Approved Drug Label (PDF)
5
Warnings and Precautions
5.6 Glatiramer Acetate Products and Administration Errors
New
subsection added:
Medication
errors have occurred when glatiramer acetate products are administered with
incompatible autoinjectors. Some glatiramer acetate products can be administered
by an optional compatible autoinjector, should one be available; however, not
all glatiramer acetate products have a marketed optional compatible
autoinjector for administration [see
Dosage and Administration (2.2) and How Supplied/Storage and Handling (16)].
Using
an optional autoinjector that is not compatible for use with TEVA’s COPAXONE
may increase the risk for medication errors, such as dose omission or administration
of a partial dose.
If
using an optional autoinjector for administration, ensure the device is compatible
for use with the specific glatiramer acetate product by referring to the
autoinjector labeling. The availability of compatible autoinjectors for each
glatiramer acetate product may change with time.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING
INFORMATION
Additions
and/or revisions underlined:
…
Important
Administration Instructions
Advise
patients with new or existing glatiramer acetate prescriptions to consult their
pharmacist or healthcare provider if they would like information about
using an optional compatible autoinjector device, if available.
Additionally, advise patients who
would like to use an autoinjector for administration, should one be available, that
not all available autoinjectors are compatible with all glatiramer
acetate products and the availability of compatible autoinjectors may change
with time. If you have questions about the availability or compatibility of an autoinjector,
contact the manufacturer of the prescribed glatiramer acetate product for more
information.
Advise
patients that
using an optional autoinjector that is not compatible with the glatiramer
acetate product may increase the risk for medication errors, such as
missing a dose or administration of a partial dose [see Warnings and Precautions (5.6)].
…
PATIENT
INFORMATION
Additions
and/or revisions underlined:
…
How
should I use COPAXONE?
…
Approved Drug Label (PDF)
8
Use in Specific Populations
8.2 Lactation
Additions
and revisions underlined:
Risk Summary
There are no data on the presence of glatiramer
acetate in human milk. Based on the low systemic exposure because of
substantial local hydrolysis of glatiramer acetate following subcutaneous
administration, breastfeeding is not expected to result in clinically relevant
exposure of the infant to the drug [see
Clinical Pharmacology (12.3)]. There are no data on the effects of
glatiramer acetate on milk production.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
Patient Information
Additions
and revisions underlined:
What should I tell
my doctor before using COPAXONE? Before you use COPAXONE, tell your doctor if
you:
· are pregnant or plan to become pregnant. It is not
known if COPAXONE will harm your unborn baby.
· are breastfeeding or plan to breastfeed. It is not
known if COPAXONE passes into your breast milk, but any amount is expected
to be low if it does. Talk to your doctor about the best way to feed your
baby while using COPAXONE.
Approved Drug Label (PDF)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
Additions and/or revisions
underlined:
Advise the patient to read the
FDA-approved patient labeling
(Patient Information and Instructions for Use).
Optional Autoinjector
Advise patients with new or
existing glatiramer acetate prescriptions to consult their pharmacist or healthcare provider about using an optional prescribed compatible autoinjector device. Advise
patients that not all
optional prescribed autoinjectors
are
compatible with all glatiramer acetate products and using an autoinjector that
is not compatible may increase the risk for medication errors,
such as missing a dose or administration of a partial dose.
Additions and/or revisions
underlined:
How should I use COPAXONE?
Approved Drug Label (PDF)
5
Warnings and Precautions
5.5 Hepatic Injury
(Newly added section)
Cases of hepatic injury, some severe, including
liver failure
and hepatitis with jaundice, have been reported with COPAXONE. Hepatic injury has occurred from days to years after initiating treatment with COPAXONE.
If signs or symptoms
of liver dysfunction occur, consider discontinuation
of COPAXONE.
6
Adverse Reactions
6.2 Postmarketing Experience
(Newly added information)
Hepatobiliary Disorders: cholelithiasis; liver function
abnormality; cirrhosis
of the liver; hepatitis; hepatic injury [see Warnings and Precautions (5.5)]
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
Patient Counseling Information
Hepatic
Injury
(Newly added information)
Advise patients
that hepatic injury, including hepatic failure and hepatitis with jaundice, has been reported with the use of COPAXONE. Educate patients about the signs and symptoms
of hepatic injury and instruct
patients to report them immediately
to their healthcare
provider [see Warnings and Precautions (5.5)].
Patient Information
(Newly added information)
Liver problems. Liver problems, including liver failure, can occur with COPAXONE. Call your healthcare provider right away if you have symptoms,
such as:
nausea
loss of appetite
tiredness
dark colored urine and pale stools
yellowing of your skin or the white part of your eye
bleeding more easily than normal
confusion
sleepiness
Approved Drug Label (PDF)
8
Use in Specific Populations
Lactation
(PLLR conversion.
Please refer to label for complete information.)
Pregnancy
(PLLR conversion.
Please refer to label for complete information.)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
(Newly added
information)
Lactation
Advise patients to notify their
healthcare provider if they are breastfeeding or intend to breastfeed during COPAXONE
therapy
[see Use in Specific
Populations (8.2)].
