Approved Drug Label (PDF)
4
Contraindications
Additions and/or revisions underlined:
NEXLIZET is contraindicated in patients with a
prior
hypersensitivity to ezetimibe
or bempedoic acid or any of the excipients in
NEXLIZET [see Adverse Reactions (6.2)].
Serious hypersensitivity reactions,
such as anaphylaxis,
angioedema, rash and urticaria have been reported with ezetimibe
or
bempedoic acid
5
Warnings and Precautions
5.1 Hyperuricemia
Additions and/or revisions underlined:
Bempedoic
acid, a component of NEXLIZET, inhibits renal tubular OAT2 and may increase
blood uric acid levels [see Clinical
Pharmacology (12.3)]. In the primary hyperlipidemia trials [see Clinical Studies (14.1)],
26% of bempedoic acid-treated patients with normal baseline uric acid values
(versus 9.5% placebo) experienced hyperuricemia one or more times, and 3.5% of
patients experienced clinically significant hyperuricemia reported as an
adverse reaction (versus 1.1% placebo). Increases in uric acid levels usually
occurred within the first 4 weeks of treatment initiation, persisted throughout
treatment, and returned to baseline following discontinuation of treatment.
After 12 weeks of treatment, the mean placebo-adjusted increase in uric acid
compared to baseline was 0.8 mg/dL for patients treated with bempedoic acid.
In the cardiovascular outcomes trial [see
Clinical Studies (14.2)], 16.4% of bempedoic acid-treated patients
experienced clinically significant hyperuricemia reported as an adverse
reaction (versus 8.2% placebo).
Elevated
blood uric acid may lead to the development of gout. In the primary
hyperlipidemia trials, gout was reported in 1.5% of patients treated with
bempedoic acid versus 0.4% of patients treated with placebo. In the
cardiovascular outcomes trial, gout was reported in 3.2% of
patients treated with bempedoic acid and 2.2% treated with placebo.
…
5.2 Tendon Rupture
Additions
and/or revisions underlined:
Bempedoic
acid, a component of NEXLIZET, is associated with an increased risk of tendon
rupture or injury. In the primary hyperlipidemia trials [see Clinical Studies (14.1)],
tendon rupture occurred in 0.5% of patients treated with bempedoic acid versus
0% of placebo-treated patients and involved the rotator cuff (the shoulder),
biceps tendon, or Achilles tendon. Tendon rupture occurred within weeks to
months of starting bempedoic acid. In the cardiovascular outcomes trial [see Clinical Studies (14.2)], tendon
rupture events occurred in 1.2% of bempedoic acid-treated patients versus 0.9%
of placebo-treated patients. Tendon rupture may occur more frequently in
patients over 60 years of age, in those taking corticosteroid or
fluoroquinolone drugs, in patients with renal failure, and in patients with
previous tendon disorders.
6
Adverse Reactions
6.1 Clinical
Trials Experience
Extensive changes;
please refer to label for complete information
6.2 Postmarketing
Experience
Additions and/or revisions underlined:
The following additional adverse reactions have been
reported in postmarketing experience for ezetimibe and/or bempedoic acid.
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.
Blood Disorders: thrombocytopenia
Gastrointestinal Disorders: abdominal pain;
pancreatitis; nausea
Hepatobiliary Disorders: elevations in liver transaminases, including
elevations more than 5× ULN; hepatitis; cholelithiasis; cholecystitis
Immune System Disorders: Hypersensitivity reactions including: anaphylaxis,
angioedema, wheezing, rash, and urticaria
Musculoskeletal Disorders: elevated
creatine phosphokinase; myopathy/rhabdomyolysis
Nervous System Disorders: dizziness;
paresthesia; depression; headache
Skin and Subcutaneous Tissue Disorders: erythema
multiforme
8
Use in Specific Populations
8.1 Pregnancy
Additions
and/or revisions underlined:
…
There
are insufficient data on bempedoic acid use in pregnant women to
evaluate for a
drug-associated
risk of major birth defects, miscarriage, or adverse maternal or fetal
outcomes.
