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]
Pharmacology
Mechanism of Action
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.
Pharmacokinetics/Pharmacodynamics
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.
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
Dosage and Administration
Dosing: Adult
Ankylosing spondylitis: 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 in patients who continue to have active psoriatic arthritis
Without a loading dose: 150 mg every 4 weeks; consider an increase to 300 mg 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. 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
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. Consider therapy modification
Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. 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. 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
Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy
Upadacitinib: Immunosuppressants may enhance the immunosuppressive effect of Upadacitinib. 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
Frequency not always defined.
Central nervous system: Headache (≥2%)
Dermatologic: Urticaria (≤1%), candidiasis
Endocrine & metabolic: Hypercholesterolemia (≥2%)
Gastrointestinal: Diarrhea (3% to 4%), nausea (≥2%), mucocutaneous candidiasis (1%), inflammatory bowel disease (≤1%; includes exacerbation), oral herpes (≤1%)
Hypersensitivity: Anaphylaxis, hypersensitivity
Infection: Infection (29% to 48%), serious infection (≤1%), herpes virus infection, staphylococcal infection
Respiratory: Nasopharyngitis (11% to 12%), upper respiratory tract infection (3%), pharyngitis (1%), rhinitis (1%), rhinorrhea (≤1%)
<1%, postmarketing, and/or case reports: Conjunctivitis, Crohn disease, exacerbation of Crohn disease, exacerbation of ulcerative colitis, immunogenicity (neutralizing antibodies not associated with drug efficacy), impetigo, increased serum transaminases, neutropenia, oral candidiasis, otitis externa, otitis media, sinusitis, tinea pedis, tonsillitis, ulcerative colitis
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
Pregnancy
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).
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.
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.
Frequently reported side effects of this drug
- Common cold
- Stuffy nose
- Sore throat
- Diarrhea
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- 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 a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of 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 brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
