Penpulimab
FDA Drug Information • Also known as: Penpulimab Kcqx
- Brand Names
- Penpulimab Kcqx
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION Penpulimab-kcqx is a programmed death receptor-1 (PD 1)-blocking antibody. Penpulimab-kcqx is a humanized monoclonal IgG1 antibody with an approximate molecular weight of 150 kDa. Penpulimab-kcqx is produced in Chinese hamster ovary (CHO) cells. Penpulimab-kcqx injection is a sterile, preservative-free, clear to slightly opalescent, colorless to yellowish solution for intravenous infusion after dilution. Each vial contains 100 mg of penpulimab-kcqx in 10 mL solution. Each mL of solution contains: penpulimab-kcqx 10 mg, acetic acid (0.09 mg), polysorbate 80 (0.2 mg), sodium acetate (2.52 mg), sorbitol (45 mg), and Water for Injection, USP. The pH of the solution is 5.8.
What Is Penpulimab Used For?
1 INDICATIONS AND USAGE Penpulimab-kcqx is a programmed death receptor-1 (PD-1)-blocking antibody indicated: in combination with either cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) ( 1.1 ) as a single agent for the treatment of adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. ( 1.2 ) 1.1 First-line Treatment of Recurrent or Metastatic Non-Keratinizing Nasopharyngeal Carcinoma Penpulimab-kcqx, in combination with either cisplatin or carboplatin and gemcitabine, is indicated for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). 1.2 Recurrent Metastatic Non-Keratinizing Nasopharyngeal Carcinoma Penpulimab-kcqx, as a single agent, is indicated for the treatment of adults with metastatic non-keratinizing NPC and disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Penpulimab-kcqx in combination with either cisplatin or carboplatin and gemcitabine: 200 mg intravenously over 60 minutes every 3 weeks until disease progression or a maximum of 24 months. ( 2.1 ) Penpulimab-kcqx as a single agent: 200 mg intravenously over 60 minutes every 2 weeks until disease progression or a maximum of 24 months. ( 2.2 ) Dilute prior to administration. ( 2.4 ) 2.1 Recommended Dosage of Penpulimab-kcqx in Combination with Either Cisplatin or Carboplatin and Gemcitabine – Every 3 Week Dosing First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma The recommended dosage of penpulimab-kcqx is 200 mg administered as an intravenous infusion over 60 minutes every 3 weeks until disease progression or unacceptable toxicity, for a maximum of 24 months. Table 1 Order of Administration and Regimen for Penpulimab-kcqx in Combination with Either Cisplatin or Carboplatin and Gemcitabine Administer the regimen in the following order: penpulimab-kcqx first, gemcitabine second and cisplatin or carboplatin last. Drug and Dose Duration/ Timing of Treatment penpulimab-kcqx 200 mg intravenously Every 3 weeks for 6 cycles, and then every 3 weeks until unacceptable toxicity or disease progression for a maximum of 24 months gemcitabine 1000 mg/m 2 intravenously Every 3 weeks for 6 cycles cisplatin 80 mg/m 2 intravenously or carboplatin AUC 5 intravenously Every 3 weeks for 6 cycles 2.2 Recommended Dosage of Penpulimab-kcqx as a Single Agent – Every 2 Week Dosing Recurrent Metastatic Non-Keratinizing Nasopharyngeal Carcinoma The recommended dosage of penpulimab-kcqx is 200 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity, for a maximum of 24 months. 2.3 Dosage Modifications of Penpulimab-kcqx for Adverse Reactions No dose reduction for penpulimab-kcqx is recommended. In general, withhold penpulimab-kcqx for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue penpulimab-kcqx 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 penpulimab-kcqx in combination or penpulimab-kcqx as a single agent for adverse reactions that require management different from these general guidelines are summarized in Table 2 . Table 2 Recommended Dosage Modification for Adverse Reactions Adverse Reaction Severity* Dosage Modification Immune-Mediated Adverse Reactions [see Warnings 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 ULN or Total...
