Does Repatha (evolocumab) cause side effects?
Repatha (evolocumab) is a human monoclonal immunoglobulin G2 (IgG2) used along with diet, exercise and maximum tolerated doses of statins to reduce LDL cholesterol in adults with heterozygous familial hypercholesterolemia (and inherited disorder that causes high levels of LDL) or adults with heart problems related to excess cholesterol in the body.
Repatha is also used along with diet and other LDL-lowering treatments, for example, statins, ezetimibe (Zetia) and LDL apheresis, to reduce cholesterol in people with homozygous familial hypercholesterolemia (an inherited disorder that causes high levels of LDL).
Common side effects of Repatha include
- injection site reactions,
- back pain,
- common cold symptoms,
- flu-like symptoms,
- muscle pain,
- muscle spasm,
- urinary tract infections (UTIs),
- allergic reactions,
- high blood pressure (hypertension),
- joint pain,
- nausea, and
Serious side effects of Repatha include
No clinically significant drug-drug interactions are known for Repatha. There is no data on the use of Repatha in pregnant women. It is unknown if Repatha passes into breast milk or if it can cause harm to a nursing infant. Consult your doctor before breastfeeding.
Repatha (evolocumab) is a drug that belongs to the drug class called proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors. Repatha is prescribed to reduce LDL cholesterol in adults with heterozygous or homozygous familial hypercholesterolemia or adults with heart problems related to excess cholesterol in the body.
What are the important side effects of Repatha (evolocumab)?
The most common side effects associated with Repatha treatment include
Other side effects include
- muscle pain,
- muscle spasm,
- urinary tract infections (UTIs),
- allergic reactions,
- joint pain,
- confusion, and
A more serious side effect is:
- Hypersensitivity reactions. Repatha should not be used in patients with a history of serious hypersensitivity reactions to the product. Hypersensitivity reactions include itching, rash, and hives, have occurred. Repatha should be discontinued if signs or symptoms of serious allergic reactions occur.
Repatha (evolocumab) side effects list for healthcare professionals
The following adverse reactions are also discussed in other sections of the label:
- Allergic Reactions
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 Adults With Primary Hyperlipidemia (including Heterozygous Familial Hypercholesterolemia)
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, including:
- 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 3 [DESCARTES, NCT01516879]), 599 patients received 420 mg of Repatha subcutaneously once monthly.
The mean age was 56 years (range: 22 to 75 years), 23% were older than 65 years, 52% women, including:
- 80% White,
- 8% Black,
- 6% Asian;
- 6% identified as Hispanic ethnicity.
Adverse reactions reported in at least 3% of Repatha-treated patients, and more frequently than in placebo-treated patients in DESCARTES, 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).
Table 1: Adverse Reactions Occurring in Greater than or Equal to 3% of Repatha-treated Patients and More Frequently than with Placebo in DESCARTES
(N = 302) %
(N = 599) %
|Upper respiratory tract infection||6.3||9.3|
|Injection site reactions†||5.0||5.7|
|Urinary tract infection||3.6||4.5|
|†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, including:
- 85% White,
- 5% Black,
- 9% Asian;
- 5% identified as Hispanic ethnicity.
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 Trials
(N = 1224) %
(N = 2052) %
|Upper respiratory tract infection||2.0||2.1|
|Urinary tract infection||1.2||1.3|
|†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 (DESCARTES) 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 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%).
Adverse Reactions In The Cardiovascular Outcomes
Trial In a double-blind, randomized, placebo-controlled cardiovascular outcomes trial (Study 1 [Repatha Cardiovascular Outcomes Trial, FOURIER, NCT01764633]), 27,525 patients received at least one dose of Repatha or placebo.
The mean age was 62.5 years (range: 40 to 86 years), 45% were 65 years or older, 9% were 75 years or older, 25% women, including:
- 85% White,
- 2% Black and
- 10% Asian;
- 8% identified as Hispanic ethnicity.
Patients were exposed to Repatha or placebo for a median of 24.8 months; 91% of patients were exposed for ≥ 12 months, 54% were exposed for ≥ 24 months and 5% were exposed for ≥ 36 months.
The safety profile of Repatha in this trial was generally consistent with the safety profile described above in the 12-and 52-week controlled trials involving patients with primary hyperlipidemia (including HeFH).
Serious adverse events occurred in 24.8% and 24.7% of Repatha-treated and placebo-treated patients, respectively. Adverse events led to discontinuation of study treatment in 4.4% of patients assigned to Repatha and 4.2% assigned to placebo.
Common adverse reactions (> 5% of patients treated with Repatha and occurring more frequently than placebo) included
- diabetes mellitus (8.8% Repatha, 8.2% placebo),
- nasopharyngitis (7.8% Repatha, 7.4% placebo), and
- upper respiratory tract infection (5.1% Repatha, 4.8% placebo).
Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients assigned to Repatha compared with 7.7% in those assigned to placebo.
Adverse Reactions In Patients With Homozygous Familial Hypercholesterolemia
In a 12-week, double-blind, randomized, placebo-controlled trial of 49 patients with HoFH (Study 6 [TESLA, NCT01588496]), 33 patients received 420 mg of Repatha subcutaneously once monthly.
The mean age was 31 years (range: 13 to 57 years), 49% were women, including:
- 90% White,
- 4% Asian, and
- 6% other.
The adverse reactions that occurred in at least two (6.1%) Repatha-treated patients, and more frequently than in placebo-treated patients, included:
- Upper respiratory tract infection (9.1% versus 6.3%)
- Influenza (9.1% versus 0%)
- Gastroenteritis (6.1% versus 0%)
- Nasopharyngitis (6.1% versus 0%)
- As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay.
- Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Repatha in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.
- The immunogenicity of Repatha has been evaluated using an electrochemiluminescent bridging screening immunoassay for the detection of binding anti-drug antibodies. For patients whose sera tested positive in the screening immunoassay, an in vitro biological assay was performed to detect neutralizing antibodies.
- In a pool of placebo-and active-controlled clinical trials, 0.3% (48 out of 17,992) of patients treated with at least one dose of Repatha tested positive for the development of binding antibodies. Patients whose sera tested positive for binding antibodies were further evaluated for neutralizing antibodies; none of the patients tested positive for neutralizing antibodies.
- There was no evidence that the presence of anti-drug binding antibodies impacted the pharmacokinetic profile, clinical response, or safety of Repatha, but the long-term consequences of continuing Repatha treatment in the presence of anti-drug binding antibodies are unknown.
The following additional adverse reactions have been identified during post-approval use of Repatha. 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.
- Allergic reactions: Angioedema
- Influenza-like illness
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.