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Secukinumab

Medically reviewed by Drugs.com. Last updated on Jun 5, 2020.

Pronunciation

(sek ue KIN ue mab)

Index Terms

  • AIN457

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Auto-injector, Subcutaneous [preservative free]:

Cosentyx Sensoready (300 MG): 150 mg/mL (1 mL) [contains mouse (murine) and/or hamster protein, polysorbate 80]

Cosentyx Sensoready Pen: 150 mg/mL (1 mL) [contains polysorbate 80]

Solution Prefilled Syringe, Subcutaneous [preservative free]:

Cosentyx: 150 mg/mL (1 mL) [contains polysorbate 80]

Cosentyx (300 MG Dose): 150 mg/mL (1 mL) [contains mouse (murine) and/or hamster protein, polysorbate 80]

Brand Names: U.S.

  • Cosentyx
  • Cosentyx (300 MG Dose)
  • Cosentyx Sensoready (300 MG)
  • Cosentyx Sensoready Pen

Pharmacologic Category

  • Anti-interleukin 17A Monoclonal Antibody
  • Antipsoriatic Agent
  • Monoclonal Antibody

Pharmacology

Secukinumab is a human IgG1 monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine involved in normal inflammatory and immune responses. Secukinumab inhibits the release of proinflammatory cytokines and chemokines.

Distribution

Vd: 7.1 to 8.6 L

Metabolism

Expected to be degraded into small peptides and amino acids via catabolic pathways similar to that which is seen with endogenous IgG

Time to Peak

~6 days

Half-Life Elimination

22 to 31 days

Use: Labeled Indications

Ankylosing spondylitis: Treatment of active ankylosing spondylitis in adults.

Axial spondyloarthritis (nonradiographic): Treatment of active nonradiographic axial spondyloarthritis in adults with objective signs of inflammation.

Plaque psoriasis: Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Psoriatic arthritis: Treatment of active psoriatic arthritis in adults.

Contraindications

Serious hypersensitivity reaction to secukinumab or any component of the formulation

Dosing: Adult

Note: Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with secukinumab.

Ankylosing spondylitis: SubQ:

With a loading dose: 150 mg at weeks 0, 1, 2, 3, and 4 followed by 150 mg every 4 weeks; consider an increase to 300 mg every 4 weeks in patients who continue to have active ankylosing spondylitis.

Without a loading dose: 150 mg every 4 weeks; consider an increase to 300 mg every 4 weeks in patients who continue to have active ankylosing spondylitis.

Axial spondyloarthritis (nonradiographic): SubQ:

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

Without a loading dose: 150 mg every 4 weeks.

Plaque psoriasis: SubQ: 300 mg once weekly at weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks. Some patients may only require 150 mg per dose.

Psoriatic arthritis: SubQ:

With a loading dose: 150 mg at weeks 0, 1, 2, 3, and 4 followed by 150 mg every 4 weeks; consider an increase to 300 mg every 4 weeks in patients who continue to have active psoriatic arthritis.

Without a loading dose: 150 mg every 4 weeks; consider an increase to 300 mg every 4 weeks in patients who continue to have active psoriatic arthritis.

Coexistent moderate to severe plaque psoriasis: 300 mg once weekly at weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks. Some patients may only require 150 mg per dose.

Dosing: Geriatric

Refer to adult dosing.

Reconstitution

Remove vial from the refrigerator and allow to stand for 15 to 30 minutes to reach room temperature. Reconstitute by slowly injecting 1 mL of sterile water onto the powder. Tilt the vial approximately 45 degrees and gently rotate between the fingertips for approximately 1 minute; do not shake or invert. Let the vial sit at room temperature for 10 minutes to allow for dissolution (foaming may occur). Tilt the vial approximately 45 degrees and gently rotate between the fingertips for approximately 1 minute again; do not shake or invert. Allow the vial to stand undisturbed at room temperature for approximately 5 minutes. The reconstituted solution should be essentially free of visible particles, clear to opalescent, and colorless to slightly yellow. Do not use if the lyophilized powder has not fully dissolved or if the liquid contains visible particles, is cloudy, or discolored.