…
8.2 Lactation
Additions
and/or revisions underlined:
Risk
Summary
There
is no information regarding the presence of bempedoic acid in human or animal
milk, the effects of the drug on the breastfed infant, or the effects of the
drug on milk production. There is no information about the presence of ezetimibe
in human milk. Ezetimibe is present in rat milk (see Data). When a drug is present in animal milk, it is likely that
the drug will be present in human milk. There is no information about the
effects of ezetimibe on the breastfed infant or the effects of ezetimibe
on milk production.
…
8.5
Geriatric Use
Additions
and/or revisions underlined:
Of
the 301 patients in the clinical trial of NEXLIZET, 149 (50%) were 65 years
of age and older, while 49 (16%) were 75 years of age and
over. No overall differences in safety or effectiveness of NEXLIZET have
been observed between patients 65 years of age and older and younger
adult patients.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT INFORMATION
Extensive changes; please refer to label for
complete information
Approved Drug Label (PDF)
4
Contraindications
Additions
and/or revisions underlined:
NEXLIZET
is contraindicated in patients with a prior hypersensitivity to
ezetimibe or bempedoic acid or any of the excipients in NEXLIZET [see Adverse Reactions (6.2)]. Serious
hypersensitivity reactions, such as anaphylaxis, angioedema, rash and
urticaria have been reported with ezetimibe or bempedoic acid.
5
Warnings and Precautions
5.1 Hyperuricemia
Additions and/or revisions underlined:
Bempedoic
acid, a component of NEXLIZET, inhibits renal tubular OAT2 and may increase
blood uric acid levels [see Clinical
Pharmacology (12.3)]. In the primary hyperlipidemia trials [see Clinical Studies (14.1)],
26% of bempedoic acid-treated patients with normal baseline uric acid values
(versus 9.5% placebo) experienced hyperuricemia one or more times, and 3.5% of
patients experienced clinically significant hyperuricemia reported as an
adverse reaction (versus 1.1% placebo). Increases in uric acid levels usually
occurred within the first 4 weeks of treatment initiation, persisted throughout
treatment, and returned to baseline following discontinuation of treatment.
After 12 weeks of treatment, the mean placebo-adjusted increase in uric acid
compared to baseline was 0.8 mg/dL for patients treated with bempedoic acid.
In the cardiovascular outcomes trial [see
Clinical Studies (14.2)], 16.4% of bempedoic acid-treated patients
experienced clinically significant hyperuricemia reported as an adverse
reaction (versus 8.2% placebo).
Elevated
blood uric acid may lead to the development of gout. In the primary
hyperlipidemia trials, gout was reported in 1.5% of patients treated with
bempedoic acid versus 0.4% of patients treated with placebo. In the
cardiovascular outcomes trial, gout was reported in 3.2% of
patients treated with bempedoic acid and 2.2% treated with placebo.
…
5.2 Tendon Rupture
Additions
and/or revisions underlined:
Bempedoic
acid, a component of NEXLIZET, is associated with an increased risk of tendon
rupture or injury. In the primary hyperlipidemia trials [see Clinical Studies (14.1)],
tendon rupture occurred in 0.5% of patients treated with bempedoic acid versus
0% of placebo-treated patients and involved the rotator cuff (the shoulder),
biceps tendon, or Achilles tendon. Tendon rupture occurred within weeks to
months of starting bempedoic acid. In the cardiovascular outcomes trial [see Clinical Studies (14.2)], tendon
rupture events occurred in 1.2% of bempedoic acid-treated patients versus 0.9%
of placebo-treated patients. Tendon rupture may occur more frequently in
patients over 60 years of age, in those taking corticosteroid or
fluoroquinolone drugs, in patients with renal failure, and in patients with
previous tendon disorders.
6
Adverse Reactions
6.1 Clinical
Trials Experience
Extensive changes;
please refer to label for complete information
6.2 Postmarketing
Experience
Additions and/or revisions underlined:
The following additional adverse reactions have been
reported in postmarketing experience for ezetimibe and/or bempedoic acid.
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.
