Approved Drug Label (PDF)
5
Warnings and Precautions
5.6 Steatorrhea
and Malabsorption of Dietary Fats
Additions and/or
revisions underlined:
New
onset steatorrhea, stool discoloration and loose stools have been reported in
patients receiving somatostatin analogs, including SOMATULINE DEPOT.
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 SOMATULINE DEPOT, evaluate patients
for potential pancreatic exocrine insufficiency and manage accordingly.
6
Adverse Reactions
Addition of the
following to the bulleted line listing:
6.3 Postmarketing
Experience
Additions and/or
revisions underlined:
The
following adverse reactions have been identified during post-approval use of
SOMATULINE DEPOT. 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.
Gastrointestinal disorders: pancreatic exocrine insufficiency
Hepatobiliary: steatorrhea; cholecystitis, cholangitis, pancreatitis, which have sometimes required cholecystectomy
Hypersensitivity: angioedema and anaphylaxis
Injection site reactions: injection
site abscess
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
SOMATULINE DEPOT?
SOMATULINE DEPOT may cause serious
side effects, including:
…
Fatty stool.
SOMATULINE DEPOT 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.
…
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)].
…
Approved Drug Label (PDF)
6
Adverse Reactions
6.1 Clinical Trials Experience
Newly
added information:
Carcinoid Syndrome
The safety of SOMATULINE DEPOT 120 mg in
patients with histopathologically confirmed neuroendocrine tumors and a history
of carcinoid syndrome (flushing and/or diarrhea) was evaluated in Study 4, a
double-blind, placebo-controlled trial.
Patients were randomized to receive SOMATULINE DEPOT (N=59) or placebo
(N=56) administered by deep subcutaneous injection once every 4 weeks. Patients in both arms of Study 4 had access
to subcutaneous octreotide as rescue medication for symptom control.
Adverse reactions reported in Study 4
were generally similar to those reported in Study 3 for the GEP-NETs population
shown in Table 3 above. Adverse
reactions occurring in Study 4 in 5% and
greater of SOMATULINE DEPOT-treated patients and occurring at least 5% more
than in placebo-treated patients were headache (12% vs 5%, respectively),
dizziness (7% vs 0%, respectively), and muscle spasm (5% vs 0%, respectively)
by week 16.
6.2 Immunogenicity
Additions
and/or revisions underlined:
As with all peptides, there is potential
for immunogenicity. The detection of antibody formation … timing
of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the
incidence of antibodies to lanreotide in the studies described below with the
incidence of antibodies in other studies or to other products may be
misleading.
Assessment for neutralizing antibodies
was not conducted. In Study 4, less
than 2% (2 of 108) of the patients treated with SOMATULINE DEPOT developed anti-lanreotide antibodies.
6.3 Postmarketing Experience
Additions
and/or revisions underlined:
The
following adverse reactions have been identified during post-approval
use of SOMATULINE DEPOT. Because these reactions are reported
voluntarily from a population …
Hepatobiliary:
Steatorrhea,
cholecystitis, pancreatitis
Body
as a Whole: angioedema and
anaphylaxis
7
Drug Interactions
Additions
and/or revisions underlined:
7.2
Cyclosporine
Concomitant administration of
cyclosporine with SOMATULINE DEPOT may decrease the absorption of cyclosporine, and
therefore, may necessitate adjustment of cyclosporine dose to maintain
therapeutic drug concentrations.
7.3
Bromocriptine
Limited published data indicate that
concomitant administration of a somatostatin analog and bromocriptine may
increase the absorption of
bromocriptine.
7.4
Bradycardia-Inducing Drugs
Concomitant administration of
bradycardia-inducing drugs (e.g., beta-blockers) …
7.5
Drug Metabolism Interactions
Since it cannot be excluded that SOMATULINE DEPOT may have this effect, avoid
other drugs mainly metabolized by CYP3A4 and which have a low therapeutic index
(e.g., quinidine, terfenadine.
8
Use in Specific Populations
Additions
and/or revisions underlined:
8.5
Geriatric Use
… in responses between the elderly and
younger patients, but greater sensitivity of some older individuals cannot be
ruled out. Studies 3 and 4, conducted in patients with neuroendocrine tumors, did not include
sufficient numbers of patients
8.6
Renal Impairment
Acromegaly
Lanreotide has been studied in patients
with end-stage …
Neuroendocrine Tumors (NET) – Gastroenteropancreatic
Neuroendocrine Tumors
No effect was observed in total
clearance …
8.7
Hepatic Impairment
Acromegaly
It is recommended that patients with
moderate or severe …
Neuroendocrine Tumors (NET) – Gastroenteropancreatic
Neuroendocrine Tumors
SOMATULINE DEPOT has not been studied in
patients …
8.1 Pregnancy
PLLR
conversion; as below:
Risk Summary
Limited available data based on
postmarketing case reports with SOMATULINE DEPOT use in pregnant women are not
sufficient to determine a drug-associated risk of adverse developmental
outcomes. In animal reproduction studies, decreased embryo/fetal survival was
observed in pregnant rats and rabbits at
subcutaneous doses 5- and 2-times the maximum recommended human dose (MRHD) of
120 mg, respectively.
