YERVOY

YERVOY- ipilimumab injection
E.R. Squibb & Sons, L.L.C.

1 INDICATIONS AND USAGE

1.1 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.

1.2 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.

1.3 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).

1.4 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 [see Clinical Studies (14.4)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

1.5 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 [see Clinical Studies (14.5)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

1.6 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 [see Dosage and Administration (2.1)] , 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.

1.7 Malignant Pleural Mesothelioma

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

2 DOSAGE AND ADMINISTRATION

2.1 Patient Selection

Select patients with metastatic NSCLC for treatment with YERVOY in combination with nivolumab based on PD-L1 expression [see Clinical Studies (14.6)].

Information on FDA-approved tests for the determination of PD-L1 expression in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics.

2.2 Recommended Dosage

The recommended dosages of YERVOY as a single agent are presented in Table 1.

Table 1: Recommended Dosages for YERVOY as a Single Agent

Indication

Recommended YERVOY Dosage

Duration of Therapy

Unresectable or metastatic melanoma

3 mg/kg every 3 weeks

(90-minute intravenous infusion)

Maximum of 4 doses

Adjuvant treatment of melanoma

10 mg/kg every 3 weeks

followed by 10 mg/kg every 12 weeks

(90-minute intravenous infusion)

Every 3 weeks up to a maximum of 4 doses

Every 12 weeks for up to 3 years

The recommended dosages of YERVOY in combination with other therapeutic agents are presented in Table 2. Refer to the respective Prescribing Information for each therapeutic agent administered in combination with YERVOY for recommended dosage information, as appropriate.

Table 2: Recommended Dosages of YERVOY in Combination with Other Therapeutic Agents*
* Refer to the Prescribing Information for the agents administered in combination with YERVOY for recommended dosing information, as appropriate.† Refer to the Prescribing Information for nivolumab for dosage information after completing use in combination with YERVOY.

Indication

Recommended YERVOY Dosage

Duration of Therapy

Unresectable or metastatic melanoma

3 mg/kg every 3 weeks

(90-minute intravenous infusion)

with nivolumab 1 mg/kg

(30-minute intravenous infusion on the same day)

In combination with nivolumab for a maximum of 4 doses or until unacceptable toxicity, whichever occurs earlier.

After completing 4 doses of combination therapy, administer nivolumab as a single agent until disease progression or unacceptable toxicity.

Advanced renal cell carcinoma

1 mg/kg every 3 weeks

with nivolumab 3 mg/kg

(30-minute intravenous infusion on the same day)

In combination with nivolumabfor a maximum of 4 doses.

After completing 4 doses of combination therapy, administer nivolumab as single agent until disease progression or unacceptable toxicity.

Microsatellite instability-high (MSI‑H) or mismatch repair deficient (dMMR) metastatic colorectal cancer

1 mg/kg every 3 weeks

with nivolumab 3 mg/kg

(30-minute intravenous infusion on the same day)

After completing 4 doses of combination therapy, administer nivolumab as single agent until disease progression or unacceptable toxicity.

Hepatocellular carcinoma

3 mg/kg every 3 weeks

with nivolumab 1 mg/kg

(30-minute intravenous infusion on the same day)

In combination with nivolumabfor 4 doses.

After completing 4 doses of combination therapy, administer nivolumab as single agent until disease progression or unacceptable toxicity.

Metastatic non-small cell lung cancer expressing PD‑L1

1 mg/kg every 6 weeks

with nivolumab 3 mg/kg every 2 weeks

(30-minute intravenous infusion)

In combination with nivolumab until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression.

Metastatic or recurrent non-small cell lung cancer

1 mg/kg every 6 weeks

with nivolumab 360 mg every 3 weeks

(30-minute intravenous infusion)

and histology-based platinum‑doublet chemotherapy every 3 weeks

In combination with nivolumab until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression.

2 cycles of histology-based platinum-doublet chemotherapy

Malignant pleural mesothelioma

1 mg/kg every 6 weeks

with nivolumab 360 mg every 3 weeks

(30-minute intravenous infusion)

In combination with nivolumab until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.