Approved Drug Label (PDF)
6
Adverse Reactions
6.1 Clinical Trials
Experience
(Additions
and/or revisions underlined)
Because
clinical trials are conducted under widely varying conditions, adverse reaction
rates observed in the clinical trials
of a drug cannot be directly compared
to rates in the clinical
trials of another drug and may not reflect the rates observed in
practice.
In
clinical trials, 139 patients with Fabry disease (79 females, 60 males, 92%
Caucasian, ages 16 to 72 years),
who were naïve
to GALAFOLD or previously treated
with enzyme replacement therapy, were exposed to at
least one dose of GALAFOLD. Of the 139 patients, 127 patients were exposed to
GALAFOLD 123 mg every other day for 6 months and 123 patients were exposed for
greater than one year. The clinical trials included one randomized,
double-blind, placebo-controlled clinical trial of 6 months duration followed
by a 6-month open-label treatment phase (Study 1) [see Clinical Studies
(14)]. A second trial was a randomized, open-label,
active-controlled clinical trial of 18 months duration in patients with Fabry
disease receiving enzyme replacement therapy who were randomized to either switch
to GALAFOLD or continue enzyme replacement therapy
(Study 2; NCT01218659). In addition, there were two open-label, long-term
extension trials.
The
most common adverse reactions reported with GALAFOLD (? 10%) during the 6-month
placebo-controlled, double-blind phase of Study 1 were headache, nasopharyngitis, urinary tract
infection, nausea, and pyrexia.
Table
1
shows adverse reactions that occurred in at least 5% of patients treated
with GALAFOLD during the 6-month placebo-controlled, double-blind phase of Study 1.
Adverse
reactions that occurred in > 5% of patients who received GALAFOLD in
the 6-month open-label treatment phase of Study 1, in Study 2, and in the long-term extension trials (N = 115, mean duration of treatment 2.7
years) included those in Table 1 with the addition of vomiting.
7
Drug Interactions
7.1 Effect of Other Drugs on GALAFOLD
(Newly
added section)
Co-administration of GALAFOLD with caffeine decreases
migalastat AUC and Cmax [see Clinical
Pharmacology (12.3)] which
may reduce GALAFOLD efficacy. Avoid
co-administration of GALAFOLD
with caffeine at least 2 hours before
and 2 hours after taking GALAFOLD [see Dosage and
Administration (2.2)].
8
Use in Specific Populations
8.1
Pregnancy
Risk Summary
(Additions and/or revisions underlined)
There were three pregnant
women with Fabry disease exposed
to GALAFOLD in clinical trials. As such, the available data are
not sufficient to assess drug associated risks of major birth defects,
miscarriage, or adverse maternal or fetal outcomes. In animal reproduction
studies, no adverse developmental effects were observed (see Data).
The background risk for major birth defects
and miscarriage for the indicated population is
unknown. All pregnancies have a background risk of birth defects, loss,
or other adverse outcomes. In the U.S. general
population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and
15% to 20%, respectively.
There
is a study that collects data on pregnant women with Fabry disease, either
exposed or unexposed to GALAFOLD. Healthcare providers are encouraged to register patients
or obtain additional
information by contacting the Pregnancy Coordinating Center at 1-888-239-0758,
emailing fabrypregnancy@ubc.com,
or visiting www.fabrypregnancyregistry.com.
8.2 Lactation
Risk Summary
(Additions
and/or revisions underlined)
There
are no data on the presence of migalastat in human milk, the effects on the
breastfed infant, or the effects on milk production. Migalastat is present in
the milk of lactating rats (see Data). When a drug is present
in animal milk, it is likely that the drug will be present in human
milk. The developmental and health benefits of breastfeeding should be
considered along with the mother’s clinical need for GALAFOLD and any potential
adverse effects on the breastfed infant from GALAFOLD or from the
underlying maternal condition.
8.5 Geriatric Use
(Additions
and/or revisions underlined)
Clinical trials
of GALAFOLD did not include
sufficient numbers of patients 65 years of
age and older to determine
whether they respond differently from younger adult patients.
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).
Administration
Advise
the patient:
- To take GALAFOLD
once every other day at the same time of day
and do not take on consecutive days [see Dosage and
Administration (2.2)].
- Swallow
capsule whole. Do not cut, crush, or chew the capsule [see Dosage and
Administration (2.2)].
- Take GALAFOLD on an empty
stomach. Do not consume food or caffeine at least 2 hours
prior to and 2 hours after taking GALAFOLD to give a minimum 4 hour fast
[see Dosage and Administration (2.2)].
