Usual Adult Dose for Malignant Melanoma

200 mg IV every 3 weeks or 400 mg IV every 6 weeks

Duration of Therapy:

• Unresectable or metastatic melanoma: Until disease progression or unacceptable toxicity
• Adjuvant treatment: Until disease recurrence, unacceptable toxicity, or up to 12 months

Uses:

• For the treatment of patients with unresectable or metastatic melanoma
• For the adjuvant treatment of patients with stage IIB, IIC, or III melanoma after complete resection

Usual Adult Dose for Melanoma - Metastatic

200 mg IV every 3 weeks or 400 mg IV every 6 weeks

Duration of Therapy:

• Unresectable or metastatic melanoma: Until disease progression or unacceptable toxicity
• Adjuvant treatment: Until disease recurrence, unacceptable toxicity, or up to 12 months

Uses:

• For the treatment of patients with unresectable or metastatic melanoma
• For the adjuvant treatment of patients with stage IIB, IIC, or III melanoma after complete resection

Usual Adult Dose for Non-Small Cell Lung Cancer

200 mg IV every 3 weeks or 400 mg IV every 6 weeks
Duration of therapy: Until disease progression, unacceptable toxicity, or up to 24 months (up to 12 months for adjuvant treatment)

Comments:

• As a single agent: Selection of patients for treatment should be based on the presence of positive programmed death ligand-1 (PD-L1) expression in:
• stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation.
• metastatic NSCLC.
• Combination therapy: This drug should be administered before chemotherapy when given on the same day.

Uses:

• As a single agent, for the first-line treatment of patients with NSCLC expressing PD-L1 (tumor proportion score [TPS] at least 1%) as determined by a US FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma receptor tyrosine kinase (ALK) genomic tumor aberrations, and is:
• stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
• metastatic
• As a single agent, for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS at least 1%) as determined by a US FDA-approved test, with disease progression on or after platinum-containing chemotherapy; patients with EGFR or ALK genomic tumor aberrations should have disease progression on US FDA-approved therapy for these aberrations before receiving this drug.
• As a single agent, as adjuvant treatment after resection and platinum-based chemotherapy for patients with stage 1B (T2a at least 4 cm), II, or IIA NSCLC
• In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations
• In combination with carboplatin and either paclitaxel or paclitaxel protein-bound, for the first-line treatment of patients with metastatic squamous NSCLC

Usual Adult Dose for Head and Neck Cancer

200 mg IV every 3 weeks or 400 mg IV every 6 weeks
Duration of therapy: Until disease progression, unacceptable toxicity, or up to 24 months

Comments:

• As a single agent: Selection of patients for treatment should be based on the presence of positive PD-L1 expression in first-line treatment of metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
• Combination therapy: This drug should be administered before chemotherapy when given on the same day.

Uses:

• As a single agent, for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 (combined positive score [CPS] at least 1) as determined by a US FDA-approved test
• As a single agent, for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy
• In combination with platinum and fluorouracil, for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC

Usual Adult Dose for Hodgkin's Disease

200 mg IV every 3 weeks

• Alternatively: 400 mg IV every 6 weeks

Duration of therapy: Until disease progression, unacceptable toxicity, or up to 24 months

Comments:

• The alternative dosage (400 mg IV every 6 weeks) is approved under accelerated approval based on pharmacokinetic data and the relationships of exposure to efficacy and safety; continued approval for this dosage may depend on verification and description of clinical benefit in confirmatory trials.

Use: For the treatment of patients with relapsed or refractory classical Hodgkin lymphoma (cHL)

Usual Adult Dose for Lymphoma

200 mg IV every 3 weeks

• Alternatively: 400 mg IV every 6 weeks

Duration of therapy: Until disease progression, unacceptable toxicity, or up to 24 months

Comments:

• Limitations of Use: This drug is not recommended for treatment of patients with primary mediastinal large B-cell lymphoma (PMBCL) who require urgent cytoreductive therapy.
• The alternative dosage (400 mg IV every 6 weeks) is approved under accelerated approval based on pharmacokinetic data and the relationships of exposure to efficacy and safety; continued approval for this dosage may depend on verification and description of clinical benefit in confirmatory trials.

