Secukinumab (Monograph)

Brand name: Cosentyx
Drug class: Interleukin-mediated Agents, Miscellaneous

Medically reviewed by Drugs.com on Jul 10, 2024. 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 and pediatric patients ≥2 years of age.

Adult guidelines generally support use of IL-17 blocking agents, including secukinumab, as second-line therapy after tumor necrosis factor (TNF) inhibitors for treatment of psoriatic arthritis. Disease-modifying treatments for adults with psoriatic arthritis include oral small molecules (OSM, e.g., methotrexate, sulfasalazine, cyclosporine, leflunomide, apremilast), biologic disease modifying antirheumatic drugs (DMARDs; e.g., TNF blocking agents, secukinumab, ixekizumab, ustekinumab, brodalumab, abatacept), and/or targeted synthetic DMARDs (e.g., tofacitinib). 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).

Specific place in therapy for secukinumab for treatment of juvenile psoriatic arthritis not yet been established. Treatments for juvenile idiopathic arthritis (including psoriatic arthritis) include NSAIAs, DMARDs, glucocorticoids, and biologic agents (eg, TNF inhibitors).

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 treatment of nonradiographic axial spondyloarthritis largely extrapolated from evidence in 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.

Enthesitis-related Arthritis

Used for management of active enthesitis-related arthritis in pediatric patients ≥4 years of age.

Specific place in therapy for secukinumab for treatment of enthesitis-related arthritis not yet established.

Hidradenitis Suppurativa

Used for management of moderate to severe hidradenitis suppurativa in adults.

Specific place in therapy for secukinumab for treatment of hidradenitis suppurativa not yet established.

Secukinumab Dosage and Administration

General

Pretreatment Screening

• Evaluate for active or latent 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 (including juvenile psoriatic arthritis).

Administration

Commercially available as IV injection containing 125 mg/5 mL solution in a single-dose vial.

Commercially available as sub-Q injection containing 300 mg/2 mL solution in a single-dose pen (UnoReady) or single-dose prefilled syringe; 150 mg/mL solution in a single-dose pen (Sensoready) or single-dose prefilled syringe; and 75 mg/0.5 mL solution in a single-dose prefilled syringe (for pediatric patients). Injection pens and prefilled syringes supplied with 27-gauge, ½-inch needle.

Administer by sub-Q injection or IV infusion. Intended for use under the guidance and supervision of a clinician.

IV Administration

Intended for administration by a healthcare professional in a healthcare setting.

May be administered as IV infusion only in adults with active psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.

Dilute using proper aseptic technique prior to administration.

Calculate secukinumab total volume (in mL) required based on patient’s actual body weight as follows: 0.24 mL/kg for loading dose (6 mg/kg), and 0.07 mL/kg for maintenance dose (1.75 mg/kg). Use number of vials based on total volume needed.

Following dilution, discard unused secukinumab in vials (does not contain preservatives).

Use only an infusion set with a sterile, in-line, nonpyrogenic, low protein-binding, 0.2 micron filter for administration. Information on physical and/or chemical compatibility of secukinumab with other drugs unavailable; should not be infused through the same IV line as other drugs. When secukinumab infusion complete, flush infusion line with ≥50 mL of 0.9% sodium chloride.

Dilution

Prior to dilution, allow secukinumab vials to sit at room temperature (20-25°C) for approximately 20 minutes.

Patients weighing >52 kg: Dilute loading and maintenance dose in 100 mL infusion bag of 0.9% sodium chloride.

Patients weighing ≤52 kg: Dilute loading and maintenance dose in 100 mL and 50 mL infusion bag of 0.9% sodium chloride, respectively. If 50 mL infusion bag not available to dilute maintenance dose, use 100 mL infusion bag; withdraw and discard 50 mL of saline using aseptic technique, and continue to follow preparation and administration steps.

From infusion bag, withdraw and discard a volume of 0.9% sodium chloride equal to the calculated volume of secukinumab solution required for patient's dose. From secukinumab vial(s), withdraw calculated voume (mL) of secukinumab solution and add slowly into 0.9% sodium chloride infusion bag. To mix solution, gently invert bag to avoid foaming; do not shake.

Rate of Administration

Administer infusion at a flow rate of about 3.3 mL/minute for 100 mL bag or 1.7 mL/minute for 50 mL bag; administer over 30 minutes.

Sub-Q Administration

May be self-administered sub-Q by adults if clinician determines the patient and/or caregiver is competent to safely administer the drug after appropriate training. Pediatric patients ineligible for self-administration; however, adult caregiver can administer to pediatric patients after proper training.

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. Administration in upper, outer arm may be performed by caregiver or clinician. Do not make injections into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis.

Visually inspect solution for particulate matter or discoloration prior to administration; discard if cloudy, discolored, or contains particulates.

For single use only; discard any unused portions.

