Vectibix (Page 7 of 7)
14.3 RAS -Mutant mCRC
Vectibix is not effective for the treatment of patients with RAS -mutant mCRC, defined as a RAS mutation in exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), or exon 4 (codons 117 and 146) of KRAS and NRAS.
In Study 20050203, among patients with RAS -mutant tumors, the median PFS was 7.3 months (95% CI: 6.3, 7.9) among 272 patients receiving Vectibix plus FOLFOX and 8.7 months (95% CI: 7.6, 9.4) among patients who received FOLFOX alone (HR = 1.31, 95% CI: 1.07, 1.60). The median OS was 15.6 months (95% CI: 13.4, 17.9) among patients receiving Vectibix plus FOLFOX and 19.2 months (95% CI: 16.7, 21.8) among patients who received FOLFOX alone (HR = 1.25, 95% CI: 1.02, 1.55).
In Study 20100007, among patients with RAS -mutant tumors, no differences in OS or PFS were observed between the treatment arms [n = 54; OS HR = 0.99 (95% CI: 0.49, 2.00); PFS HR = 1.03 (95% CI: 0.56, 1.90)].
16 HOW SUPPLIED/STORAGE AND HANDLING
Vectibix is supplied as a sterile, colorless, preservative-free solution containing 20 mg/mL panitumumab in a single-dose vial. Vectibix is provided as one vial per carton.
- Each 5 mL single-dose vial contains 100 mg of panitumumab in 5 mL (20 mg/mL) (NDC 55513-954-01).
- Each 20 mL single-dose vial contains 400 mg of panitumumab in 20 mL (20 mg/mL) (NDC 55513-956-01).
Store vials in the original carton under refrigeration at 2° to 8°C (36° to 46°F) until time of use. Protect from direct sunlight. DO NOT FREEZE. Discard any unused portion remaining in the vial.
17 PATIENT COUNSELING INFORMATION
Discuss the following with patients prior to treatment with Vectibix:
Skin and eye disorders:
Advise patients to contact a healthcare professional if they experience skin or ocular/visual changes [see Boxed Warning, Dosage and Administration ( 2.3), Warnings and Precautions ( 5.1, 5.8) , and Adverse Reactions ( 6.1, 6.3) ].
Electrolyte monitoring:
Inform patients of the need for periodic monitoring of electrolytes [see Warnings and Precautions ( 5.3)].
Dehydration:
Advise patients of the increased risk of diarrhea and dehydration which may lead to acute renal failure and electrolyte depletion when Vectibix is administered in combination with chemotherapy [see Warnings and Precautions ( 5.5)].
Infusion reactions:
Advise patients of the risk of infusion reactions [see Dosage and Administration ( 2.3), Warnings and Precautions ( 5.4) , and Adverse Reactions ( 6.1, 6.3) ].
Respiratory:
Advise patients to contact a healthcare professional if they experience persistent or recurrent coughing, wheezing, dyspnea, or new-onset facial swelling [see Warnings and Precautions ( 5.6) and Adverse Reactions ( 6.1) ].
Embryo – fetal Toxicity
Advise pregnant women and females of reproductive potential that Vectibix can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment with Vectibix, and for at least 2 months after the last dose and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.10), Use in Specific Populations ( 8.1, 8.3) ] .
Lactation :
Advise women not to breastfeed during treatment with Vectibix and for 2 months after the last dose [see Use in Specific Populations ( 8.2)].
Infertility:
Advise females of reproductive potential of the potential for reduced fertility from Vectibix [see Use in Specific Populations ( 8.3)].
Sun exposure:
Advise patients to limit sun exposure (use sunscreen, wear hats) while receiving Vectibix and for 2 months after the last dose of Vectibix therapy [see Warnings and Precautions ( 5.7)].
Vectibix® (panitumumab)
Manufactured by:
Amgen Inc.One Amgen Center Drive
Thousand Oaks, CA 91320-1799 USA
U.S. License No. 1080
Patent: http://pat.amgen.com/vectibix/
© 2006-2021 Amgen Inc. All rights reserved.
1xxxxxx – v25
PRINCIPAL DISPLAY PANEL
Single-Dose Vial
NDC 55513-954-01
AMGEN®
Vectibix®
(panitumumab)
Injection
100 mg
Each 5 mL single-dose vial of
Vectibix® contains 100 mg
panitumumab in a sterile,
preservative-free solution
(pH 5.8) containing 29 mg sodium
chloride and 34 mg sodium acetate
in Water for Injection, USP.
Store at 2° to 8°C.
Do not freeze or shake.
Protect from direct sunlight.
Rx Only
PRINCIPAL DISPLAY PANEL
Single-Dose Vial
NDC55513-956-01
AMGEN®
Vectibix®
(panitumumab)
Injection
400 mg
Each 20 mL single-dose vial
of Vectibix® contains 400 mg
panitumumab in a sterile,
preservative-free solution
(pH 5.8) containing 117 mg
sodium chloride and 136 mg
sodium acetate in Water for
Injection, USP.
Store at 2° to 8°C.
Do not freeze or shake.
Protect from direct sunlight.
Rx Only
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Labeler — Amgen Inc (039976196) |
Revised: 08/2021 Amgen Inc
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