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.

TEPMETKO (NDA-214096)

(TEPOTINIB HYDROCHLORIDE)

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

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02/15/2024 (SUPPL-3)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Interstitial Lung Disease (ILD)/Pneumonitis

Additions and/or revisions underlined:

ILD/pneumonitis, which can be fatal, occurred in patients treated with TEPMETKO [see Adverse Reactions (6.1)]. ILD/pneumonitis occurred in 2% patients treated with TEPMETKO, with one patient experiencing a Grade 3 or higher event; this event resulted in death. Five patients (1%) discontinued TEPMETKO due to ILD/pneumonitis.

…

5.2 Hepatotoxicity

Additions and/or revisions underlined:

Hepatotoxicity occurred in patients treated with TEPMETKO [see Adverse Reactions (6.1)]. Increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST) occurred in 18% of patients treated with TEPMETKO. Grade 3 or 4 increased ALT/AST occurred in 4.7% of patients. A fatal adverse reaction of hepatic failure occurred in one patient (0.2%). Four patients (0.8%) discontinued TEPMETKO due to increased ALT/AST. The median time-to-onset of Grade 3 or higher increased ALT/AST was 47 days (range 1 to 262).

…

5.3 Pancreatic Toxicity

Newly added section:

Elevations in amylase and lipase levels occurred in patients treated with TEPMETKO [see Adverse Reactions (6.1)]. Increased amylase and/or lipase occurred in 13% of patients treated with TEPMETKO. Grade 3 and 4 increased amylase and/or lipase occurred in 5% and 1.2% of patients, respectively. Monitor amylase and lipase at baseline and regularly during treatment with TEPMETKO. Based on the severity of the adverse drug reaction, temporarily withhold, dose reduce, or permanently discontinue TEPMETKO [see Dosage and Administration (2.4)].

6 Adverse Reactions

Addition of the following to the bulleted line listing:

Pancreatic Toxicity [see Warnings and Precautions (5.3)]

6.1 Clinical Trials Experience

Extensive changes; please refer to label for complete information

8 Use in Specific Populations

8.5 Geriatric Use

Additions and/or revisions underlined:

Of 313 patients with NSCLC positive for METex14 skipping alterations in VISION who received 450 mg TEMETKO once daily, 79% were 65 years or older, and 41% were 75 years or older. No clinically important differences in safety or efficacy were observed between patients aged 65 years or older and younger patients.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Pancreatic Toxicity

Inform patients that they will need to undergo lab tests to monitor pancreatic function. Advise patients to immediately contact their healthcare provider for signs and symptoms of pancreatitis [see Warnings and Precautions (5.3)]

PATIENT INFORMATION

Additions and/or revisions underlined:

Before you take TEPMETKO, tell your healthcare provider about all of your medical conditions, including if you:

have or have had lung or breathing problems other than your lung cancer
have or have had liver problems
have or have had pancreatic problems
are pregnant or plan to become pregnant. TEPMETKO can harm your unborn baby.
…
Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment with TEPMETKO and for 1 week after the last dose of TEPMETKO.

…

How should I take TEPMETKO?

…

If you cannot swallow TEPMETKO tablets whole:

Place your prescribed dose of TEPMETKO tablets in a glass that contains 30 mL (1 ounce) of non- carbonated water.…

What are the possible side effects of TEPMETKO?

TEPMETKO may cause serious side effects, including:

…

Pancreas problems. TEPMETKO may cause increases in your blood amylase and lipase levels that may indicate a problem with your pancreas. Your healthcare provider will do blood tests to check your pancreatic function before you start treatment and during treatment with TEPMETKO. Tell your healthcare provider right away if you develop any signs and symptoms of pancreas problems, including:

upper stomach (abdominal) pain that may spread to your back and get worse with eating
nausea
vomiting
weight loss

The most common side effects of TEPMETKO include:

swelling in your face or other parts of your body
shortness of breath
nausea
loss of appetite
tiredness
rash
muscle and joint pain
changes in certain blood tests
diarrhea

03/23/2023 (SUPPL-2)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and revisions underlined:

The most common adverse reactions (? 20%) in patients who received TEPMETKO were edema, fatigue, nausea, diarrhea, musculoskeletal pain, and dyspnea. The most common Grade 3 to 4 laboratory abnormalities (? 2%) were decreased lymphocytes, decreased albumin, decreased sodium, increased gamma-glutamyltransferase, increased amylase, increased ALT, increased lipase, increased AST, and decreased hemoglobin.

7 Drug Interactions

7.1 Effects of TEPMETKO on Other Drugs

Section title revised

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

Patient Information

Newly added information:

· If you cannot swallow TEPMETKO tablets whole:

o Place your prescribed dose of TEPMETKO tablets in a glass that contains 30 mL of non-carbonated water.

Do not use or add any other liquids.

o Stir the TEPMETKO tablets and water until the TEPMETKO tablets are in small pieces (the tablets will not completely dissolve). Do not crush TEPMETKO tablets.

o Drink the TEPMETKO and water mixture right away or within 1 hour. Make sure to swallow the mixture. Do not chew pieces of the tablet.

o Add another 30 mL of non-carbonated water to the glass and drink it right away to get your full dose of TEPMETKO.

If you have a nasogastric (NG) tube that is 8 French gauge or larger:

o Follow the same instructions for mixing TEPMETKO tablets in a glass that contains 30 ml of non- carbonated water.

o Do not use or add any other liquids.

o Stir the TEPMETKO tablets and water until the TEPMETKO tablets are in small pieces (the tablets will not completely dissolve). Do not crush TEPMETKO tablets.

o Give the TEPMETKO tablet and water mixture using the NG tube manufacturer instructions right away or within 1 hour.

o Pieces of the tablet may remain in the glass. Right away, add 30 ml of non-carbonated water into the glass. Give the water and any remaining TEPMETKO through the NG tube right away to make sure that all of the medicine is given. Repeat this step. This will help to ensure that no medicine is left in the glass or syringe and the full prescribed dose of TEPMETKO is given.

· If you miss a dose of TEPMETKO, take it as soon as you remember. If your next dose is due within 8 hours, skip the missed dose and take your next dose at your regular scheduled time.

· If you vomit after taking a dose of TEPMEKTO, take your next dose at your regular scheduled time.