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.

SUCRAID (BLA-020772)

(SACROSIDASE)

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

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08/02/2024 (SUPPL-31)

Approved Drug Label (PDF)

5 Warnings and Precautions

Additions and/or revisions underlined:

WARNINGS

Severe Hypersensitivity Reactions

Severe hypersensitivity reactions, including wheezing, rash, and pruritis, have been reported with administration of Sucraid. Sucraid contains papain, which is associated with hypersensitivity reactions (see DESCRIPTION).

A pediatric patient in the clinical trials experienced a hypersensitivity reaction of severe wheezing that required hospitalization. Postmarketing cases of cutaneous hypersensitivity reactions have also been reported.

Instruct patients or caregivers to stop Sucraid and seek medical attention if symptoms suggestive of a hypersensitivity reaction occur. Sucraid is contraindicated in patients who have had a known hypersensitivity reaction (see CONTRAINDICATIONS).

PRECAUTIONS

Increased Blood Glucose Concentrations in Patients with Diabetes Mellitus

Sucraid enables the products of sucrose hydrolysis, glucose and fructose, to be absorbed and may increase blood glucose concentrations. Monitor blood glucose concentrations and adjust the diet accordingly for patients with diabetes mellitus.

Dietary Starch Restriction

Sucraid does not replace isomaltase. Therefore, patients may still experience symptoms of CSID while taking Sucraid. Consider dietary starch restriction in addition to Sucraid, especially in patients in whom symptoms are not adequately controlled by Sucraid.

6 Adverse Reactions

Additions and/or revisions underlined:

The following adverse reactions associated with the use of sacrosidase were identified in clinical studies or postmarketing reports. Because some of these reactions were 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.

In clinical studies of up to 54 months duration, a total of 52 patients were treated with Sucraid. The reported adverse reactions (number of patients) were as follows: abdominal pain (4), vomiting (3), nausea (2), diarrhea (2), constipation (2), insomnia (1), headache (1), nervousness (1), and dehydration (1).

Hypersensitivity reactions (wheezing, rash, and pruritis) have been reported (see WARNINGS).

7 Drug Interactions

Additions and/or revisions underlined:

Fruit Juice

The acidity in fruit juice may reduce the enzyme activity in Sucraid. Administration of Sucraid with liquids other than water, milk, or infant formula has not been studied and is not recommended (see DOSAGE AND ADMINISTRATION, Administration Instructions).

8 Use in Specific Populations

Pediatric Use

Additions and/or revisions underlined:

The safety and effectiveness of Sucraid for the treatment of sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID), have been established in pediatric patients aged 5 months and older. Use of Sucraid for this indication is supported by evidence from adequate and well-controlled studies in pediatric patients (see CLINICAL STUDIES and ADVERSE REACTIONS).

Geriatric Use

Additions and/or revisions underlined:

Clinical trials of Sucraid did not include patients 65 years of age and older to determine if they respond differently from younger adult patients.

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

PATIENT INFORMATION

Additions and/or revisions underlined:

…

What are the possible side effects of SUCRAID?

SUCRAID may cause serious side effects, including:

severe allergic reactions. Severe allergic reactions have happened in some people taking SUCRAID. Tell your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms:

difficulty breathing
wheezing
rash
swelling of the face, lips, mouth, or tongue
…