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BORTEZOMIB injection, powder, lyophilized, for solution


  1. Ability To Drive Or Operate Machinery Or Impairment Of Mental Ability:
  2. Embryo-fetal Toxicity:
  3. Concomitant Medications:
  4. Diabetic Patients:
  5. Peripheral Neuropathy And Nervous System:
  6. Cardiac:
  7. Respiratory:
  8. Hepatic:
  9. Revised: 5/2018document Id:

Ability To Drive Or Operate Machinery Or Impairment Of Mental Ability: 

Bortezomib for Injection may cause fatigue, dizziness, syncope, orthostatic/postural hypotension. Advise patients not to drive or operate machinery if they experience any of these symptoms[see Warnings and Precautions (5.2)].

Dehydration/Hypotension: Patients receiving Bortezomib for Injection therapy may experience vomiting and/or diarrhea. Advise patients how to avoid dehydration. Instruct patients to seek medical advice if they experience symptoms of dizziness, light headedness or fainting spells, or muscle cramps[see Warnings and Precautions (5.2)].

Embryo-fetal Toxicity: 

Advise females of the potential risk to the fetus and to avoid pregnancy during treatment with Bortezomib for Injection. Advise female patients to use effective contraceptive measures to prevent pregnancy during treatment with Bortezomib for Injection and for 7 months following cessation of therapy. Advise male patients with female sexual partners of reproductive potential to use effective contraception during treatment with Bortezomib for Injection and for 4 months following cessation of therapy. Instruct patients to report pregnancy to their physicians immediately if they or their female partner becomes pregnant during treatment or within 6 months following treatment[see Warnings and Precautions (5.10)].

Lactation: Advise patients to avoid breastfeeding while receiving Bortezomib for Injection and for 2 months after treatment[see Use in Specific Populations (8.2)].

Concomitant Medications: 

Advise patients to speak with their physicians about any other medication they are currently taking.

Diabetic Patients: 

Advise patients to check their blood sugar frequently if using an oral antidiabetic medication and to notify their physicians of any changes in blood sugar level[see Use in Specific Populations (8.8)].

Peripheral Neuropathy And Nervous System: 

Advise patients to contact their physicians if they experience new or worsening symptoms of peripheral neuropathy such as tingling, numbness, pain, a burning feeling in the feet or hands, or weakness in the arms or legs. Advise patients to contact their physicians if they experience symptoms possibly indicative of PRES[see Warnings and Precautions (5.5)]or PML, such as convulsion, persistent headache, reduced eyesight, blurred vision, confusion, lethargy, altered ability to think, or difficulty walking.

Cardiac: 

Advise patients to contact their physicians if they experience swelling of the feet, ankles, or legs or other heart-related problems[see Warnings and Precautions (5.3)].

Respiratory: 

Advise patients to contact their physicians if they experience shortness of breath, cough, or other lung problems[see Warnings and Precautions (5.4)].

Hepatic: 

Advise patients to contact their physicians if they experience jaundice or right upper quadrant abdominal pain[see Warnings and Precautions (5.9)].

Dermal:Advise patients to contact their physicians if they experience rash, severe injection site reactions[see Dosage and Administration (2.7)], or skin pain. Discuss with patients the option for antiviral prophylaxis for herpes virus infection[see Adverse Reactions (6.1)].

Other:Instruct patients to contact their physicians if they develop an increase in blood pressure, bleeding, fever, constipation, or decreased appetite.

U.S. Patent 8,962,572

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Lake Zurich, IL 60047
www.fresenius-kabi.com/us
451289B

Principal Display Panel - Bortezomib For Injection Vial Label

NDC 63323-721-10 761210

BORTEZOMIB
FOR INJECTION

3.5 mg per vial

FOR INTRAVENOUS USE ONLY

Single-Dose Vial

Discard Unused Portion.

Rx only

Principal Display Panel - Bortezomib For Injection Vial Label

Principal Display Panel - Bortezomib For Injection Carton Label

NDC 63323-721-10 761210

BORTEZOMIB
FOR INJECTION

3.5 mg per vial

FOR INTRAVENOUS USE
ONLY

Single-Dose Vial.

Discard Unused Portion.

Rx only

FRESENIUS
KABI

Principal Display Panel - Bortezomib For Injection Carton Label
BORTEZOMIB
bortezomib injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-721
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bortezomib(UNII: 69G8BD63PP) (Bortezomib - UNII:69G8BD63PP)Bortezomib1 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
Boric Acid(UNII: R57ZHV85D4)
Glycine(UNII: TE7660XO1C)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-721-101 in 1 CARTON11/06/2017
110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20500411/06/2017
Labeler -Fresenius Kabi USA, LLC (608775388)
Establishment
NameAddressID/FEIBusiness Operations
Fresenius Kabi USA, LLC840771732MANUFACTURE(63323-721)

Revised: 5/2018document Id: 

b22d7e31-670d-4a30-8a4e-db7d8260e7b0Set id: 042329d6-8077-4af2-816f-cd0a2bbcbbd3Version: 4Effective Time: 20180521Fresenius Kabi USA, LLC



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