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.

CINVANTI (NDA-209296)

(APREPITANT)

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

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10/21/2019 (SUPPL-4)

Approved Drug Label (PDF)

6 Adverse Reactions

(newly added section information)

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

Hypersensitivity Reactions

6.1 Clinical Trials Experience

(extensive revisions; please refer to labeling for complete information)

7 Drug Interactions

7.1 Effect of Aprepitant on the Pharmacokinetics of Other Drugs

(additions and/or revisions are underlined)

Table 8. Effects of Aprepitant on the Pharmacokinetics of Other Drugs

7.2 Effect of Other Drugs on the Pharmacokinetics of Aprepitant

(additions and/or revisions are underlined)

Aprepitant is a CYP3A4 substrate. Co-administration of CINVANTI with drugs that are inhibitors or inducers of CYP3A4 may result in increased or decreased plasma concentrations of aprepitant, respectively, as shown in Table 9.

Table 9. Effects of Other Drugs on Pharmacokinetics of Aprepitant

8 Use in Specific Populations

8.5 Geriatric Use

(additions and/or revisions are underlined)

Of the 1649 adult cancer patients treated with intravenous fosaprepitant in HEC and MEC clinical studies, 27% were aged 65 and over, while 5% were aged 75 and over. Other reported clinical experience with fosaprepitant and/or oral aprepitant has not identified differences in responses between elderly and younger patients. In general, use caution when dosing elderly patients as they have a greater frequency of decreased hepatic, renal or cardiac function and concomitant disease or other drug therapy.

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

PATIENT INFORMATION

(additions and/or revisions are underlined)

What are the possible side effects of CINVANTI?

CINVANTI may cause serious side effects, including:

• Serious allergic reactions. Serious allergic reactions can happen during your CINVANTI infusion. Tell your healthcare

provider or nurse right away if you get any of these symptoms during or soon after your infusion:

o trouble breathing or swallowing, shortness of breath or wheezing

o swelling of your eyes, face, tongue, or throat

o flushing or redness of your face or skin

o hives, rash, itching

o dizziness, a rapid or weak heartbeat, or you feel faint

The most common side effects of CINVANTI include:

tiredness
headache
diarrhea
indigestion
low white blood cell and red blood cell counts
urinary tract infection
weakness
belching or burping
feeling weak or numb in your arms and legs
pain in your arms and legs

Infusion-site side effects with CINVANTI may include: pain, hardening, redness or itching at the site of infusion. Swelling (inflammation) of a vein caused by a blood clot can also happen at the infusion site. Tell your healthcare provider if you get any infusion-site side effects.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of CINVANTI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

02/26/2019 (SUPPL-3)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Hypersensitivity Reactions

Additions and/or revisions underlined:

Serious hypersensitivity reactions, including anaphylaxis, during or soon after administration of CINVANTI have occurred. Symptoms including dyspnea, eye swelling, flushing, pruritus and wheezing have been reported.

Monitor patients during and after administration. If hypersensitivity reactions occur, discontinue CINVANTI and administer appropriate medical therapy. Do not reinitiate CINVANTI in patients who experience these symptoms with previous use.

6 Adverse Reactions

6.1 Clinical Trials Experience

Safety of CINVANTI

Addition of the following:

The safety profile of CINVANTI in 50 healthy subjects who received a single 2-minute injection was similar to that seen with a 30-minute infusion.

6.2 Postmarketing Experience

Additions and/or revisions underlined:

The following adverse reactions have been identified during post-approval use of intravenous fosaprepitant and/or intravenous or oral aprepitant.