Use: For the treatment of patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of therapy

Usual Adult Dose for Urothelial Carcinoma

200 mg IV every 3 weeks or 400 mg IV every 6 weeks
Duration of therapy: Until disease progression, unacceptable toxicity, or up to 24 months

Comments:

• Combination therapy: This drug should be administered after enfortumab vedotin when given on the same day.
• Combination therapy with enfortumab vedotin: Approved under accelerated approval based on tumor response rate and durability of response; continued approval may depend on verification and description of clinical benefit in confirmatory trials.

Uses:

• As a single agent, for the treatment of patients with locally advanced or metastatic urothelial carcinoma:
• who are not eligible for any platinum-containing chemotherapy, or
• who have disease progression during or after platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
• In combination with enfortumab vedotin, for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy

Usual Adult Dose for Bladder Cancer

200 mg IV every 3 weeks or 400 mg IV every 6 weeks
Duration of therapy: Until persistent or recurrent high-risk non-muscle invasive bladder cancer (NMIBC), disease progression, unacceptable toxicity, or up to 24 months

Use: As a single agent, for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk NMIBC with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy

Usual Adult Dose for Solid Tumors

200 mg IV every 3 weeks or 400 mg IV every 6 weeks
Duration of therapy: Until disease progression, unacceptable toxicity, or up to 24 months

Comments:

• As a single agent, for the microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) indication: Selection of patients for treatment should be based on MSI-H/dMMR status in tumor specimens.
• As a single agent, for the tumor mutational burden-high (TMB-H) indication: Selection of patients for treatment should be based on TMB-H status in tumor specimens.
• Due to discordance between local tests and US FDA-approved tests, confirmation of MSI-H or dMMR status is recommended by a US FDA-approved test in patients with MSI-H or dMMR solid tumors, if feasible; if unable to perform confirmatory MSI-H/dMMR testing, the presence of TMB at least 10 mutations/megabase (mut/Mb), as determined by a US FDA-approved test, may be used to select patients for treatment.
• TMB-H cancer: Approved under accelerated approval based on tumor response rate and durability of response; continued approval may depend on verification and description of clinical benefit in confirmatory trials.

Uses:

• For the treatment of patients with unresectable or metastatic MSI-H or dMMR solid tumors, as determined by a US FDA-approved test, that have progressed after prior treatment and who have no satisfactory alternative treatment options
• For the treatment of patients with unresectable or metastatic TMB-H (at least 10 mut/Mb) solid tumors, as determined by a US FDA-approved test, that have progressed after prior treatment and who have no satisfactory alternative treatment options

Usual Adult Dose for Colorectal Cancer

200 mg IV every 3 weeks or 400 mg IV every 6 weeks
Duration of therapy: Until disease progression, unacceptable toxicity, or up to 24 months

Comments:

• As a single agent: Selection of patients for treatment should be based on MSI-H/dMMR status in tumor specimens.

Use: For the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by a US FDA-approved test

Usual Adult Dose for Gastric Cancer

200 mg IV every 3 weeks or 400 mg IV every 6 weeks
Duration of therapy: Until disease progression, unacceptable toxicity, or up to 24 months

Comments:

• This drug should be administered before trastuzumab and chemotherapy when given on the same day.
• Approved under accelerated approval based on tumor response rate and durability of response; continued approval may depend on verification and description of clinical benefit in confirmatory trials.

Use: In combination with trastuzumab plus fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma

Usual Adult Dose for Esophageal Carcinoma

200 mg IV every 3 weeks or 400 mg IV every 6 weeks
Duration of therapy: Until disease progression, unacceptable toxicity, or up to 24 months

Comments:

• As a single agent: Selection of patients for treatment should be based on the presence of positive PD-L1 expression in previously treated recurrent locally advanced or metastatic esophageal cancer.
• Combination therapy: This drug should be administered before chemotherapy when given on the same day.

Uses: For the treatment of patients with locally advanced or metastatic esophageal or GEJ (tumors with epicenter 1 to 5 cm above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:

• as a single agent after 1 or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS at least 10) as determined by a US FDA-approved test, or
• in combination with platinum- and fluoropyrimidine-based chemotherapy

Usual Adult Dose for Cervical Cancer

200 mg IV every 3 weeks or 400 mg IV every 6 weeks
Duration of therapy: Until disease progression, unacceptable toxicity, or up to 24 months

Comments:

• As a single agent: Selection of patients for treatment should be based on the presence of positive PD-L1 expression in recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
• In combination with chemotherapy, with or without bevacizumab: Selection of patients should be based on the presence of positive PD-L1 expression in persistent, recurrent, or metastatic cervical cancer.
• Combination therapy: This drug should be administered before chemotherapy with or without bevacizumab when given on the same day.

