Penpulimab
Generic Name: penpulimab
Brand Names:
Penpulimab Kcqx
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.
Overview
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.
Uses
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.
Dosage
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.
Side Effects
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.
Warnings
5 WARNINGS AND PRECAUTIONS Immune-Mediated Adverse Reactions ( 5.1 ) 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. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. o Withhold or permanently discontinue penpulimab-kcqx based on severity and type of reaction. 4 CONTRAINDICATIONS None. None.(4)
Storage
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.
Frequently Asked Questions
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.
What are the side effects of Penpulimab?▼
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.
What are the important warnings for Penpulimab?▼
5 WARNINGS AND PRECAUTIONS Immune-Mediated Adverse Reactions ( 5.1 ) 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. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. o Withhold or permanently discontinue penpulimab-kcqx based on severity and type of reaction. 4 CONTRAINDICATIONS None. None.(4)
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.