Approved Drug Label (PDF)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT INFORMATION
(additions
underlined)
…
What is
COPAXONE?
COPAXONE
is a prescription medicine that is used to treat relapsing forms of multiple
sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting
disease, and active secondary progressive disease, in adults.
…
Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Immediate Post-Injection Reaction
(Additions and/or revisions are
underlined)
Approximately 16% of patients
exposed to COPAXONE
20 mg per mL in the 5
placebo- controlled trials compared
to 4% of those on placebo, and approximately 2% of patients exposed to COPAXONE 40 mg per mL in a placebo-controlled trial compared
to none on placebo, experienced a constellation of symptoms
that may occur immediately (within seconds to minutes, with the majority of symptoms
observed within 1 hour) after injection and included at least two of the following:
flushing, chest pain,
palpitations, tachycardia, anxiety, dyspnea, constriction
of the throat,
and urticaria. In general, these symptoms have their onset several months after the initiation
of treatment, although
they may occur earlier, and a given patient may experience
one or several
episodes of these symptoms.
Whether or not any of these symptoms actually
represent a specific
syndrome is uncertain.
Typically, the symptoms were transient and self-limited
and
did not require treatment; however,
there have been reports of patients
with similar symptoms who
received emergency medical care.
Whether an immunologic or nonimmunologic mechanism mediates these episodes, or whether
several similar episodes seen in a given patient have identical
mechanisms, is unknown.
5.2 Chest Pain
(Additions and/or revisions are underlined)
Approximately 13% of COPAXONE 20 mg per mL patients
in the 5 placebo-controlled studies compared to
6% of placebo patients, and approximately 2% of patients exposed
to
COPAXONE 40 mg per mL in a placebo-controlled trial compared
to 1% of placebo patients, experienced at least one
episode of transient
chest pain. While some of these episodes
occurred in the context
of the Immediate Post-Injection Reaction
described above, many did not. ….
6
Adverse Reactions
6 ADVERSE REACTIONS
(Additions
and/or revisions are underlined)
The following
serious adverse reactions are described elsewhere
in the labeling:
Immediate Post-Injection Reaction
Chest Pain
Lipoatrophy and Skin Necrosis
Potential Effects on Immune Response
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions and/or revisions are underlined)
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Immediate Post-Injection Reaction
Advise patients that COPAXONE may cause various symptoms
after injection,
including flushing, chest pain,
palpitations, tachycardia, anxiety, dyspnea, constriction
of the throat,
and urticaria. These symptoms occur within
seconds to minutes after injection
and are generally transient and self-limited
and
do not require specific treatment. Inform patients that these symptoms may occur early or may have their onset several
months after the initiation
of treatment. A patient may experience one or several
episodes of these symptoms.
Chest Pain
Advise patients
that they may experience transient chest pain either as part of the Immediate Post-Injection Reaction
or in isolation. Inform patients that the pain should be transient. Some patients may experience more than one such episode, usually beginning at least one month after the initiation of treatment. Patients should be
advised to seek medical attention
if they experience chest pain of unusual
duration or intensity.
Patient Information
(Additions and/or revisions are underlined)
What are the possible
side effects of COPAXONE? COPAXONE
may cause serious
side effects, including:
Immediate Post-Injection Reactions. Serious side effects may happen right after or within minutes after you inject COPAXONE at any time during your course of treatment. Call your doctor right away if you have any of these immediate post-injection
reaction symptoms including:
redness to your cheeks or other parts
of the body (flushing)
chest pain
fast heart beat
anxiety
breathing problems or tightness
in your throat
swelling, rash, hives, or itching
If you have symptoms of an immediate post-injection reaction, do not give yourself more injections until a doctor tells you to.
Chest Pain. You can have chest pain as part of an immediate post- injection
reaction or by itself. This type of chest pain usually lasts a few minutes
and can begin around 1 month after you start using COPAXONE. Call your doctor right away if you have chest pain while using COPAXONE.
Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Post-Injection Reaction
(Additions and/or revisions are underlined)
Approximately 16% of patients exposed to COPAXONE 20 mg per
mL in the 5 placebo- controlled trials compared to 4% of those on placebo, and
approximately 2% of patients exposed to COPAXONE 40 mg per mL in a
placebo-controlled trial compared to none on placebo, experienced a
constellation of symptoms that may occur within minutes after injection and
included at least two of the following: flushing, chest pain, palpitations,
tachycardia, anxiety, dyspnea, constriction of the throat, and urticaria…
6
Adverse Reactions
(Newly added
subsection)
The following serious adverse reactions are described
elsewhere in the labeling:
6.2 Postmarketing Experience
(Additions and/or revisions are underlined)
The following adverse reactions have been identified
during postapproval use of COPAXONE. 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.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions and/or revisions are underlined)
Post-Injection Reaction
Advise patients that COPAXONE may cause various symptoms
after injection, including flushing, chest pain, palpitations, tachycardia,
anxiety, dyspnea, constriction of the throat, and urticaria…
Patient Information
(Additions and/or revisions are underlined)
What are the possible
side effects of COPAXONE? COPAXONE may cause serious side effects, including:
How should I store
COPAXONE?
…
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