Penpulimab Dosage

Usual Adult Dose for Nasopharyngeal Carcinoma

In Combination with either Cisplatin or Carboplatin and Gemcitabine:
200 mg as an IV infusion every 3 weeks

Duration of therapy: Until disease progression or unacceptable toxicity for a maximum of 24 months

Comments:

• Administer via IV infusion over 60 minutes.
• The manufacturer product information for this drug, cisplatin, carboplatin and gemcitabine should be consulted according to the chosen chemotherapy regimen for order of administration and regimen details.

As a Single Agent:
200 mg as an IV infusion every 2 weeks

Duration of therapy: Until disease progression or unacceptable toxicity for a maximum of 24 months

Comments:

• Administer via IV infusion over 60 minutes.

Uses:

• In combination with either cisplatin or carboplatin and gemcitabine, for the first-line treatment of patients with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC).
• As a single agent, for the treatment of patients with metastatic nonkeratinizing NPC and disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.

Renal Dose Adjustments

• Mild and Moderate Renal Dysfunction (CrCl 30 mL/min or greater): No adjustment recommended.
• Severe Renal Dysfunction (CrCl less than 30 mL/min): Data not available

Dose Adjustments for Renal Adverse Reactions:

• Nephritis with Renal Dysfunction:
• Grade 2 or 3 increased blood creatinine: Withhold treatment (resume if complete or partial resolution [Grades 0 to 1] after corticosteroid taper or permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less [or equivalent] within 12 weeks of initiating steroids).
• Grade 4 increased blood creatinine: Permanently discontinue

Liver Dose Adjustments

• Mild and Moderate Liver Dysfunction: No dose adjustment recommended
• Severe Liver Dysfunction (total bilirubin greater than 3 times ULN and any AST): Data not available

Dose Adjustments for Liver Adverse Reactions:

• Hepatitis with no tumor involvement of the liver:
• AST or ALT increases to more than 3 and up to 8 times ULN or total bilirubin increases to more than 1.5 and up to 3 times ULN: Withhold treatment (resume if complete or partial resolution [Grades 0 to 1] after corticosteroid taper, or permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less [or equivalent] within 12 weeks of initiating steroids).
• AST or ALT increases to more than 8 times ULN or total bilirubin increases to more than 3 times ULN: Permanently discontinue

• Hepatitis with tumor involvement of the liver:
• Baseline AST and ALT are less than or equal to ULN, withhold or permanently discontinue based on recommendations for hepatitis with no liver involvement
• Baseline AST or ALT are more than 1 and up to 3 times ULN and increases to more than 5 and up to 10 times ULN OR Baseline 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 treatment (resume if complete or partial resolution [Grades 0 to 1] after corticosteroid taper, or permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less [or equivalent] within 12 weeks of initiating steroids).
• ALT or AST increases to more than 10 times ULN OR total bilirubin increases to more than 3 times ULN: Permanently discontinue

Dose Adjustments

• No dose reduction is recommended.
• In general, withhold this drug for severe (Grade 3) immune-mediated adverse reactions.
• When withholding therapy, resume if complete or partial resolution (Grades 0 to 1) after corticosteroid taper or permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
• Permanently discontinue for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of initiating steroids.
• Dosage modifications for combination therapy or single agent treatment for adverse reactions that require management different from these general guidelines are summarized below:

PNEUMONITIS:

• Grade 2: Withhold
• Grade 3 or 4: Permanently discontinue

COLITIS:

• Grade 2 or 3: Withhold
• Grade 4: Permanently discontinue

ENDOCRINOPATHIES:

• Grade 3 or 4: Withhold until clinically stable or permanently discontinue depending on severity

EXFOLIATIVE DERMATOLOGIC CONDITIONS:

• Suspected Stevens Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), or Drug Rash with Eosinophilia and Systemic Symptoms (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

INFUSION-RELATED ADVERSE REACTIONS:

• Grade 1 or 2: Interrupt or slow rate of infusion
• Grade 3 or 4: Permanently discontinue

Precautions

US FDA requires a medication guide to assure safe use. For additional information go to: www.fda.gov/drugs/drug-safety-and-availability/medication-guides

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• The solution should be clear to slightly opalescent, colorless to yellowish. Inspect for particulate matter and discoloration. Discard if cloudy, discolored, or if it contains visible particles.
• Dilute prior to intravenous administration. The final concentration of the diluted solution should be between 2 mg/mL to 5 mg/mL. Consult the manufacturer information.
• Discard any unused product left in the vial.
• This product does not contain a preservative and should be administered 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.
• Administer diluted solution IV over 60 minutes.
• Do not co-administer other drugs through the same infusion line.

Storage requirements:

• Store vials refrigerated at 2C to 8C (36F to 46F) in the original carton to protect from light. Do not shake or freeze.
• Store the diluted solution for up to 4 hours either at room temperature 20C to 25C (68F to 77F) or refrigerated at 2C to 8C (36F to 46F). Discard after 4 hours. Do not freeze.

Reconstitution/Preparation techniques:

• Consult the manufacturer product information for further preparation of diluted solution and administration instructions.

IV compatibility: 0.9% Sodium Chloride Injection

General:

• Report any suspected adverse reactions to Akeso Biopharma Co., Ltd. at 833-662-5376 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Monitoring:

• Endocrine: Thyroid function at baseline and during treatment, hyperglycemia and other symptoms of diabetes during treatment
• Hepatic: Liver enzymes at baseline and during treatment
• Immunologic: Signs and symptoms of underlying immune-mediated adverse reactions, patients with organ or tissue transplants should be monitored for signs of rejection.
• Renal: Creatinine levels at baseline and during treatment

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• Seek medical attention if any symptoms of an infusion-related reaction occur.
• This drug can cause fetal harm when administered to a pregnant woman. Patients of childbearing potential should use effective contraception during treatment and for 4 months after the last dose.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer