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.

EMEND (NDA-022023)

(FOSAPREPITANT DIMEGLUMINE)

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

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05/02/2022 (SUPPL-21)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions underlined

… In pediatric patients 6 months to 12 years of age, the safety of the 3-day IV/oral/oral EMEND regimen was not directly evaluated. The safety of a single dose of EMEND for injection (3 mg/kg) administered on day 1 of the 3-day IV/oral/oral regimen was evaluated in one active-controlled and one single-arm study including 48 pediatric patients 6 months to 12 years of age who received a regimen of either HEC or MEC.

The safety of the 3-day (IV/IV/IV) regimen of EMEND for injection in pediatric patients (6 months to 17 years) was evaluated in a single-arm clinical study in 100 patients who received either HEC or MEC.

In these clinical studies, pediatric patients also received ondansetron with or without dexamethasone. The adverse reaction profile in pediatric patients was similar to the profile in adult patients receiving a single dose of EMEND for injection.

…

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined

… The safety of the 3-day EMEND for injection regimen in pediatric patients 6 months to 17 years of age was supported by an open-label study in 100 patients receiving HEC or MEC. See the full prescribing information for EMEND capsules for complete clinical information regarding studies performed with oral aprepitant. Adverse reactions were similar to those reported in adult patients [see Dosage and Administration (2.2), Adverse Reactions (6.1), Clinical Pharmacology (12.3)].

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

PATIENT INFORMATION

Additions underlined

…

How will I receive EMEND for injection?

…

Children 6 months to 17 years of age:

EMEND for injection will be given to your child by intravenous (IV) infusion into a large vein through a type of IV line called a central venous catheter, about 1 hour to 1 ½ hours before the start of their chemotherapy treatment.

Depending on the chemotherapy treatment, there are 2 ways that EMEND for injection may be given:

EMEND for injection is given on Day 1 only (single day of chemotherapy).
EMEND for injection is given on Days 1, 2, and 3 (single or multiple days of chemotherapy).
- Your child may receive capsules of EMEND or an oral suspension of EMEND instead of EMEND for injection on Days 2 and 3. If your child will receive either of these, see the Patient Information for EMEND capsules or EMEND for oral suspension for further information.
  …

11/14/2019 (SUPPL-19)

Approved Drug Label (PDF)

7 Drug Interactions

Effect of Aprepitant on the Pharmacokinetics of Other Drugs

Updated wording in table, revision underlined

Warfarin: Decreased warfarin exposure and decreased prothrombin time.

04/03/2018 (SUPPL-17)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

(Subsection title has been revised; subsection title has been added; additions and/or revisions are underlined)

…

The overall safety of EMEND for injection was evaluated in approximately 1800 adult and pediatric patients.

Adverse Reactions in Adults for the Prevention of Nausea and Vomiting Associated with MEC

…

Adverse Reactions in Adults for the Prevention of Nausea and Vomiting Associated with HEC

…

Adverse Reactions in Pediatric Patients 6 Months to 17 Years of Age for the Prevention of Nausea and Vomiting Associated with HEC or MEC.

Single-Dose EMEND for Injection Regimen

The safety of a single dose of EMEND for injection in pediatric patients (6 months to 17 years) was evaluated in two active-controlled and a single-arm clinical study in patients who received either HEC or MEC. Patients also received ?ondansetron with or without dexamethasone. The adverse reaction profile was similar to adults. The safety analysis included 69 pediatric patients who received the recommended dose. An additional 70 patients received a single, higher-than-recommended dose. The most common adverse reactions that occurred in >15% of patients who received the recommended dose were anemia, neutropenia, thrombocytopenia, and febrile neutropenia.

3-Day IV/Oral/Oral EMEND Regimen

In pediatric patients (12 to 17 years), the safety of the 3-day IV/oral/oral EMEND regimen was evaluated in a single-arm clinical study including 12 patients who received a regimen of either HEC or MEC. In pediatric patients 6 months to 12 years of age, the safety of the 3-day IV/oral/oral EMEND regimen was not directly evaluated. The safety of a single-dose of EMEND for injection (3 mg/kg) administered on day 1 of the 3-day IV/oral/oral regimen was evaluated in one active-controlled and one single-arm study including 48 patients who received a regimen of either HEC or MEC. Patients also received ondansetron with or without dexamethasone. The adverse reaction profile was similar to adults and pediatric patients receiving a single dose of EMEND for injection.

ADVERSE REACTIONS

(Additions and/or revisions are underlined)

The following clinically significant adverse reactions are described elsewhere in the labeling:

Hypersensitivity Reactions
Infusion Site Reactions

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

Medication Guide

(Additions and/or revisions are underlined)

What is EMEND for injection?

EMEND for injection is a prescription medicine used with other medicines that treat nausea and vomiting in patients 6 months of age and older to prevent nausea and vomiting caused by certain anti-cancer (chemotherapy) medicines.

