Medicine overview
Indications of Cosentyx
Cosentyx is a biologic (monoclonal antibody) that is indicated, per approved labeling, for the following conditions:
FDA-approved / established indications
- Moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy.
- Active psoriatic arthritis in adults and pediatric patients 2 years of age and older.
- Active ankylosing spondylitis in adults and pediatric patients 12 years of age and older.
- Active non-radiographic axial spondyloarthritis with objective signs of inflammation, in adults.
- Active enthesitis-related arthritis in pediatric patients 4 years of age and older.
- Moderate-to-severe hidradenitis suppurativa in adults and pediatric patients 12 years of age and older.
Guideline-supported use
Cosentyx is also recommended in several international rheumatology and dermatology guidelines (e.g., for psoriatic disease and axial spondyloarthritis) as a treatment option, typically after inadequate response to conventional or other first-line systemic therapy, or as an alternative biologic within its approved indications above.
Cosentyx is not indicated for infectious, non-inflammatory, or unapproved conditions, and is not an antibiotic.
Composition
Each pre-filled syringe or pre-filled pen of Secukinumab for injection typically contains Secukinumab 150 mg/mL (available as 150 mg or 300 mg per dose, depending on the delivery device), along with pharmaceutical excipients (such as trehalose dihydrate, L-histidine, L-methionine, polysorbate 80, and water for injection) that stabilize the solution. It contains no preservative and is intended for single-dose use.
Description
Cosentyx is a recombinant, fully human monoclonal antibody of the IgG1/κ class that selectively binds to and neutralizes interleukin-17A (IL-17A), a cytokine central to several chronic inflammatory autoimmune diseases. It is manufactured using Chinese hamster ovary (CHO) cell technology and is supplied as a sterile, preservative-free solution for subcutaneous injection (and, for certain adult indications, as a formulation for intravenous infusion).
By blocking IL-17A signaling, Cosentyx reduces downstream inflammatory processes that drive skin, joint, and entheseal disease activity in conditions such as psoriasis and spondyloarthritis.
Therapeutic Class
Cosentyx belongs to the therapeutic class of Interleukin-17A (IL-17A) inhibitors — a biologic, targeted immunomodulator/anti-inflammatory monoclonal antibody used in chronic inflammatory autoimmune disease.
Pharmacology
Mechanism of action
Secukinumab is a monoclonal antibody that selectively binds circulating IL-17A and prevents it from interacting with the IL-17 receptor on target cells. IL-17A is a naturally occurring cytokine that drives normal and pathological inflammation, and is implicated in the pathogenesis of plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, and hidradenitis suppurativa. By neutralizing IL-17A, Secukinumab reduces the release of downstream pro-inflammatory cytokines, chemokines, and mediators of tissue damage.
Pharmacokinetics
- Absorption: Following subcutaneous injection, peak plasma concentrations are reached in approximately 5–6 days; estimated absolute bioavailability is around 60–73%.
- Distribution: Consistent with a monoclonal antibody, distribution is largely limited to the vascular and interstitial space.
- Metabolism/Elimination: Secukinumab is expected to be degraded into small peptides and amino acids via general protein catabolism pathways, similar to endogenous IgG, rather than through hepatic or renal clearance.
- Half-life: Approximately 22–31 days, supporting once-monthly maintenance dosing after an initial loading phase.
Dosage & Administration of Cosentyx
Dosing of Cosentyx is individualized by indication, and, for pediatric patients, by body weight. It is administered by subcutaneous injection in most settings; an intravenous loading option is available for certain adult indications and must be given by a healthcare professional.