Uses:

• As a single agent, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS at least 1) as determined by a US FDA-approved test
• In combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS at least 1) as determined by a US FDA-approved test

Usual Adult Dose for Hepatocellular Carcinoma

200 mg IV every 3 weeks or 400 mg IV every 6 weeks
Duration of therapy: Until disease progression, unacceptable toxicity, or up to 24 months

Comments:

• Approved under accelerated approval based on tumor response rate and durability of response; continued approval may depend on verification and description of clinical benefit in confirmatory trials.

Use: For the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib

Usual Adult Dose for Merkel Cell Carcinoma

200 mg IV every 3 weeks or 400 mg IV every 6 weeks
Duration of therapy: Until disease progression, unacceptable toxicity, or up to 24 months

Comments:

• Approved under accelerated approval based on tumor response rate and durability of response; continued approval may depend on verification and description of clinical benefit in confirmatory trials.

Use: For the treatment of patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC)

Usual Adult Dose for Renal Cell Carcinoma

200 mg IV every 3 weeks or 400 mg IV every 6 weeks

Duration of Therapy:

• Monotherapy (adjuvant treatment): Until disease recurrence, unacceptable toxicity, or up to 12 months
• Combination therapy: Until disease recurrence, unacceptable toxicity, or up to 24 months

Comments:

• Combination therapy: This drug should be administered in combination with axitinib (5 mg orally twice a day) or lenvatinib (20 mg orally once a day).
• When axitinib is used in combination with this drug, dose escalation of axitinib (above the initial 5 mg dose) may be considered at intervals of 6 weeks or longer.

Uses:

• For the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence after nephrectomy, or after nephrectomy and resection of metastatic lesions
• In combination with axitinib, for the first-line treatment of patients with advanced RCC
• In combination with lenvatinib, for the first-line treatment of patients with advanced RCC

Usual Adult Dose for Endometrial Carcinoma

200 mg IV every 3 weeks or 400 mg IV every 6 weeks
Duration of therapy: Until disease progression, unacceptable toxicity, or up to 24 months

Comments:

• As a single agent: Selection of patients for treatment should be based on MSI-H/dMMR status in tumor specimens.
• In combination with lenvatinib: Selection of patients for treatment should be based on microsatellite instability (MSI) or mismatch repair (MMR) status in tumor specimens.
• A US FDA-approved test for the detection of not MSI-H is currently unavailable for the selection of patients with not MSI-H endometrial carcinoma.
• Combination therapy: This drug should be administered in combination with lenvatinib (20 mg orally once a day).

Uses:

• As a single agent, for the treatment of patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by a US FDA-approved test, who have disease progression after prior systemic therapy in any setting and are not candidates for curative surgery or radiation
• In combination with lenvatinib, for the treatment of patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) as determined by a US FDA-approved test or not MSI-H, who have disease progression after prior systemic therapy in any setting and are not candidates for curative surgery or radiation

Usual Adult Dose for Squamous Cell Carcinoma

200 mg IV every 3 weeks or 400 mg IV every 6 weeks
Duration of therapy: Until disease progression, unacceptable toxicity, or up to 24 months

Use: For the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation

Usual Adult Dose for Breast Cancer

200 mg IV every 3 weeks or 400 mg IV every 6 weeks

Duration/Timing of Therapy:

• High-risk early-stage triple-negative breast cancer (TNBC):
• Neoadjuvant treatment (in combination with chemotherapy): 24 weeks (200 mg IV every 3 weeks for 8 doses or 400 mg IV every 6 weeks for 4 doses) or until disease progression or unacceptable toxicity, followed by
• Adjuvant treatment (with this drug as a single agent): Up to 27 weeks (200 mg IV every 3 weeks for 9 doses or 400 mg IV every 6 weeks for 5 doses) or until disease recurrence or unacceptable toxicity
• Locally recurrent unresectable or metastatic TNBC: Until disease progression, unacceptable toxicity, or up to 24 months

Comments:

• In combination with chemotherapy: Selection of patients for treatment should be based on the presence of positive PD-L1 expression in locally recurrent unresectable or metastatic TNBC.
• Combination therapy: This drug should be administered before chemotherapy when given on the same day.
• Patients who have disease progression or unacceptable toxicity related to this drug during neoadjuvant treatment (in combination with chemotherapy) should not receive adjuvant treatment with this drug as a single agent.

