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.

CHIRHOSTIM (NDA-021256)

(SECRETIN SYNTHETIC HUMAN)

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

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07/18/2017 (SUPPL-13)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Hyporesponse to Secretin Stimulation Testing (Subsection Title revised)

Additions and/or revisions underlined:

Patients who have undergone vagotomy, have inflammatory bowel disease or are receiving anticholinergic drugs at the time of ChiRhoStim® stimulation testing, may be hyporesponsive to ChiRhoStim® stimulation falsely suggesting pancreatic disease.

Discontinue anticholinergic drugs at least 5 half-lives prior to stimulation testing. Consider additional testing and clinical assessments for aid in diagnosis.

Newly added subsection:

5.2 Hyperresponse to Secretin Stimulation Testing

Gastrin Secretion

Patients receiving H2-receptor antagonists or PPIs at the time of stimulation testing with ChiRhoStim® to aid in the diagnosis of gastrinoma may be hyperresponsive to secretin stimulation, falsely suggesting gastrinoma. Discontinue H2-receptor antagonists at least 2 days prior to stimulation testing. Consult the prescribing information of each specific PPI before administering ChiRhoStim®

Additions and/or revisions underlined below:

Pancreatic Secretions

Patients with alcoholic or other liver disease may be hyperresponsive to stimulation with ChiRhoStim®, masking the presence of coexisting pancreatic disease. Consider additional testing and clinical assessments for aid in diagnosis.

6 Adverse Reactions

Newly added information below:

6.1 Clinical Trials Experience

Because clinical trials are conducted under varying conditions, adverse reaction rates observed during the clinical trials of a drug cannot always be directly compared to the rates observed during the clinical trials of another drug and may not reflect the adverse reaction rates observed in practice.

The data described below reflect exposure to ChiRhoStim® in 531 patients from an open-label clinical trial. The population consisted of patients aged 1 to 91 years, 185 males, 346 females, 480 Caucasians, 31 Blacks, 12 American Indians, 6 Hispanics, and 2 Asians with known or suspected diseases of the exocrine pancreas including chronic pancreatitis and pancreatic cancer. Most patients received a single dose of ChiRhoStim® in a dose range of 0.2 mcg/kg to 0.4 mcg/kg. The most common adverse reactions (reported in at least 2 patients in the trial) are listed in Table 2.

TABLE 2 (Replaces Table 1 from previous label)

Adverse Reactions in at Least 2 Patients Treated with a Single-Dose of ChiRhoStim® in a Clinical Trial Data in Table 2 is new; please refer to label for complete information.

7 Drug Interactions

Newly added subsections below:

7.1 Hyporesponse with Anticholinergics

The concomitant use of anticholinergic drugs may cause a hyporesponse to stimulation testing with ChiRhoStim®. Discontinue anticholinergic drugs at least 5 half-lives before administering ChiRhoStim®.

7.2 Hyperresponse of Gastrin Secretion with H2-Receptor Antagonists and PPIs

The concomitant use of H2-receptor antagonists or PPIs may cause a hyperresponse in gastrin secretion in response to stimulation testing with ChiRhoStim®, falsely suggesting gastrinoma.

Discontinue H2-receptor antagonists at least 2 days before administering ChiRhoStim® to aid in the diagnosis of gastrinoma.

The time it takes for serum gastrin concentrations to return to baseline following discontinuation of PPIs is specific to the individual drug. Consult the prescribing information of each specific PPI before administering ChiRhoStim® to aid in the diagnosis of gastrinoma.

8 Use in Specific Populations

8.1 Pregnancy

PLLR conversion, revised as below:

Risk Summary

There are no available data (either clinical studies or postmarketing reports) of use of synthetic human secretin in pregnant women. Animal reproduction studies have not been conducted with synthetic human secretin.

The estimated background risk of major birth defects and miscarriage for the indicated populations 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, revised as below:

Risk Summary

There are no data on the presence of synthetic human secretin in human or animal milk, the effects of synthetic human secretin on the breastfed infant, or the effects of synthetic human secretin on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ChiRhoStim® and any potential adverse effects on the breastfed infant from ChiRhoStim® or from the underlying maternal condition.

8.5 Geriatric Use

Additions and/or revisions underlined:

Among the 531 patients who have received ChiRhoStim® in a clinical trial, 11% were 65 years of age or older and 5% were 75 years of age or older. No overall differences in safety, pharmacologic response, or diagnostic effectiveness were observed between these subjects and younger subjects, and other reported clinical …

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

PATIENT COUNSELING INFORMATION

Newly added information:

Advise the patient to tell their healthcare provider all the medications they are taking, including anticholinergic drugs, H2-receptor antagonists or PPIs.