REPATHA®: AN ESTABLISHED
SAFETY PROFILE1


ADVERSE REACTIONS
REPATHA®
PLACEBO
OCCURRING IN ≥ 3% OF REPATHA®-TREATED PATIENTS AND MORE FREQUENTLY THAN WITH PLACEBO IN ONE 52-WEEK CONTROLLED TRIAL*
REPATHA®
(N = 599)
PLACEBO
(N = 302)
Nasopharyngitis 10.5% 9.6%
Upper respiratory tract infection 9.3% 6.3%
Influenza 7.5% 6.3%
Back pain 6.2% 5.6%
Injection site reactions 5.7% 5.0%
Cough 4.5% 3.6%
Urinary tract infection 4.5% 3.6%
Sinusitis 4.2% 3.0%
Headache 4.0% 3.6%
Myalgia 4.0% 3.0%
Dizziness 3.7% 2.6%
Musculoskeletal pain 3.3% 3.0%
Hypertension 3.2% 2.3%
Diarrhea 3.0% 2.6%
Gastroenteritis 3.0% 2.0%
OCCURRING IN > 1% of REPATHA®-TREATED PATIENTS AND MORE FREQUENTLY THAN WITH PLACEBO IN SEVEN POOLED 12-WEEK CONTROLLED TRIALS
REPATHA®
(N = 2,052)
PLACEBO
(N = 1,224)
Nasopharyngitis 4.0% 3.9%
Back pain 2.3% 2.2%
Upper respiratory tract infection 2.1% 2.0%
Arthralgia 1.8% 1.6%
Nausea 1.8% 1.2%
Fatigue 1.6% 1.0%
Muscle spasms 1.3% 1.2%
Urinary tract infection 1.3% 1.2%
Cough 1.2% 0.7%
Influenza 1.2% 1.1%
Contusion 1.0% 0.5%
  • In a 52-week controlled trial,* adverse reactions led to discontinuation of treatment in 2.2% of Repatha®-treated patients and 1.0% 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)1
  • In seven pooled 12-week controlled trials, adverse reactions led to discontinuation of treatment in 1.7% of Repatha®-treated patients and 1.7% of placebo-treated patients2

*Repatha® 420 mg once monthly.

Includes erythema, pain, or bruising.

Repatha® 140 mg every two weeks and 420 mg once monthly.

Low LDL-C Levels1

  • In a pool of placebo- and active-controlled trials, as well as open-label extension studies that followed them, a total of 1,988 patients treated with Repatha® had at least one LDL-C value < 25 mg/dL.1
  • Changes to background lipid-altering therapy were not made in response to low LDL-C values, and Repatha® dosing was not modified or interrupted on this basis1
  • Although adverse consequences of very low LDL-C were not identified in these trials, the long-term effects of very low levels of LDL-C induced by Repatha® are unknown1
AN INTEGRATED ANALYSIS OF PHASE 2 AND 3 RANDOMIZED PLACEBO AND ACTIVE CONTROLLED STUDIES OF REPATHA® FOR UP TO 52 WEEKS DURATION3
ALL LDL-C ≥ 40 MG/DL ANY LDL-C < 40 MG/DL ANY LDL-C < 25 MG/DL
SoC
N = 2,038
Repatha® + SoC
N = 1,339
Repatha® + SoC
N = 2,565
Repatha® + SoC
N = 1,609
Adverse events 50.0% 52.0% 51.0% 51.3%
Serious adverse events 2.0% 2.6% 2.7% 2.9%

SoC = Standard of Care.

References:

  1. Repatha® (evolocumab) Prescribing Information, Amgen.
  2. Data on file, Amgen[3]; 2015.
  3. Amgen EMDAC Briefing Document 2015; http://www.fda.gov/downloads/AdvisoryCommittees/
    CommitteesMeetingMaterials/
    Drugs/
    EndocrinologicandMetabolicDrugsAdvisoryCommittee/
    UCM450076.pdf.
IMPORTANT SAFETY INFORMATION
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IMPORTANT SAFETY INFORMATION

Contraindication: Repatha® is contraindicated in patients with a history of a serious hypersensitivity reaction to Repatha®.

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.

Adverse reactions: The most common adverse reactions (> 5% of Repatha®-treated patients and more common than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.

In a 52-week trial, 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).

Adverse reactions from a pool of the 52-week trial and seven 12-week trials:
Local 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 occurred in 5.1% and 4.7% of Repatha®-treated and placebo-treated 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 were reported in less than or equal to 0.2% in Repatha®-treated and placebo-treated patients.

In a pool of placebo- and active-controlled trials, as well as open-label extension studies that followed them, a total of 1,988 patients treated with Repatha® had at least one LDL‑C value < 25 mg/dL. Changes to background lipid-altering therapy were not made in response to low LDL-C values, and Repatha® dosing was not modified or interrupted on this basis. Although adverse consequences of very low LDL-C were not identified in these trials, the long-term effects of very low levels of LDL-C induced by Repatha® are unknown.

Musculoskeletal adverse reactions were reported in 14.3% of Repatha®-treated patients and 12.8% of placebo-treated patients. The most common adverse reactions that occurred at a rate greater than placebo were back pain (3.2% versus 2.9% for Repatha® and placebo, respectively), arthralgia (2.3% versus 2.2%), and myalgia (2.0% versus 1.8%).

Immunogenicity: Repatha® is a human monoclonal antibody. As with all therapeutic proteins, there is a potential for immunogenicity with Repatha®.

INDICATION

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).

The effect of Repatha® on cardiovascular morbidity and mortality has not been determined.

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