Approved Drug Label (PDF)
4
Contraindications
Additions and/or
revisions underlined:
MAVENCLAD
is contraindicated:
in
patients with current malignancy [see
Warnings and Precautions (5.1)].
in
pregnant women and in females and males of reproductive potential who do not
plan to use effective contraception during MAVENCLAD dosing and for 6 months
after the lastdose in each treatment course for females, and 14 weeks for
males. May cause fetal harm [see
Warnings and Precautions (5.2) and Use in Specific Populations (8.1, 8.3)].
.
. .
8
Use in Specific Populations
8.1 Pregnancy
Additions and/or
revisions underlined:
.
. .
There
is a pregnancy safety study that monitors the pregnancy and infant outcomes
following exposure to cladribine. Physicians and patients are encouraged to
report pregnancies of female patients with multiple sclerosis exposed to oral
cladribine during pregnancy or within 6 months before conception as well as
pregnancies fathered by male patients with multiple sclerosis who had taken
oral cladribine within 14 weeks before conception by calling EMD
Serono’s Adverse Event reporting line at 1-800-283-8088 ext. 5563 or by faxing
1-781-681-2961.
.
. .
8.2 Lactation
Additions and/or
revisions underlined:
Risk
Summary
MAVENCLAD
is contraindicated in breastfeeding females because of the potential for
serious adverse reactions in breastfed infants, including infections and
hematologic toxicity [see
Contraindications (4) and Warnings and Precautions(5)]. Advise women not to
breastfeed during dosing with MAVENCLAD and for 10 days after the last dose [see Clinical Pharmacology (12.3)].
Literature
data shows that cladribine is present in human milk. There are no data
on the effects on the breastfed infant, or the effects on milk production.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING
INFORMATION
Additions and/or
revisions underlined:
.
. .
Risk
of Teratogenicity
Inform
patients that MAVENCLAD may cause fetal harm. Discuss with females of
reproductive potential whether they are pregnant, might be pregnant, or are
trying to become pregnant. Before initiating each treatment course, inform
patients about the potential risk to the fetus if female patients or partners
of male patients get pregnant during MAVENCLAD dosing or within 6 months after
the last dose for female patients, and within 14 weeks after the last dose
for male patients, in each treatment course [see Warnings and Precautions (5.2) and Use in Specific Populations
(8.1, 8.3)].
.
. .
Instruct
males of reproductive potential to take precautions to prevent pregnancy
of their partner during MAVENCLAD dosing and for at least 14 weeks after
the last dose in each treatment course.
.
. .
Advise
patients that there is a pregnancy safety study that monitors the pregnancy
outcomes in female patients exposed to cladribine during pregnancy or within 6
months before conception, as well as pregnancies fathered by male patients
exposed to cladribine within 14 weeks before conception, and they can
report the pregnancy by calling EMD Serono’s Adverse Event reporting line at
1-800-283-8088 ext. 5563 or by faxing 1-781-681-2961 [see Use in Specific Populations (8.1)].
.
. .
MEDICATION GUIDE
Additions and/or
revisions underlined:
.
. .
.
. .
Before you take
MAVENCLAD, tell your healthcare provider about all of your medical conditions,
including if
you:
.
. .
.
. .
Approved Drug Label (PDF)
5
Warnings and Precautions
5.7 Liver Injury
Additions and/or
revisions underlined:
Mavenclad can
cause liver injury. In clinical studies, 0.3% of MAVENCLAD-treated
patients had liver injury (serious or causing treatment discontinuation)
considered related to treatment, compared to 0 placebo patients. Onset ranged
from a few weeks to several months after initiation of treatment with
MAVENCLAD. Signs and symptoms of liver injury, including elevation of serum
aminotransferases to greater than 20-fold the upper limit of normal, were
observed. These abnormalities resolved upon treatment discontinuation.
Clinically significant and life-threatening liver
injury has been reported in patients treated with MAVENCLAD in the
postmarketing setting. Patients with pre-existing liver disease and patients
taking other hepatotoxic drugs may be at increased risk for developing liver
injury when taking MAVENCLAD. Most reported cases of liver injury associated
with MAVENCLAD occurred approximately 30 days after initiation (i.e., course 1,
cycle 1) of treatment.
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MAVENCLAD is
not recommended in patients with moderate to severe hepatic impairment
(Child-Pugh score greater than 6) [see Use in Specific
Populations (8.7), Clinical
Pharmacology (12.3)].
Obtain serum aminotransferase, alkaline
phosphatase, and total bilirubin levels prior to each treatment cycle
and course [see Dosage and Administration (2.1)]. If a patient develops clinical signs, including unexplained liver
enzyme elevations, or symptoms suggestive of hepatic dysfunction (e.g.,
unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice
and/or dark urine), promptly measure serum transaminases and total bilirubin
and interrupt or discontinue treatment with MAVENCLAD, as appropriate.
6
Adverse Reactions
6.2 Postmarketing Experience
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 in patients receiving
MAVENCLAD. Instruct patients treated with MAVENCLAD to report promptly any
symptoms that may indicate liver injury, including fatigue, anorexia, right
upper abdominal discomfort, dark urine, or jaundice. A blood test should be
obtained prior to each treatment cycle and course with MAVENCLAD and as
clinically indicated thereafter [see Warnings and
Precautions (5.7).
…
MEDICATION GUIDE
Additions
and/or revisions underlined:
…
What are the
possible side effects of MAVENCLAD?