Uses:

• For the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery
• In combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS at least 10) as determined by a US FDA-approved test

Usual Pediatric Dose for Hodgkin's Disease

2 mg/kg IV every 3 weeks
Maximum dose: 200 mg/dose
Duration of therapy: Until disease progression, unacceptable toxicity, or up to 24 months

Use: For the treatment of patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy

Usual Pediatric Dose for Lymphoma

2 mg/kg IV every 3 weeks
Maximum dose: 200 mg/dose
Duration of therapy: Until disease progression, unacceptable toxicity, or up to 24 months

Comments:

• Limitations of Use: This drug is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Use: For the treatment of patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of therapy

Usual Pediatric Dose for Merkel Cell Carcinoma

2 mg/kg IV every 3 weeks
Maximum dose: 200 mg/dose
Duration of therapy: Until disease progression, unacceptable toxicity, or up to 24 months

Comments:

• Approved under accelerated approval based on tumor response rate and durability of response; continued approval may depend on verification and description of clinical benefit in confirmatory trials.

Use: For the treatment of patients with recurrent locally advanced or metastatic MCC

Usual Pediatric Dose for Solid Tumors

2 mg/kg IV every 3 weeks
Maximum dose: 200 mg/dose
Duration of therapy: Until disease progression, unacceptable toxicity, or up to 24 months

Comments:

• Limitations of Use: Safety and efficacy have not been established in pediatric patients with TMB-H CNS cancers.
• As a single agent, for the MSI-H/dMMR indication: Selection of patients for treatment should be based on MSI-H/dMMR status in tumor specimens.
• As a single agent, for the TMB-H indication: Selection of patients for treatment should be based on TMB-H status in tumor specimens.
• Due to discordance between local tests and US FDA-approved tests, confirmation of MSI-H or dMMR status is recommended by a US FDA-approved test in patients with MSI-H or dMMR solid tumors, if feasible; if unable to perform confirmatory MSI-H/dMMR testing, the presence of TMB at least 10 mut/Mb, as determined by a US FDA-approved test, may be used to select patients for treatment.
• TMB-H cancer: Approved under accelerated approval based on tumor response rate and durability of response; continued approval may depend on verification and description of clinical benefit in confirmatory trials.

Uses:

• For the treatment of patients with unresectable or metastatic MSI-H or dMMR solid tumors, as determined by a US FDA-approved test, that have progressed after prior treatment and who have no satisfactory alternative treatment options
• For the treatment of patients with unresectable or metastatic TMB-H (at least 10 mut/Mb) solid tumors, as determined by a US FDA-approved test, that have progressed after prior treatment and who have no satisfactory alternative treatment options

Usual Pediatric Dose for Malignant Melanoma

12 years and older: 2 mg/kg IV every 3 weeks
Maximum dose: 200 mg/dose
Duration of therapy: Until disease progression, unacceptable toxicity, or up to 12 months

Use: For the adjuvant treatment of patients with stage IIB, IIC, or III melanoma after complete resection

Usual Pediatric Dose for Melanoma - Metastatic

12 years and older: 2 mg/kg IV every 3 weeks
Maximum dose: 200 mg/dose
Duration of therapy: Until disease progression, unacceptable toxicity, or up to 12 months

Use: For the adjuvant treatment of patients with stage IIB, IIC, or III melanoma after complete resection

Renal Dose Adjustments

Renal dysfunction: Data not available

If Immune-Mediated Nephritis with Renal Dysfunction Develops During Therapy:

• Grade 2 or 3 increased blood creatinine: This drug should be withheld.
• Complete or partial resolution (grade 0 or 1) after corticosteroid taper: This drug should resume.
• If no complete or partial resolution within 12 weeks of starting steroids or inability to reduce prednisone to 10 mg/day or less (or equivalent) within 12 weeks of starting steroids: This drug should be permanently discontinued.
• Grade 4 increased blood creatinine: This drug should be permanently discontinued.

Comments:

• Renal dysfunction (estimated GFR at least 15 mL/min/1.73 m2) had no clinically significant effect on the clearance of this drug.

