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.

VAPRISOL (NDA-021697)

(CONIVAPTAN HYDROCHLORIDE)

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

Download Data

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10/14/2016 (SUPPL-5)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 Hypovolemia or Hypotension (subsection revised)

For patients who develop hypovolemia or hypotension while receiving VAPRISOL, VAPRISOL should be discontinued, and volume status and vital signs should be frequently monitored. Once the patient is again euvolemic and is no longer hypotensive, VAPRISOL may be resumed at a reduced dose if the patient remains hyponatremic.

7 Drug Interactions

7.1 CYP3A Inhibitors and Substrates (additions underlined)

Conivaptan is a sensitive substrate of CYP3A. Coadministration with strong CYP3A inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, ritonavir and indinavir) increases conivaptan exposure and is contraindicated .)

Coadministration with CYP3A substrates results in increased exposure of the other drug. Avoid concomitant use with drugs eliminated primarily by CYP3A-mediated metabolism. Subsequent treatment with CYP3A substrates may be initiated no sooner than 1 week after the infusion of VAPRISOL is completed.

7.2 Digoxin (additions underlined)

Coadministration of digoxin with oral conivaptan resulted in a 1.8- and 1.4-fold increase in digoxin Cmax and AUC, respectively. Monitor digoxin levels.

8 Use in Specific Populations

8.1 Pregnancy (PLLR conversion)

8.2 Lactation (PLLR conversion)

8.3 Females and Males of Reproductive Potential (subsection revised, addition underlined)

Infertility

Females

Based on findings of decreased fertility in female rats, conivaptan may impair fertility in females of reproductive potential. It is not known whether these effects on fertility are reversible.

8.6 Use in Patients with Hepatic Impairment (addition underlined)

No clinically relevant increase in exposure was observed in subjects with mild hepatic impairment; therefore no dose adjustment of VAPRISOL is necessary. The systemic exposure to unbound conivaptan doubled in subjects with moderate and severe hepatic impairment.

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

17 PATIENT COUNSELING INFORMATION (addition underlined)

Lactation

Advise women not to breastfeed during treatment with VAPRISOL.