Secukinumab (Monograph)

Brand name: Cosentyx
Drug class: Disease-modifying Antirheumatic Drugs
Chemical name: Anti-(human interleukin-17A (IL-17, cytotoxic T-lymphocyte-associated antigen 8)) immunoglobulin G1; human monoclonal AIN457 γ1 heavy chain (230-215′)-disulfide with human monoclonal AIN457 κ light chain dimer (236-236″:239-239″)-bisdisulfide
Molecular formula: C₆₅₈₄H₁₀₁₃₄N₁₇₅₄O₂₀₄₂S₄₄
CAS number: 1229022-83-6

Medically reviewed by Drugs.com on May 23, 2022. Written by ASHP.

Introduction

Recombinant human IgG₁ kappa monoclonal antibody that binds specifically to interleukin-17A (IL-17A).

Uses for Secukinumab

Plaque Psoriasis

Management of moderate to severe plaque psoriasis in adults and pediatric patients ≥6 years of age who are candidates for phototherapy or systemic therapy.

Adult guidelines generally support the use of IL-17 inhibitors as monotherapy for treatment of moderate to severe psoriasis.

Pediatric guidelines have not yet incorporated recommendations for use of IL-17 blocking agents for the treatment of pediatric plaque psoriasis.

Recommendations for use and selection of psoriasis therapies vary based on patient age, disease characteristics (e.g., severity, location, presence of psoriatic arthritis), and comorbidities (e.g., inflammatory bowel disease).

Psoriatic Arthritis

Management of active psoriatic arthritis in adults.

Disease-modifying treatments for psoriatic arthritis include oral small molecules (OSMs; e.g., methotrexate, sulfasalazine, cyclosporine, leflunomide, apremilast), biologic DMARDs (e.g., TNF blocking agents, secukinumab, ixekizumab, ustekinumab, brodalumab, abatacept), and/or targeted synthetic DMARDs (e.g., tofacitinib).

Guidelines generally support the use of IL-17 blocking agents, including secukinumab, as second-line therapy after TNF inhibitors for treatment of psoriatic arthritis.

Recommendations for the use and selection of disease-modifying therapies in psoriatic arthritis vary based on the presence of certain disease characteristics (e.g., psoriatic spondylitis/axial disease, enthesitis) and comorbidities (e.g., inflammatory bowel disease, diabetes).

Ankylosing Spondylitis

Management of active ankylosing spondylitis in adults.

Treatments for ankylosing spondylitis include NSAIAs, conventional DMARDs (e.g., methotrexate, sulfasalazine), biologic DMARDs (e.g., TNF blocking agents, secukinumab, ixekizumab), and/or targeted synthetic DMARDs (e.g., tofacitinib).

Guidelines generally support the use of IL-17 inhibitors, including secukinumab, as second-line therapy after TNF blocking agents for the treatment of ankylosing spondylitis in patients with active disease despite treatment with NSAIAs.

Recommendations for treatment selection in ankylosing spondylitis vary based on the presence of certain comorbidities (e.g., iritis, inflammatory bowel disease).

Nonradiographic Axial Spondyloarthritis

Management of active nonradiographic axial spondyloarthritis in adults with objective signs of inflammation.

Recommendations for the treatment of nonradiographic axial spondyloarthritis are largely extrapolated from evidence in the treatment of ankylosing spondylitis. Guidelines generally support the use of IL-17 inhibitors, including secukinumab, as second-line therapy after TNF blocking agents in patients with active disease despite treatment with NSAIAs.

Secukinumab Dosage and Administration

General

Pretreatment Screening

• Evaluate for tuberculosis infection prior to initiating therapy; start antimycobacterial therapy if indicated.

• Administer all age-appropriate vaccines prior to starting therapy.

Patient Monitoring

• Monitor closely for signs or symptoms of infection or active tuberculosis during and after treatment with secukinumab.

• Monitor for signs and symptoms of inflammatory bowel disease during treatment.

Other General Considerations

• Secukinumab may be used alone or in combination with methotrexate for the treatment of psoriatic arthritis.

Administration

Administer by sub-Q injection; IV use not recommended by manufacturer.

Sub-Q Administration

Available as injection pen, prefilled syringe, and lyophilized drug in vial. Lyophilized drug intended for institutional use only.