- Water (plain, flavored, or sweetened),
fruit juices without pulp, and caffeine-free carbonated beverages can be consumed
during the fasting period [see Dosage
and Administration (2.2)].
- If the GALAFOLD dose is missed,
take the missed dose if it is within 12 hours of the time that the dose should
have been taken.
If more than 12 hours
have passed, take
GALAFOLD at the next planned dosing day and time following the
original every-other-day dosing schedule [see Dosage and
Administration (2.3)].
- To inform the healthcare provider
of all medicines the patient
takes, including prescription and over-the-counter
medicines, vitamins, and herbal supplements [see Drug Interactions (7.1)].
Pregnancy and Lactation Study
Inform the patient
and/or caregiver that there is a study that collects data on pregnant women
with Fabry disease, and data on the effects of GALAFOLD on lactation in women
with Fabry disease and their neonates and infants up to 1 year of age who are
exposed through breast milk. Encourage the patient
and/or caregiver to
participate and state that participation is voluntary [see Use in Specific Populations
(8.1)].
Approved Drug Label (PDF)
6
Adverse Reactions
6.1 Clinical Trials
Experience
(Additions
and/or revisions underlined)
Because
clinical trials are conducted under widely varying conditions, adverse reaction
rates observed in the clinical trials
of a drug cannot be directly compared
to rates in the clinical
trials of another drug and may not reflect the rates observed in
practice.
In
clinical trials, 139 patients with Fabry disease (79 females, 60 males, 92%
Caucasian, ages 16 to 72 years),
who were naïve
to GALAFOLD or previously treated
with enzyme replacement therapy, were exposed to at
least one dose of GALAFOLD. Of the 139 patients, 127 patients were exposed to
GALAFOLD 123 mg every other day for 6 months and 123 patients were exposed for
greater than one year. The clinical trials included one randomized,
double-blind, placebo-controlled clinical trial of 6 months duration followed
by a 6-month open-label treatment phase (Study 1) [see Clinical Studies
(14)]. A second trial was a randomized, open-label,
active-controlled clinical trial of 18 months duration in patients with Fabry
disease receiving enzyme replacement therapy who were randomized to either switch
to GALAFOLD or continue enzyme replacement therapy
(Study 2; NCT01218659). In addition, there were two open-label, long-term
extension trials.
The
most common adverse reactions reported with GALAFOLD (? 10%) during the 6-month
placebo-controlled, double-blind phase of Study 1 were headache, nasopharyngitis, urinary tract
infection, nausea, and pyrexia.
Table
1
shows adverse reactions that occurred in at least 5% of patients treated
with GALAFOLD during the 6-month placebo-controlled, double-blind phase of Study 1.
Adverse
reactions that occurred in > 5% of patients who received GALAFOLD in
the 6-month open-label treatment phase of Study 1, in Study 2, and in the long-term extension trials (N = 115, mean duration of treatment 2.7
years) included those in Table 1 with the addition of vomiting.
7
Drug Interactions
7.1 Effect of Other Drugs on GALAFOLD
(Newly
added section)
Co-administration of GALAFOLD with caffeine decreases
migalastat AUC and Cmax [see Clinical
Pharmacology (12.3)] which
may reduce GALAFOLD efficacy. Avoid
co-administration of GALAFOLD
with caffeine at least 2 hours before
and 2 hours after taking GALAFOLD [see Dosage and
Administration (2.2)].
8
Use in Specific Populations
8.1
Pregnancy
Risk Summary
(Additions and/or revisions underlined)
There were three pregnant
women with Fabry disease exposed
to GALAFOLD in clinical trials. As such, the available data are
not sufficient to assess drug associated risks of major birth defects,
miscarriage, or adverse maternal or fetal outcomes. In animal reproduction
studies, no adverse developmental effects were observed (see Data).
The background risk for major birth defects
and miscarriage for the indicated population is
unknown. All pregnancies have a background risk of birth defects, loss,
or other adverse outcomes. In the U.S. general
population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and
15% to 20%, respectively.
There
is a study that collects data on pregnant women with Fabry disease, either
exposed or unexposed to GALAFOLD. Healthcare providers are encouraged to register patients
or obtain additional
information by contacting the Pregnancy Coordinating Center at 1-888-239-0758,
emailing fabrypregnancy@ubc.com,
or visiting www.fabrypregnancyregistry.com.
