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

VECTIBIX panitumumab solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55513-954 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PANITUMUMAB (PANITUMUMAB) PANITUMUMAB 100 mg in 5 mL

Inactive Ingredients Ingredient Name Strength SODIUM ACETATE 34 mg in 5 mL SODIUM CHLORIDE 29 mg in 5 mL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55513-954-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE 1 5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (55513-954-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125147 10/10/2006

VECTIBIX panitumumab solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55513-956 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PANITUMUMAB (PANITUMUMAB) PANITUMUMAB 400 mg in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM ACETATE 136 mg in 20 mL SODIUM CHLORIDE 117 mg in 20 mL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55513-956-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE 1 20 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (55513-956-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125147 10/10/2006

Labeler — Amgen Inc (039976196)

Revised: 08/2021 Amgen Inc