VIBATIV: Package Insert and Label Information (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

  • Individual cartons of 750 mg single-dose vials (NDC 66220-315-11)
  • Cartons of 12 individually packaged 750 mg single-dose vials (NDC 66220-315-22)

Store original packages at refrigerated temperatures of 2°C to 8°C (35°F to 46°F). Excursions to ambient temperatures (up to 25°C (77°F) are acceptable. Avoid excessive heat.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Embryo-Fetal Toxicity

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.4) and Use in Specific Populations (8.1, 8.3)].

Advise female patients of reproductive potential to use effective contraception during treatment with VIBATIV and for 2 days after the final dose [see Use in Specific Populations (8.3)]

Diarrhea

Diarrhea is a common problem caused by antibiotics that usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having received the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Antibacterial Resistance

Patients should be counseled that antibacterial drugs including VIBATIV should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When VIBATIV is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of immediate treatment, and (2) increase the likelihood that the bacteria will develop resistance and will not be treatable by VIBATIV or other antibacterial drugs in the future.

Common Adverse Effects

Patients should be informed about the common adverse effects of VIBATIV including diarrhea, taste disturbance, nausea, vomiting, headache, and foamy urine. Patients should be instructed to inform their healthcare provider if they develop any unusual symptom, or if any known symptom persists or worsens. Patients should be instructed to inform their healthcare provider of any other medications they are currently taking with VIBATIV, including over-thecounter medications.

Manufactured for:

Cumberland Pharmaceuticals Inc.

Nashville, TN 37203

US Patent Nos. 6,635,618 B2; 6,858,584 B2; 6,872,701 B2; 7,008,923 B2; 7,208,471 B2; 7,351,691 B2; 7,531,623 B2; 7,544,364 B2; 7,700,550 B2; 8,101,575 B2; 8,158,580 B2.

VIBATIV® and the VIBATIV® logo are a registered trademark of Cumberland Pharmaceuticals Inc.

This Medication Guide has been approved by the U.S. Food and Drug Administration

Revised: 01/2021

MEDICATION GUIDE VIBATIV ® (vy-‘ba-tiv) (telavancin) for injection, for intravenous use
Read this Medication Guide before you receive VIBATIV. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about VIBATIV? VIBATIV can cause serious side effects, including:

