Penpulimab
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
4 CONTRAINDICATIONS None. None. 5 WARNINGS AND PRECAUTIONS Immune-Mediated Adverse Reactions o Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis and hepatotoxicity, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, immune-mediated dermatologic adverse reactions and solid organ transplant rejection. o Monitor for early identification and management.
Hepatitis led to permanent discontinuation of penpulimab-kcqx in 0.3% (1/372) and withholding of penpulimab-kcqx in 2.2% (8/372) of patients. Hepatitis resolved in 64% (9/14) of these patients. Immune-Mediated Endocrinopathies Adrenal Insufficiency Penpulimab-kcqx can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated.
Diabetes was resolving in 75% (3/4) of these patients. Penpulimab-kcqx as a Single Agent Diabetes occurred in 0.8% (3/372) of patients receiving penpulimab-kcqx as a single agent, including Grade 1 (0.8%) adverse reactions. Diabetes resolved in 67% (2/3) of these patients. Immune-Mediated Nephritis with Renal Dysfunction Penpulimab-kcqx can cause immune-mediated nephritis and renal dysfunction.
Gastrointestinal: Pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis. Musculoskeletal and Connective Tissue : Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic. Endocrine: Hypoparathyroidism. Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection, other transplant (including corneal graft) rejection.
| Adverse Reaction | Severity* | Dosage Modification |
| Immune-Mediated Adverse Reactions [seeWarnings and Precautions (5.1)] | ||
| Pneumonitis | Grade 2 | Withhold † |
| Grade 3 or 4 | Permanently discontinue | |
| Colitis | Grade 2 or 3 | Withhold † |
| Grade 4 | Permanently discontinue | |
| Hepatitis with no tumor involvement of the liver | AST or ALT increases to more than 3 and up to 8 times ULNorTotal bilirubin increases to more than 1.5 and up to 3 times ULN | Withhold † |
| AST or ALT increases to more than 8 times ULNorTotal bilirubin increases to more than 3 times ULN | Permanently discontinue | |
| Hepatitis with tumor involvement of the liver ‡ | Baseline AST or ALT is more than 1 and up to 3 times ULN and increases to more than 5 and up to 10 times ULN orBaseline AST or ALT is more than 3 and up to 5 times ULN and increases to more than 8 and up to 10 times ULN | Withhold † |
| ALT or AST increases to more than 10 times ULNorTotal bilirubin increases to more than 3 times ULN | Permanently discontinue | |
| Endocrinopathies | Grade 3 or 4 | Withhold until clinically stable or permanently discontinue depending on severity |
| Nephritis with Renal Dysfunction | Grade 2 or 3 increased blood creatinine | Withhold † |
| Grade 4 increased blood creatinine | Permanently discontinue | |
| Exfoliative Dermatologic Conditions | Suspected SJS, TEN, or DRESS | Withhold † |
| Confirmed SJS, TEN, or DRESS | Permanently discontinue | |
| Myocarditis | Grade 2, 3, or 4 | Permanently discontinue |
| Neurological Toxicities | Grade 2 | Withhold † |
| Grade 3 or 4 | Permanently discontinue | |
| Other Adverse Reactions | ||
| Infusion-Related Reactions [seeWarnings and Precautions (5.2)] | Grade 1 or 2 | Interrupt or slow the rate of infusion |
| Grade 3 or 4 | Permanently discontinue | |
Preparation and administration
Prepare this dose
Your numbers for penpulimab. Take vial strength, diluent, and limits from the label below.
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Preparation and Administration Preparation and Storage of Diluted Solution Inspect the solution for particulate matter and discoloration. The solution is clear to slightly opalescent, colorless to yellowish. Discard the vial if the solution is cloudy, discolored, or contains visible particles. Dilute penpulimab-kcqx injection prior to intravenous administration.
Withdraw the required volume from two vials of penpulimab-kcqx and transfer into an intravenous (IV) bag containing 100 mL or less of 0.9% Sodium Chloride Injection, USP. Gently invert the bag to mix the diluted solution . Do not shake. The final concentration of the diluted solution should be between 2 mg/mL to 5 mg/mL.
Discard any unused portion left in the vial. The product does not contain a preservative. Administer diluted solution immediately once prepared. If diluted solution is not administered immediately the total time from dilution to the end of the infusion should not exceed 4 hours. Store the diluted solution up to 4 hours either at room temperature 20°C to 25°C (68°F to 77°F), or refrigerated at 2°C to 8°C (36°F to 46°F).
Discard after 4 hours. Do not freeze. Administration Administer diluted solution intravenously over 60 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding 0.2 micron to 0.22 micron in-line or add-on filter. Do not co-administer other drugs through the same infusion line.
| Adverse Reaction | Severity* | Dosage Modification |
| Immune-Mediated Adverse Reactions [seeWarnings and Precautions (5.1)] | ||
| Pneumonitis | Grade 2 | Withhold † |
| Grade 3 or 4 | Permanently discontinue | |
| Colitis | Grade 2 or 3 | Withhold † |
| Grade 4 | Permanently discontinue | |
| Hepatitis with no tumor involvement of the liver | AST or ALT increases to more than 3 and up to 8 times ULNorTotal bilirubin increases to more than 1.5 and up to 3 times ULN | Withhold † |
| AST or ALT increases to more than 8 times ULNorTotal bilirubin increases to more than 3 times ULN | Permanently discontinue | |
| Hepatitis with tumor involvement of the liver ‡ | Baseline AST or ALT is more than 1 and up to 3 times ULN and increases to more than 5 and up to 10 times ULN orBaseline AST or ALT is more than 3 and up to 5 times ULN and increases to more than 8 and up to 10 times ULN | Withhold † |
| ALT or AST increases to more than 10 times ULNorTotal bilirubin increases to more than 3 times ULN | Permanently discontinue | |
| Endocrinopathies | Grade 3 or 4 | Withhold until clinically stable or permanently discontinue depending on severity |
| Nephritis with Renal Dysfunction | Grade 2 or 3 increased blood creatinine | Withhold † |
| Grade 4 increased blood creatinine | Permanently discontinue | |
| Exfoliative Dermatologic Conditions | Suspected SJS, TEN, or DRESS | Withhold † |
| Confirmed SJS, TEN, or DRESS | Permanently discontinue | |
| Myocarditis | Grade 2, 3, or 4 | Permanently discontinue |
| Neurological Toxicities | Grade 2 | Withhold † |
| Grade 3 or 4 | Permanently discontinue | |
| Other Adverse Reactions | ||
| Infusion-Related Reactions [seeWarnings and Precautions (5.2)] | Grade 1 or 2 | Interrupt or slow the rate of infusion |
| Grade 3 or 4 | Permanently discontinue | |
Contraindications
None. None.( 4 )
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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