Once removed from refrigerator, allow injection pen (150 mg/mL) or prefilled syringe (150 mg/mL, 75 mg/0.5 mL) to sit at room temperature in the unopened carton for 15–30 minutes prior to injection. For injection pen (300 mg/2 mL) or prefilled syringe (300 mg/2 mL), allow to sit at room temperature for 30–45 minutes prior to injection. Do not remove needle cap while pen or prefilled syringe is warming to room temperature.

Removable cap of injection pen (150 mg/mL) and prefilled syringe (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex; should not be handled by latex-sensitive individuals.

Refer to the instructions for use in the prescribing information for more detailed instructions on preparation and administration of each presentation and strength of secukinumab.

Dosage

IV dosage based on actual body weight.

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.

Juvenile Psoriatic Arthritis

Sub-Q

Pediatric patients ≥2 years of age weighing ≥15 kg and <50 kg: 75 mg at weeks 0, 1, 2, 3, and 4, followed by 75 mg once every 4 weeks.

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

May be administered with or without methotrexate.

Enthesitis-related Arthritis

Sub-Q

Pediatric patients ≥4 years of age weighing ≥15 kg and <50 kg: 75 mg at weeks 0, 1, 2, 3, and 4, followed by 75 mg once every 4 weeks.

Pediatric patients ≥4 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. Each 300-mg dose can be administered as 2 injections of 150 mg or one 300-mg injection. 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.

Consider dosage escalation to 300 mg once every 4 weeks in patients who continue to experience psoriatic arthritis; each 300-mg dose can be administered as 2 injections of 150 mg or one 300-mg injection.

In patients with coexisting moderate to severe plaque psoriasis, use dosage recommendations for plaque psoriasis in adults.

IV

With a loading dose: 6 mg/kg administered at week 0, followed by 1.75 mg/kg every 4 weeks.

Without a loading dose: 1.75 mg/kg administered once every 4 weeks.

For maintenance doses of 1.75 mg/kg, do not exceed total doses of 300 mg.

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 patient continues to have active ankylosing spondylitis, consider a dosage of 300 mg every 4 weeks; each 300-mg dose can be administered as 2 injections of 150 mg or one 300-mg injection.

IV

With a loading dose: 6 mg/kg administered at week 0, followed by 1.75 mg/kg every 4 weeks.

Without a loading dose: 1.75 mg/kg administered once every 4 weeks.

Do not exceed maintenance dose of 300 mg.

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.

IV

With a loading dose: 6 mg/kg administered at week 0, followed by 1.75 mg/kg every 4 weeks.

Without a loading dose: 1.75 mg/kg administered once every 4 weeks.

For maintenance doses of 1.75 mg/kg, do not exceed total doses of 300 mg per infusion.

Hidradenitis Suppurativa

Sub-Q

300 mg administered at weeks 0, 1, 2, 3, and 4, followed by 300 mg every 4 weeks.

If patient continues to experience hidradenitis suppurativa, consider a dosage of 300 mg every 2 weeks; each 300-mg dose can be administered as 2 injections of 150 mg or one 300-mg injection.

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.

Renal Impairment

No specific dosage recommendations at this time.

Geriatric Patients

No specific dosage recommendations at this time.

Cautions for Secukinumab

Contraindications

• Serious hypersensitivity to secukinumab or any excipients in the formulation.

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylaxis and urticaria reported. 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 150 mg/mL injection pen and 1 mL and 0.5 mL prefilled syringes contain natural rubber latex; may cause a hypersensitivity reaction 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 150 mg/mL injection pen or 1 mL and 0.5 mL prefilled syringes 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 (including fungal) 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 serious infection develops, monitor patient closely and discontinue drug until infection resolves.

Evaluate patients for active or latent 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

Exacerbations of inflammatory bowel disease reported, some of which were serious and/or led to secukinumab discontinuation. Cases of new-onset inflammatory bowel disease also reported.

Use with caution in patients with inflammatory bowel disease. Monitor for signs and symptoms of inflammatory bowel disease in patients treated with secukinumab.

Eczematous Eruptions

Severe eczematous eruptions (including atopic dermatitis-like eruptions, dyshidrotic eczema, and erythrodema) some resulting in hospitalization, reported. Onset variable, may range from days to months after initiation.

Treatment discontinuation may be necessary, although some patients have been successfully treated without discontinuation.

Immunization

Consider administering all age-appropriate vaccines recommended by current immunization guidelines before initiating secukinumab. May alter the immune response to live vaccinations.

Avoid live vaccines during therapy.

Immunogenicity

Formation of antisecukinumab antibodies, including neutralizing antibodies, reported. Effect on pharmacokinetics, pharmacodynamics, safety, or efficacy of secukinumab not known.

Specific Populations

Pregnancy

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

Lactation

Not known whether distributed into human milk or absorbed systemically after ingestion.

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

Pediatric Use

Safety and efficacy established for treatment of moderate to severe plaque psoriasis in pediatric patients ≥6 years of age who are candidates for systemic therapy or phototherapy. Safety and efficacy in pediatric patients <6 years of age with plaque psoriasis not established.

