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.

LEVULAN (NDA-020965)

(AMINOLEVULINIC ACID HYDROCHLORIDE)

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

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05/09/2022 (SUPPL-17)

Approved Drug Label (PDF)

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

Patient Information

Additions and revisions underlined:

LEVULAN KERASTICK may cause serious side effects, including:

Temporary memory problems. Temporary memory problems have happened during treatment with LEVULAN KERASTICK in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. You or your family members or caregiver should call your healthcare provider right away if you develop any problems with memory, confusion, or disorientation during treatment.

04/19/2018 (SUPPL-16)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Transient Amnestic Episodes

(new subsection added)

Transient amnestic episodes have been reported during postmarketing use of Levulan Kerastick in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. Inform patients and their caregivers that Levulan Kerastick in combination with PDT may cause transient amnestic episodes. Advise them to contact the healthcare provider if the patient develops amnesia after treatment.

6 Adverse Reactions

(addition underlined)

The following adverse reactions are discussed in greater detail in the other sections of the labeling:

Transient Amnestic Episodes

…

6.2 Postmarketing Experience:

(new subsection added)

The following adverse reactions have been reported during post-approval use of LEVULAN KERASTICK. 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.

Nervous system disorders: transient amnestic episodes

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

PATIENT COUNSELING INFORMATION

(additions underlined)

Transient Amnestic Episodes

Transient episodes of amnesia have been reported with Levulan Kerastick in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. Advise patients and their families or caregivers to contact their healthcare provider if memory impairment, confusion, or disorientation is observed.

03/06/2018 (SUPPL-15)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Photosensitivity

(additions underlined)

After LEVULAN KERASTICK topical solution has been applied, the treatment site will become photosensitive and patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) for 40 hours. Exposure may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions.

Therefore, before exposure to sunlight, patients should protect treated lesions from the sun by wearing a wide- brimmed hat or similar head covering of light-opaque material, and/or a long-sleeved shirt and/or gloves.

Sunscreens will not protect against photosensitivity reactions caused by visible light. It has not been determined if perspiration can spread the LEVULAN KERASTICK topical solution outside the treatment site to the eye or surrounding skin.

of LEVULAN KERASTICK topical solution to perilesional areas of photodamaged skin of the face, scalp or upper extremities may result in photosensitization. Upon exposure to activating light from the BLU-U, such photosensitized skin may produce a stinging and/or burning sensation and may become erythematous and/or edematous in a manner similar to that of actinic keratoses treated with LEVULAN KERASTICK Photodynamic Therapy. Because of the potential for skin to become photosensitized, the LEVULAN KERASTICK topical solution should be used by a qualified health professional to apply drug to no more than 5mm of perilesional skin surrounding the target actinic keratosis lesions.

...

5.2 Irritation

(additions underlined)

The LEVULAN KERASTICK topical solution contains alcohol and is intended for topical use only. Irritation may be experienced if this product is applied to eyes or mucus membranes. Do not apply to the eyes or to mucous membranes. Excessive irritation may be experienced if this product is applied under occlusion longer than 3 hours.

6 Adverse Reactions

(section revised, additions underlined)

The following adverse reactions are discussed in greater detail in the other sections of the labeling:

Increased Photosensitivity
Irritation
Coagulation defects

6.1 Clinical Trial Experience

(subsection added, please refer to label)

8 Use in Specific Populations

8.1 Pregnancy

(PLLR converson)

Risk Summary

Limited available data with LEVULAN KERASTICK topical solution use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. Animal developmental toxicology studies were not conducted with aminolevulinic acid. LEVULAN KERASTICK solution has low systemic absorption following topical administration, and the risk of maternal use resulting in fetal exposure to the drug is unknown.

The estimated background risk of major birth defects and miscarriage for the indicated population are 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.

8.2 Lactation

(PLLR conversion)

Risk Summary

There are no data on the presence of LEVULAN KERASTICK topical solution in either human or animal milk, the effects 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 LEVULAN KERASTICK topical solution and any potential adverse effects on the breastfeeding child from LEVULAN KERASTICK topical solution or from the underlying maternal condition.

8.4 Pediatric Use

(additions underlined)

The safety and effectiveness in pediatric patients below the age of 18 have not been established. Actinic keratosis is not a disease generally seen in the pediatric population.

8.5 Geriatric Use

(additions and revisions underlined)

Of the 512 subjects in Phase 3 clinical trials of LEVULAN KERASTICK topical solution, 63% (321/512) were 65 years old and over, while 24% (123/512) were 75 years old and over. No overall differences in safety or substantial differences in effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

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

PATIENT COUNSELING INFORMATION

(section revised, additions underlined)

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Photosensitivity

Advise patients that after LEVULAN KERASTICK topical solution has been applied, the treatment site will become photosensitive and that they should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) for 40 hours. Exposure may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions.

Advise patients to protect treated lesions from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material, and/or a long-sleeved shirt and/or gloves. Advise patients sunscreens will not protect against photosensitivity reactions caused by visible light. It has not been determined if perspiration can spread the LEVULAN KERASTICK topical solution outside the treatment site to the eye or surrounding skin.

If for any reason the patient cannot return for blue light treatment during the prescribed period after applying LEVULAN KERASTICK topical solution, advise patients to call the doctor. Advise patient to continue to avoid exposure of the photosensitized lesions to sunlight or prolonged or intense light for at least 40 hours. If stinging and/or burning is noted, exposure to light should be reduced.

Advise patients to avoid certain medications that may enhance the phototoxic reaction to PDT.

Common Adverse Reactions

Inform patients that treatment with LEVULAN KERASTICK topical solution plus BLU-U Blue Light Photodynamic Therapy Illuminator may result in sensitivity to light, skin irritation and local skin reactions including erythema, edema, stinging/burning, scaling, crusting, oozing, vesiculation, wheal, scabbing, pustules, ulceration, itching, erosion, hypo/hyperpigmentation, bleeding, tenderness, dysesthesia, and dryness.