  • Increased risk of death. VIBATIV was associated with an increased risk of death compared to vancomycin in people who already had kidney problems and were treated for bacterial pneumonia that you can get when you are in the hospital.
  • New or worsening kidney problems. Your healthcare provider should do a blood test to check your kidneys before you start, while you receive, and after you stop receiving VIBATIV.
  • VIBATIV may harm your unborn baby. If you are a woman who can become pregnant, your healthcare provider should do a pregnancy test before you start receiving VIBATIV.
    • Talk to your healthcare provider if you are pregnant or plan to become pregnant. Your healthcare provider will decide if VIBATIV is the right medicine for you.
    • Women who can become pregnant should use effective birth control (contraception) while receiving VIBATIV and for 2 days after the last dose of VIBATIV. Talk to your healthcare provider if you have questions about birth control.
What is VIBATIV? VIBATIV is a prescription antibacterial medicine used alone, or with other medicines, to treat adults with certain types of germs (bacteria) that cause:
  • serious skin infections
  • Hospital-Acquired Bacterial Pneumonia (HABP)
  • Ventilator-Associated Bacterial Pneumonia (VABP)
It is not known if VIBATIV is safe or effective in children.
Who should not receive VIBATIV? Do not receive VIBATIV if you:
  • are allergic to telavancin or any of the ingredients in VIBATIV. See the end of this Medication Guide for a complete list of ingredients in VIBATIV.
What should I tell my healthcare provider before receiving VIBATIV? Before you receive VIBATIV, tell your healthcare provider about all of your medical conditions, including if you:
  • have had a serious allergic reaction to VIBATIV or vancomycin.
  • have kidney problems.
  • have diabetes.
  • have, have had or have a family history of heart problems, including QTc prolongation.
  • have high blood pressure.
  • are pregnant or plan to become pregnant. See “What is the most important information I should know about VIBATIV?
  • are breastfeeding or plan to breastfeed. It is not known if VIBATIV passes into breast milk. You and your healthcare provider should decide if you will breastfeed while receiving VIBATIV.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VIBATIV and other medicines can affect each other causing side effects. Especially tell your healthcare provider if you take:
  • a Non-Steroidal Anti-Inflammatory Drug (NSAID)
  • certain blood pressure medicines called Angiotensin-Converting Enzyme (ACE) Inhibitors or Angiotensin Receptor Blockers (ARBs)
  • water pills (diuretics)
  • a blood thinner
  • medicine to control your heart rate or rhythm (antiarrhythmics)
Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
How will I receive VIBATIV?
  • VIBATIV is given by your healthcare provider through a needle placed into your vein (IV infusion) slowly over 1 hour, 1 time each day, for 7 to 21 days.
  • Do not stop receiving VIBATIV unless your healthcare provider tells you to, even if you feel better.
  • Your healthcare provider will do blood tests before you start and while you receive VIBATIV.
What are the possible side effects of VIBATIV? VIBATIV may cause serious side effects, including: See What is the most important information I should know about VIBATIV?
  • Serious allergic reactions. Allergic reactions can happen in people who receive VIBATIV, even after only 1 dose. Stop receiving VIBATIV and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction:
  • hives
  • trouble breathing or swallowing
  • swelling of the lips, tongue, face
  • throat tightness, hoarseness
  • rapid heartbeat
  • faint
  • Infusion-related reactions. People who receive VIBATIV too quickly can have a certain type of skin reaction called “Redman Syndrome”. Signs and symptoms of Red-man Syndrome can include:
  • red color (flushing)
  • rash
  • itching
  • Problems with the electrical system of your heart (QTc prolongation). Tell your healthcare provider right away if you have a change in your heartbeat such as a fast or irregular heartbeat or if you had a fainting episode.
Call your healthcare provider right away if you have any of the serious side effects listed above.The most common side effects of VIBATIV include:
  • change in your sense of taste
  • nausea
  • vomiting
  • foamy urine
  • diarrhea
Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of VIBATIV. For more information, ask your healthcare provider or pharmacist.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of VIBATIV. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.This Medication Guide summarizes the most important information about VIBATIV. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about VIBATIV that is written for health professionals.
What are the ingredients in VIBATIV? Active ingredient: telavancin hydrochlorideInactive ingredients: hydroxypropylbetadex, Ph. Eur (hydroxypropyl-beta-cyclodextrin), mannitol, sodium hydroxide and hydrochloric acidManufactured for: Cumberland Pharmaceuticals Inc.Marketed by: Cumberland Pharmaceuticals Inc., Nashville, TN 37203VIBATIV® is a registered trademark of Cumberland Pharmaceuticals Inc.For more information about VIBATIV, go to www.vibativ.com or call 1-877-683-6110.

Principal Display Panel — 750 mg/vial Carton Label

NDC 66220-315-11

VIBATIV®
(telavancin) for injection

750 mg/
vial

Rx Only

Single Dose Vial-
Discard Unused Portion

Prior to Reconstitution: Store at 2
to 8°C (36° to 46°F).

After Reconstitution: Use within 12
hours at room temperature or within
7 days at 2 to 8°C (36° to 46°F)

See Package Insert for complete
directions for use.

CUMBERLAND® PHARMACEUTICALS

Principal Display Panel -- 750 mg/vial Carton Label
(click image for full-size original)

Principal Display Panel — 750 mg/vial Vial Label

NDC 66220-315-11

VIBATIV®

(telavancin) for injection

750 mg/vial

For Intravenous Infusion Only

Single Dose Vial-

Discard Unused Portion

ATTENTION: Dispense with enclosed Medication Guide.

Rx Only

CUMBERLAND® PHARMACEUTICALS

Principal Display Panel -- 750 mg/vial Vial Label
(click image for full-size original)
VIBATIV telavancin hydrochloride injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66220-315
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
telavancin hydrochloride (telavancin) telavancin 15 mg in 1 mg
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66220-315-11 1 VIAL in 1 CARTON contains a VIAL
1 15 mg in 1 VIAL This package is contained within the CARTON (66220-315-11)
2 NDC:66220-315-22 12 VIAL in 1 CASE contains a VIAL
2 15 mg in 1 VIAL This package is contained within the CASE (66220-315-22)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022110 01/01/2021
Labeler — Cumberland Pharmaceuticals Inc. (069532880)

Revised: 01/2021 Cumberland Pharmaceuticals Inc.

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