Drug Safety-related Labeling Changes (SrLC)

Get Email Alerts | Guide

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.

STRIVERDI RESPIMAT (NDA-203108)

(OLODATEROL HYDROCHLORIDE)

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

Download Data

Expand all

05/29/2019 (SUPPL-8)

Approved Drug Label (PDF)

4 Contraindications

(additions underlined)

Use of a LABA, including STRIVERDI RESPIMAT, without an inhaled corticosteroid is contraindicated in patients with asthma .STRIVERDI RESPIMAT is not indicated for the treatment of asthma.

5 Warnings and Precautions

5.1 Serious Asthma-Related Events – Hospitalizations, Intubations, Death

(additions underlined)

The safety and efficacy of STRIVERDI RESPIMAT in patients with asthma have not been established. STRIVERDI RESPIMAT is not indicated for the treatment of asthma .
Use of long-acting beta2-adrenergic agonists (LABA) as monotherapy [without inhaled corticosteroids (ICS)] for asthma is associated with an increased risk of asthma-related death. Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. These findings are considered a class effect of LABA monotherapy. When LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone.

…

Available data do not suggest an increased risk of death with use of LABA in patients with COPD.

6 Adverse Reactions

(additions underlined)

Long-acting beta2-adrenergic agonists, such as STRIVERDI RESPIMAT, as monotherapy (without an inhaled corticosteroid) for asthma, increase the risk of asthma- related events. STRIVERDI RESPIMAT is not indicated for the treatment of asthma.

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

PATIENT COUNSELING INFORMATION

(additions underlined)

…

Serious Asthma-Related Events

Inform patients that LABA, such as STRIVERDI RESPIMAT, when used as monotherapy [without an inhaled corticosteroid], increase the risk of serious asthma- related events, including asthma-related death. STRIVERDI RESPIMAT is not indicated for the treatment of asthma.

…

PATIENT INFORMATION

( Medication Guide replaced with a Patient Package Insert, please refer to label for more information)

04/02/2018 (SUPPL-6)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; additions and/or revisions are underlined)

There are no adequate and well-controlled clinical studies with STRIVERDI RESPIMAT in pregnant women to inform of drug-associated risk of adverse pregnancy- related outcomes. There are clinical considerations with the use of STRIVERDI RESPIMAT in pregnant women. Based on animal studies, olodaterol was not teratogenic when administered to pregnant rats or rabbits during organogenesis at inhalation doses of approximately 2731 or 1353 times the maximum recommended human daily inhalation dose (MRHDID) (on an AUC basis) in rats or rabbits, respectively 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.

Clinical Considerations

Labor and Delivery

There are no adequate and well-controlled human studies that have investigated the effects of STRIVERDI RESPIMAT during labor and delivery. Because of the potential for beta-agonist interference with uterine contractility, use of STRIVERDI RESPIMAT during labor should be restricted to those patients in whom the benefits clearly outweigh the risks.

Data

Animal Data

STRIVERDI RESPIMAT was not teratogenic in rats at inhalation doses approximately 2731 times the MRHDID (on an AUC basis at a maternal inhalation dose of 1054 mcg/kg/day). No significant effects occurred in rabbits at inhalation doses approximately 1353 times the MRHDID in adults (on an AUC basis at a maternal inhalation dose of 974 mcg/kg/day). Placental transfer of olodaterol was observed in pregnant rats.

Olodaterol has been shown to be teratogenic in New Zealand rabbits at inhalation doses approximately 7130 times the MRHDID in adults (on an AUC basis at a maternal inhalation dose of 2489 mcg/kg/day). STRIVERDI RESPIMAT exhibited the following fetal toxicities: enlarged or small heart atria or ventricles, eye abnormalities, and split or distorted sternum.

8.2 Lactation

(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; additions and/or revisions are underlined)

Risk Summary

There are no available data on the presence of olodaterol in human milk, the effects on the breastfed infant, or the effects on milk production. Olodaterol, the active component of STRIVERDI RESPIMAT, and/or its metabolites are present in the milk of lactating rats, however, due to species-specific differences in lactation physiology, the clinical relevance of these data are not clear [see Data]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for STRIVERDI RESPIMAT and any potential adverse effects on the breastfed child from STRIVERDI RESPIMAT or from the underlying maternal condition.

Data

The distribution olodaterol into milk was investigated after a single intravenous administration of 0.4 ?mol/kg to lactating rats. Olodaterol and/or its metabolites are present in the milk of lactating rats at concentrations above those in plasma.

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

17 PATIENT COUNSELING INFORMATION

(Newly added subsection)

….

Paradoxical Bronchospasm

Inform patients that STRIVERDI RESPIMAT can produce paradoxical bronchospasm. Advise patients that if paradoxical bronchospasm occurs, patients should discontinue STRIVERDI RESPIMAT.

Hypersensitivity Reactions

Inform patients that immediate hypersensitivity reactions, including angioedema, may occur after administration of STRIVERDI RESPIMAT. Advise patient to immediately discontinue STRIVERDI RESPIMAT and consult a physician.

Instructions for Administering STRIVERDI RESPIMAT

It is important for patients to understand how to correctly administer STRIVERDI RESPIMAT inhalation spray using the STRIVERDI RESPIMAT inhaler. Instruct patients that STRIVERDI RESPIMAT inhalation spray should only be administered via the STRIVERDI RESPIMAT inhaler and the STRIVERDI RESPIMAT inhaler should not be used for administering other medications.

MEDICATION GUIDE

(Medication Guide Format has been revised; please refer to label)