YERVOY Ipilimumab Application Scope

Melanoma: Unresectable or metastatic (adults and ≥12 years) as monotherapy or with nivolumab; adjuvant treatment of cutaneous melanoma with nodal involvement (>1 mm) after complete resection.
Renal Cell Carcinoma (RCC): First-line, intermediate/poor risk, in combination with nivolumab.
Colorectal Cancer (MSI-H/dMMR): Unresectable or metastatic, with nivolumab (adults and ≥12 years).
Hepatocellular Carcinoma (HCC): First-line with nivolumab; also with nivolumab after prior sorafenib.
Non-Small Cell Lung Cancer (NSCLC): First-line with nivolumab for PD-L1 ≥ 1% and, separately, with nivolumab + 2 cycles of platinum-doublet chemotherapy (no EGFR/ALK).
Malignant Pleural Mesothelioma (MPM): First-line with nivolumab.
Esophageal Squamous Cell Carcinoma (ESCC): First-line with nivolumab for PD-L1 ≥ 1.

YERVOY Ipilimumab Characteristics

Ingredients: Ipilimumab
Properties: A sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution for intravenous infusion
Packaging Specification:
- 50 mg/10 mL (5 mg/mL) single-use vial.
- 200 mg/40 mL (5 mg/mL) single-use vial
Storage: Store unopened vials in a refrigerator at 2°C to 8°C in the original package to protect from light. Do not freeze
Expiry Date: 36 months for unopened vials
Executive Standard: Follow the manufacturer’s prescribing information and local pharmacopeial standards.
Approval Number: 国药准字SJ20210019
Date of Revision: Please refer to the latest version of the package insert for the most recent revision date
Manufacturer: Bristol-Myers Squibb (BMS)

Guidelines for the Use of YERVOY Ipilimumab

Dosage and Administration:
- Recommended Dose:
  - Unresectable or Metastatic Melanoma (Monotherapy): 3 mg/kg every 3 weeks for 4 doses.
  - Adjuvant Treatment of Melanoma: 10 mg/kg every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks for up to 3 years.
  - Combination Therapy with Nivolumab (e.g., for RCC, NSCLC, MPM, etc.): Ipilimumab is typically dosed at 1 mg/kg or 3 mg/kg on specific schedules alongside nivolumab, as per the approved regimen.
  - Dose modifications or permanent discontinuation may be required based on adverse reactions.
- Administration:
  - Administer via intravenous infusion over 30 minutes (for most combination regimens) or 90 minutes (for monotherapy).
  - When used in combination with nivolumab, nivolumab is usually infused first, followed by ipilimumab on the same day.
  - Dilute the required volume of YERVOY in 0.9% Sodium Chloride Injection or 5% Dextrose Injection to a final concentration between 1 mg/mL and 2 mg/mL.
  - Use a sterile, non-pyrogenic, low-protein binding in-line filter.
  - Do not mix with other medicinal products via the same intravenous line
- Missed Dose: If a dose is missed, administer as soon as possible. Adjust the subsequent dose schedule to maintain the recommended interval. Consult the prescribing physician for specific guidance.
Adverse Reactions:
- Common Adverse Reactions: Fatigue, diarrhea, pruritus (itching), rash, colitis, nausea, vomiting, decreased appetite, abdominal pain, endocrinopathies (e.g., hypothyroidism), and fever.
- Serious Adverse Reactions:
  - Immune-mediated enterocolitis: Severe diarrhea, abdominal pain, hematochezia, or perforation.
  - Immune-mediated hepatitis: Increased liver enzymes, jaundice.
  - Immune-mediated dermatitis: Severe skin reactions, including toxic epidermal necrolysis.
  - Immune-mediated endocrinopathies: hypophysitis, thyroid disorders, adrenal insufficiency.
  - Immune-mediated neuropathies: Motor or sensory neuropathy.
  - Other serious irAEs can involve the lungs (pneumonitis), kidneys (nephritis), eyes (uveitis), and heart (myocarditis).
Contraindications: History of severe hypersensitivity reaction to ipilimumab or any of its excipients
Precautions:
- Immune-Mediated Reactions: Permanently discontinue YERVOY for severe (Grade 3-4) immune-mediated reactions. Initiate high-dose corticosteroids and appropriate medical management
- Endocrinopathies: Monitor thyroid function tests and assess for signs/symptoms of endocrinopathies (e.g., headache, fatigue, changes in mood/behavior, dizziness, fainting)
- Gastrointestinal Toxicity: Evaluate patients for signs of diarrhea or colitis. Rule out infectious etiologies
- Neurologic Toxicity: Monitor for motor or sensory neuropathy

YERVOY Interactions

No formal pharmacokinetic drug interaction studies have been conducted.
Use caution with other immunosuppressive agents, as this may increase the risk of infections.
Avoid live vaccines during treatment with YERVOY due to potential decreased immune response and increased risk of infection.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.