Approved Drug Label (PDF)
5
Warnings and Precautions
5.5 Steatorrhea and Malabsorption of Dietary Fats
Newly added subsection:
New onset steatorrhea, stool discoloration and loose stools
have been reported
in patients receiving somatostatin analogs, including Sandostatin. 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 Sandostatin, evaluate patients for potential pancreatic exocrine insufficiency and manage accordingly.
5.6 Changes in Vitamin B12 Levels
Subsection title revised
Depressed vitamin B12 levels and abnormal Schilling’s tests have been observed in some patients
receiving Sandostatin Injection therapy, and monitoring of vitamin B12 levels is recommended during Sandostatin Injection
therapy.
6
Adverse Reactions
Newly added information:
The following
clinically significant adverse
reactions are described elsewhere in the labeling:
Complete Atrioventricular Block [see Warnings and Precautions (5.1)]
Cholelithiasis and Complications of Cholelithiasis [see Warnings
and Precautions (5.2)]
Hyperglycemia and Hypoglycemia [see Warnings
and Precautions (5.3)]
Thyroid Function
Abnormalities [see Warnings and Precautions (5.4)]
Steatorrhea and Malabsorption of Dietary Fats [see Warnings and Precautions (5.5)]
Changes in Vitamin B12 Levels [see Warnings
and Precautions (5.6)]
6.2 Postmarketing Experience
Additions and revisions underlined:
The following adverse
reactions have been identified during
postapproval use of Sandostatin Injection. 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.
Hepatobiliary:
cholelithiasis, cholecystitis, cholangitis and pancreatitis, which have sometimes
required cholecystectomy
Gastrointestinal: intestinal obstruction, pancreatic exocrine
insufficiency
Hematologic: thrombocytopenia
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and revisions underlined:
Sterile Subcutaneous Injection Technique
Careful instruction in sterile subcutaneous injection technique should be given to the patients and to other persons who may administer
Sandostatin Injection.
Cholelithiasis and Complications of Cholelithiasis
Advise patients to contact
their healthcare provider
if they experience signs or symptoms of gallstones
(cholelithiasis) or complications of cholelithiasis (e.g.,
cholecystitis, cholangitis, and pancreatitis) [see
Warnings and Precautions (5.2)].
Steatorrhea and Malabsorption of Dietary Fats
Advise patients to contact their
healthcare provider if they experience new or worsening of steatorrhea, stool discoloration, loose stools,
abdominal bloating, and weight loss [see
Warnings and Precautions (5.5)].
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.
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.
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
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