Approved Drug Label (PDF)
5
Warnings and Precautions
5.2 Infections
Additions and/or
revisions underlined:
…
Progressive Multifocal Leukoencephalopathy (PML)
PML is an
opportunistic viral infection of the brain caused by the JC virus (JCV) that
typically only occurs in patients who are immunocompromised, and that usually
leads to death or severe disability. JCV infection
resulting in PML has been observed in patients treated
with anti-CD20 antibodies, including
BRIUMVI, and other MS therapies. At the first sign or symptom suggestive of
PML, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical
symptoms associated with PML are diverse, progress over days to weeks, and
include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and
orientation leading to confusion and personality changes.
…
6
Adverse Reactions
6.2 Postmarketing
Experience
Additions and/or
revisions underlined:
The
following adverse reactions have been identified during postapproval use of BRIUMVI.
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 Disorders: Liver injury
[see Warnings and Precautions (5.5)]
Infections and Infestations: Progressive multifocal leukoencephalopathy [see Warnings
and Precautions (5.2)]
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
Additions and/or
revisions underlined:
…
Advise patients
that PML has happened with BRIUMVI. Inform the patient that PML is characterized
by a progression of deficits and usually leads to death or severe disability
over weeks or months. Instruct the patient of the importance of contacting their doctor if they develop any symptoms suggestive of PML.
Inform the patient that typical symptoms associated with PML are diverse,
progress over days to weeks, and include progressive weakness on one side of
the body or clumsiness of limbs, disturbance of vision, and changes in
thinking, memory, and orientation leading to confusion and personality changes [see Warnings and Precautions (5.2)].
…
MEDICATION GUIDE
Additions and/or
revisions underlined:
…
Infections.
Infections
are a common side effect, and upper
respiratory tract infections are one of the most common side effects of BRIUMVI. BRIUMVI increases your risk of
getting infections caused by bacteria or viruses that may be life-threatening or cause death.
Tell your healthcare provider if you have an infection or have any of the following
signs of infection including fever, chills, a cough that does not go away, or
painful urination. Your healthcare provider should delay your treatment with
BRIUMVI until your infection is gone.
…
Progressive Multifocal Leukoencephalopathy (PML): PML has happened with
BRIUMVI. PML is a rare, serious brain infection caused by a
virus that may get worse over days or weeks. PML can result in death or severe disability.
Tell your healthcare provider right away if you have any new or worsening neurologic
signs or symptoms. These symptoms may include weakness on one side of your
body, loss of coordination in arms
and legs, vision problems, changes in thinking and memory which may lead to
confusion, and personality changes.
…
Approved Drug Label (PDF)
5
Warnings and Precautions
5.5 Liver Injury
Newly added
subsection:
Clinically significant liver injury, without
findings of viral hepatitis, has been reported in the postmarketing setting in
patients treated with anti-CD20 B-cell depleting therapies approved for the
treatment of MS, including BRIUMVI. Signs of liver injury, including markedly
elevated serum hepatic enzymes with elevated total bilirubin, have occurred
from weeks to months after administration.
Patients treated with BRIUMVI found to have an
alanine aminotransaminase (ALT) or aspartate aminotransferase (AST) greater
than 3x the upper limit of normal (ULN) with serum total bilirubin greater than
2x ULN are potentially at risk for severe drug-induced liver injury.
Obtain liver function tests prior to initiating
treatment with BRIUMVI [see Dosage and Administration (2.1)], and
monitor for signs and symptoms of any hepatic injury during treatment. Measure
serum aminotransferases, alkaline phosphatase, and bilirubin levels promptly in
patients who report symptoms that may indicate liver injury, including new or
worsening fatigue, anorexia, nausea, vomiting, right upper abdominal
discomfort, dark urine, or jaundice. If liver injury is present and an
alternative etiology is not identified, discontinue BRIUMVI.
6
Adverse Reactions
Addition of the
following to the bulleted line listing:
6.2 Postmarketing
Experience
Newly
added subsection:
The
following adverse reactions have been identified during postapproval use of
BRIUMVI. 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
Disorders: Liver injury [see Warnings and
Precautions (5.5)]
8
Use in Specific Populations
8.1 Pregnancy
Additions
and/or revisions underlined:
…
Risk
Summary
…
In
pregnant transgenic huCD20 mice, a pharmacologically relevant animal model,
weekly
intravenous administration of ublituximab-xiiy during organogenesis
resulted in no adverse pregnancy or embryofetal outcomes (see Data).