Liver Dose Adjustments

Liver dysfunction: Data not available

If Immune-Mediated Hepatitis with No Tumor Involvement of The Liver Develops During Therapy:

• AST or ALT increases to greater than 3 to 8 times the upper limit of normal (3 to 8 x ULN) or total bilirubin (TB) increases to greater than 1.5 to 3 x ULN: This drug should be withheld.
• Complete or partial resolution (grade 0 or 1) after corticosteroid taper: This drug should resume.
• If no complete or partial resolution within 12 weeks of starting steroids or inability to reduce prednisone to 10 mg/day or less (or equivalent) within 12 weeks of starting steroids: This drug should be permanently discontinued.
• AST or ALT increases to greater than 8 x ULN or TB increases to greater than 3 x ULN: This drug should be permanently discontinued.

If Immune-Mediated Hepatitis with Tumor Involvement of The Liver Develops During Therapy:

• Baseline AST and ALT up to ULN: This drug should be withheld or permanently discontinued based on recommendations for hepatitis with no liver involvement.
• Baseline AST or ALT greater than 1 to 3 x ULN and increases to greater than 5 to 10 x ULN OR baseline AST or ALT greater than 3 to 5 x ULN and increases to greater than 8 to 10 x ULN: This drug should be withheld.
• Complete or partial resolution (grade 0 or 1) after corticosteroid taper: This drug should resume.
• If no complete or partial resolution within 12 weeks of starting steroids or inability to reduce prednisone to 10 mg/day or less (or equivalent) within 12 weeks of starting steroids: This drug should be permanently discontinued.
• AST or ALT increases to greater than 10 x ULN or TB increases to greater than 3 x ULN: This drug should be permanently discontinued.

If Liver Enzyme Elevations Develop During Therapy with This Drug in Combination with Axitinib:

• Corticosteroid therapy should be considered.
• ALT or AST increases to 3 to less than 10 x ULN without concurrent TB at least 2 x ULN: This drug and axitinib should be withheld until resolution to grades 0 or 1.
• Rechallenge with a single drug or sequential rechallenge with both drugs should be considered after recovery; if rechallenging with axitinib, dose reduction as per the manufacturer product information for axitinib should be considered.
• ALT or AST increases to greater than 3 x ULN with concurrent TB at least 2 times ULN or ALT or AST at least 10 x ULN: This drug and axitinib should be permanently discontinued.

Comments:

• Mild liver dysfunction (TB up to ULN and AST greater than ULN or TB greater than 1 to 1.5 x ULN and any AST) had no clinically significant effect on the clearance of this drug.
• The effect of moderate or severe liver dysfunction on the pharmacokinetics of this drug is unknown.

Dose Adjustments

No dose reduction is recommended for this drug.

General Guidelines:

• For severe (grade 3) immune-mediated adverse reactions: This drug should be withheld.
• For life-threatening (grade 4) immune-mediated adverse reactions, recurrent severe (grade 3) immune-mediated reactions that require systemic immunosuppressive therapy, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of starting steroids: This drug should be permanently discontinued.

Dosage Modifications for Immune-Mediated Adverse Reactions:
Colitis:

• Grade 2 or 3: This drug should be withheld.
• Complete or partial resolution (grade 0 or 1) after corticosteroid taper: This drug should resume.
• If no complete or partial resolution within 12 weeks of starting steroids or inability to reduce prednisone to 10 mg/day or less (or equivalent) within 12 weeks of starting steroids: This drug should be permanently discontinued.
• Grade 4: This drug should be permanently discontinued.

Endocrinopathies:

• Grade 3 or 4: This drug should be withheld until clinically stable or permanently discontinued depending on severity.

Exfoliative Dermatologic Conditions:

• Suspected Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or drug rash with eosinophilia and systemic symptoms (DRESS): This drug should be withheld.
• Complete or partial resolution (grade 0 or 1) after corticosteroid taper: This drug should resume.
• If no complete or partial resolution within 12 weeks of starting steroids or inability to reduce prednisone to 10 mg/day or less (or equivalent) within 12 weeks of starting steroids: This drug should be permanently discontinued.
• Confirmed SJS, TEN, or DRESS: This drug should be permanently discontinued.

Hematologic Toxicity in Patients with cHL or PMBCL:

• Grade 4: This drug should be withheld until resolution to grades 0 or 1.

Infusion-Related Reactions:

• Grade 1 or 2: The rate of infusion should be interrupted or slowed.
• Grade 3 or 4: This drug should be permanently discontinued.

Myocarditis:

• Grade 2, 3, or 4: This drug should be permanently discontinued.