Blood Disorders: thrombocytopenia
Gastrointestinal Disorders: abdominal pain;
pancreatitis; nausea
Hepatobiliary Disorders: elevations in liver transaminases, including
elevations more than 5× ULN; hepatitis; cholelithiasis; cholecystitis
Immune System Disorders: Hypersensitivity reactions including: anaphylaxis,
angioedema, wheezing, rash, and urticaria
Musculoskeletal Disorders: elevated
creatine phosphokinase; myopathy/rhabdomyolysis
Nervous System Disorders: dizziness;
paresthesia; depression; headache
Skin and Subcutaneous Tissue Disorders: erythema
multiforme
8
Use in Specific Populations
8.1 Pregnancy
Additions
and/or revisions underlined:
…
There
are insufficient data on bempedoic acid use in pregnant women to
evaluate for a
drug-associated
risk of major birth defects, miscarriage, or adverse maternal or fetal
outcomes.
…
8.2 Lactation
Additions
and/or revisions underlined:
Risk
Summary
There
is no information regarding the presence of bempedoic acid in human or animal
milk, the effects of the drug on the breastfed infant, or the effects of the
drug on milk production. There is no information about the presence of ezetimibe
in human milk. Ezetimibe is present in rat milk (see Data). When a drug is present in animal milk, it is likely that
the drug will be present in human milk. There is no information about the
effects of ezetimibe on the breastfed infant or the effects of ezetimibe
on milk production.
…
8.5
Geriatric Use
Additions
and/or revisions underlined:
Of
the 301 patients in the clinical trial of NEXLIZET, 149 (50%) were 65 years
of age and older, while 49 (16%) were 75 years of age and
over. No overall differences in safety or effectiveness of NEXLIZET have
been observed between patients 65 years of age and older and younger
adult patients.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT INFORMATION
Extensive changes; please refer to label for
complete information
Approved Drug Label (PDF)
6
Adverse Reactions
6.2 Postmarketing Experience
Newly
added subsection:
The following adverse reactions have been identified during postapproval use of NEXLETOL. 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: angioedema, wheezing, rash, and
urticaria.
8
Use in Specific Populations
8.1 Pregnancy
Additions and/or
revisions underlined:
…
The estimated background risk of
major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in
clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Report pregnancies to the Esperion
Therapeutics, Inc. Adverse
Event reporting line at 1-833- 377-7633.
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or
revisions underlined:
…
Pregnancy
Advise pregnant women of the
potential risk to a fetus based on NEXLETOL’s mechanism of action. Advise
females to inform
their healthcare provider
of a known or suspected pregnancy. Advise patients that there is a pregnancy safety
study that monitors pregnancy outcomes in patients exposed to NEXLETOL during
pregnancy. Encourage these patients to report their pregnancy to Esperion at
1-833-377-7633 [see Use in
Specific Populations (8.1)].
…
PATIENT INFORMATION
Additions and/or
revisions underlined:
…
Before you start taking NEXLETOL, tell your healthcare provider about all your medical conditions, including if you:
·
have or had gout.
·
have or had tendon problems.
·
are pregnant. Tell your healthcare provider right away if you
become pregnant while taking NEXLETOL. You and your healthcare provider will decide
if you should take NEXLETOL
while you are pregnant. If
you are pregnant during NEXLETOL treatment, you are encouraged to call Esperion
at 1-833-377-7633 to share information about the health of you and your baby.
·
are breastfeeding or plan to breastfeed. It is not known if NEXLETOL passes
into your breast
milk. You and your healthcare provider should decide if you will take
NEXLETOL or breastfeed. You should not do both.
·
have severe kidney
problems.
·
have severe liver
problems.
…
What are possible side effects of NEXLIZET?
NEXLIZET may cause serious side effects, including:
…
·
tendon rupture or injury. Tendon
problems can happen
in people who take bempedoic acid, one of the medicines in NEXLIZET. Tendons are tough
cords of tissue that connect muscles to bones. Symptoms of tendon problems may
include pain, swelling, tears, and inflammation of tendons including the arm,
shoulder, and back of the ankle (Achilles).
…
- Stop taking
NEXLIZET immediately and get medical
help right away if you get any of the following signs or symptoms of a
tendon rupture:
- hear or feel a snap or pop in a tendon
area
- bruising right after an injury in a tendon
area
- unable to move the affected area or put weight on the affected
area
Stop taking NEXLIZET until tendon rupture has been ruled out by
your healthcare provider. Avoid exercise and using the affected area. The most common
areas of pain and swelling
are the rotator cuff (the shoulder), the biceps tendon (upper arm), and
the Achilles tendon at the back of the ankle. This can happen with other
tendons.
…
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