panitumumab

pan-i-TU-mu-mab

Therapeutic Classification: antineoplastics

Pharmacologic Classification: kinase inhibitors

High Alert

Treatment of wild-type RAS (wild type in KRAS and NRAS) metastatic colorectal cancer that has failed fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy (to be used as monotherapy).
Treatment of wild-type RAS (wild type in KRAS and NRAS) metastatic colorectal cancer (as first-line therapy with FOLFOX).

Binds to epidermal growth factor receptor resulting in inactivation of kinases that regulate proliferation and transformation.

Therapeutic effects:

Decreased progression of colorectal cancer.

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 7.5 days.

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	end of infusion	unknown

Contraindicated in:

Concurrent use of leucovorin;
RAS: mutant metastatic colorectal cancer or unknown RAS mutation status (↑ mortality and tumor progression);
OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

Rep: Women of reproductive potential;
Pedi: Safety and effectiveness not established in children.

CV: edema

Derm: acneiform dermatitis, dry skin, erythema, paronychia, pruritus, rash, skin exfoliation, skin fissures, abscesses, NECROTIZING FASCIITIS, photosensitivity

EENT: corneal perforation, eyelash growth, keratitis, ulcerative keratitis

F and E: hypocalcemia, hypomagnesemia

GI: abdominal pain, constipation, diarrhea, nausea, vomiting, stomatitis

GU: acute renal failure

Neuro: fatigue

Resp: cough, INTERSTITIAL LUNG DISEASE (ILD), PULMONARY FIBROSIS

Misc: INFUSION REACTIONS, SEPSIS

Drug-drug:

None reported.

IV (Adults ): 6 mg/kg every 14 days.

Solution for injection: 20 mg/mL

Assess for dermatologic toxicity (dermatitis acneiform, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, skin fissures). If severe, may lead to infection (sepsis, septic death, abscesses requiring incision and drainage). With severe reactions, hold panitumumab and monitor for inflammatory or infectious sequelae. If severe dermatologic toxicities (Grade 3 or higher) or those considered intolerable occur, hold panitumumab. Upon 1st occurrence of a grade 3 dermatologic toxicity, hold 1–2 doses; if skin improves to <Grade 3, reinitiate at original dose. For 2nd occurrence of a grade 3 dermatologic toxicity, hold 1–2 doses; if skin improves to <Grade 3, reinitiate at 80% of original dose. For 3rd occurrence of a grade 3 dermatologic toxicity, hold 1–2 doses; if skin improves to <Grade 3, reinitiate at 60% of original dose. For 4th occurrence of a grade 3 dermatologic toxicity, permanently discontinue panitumumab.
Monitor for severe infusion reactions (anaphylactic reaction, bronchospasm, fever, chills, hypotension). If severe reaction occurs, stop panitumumab; may require permanent discontinuation.
Assess for pulmonary fibrosis (cough, wheezing, exertional dyspnea, ILD, pneumonitis, lung infiltrates). Permanently discontinue panitumumab if these signs occur.
Monitor for diarrhea and dehydration during therapy.
Monitor for evidence of keratitis, ulcerative keratitis, or corneal perforation. Interrupt or discontinue panitumumab for acute or worsening keratitis, ulcerative keratitis, or corneal perforation.

Lab Test Considerations:

Patient selection is based on RAS status. Prior to administration, assess RAS mutational status in colorectal tumors and confirm the absence of a RAS mutation. Information on FDA-approved tests for the detection of RAS mutations in patients with metastatic colorectal cancer is available at: http://www.fda.gov/CompanionDiagnostics.
Monitor electrolyte levels periodically during and for 8 wk after completion of therapy. May cause hypomagnesemia, hypocalcemia, and hypokalemia. Replace electrolytes as needed.

Y-Site Incompatibility:

Intermittent Infusion: Diluent: Withdraw necessary amount of panitumumab. Dilute to a volume of 100 mL with 0.9% NaCl; dilute doses >1000 mg with 150 mL.Concentration: 10 mg/mL. Mix by inverting gently; do not shake. Administer via infusion pump using a low-protein binding 0.2 mcg or 0.22 mcg in-line filter. Solution is colorless and may contain a small amount of visible translucent to white, amorphous, proteinaceous particles. Do not administer solutions that are discolored or contain particulate matter. Store in refrigerator; do not freeze. Use diluted solution within 6 hr of preparation if stored at room temperature or within 24 hr if refrigerated.
Rate: Administer over 60 min every 14 days. If 1st infusion is tolerated, subsequent infusions may be infused over 30–60 min. Administer doses >1000 mg over 90 min.
- If mild to moderate infusion reaction (Grade 1 or 2) occurs, decrease infusion rate by 50%. If severe reaction (Grade 3 or 4) occurs, immediately and permanently discontinue panitumumab.

Explain purpose of panitumumab to patient.
May cause photosensitivity. Caution patient to wear sunscreen and hats and to limit sun exposure.
Advise patient to notify health care professional if signs and symptoms of dermatologic toxicity, infusion reactions, pulmonary fibrosis, or ocular changes occur.
Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception and to avoid breastfeeding during and for 2 months after last dose. May impair fertility in females.
Emphasize the need for periodic blood tests to monitor electrolyte levels.

Decreased progression of colorectal cancer.

Vectibix

NDC Code

55513- Amgen Inc
- 55513-954- Vectibix
  - 55513-954-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (55513-954-01) > 5 mL in 1 VIAL, SINGLE-DOSE

55513- Amgen Inc
- 55513-956- Vectibix
  - 55513-956-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (55513-956-01) > 20 mL in 1 VIAL, SINGLE-DOSE

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