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.

SANDOSTATIN (NDA-019667)

(OCTREOTIDE ACETATE)

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

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11/03/2023 (SUPPL-76)

Approved Drug Label (PDF)

5 Warnings and Precautions

PLR Conversion; please refer to label for complete information

8 Use in Specific Populations

PLLR conversion; please refer to label for complete information

Other

PLR Conversion; please refer to label for complete information

PLLR conversion; please refer to label for complete information

10/04/2022 (SUPPL-73)

Approved Drug Label (PDF)

7 Drug Interactions

Additions and/or revisions underlined:

Octreotide has been associated with alterations in nutrient absorption, so it may have an effect on absorption of orally administered drugs. Concomitant administration of Sandostatin Injection with cyclosporine may decrease blood levels of cyclosporine and result in transplant rejection.

Patients receiving insulin, oral hypoglycemic agents, beta blockers, calcium channel blockers, or agents to control fluid and electrolyte balance, may require dose adjustments of these therapeutic agents.

Concomitant administration of octreotide and bromocriptine increases the availability of bromocriptine. Limited published data indicate that somatostatin analogs might decrease the metabolic clearance of compounds known to be metabolized by cytochrome P450 enzymes, which may be due to the suppression of growth hormone (GH). Since it cannot be excluded that octreotide may have this effect, other drugs mainly metabolized by CYP3A4 and which have a low therapeutic index (e.g., quinidine, terfenadine) should therefore be used with caution.

Octreotide competitively binds to somatostatin receptors and may interfere with the efficacy of lutetium Lu 177 dotatate. Discontinue Sandostatin Injection at least 24 hours prior to each lutetium Lu 177 dotatate dose.

05/25/2021 (SUPPL-70)

Approved Drug Label (PDF)

5 Warnings and Precautions

PRECAUTIONS

(Additions and/or revisions underlined)

General

Risk of Pregnancy with Normalization of Insulin Growth Factor-1 (IGF-1; somatomedin C) and Growth Hormone (GH)

Although acromegaly may lead to infertility, there are reports of pregnancy in acromegalic women. In women with active acromegaly who have been unable to become pregnant, normalization of GH and IGF-1 (somatomedin C) may restore fertility. Female patients of child- bearing potential should be advised to use adequate contraception during treatment with octreotide.

Hyperglycemia and Hypoglycemia

In patients with concomitant Type I diabetes mellitus, Sandostatin Injection may affect glucose regulation, and insulin requirements may be reduced. Symptomatic hypoglycemia, which may be severe, has been reported in these patients. In nondiabetics and Type II diabetics with partially intact insulin reserves, Sandostatin Injection administration may result in decreases in plasma insulin levels and hyperglycemia. It is therefore recommended that glucose tolerance and anti- diabetic treatment be periodically monitored during therapy with these drugs.

Cardiac Function Abnormalties [see WARNINGS; Complete Atrioventricular Block]

Other electrocardiogram (ECG) changes observed included QT prolongation, axis shifts, early repolarization, low voltage, R/S transition, and early R-wave progression. These ECG changes are not uncommon in acromegalic patients.

Dose adjustments in drugs such as beta-blockers that have bradycardia effects may be necessary.

In one acromegalic patient with severe congestive heart failure, initiation of Sandostatin therapy resulted in worsening of congestive heart failure with improvement when drug was discontinued.

Increased half-life of Sandostatin in patients with renal failure on dialysis

In patients with severe renal failure requiring dialysis, the half-life of Sandostatin may be increased, necessitating adjustment of the maintenance dosage.

WARNINGS

(Additions and/or revisions underlined)

Cholelithiasis and Complications of Cholelithiasis

Single doses of Sandostatin® (octreotide acetate) Injection have been shown to inhibit gallbladder contractility and decrease bile secretion in normal volunteers. In clinical trials (primarily patients with acromegaly or psoriasis), the incidence of biliary tract abnormalities was 63% (27% gallstones, 24% sludge without stones, 12% biliary duct dilatation). The incidence of stones or sludge in patients who received Sandostatin for 12 months or longer was 52%. Less than 2% of patients treated with Sandostatin for 1 month or less developed gallstones. The incidence of gallstones did not appear related to age, sex, or dose. Like patients without gallbladder abnormalities, the majority of patients developing gallbladder abnormalities on ultrasound had gastrointestinal symptoms. The symptoms were not specific for gallbladder disease. A few patients developed acute cholecystitis, ascending cholangitis, biliary obstruction, cholestatic hepatitis, or pancreatitis during Sandostatin therapy or following its withdrawal. One patient developed ascending cholangitis during Sandostatin therapy and died. There have been postmarketing reports of cholelithiasis (gallstones) resulting in complications requiring cholecystectomy. If complications of cholelithiasis are suspected, discontinue Sandostatin and treat appropriately.

Complete Atrioventricular Block

Patients who receive Sandostatin Injection intravenously may be at increased risk for higher degree atrioventricular blocks. In postmarketing reports, complete atrioventricular block was reported in patients receiving intravenous Sandostatin during surgical procedures. In majority of patients, Sandostatin was given at higher than recommended doses and/or as a continuous intravenous infusion. The safety of continuous intravenous infusion has not been established in patients receiving Sandostatin for the approved indications. Consider cardiac monitoring in patients receiving Sandostatin intravenously.

8 Use in Specific Populations

Pediatric Use

(Additions and/or revisions underlined)

The efficacy and safety of Sandostatin Injection using the octreotide acetate for injectable suspension formulation was examined in a single randomized, double-blind, placebo-controlled, 6 month pharmacokinetics study in 60 pediatric patients age 6 to 17 years with hypothalamic obesity resulting from cranial insult. The mean octreotide concentration after 6 doses of 40 mg octreotide acetate for injectable suspension administered by intramuscular (IM) injection every 4 weeks was approximately 3 ng/mL. Steady-state concentrations was achieved after 3 injections of a 40-mg dose. Mean BMI increased 0.1 kg/m2 in octreotide acetate for injectable suspension- treated subjects compared to 0.0 kg/m2 in saline control-treated subjects. Efficacy was not demonstrated. Diarrhea occurred in 11 of 30 (37%) patients treated with octreotide acetate for injectable suspension. No unexpected adverse events were observed. However, with octreotide acetate for injectable suspension at 40 mg once a month, the incidence of new cholelithiasis in this pediatric population (33%) was higher than that seen in other adult indications such as acromegaly (22%) or malignant carcinoid syndrome (24%), where octreotide acetate for injectable suspension was 10 to 30 mg once a month.

04/11/2019 (SUPPL-67)

Approved Drug Label (PDF)

5 Warnings and Precautions

PRECAUTIONS

Information for Patients

Newly added information to end of section:

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

WARNINGS

Newly added information to end of section:

There have been postmarketing reports of cholelithiasis (gallstones) resulting in complications requiring cholecystectomy. If complications of cholelithiasis are suspected, discontinue Sandostatin and treat appropriately.

6 Adverse Reactions

Postmarketing Experience

Newly added:

Hepatobiliary: cholelithiasis, cholecystitis, cholangitis and pancreatitis, which have sometimes required cholecystectomy