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.

ZOKINVY (NDA-213969)

(LONAFARNIB)

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

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03/21/2024 (SUPPL-2)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:

ZOKINVY is contraindicated in patients taking:

Strong CYP3A inhibitors [see Drug Interactions (7.1)]

7 Drug Interactions

7.1 Effects of Other Drugs on ZOKINVY

Extensive changes; please refer to label for complete information

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Drug Interactions [see Dosage and Administration (2.2, 2.3), Contraindications (4), Warnings and Precautions (5.1, 5.2), Drug Interactions (7.1)]

Inform patients and caregivers that ZOKINVY may interact with several drugs. Advise patients and their caregivers to inform their healthcare provider before starting or discontinuing a prescription or non-prescription drug, supplement, or strong CYP3A inhibitor.

PATIENT INFORMATION

Additions and/or revisions underlined:

Do not take ZOKINVY if you are taking:

a strong CYP3A inhibitor

…

Before taking ZOKINVY, tell your healthcare provider about all of your medical conditions, including if you:

have a history of QTc interval prolongation or other abnormal heartbeat.
have slow heartbeat.

have low magnesium levels or low potassium levels.

…

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking ZOKINVY with certain other medicines may affect how the other medicines work and other medicines may affect how ZOKINVY works, and may increase your risk of side effects, including a heart rhythm problem called QTc interval prolongation. Especially tell your healthcare provider if you take any other medicines that may cause QTc interval prolongation.

…

What are the possible side effects of ZOKINVY?

ZOKINVY may cause serious side effects, including:

A serious heart rhythm problem called QTc Interval Prolongation. This condition can cause an abnormal heartbeat in people who take ZOKINVY and may lead to death. Your healthcare provider should check your heart and do blood tests before and during treatment with ZOKINVY. Tell your healthcare provider right away if you feel dizzy, lightheaded, faint, or have a change in your heartbeat (a fast or irregular heartbeat).

03/21/2024 (SUPPL-3)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 QTc Interval Prolongation

Newly added subsection

ZOKINVY prolongs the QTc interval. Prolongation of the QTc interval increases the risk of Torsade de pointes, other serious arrhythmias, and sudden death.

Avoid use of ZOKINVY in patients with a history of cardiac arrhythmias, as well as in other circumstances that may increase the risk of the occurrence of Torsade de pointes or sudden death, including symptomatic bradycardia, hypokalemia, or hypomagnesemia. Avoid use of ZOKINVY in combination with other drugs known or suspected to prolong the QTc interval [see Drug Interactions (7.1)].

Monitor ECGs prior to initiating ZOKINVY, during treatment, and as clinically indicated. If QTc interval is greater than 500 msec, withhold ZOKINVY until QTc interval is less than 470 msec, then resume ZOKINVY at same dosage.

Obtain serum electrolytes prior to initiating ZOKIVNY and during treatment as clinically indicated. Correct serum electrolyte abnormalities.

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

PATIENT COUNSELING INFORMATION

Newly added information:

QTc Interval Prolongation [see Warnings and Precautions (5.1), Drug Interactions (7.1), Clinical Pharmacology (12.2)]

Inform patients and caregivers that ZOKINVY causes QTc interval prolongation and may increase the risk of Torsades de pointes, other ventricular arrhythmias, and sudden death.
Instruct patients or caregivers to notify their healthcare provider if they experience symptoms such as dizziness, lightheadedness, heart palpitations, or loss of consciousness.
Instruct patients to inform their healthcare provider if they are taking any other medications that may prolong the QTc interval.

PATIENT INFORMATION

Additions and/or revisions underlined:

Do not take ZOKINVY if you are taking:

a strong CYP3A inhibitor

…

Before taking ZOKINVY, tell your healthcare provider about all of your medical conditions, including if you:

have a history of QTc interval prolongation or other abnormal heartbeat.
have slow heartbeat.

have low magnesium levels or low potassium levels.

…

What are the possible side effects of ZOKINVY?

ZOKINVY may cause serious side effects, including:

A serious heart rhythm problem called QTc Interval Prolongation. This condition can cause an abnormal heartbeat in people who take ZOKINVY and may lead to death. Your healthcare provider should check your heart and do blood tests before and during treatment with ZOKINVY. Tell your healthcare provider right away if you feel dizzy, lightheaded, faint, or have a change in your heartbeat (a fast or irregular heartbeat).