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.

AMELUZ (NDA-208081)

(AMINOLEVULINIC ACID HYDROCHLORIDE)

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

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05/25/2021 (SUPPL-11)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Hypersensitivity

(Newly Added Subsection)

Several cases of hypersensitivity were reported during postmarketing use of AMELUZ prior to PDT illumination [see Adverse Reactions (6.2)]. If allergic reactions occur, clean the area of skin where the product was applied and institute appropriate therapy. Inform patients and their caregivers that AMELUZ may cause hypersensitivity, potentially including severe courses (anaphylaxis).

6 Adverse Reactions

(Additions and/or revisions underlined)

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

Hypersensitivity [see Warnings and Precautions (5.1)].
Transient Amnestic Episodes [see Warnings and Precautions (5.2)].
Risk of BF-RhodoLED Lamp Induced Eye Injury [see Warnings and Precautions (5.3)].
Increased Photosensitivity [see Warnings and Precautions (5.4)].
Risk of Bleeding in Patients with Coagulation Disorders [see Warnings and Precautions (5.5)].
Ophthalmic Adverse Reactions [see Warnings and Precautions (5.6)].
Risk of Mucous Membrane Irritation [see Warnings and Precautions (5.67)].

6.2 Postmarketing Experience

(Additions and/or revisions underlined)

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

Skin and subcutaneous tissue disorders: allergic dermatitis, application site inflammation, application site discoloration.

Eye disorders: eye irritation, diplopia, ocular hyperemia, photophobia, and blurred vision.

General disorders and administration site conditions: fatigue.

Immune System disorders: hypersensitivity.

Nervous system disorders: dysaesthesia, transient amnestic episodes.

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions underlined)

Inform patients of the following:

Hypersensitivity

Hypersensitivity has been reported with use of AMELUZ. Inform patients and their caregivers that AMELUZ may cause hypersensitivity potentially including severe courses (anaphylaxis) [see Warnings and Precautions (5.1)].

09/06/2017 (SUPPL-2)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Transient Amnestic Episodes

(Newly added subsection)

Transient amnestic episodes have been reported during postmarketing use of AMELUZ in combination with photodynamic therapy. Inform patients and their caregivers that AMELUZ in combination with photodynamic therapy may cause transient amnestic episodes. Advise them to contact the healthcare provider if the patient develops amnesia after treatment.

6 Adverse Reactions

(Additions and/or revisions are underlined)

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

Transient Amnestic Episodes
Risk of BF-RhodoLED Lamp Induced Eye Injury
Increased Photosensitivity
Risk of Bleeding in Patients with Coagulation Disorders
Ophthalmic Adverse Reactions
Risk of Mucous Membrane Irritation

6.1 Clinical Trial Experience

(Additions and/or revisions are underlined)

Common (greater than or equal to 1%, <10%) adverse reactions not at the application site for AMELUZ were headache, skin exfoliation, chills and eyelid edema.

Less common (greater than or equal to 0.1%, <1%) adverse reactions at the application site for AMELUZ were hemorrhage and swelling. The adverse reactions not at the application site were blister, feeling hot, pruritus, pyrexia, scab, nervousness, pain, petechiae, rash pustular, skin erosion and ulcer.

6.2 Postmarketing Experience

(Additions and/or revisions are underlined)

Skin and subcutaneous tissue disorders: application site inflammation, application site discoloration.

Eye disorders: eye irritation, diplopia, ocular hyperemia, photophobia, and blurred vision.

General disorders and administration site conditions: fatigue.

Nervous system disorders: dysaesthesia, transient amnestic episodes.

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

17. PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Transient amnestic episodes

Transient amnestic episodes have been reported with use of AMELUZ in combination with photodynamic therapy. Advise patients and their families or caregivers to contact their healthcare provider if memory impairment, confusion, or disorientation is observed.