Administer by sub-Q injection into the upper arms, thighs, or any quadrant of the abdomen; do not make abdominal injections within 2 inches of the navel. Rotate injection sites. Do not make injections into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis.

Intended for use under the guidance and supervision of a clinician, but may be self-administered if clinician determines the patient and/or their caregiver is competent to safely administer the drug after appropriate training. Pediatric patients are not eligible for self-administration; however, an adult caregiver can administer to pediatric patients after proper training.

Use of injection pen may result in higher trough concentrations.

Use of Injection Pen or Prefilled Syringe

Remove injection pen or prefilled syringe from refrigerator and allow to sit at room temperature in the unopened carton for 15–30 minutes prior to injection. Do not remove needle cap while pen or prefilled syringe is warming to room temperature. Administer within 1 hour after removal from refrigerator.

Do not shake the solution.

Discard any unused portions of solution.

Reconstitution of Lyophilized Secukinumab

Reconstitution of secukinumab lyophilized powder must proceed without interruption. Preparation time from vial puncture until end of reconstitution on average is 20 minutes; do not exceed 90 minutes.

Remove the appropriate number of vials containing secukinumab lyophilized powder from refrigerator and allow drug to sit for 15–30 minutes to reach room temperature prior to reconstitution.

Reconstitute drug by slowly adding 1 mL of sterile water for injection (also at room temperature) to a vial containing 150 mg of secukinumab to provide a solution containing 150 mg/mL; direct stream of diluent onto the lyophilized powder.

Tilt vial at an angle of approximately 45 degrees and gently rotate between the fingertips for approximately 1 minute; do not shake or invert vial. Allow vial to sit for approximately 10 minutes at room temperature to allow for dissolution; foaming may occur.

Tilt vial again at an angle of approximately 45 degrees and gently rotate between the fingertips for approximately 1 minute; do not shake or invert vial. Allow vial to sit undisturbed for approximately 5 minutes at room temperature.

Administer solution immediately following reconstitution or refrigerate for up to 24 hours. If stored in refrigerator, allow solution to sit for 15–30 minutes to reach room temperature prior to administration; administer within 1 hour following removal from refrigerator.

Do not invert vial when withdrawing solution for administration.

Discard any unused portions of solution.

Dosage

Pediatric Patients

Plaque Psoriasis

Sub-Q

Pediatric patients ≥6 years of age weighing <50 kg: 75 mg at weeks 0, 1, 2, 3, and 4, followed by 75 mg once every 4 weeks.

Pediatric patients ≥6 years of age weighing ≥50 kg: 150 mg at weeks 0, 1, 2, 3, and 4, followed by 150 mg once every 4 weeks.

Adults

Plaque Psoriasis

Sub-Q

300 mg at weeks 0, 1, 2, 3, and 4, followed by 300 mg every 4 weeks. Doses of 150 mg may be acceptable for some patients (e.g., those with lower body weight and less severe disease).

Psoriatic Arthritis

Sub-Q

With a loading dose: 150 mg administered at weeks 0, 1, 2, 3, and 4, followed by 150 mg every 4 weeks.

Without a loading dose: 150 mg administered once every 4 weeks.

In psoriatic arthritis patients with coexisting moderate to severe plaque psoriasis, use dosage recommendations for plaque psoriasis in adults. (See Plaque Psoriasis under Dosage and Administration.)

Ankylosing Spondylitis

Sub-Q

With a loading dose: 150 mg administered at weeks 0, 1, 2, 3, and 4, followed by 150 mg every 4 weeks.

Without a loading dose: 150 mg administered once every 4 weeks.

If the patient continues to have active ankylosing spondylitis, consider a dosage of 300 mg every 4 weeks.

Nonradiographic Axial Spondyloarthritis

Sub-Q

With a loading dose: 150 mg administered at weeks 0, 1, 2, 3, and 4, followed by 150 mg every 4 weeks.

Without a loading dose: 150 mg administered once every 4 weeks.

Special Populations

Hepatic Impairment

Manufacturer makes no specific dosage recommendations.

Renal Impairment

Manufacturer makes no specific dosage recommendations.

Geriatric Patients

Manufacturer makes no specific dosage recommendations.

Cautions for Secukinumab

Contraindications

• Known hypersensitivity to secukinumab or any ingredient in the formulation.

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylaxis and urticaria reported. (See Contraindications under Cautions.) If an anaphylactic or other serious allergic reaction occurs, discontinue drug immediately and administer appropriate supportive treatment.

