REPATHA® (evolocumab)
BRIEF SUMMARY OF PRESCRIBING INFORMATION
Table 1. Adverse Reactions Occurring in Greater than or Equal to 3% of
REPATHA-treated Patients and More Frequently than with Placebo in Study 2
Placebo
(N=302)
%
REPATHA
(N=599)
%
Nasopharyngitis
9.6
10.5
Upper respiratory tract infection
6.3
9.3
Influenza
6.3
7.5
Back pain
5.6
6.2
Injection site reactions†
5.0
5.7
Cough
3.6
4.5
Urinary tract infection
3.6
4.5
Sinusitis
3.0
4.2
Headache
3.6
4.0
Myalgia
3.0
4.0
Dizziness
2.6
3.7
Please see package insert for full Prescribing Information
1. INDICATIONS AND USAGE
1.1 Primary Hyperlipidemia
REPATHA is indicated as an adjunct to diet and maximally tolerated statin therapy for
the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or
clinical atherosclerotic cardiovascular disease (CVD), who require additional lowering
of low density lipoprotein cholesterol (LDL-C).
1.2 Homozygous Familial Hypercholesterolemia
REPATHA is indicated as an adjunct to diet and other LDL-lowering therapies (e.g.,
statins, ezetimibe, LDL apheresis) for the treatment of patients with homozygous
familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C.
1.3 Limitations of Use
Musculoskeletal pain
3.0
3.3
The effect of REPATHA on cardiovascular morbidity and mortality has not been
determined.
Hypertension
2.3
3.2
Diarrhea
2.6
3.0
4. CONTRAINDICATIONS
Gastroenteritis
2.0
3.0
REPATHA is contraindicated in patients with a history of a serious hypersensitivity
reaction to REPATHA [see Warnings and Precautions (5.1)].
5. WARNINGS AND PRECAUTIONS
5.1 Allergic Reactions
Hypersensitivity reactions (e.g., rash, urticaria) have been reported in patients
treated with REPATHA, including some that led to discontinuation of therapy. If
signs or symptoms of serious allergic reactions occur, discontinue treatment with
REPATHA, treat according to the standard of care, and monitor until signs and
symptoms resolve.
includes erythema, pain, bruising
Adverse Reactions in Seven Pooled 12-Week Controlled Trials
In seven pooled 12-week, double-blind, randomized, placebo-controlled trials,
993 patients received 140 mg of REPATHA subcutaneously every 2 weeks and
1059 patients received 420 mg of REPATHA subcutaneously monthly. The mean
age was 57 years (range: 18 to 80 years), 29% were older than 65 years, 49%
women, 85% White, 5% Black, 9% Asian, and 5% Hispanic. Adverse reactions
reported in at least 1% of REPATHA-treated patients, and more frequently than
in placebo-treated patients, are shown in Table 2.
Table 2. Adverse Reactions Occurring in Greater than 1% of REPATHA-treated
Patients and More Frequently than with Placebo in Pooled 12-Week Studies
†
6. ADVERSE REACTIONS
The following adverse reactions are also discussed in other sections of the label:
Nasopharyngitis
Back pain
Upper respiratory tract infection
Arthralgia
Nausea
Fatigue
Muscle spasms
Urinary tract infection
Cough
Influenza
Contusion
• Allergic Reactions [see Warnings and Precautions (5.1)]
6.1 Clinical Trials Experience
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 clinical practice.
Adverse Reactions in Patients with Primary Hyperlipidemia and in Patients with
Heterozygous Familial Hypercholesterolemia
REPATHA is not indicated for use in patients without familial hypercholesterolemia
or atherosclerotic CVD [see Indications and Usage (1.1)].
The data described below reflect exposure to REPATHA in 8 placebo-controlled
trials that included 2651 patients treated with REPATHA, including 557 exposed
for 6 months and 515 exposed for 1 year (median treatment duration of 12
weeks). The mean age of the population was 57 years, 49% of the population
were women, 85% White, 6% Black, 8% Asians, and 2% other races.
Adverse Reactions in a 52-Week Controlled Trial
In a 52-week, double-blind, randomized, placebo-controlled trial (Study 2),
599 patients received 420 mg of REPATHA subcutaneously once monthly [see
Clinical Studies (14.1)]. The mean age was 56 years (range: 22 to 75 years),
23% were older than 65 years, 52% women, 80% White, 8% B lack, 6% Asian,
and 6% Hispanic. Adverse reactions reported in at least 3% of REPATHAtreated patients, and more frequently than in placebo-treated patients in Study
2, are shown in Table 1. Adverse reactions led to discontinuation of treatment
in 2.2% of REPATHA-treated patients and 1% of placebo-treated patients. The
most common adverse reaction that led to REPATHA treatment discontinuation
and occurred at a rate greater than placebo was myalgia (0.3% versus 0% for
REPATHA and placebo, respectively).
USA-145-122473_RepathaJBS_Island_CWN_3-1-16_Z1.indd 2
Placebo
(N=1224)
%
REPATHA†
(N=2052)
%
3.9
2.2
2.0
1.6
1.2
1.0
1.2
1.2
0.7
1.1
0.5
4.0
2.3
2.1
1.8
1.8
1.6
1.3
1.3
1.2
1.2
1.0
140 mg every 2 weeks and 420 mg once monthly combined
Adverse Reactions in Eight Pooled Controlled Trials (Seven 12-Week Trials and One
52-Week Trial)
The adverse reactions described below are from a pool of the 52-week trial (Study 2)
and seven 12-week trials. The mean and median exposure durations of REPATHA in
this pool of eight trials were 20 weeks and 12 weeks, respectively.
Local Injection Site Reactions
Injection site reactions occurred in 3.2% and 3.0% of REPATHA-treated and
placebo-treated patients, respectively. The most common injection site reactions
were erythema, pain, and bruising. The proportions of patients who discontinued
treatment due to local injection site reactions in REPATHA-treated patients and
placebo-treated patients were 0.1% and 0%, respectively.
Allergic Reactions
Allergic reactions occurred in 5.1% and 4.7% of REPATHA-treated and placebotreated patients, respectively. The most common allergic reactions were rash (1.0%
versus 0.5% for REPATHA and placebo, respectively), eczema (0.4% versus 0.2%),
erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).
Neurocognitive Events
In placebo-controlled trials, neurocognitive events were reported in less than or
equal to 0.2% in REPATHA-treated and placebo-treated patients.
†
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