EMEND for injection is not used to treat nausea and vomiting that you already have.
It is not known if EMEND for injection is safe and effective in children less than 6 months of age.
…

How will I receive EMEND for injection? Adults 18 years of age and older:

EMEND for injection will be given on Day 1 of chemotherapy treatment. It will be given to you by intravenous (IV) infusion in your vein about 50 to 60 minutes before you start your chemotherapy treatment.

Children 6 months to 17 years of age:

EMEND for injection will be given on Day 1 of chemotherapy treatment. It will be given to your child by intravenous (IV) infusion into a large vein through a type of IV line called a central venous catheter, about 1 hour to 1 ½ hours before the start of their chemotherapy treatment.

Your child may also receive:

capsules of EMEND or an oral suspension of EMEND on Days 2 and 3. If your child will receive either of these, see the Patient Information for EMEND capsules or EMEND for oral suspension for further information.

If you take the blood thinner medicine warfarin sodium (COUMADIN®, JANTOVEN®), your healthcare provider may do blood tests after you receive EMEND for injection to check your blood clotting.

What are the possible side effects of EMEND for injection? EMEND for injection may cause serious side effects, including:

Serious allergic reactions. Allergic reactions can happen with EMEND for injection and may be serious. Tell your doctor or nurse right away if you have hives, rash, itching, flushing or redness of your face or skin, trouble breathing or swallowing, dizziness, a rapid or weak heartbeat, or you feel faint during or soon after you receive EMEND for injection, as you may need emergency medical care.
…

In adults, the most common side effects of EMEND for injection include:

tiredness
feeling weak or numb in your arms and legs
diarrhea
painful, difficult, or changes in your digestion(dyspepsia
low white blood cell and red blood cell counts
urinary tract infection
weakness
pain in your arms and legs

In children 6 months to 17 years of age, the most common side effects of EMEND for injection include:

low red blood cell count
low blood platelet count
low white blood cell count
low white blood cell count with a fever

03/26/2018 (SUPPL-18)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 Infusion Site Reactions

(Newly Added Subsection)

Infusion site reactions (ISRs) have been reported with the use of EMEND for injection. The majority of severe ISRs, including thrombophlebitis and vasculitis, were reported with concomitant vesicant (anthracycline-based) chemotherapy administration, particularly when associated with extravasation. Necrosis was also reported in some patients with concomitant vesicant chemotherapy. Most ISRs occurred with the first, second or third exposure to single doses of EMEND for injection and in some cases, reactions persisted for two weeks or longer. Treatment of severe ISRs consisted of medical, and in some cases surgical, intervention.

Avoid infusion of EMEND for injection into small veins or through a butterfly catheter. If a severe ISR develops during infusion, discontinue the infusion and administer appropriate medical treatment.

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Infusion Site Reactions

Advise patients to seek medical attention if they experience new or worsening signs or symptoms of an infusion site reaction, such as erythema, edema, pain, necrosis, vasculitis, or thrombophlebitis at or near the infusion site.

08/09/2017 (SUPPL-16)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Hypersensitivity Reactions

(Additions and/or revisions are underlined)

Serious hypersensitivity reactions, including anaphylaxis and anaphylactic shock, during or soon after infusion of fosaprepitant have occurred. Symptoms including flushing, erythema, dyspnea, hypotension and syncope have been reported.

Monitor patients during and after infusion. If hypersensitivity reactions occur, discontinue the infusion and administer appropriate medical therapy. Do not reinitiate EMEND in patients who experience these symptoms with first-time use.

6 Adverse Reactions

6.2 Postmarketing Experience

(Additions and/or revisions are underlined)

Immune system disorders: hypersensitivity reactions including anaphylaxis and anaphylactic shock

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Hypersensitivity and Infusion Site Reactions

Advise patients that hypersensitivity reactions, including anaphylaxis and anaphylactic shock, have been reported in patients taking EMEND. Advise patients to seek immediate medical attention if they experience signs or symptoms of a hypersensitivity reaction, such as hives, rash and itching, skin peeling or sores, flushing, difficulty in breathing or swallowing, or dizziness, rapid or weak heartbeat or feeling faint. Advise patients local infusion site reactions, such as erythema, edema, pain, or thrombophlebitis, can also occur and instruct them on how to care for the local reaction and when to seek further evaluation.

Patient Information

(Additions and/or revisions are underlined)

What are the possible side effects of EMEND for Injection?

EMEND for Injection may cause serious side effects, including:

Serious allergic reactions. Allergic reactions can happen with EMEND for Injection and may be serious. Tell your doctor or nurse right away if you have hives, rash, itching, flushing or redness of your face or skin, trouble breathing or swallowing, dizziness, a rapid or weak heartbeat, or you feel faint during or soon after you receive EMEND for Injection, as you may need emergency medical care.

05/31/2017 (SUPPL-15)

Approved Drug Label (PDF)

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

Patient Information

(new section added, please refer to label)