). If anaphylaxis occurs, immediately discontinue the infusion ( ). Hematologic toxicities: Monitor complete blood counts. Monitor for signs of infection. _____ INDICATIONS AND USAGE _____ Manage using dose delays and growth factor support ( ). ADCETRIS is a CD30-directed antibody-drug conjugate indicated for treatment of adult Serious infections and opportunistic infections: Closely monitor patients for the patients with: emergence of bacterial, fungal or viral infections ( ). Tumor lysis syndrome: Closely monitor patients with rapidly proliferating tumor or high Previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination tumor burden ( ). with doxorubicin, vinblastine, and dacarbazine ( ). Hepatotoxicity: Monitor liver enzymes and bilirubin ( ). Classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post- Pulmonary toxicity: Monitor patients for new or worsening symptoms ( ).

3 Autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation ( ). Serious dermatologic reactions: Discontinue if Stevens-Johnson syndrome or toxic Classical Hodgkin lymphoma (cHL) after failure of auto-HSCT or after failure of at least epidermal necrolysis occurs ( ). two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT Gastrointestinal complications: Monitor patients for new or worsening symptoms ( ). candidates ( ). Hyperglycemia: Monitor patients for new or worsening hyperglycemia. Manage with anti- hyperglycemic medications as clinically indicated ( ). Previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30- Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell the potential risk to a fetus and to avoid pregnancy ( ).

4 Lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, _____ ADVERSE REACTIONS _____. doxorubicin, and prednisone ( ). The most common adverse reactions ( 20% in any study) were peripheral neuropathy, Systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi- fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, agent chemotherapy regimen ( ). constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, Primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing lymphopenia, and mucositis ( ). mycosis fungoides (MF) who have received prior systemic therapy ( ). To report SUSPECTED ADVERSE REACTIONS, contact Seattle Genetics, Inc. at _____ DOSAGE AND ADMINISTRATION _____ 1-855-473-2436 or FDA at 1-800-FDA-1088 or Administer only as an intravenous infusion over 30 minutes ( ).

5 _____ DRUG INTERACTIONS _____. The recommended dose as monotherapy is mg/kg up to a maximum of 180 mg Concomitant use of strong CYP3A4 inhibitors or inducers has the potential to affect the every 3 weeks ( ). exposure to monomethyl auristatin E (MMAE) ( ). The recommended dose in combination with chemotherapy for previously untreated _____ USE IN SPECIFIC POPULATIONS _____. Stage III or IV cHL is mg/kg up to a maximum of 120 mg every 2 weeks for a Moderate or severe hepatic impairment or severe renal impairment: MMAE exposure and maximum of 12 doses ( ). adverse reactions are increased. Avoid use (6, 7, , ). The recommended dose in combination with chemotherapy for previously untreated Lactation: Advise women not to breastfeed ( ). PTCL is mg/kg up to a maximum of 180 mg every 3 weeks for 6 to 8 doses ( ). See 17 for PATIENT COUNSELING INFORMATION . Reduce dose in patients with mild hepatic impairment ( ).

6 Revised: 10/2019. full PRESCRIBING INFORMATION : CONTENTS* 6 ADVERSE REACTIONS. WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) Clinical Trial Experience 1 INDICATIONS AND USAGE Post Marketing Experience Previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in Immunogenicity combination with chemotherapy 7 DRUG INTERACTIONS. Classical Hodgkin lymphoma (cHL) consolidation Effect of Other Drugs on ADCETRIS. Relapsed classical Hodgkin lymphoma (cHL) 8 USE IN SPECIFIC POPULATIONS. Previously untreated systemic anaplastic large cell lymphoma (sALCL) or Pregnancy other CD30-expressing peripheral T-cell lymphomas (PTCL), in combination Lactation with chemotherapy Females and Males of Reproductive Potential Relapsed systemic anaplastic large cell lymphoma (sALCL) Pediatric Use Relapsed primary cutaneous anaplastic large cell lymphoma (pcALCL) or Geriatric Use CD30-expressing mycosis fungoides (MF) Renal Impairment 2 DOSAGE AND ADMINISTRATION Hepatic Impairment Recommended DOSAGE 10 OVERDOSAGE.

