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CYRAMZA- ramucirumab solution


  1. Patient Information
  2. Revised: 7/2019document Id:

Patient Information 

Hemorrhage

Advise patients that CYRAMZA can cause severe bleeding. Advise patients to contact their health care provider for bleeding or symptoms of bleeding including lightheadedness[see Warnings and Precautions (5.1)].

Gastrointestinal Perforations

Advise patients to notify their health care provider for severe diarrhea, vomiting, or severe abdominal pain[see Warnings and Precautions (5.2)].

Impaired Wound Healing

Advise patients that CYRAMZA has the potential to impair wound healing. Instruct patients not to undergo surgery without first discussing this potential risk with their healthcare provider[see Warnings and Precautions (5.3)].

Arterial Thromboembolic Events

Advise patients of an increased risk of an arterial thromboembolic event[see Warnings and Precautions (5.4)].

Hypertension

Advise patients to undergo routine blood pressure monitoring and to contact their healthcare provider if blood pressure is elevated or if symptoms from hypertension occur including severe headache, lightheadedness, or neurologic symptoms[see Warnings and Precautions (5.5)].

Embryo-Fetal Toxicity

Advise females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy and to use effective contraception during CYRAMZA treatment and for 3 months after the last dose[see Warnings and Precautions (5.11), Use in Specific Populations (8.1,8.3)].

Lactation

Advise women not to breastfeed during CYRAMZA treatment and for 2 months after the last dose[see Use in Specific Populations (8.2)].

Infertility

Advise females of reproductive potential that CYRAMZA may impair fertility[see Use in Specific Populations (8.3)].

Eli Lilly and Company, Indianapolis, IN 46285, USA

US License No. 1891

Copyright 2014, 2019, Eli Lilly and Company. All rights reserved.

CYR-0011-USPI-20190731

PACKAGE LABELING

This section contains a representative sample of product package labeling. Product may be manufactured at other manufacturing sites.

PACKAGE CARTON CYRAMZA 100 mg/10 mL single-use vial.

NDC 0002-7669-01

Cyramza

(ramucirumab)

Injection

100 mg/10 mL

(10 mg/mL)

For Intravenous Infusion Only

Must Dilute Prior to Use

Single-Dose Vial

Discard Unused Portion

Keep Refrigerated

Rx only

www.cyramza.com

Lilly

CARTON FOR US ORIGIN

PACKAGE CARTON     CYRAMZA 100 mg/10 mL single-use vial

CARTON FOR IRELAND ORIGIN

PACKAGE CARTON     CYRAMZA 100 mg/50 mL single-use vial

PACKAGE CARTON CYRAMZA 500 mg/50mL single-use vial.

NDC 0002-7678-01

Cyramza

(ramucirumab)

Injection

500 mg/50 mL

(10 mg/mL)

For Intravenous Infusion Only

Must Dilute Prior to Use

Single-Dose Vial

Discard Unused Portion

Keep Refrigerated

Rx only

www.cyramza.com

Lilly

CARTON FOR US ORIGIN

PACKAGE CARTON     CYRAMZA 500 mg/50 mL single-use vial

CARTON FOR IRELAND ORIGIN

PACKAGE CARTON     CYRAMZA 500 mg/50 mL single-use vial
CYRAMZA
ramucirumab solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0002-7669
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ramucirumab(UNII: D99YVK4L0X) (ramucirumab - UNII:D99YVK4L0X)ramucirumab10 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
histidine(UNII: 4QD397987E)0.65 mg in 1 mL
histidine monohydrochloride(UNII: 1D5Q932XM6)1.22 mg in 1 mL
sodium chloride(UNII: 451W47IQ8X)4.38 mg in 1 mL
glycine(UNII: TE7660XO1C)9.98 mg in 1 mL
polysorbate 80(UNII: 6OZP39ZG8H)0.1 mg in 1 mL
water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0002-7669-011 in 1 CARTON04/21/2014
110 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA12547704/21/2014
CYRAMZA
ramucirumab solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0002-7678
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ramucirumab(UNII: D99YVK4L0X) (ramucirumab - UNII:D99YVK4L0X)ramucirumab10 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
histidine(UNII: 4QD397987E)0.65 mg in 1 mL
histidine monohydrochloride(UNII: 1D5Q932XM6)1.22 mg in 1 mL
sodium chloride(UNII: 451W47IQ8X)4.38 mg in 1 mL
glycine(UNII: TE7660XO1C)9.98 mg in 1 mL
polysorbate 80(UNII: 6OZP39ZG8H)0.1 mg in 1 mL
water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0002-7678-011 in 1 CARTON04/21/2014
150 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA12547704/21/2014
Labeler -Eli Lilly and Company (006421325)

Revised: 7/2019document Id: 

b31b275e-fd20-4b53-8f44-7a48f0b8e3dcSet id: c6080942-dee6-423e-b688-1272c2ae90d4Version: 27Effective Time: 20190731Eli Lilly and Company



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