The Sensoready pen or prefilled syringe should be removed from the refrigerator and allowed to stand for 15 to 30 minutes to reach room temperature prior to administration.

Administration

SubQ: Allow to reach room temperature prior to injection. Inject into the front of thighs, lower abdomen (≥2 inches away from the navel) or outer upper arms; administer each injection at a different anatomic location than a previous injection and avoid areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis, or where there are scars or stretch marks. The Sensoready pen or prefilled syringe may be self-injected by the patient following proper training in SubQ injection technique; the lyophilized powder is to be administered by health care providers only.

The 300 mg dose should be divided into two 150 mg SubQ injections.

Storage

Store intact vials, Sensoready pens, and prefilled syringes refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light; keep in original carton. Do not freeze or shake. After reconstitution of the vial, use the solution immediately or store in the refrigerator at 2ºC to 8ºC (36ºF to 46ºF) for up to 24 hours. Do not freeze. The Sensoready pen or prefilled syringe may be stored at room temperature for up to an hour immediately prior to administration. Discard any unused portion.

Drug Interactions

Baricitinib: Immunosuppressants may enhance the immunosuppressive effect of Baricitinib. Management: Use of baricitinib in combination with potent immunosuppressants such as azathioprine or cyclosporine is not recommended. Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted. Consider therapy modification

BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

Belimumab: May enhance the immunosuppressive effect of Biologic Anti-Psoriasis Agents. Avoid combination

Cladribine: May enhance the immunosuppressive effect of Immunosuppressants. Avoid combination

Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy

Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy

Echinacea: May diminish the therapeutic effect of Immunosuppressants. Management: Consider avoiding Echinacea in patients receiving therapeutic immunosuppressants. If coadministered, monitor for reduced efficacy of the immunosuppressant during concomitant use. Consider therapy modification

Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification

Inebilizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy

InFLIXimab: May enhance the immunosuppressive effect of Biologic Anti-Psoriasis Agents. Avoid combination

Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification

Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination

Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Management: Avoid use of immunosuppressants (including systemic corticosteroids) prior to initiation of nivolumab. Use of immunosuppressants after administration of nivolumab (eg, for immune-related toxicity) is unlikely to affect nivolumab efficacy. Consider therapy modification

Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy

Ozanimod: Immunosuppressants may enhance the immunosuppressive effect of Ozanimod. Monitor therapy

Pidotimod: Immunosuppressants may diminish the therapeutic effect of Pidotimod. Monitor therapy

Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Management: Consider avoiding concomitant use of roflumilast and immunosuppressants as recommended by the Canadian product monograph. Inhaled or short-term corticosteroids are unlikely to be problematic. Consider therapy modification

Siponimod: Immunosuppressants may enhance the immunosuppressive effect of Siponimod. Monitor therapy

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Management: Evaluate patients to see if it is medically appropriate to reduce or discontinue therapy with immunosuppressants prior to initiating sipuleucel-T therapy. Consider therapy modification

Smallpox and Monkeypox Vaccine (Live): Immunosuppressants may diminish the therapeutic effect of Smallpox and Monkeypox Vaccine (Live). Monitor therapy

Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy

Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Consider therapy modification

Upadacitinib: Immunosuppressants may enhance the immunosuppressive effect of Upadacitinib. Management: Concomitant use of upadacitinib with potent immunosuppressants is not recommended. Drugs listed as exceptions to this monograph are discussed in separate drug interaction monographs. Avoid combination

Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification

Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Exceptions: Smallpox and Monkeypox Vaccine (Live). Avoid combination

Adverse Reactions

>10%:

Infection: Infection (29% to 48%; serious infection: ≤1%)

Respiratory: Nasopharyngitis (11% to 12%)

1% to 10%:

Dermatologic: Urticaria (≤1%)

Endocrine & metabolic: Hypercholesterolemia (≥2%)

