Version July 2025
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults. Reactions listed may be reported for other agents in the same pharmacological class (PD-1/PD-L1-blocking antibodies) and may not be specifically reported for penpulimab.
>10%:
Dermatologic: Dermatitis (≤12%), skin rash (≤12%; including acneiform eruption, eczema, pemphigoid)
Endocrine & metabolic: Decreased serum albumin (45%), decreased serum magnesium (28%), decreased serum phosphate (47%), decreased serum sodium (46%), hypothyroidism (19% to 39%), increased serum glucose (34%), increased serum triglycerides (38%), weight loss (19%)
Hematologic & oncologic: Anemia (25%), lymphocytopenia (43%; grades 3/4: 11% to 16%), prolonged partial thromboplastin time (22%)
Hepatic: Increased gamma-glutamyl transferase (34%), increased serum alanine aminotransferase (20%), increased serum alkaline phosphatase (35%), increased serum aspartate aminotransferase (33%)
Neuromuscular & skeletal: Musculoskeletal pain (25%; including arthralgia, back pain, limb pain, musculoskeletal chest pain, neck pain, noncardiac chest pain, ostealgia)
Renal: Increased serum creatinine (81%)
Respiratory: Cough (11%), upper respiratory tract infection (13%)
Miscellaneous: Fever (15%)
1% to 10%:
Endocrine & metabolic: Hypermagnesemia (grades 3/4: 3%), hyperthyroidism (7%)
Gastrointestinal: Colitis (1%)
Hematologic & oncologic: Decreased platelet count (grades 3/4: 3%)
Hepatic: Hepatitis (4%), increased serum bilirubin (grades 3/4: 3%)
Hypersensitivity: Infusion-related reaction (10%)
Respiratory: Pneumonitis (1%)
<1%:
Cardiovascular: Myocarditis, pericarditis, vasculitis
Endocrine & metabolic: Diabetes mellitus, hypoparathyroidism, thyroiditis
Gastrointestinal: Duodenitis, gastritis, increased serum amylase, increased serum lipase, pancreatitis
Hematologic & oncologic: Aplastic anemia, hemolytic anemia, hemophagocytic lymphohistiocytosis, immune thrombocytopenia, lymphadenitis (histiocytic necrotizing lymphadenitis [Kikuchi lymphadenitis])
Immunologic: Organ transplant rejection (corneal graft, solid), sarcoidosis
Infection: Systemic inflammatory response syndrome
Nervous system: Demyelinating disease, encephalitis, Guillain-Barré syndrome, meningitis, myasthenia (myasthenic syndrome), myasthenia gravis (including exacerbation of myasthenia gravis), neuropathy (autoimmune), nerve injury, paresis (nerve)
Neuromuscular & skeletal: Myelitis, myositis, polymyositis, rhabdomyolysis
Ophthalmic: Iritis, uveitis
Renal: Nephritis
Frequency not defined:
Hematologic & oncologic: Decreased white blood cell count
Hepatic: Herpes zoster infection
Nervous system: Spinal cord compression
Respiratory: Pleural effusion, pneumonia, respiratory failure
There are no contraindications listed in the manufacturer's labeling.
Penpulimab: FDA approved April 2025; anticipated availability is currently unknown.
Nonkeratinizing nasopharyngeal carcinoma, recurrent or metastatic: First-line treatment (in combination with either cisplatin or carboplatin and gemcitabine) of recurrent or metastatic nonkeratinizing nasopharyngeal carcinoma (NPC) in adults.
Metastatic nonkeratinizing nasopharyngeal carcinoma, recurrent: Treatment (as a single agent) of metastatic nonkeratinizing NPC and disease progression on or after platinum-based chemotherapy and ≥1 other prior line of therapy in adults.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetaminophen: May decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor
Antibiotics: May decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor
Corticosteroids (Systemic): May decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Management: Carefully consider the need for corticosteroids, at doses of a prednisone-equivalent of 10 mg or more per day, during the initiation of immune checkpoint inhibitor therapy. Use of corticosteroids to treat immune related adverse events is still recommended Risk D: Consider Therapy Modification
Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Inhibitors of the Proton Pump (PPIs and PCABs): May decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor
Ketoconazole (Systemic): Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies) may increase hepatotoxic effects of Ketoconazole (Systemic). Risk C: Monitor
Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Opioid Agonists: Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies) may decrease therapeutic effects of Opioid Agonists. Opioid Agonists may decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor
Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Vitamin K Antagonists: Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies) may increase anticoagulant effects of Vitamin K Antagonists. Risk C: Monitor