The estimated background risk of major birth
defects and miscarriage for the indicated populations is 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.
Data
Animal
Data
A reproductive study in pregnant rats
given 30 mg/kg of lanreotide by subcutaneous injection every 2 weeks (5 times
the human dose, based on body surface area comparisons) resulted in decreased
embryo/fetal survival. A study in pregnant rabbits given subcutaneous
injections of 0.45 mg/kg/day (2 times the human
therapeutic exposures at the maximum recommended dose of 120 mg, based on comparisons of
relative body surface area) shows decreased fetal survival and increased fetal
skeletal/soft tissue abnormalities.
8.2 Lactation
PLLR
conversion, as below:
Risk Summary
There is no information available on the
presence of lanreotide in human milk, the effects of the drug on the breastfed
infant, or the effects of the drug on milk production. Studies show that
lanreotide acetate administered subcutaneously passes into the milk of
lactating rats; however, due to specifies-specific differences in lactation
physiology, animal data may not reliably predict drug levels in human milk. Because
of the potential for serious adverse reactions in breastfed infants from
SOMATULINE DEPOT, including effects on glucose metabolism and bradycardia,
advise women not to breastfeed during treatment with SOMATULINE DEPOT and for 6
months (6 half-lives) following the last dose.
8.3 Females and Males of Reproductive Potential
PLLR
conversion, as below:
Infertility
Females
Based on results from animal studies
conducted in female rats, SOMATULINE DEPOT may reduce fertility in females of
reproductive potential.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions
and/or revisions underlined:
What should I avoid while
receiving SOMATULINE DEPOT?
SOMATULINE DEPOT can cause dizziness. If
you have dizziness, do not drive a car or operate machinery.
What are the possible side effects of
SOMATULINE DEPOT? SOMATULINE DEPOT may cause serious side effects, including:
Gallstones. Gallstones can
happen in people who receive SOMATULINE DEPOT and are a common side effect in
people with acromegaly and GEP-NET. Tell your healthcare provider if
you get any symptoms of gallstones, including: …
… Your
healthcare provider may change your dose of diabetes medicine especially
when you first start receiving SOMATULINE DEPOT or if your dose of SOMATULINE
DEPOT changes. High blood sugar is a common side effect in people with
GEP-NET. Tell your healthcare provider right away if you have any signs or
symptoms of high blood sugar or low blood sugar.
Newly
added information:
Signs
and symptoms of high blood sugar may include:
Signs
and symptoms of low blood sugar may include:
dizziness or
lightheadedness
fainting or
near-fainting
chest pain
shortness of
breath
confusion or
memory problems
weakness,
extreme tiredness
High blood pressure. High blood
pressure can happen in people who receive SOMATULINE DEPOT and is a common side
effect in people with GEP-NET.
Changes in thyroid function. SOMATULINE
DEPOT can cause the thyroid gland to not make enough thyroid hormones that the
body needs (hypothyroidism) in people who have acromegaly. Tell your healthcare
provider if you have signs and symptoms of low thyroid hormones levels,
including:
Additions
and/or revisions underlined:
The
most common side effects of SOMATULINE
DEPOT
in people with carcinoid syndrome
include:
Tell your healthcare provider right
away if you have signs of an allergic reaction after receiving SOMATULINE
DEPOT, including: …
PATIENT COUNSELING INFORMATION
Additions
and/or revisions underlined:
Hypersensitivity
Reactions
Advise patients to immediately contact their healthcare provider if they experience
serious hypersensitivity reactions, such as angioedema or anaphylaxis.
Cholelithiasis and Gallbladder Sludge
Advise patients to contact their
healthcare provider if they experience signs or symptoms of gallstones.
Hyperglycemia and Hypoglycemia
Advise patients to immediately contact
their healthcare provider if they experience signs or symptoms of hyper- or
hypoglycemia.
Cardiovascular Abnormalities
Advise patients to immediately contact
their healthcare provider if they experience bradycardia.
Thyroid Function Abnormalities
Advise patients to contact their
healthcare provider if they experience signs or symptoms of hypothyroidism.
Laboratory Tests
Advise patients with acromegaly that
response to SOMATULINE DEPOT …
Lactation
Advise women not to breastfeed during
treatment with SOMATULINE DEPOT and for 6 months after the last dose.
Infertility
Advise females of reproductive potential
of the potential for reduced fertility from SOMATULINE DEPOT.
Get Email Alerts |
Guide
