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.

KYNAMRO (NDA-203568)

(MIPOMERSEN SODIUM)

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

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03/18/2019 (SUPPL-11)

Approved Drug Label (PDF)

4 Contraindications

4 CONTRAINDICATIONS

(Additions and/or revisions are underlined)

Patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions (e.g., urticaria, rash, angioedema) have occurred with KYNAMRO.

5 Warnings and Precautions

5.5 Hypersensitivity

(Newly added subsection)

There have been reports of generalized hypersensitivity (e.g. angioedema, urticaria, or generalized rash) in patients taking KYNAMRO. If a hypersensitivity reaction occurs, instruct the patient to promptly seek medical advice regarding discontinuation of KYNAMRO.

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

…..

Hypersensitivity Reactions

Inform patients that hypersensitivity reactions (e.g., angioedema, urticaria, or generalized rash) have occurred in patients taking KYNAMRO.

Instruct patients to promptly seek medical attention if a hypersensitivity reaction occurs.

…

05/20/2016 (SUPPL-8)

Approved Drug Label (PDF)

Boxed Warning

(addition to 4th paragraph)

Prescribe KYNAMRO only to patients with a clinical or laboratory diagnosis consistent with HoFH. The safety and effectiveness of KYNAMRO have not been established in patients with hypercholesterolemia who do not have HoFH.

5 Warnings and Precautions

Risk of Hepatotoxicity

Monitoring of Transaminases

Before initiating KYNAMRO and during treatment, monitor transaminases as recommended in Table 2.

Table 2: Recommendations for Monitoring Transaminases

Before initiating treatment
- Measure ALT, AST, alkaline phosphatase, and total bilirubin.
- If abnormal, consider initiating KYNAMRO only after an appropriate work-up and the baseline abnormalities have been explained or resolved.
- KYNAMRO is contraindicated in patients with moderate or severe hepatic impairment, or active liver disease, including unexplained persistent elevations of serum transaminases.
During the first year
- Measure liver-related tests (ALT and AST, at a minimum) prior to each increase in dose or monthly, whichever occurs first.
- After the first year
- Measure liver-related tests (ALT and AST, at a minimum) at least every 3 months and before any increase in dose.
At any time during treatment
- If transaminases are abnormal, reduce or withhold dosing of KYNAMRO and monitor as recommended.
- Discontinue JUXTAPID for persistent or clinically significant elevations.
- If transaminase elevations are accompanied by clinical symptoms of liver injury (such as nausea, vomiting, abdominal pain, fever, jaundice, lethargy, flu-like symptoms), increases in bilirubin =2x ULN, or active liver disease, discontinue treatment with JUXTAPID and identify the probable cause.

6 Adverse Reactions

Post Marketing Experience (addition)

Allergic Reactions: Hypersensitivity reactions (e.g., urticaria, rash, angioedema)

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

KYNAMRO may cause serious side effects, including liver problems. KYNAMRO can cause liver problems such as increased liver enzymes orincreased fat in the liver.
(addition to the stomach pain bullet) stomach pain that gets worse, does not go away, or changes