Vectibix

Panitumumab (Vectibix) Instructions
Generic Name: Panitumumab
Trade Name: Vectibix
Full Names: Panitumumab, Panitumumab, Vectibix

Indications:
Vectibix (panitumumab) is used to treat patients with wild-type RAS metastatic colorectal cancer (cancer that has spread to the outside of the colon and rectum). RAS status is determined by an FDA-approved test. Wild-type RAS is a cancer without mutations in the KRAS and NRAS genes.

Usage and Dosage:
The recommended dose of Vectibix is ​​6 mg/kg, administered as an intravenous infusion over 60 minutes, once every 14 days. Doses above 1000 should be administered over 90 minutes.

Adverse reactions:
> 10%
Erythema (65%)
Dermatitis acneiformis (57%)
Pruritus (57%)
Hypomagnesemia (39%)
Fatigue (26%)
Abdominal pain (25%)
A Grout (25%)
Skin peeling (25%)
Nausea (23%)
Skin rash (22%)
Constipation (21%)
Diarrhea (21%)
Vomiting (21%)
Skin Skin fissures (20%)
Cough (14%)
Skin toxicity, grade 3 and 4 (14%)
Acne (13%)
Peripheral edema (12%)

1-10%< br>Abdominal pain, Grades 3 and 4 (7%)
Pulmonary embolism, Grades 3 to 5 (7%)
Hypomagnesemia, Grades 3 and 4 (4%)
Angioedema (3% to 4%)
Infusion complications (3% to 4%)
Constipation (3%)
Binding antibodies (0.4-3.8%)
Grade 3 and 4 diarrhea (2%)
Vomiting (2%)
Nausea (1%)
Allergic reaction (1%)Grade 3 and 4 infusion complications (1%)
Sepsis (1%)

<1%
Pulmonary fibrosis
Frequency undefined
Conjunctivitis
Lash growth
Tear growth Add
Ocular hyperemia
Mucositis
Stomatitis

Postmarketing Reports
Skin and subcutaneous tissue disorders: Cutaneous necrosis, angioedema
Immune system disorders: Anaphylactoid reactions
Eye disorders: Keratitis/ulcerative keratitis
Life-threatening and fatal bullous mucodermatosis

Contraindications:
Panitumumab is not indicated for use in patients with KRAS or NRAS mutations.

Notes:
Patients with RAS-mutant mCRC have increased tumor progression, increased mortality, or inadequate benefit; determine RAS-mutant tumor status in an experienced laboratory using an FDA-approved test before treatment
Monitor patients who develop skin toxicity while receiving panitumumab for the development of inflammatory or infectious sequelae; limit sun exposure
Panitumumab does not Recommended for use in combination with chemotherapy due to increased mortality or toxicity
Permanently discontinue in patients who develop pulmonary fibrosis/interstitial lung disease
Monitor electrolytes and take appropriate management as needed
Discontinue infusion for serious infusion reaction
Report ocular toxicity; monitor for keratitis or ulcerative keratitis; interrupt or discontinue acute or worsening keratitis
If patient develops interstitial lung disease Disease, pneumonia, or pulmonary infiltrates, please permanently discontinue treatment
Avoid pregnancy
Gradual decreases in serum magnesium levels have been reported, resulting in severe (Grade 3-4) hypomagnesemia; monitor patients regularly for hypomagnesemia and hypocalcemia before initiating treatment, during treatment, and for eight weeks after the end of treatment; other electrolyte disorders, including hypokalemia, have also been observed; supplement magnesium and other electrolytes appropriately

Storage:

Unopened vials
Store vials in original carton refrigerated at 2-8°C (36-46°F) until use
Avoid direct sunlight
Do not freeze
Discard any unused solution remaining in vial

Dilute solution
Room temperature: Use within 6 hours of preparation
Refrigerate (2-8°C [36-46°]): Take within 24 hours after preparation
Do not freeze

Mechanism of action:
Panitumumab specifically binds to EGFR on normal and tumor cells and competitively inhibits the binding of EGFR ligands. Non-clinical studies have shown that panitumumab binding to EGFR prevents ligand-induced receptor autophosphorylation and activation of receptor-associated kinases, thereby inhibiting cell growth, inducing apoptosis, reducing the production of pro-inflammatory cytokines and vascular growth factors, as well as intrinsic intrinsic effects.

Efficacy and safety:
FDA approval of panitumumab is based on the results of a clinical trial, which included 463 patients with metastatic colorectal cancer in Europe.
These 463 patients have already received chemotherapy, including three chemotherapy drugs. After that, all 463 patients received "optimal supportive care."
Half of the patients also received panitumumab at the start of the trial, and the remaining half were allowed to use Vectibix if their tumors worsened.
Dr. J. Randolph Hecht told WebMD that almost every patient's condition has progressed during 48 weeks. "Progression" here refers to the "worsening" of their tumors. Dr. Hecht pointed out that at the first observation at 8 weeks, 70% of the people in the best supportive care group had worsened, and only 51% of the people in the panitumumab group had worsened. The 20% difference with panitumumab will last for a while, and by 32 weeks of panitumumab, there will be no big difference.
In addition, 8% of patients taking panitumumab saw their tumors shrink, and in some cases, those tumors shrank to less than half their pre-treatment size.
Dr. Hecht said that by observing at each different time point, it can be seen that the tumor progression in the panitumumab group is much better than that in the best supportive care group