Gastrointestinal: Diarrhea (3% to 4%), inflammatory bowel disease (≤1%; Crohn’s disease, exacerbation of Crohn’s disease, exacerbation of ulcerative colitis, ulcerative colitis: <1%), mucocutaneous candidiasis (1%), nausea (≥2%), oral herpes simplex infection (≤1%)

Nervous system: Headache (≥2%)

Respiratory: Pharyngitis (1%), rhinitis (1%), rhinorrhea (≤1%), upper respiratory tract infection (3%)

Frequency not defined:

Gastrointestinal: Colitis, gastritis, hematochezia, lower abdominal pain

Genitourinary: Urinary tract infection

Hypersensitivity: Anaphylaxis, hypersensitivity reaction

Infection: Candidiasis, herpes virus infection, staphylococcal infection

<1%, postmarketing, and/or case reports: Antibody development (including neutralizing; neutralizing antibodies not associated with drug efficacy), conjunctivitis, impetigo, increased serum transaminases, neutropenia, oral candidiasis, otitis externa, otitis media, sinusitis, tinea pedis, tonsillitis

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Urticaria and anaphylaxis have been reported; discontinue immediately if signs/symptoms of a serious hypersensitivity reaction develop and initiate appropriate treatment.

• Infections: Secukinumab may increase the risk of infections. A higher rate of infections was observed with secukinumab treatment in clinical trials, including nasopharyngitis, upper respiratory tract infection, and mucocutaneous candida infection; the incidence of some types of infection appeared to be dose-dependent. Use with caution in patients with a chronic infection or a history of recurrent infection. In patients who develop a serious infection, monitor closely and discontinue use until the infection resolves.

• Tuberculosis: Patients should be evaluated for tuberculosis infection prior to initiating therapy; do not initiate therapy in patients with an active tuberculosis infection. Consider antituberculosis therapy if an adequate course of treatment cannot be confirmed in patients with a history of latent or active tuberculosis. Monitor all patients for signs and symptoms of active tuberculosis during and after treatment.

Disease related concerns:

• Inflammatory bowel disease: Treatment with secukinumab may cause exacerbations (some serious) and new onset of inflammatory bowel of inflammatory bowel disease; monitor patients for signs and symptoms of inflammatory bowel disease.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Latex: Some dosage forms may contain dry natural rubber (latex).

Other warnings/precautions:

• Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should not be given concurrently; non-live vaccines administered during secukinumab therapy may not elicit an immune response sufficient to prevent disease.

Monitoring Parameters

Signs and symptoms of infection, active tuberculosis (during and after treatment), and signs/symptoms of inflammatory bowel disease

Reproductive Considerations

The American Academy of Dermatology considers secukinumab for the treatment of psoriasis to be likely compatible for use in male patients planning to father a child (AAD-NPF [Menter 2019]).

Women and men with well-controlled psoriasis who are planning a pregnancy and wish to avoid fetal exposure can consider discontinuing secukinumab 19 weeks prior to attempting pregnancy (Rademaker 2018).

Possible failure of tubal sterilization following placement of an implantable birth control device (Essure) was observed in a female treated with secukinumab (Nardin 2018). Note: Distribution of Essure in the United States was stopped in December 2018.

Pregnancy Considerations

Secukinumab is a humanized monoclonal antibody (IgG1). Placental transfer of human IgG is dependent upon the IgG subclass, maternal serum concentrations, birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).

Outcome information following exposure to secukinumab in pregnancy is limited (Nardin 2018; Warren 2018).

Patient Education

What is this drug used for?

• It is used to treat plaque psoriasis.

• It is used to treat psoriatic arthritis.

• It is used to treat ankylosing spondylitis.

• It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Common cold

• Stuffy nose

• Sore throat

• Diarrhea

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Infection

• Sweating a lot

• Muscle pain

• Muscle weakness

• Shortness of breath

• Passing a lot of urine

• Severe dizziness

• Passing out

• Warm, red, or painful skin or sores on the body

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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