Latex Sensitivity

Some packaging components (i.e., removable cap) of injection pen and prefilled syringe contain natural rubber latex and should not be handled by individuals sensitive to latex.

Some individuals may be hypersensitive to natural latex proteins; rarely, hypersensitivity reactions to natural latex proteins have been fatal.

Manufacturer states safety of using secukinumab injection pen or prefilled syringe in latex-sensitive individuals not established.

Infectious Complications

Increased risk of infections. Higher rates of common infections (e.g., nasopharyngitis, upper respiratory tract infection, mucocutaneous candidiasis) observed in patients receiving secukinumab compared with those receiving placebo. Serious and some fatal infections also reported. Incidence of some types of infections appeared to be dose dependent.

Secukinumab-associated neutropenia, generally transient and reversible, reported; no serious neutropenia-associated infections reported in the controlled portion of clinical trials. Some cases of serious infections were associated with neutropenia in open-label extensions of clinical trials, but a causal relationship was not established.

Exercise caution when considering use in patients with chronic or recurrent infections.

If a serious infection develops, monitor patient closely and discontinue drug until infection resolves.

Evaluate patients for tuberculosis before initiating secukinumab. Do not administer to patients with active tuberculosis infection. When indicated, initiate appropriate antimycobacterial regimen for treatment of latent tuberculosis infection before initiating secukinumab. Also consider antimycobacterial therapy for patients with a history of latent or active tuberculosis in whom an adequate course of antimycobacterial treatment cannot be confirmed. Closely monitor patients for active tuberculosis during and after secukinumab treatment.

Inflammatory Bowel Disease

Use with caution and close monitoring in patients with coexisting inflammatory bowel disease. Exacerbations of such disease reported, some of which were serious. Cases of new-onset inflammatory bowel disease also reported.

Immunization

Consider administering all age-appropriate vaccines recommended by current immunization guidelines before initiating secukinumab.

Avoid live vaccines during therapy. Patients may receive inactivated vaccines.

Immunogenicity

Formation of antisecukinumab antibodies, including neutralizing antibodies, reported; neutralizing antibodies were not associated with loss of efficacy.

Specific Populations

Pregnancy

Reproductive and developmental toxicity studies in monkeys revealed no evidence of adverse developmental effects on fetuses or neonatal offspring. Data regarding secukinumab use in pregnant women are insufficient to inform a drug-associated risk.

Lactation

Not known whether secukinumab is distributed into human milk or absorbed systemically after ingestion. Use caution.

Potential effects on milk production or on breast-fed infants are unknown. Consider benefits of breast-feeding and the importance of secukinumab to the woman as well as potential adverse effects on the breast-fed infant from the drug or underlying maternal condition.

Pediatric Use

Safety and efficacy not established in pediatric patients <6 years of age for plaque psoriasis and in pediatric patients <18 years of age for all other indications.

Geriatric Use

No apparent differences in safety or efficacy between geriatric patients and younger adults with plaque psoriasis; however, insufficient experience in patients ≥65 years of age to determine whether they respond differently than younger adults.

Hepatic Impairment

No formal pharmacokinetic studies to date.

Renal Impairment

No formal pharmacokinetic studies to date.

Common Adverse Effects

Adverse effects reported in ≥1% of patients receiving secukinumab include nasopharyngitis, diarrhea, and upper respiratory tract infection.

Drug Interactions

Drugs Metabolized by Hepatic Microsomal Enzymes

Manufacturer states role of IL-17A in the regulation of CYP isoenzymes not elucidated. Because elevated levels of certain cytokines during chronic inflammation may alter formation of CYP isoenzymes, antagonism of IL-17A activity by secukinumab could normalize formation of CYP enzymes.

CYP substrates: Upon initiation or discontinuance of secukinumab, consider monitoring for therapeutic effect or drug concentration and consider dosage adjustment of the CYP substrate, especially if substrate has a narrow therapeutic index.

Vaccines

Inactivated vaccines: Patients may receive inactivated vaccines.

Live vaccines: Avoid live vaccines.

Specific Drugs

Secukinumab Pharmacokinetics

Absorption

Bioavailability

Bioavailability is 55–77% following sub-Q administration.

Peak serum concentrations achieved by approximately 6 days following sub-Q administration of secukinumab 150 or 300 mg.