Plaque psoriasis
| Population | Dose | Schedule |
|---|---|---|
| Adults | 300 mg SC (150 mg may be used in some patients) | Weeks 0, 1, 2, 3, 4; then every 4 weeks |
| Children ≥6 yrs, <50 kg | 75 mg SC | Weeks 0, 1, 2, 3, 4; then every 4 weeks |
| Children ≥6 yrs, ≥50 kg | 150 mg SC | Weeks 0, 1, 2, 3, 4; then every 4 weeks |
Psoriatic arthritis
| Population | Dose | Schedule |
|---|---|---|
| Adults (SC) | 150 mg (up to 300 mg if inadequate response) | With or without loading doses at Weeks 0–4; then every 4 weeks |
| Adults (IV loading, specialist use) | 6 mg/kg once, then 1.75 mg/kg (max 300 mg) | Week 0, then every 4 weeks |
| Children ≥2 yrs, 15 to <50 kg | 75 mg SC | Weeks 0, 1, 2, 3, 4; then every 4 weeks |
| Children ≥2 yrs, ≥50 kg | 150 mg SC | Weeks 0, 1, 2, 3, 4; then every 4 weeks |
Ankylosing spondylitis and non-radiographic axial spondyloarthritis
| Population | Dose | Schedule |
|---|---|---|
| Adults (SC) | 150 mg (up to 300 mg if inadequate response) | With or without loading doses at Weeks 0–4; then every 4 weeks |
| Adults (IV loading, specialist use) | 6 mg/kg once, then 1.75 mg/kg (max 300 mg) | Week 0, then every 4 weeks |
| Children ≥12 yrs (ankylosing spondylitis only), <50 kg | 75 mg SC | Weeks 0, 1, 2, 3, 4; then every 4 weeks |
| Children ≥12 yrs (ankylosing spondylitis only), ≥50 kg | 150 mg SC | Weeks 0, 1, 2, 3, 4; then every 4 weeks |
Enthesitis-related arthritis (pediatric)
| Population | Dose | Schedule |
|---|---|---|
| Children ≥4 yrs, 15 to <50 kg | 75 mg SC | Weeks 0, 1, 2, 3, 4; then every 4 weeks |
| Children ≥4 yrs, ≥50 kg | 150 mg SC | Weeks 0, 1, 2, 3, 4; then every 4 weeks |
Hidradenitis suppurativa
| Population | Dose | Schedule |
|---|---|---|
| Adults | 300 mg SC (may increase to every 2 weeks if inadequate response) | Weeks 0, 1, 2, 3, 4; then every 4 weeks |
| Children ≥12 yrs, 30 to <90 kg | 150 mg SC | Weeks 0, 1, 2, 3, 4; then every 4 weeks |
| Children ≥12 yrs, ≥90 kg | 300 mg SC | Weeks 0, 1, 2, 3, 4; then every 4 weeks |
Renal/hepatic impairment
No formal dose-adjustment studies have been conducted; because Cosentyx is a monoclonal antibody cleared by general protein catabolism rather than renal or hepatic pathways, no specific dose adjustment is established. Use with routine clinical judgement in patients with significant organ impairment.
Administration technique
Allow the pre-filled syringe or pen to warm to room temperature for the time specified on the product before injecting. Inject subcutaneously into the thigh, abdomen (avoiding a 2-inch/5 cm area around the navel), or upper arm, rotating injection sites and avoiding skin that is tender, bruised, red, indurated, or affected by psoriasis. Patients or caregivers may self-inject after adequate training; the intravenous formulation is given only by a healthcare professional as a 30-minute infusion using an in-line filter, and is not established for pediatric use.
Administration of Cosentyx
Cosentyx is given by subcutaneous injection into the thigh, abdomen, or upper arm, with injection sites rotated each time; it may be self-administered by the patient or a caregiver after proper training. An intravenous loading-dose option exists for certain adult indications but must be administered by a healthcare professional as a slow infusion. Do not inject into skin that is bruised, tender, red, or affected by psoriasis, and note that some delivery devices contain latex in the needle cap.
Interaction of Cosentyx
Live vaccines
Live (attenuated) vaccines should be avoided during treatment with Cosentyx, as it may alter the immune response to these vaccines and increase the risk of vaccine-related infection. Patients should ideally complete all age-appropriate immunizations before starting Cosentyx.
CYP450 substrate drugs
Chronic inflammation can suppress certain cytochrome P450 (CYP450) enzymes; by reducing inflammatory cytokine activity, Cosentyx may normalize CYP450 activity. When Cosentyx is started or stopped in a patient taking a CYP450 substrate with a narrow therapeutic index (e.g., warfarin, ciclosporin), monitor drug effect or level and adjust the dose of that medication as needed.
Other immunosuppressants
Concomitant use with other biologic immunosuppressants or systemic immunosuppressive therapy has not been formally studied and may increase overall infection risk; use with caution and close monitoring if combination is clinically necessary.
Contraindications
Secukinumab is contraindicated in patients with:
- Known serious hypersensitivity to Secukinumab or to any excipient of the formulation — serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported.
- Clinically important active infection — Secukinumab should not be initiated in a patient with an active, clinically significant infection until the infection resolves or is adequately treated (see Precautions and Warnings for infection monitoring).
Side Effects of Cosentyx
The most commonly reported side effects of Cosentyx include:
- Nasopharyngitis (common cold-like symptoms)
- Diarrhea
- Upper respiratory tract infection
- Rhinitis and pharyngitis
- Headache
- Oral herpes
- Injection-site reactions (redness, pain, swelling)
Less common but clinically important effects include transient neutropenia, mucocutaneous candida infections, and new-onset or worsening inflammatory bowel disease. Serious hypersensitivity reactions (anaphylaxis, angioedema, urticaria) and serious infections have been reported; see Precautions and Warnings for details and required monitoring.