Safety and efficacy established for treatment of active juvenile psoriatic arthritis in pediatric patients ≥2 years of age who weigh ≥15 kg. Safety and efficacy in pediatric patients with juvenile psoriatic arthritis <2 years of age or who weigh <15 kg not established.

Safety and efficacy established for treatment of active ethesitis-related arthritis in pediatric patients ≥4 years of age who weigh ≥15 kg. Safety and efficacy in pediatric patients with ethesitis-related arthritis <4 years of age or who weigh <15 kg not established.

Safety and efficacy in pediatric patients with hidradenitis suppurativa not established.

Safety and efficacy of IV secukinumab in pediatric patients not established.

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.

Clinical trials in hidradenitis suppurativa did not include sufficient number of patients ≥65 years of age to assess differences in response compared to younger adults.

Hepatic Impairment

No formal pharmacokinetic studies to date.

Renal Impairment

No formal pharmacokinetic studies to date.

Common Adverse Effects

Adverse effects (>1%): nasopharyngitis, diarrhea, upper respiratory tract infection.

Drug Interactions

Drugs Metabolized by Hepatic Microsomal Enzymes

Increased concentrations of cytokines (e.g., interleukin-17) during chronic inflammation may suppress formation of CYP isoenzymes.

CYP substrates: Upon initiation or discontinuance of secukinumab, consider monitoring for therapeutic effect or drug concentration of CYP substrate and consider dosage adjustment of CYP substrate, especially if minimal decreases in the concentration could reduce the CYP substrate efficacy or minimal increases in the concentration could increase CYP substrate adverse reactions.

Vaccines

Live vaccines: Avoid live vaccines.

Specific Drugs

Secukinumab Pharmacokinetics

Absorption

Bioavailability

Bioavailability is 55–77% following sub-Q dose of 150 or 300 mg.

Pharmacokinetics dose proportional over a sub-Q dose range of 25–300 mg in patients with plaque psoriasis.

Peak serum concentrations achieved by approximately 6 days following sub-Q administration of 150 or 300 mg in patients with plaque psoriasis.

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

Mean steady-state trough concentrations in patients with hidradenitis suppurativa approximately 26% lower than observed in patients with plaque psoriasis.

Administration by Sensoready injection pen may result in higher trough concentrations (30% higher compared with sub-Q injection of prefilled syringe).

Following multiple subcutaneous doses of 300 mg administered using the 300 mg/2 mL UnoReady pen, mean trough concentrations generally similar to those delivered using the Sensoready pen to administer 300 mg.

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.

Following IV administration of maintenance dose of 1.75 mg/kg every 4 weeks (with or without a loading dose of 6 mg/kg at day 0), secukinumab plasma concentrations estimated within the range of steady state concentrations achieved following sub-Q dose of 150 mg or 300 mg administered every 4 weeks.

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 in plaque psoriasis.

23 days in hidradenitis suppurativa.

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 patients <65 years of age.

Pharmacokinetics similar in pediatric patients with enthesitis-related arthritis and plaque psoriasis for same weight-tiered dosing regimen.

Clearance increases as body weight increases.

Stability

Storage

Parenteral

Injection for Sub-Q use

Injection pen (300 mg/2 mL, 150 mg/mL) or prefilled syringe (150 mg/mL, 75 mg/0.5 mL): 2–8°C. Keep in original carton; protect from light. Do not freeze or shake.

Injection pen (150 mg/mL) or prefilled syringe (150 mg/mL, 75 mg/ 0.5 mL): If removed from refrigeration, may store at room temperature (not to exceed 30°C) for ≤4 days. If product not used within 4 days, may be returned to refrigerator (only 1 time); discard if stored outside of refrigeration for >4 days.

Injection for IV use

Unused solution: 2–8°C. Keep in original carton and protect from light. Do not freeze or shake.

Diluted solution: If not administered immediately, store at 20–25°C for ≤4.5 hours from start of preparation to completion of infusion, or at 2–8°C for ≤24 hours from start of preparation to completion of infusion. Protect from light.

Actions

• Binds to interleukin-17A (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

• Advise patients to read the FDA-approved patient labeling (medication guide and instructions for use).

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

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

• Advise patients on the increased susceptibility to infection. Advise patients to promptly inform their 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.

• Inform patients that skin reactions that resemble eczema may occur while taking secukinumab, and that they should seek medical advice if signs or symptoms of eczema occur.

• Advise patients to review their vaccination status with clinicians and receive all appropriate vaccinations prior to initiation of secukinumab. Advise patients that vaccination with live vaccines is not recommended during secukinumab therapy. Instruct patients to inform their clinician that they are taking secukinumab prior to a potential vaccination.

• Advise patients to alert their clinician if allergy to latex exists. Advise latex-sensitive patients that the removal caps of some secukinumab preparations contain natural rubber latex, which may cause an allergic reaction.

• Advise patients to seek 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.

• Advise patients to inform their 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.

• Advise females of childbearing age to inform clinicians if they are or plan to become pregnant or plan to breast-feed.

• Inform patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

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.

Reload page with references included

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