Approved Drug Label (PDF)
4
Contraindications
(addition underlined)
…
• With a known hypersensitivity
reaction to VIBERZI
…
5
Warnings and Precautions
5.3 Hypersensitivity Reactions
(new subsection added)
In
postmarketing experience, serious hypersensitivity reactions (including
anaphylaxis) have been reported following VIBERZI administration. Some of these
reactions occurred after the first one or two doses of VIBERZI.
Instruct
patients to immediately stop VIBERZI and seek medical attention if they
experience symptoms suggestive of a hypersensitivity reaction.
6
Adverse Reactions
(addition underlined)
6.2 Postmarketing Experience
(new subsection added)
The following
adverse reactions have been identified during post-approval use of VIBERZI.
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. Hypersensitivity:
anaphylaxis, angioedema (e.g. swollen face and throat), dyspnea, throat
tightness, and chest pain/tightness.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
(additions underlined)
What is the most important information
I should know about VIBERZI? VIBERZI can cause serious side effects, including:
…
• Serious allergic reactions. Serious
allergic reactions have happened in some people after taking 1 or 2 doses of
VIBERZI. Stop taking VIBERZI right away and get emergency medical care if you
have signs or symptoms of an allergic reaction, including:
o swelling
of your face, lips, mouth or tongue
o rash
o shortness
of breath or other breathing problems
o hives
o itching
…
Do not take
VIBERZI if you:
…
• have had an allergic reaction to
VIBERZI.
…
PATIENT COUNSELING INFORMATION
(addition underlined)
…
• stop VIBERZI immediately and seek
medical attention if symptoms of a hypersensitivity reaction develop
…
Approved Drug Label (PDF)
4
Contraindications
(Additions and/or revisions are underlined)
VIBERZI is contraindicated in patients:
5
Warnings and Precautions
5.1 Pancreatitis
(Additions and/or revisions are underlined)
Pancreatitis, with or without sphincter of Oddi spasm,
has been reported in patients taking either the 75 mg or 100 mg dosage of
VIBERZI, including serious cases resulting in hospitalization, primarily in
patients without a gallbladder. Fatal
cases have also been reported in patients without a gallbladder. VIBERZI is
contraindicated in patients without a gallbladder. Most of the reported cases of serious
pancreatitis occurred within a week of starting treatment with VIBERZI and some
developed symptoms after one to two doses.
In patients with a gallbladder, evaluate a patient’s
alcohol intake prior to starting VIBERZI. Instruct patients to avoid
chronic or acute excessive alcohol use while taking VIBERZI. Monitor for new or
worsening abdominal pain that may radiate to the back or shoulder, with or
without nausea and vomiting. Instruct
patients to immediately stop VIBERZI and seek medical attention if they
experience symptoms suggestive of pancreatitis such as acute abdominal or
epigastric pain radiating to the back or shoulder associated with
elevations of pancreatic enzymes with or without nausea and vomiting.
5.2 Sphincter of Oddi Spasm
(Additions and/or revisions are underlined)
There is a risk of sphincter of Oddi spasm, resulting
in pancreatitis or hepatic enzyme elevation associated with acute abdominal pain
(e.g., biliary-type pain) in patients taking VIBERZI. Postmarketing serious adverse reactions of
sphincter of Oddi spasm with or without pancreatitis resulting in
hospitalization have been reported, primarily in patients without a
gallbladder. Most of the reported cases of
serious sphincter of Oddi spasm occurred within a week of starting
treatment with VIBERZI and
some developed symptoms after one to
two doses. VIBERZI is contraindicated in patients without
a gallbladder.
Instruct patients to immediately stop VIBERZI and seek
medical attention if they experience symptoms suggestive of sphincter of Oddi spasm
such as acute worsening of abdominal pain,…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions and/or
revisions are underlined)
Instruct patients to:
stop VIBERZI immediately and seek medical attention
if unusual or severe abdominal pain that may radiate to the back or shoulder
with or without nausea and vomiting, develops
discontinue
VIBERZI and call
their health care
provider if they
experience severe constipation
MEDICATION GUIDE
(Additions and/or revisions are underlined)
What is the most important information I should know
about VIBERZI?
VIBERZI can cause serious side effects, including:
Inflammation of the pancreas (pancreatitis). Pancreatitis
has happened most often in people who do not have a gallbladder and can lead to
hospitalization. Pancreatitis has led to death in some people who do not have a
gallbladder. Pancreatitis usually happens within the first week of treatment
with VIBERZI but can happen after 1 to 2 doses of VIBERZI…
Sphincter
of Oddi spasm. The sphincter of Oddi is a muscular valve that controls the
flow of digestive juices (bile and pancreatic juice) to the first part of your
small intestine. A sphincter of Oddi spasm can cause an increase in your liver
and pancreas enzymes and inflammation of the pancreas (pancreatitis) that can
cause sudden stomach-area (abdomen) pain. Sphincter of Oddi spasm has
happened most often in people who do not have a gallbladder and can lead
to hospitalization. This spasm usually happens within the first week of
treatment with VIBERZI but can happen after 1 or 2 doses of VIBERZI.
Stop taking VIBERZI right away and get emergency medical
care if you have new or worsening stomach-area (abdomen) pain or pain in
the upper right side of your stomach-area (abdomen) that may move to your
back or shoulder, with or without nausea and vomiting.
Do not take VIBERZI if you:
What are the possible side effects of VIBERZI?
The most common side effects of VIBERZI include: constipation,
nausea, and abdominal pain. Stop taking VIBERZI and call your doctor if you
have constipation that is severe.
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