#高警訊藥品

轉移性大腸直腸癌
Colorectal cancer (metastatic): Treatment of patients with wild-type RAS metastatic colorectal cancer, either as first-line therapy in combination with FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or as a single agent

Antineoplastic Agent, Epidermal Growth Factor Receptor (EGFR) Inhibitor; Monoclonal Antibody
Panitumumab is a recombinant human IgG2 monoclonal antibody which binds specifically to the epidermal growth factor receptor (EGFR, HER1, c-ErbB-1) and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands. Binding to the EGFR blocks phosphorylation and activation of intracellular tyrosine kinases, resulting in inhibition of cell survival, growth, proliferation, and transformation.

Half-life elimination: ~7.5 days

History of severe or life-threatening hypersensitivity reactions to panitumumab or any component of the formulation.

Based on animal reproduction studies and on the mechanism of action, panitumumab may cause fetal harm if administered during pregnancy.

Due to the potential for serious adverse reactions in the breastfeeding infant, the manufacturer recommends women not breastfeed during therapy and for 2 months after the final panitumumab dose.

Common:
1. Cardiovascular: Peripheral edema
2. Dermatologic: Acneiform eruption, Fissure in skin, Generalized exfoliative dermatitis, Nail changes, Paronychia, Pruritus, Rash
3. Gastrointestinal: Abdominal pain, Constipation, Diarrhea, Nausea, Vomiting
4. Ophthalmic: Eye symptom
5. Respiratory: Cough, Dyspnea
6. Other: Fatigue
Serious:
1. Dermatologic: Dermatologic toxicity
2. Endocrine metabolic: Hypomagnesemia
3. Gastrointestinal: Abdominal pain
4. Immunologic: Anaphylaxis, Infusion reaction, Sepsis
5. Ophthalmic: Keratitis
6. Renal: Acute renal failure
7. Respiratory: Interstitial lung disease, Pulmonary fibrosis

Colorectal cancer, metastatic, RAS wild-type:
IV 6 mg/kg every 14 days as a single agent or in combination with FOLFOX (fluorouracil, leucovorin, and oxaliplatin); continue until disease progression or unacceptable toxicity

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).