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.

LAMISIL (NDA-022071)

(TERBINAFINE HYDROCHLORIDE)

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

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03/29/2019 (SUPPL-15)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

8.2 Lactation

PLLR conversion. Please refer to label for complete information.

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

PATIENT COUNSELING INFORMATION

Newly added:

Advise patients to call their physician if they become pregnant during treatment with LAMISIL Tablets.

01/19/2017 (SUPPL-13)

Approved Drug Label (PDF)

4 Contraindications

(Additions and/or revisions are underlined)

LAMISIL (terbinafine hydrochloride) Oral Granules are contraindicated in patients with:

Chronic or active liver disease

5 Warnings and Precautions

5.1 Hepatotoxicity

(Additions and/or revisions are underlined)

LAMISIL Oral Granules are contraindicated for patients with chronic or active liver disease. Before prescribing LAMISIL Oral Granules, perform liver function tests because hepatotoxicity may occur in patients with and without preexisting liver disease…

The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease. Periodic monitoring of liver function tests is recommended. Discontinue LAMISIL Oral Granules if biochemical or clinical evidence of liver injury develops.

Warn patients prescribed LAMISIL Oral Granules and/or their caregivers to report immediately to their healthcare providers any symptoms or signs of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain or jaundice, dark urine, or pale stools. Advise patients with these symptoms to discontinue LAMISIL Oral Granules, and immediately evaluate the patient’s liver function.

5.8 Thrombotic Microangiopathy

(Newly added subsection)

Cases of thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, some fatal, have been reported with terbinafine. Discontinue terbinafine if clinical symptoms and laboratory findings consistent with TMA occur. The findings of unexplained thrombocytopenia and anemia should prompt further evaluation and consideration of diagnosis of TMA.

6 Adverse Reactions

6.2 Postmarketing Experience

(Additions and/or revisions are underlined)

Blood and lymphatic system disorders: Pancytopenia, agranulocytosis, severe neutropenia, thrombocytopenia, anemia, thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome.

8 Use in Specific Populations

8.7 Hepatic Impairment

(Newly added subsection)

LAMISIL Oral Granules are contraindicated for patients with chronic or active liver disease. Cases of liver failure, some leading to liver transplant or death, have occurred with the use of oral terbinafine during postmarketing experience in individuals with and without preexisting liver disease. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease.

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Advise the patient to read the FDA-Approved Medication Guide and Instructions for Use.

MEDICATION GUIDE LAMISIL® (lam-i-sil) (terbinafine hydrochloride) Oral Granules

(Additions and/or revisions are underlined)

What is the most important information I should know about LAMISIL Oral Granules?

LAMISIL Oral Granules may cause serious side effects, including:

Liver problems that can lead to the need for a liver transplant, or death. This can happen in people who have liver problems and in people who have never had liver problems. Tell your doctor right away if you get any of these symptoms of a liver problem:

nausea
poor appetite
tiredness
vomiting
upper right stomach-area (abdomen) pain
yellowing of your skin or eyes (jaundice)
dark (tea-colored) urine
pale or light colored stools

Your doctor should do a blood test to check you for liver problems before you start treatment with LAMISIL Oral Granules. Your doctor may also check you for liver problems during treatment, and tell you to stop taking LAMISIL Oral Granules if you develop liver problems.

What is LAMISIL Oral Granules?

Who should not take LAMISIL Oral Granules? Do not take LAMISIL Oral Granules if you:

have had a severe allergic reaction to terbinafine hydrochloride when taken by mouth.
have had liver disease for a long time (chronic) or have active liver disease.

Before taking LAMISIL Oral Granules, tell your doctor about all of your medical conditions, including if you:

are breastfeeding or plan to breastfeed. LAMISIL passes into your breast milk and may harm your baby. You should not breastfeed while taking LAMISIL Oral Granules…

How should I take LAMISIL Oral Granules?

See the Instructions for Use that come with LAMISIL Oral Granules for information about the correct way to prepare and take or give a dose.
Take LAMISIL Oral Granules exactly as your doctor tells you to take it.
Do not use applesauce or a fruit-based food

See “What is the most important information I should know about LAMISIL Oral Granules?”

Change in your sense of taste or loss of taste may happen with LAMISIL Oral Granules, but can also be severe…

Change in your sense of smell or loss of smell may happen with LAMISIL Oral Granules. This may improve after you stop taking LAMISIL Oral Granules, but may last for a long time or may become permanent. Tell your doctor if you have a change in your sense of smell or loss of smell.

Serious skin or allergic reactions, which may include problems with some of your body organs. Tell your doctor right away or get emergency medical help if you get any of these symptoms:

Also tell your doctor about any new symptoms, such as cough, chest pain, fast heartbeat, or blood in your urine.

Blood clotting problems. When taking LAMISIL Oral Granules, you may develop a blood clotting problem. Tell your doctor, if you get any unexplained bleeding or bruising.

08/23/2016 (SUPPL-11)

4 Contraindications

LAMISIL (terbinafine hydrochloride) Oral Granules are contraindicated in patients with:

Chronic or active liver disease (addition)

5 Warnings and Precautions

Hepatotoxicity

Addition of the following two paragraphs:

LAMISIL Oral Granules are contraindicated for patients with chronic or active liver disease. Before prescribing LAMISIL Oral Granules, perform liver function tests because hepatotoxicity may occur in patients with and without preexisting liver disease. Cases of liver failure, some leading to liver transplant or death, have occurred with the use of oral terbinafine during postmarketing experience in individuals with and without preexisting liver disease. In the majority of liver cases reported in association with oral terbinafine use, the patients had serious underlying systemic conditions. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease. Periodic monitoring of liver function tests is recommended. Discontinue LAMISIL Oral Granules if biochemical or clinical evidence of liver injury develops.

Warn patients prescribed LAMISIL Oral Granules and/or their caregivers to report immediately to their healthcare providers any symptoms or signs of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain or jaundice, dark urine, or pale stools. Advise patients with these symptoms to discontinue LAMISIL Oral Granules, and immediately evaluate the patient’s liver function.

8 Use in Specific Populations

Hepatic Impairment

LAMISIL Oral Granules are contraindicated for patients with chronic or active liver disease. Cases of liver failure, some leading to liver transplant or death, have occurred with the use of oral terbinafine during postmarketing experience in individuals with and without preexisting liver disease. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease.

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

Added; please refer to label.