VECTIBIX
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Package(a):
VIAL: 1 x 5 ml.
Dosage(a):
Treatment should be supervised by a physician experienced in the use of anti-cancer therapy. Detection of non-mutated KRAS expression should be performed by an experienced laboratory using a validated test method.
The recommended dose is 6 mg/kg bodyweight given once every two weeks. Prior to infusion, contents should be diluted in 0.9% sodium chloride injection to a final concentration not to exceed 10 mg/ml.
Must be administered as an IV infusion via an infusion pump, using a low protein binding 0.2 or 0.22 micrometer in-line filter, through a peripheral line or indwelling catheter. The recommended infusion time is approximately 60 minutes. Doses higher than 1,000 mg should be infused over approximately 90 minutes.
Do not administer as an IV push or bolus.
Renal/hepatic impairment: Safety and efficacy have not been studied.
The elderly: Dose adjustment is not required.
Pediatrics: There is no experience and Vectibix should not be used in patients less than 18 years of age.
Prescribing Restrictions: None
Package(b):
VIAL: 1 x 20 ml.
Dosage(b):
Treatment should be supervised by a physician experienced in the use of anti-cancer therapy. Detection of non-mutated KRAS expression should be performed by an experienced laboratory using a validated test method.
The recommended dose is 6 mg/kg bodyweight given once every two weeks. Prior to infusion, contents should be diluted in 0.9% sodium chloride injection to a final concentration not to exceed 10 mg/ml.
Must be administered as an IV infusion via an infusion pump, using a low protein binding 0.2 or 0.22 micrometer in-line filter, through a peripheral line or indwelling catheter. The recommended infusion time is approximately 60 minutes. Doses higher than 1,000 mg should be infused over approximately 90 minutes.
Do not administer as an IV push or bolus.
Renal/hepatic impairment: Safety and efficacy have not been studied.
The elderly: Dose adjustment is not required.
Pediatrics: There is no experience and Vectibix should not be used in patients less than 18 years of age.
Prescribing Restrictions: None
Indications:
In combination with chemotherapy for the treatment of unresectable, advanced or recurrent colorectal cancer (mCRC) with wild-type KRAS.
Monotherapy for the treatment of patients with metastatic colorectal carcinoma with wild-type KRAS after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
Contra-Indications:
Patients with a history of severe or life-threatening hypersensitivity reactions to the active substance or to any of the excipients. Patients with interstitial pneumonitis or pulmonary fibrosis.
Special Precautions:
Dermatologic related reactions are experienced with nearly all patients (approximately 90%), the majority are mild to moderate in nature. Patients with a history of, or evidence of, interstitial pneumonitis or pulmonary fibrosis were excluded from clinical studies. Progressively decreasing serum magnesium levels leading to severe (grade 4) hypomagnesemia have been observed in some patients. Patients should be periodically monitored for hypomagnesemia and accompanying hypocalcemia prior to initiating treatment, and periodically thereafter for up to 8 weeks after the completion of treatment. Other electrolyte disturbances, including hypokalemia, have also been observed. Contains 0.150 mmol sodium (3.45 mg sodium) per ml of concentrate, which should be taken into consideration by patients on a controlled sodium diet. Acute renal failure has been observed in patients who develop severe diarrhea and dehydration.
Pregnancy and lactation: In women of childbearing potential, appropriate contraceptive measures must be used during treatment, and for 6 months following the last dose. If used during pregnancy or if the patient becomes pregnant while receiving this medicinal product, she should be advised of the potential risk for loss of the pregnancy or potential hazard to the fetus. It is unknown whether panitumumab is excreted in human breast milk. The potential for absorption and harm to the infant after ingestion is unknown. It is recommended that women do not breast feed during treatment and for 3 months after the last dose. See prescribing information for full details.
Side Effects:
Very common: Dermatitis acneiform, rash, exfoliative rash, erythema, skin exfoliation, pruritus, dry skin, skin fissures, acne. Diarrhea, nausea, vomiting, abdominal pain, stomatitis, constipation. Fatigue, pyrexia, paronychia, dyspnea, cough.
Common: Palmar-plantar erythrodysaesthesia syndrome, papular rash, pruritic rash, erythematous rash, macular rash, maculo-papular rash, skin ulcer, scab, hypertrichosis, alopecia, onychoclasis, nail disorder (onycholysis). Dry mouth, infusion-related reaction, mucosal inflammation, chills, chest discomfort. Pustular rash, eye infection, eyelid infection, cellulitis. Hypomagnesemia, hypocalcemia, hypokalemia, dehydration. Pulmonary embolism, epistaxis, nasal dryness, headache, dizziness. Conjunctivitis, growth of eyelashes, increased lacrimation, ocular hyperemia, dry eye, eye pruritus, eyelid irritation, eye irritation. Hypersensitivity, tachycardia, back pain. See prescribing information for full details.
Drug Interactions:
No interaction studies have been performed. Should not be administered in combination with IFL chemotherapy or with bevacizumab-containing chemotherapy. Should not be administered to mCRC patients with mutant KRAS tumors or for whom KRAS status is unknown in combination with oxaliplatin-containing chemotherapy. See prescribing information for full details.