Pregnancy & Lactation
Pregnancy
Data on the use of Cosentyx in pregnant women are limited and are not sufficient to establish a drug-associated risk of major birth defects or miscarriage. Monoclonal antibodies such as Cosentyx are known to cross the placenta, particularly in the third trimester, and could affect the immune response of an infant exposed in utero. Cosentyx should be used during pregnancy only if clearly needed and if the potential benefit to the mother justifies the potential risk to the fetus; a physician should be consulted before use in pregnancy.
Lactation
It is not known whether Cosentyx passes into human breast milk or affects the breastfed infant. Because maternal IgG antibodies are known to transfer into breast milk, the developmental and health benefits of breastfeeding should be weighed against the mother's clinical need for Cosentyx and any potential effect on the infant; consult a physician before breastfeeding while using this medicine.
Precautions & Warnings
Infections
Cosentyx may increase susceptibility to infections, including serious and, rarely, fatal infections. Use with caution in patients with a history of chronic or recurrent infection, and discontinue if a patient develops a serious infection until it is controlled.
Tuberculosis
Evaluate patients for active and latent tuberculosis (TB) before starting Cosentyx. Do not administer to patients with active TB. If latent TB is diagnosed, start anti-TB therapy before initiating Cosentyx. Monitor all patients for signs and symptoms of active TB during and after treatment.
Inflammatory bowel disease
New-onset or exacerbation of Crohn's disease and ulcerative colitis has been reported with Cosentyx. Use with caution in patients with known inflammatory bowel disease and monitor for worsening symptoms.
Hypersensitivity reactions
Serious hypersensitivity reactions, including anaphylaxis and angioedema, have occurred with Cosentyx (see Contraindications). If a serious reaction occurs, discontinue Cosentyx immediately and initiate appropriate emergency treatment.
Eczematous eruptions
Severe eczematous skin reactions, including atopic-dermatitis-like eruptions and erythroderma, have been reported, sometimes requiring hospitalization; discontinuation of Cosentyx may be necessary in such cases.
Live vaccines and latex
Avoid live vaccines during treatment (see Interactions). The removable needle cap of certain Cosentyx delivery devices (pre-filled syringes/pens) contains natural rubber latex, which may cause reactions in latex-sensitive individuals.
Laboratory monitoring
Transient reductions in neutrophil counts have been observed; periodic monitoring may be considered, particularly in patients with additional risk factors for neutropenia.
Overdose Effects of Cosentyx
There is limited clinical experience with Cosentyx overdose. Doses substantially higher than the recommended dose have not been associated with specific dose-limiting toxicity in available data, but this does not guarantee safety at higher-than-recommended exposure. In case of suspected overdose, the patient should be closely monitored for any signs or symptoms of adverse effects (particularly infection or hypersensitivity reaction), and appropriate symptomatic and supportive treatment instituted immediately. Contact a physician, hospital emergency department, or poison control center promptly for guidance; there is no specific antidote for Cosentyx.
Storage Conditions
Store Cosentyx pre-filled syringes/pens in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Keep in the original carton to protect from light until time of use. Do not shake. If needed, the product may be allowed to reach room temperature before injection as directed on the pack, but should not be left out of the refrigerator for extended, repeated periods. Keep out of reach of children.
Use In Special Populations
Renal and hepatic impairment
Cosentyx has not been formally studied in patients with renal or hepatic impairment. As a monoclonal antibody cleared by catabolic protein pathways rather than the kidney or liver, no specific dose adjustment is currently established, but routine clinical monitoring is advised.
Elderly patients
Limited data are available in patients 65 years and older. Available data do not suggest a difference in effectiveness or overall safety profile compared with younger adults, but such patients often have a higher baseline risk of infection, so clinical monitoring for infection is advised.
Pediatric patients
See Pediatric Uses for indication-specific approved age ranges and weight-based dosing.
Immunocompromised patients
Use with caution and close monitoring in patients who are immunocompromised or have a history of recurrent serious infection, given the increased infection risk associated with Cosentyx (see Precautions and Warnings).
Duration Of Treatment
Duration of therapy with Cosentyx is individualized based on indication and clinical response. In most chronic inflammatory conditions, an adequate treatment trial (including the initial loading phase) of approximately 16 weeks is used to assess response; if no meaningful clinical improvement is observed by that time, continued treatment should be reconsidered. If the response is adequate, Cosentyx is typically continued long-term as maintenance therapy (dosed every 4 weeks, or every 2 weeks in select hidradenitis suppurativa patients) for as long as it remains effective and well tolerated, under ongoing physician supervision.
