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.

TANZEUM (BLA-125431)

(ALBIGLUTIDE)

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

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12/20/2017 (SUPPL-20)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.5 Acute Kidney Injury

Additions and/or revisions underlined:

There have been postmarketing cases of worsening renal function and acute kidney injury in patients treated with TANZEUM, some of which required hemodialysis. Some of the postmarketing events were reported in the absence of gastrointestinal adverse reactions and in patients without known underlying renal disease.

In a trial of TANZEUM in patients with renal impairment, the frequency of such gastrointestinal reactions increased as renal function declined. Because these reactions may worsen renal function, use caution when initiating or escalating doses of TANZEUM in patients with renal impairment and/or in those reporting severe gastrointestinal symptoms. Advise patients treated with TANZEUM of the potential risk of dehydration in relation to gastrointestinal side effects and to take precautions to avoid fluid depletion.

6 Adverse Reactions

Newly added information:

6.2 Immunogenecity

Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with TANZEUM may develop anti-albiglutide antibodies. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, the incidence of antibodies to albiglutide in the studies described below cannot be directly compared with the incidence of antibodies in other studies or to other products.

In the pool of 7 placebo- and active-controlled trials, 116 (5.5%) of 2,098 patients exposed to TANZEUM tested positive for anti-albiglutide antibodies at any time during the trials. None of these antibodies were shown to neutralize the activity of albiglutide in an in vitro bioassay.

8 Use in Specific Populations

8.6 Renal Impairment

Additions and/or revisions underlined:

… Therefore, caution is recommended when initiating or escalating doses of TANZEUM in patients with renal impairment and/or in those reporting severe gastrointestinal symptoms.

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

MEDICATION GUIDE

What are the possible side effects of TANZEUM? TANZEUM may cause serious side effects, including:

Newly Added information:

kidney injury. Worsening kidney function and kidney injury have happened in people with kidney problems and in people without kidney problems, who have taken TANZEUM. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney function to get worse. Tell your healthcare provider if you have diarrhea, nausea, or vomiting. Drink plenty of fluids to help reduce your risk of dehydration during treatment with TANZEUM.

PATIENT COUNSELING INFORMATION

Addition of the following:

Advise patients of the potential risk of dehydration in relation to gastrointestinal side effects and to take precautions to avoid fluid depletion.

08/01/2017 (SUPPL-19)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:

TANZEUM is contraindicated in patients with a prior serious hypersensitivity reaction to albiglutide or to any of the product components. Serious hypersensitivity reactions including angioedema have been reported with TANZEUM.

5 Warnings and Precautions

5.4 Hypersensitivity Reactions

Additions and/or revisions underlined:

Serious hypersensitivity reactions (including angioedema and generalized pruritus and rash with dyspnea) have been reported with TANZEUM. If hypersensitivity reactions occur, discontinue use of TANZEUM; treat promptly per standard of care, and monitor until signs and symptoms resolve. Do not use in patients with a previous hypersensitivity reaction to TANZEUM.

Anaphylaxis and angioedema have been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to these reactions with TANZEUM.

6 Adverse Reactions

Addition of the following:

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of TANZEUM. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Angioedema.

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

MEDICATION GUIDE

Additions and/or revisions underlined:

What are the possible side effects of TANZEUM? TANZEUM may cause serious side effects, including:

serious allergic reactions. Stop using TANZEUM and get medical help right away if you have any symptoms of a serious allergic reaction including:

swelling of your face, lips, tongue or throat
problems breathing or swallowing
severe rash or itching
fainting or feeling dizzy
very rapid heartbeat
The most common side effects of TANZEUM may include:
Addition of the following:
upper respiratory tract infection
back pain
joint pain
inflammation of the sinuses

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Inform patients that serious hypersensitivity reactions have been reported with use of TANZEUM. Advise patients on the symptoms of hypersensitivity reactions …

09/13/2016 (SUPPL-18)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Acute Pancreatitis (updated)

Across 8 Phase III clinical trials…..or active comparators (2 of 2,062 [0.1%]).

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

17 PATIENT COUNSELING INFORMATION

Instruct patients to read the Instructions for Use including the Frequently Asked Questions before starting therapy and to read again each time before injecting the dose. (added)

Medication Guide

How should I use TANZEUM? (revised)

• Read the Instructions for Use including the Frequently Asked Questions (added) that comes with TANZEUM the first time you give yourself an injection and again each time you give yourself an injection.

• Use TANZEUM exactly as your healthcare provider tells you to.

Your healthcare provider should show you how to use TANZEUM before you use it for the first time. x TANZEUM is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm ……