Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

VIBATIV (NDA-022110)

(TELAVANCIN HYDROCHLORIDE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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07/07/2020 (SUPPL-16)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.4 Pediatric Use

(Additions underlined)

The safety and effectiveness of VIBATIV has not been established in pediatric patients. In particular, there is a concern for poor clinical outcomes in pediatric patients less than one year of age due to immature renal function. Increased mortality in adult patients with HABP/VABP and renal impairment and decreased clinical response in adults with cSSSI and renal impairment were observed [see Boxed Warning and Warnings and Precautions (5.1, 5.2)].

02/20/2020 (SUPPL-15)

Approved Drug Label (PDF)

Boxed Warning

(additions underlined)

…

Embryofetal Toxicity: VIBATIV may cause fetal harm. In animal reproduction studies, adverse developmental outcomes were observed in 3 animal species at clinically relevant doses. Verify pregnancy status in females of reproductive potential prior to initiating VIBATIV. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with VIBATIV and for 2 days after the final dose.

5 Warnings and Precautions

5.4 Embryo-Fetal Toxicity

(additions underlined)

Based on findings in animal reproduction studies, VIBATIV may cause fetal harm. VIBATIV caused adverse developmental outcomes in 3 animal species at clinically relevant doses. Verify pregnancy status in females of reproductive potential prior to initiating VIBATIV. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with VIBATIV and for 2 days after the final dose.

8 Use in Specific Populations

8.1 Pregnancy

(PLLR conversion)

Pregnancy Exposure Registry

There is a pregnancy registry that monitors pregnancy outcomes in women exposed to VIBATIV during pregnancy. Physicians are encouraged to register pregnant patients, or pregnant women may enroll themselves in the VIBATIV pregnancy registry by calling 1-877-484-2700.

Risk Summary

Based on findings in animal reproduction studies, VIBATIV may cause fetal harm. There are no available data on VIBATIV use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In embryo-fetal development studies in rats, rabbits, and minipigs, telavancin demonstrated the potential to cause limb and skeletal malformations when given intravenously during the period of organogenesis at doses providing approximately 1- to 2-fold the human exposure at the maximum recommended clinical dose (see Data). Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data

Animal Data

In embryo-fetal development studies in rats, rabbits, and minipigs, telavancin demonstrated the potential to cause limb and skeletal malformations when given intravenously during the period of organogenesis at doses up to 150, 45, or 75 mg/kg/day, respectively. These doses resulted in exposure levels approximately 1- to 2-fold the human exposure (AUC) at the maximum recommended clinical dose. Malformations observed at <1% (but absent or at lower rates in historical or concurrent controls), included brachymelia (rats and rabbits), syndactyly (rats, minipigs), adactyly (rabbits), and polydactyly (minipigs). Additional findings in rabbits included flexed front paw and absent ulna, and in the minipigs included misshapen digits and deformed front leg. Fetal body weights were decreased in rats.

In a prenatal/perinatal development study, pregnant rats received intravenous telavancin at up to 150 mg/kg/day (approximately the same AUC as observed at the maximum clinical dose) from the start of organogenesis through lactation. Offspring showed decreases in fetal body weight and an increase in the number of stillborn pups. Brachymelia was also observed. Developmental milestones and fertility of the pups were unaffected.

8.2 Lactation

(PLLR conversion)

Risk Summary

There are no data on the presence of telavancin in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VIBATIV and any potential adverse effects on the breastfed child from VIBATIV or from the underlying maternal conditions.

8.3 Females and Males of Reproductive Potential

(PLLR conversion)

Pregnancy Testing

Verify pregnancy status in females of reproductive potential prior to initiating VIBATIV.

Contraception

Females

VIBATIV may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment and for 2 days after the final dose.

Infertility

Males

Based on findings in rats, VIBATIV may impair male fertility. The effect on fertility was reversible in rats.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

(additions and revisions underlined)

…

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.
  If you become pregnant while receiving VIBATIV, tell your healthcare provider right away. Talk to your healthcare provider about taking part in the VIBATIV Pregnancy Registry. This is a study to learn how VIBATIV affects pregnancy and babies. You can enroll in this registry by calling 1-877-484-2700.
  …
  What should I tell my healthcare provider before receiving VIBATIV?
  …

are pregnant or plan to become pregnant. See “What is the most important information I should know about VIBATIV?”
…

PATIENT COUNSELING INFORMATION

(section revised, additions underlined)

…

Pregnancy Registry

Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to VIBATIV during pregnancy. Physicians are encouraged to register pregnant patients, or pregnant women may enroll themselves in the pregnancy registry by calling 1-877-484-2700.

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.

Advise female patients of reproductive potential to use effective contraception during treatment with VIBATIV and for 2 days after the final dose.

…