Neurological Toxicities:

• Grade 2: This drug should be withheld.
• Complete or partial resolution (grade 0 or 1) after corticosteroid taper: This drug should resume.
• If no complete or partial resolution within 12 weeks of starting steroids or inability to reduce prednisone to 10 mg/day or less (or equivalent) within 12 weeks of starting steroids: This drug should be permanently discontinued.
• Grade 3 or 4: This drug should be permanently discontinued.

Pneumonitis:

• Grade 2: This drug should be withheld.
• Complete or partial resolution (grade 0 or 1) after corticosteroid taper: This drug should resume.
• If no complete or partial resolution within 12 weeks of starting steroids or inability to reduce prednisone to 10 mg/day or less (or equivalent) within 12 weeks of starting steroids: This drug should be permanently discontinued.
• Grade 3 or 4: This drug should be permanently discontinued.

Adverse Reactions for This Drug in Combination with Lenvatinib:

• The dosage of 1 or both drugs should be modified.
• This drug should be withheld or discontinued as described above.
• The manufacturer product information for lenvatinib should be consulted for additional dose modification information.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy as a single agent have been established in pediatric patients with melanoma, cHL, PMBCL, MCC, MSI-H or dMMR cancer, and TMB-H cancer; safety and efficacy for other indications have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer via 30-minute IV infusion; use an IV line containing a sterile, nonpyrogenic, low-protein binding 0.2 to 5 micron in-line or add-on filter.
• Do not coadminister other drugs through the same infusion line.

Storage requirements:

• Before dilution: Store vials under refrigeration at 2C to 8C (36F to 46F) in original carton to protect from light; do not freeze or shake.
• Diluted solution: Store at room temperature for no more than 6 hours from time of dilution; this includes room temperature storage of diluted solution and the duration of infusion. Alternatively, store under refrigeration at 2C to 8C (36F to 46F) for no more than 96 hours from time of dilution; if refrigerated, allow to come to room temperature before administration. Do not shake.
• Discard after 6 hours at room temperature or after 96 hours under refrigeration.
• Do not freeze.

Reconstitution/preparation techniques:

• This drug should be diluted prior to IV administration.
• The manufacturer product information should be consulted.

IV compatibility:

• Compatible: 0.9% Sodium Chloride Injection, USP; 5% Dextrose Injection, USP

General:

• For information on US FDA-approved tests for patient selection: www.fda.gov/CompanionDiagnostics
• Because subclonal dMMR mutations and microsatellite instability may arise in high-grade gliomas during temozolomide therapy, testing for TMB-H, MSI-H, and dMMR is recommended in the primary tumor specimens obtained before temozolomide chemotherapy has been started in patients with high-grade gliomas.
• The manufacturer product information for the coadministered agents should be consulted for recommended dosing information, as appropriate.

Monitoring:

• Endocrine: Thyroid function (at baseline and periodically during therapy); blood cortisol in patients with TNBC (in the neoadjuvant setting at baseline, prior to surgery, and as clinically indicated)
• General: For signs/symptoms of infusion-related reactions
• Hepatic: Liver enzymes (at baseline and periodically during therapy; more frequently should be considered when used in combination with axitinib)
• Immunologic: For signs/symptoms of underlying immune-mediated adverse reactions
• Metabolic: For hyperglycemia or other signs/symptoms of diabetes
• Renal: Creatinine (at baseline and periodically during therapy)

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• Contact health care provider immediately for new or worsening cough, chest pain, or shortness of breath.
• Contact health care provider immediately for diarrhea or severe abdominal pain.
• Contact health care provider immediately for jaundice, severe nausea/vomiting, or easy bruising/bleeding.
• Contact health care provider immediately for signs/symptoms of adrenal insufficiency, hypophysitis, hypothyroidism, hyperthyroidism, or type 1 diabetes mellitus.
• Contact health care provider immediately for signs/symptoms of nephritis.
• Contact health care provider immediately for any signs/symptoms of severe skin reactions, SJS, or TEN.
• Because immune-mediated adverse reactions may involve any organ system, contact health care provider immediately for any new or worsening signs/symptoms.
• Contact health care provider immediately for signs/symptoms of organ transplant rejection.
• Contact health care provider immediately for signs/symptoms of infusion-related reactions.
• Inform health care provider of a known/suspected pregnancy.
• Patients of childbearing potential: Use effective contraception during therapy and for 4 months after the last dose.
• Do not breastfeed during therapy and for 4 months after the last dose.
• It is important to keep scheduled appointments for blood work or other laboratory tests.

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