Steady-state concentrations achieved by week 24 following sub-Q administration of secukinumab every 4 weeks.

Cross-study comparisons suggest that administration by injection pen may result in higher trough concentrations (23–26% higher compared with prefilled syringe or 23–30% higher compared with sub-Q injection of reconstituted powder).

Concentrations in interstitial fluid in lesional and nonlesional skin of patients with plaque psoriasis were 27–40% of those in serum at 1 and 2 weeks after a single 300-mg sub-Q dose.

Pharmacokinetics are dose proportional over a sub-Q dose range of 25–300 mg.

Special Populations

Serum concentrations higher in patients with lower body weight than in those with higher body weight.

Distribution

Extent

Not known whether distributed into human milk.

Special Populations

Volume of distribution increases as body weight increases.

Elimination

Metabolism

Metabolic pathway not characterized.

Expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.

Half-life

22–31 days.

Special Populations

Pharmacokinetics not formally studied in renal or hepatic impairment.

Population analysis suggests age does not substantially affect clearance in adults with plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. Clearance appears to be similar in patients ≥65 years of age and younger adults.

Clearance increases as body weight increases.

Stability

Storage

Parenteral

Injection

Injection pen or prefilled syringe: 2–8°C. Keep in original carton and protect from light. Do not freeze. May store at room temperature (not to exceed 30°C) for up to 4 days; discard if stored outside of refrigeration for more than 4 days.

Powder for Injection

2–8°C. Keep in original carton and protect from light. Do not freeze.

Reconstituted solution: 2–8°C for up to 24 hours. Do not freeze.

Actions

• Binds to IL-17A and inhibits interaction with the IL-17 receptor.

• Neutralizes biologic activity of IL-17A and inhibits release of proinflammatory cytokines, chemokines, and mediators of tissue damage.

• Elevated levels of IL-17A found in psoriatic lesions and blood of individuals with psoriasis.

• Increased numbers of IL-17A-producing lymphocytes and innate immune cells and increased levels of IL-17A found in blood of patients with psoriatic arthritis and ankylosing spondylitis.

• Increased numbers of IL-17-A producing lymphocytes observed in patients with nonradiographic axial spondyloarthritis

Advice to Patients

• Provide all patients with a copy of the manufacturer's patient information (medication guide) with each prescription of the drug. Importance of advising patients about potential benefits and risks of secukinumab. Importance of patients reading the medication guide prior to initiation of therapy and each time the prescription is refilled.

• Instruct patient and/or caregiver regarding proper storage, dosage, and administration of secukinumab, including the use of aseptic technique, and proper disposal of needles and syringes if it is determined the patient and/or caregiver is competent to safely administer the drug.

• For pediatric patients, inform patient and/or caregivers that pediatric patients should not self-administer secukinumab using the prefilled syringe or injection pen.

• Increased susceptibility to infection. Importance of promptly informing clinician if any signs or symptoms of infection (e.g., fever, sweats, or chills; muscle aches; cough or shortness of breath; blood in phlegm; weight loss; warm, red or painful sores on the body; diarrhea or stomach pain; burning upon urination or increased urination) occur.

• Advise patients to inform their clinician if they develop new or worsening signs and symptoms of inflammatory bowel disease (e.g., stomach pain, diarrhea) during secukinumab therapy.

• Importance of reviewing vaccination status with clinician and receiving all appropriate vaccinations prior to initiation of secukinumab.

• Importance of alerting clinician if allergy to latex exists.

• Importance of seeking immediate medical attention if symptoms of a serious allergic reaction (e.g., feeling faint; swelling of eyelids, face, lips, mouth, tongue, or throat; dyspnea or throat tightness; chest tightness; rash) occur.

• Importance of informing clinicians of existing or contemplated therapy, including prescription or OTC drugs, as well as any concomitant illnesses (e.g., active infection, inflammatory bowel disease) or any history of tuberculosis or other infections.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing patients of other important precautionary information.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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Frequently asked questions

• Cosentyx vs Humira: How do they compare?
• Is Cosentyx a biologic / immunosuppressant?
• Does Cosentyx have a black box warning?
• What are the new drugs for plaque psoriasis?
• How long does Cosentyx take to work?
• How and where do you inject Cosentyx?
• Can I get a flu shot while taking Cosentyx?
• Does Cosentyx treat Rheumatoid Arthritis?

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