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS The following adverse reactions are described in other sections of the labeling: Severe and Fatal Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1) ] Infusion-Related Reactions[see Warnings and Precautions (5.2) ] Complications of Allogeneic HSCT [see Warnings and Precautions (5.3) ] Penpulimab-kcqx in combination with either cisplatin or carboplatin and gemcitabine : The most common adverse reactions (≥20%) were nausea, vomiting, hypothyroidism, constipation, decreased appetite, decreased weight, cough, COVID-19 infection, fatigue, rash, and pyrexia. (6.1) Penpulimab-kcqx as a single agent : The most common adverse reactions (≥20%) were anemia and hypothyroidism. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Akeso Biopharma Co., Ltd. at toll-free phone 833-662-5376 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to those observed in the clinical trials of another drug and may not reflect the rates observed in practice. The data described in the WARNINGS AND PRECAUTIONS reflect exposure to penpulimab-kcqx in 146 patients in Study AK105-304 [see Clinical Studies (14.1) ] . Patients received 6 cycles every 3 weeks of intravenous penpulimab-kcqx 200 mg in combination with either cisplatin 80 mg/m 2 or carboplatin AUC 5 and gemcitabine 1000 mg/m 2 followed by single-agent penpulimab-kcqx 200 mg every 3 weeks until disease progression or a maximum of 24 months. Among the 146 patients who received penpulimab-kcqx in combination with either cisplatin or carboplatin and gemcitabine, 71% were exposed for 6 months or longer and 38% were exposed for greater than one year. In this safety population, the most common (≥ 20%) adverse reactions were nausea (58%), vomiting (55%), hypothyroidism (45%), constipation (41%), decreased appetite (36%), decreased weight (26%), cough (25%), COVID-19 infection (25%), fatigue (25%), rash (24%) and pyrexia (21%). The most common Grade 3 to 4 laboratory abnormalities (≥ 2%) were decreased lymphocytes (70%), decreased neutrophils (61%), decreased white blood cells (58%), decreased hemoglobin (49%), decreased platelets (33%), decreased potassium (14%), increased lipase (11%), increased ALT (8%), decreased sodium (7%), increased AST (6%), increased triglycerides (4.3%), decreased magnesium (4.2%), decreased CPK (4.1%), increased amylase (2.9%), increased potassium (2.8%), increased cholesterol (2.2%), increased calcium (2.1%) and increased blood bilirubin (2.1%). The data described in the WARNINGS AND PRECAUTIONS also reflect exposure to single-agent intravenous penpulimab-kcqx 200 mg every 2 weeks until disease progression or a maximum of 24 months in 372 patients in studies: AK105-101 [NCT03352531], AK-105-201 [NCT03722147], AK105-202 [see Clinical Studies (14.2)] , AK105-204 [NCT 04172506]. Among the 372 patients who received single-agent penpulimab-kcqx, 49% were exposed for 6 months or longer and 34% were exposed for at least one year. In this safety population, the most common (≥20%) adverse reactions were anemia (25%) and hypothyroidism (23%). The most common Grade 3 to 4 laboratory abnormalities (≥ 2%) were decreased lymphocytes (11%), increased GGT (9%), decreased phosphate (6%), decreased sodium (4.7%), increased aspartate aminotransferase (4.4%), increased alkaline phosphatase (4%), decreased hemoglobin (3.6%), increased bilirubin (2.7%), increased glucose (3%), increased triglycerides (2.8%), increased alanine aminotransferase (2.5%), increased magnesium (3.3%), and decreased platelets (2.5%). First line Recurrent or Metastatic Nasopharyngeal Carcinoma Study AK105-304 The safety of penpulimab-kcqx in combination with either cisplatin or carboplatin and gemcitabine was evaluated in Study AK105-304 [see Clinical Studies (14.1) ] . Patients received intravenous...
Contraindications
4 CONTRAINDICATIONS None. None.(4)
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Penpulimab-kcqx injection is a sterile, preservative-free, clear to slightly opalescent, colorless to yellowish solution supplied as: Carton containing one 100 mg/10 mL (10 mg/mL) single-dose vial NDC 83654-105-01 Storage and Handling Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not shake. Do not freeze.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.