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.

KINEVAC (NDA-017697)

(SINCALIDE)

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

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10/17/2023 (SUPPL-38)

Approved Drug Label (PDF)

4 Contraindications

Additions and revisions underlined:

KINEVAC is contraindicated in patients with:

a history of hypersensitivity to sulfites or sincalide. Serious hypersensitivity reactions have included anaphylaxis and anaphylactic shock [see Warnings and Precautions (5.1), Adverse Reactions (6)].
intestinal obstruction.

5 Warnings and Precautions

5.1 Anaphylaxis, Anaphylactic Shock and Other Serious Hypersensitivity Reactions

Additions and revisions underlined:

Contains sodium metabisulfite [see Description (11)], a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

In postmarketing experience, anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported during and within one hour following administration of Kinevac [see Adverse Reactions (6)].

Kinevac is contraindicated in patients with a history of hypersensitivity to sulfites.

6 Adverse Reactions

Newly added information:

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

Anaphylaxis, anaphylactic shock, and other serious hypersensitivity reactions [see Warnings and Precautions (5.1)]
Evacuation of gallstones [see Warnings and Precautions (5.2)]
Adverse reactions with intravenous injection [see Warnings and Precautions (5.3)]
Preterm labor or spontaneous abortion [see Warnings and Precautions (5.4)]

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

PATIENT COUNSELING INFORMATION

Additions and revisions underlined:

Anaphylaxis, Anaphylactic Shock and Other Serious Hypersensitivity Reactions

Inform patients that serious hypersensitivity reactions, including anaphylaxis and anaphylactic shock have been reported during or following administration of Kinevac.

12/18/2018 (SUPPL-33)

Approved Drug Label (PDF)

Other

(Physicians Labeling Rule (PLR) Conversion; please refer to label)

03/21/2018 (SUPPL-32)

Approved Drug Label (PDF)

4 Contraindications

(additions underlined)

The preparation is contraindicated in patients with:

a history of hypersensitivity to sincalide. Serious hypersensitivity reactions have included anaphylaxis and anaphylactic shock.
intestinal obstruction.

5 Warnings and Precautions

WARNINGS

(additions underlined)

Anaphylaxis, Anaphylactic Shock and Other Hypersensitivity Reactions

Due to the potential for anaphylaxis, appropriate medical support should be readily available when Kinevac is administered. If anaphylaxis or other hypersensitivity reactions occur, immediately discontinue the infusion and initiate appropriate medical treatment. Observe patients closely during and after the infusion. Do not reinitiate Kinevac in patients who have experienced symptoms of hypersensitivity. (see CONTRAINDICATIONS).

Preterm Labor or Spontaneous Abortion

Because of Kinevac’s effect on smooth muscle, pregnant patients should be advised that spontaneous abortion or premature induction of labor may occur (see Pregnancy Category B).

6 Adverse Reactions

(additions underlined)

The following adverse reactions associated with the use of sincalide were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure.

…

Less common adverse reactions include:

Hypersensitivity reactions: anaphylaxis and anaphylactic shock, hypotension, throat tightness, bradycardia, shortness of breath, nausea, abdominal cramping, diaphoresis, hives, rash, itching; and numbness of face, lips and eye (see CONTRAINDICATIONS, WARNINGS).

Other: vomiting, flushing, hypertension, urge to defecate, headache, diarrhea, sneezing, and numbness was less than 1 percent; dizziness was reported in approximately 2 percent of patients. These manifestations are usually lessened by slower injection rate.