7 Recommended Prophylactic Medications 11 DESCRIPTION. Dose Modification 12 CLINICAL PHARMACOLOGY. Instructions for Preparation and Administration Mechanism of Action 3 DOSAGE FORMS AND STRENGTHS Pharmacodynamics 4 CONTRAINDICATIONS Pharmacokinetics 5 WARNINGS AND PRECAUTIONS 13 NONCLINICAL TOXICOLOGY. Peripheral Neuropathy Carcinogenesis, Mutagenesis, Impairment of Fertility Anaphylaxis and Infusion Reactions 14 CLINICAL STUDIES. Hematologic Toxicities Classical Hodgkin Lymphoma Serious Infections and Opportunistic Infections Systemic Anaplastic Large Cell Lymphoma and Other CD30-Expressing Tumor Lysis Syndrome Peripheral T-Cell Lymphomas Increased Toxicity in the Presence of Severe Renal Impairment Systemic Anaplastic Large Cell Lymphoma Increased Toxicity in the Presence of Moderate or Severe Hepatic Impairment Primary Cutaneous Anaplastic Large Cell Lymphoma and CD30-Expressing Hepatotoxicity Mycosis Fungoides Progressive Multifocal Leukoencephalopathy 15 REFERENCES.

8 Pulmonary Toxicity 16 HOW SUPPLIED/STORAGE AND HANDLING. Serious Dermatologic Reactions How Supplied Gastrointestinal Complications Storage Hyperglycemia Special Handling Embryo-Fetal Toxicity 17 PATIENT COUNSELING INFORMATION . *Sections or subsections omitted from the full PRESCRIBING INFORMATION are not listed. full PRESCRIBING INFORMATION Table 2: Recommended Dose for Patients with Renal or Hepatic Impairment WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) Recommended Degree of Impairment Recommended Dose*. JC virus infection resulting in PML and death can occur in patients receiving Dose* from Table 1. ADCETRIS [see Warnings and Precautions ( ), Adverse Reactions ( )]. Renal Impairment 1 INDICATIONS AND USAGE mg/kg up to a Normal mg/kg up to a Previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in maximum of 180 mg Mild (CrCL greater than 50-80 mL/min) maximum of 180 mg combination with chemotherapy every 3 weeks every 3 weeks Moderate (CrCL 30-50 mL/min).

9 ADCETRIS is indicated for the treatment of adult patients with previously untreated Stage III or IV cHL, in combination with doxorubicin, vinblastine, and dacarbazine. Severe (CrCL less than 30 mL/min) Avoid use [see Classical Hodgkin lymphoma (cHL) consolidation Warnings and ADCETRIS is indicated for the treatment of adult patients with cHL at high risk of Precautions ( )]. relapse or progression as post-autologous hematopoietic stem cell transplantation Hepatic Impairment (auto-HSCT) consolidation. Relapsed classical Hodgkin lymphoma (cHL) mg/kg up to a Normal mg/kg up to a ADCETRIS is indicated for the treatment of adult patients with cHL after failure of maximum of 120 mg maximum of 120 mg auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in every 2 weeks every 2 weeks patients who are not auto-HSCT candidates. Mild (Child-Pugh A) mg/kg up to a Previously untreated systemic anaplastic large cell lymphoma (sALCL) or other maximum of 90 mg CD30-expressing peripheral T-cell lymphomas (PTCL), in combination with every 2 weeks chemotherapy Moderate (Child-Pugh B) Avoid use [see ADCETRIS is indicated for the treatment of adult patients with previously untreated Warnings and Severe (Child-Pugh C).]

10 SALCL or other CD30-expressing PTCL, including angioimmunoblastic T-cell Precautions ( )]. lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone. mg/kg up to a Normal mg/kg up to a maximum of 180 mg maximum of 180 mg Relapsed systemic anaplastic large cell lymphoma (sALCL). every 3 weeks every 3 weeks ADCETRIS is indicated for the treatment of adult patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen. Mild (Child-Pugh A) mg/kg up to a Relapsed primary cutaneous anaplastic large cell lymphoma (pcALCL) or maximum of 120 mg CD30-expressing mycosis fungoides (MF) every 3 weeks ADCETRIS is indicated for the treatment of adult patients with pcALCL or CD30- Moderate (Child-Pugh B) Avoid use [see expressing MF who have received prior systemic therapy. Severe (Child-Pugh C) Warnings and 2 DOSAGE AND ADMINISTRATION Precautions ( )].