…
Data
Animal Data
…
The
findings in cynomolgus monkey were considered secondary to an immunogenic
reaction and are not considered relevant to humans.
In
a subsequent study conducted in pregnant CD20 (huCD20) transgenic mice, a
pharmacologically relevant animal model, intravenous administration of
ublituximab-xiiy (0, 5, 20, or 50 mg/kg) during organogenesis (gestation day 6
and 12) resulted in no adverse effects on embryofetal development. There was a
marked reduction in B-cells in fetal blood at all but the lowest dose tested.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING
INFORMATION
Additions
and/or revisions underlined:
…
Liver
Injury
Inform
patients that liver injury has been reported with anti-CD20 B-cell depleting
therapies, including BRIUMVI. Instruct patients treated with BRIUMVI to
promptly report any symptoms that may indicate liver injury, including fatigue,
anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or
jaundice. A blood test should be obtained before patients start therapy, and
during treatment as clinically indicated [see
Warnings and Precautions (5.5)].
MEDICATION GUIDE
Additions
and/or revisions underlined:
…
Before receiving
BRIUMVI, tell your healthcare provider about all of your medical conditions,
including if you:
…
have a history of liver problems.
…
are
pregnant, think that you might be pregnant, or plan to become pregnant. It
is not known if BRIUMVI will harm your unborn baby. You should use
birth control (contraception) during treatment with BRIUMVI and for at least 6
months after your last infusion of BRIUMVI. Talk with your healthcare provider
about what birth control method is right for you during this time.
…
What are the
possible side effects of BRIUMVI?
BRIUMVI may cause
serious side effects, including:
See
“What is the most important information
I should know about BRIUMVI?”
Liver damage. BRIUMVI may cause
liver damage. Your healthcare provider will do blood tests to check your liver
before
you start BRIUMVI and while you take BRIUMVI if needed. Tell your healthcare
provider right away if you have any symptoms of liver damage, such as:
Approved Drug Label (PDF)
8
Use in Specific Populations
8.1 Pregnancy
Additions and/or revisions underlined:
Pregnancy
Exposure Registry
There
is a pregnancy exposure registry that monitors pregnancy outcomes in women
exposed to BRIUMVI during pregnancy. Eligible patients are women who become
pregnant either while taking BRIUMVI or within 6 months following their last
dose of BRIUMVI. Physicians are encouraged to register patients and pregnant
women are encouraged to register themselves by calling 1-877-411-4546 or
visiting www.briumvipregnancyregistry.com.
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING
INFORMATION
Additions and/or revisions underlined:
…
Fetal
Risk
Advise
pregnant women and females of reproductive potential of the potential risk to a
fetus. Advise females of reproductive potential to use effective contraception
during treatment with BRIUMVI and for 6 months after the last BRIUMVI dose.
Advise patients to notify their healthcare provider if they are pregnant or
plan to become pregnant during treatment with BRIUMVI [see Warnings and Precautions (5.3) and Use in Specific Populations
(8.1, 8.3)].
Pregnancy
Registry
Instruct
patients that if they are pregnant or plan to become pregnant while taking
BRIUMVI they should inform their healthcare provider [see Use in Specific Populations (8.1)].
Encourage
patients to enroll in the BRIUMVI Pregnancy Registry if they become pregnant
while taking BRIUMVI or within 6 months following the last dose of BRIUMVI [see Use in Specific Populations (8.1)].
MEDICATION GUIDE
Additions and/or revisions underlined:
…
Before receiving
BRIUMVI, tell your healthcare provider about all of your medical conditions,
including if you:
…
are pregnant, think that you might be pregnant, or
plan to become pregnant. BRIUMVI may harm your unborn baby. You should use
birth control (contraception) during treatment with BRIUMVI and for at least 6 months
after your last infusion of BRIUMVI. Talk with your healthcare provider about
what birth control method is right for you during this time.
- Pregnancy Registry. There is a pregnancy registry for women who take BRIUMVI during
pregnancy. If you become pregnant while receiving BRIUMVI or within 6 months
following the last dose of BRIUMVI, tell your healthcare provider right away.
Talk to your healthcare provider about registering with the BRIUMVI Pregnancy
Registry. The purpose of this registry is to collect information about your
health and your baby’s health. Either you or your healthcare provider can
enroll you in this registry by calling 1-877-411- 4546 or visiting www.briumvipregnancyregistry.com.
…
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