INDICATIONS AND USAGE

Unresectable or Metastatic Melanoma

YERVOY is indicated for the treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years and older.

YERVOY, in combination with nivolumab, is indicated for the treatment of unresectable or metastatic melanoma in adult patients.

Adjuvant Treatment of Melanoma

YERVOY is indicated for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy.

Advanced Renal Cell Carcinoma

YERVOY, in combination with nivolumab, is indicated for the first-line treatment of patients with intermediate or poor risk advanced renal cell carcinoma (RCC).

Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer

YERVOY, in combination with nivolumab, is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Hepatocellular Carcinoma

YERVOY, in combination with nivolumab, is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Metastatic Non-Small Cell Lung Cancer

YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

YERVOY, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent NSCLC, with no EGFR or ALK genomic tumor aberrations.

Malignant Pleural Mesothelioma

YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.

DOSAGE

Patient Selection

Select patients with metastatic NSCLC for treatment with YERVOY in combination with nivolumab based on PD-L1 expression.

ADVERSE REACTIONS

YERVOY can cause serious side effects, including:

•Severe infusion-related reactions. Tell your healthcare provider or nurse right away if you get these symptoms during an infusion of YERVOY:

chills or shaking

itching or rash

flushing

shortness of breath or wheezing

dizziness

feel like passing out

fever

back or neck pain

•Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with YERVOY. Your healthcare provider will monitor you for these complications.

The most common side effects of YERVOY when used alone include:

feeling tired

diarrhea

nausea

itching

rash

vomiting

headache

weight loss

fever

decreased appetite

difficulty falling or staying asleep

The most common side effects of YERVOY when used in combination with nivolumab include:

feeling tired

diarrhea

rash

itching

nausea

pain in muscles, bones, and joints

fever

cough

decreased appetite

vomiting

stomach-area (abdominal) pain

shortness of breath

upper respiratory tract infection

headache

low thyroid hormone levels (hypothyroidism)

decreased weight

dizziness

The most common side effects of YERVOY when used in combination with nivolumab and chemotherapy include:

feeling tired

pain in muscles, bones, and joints

nausea

diarrhea

rash

decreased appetite

constipation

Itching

These are not all of the possible side effects of YERVOY.

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/2265ef30-253e-11df-8a39-0800200c9a66/spl-doc?hl=Yervoy

Yervoyinformation