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.

LUPKYNIS (NDA-213716)

(VOCLOSPORIN)

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

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10/08/2025 (SUPPL-8)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:

…

Patients with a history of serious or severe hypersensitivity reaction, including anaphylaxis, to LUPKYNIS or any of its excipients [see Warnings and Precautions (5.8)].

5 Warnings and Precautions

5.8 Hypersensitivity Reactions

Newly added section:

Postmarketing cases of hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with LUPKYNIS. If signs or symptoms of a hypersensitivity reaction occur, discontinue LUPKYNIS; treat and monitor until signs and symptoms resolve [see Contraindications (4)].

6 Adverse Reactions

Addition of the following to the bulleted line listing:

Hypersensitivity Reactions [see Warnings and Precautions (5.8)]

6.2 Postmarketing Experience

Newly added section:

The following adverse reactions have been identified during post approval use of LUPKYNIS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

Hypersensitivity reactions, including anaphylaxis and angioedema [see Warnings and Precautions (5.8)]
Nausea, vomiting

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

PATIENT COUNSELING INFORMATION

Newly added information:

Hypersensitivity Reactions

Inform patients of the potential risk of hypersensitivity reactions. Advise patients to stop taking LUPKYNIS and seek medical attention if signs or symptoms of a hypersensitivity reaction occur (such as swelling of face, lips, tongue, or throat; difficulty breathing or swallowing) [see Warning and Precautions (5.8)].

MEDICATION GUIDE

Newly added information:

…

allergic reactions. Allergic reactions, including a severe allergic reaction called anaphylaxis, can happen after taking LUPKYNIS. Stop taking LUPKYNIS and get emergency medical help right away if you have any of the following symptoms of an allergic reaction:

swelling on the face, lips, tongue, or throat
trouble breathing or swallowing
rash, hives, or itching
fast heartbeat
fainting, dizziness, feeling lightheaded
chest pain

…

04/29/2024 (SUPPL-4)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Extensive changes; please refer to label

7 Drug Interactions

7.2 Effect of LUPKYNIS on Other Drugs

Additions and revisions underlined:

OATP1B1 Substrates

Voclosporin is an inhibitor of OATP1B1 and OATP1B3 transporters. In one clinical study the concomitant administration of a single 40 mg dose of simvastatin with 23.7 mg BID voclosporin increased Cmax and AUC of the active metabolite simvastatin acid (an OATP1B1 substrate) by 3.1- fold and 1.8-fold, respectively [see Clinical Pharmacology (12.3)]. Monitor for adverse events such as myopathy and rhabdomyolysis when OATP1B1/OATP1B3 substrates (e.g., simvastatin, atorvastatin, pravastatin, rosuvastatin, pitavastatin, fluvastatin) are used concomitantly with LUPKYNIS and reduce the dosage of these substrates as recommended in their prescribing information. For example, when taking LUPKYNIS with simvastatin, limit the simvastatin dosage to 20 mg daily, or 40 mg daily for patients who have previously tolerated simvastatin 80 mg daily for at least one year without evidence of muscle toxicity.

8 Use in Specific Populations

8.2 Lactation

Newly added subsection:

Risk Summary

The available human data from a clinical lactation study detected small amounts of voclosporin in human milk. Following a single dose to lactating subjects, a fully breastfed infant was estimated to receive a daily infant dose of 0.00675 mg/kg, and relative infant dose of 1.4% the maternal weight- adjusted dose. No change is expected for infant exposure at steady state with maternal twice daily dosing (see Data). Available data from the clinical study and published scientific literature are insufficient to determine the effects of LUPKYNIS on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for LUPKYNIS and any potential adverse effects on the breastfed infant from LUPKYNIS or from the medical condition of the mother.

Data

Following a single 23.7 mg dose of voclosporin in healthy lactating subjects, an average of 0.00472 mg voclosporin was excreted in breast milk. Data showed that the voclosporin milk to maternal blood exposure ratio was in the range of 0.42 to 0.95. Based on the infant milk intake of 200 mL/kg/day, the highest estimated voclosporin dose ingested by fully breastfed infant was 1.4% of maternal weight- adjusted dose, which equals estimated daily infant dose of 0.00675 mg/kg/day. At steady state following maternal twice daily dosing regimen, the percent of voclosporin dose present in breast milk is expected to be similar to that following maternal single dose.

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

Medication Guide

Newly added information:

LUPKYNIS can pass into breastmilk.

PATIENT COUNSELING INFORMATION

Additions and revisions underlined:

Lactation

Advise female patients to inform their healthcare provider if they are breastfeeding or intend to breastfeed while taking LUPKYNIS [see Use in Specific Populations (8.2)].