in cases of severe ( grade 3) dermatological reactions (see section 4.4).
Method of administration
Vectibix must be administered as an intravenous (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. If the first infusion is tolerated, then subsequent infusions may be administered over 30 to 60 minutes. Doses higher than 1000 mg should be infused over approximately 90 minutes (for handling instructions, see section 6.6).
The infusion line should be flushed with sodium chloride solution before and after Vectibix administration to avoid mixing with other medicinal products or IV solutions.
A reduction in the rate of infusion of Vectibix may be necessary in cases of infusion-related reactions (see section 4.4).
Do not administer as an IV push or bolus.
For instructions on dilution of the medicinal product before administration, see section 6.6.
Special populations
The safety and efficacy of Vectibix have not been studied in patients with renal or hepatic impairment.
There is no clinical data to support dose adjustments in the elderly
Paediatric population
There is no experience in children and Vectibix should not be used in those patients less than 18 years of age.
4.3 Contraindications
Vectibix is contraindicated in patients with a history of severe or life-threatening hypersensitivity reactions to the active substance or to any of the excipients (see section 4.4).
Patients with interstitial pneumonitis or pulmonary fibrosis (see section 4.4).
The combination of Vectibix with oxaliplatin-containing chemotherapy is contraindicated for patients with mutant KRAS mCRC or for whom KRAS mCRC status is unknown.
4.4 Special warnings and precautions for use
Dermatological reactions
Dermatologic related reactions, a pharmacologic effect observed with epidermal growth factor receptor (EGFR) inhibitors, are experienced with nearly all patients (approximately 90%) treated with Vectibix (see section 4.8), the majority are mild to moderate in nature. If a patient develops dermatologic reactions that are grade 3 (CTCAE v 4.0) or higher, or that are considered intolerable, the following dose modification is recommended:
Occurrence of skin symptom(s):
grade 31
Administration of Vectibix
Outcome
Dose regulation
Initial occurrence
Hold 1 or 2 doses
Improved (< grade 3)
Continuing infusion at 100% of original dose
Not recovered
Discontinue
At the second occurrence
Hold 1 or 2 doses
Improved (< grade 3)
Continuing infusion at 80% of original dose
Not recovered
Discontinue
At the third occurrence
Hold 1 or 2 doses
Improved (< grade 3)
Continuing infusion at 60% of original dose
Not recovered
Discontinue
At the fourth occurrence
Discontinue
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-
1 Greater than or equal to grade 3 is defined as severe or life-threatening
In clinical studies, subsequent to the development of severe dermatological reactions (including stomatitis), infectious complications including sepsis, in rare cases leading to death, and local abscesses requiring incisions and drainage were reported. Patients who have severe dermatologic reactions or who d
