Drug Safety-related Labeling Changes (SrLC)

Get Email Alerts | Guide

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.

SIGNIFOR LAR KIT (NDA-203255)

(PASIREOTIDE PAMOATE)

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

Download Data

Expand all

07/11/2024 (SUPPL-11)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.6 Steatorrhea and Malabsorption of Dietary Fats

New subsection added:

New onset steatorrhea, stool discoloration and loose stools have been reported in patients receiving somatostatin analogs, including pasireotide products. Somatostatin analogs reversibly inhibit secretion of pancreatic enzymes and bile acids, which may result in malabsorption of dietary fats and subsequent symptoms of steatorrhea, loose stools, abdominal bloating, and weight loss. If new occurrence or worsening of these symptoms are reported in patients receiving SIGNIFOR LAR, evaluate patients for potential pancreatic exocrine insufficiency and manage accordingly.

6 Adverse Reactions

Addition of the following to the bulleted line listing:

Steatorrhea and Malabsorption of Dietary Fats [see Warnings and Precautions (5.6)]

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Steatorrhea and Malabsorption of Dietary Fats

Advise patients to contact their healthcare provider if they experience new or worsening symptoms of steatorrhea, stool discoloration, loose stools, abdominal bloating, and weight loss [see Warnings and Precautions (5.6)].
…
MEDICATION GUIDE
Additions and/or revisions underlined:
…
What are the possible side effects of SIGNIFOR LAR?
SIGNIFOR LAR may cause serious side effects, including:
…

fatty stool. SIGNIFOR LAR may cause your body to have issues absorbing dietary fats. Tell your healthcare provider if you have any new or worsening symptoms including fatty stools, changes in the color of your stools, loose stools, stomach (abdominal) bloating or weight loss.
…

07/09/2020 (SUPPL-8)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Hyperglycemia, Diabetes, and Ketoacidosis

(additions and revisions underlined)

SIGNIFOR LAR can cause increases in blood glucose levels which are sometimes severe. There have been postmarketing cases of ketoacidosis with SIGNIFOR LAR in patients with history of diabetes and in patients without history of diabetes.

In the acromegalic patient study, 5 patients naïve to drug therapy treated with SIGNIFOR LAR (2 of whom were normoglycemic at baseline) and none in the active comparator group were hospitalized for hyperglycemia (blood glucose range 359-506 mg/dL). Two additional patients who had received active comparator in the main trial and were switched to SIGNIFOR LAR in the extension trial, were hospitalized for elevated glucose levels while on SIGNIFOR LAR; one of those patients developed diabetic ketoacidosis. In the Cushing’s disease study, 2 patients were hospitalized for elevated blood glucose.

…

Patients with poor baseline glycemic control are at higher risk of developing severe hyperglycemia. Assess FPG and HbA1c prior to starting treatment with SIGNIFOR LAR [see Dosage and Administration (2.1)]. In patients with poorly controlled diabetes mellitus, optimize anti-diabetic treatment before SIGNIFOR LAR initiation.

…

the dose of SIGNIFOR LAR or discontinue SIGNIFOR LAR. Assess FPG and HbA1c after SIGNIFOR LAR discontinuation, if indicated. Patients receiving anti-diabetic treatment may require more frequent blood glucose monitoring and dose adjustment to their anti-diabetic drug therapy to mitigate the risk of hypoglycemia after discontinuing SIGNIFOR LAR.

Patients who present with signs and symptoms consistent with severe metabolic acidosis should be assessed for ketoacidosis regardless of diabetes history. In some reported post-marketing cases of ketoacidosis in patients taking SIGNIFOR LAR, factors predisposing to ketoacidosis such as acute illness, infection, pancreatic disorders (e.g. pancreatic malignancy or pancreatic surgery), and alcohol abuse were present. If ketoacidosis is suspected, discontinue SIGNIFOR LAR and promptly evaluate and treat the patient.

6 Adverse Reactions

(Addition underlined)

Clinically significant adverse reactions that appear in other sections of the labeling include:

Hyperglycemia, Diabetes, and Ketoacidosis[see Warnings and Precautions (5.1)]

…

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

PATIENT COUNSELING INFORMATION

(Additions underlined)

…

Hyperglycemia, Diabetes, and Ketoacidosis

Advise patients to assess FPG and HbA1c prior to starting treatment with SIGNIFOR LAR and advise patients to consistently monitor blood glucose levels, particularly after the start of treatment or after dose changes, so that appropriate action can be taken. Advise patients to contact their healthcare provider if they experience signs or symptoms of diabetes or ketoacidosis [see Warnings and Precautions (5.1)].

…

PATIENT INFORMATION

(Additions underlined)

…

What are the possible side effects of SIGNIFOR LAR?

SIGNIFOR LAR may cause serious side effects, including:

high blood sugar (hyperglycemia), diabetes, and increased ketones in your urine or blood (ketoacidosis). High blood sugar and diabetes are serious but common side effects of SIGNIFOR LAR. Ketoacidosis is a serious condition that should be evaluated and treated promptly.Your healthcare provider should check your blood sugar level before you start receiving SIGNIFOR LAR and while you receive it. Tell your healthcare provider right away if you have any of these symptoms:

feel very thirsty

urinate more than usual
nausea
vomiting
abdominal pain

increased appetite with weight loss

tiredness
fruity scented breath
trouble breathing
confusion
…

04/11/2019 (SUPPL-7)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.4 Cholilithiasis and Complications of Cholelithiasis

Newly added information to the end of the subsection:

There have been postmarketing reports of cholelithiasis (gallstones) resulting in complications, including cholecystitis or cholangitis and requiring cholecystectomy in patients taking SIGNIFOR LAR. Patients should be monitored periodically. If complications of cholelithiasis are suspected, discontinue SIGNIFOR LAR and treat appropriately.

6 Adverse Reactions

Addition of the following to the bulleted line listing:

Cholelithiasis and Complications of Cholelithiasis

Addition of the following subsection:

6.2 Postmarketing Experience

Additional adverse reactions have been identified during postapproval use of SIGNIFOR LAR. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cholelithiasis resulting in complications, including cholecystitis and cholangitis, which have sometimes required cholecystectomy.

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

MEDICATION GUIDE

Additions and/or revisions underlined:

What are the possible side effects of SIGNIFOR LAR? SIGNIFOR LAR may cause serious side effects, including:

gallstones (cholelithiasis) and complications that can happen if you have gallstones. Gallstones are a serious but common side effect of SIGNIFOR LAR. Possible complications of gallstones include inflammation and infection of the gall bladder. Your healthcare provider should do a test (ultrasound) to check your gall bladder before and during your …

PATIENT COUNSELING INFORMATION

Additions and/or revisions

Cholelithiasis and Complications of Cholelithiasis

Inform patients that cholelithiasis and complications of cholelithiasis have been reported with the use of SIGNIFOR LAR.
Advise patients to contact their healthcare provider if they experience signs or symptoms of gallstones (cholelithiasis) or complications of cholelithiasis (e.g., cholecystitis or cholangitis).