Ipilimumab

In this article, we will discuss about Ipilimumab (Dosage). So, let’s get started.

Indications

Unresectable or Metastatic Melanoma

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

Adjuvant Treatment of Melanoma

Ipilimumab (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

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

Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (DMMR) Metastatic Colorectal Cancer

Ipilimumab (YERVOY), in combination with nivolumab, is indicated for the treatment of adult and pediatric patients 12 years of age and older with microsatellite instability-high (MSI-H) or mismatch repair
deficient (DMMR) metastatic colorectal cancer (CRC) 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

Ipilimumab (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-Smaſ Cell Lung Cancer

Ipilimumab (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. Ipilimumab (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.

Dosage

Patient Selection

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

Recommended Dosing for Unresectable or Metastatic Melanoma

The recommended dose of Ipilimumab (YERVOY) is 3 mg/kg administered as an intravenous infusion over 90 minutes every 3 weeks for a maximum of 4 doses. In the event of toxicity, doses may be delayed, but all treatment must be administered within 16 weeks of the first dose.

Recommended Dosing for Adjuvant Treatment of Melanoma

The recommended dose of Ipilimumab (YERVOY) is 10 mg/kg administered as an intravenous infusion over 90 minutes every 3 weeks for 4 doses followed by 10 mg/kg every 12 weeks for up to 3 years. In the event of toxicity, doses are omitted, not delayed.

Recommended Dosing for Renal Cell Carcinoma

The recommended dosage is Ipilimumab (YERVOY) 1 mg/kg administered as an intravenous infusion over 30 minutes, immediately following nivolumab administered on the same day, every 3 weeks for up to 4 doses or until intolerable toxicity or disease progression. After completing 4 doses of the combination, administer nivolumab as a single agent. Review the Prescribing Information for nivolumab for full dosing and schedule information.

Recommended Dosing for Colorectal Cancer

The recommended dosage is YERVOY 1 mg/kg administered as an intravenous infusion over 30 minutes, immediately following nivolumab administered on the same day, every 3 weeks for up to 4 doses or until intolerable toxicity or disease progression. After completing 4 doses of the combination, administer nivolumab as a single agent. Review the Prescribing Information for nivolumab for full dosing and schedule information.

Recommended Dosing for Hepatocellular Carcinoma

The recommended dosage is Ipilimumab (YERVOY) 3 mg/kg administered as an intravenous infusion over 30 minutes, immediately following nivolumab administered on the same day, every 3 weeks for up to 4 doses or until intolerable toxicity or disease progression. After completing 4 doses of the combination, administer nivolumab as a single agent. Review the Prescribing Information for nivolumab for full dosing and schedule information.

Recommended Dosing for Metastatic NSCLC

The recommended dose of Ipilimumab (YERVOY) in combination with nivolumab is nivolumab 3 mg/kg administered as an intravenous infusion over 30 minutes every 2 weeks and Ipilimumab (YERVOY) 1 mg/kg administered as an intravenous infusion over 30 minutes every 6 weeks until disease progression, unacceptable toxicity, or for up to 2 years in patients without disease progression. Review the Prescribing Information for nivolumab for recommended dosing information.

The recommended dose of Ipilimumab (YERVOY) in combination with nivolumab and platinum-doublet chemotherapy is nivolumab 360 mg administered as an intravenous infusion over 30 minutes every 3 weeks and Ipilimumab (YERVOY) 1 mg/kg administered as an intravenous infusion over 30 minutes every 6 weeks and histology-based platinum-doublet chemotherapy every 3 weeks for 2 cycles until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression. Review the Prescribing Information for nivolumab and platinum-based chemotherapy for recommended dosing information.

Adverse Reactions

Most common adverse reactions (25%) with Ipilimumab (YERVOY) as a single agent are fatigue, diarrhea, pruritus, rash, and colitis. Additional common adverse reactions at the 10 mg/kg dose (25%) include nausea, vomiting, headache, weight loss, pyrexia, decreased appetite, and insomnia.

Most common adverse reactions (20%) with Ipilimumab (YERVOY) in combination with nivolumab are fatigue, rash, pruritus, diarrhea, musculoskeletal pain, cough, pyrexia, decreased appetite, nausea, abdominal pain, arthralgia, headache,
vomiting, dyspnea, dizziness, hypothyroidism, and decreased weight.

Most common adverse reactions (20%) with Ipilimumab (YERVOY) in combination with nivolumab and platinum-doublet chemotherapy are fatigue, musculoskeletal pain, nausea, diarrhea, rash, decreased appetite, constipation, and pruritus.

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