8.2 Lactation
Risk Summary
(Additions
and/or revisions underlined)
There
are no data on the presence of migalastat in human milk, the effects on the
breastfed infant, or the effects on milk production. Migalastat is present in
the milk of lactating rats (see Data). When a drug is present
in animal milk, it is likely that the drug will be present in human
milk. The developmental and health benefits of breastfeeding should be
considered along with the mother’s clinical need for GALAFOLD and any potential
adverse effects on the breastfed infant from GALAFOLD or from the
underlying maternal condition.
8.5 Geriatric Use
(Additions
and/or revisions underlined)
Clinical trials
of GALAFOLD did not include
sufficient numbers of patients 65 years of
age and older to determine
whether they respond differently from younger adult patients.
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).
Administration
Advise
the patient:
- To take GALAFOLD
once every other day at the same time of day
and do not take on consecutive days [see Dosage and
Administration (2.2)].
- Swallow
capsule whole. Do not cut, crush, or chew the capsule [see Dosage and
Administration (2.2)].
- Take GALAFOLD on an empty
stomach. Do not consume food or caffeine at least 2 hours
prior to and 2 hours after taking GALAFOLD to give a minimum 4 hour fast
[see Dosage and Administration (2.2)].
- Water (plain, flavored, or sweetened),
fruit juices without pulp, and caffeine-free carbonated beverages can be consumed
during the fasting period [see Dosage
and Administration (2.2)].
- If the GALAFOLD dose is missed,
take the missed dose if it is within 12 hours of the time that the dose should
have been taken.
If more than 12 hours
have passed, take
GALAFOLD at the next planned dosing day and time following the
original every-other-day dosing schedule [see Dosage and
Administration (2.3)].
- To inform the healthcare provider
of all medicines the patient
takes, including prescription and over-the-counter
medicines, vitamins, and herbal supplements [see Drug Interactions (7.1)].
Pregnancy and Lactation Study
Inform the patient
and/or caregiver that there is a study that collects data on pregnant women
with Fabry disease, and data on the effects of GALAFOLD on lactation in women
with Fabry disease and their neonates and infants up to 1 year of age who are
exposed through breast milk. Encourage the patient
and/or caregiver to
participate and state that participation is voluntary [see Use in Specific Populations
(8.1)].
Approved Drug Label (PDF)
8
Use in Specific Populations
8.1 Pregnancy
Newly added
information:
Pregnancy Exposure Study
There is a study that collects data on pregnant women
with Fabry disease, either exposed or unexposed to GALAFOLD. Healthcare
providers are encouraged to register patients or obtain additional information
by contacting the Pregnancy Coordinating Center at 1-888-239-0758![]()
, email fabrypregnancy@ubc.com, or visit www.fabrypregnancyregistry.com.
8.2 Lactation
Additions and/or
revisions underlined:
The developmental and health benefits of breastfeeding
should be considered along with the mother’s clinical need for GALAFOLD and any
potential adverse effects on the breastfed child from GALAFOLD or from the
underlying maternal condition.
There is a study that collects data on effects of
GALAFOLD on lactation for women with Fabry disease and their neonates and
infants up to 1 year of age who are exposed through breast milk. Healthcare
providers are encouraged to register patients or obtain additional information
by contacting the Pregnancy Coordinating Center at 1-888-239-0758![]()
, email fabrypregnancy@ubc.com, or visit www.fabrypregnancyregistry.com.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATIONS
Additions and/or revisions underlined:
Advise
the patient:
To
take GALAFOLD once every other day at the same time of day (do not take
GALAFOLD on 2 consecutive days). Swallow capsules whole: do not cut, crush, or
chew the capsules [see Dosage and
Administration (2.2)].
Pregnancy
and Lactation Study
Inform
patients that there is a study that collects data on pregnant women with Fabry
disease, and data on the effects of GALAFOLD on lactation in women with Fabry
disease and their neonates and infants up to 1 year of age who are exposed
through breast milk. Encourage patients and/or caregivers to participate and
advise them that their participation is voluntary [see Use in Specific
Populations (8.1)].
PATIENT INFORMATION
Additions and/or revisions underlined:
Before taking GALAFOLD, tell your
healthcare provider about all of your medical
conditions, including if you:
Pregnancy and Breastfeeding Exposure
Study.
There is a study that collects information on
pregnant
women with Fabry disease and women with Fabry disease who take GALAFOLD
and
breastfeed a baby up to 1 year of age. The purpose of this study is to collect
information
about
the health of you and your baby. Talk to your healthcare provider about how you
can
take
part in this study.
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