MAVENCLAD can
cause serious side effects, including:
…
Approved Drug Label (PDF)
5
Warnings and Precautions
5.4 Infections
Additions and/or revisions underlined:
Serious, including life-threatening or fatal,
bacterial, viral, parasitic, and fungal infections have been reported in
patients receiving MAVENCLAD. MAVENCLAD reduces the body's
immune defense, and an increased risk of infections has been observed
in patients receiving MAVENCLAD.
Infections occurred in 49% of MAVENCLAD-treated
patients compared to 44% of placebo patients in clinical studies; serious or
severe infections occurred in 2.4% of MAVENCLAD- treated patients and 2.0% of
placebo-treated patients. The most frequent serious infections in
MAVENCLAD-treated patients included herpes zoster and pyelonephritis (see Herpes Virus Infections). Fungal
infections were observed, including cases of coccidioidomycosis.
In the postmarketing setting, serious infections
have been reported, including nocardiosis, varicella zoster, histoplasmosis,
cryptococcosis, and toxoplasmosis. The majority of patients with these
infections who had an available absolute lymphocyte count at the time of the
event had concurrent lymphopenia, consistent with the mechanism of action of
MAVENCLAD [see Warnings and Precautions
(5.3)].
HIV infection, active tuberculosis, and active
hepatitis must be excluded before initiation of each treatment course of MAVENCLAD
[see Contraindications (4)].
Delay initiation of
MAVENCLAD in patients with an acute infection until the infection is fully resolved
or controlled.
6
Adverse Reactions
6.2 Postmarketing
Experience
Newly added subsection
The
following adverse reactions have been identified during postapproval use of
MAVENCLAD. 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.
Infections
and Infestations: nocardiosis, varicella zoster, histoplasmosis,
cryptococcosis, and toxoplasmosis [see Warnings
and Precautions (5.4)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING
INFORMATION
Additions
and/or revisions underlined:
Lymphopenia
and Other Hematologic Toxicity
Inform
patients that MAVENCLAD decreases lymphocyte counts and may also
decrease counts of other blood cells. A blood test should be obtained before
starting a treatment course, 2and 6 months after start of treatment in each
treatment course, periodically thereafter, and when clinically needed. Advise
patients to keep all appointments for lymphocyte monitoring during and after
MAVENCLAD treatment [see Dosage and
Administration (2.5) and Warnings and Precautions (5.3, 5.5)].
Infections
Inform
patients that infections, some of which were serious, have been
reported in patients receiving MAVENCLAD. Instruct patients to notify their
healthcare provider promptly if fever or other signs of infection such as
aching, painful muscles, headache, generally feeling unwell or loss of appetite
occur while on therapy orafter a course of treatment [see Warnings and Precautions (5.4)].
…
MEDICATION GUIDE
Additions and/or revisions underlined:
MAVENCLAD can cause
serious side effects, including:
…
- serious infections
such as:
Infections caused
by bacteria, viruses, parasites, or fungi that may be life-threatening or cause
death.
Approved Drug Label (PDF)
8
Use in Specific Populations
8.1 Pregnancy
Additions
and/or revisions underlined:
…
There
is a pregnancy safety study that monitors the pregnancy and infant outcomes
following exposure to cladribine. Physicians and patients are encouraged to
report pregnancies of women with multiple sclerosis exposed to oral cladribine
during pregnancy or within 6 months before conception as well as pregnancies
fathered by men with multiple sclerosis who had taken oral cladribine within 6
months before conception by calling EMD Serono’s Adverse Event reporting line
at 1-800-283-8088 ext. 5563 or by faxing 1-781- 681-2961.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING
INFORMATION
Additions
and/or revisions underlined:
…
Advise
patients that there is a pregnancy safety study that monitors the pregnancy
outcomes in women exposed to cladribine during pregnancy or within 6 months
before conception, as well as pregnancies fathered by men exposed to cladribine
within 6 months before conception, and they can report the pregnancy by calling
EMD Serono’s Adverse Event reporting line at 1-800-283-8088 ext. 5563 or by
faxing 1-781-681-2961 [see Use in
Specific Populations (8.1)].
MEDICATION GUIDE
Additions
and/or revisions underlined:
…
…
- MAVENCLAD Pregnancy Safety Study
The
purpose of this program is to assess the effect of MAVENCLAD exposure on
pregnancy and infant outcomes. Either you or your healthcare provider can
report your information by calling 1-800-283-8088 ext. 5563 or by fax
1-781-681-2961.
Approved Drug Label (PDF)
5
Warnings and Precautions
5.4 Infections
Additions and/or revisions underlined:
Herpes Virus Infections
… Vaccination of patients who are seronegative
for varicella zoster virus is recommended prior to initiation of MAVENCLAD.
Administer live attenuated or live vaccines at least 4 to 6 weeks prior to
starting MAVENCLAD. Vaccination with zoster vaccine recombinant, adjuvanted
is recommended for patients who are seropositive to VZV, either prior to or during
MAVENCLAD treatment, including when their lymphocyte counts are less than or
equal to 500 cells per microliter.
Vaccinations
Administer all immunizations (except as
noted for VZV) according to immunization guidelines prior to starting MAVENCLAD.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Infections
Newly added information:
Advise patients that some vaccines
containing live virus (live attenuated vaccines) should be avoided during and after
treatment with MAVENCLAD. Advise patients to complete any live or
live-attenuated vaccinations at least 4 to 6 weeks prior to initiation of
MAVENCLAD. Instruct patients to contact their healthcare provider prior to
receiving any vaccinations.
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