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.

ZIOPTAN (NDA-202514)

(TAFLUPROST)

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

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02/25/2026 (SUPPL-8)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.5 Contact Lens Use

Newly added subsection:

Contact lenses should be removed prior to the administration of ZIOPTAN and may be reinserted 15 minutes after administration.

8 Use in Specific Populations

8.1 Pregnancy

PLLR conversion:

Risk Summary

There are no adequate and well-controlled studies of ZIOPTAN administration in pregnant women to inform of drug-associated risks. In animal reproduction studies, intravenous administration of tafluprost to pregnant rabbits and rats throughout organogenesis resulted in embryofetal toxicities at exposures ?5-times the human dose in rabbit and ?2362-times the human dose in rat. (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data

Animal Data

In embryo-fetal development studies, intravenous administration of tafluprost to pregnant rats and rabbits during organogenesis caused increases in post-implantation losses in both species and reductions in fetal body weights in rats (?0.03 mcg/kg/day in rabbits, 5-times the maximum clinical exposure based on Cmax; ?10 mcg/kg/day in rats, 2362-times the maximum clinical exposure based on Cmax). Tafluprost also increased the incidence of vertebral skeletal abnormalities in rats and the incidence of skull, brain and spine malformations in rabbits at these same doses. In rats, there were no adverse effects on embryo-fetal development at a dose of 3 mcg/kg/day corresponding to maternal plasma levels of tafluprost acid that were 343 times the maximum clinical exposure based on Cmax. At the no-effect dose in rabbits (0.01 mcg/kg/day), maternal plasma levels of tafluprost acid were below the lower level of quantification (20 pg/mL).

In a pre- and postnatal development study, intravenous administration of tafluprost to pregnant rats during organogenesis and through birth and lactation, caused increased mortality of newborns, decreased body weights and delayed pinna unfolding in offsprings. The no observed adverse effect level was at a tafluprost intravenous dose of 0.3 mcg/kg/day which is greater than 3 times the maximum recommended clinical dose based on body surface area comparison.

8.2 Lactation

PLLR conversion:

Risk Summary

There are no data on the presence of tafluprost or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production following topical ocular administration.

Tafluprost and/or its metabolites are present in rat milk following ocular administration. When a drug is present in animal milk, it is likely that the drug will be present in human milk.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Advise patients to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

…

Once Nightly Application

Advise patients to not exceed once daily dosing since more frequent administration may decrease the intraocular pressure lowering effect of ZIOPTAN.

Handling the Single-Dose Container

Advise patients that ZIOPTAN is a sterile solution that does not contain a preservative. The solution from one single-dose container is to be used immediately after opening for administration to one or both eyes. Since sterility cannot be maintained after the single-dose container is opened, discard the open container and remaining contents immediately after administration. Open a new single-dose container every time you use ZIOPTAN.

…

PATIENT INFORMATION

ZIOPTAN® (zye OP tan)

(tafluprost ophthalmic solution) 0.0015%

for topical ophthalmic use

What is ZIOPTAN?

…

ZIOPTAN is not recommended for use in children.

How should I use ZIOPTAN?

Use 1 drop of ZIOPTAN in your affected eye or eyes each evening.

…

Contact lenses should be taken out before using ZIOPTAN and you should wait at least 15 minutes after giving the dose of ZIOPTAN before putting the contact lenses back into your eyes.

Use your ZIOPTAN right away after opening for use in 1 or both eyes. Each ZIOPTAN single-dose container is sterile and is to be used 1 time then thrown away. Do not save any ZIOPTAN that may be left over after you use your medicine. Using ZIOPTAN that is not sterile may cause other eye problems.

What are the possible side effects of ZIOPTAN?

ZIOPTAN may cause serious side effects including:

…

increasing the length, thickness, color, shape and number of your eyelashes.

…

inner eye swelling (inflammation). Swelling or thickening may occur in the center of

your eye (macular edema) and swelling in the middle layer of your eye (uveitis, intraocular inflammation) while using ZIOPTAN. Tell your healthcare provider if you experience eye inflammation or have a known risk of macular edema.

The most common side effects of ZIOPTAN include:

• redness, stinging or itching of your eye (conjunctival hyperemia or allergic conjunctivitis)

…

How should I store ZIOPTAN?

Important information for Mail-Order Patients:

• Do not use ZIOPTAN if the prescription is not received within 2 days of the pharmacy filling (dispensing) date located on the prescription label.

Keep the foil pouches and ZIOPTAN single-dose containers dry.

…

After opening the foil pouch:

• Write down the date of first opening the foil pouch in the space provided on the pouch.

• Store the opened foil pouch at room temperature, between 68°F to 77°F (20°C to 25°C), for up to 30 days.

• Throw away all unused ZIOPTAN single-dose containers in the opened foil pouch after 30 days.

• Keep the ZIOPTAN single-dose containers in their original foil pouch.

General information about the safe and effective use of ZIOPTAN.

Medicines are sometimes prescribed for purposes other than those listed in a Patient

Information leaflet.

…

What are the ingredients in ZIOPTAN?

Active ingredients: tafluprost

Inactive ingredients: glycerol, sodium dihydrogen phosphate dihydrate, disodium edetate,

polysorbate 80, hydrochloric acid and sodium hydroxide, and water for injection.