Drug Classes
Secukinumab is classified as: Biologic agent; Monoclonal antibody (human IgG1/κ); Interleukin-17A (IL-17A) antagonist; Targeted immunomodulator/anti-inflammatory agent.
Mode Of Action
Secukinumab works by selectively targeting and binding to interleukin-17A (IL-17A), a cytokine that plays a central role in the inflammatory cascade underlying plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, and hidradenitis suppurativa. By binding IL-17A, Secukinumab prevents it from engaging its receptor on keratinocytes, synoviocytes, and other target cells, thereby interrupting the downstream release of pro-inflammatory cytokines, chemokines, and tissue-damaging mediators. This reduction in IL-17A-driven inflammation translates clinically into improvement of skin lesions, joint inflammation, and entheseal/axial disease activity.
Pediatric Uses
Approved pediatric use of Cosentyx is indication-specific:
- Plaque psoriasis: approved for children 6 years of age and older, dosed by body weight (75 mg if <50 kg; 150 mg if ≥50 kg).
- Psoriatic arthritis: approved for children 2 years of age and older, dosed by body weight.
- Ankylosing spondylitis: approved for children 12 years of age and older, dosed by body weight.
- Enthesitis-related arthritis: approved for children 4 years of age and older, dosed by body weight.
- Hidradenitis suppurativa: approved for children 12 years of age and older, dosed by body weight.
Safety and efficacy of Cosentyx have not been established in children below the approved age for each specific indication, or for non-radiographic axial spondyloarthritis in pediatric patients, and intravenous administration has not been established in pediatric patients of any age. In clinical trials, a higher proportion of pediatric patients experienced Grade 2 neutropenia than adults; routine monitoring per physician judgement is advised. Pediatric doses should always be administered by a trained adult caregiver.
Frequently Asked Questions
Q: What is Cosentyx 150 mg/ml Injection used for?
A: Cosentyx 150 mg/ml Injection is a biologic medicine (an interleukin-17A inhibitor) used to treat moderate-to-severe plaque psoriasis, active psoriatic arthritis, active ankylosing spondylitis, active non-radiographic axial spondyloarthritis, enthesitis-related arthritis in children, and moderate-to-severe hidradenitis suppurativa, in patients who meet the approved age criteria for each condition.
Q: How is Cosentyx 150 mg/ml Injection given, and how often?
A: Cosentyx 150 mg/ml Injection is usually given as a subcutaneous injection into the thigh, abdomen, or upper arm. Most regimens start with weekly doses at Weeks 0, 1, 2, 3 and 4, followed by maintenance dosing every 4 weeks (every 2 weeks in some hidradenitis suppurativa cases). The exact dose (75 mg, 150 mg, or 300 mg) depends on the condition being treated and, in children, on body weight.
Q: Who should not use Cosentyx 150 mg/ml Injection?
A: Cosentyx 150 mg/ml Injection should not be used by anyone with a known serious allergy (hypersensitivity) to Cosentyx 150 mg/ml Injection or any ingredient in the injection, as anaphylaxis and angioedema have been reported. It should also not be started in someone with an active, clinically significant infection until that infection has been properly treated and resolved.
Q: Is Cosentyx 150 mg/ml Injection safe during pregnancy or breastfeeding?
A: Information on Cosentyx 150 mg/ml Injection use during pregnancy is limited, so it should be used in pregnancy only if clearly needed and if the expected benefit to the mother outweighs any possible risk to the baby; a physician should be consulted first. It is not known whether Cosentyx 150 mg/ml Injection passes into breast milk, so a doctor should help weigh the benefits of breastfeeding against the mother's need for treatment before it is used while breastfeeding.
Q: What are the most common side effects of Cosentyx 150 mg/ml Injection?
A: The most frequently reported side effects of Cosentyx 150 mg/ml Injection are nasopharyngitis (cold-like symptoms), diarrhea, upper respiratory tract infection, headache, and injection-site reactions. Because Cosentyx 150 mg/ml Injection can increase the risk of infection, patients should tell their doctor promptly about any signs of infection, fever, or unusual illness during treatment.
Q: Do I need any tests before starting Cosentyx 150 mg/ml Injection?
A: Yes. Because Cosentyx 150 mg/ml Injection can increase infection risk, doctors typically screen patients for tuberculosis (TB) (active and latent) before starting treatment, and latent TB is treated first if found. Patients should also make sure routine vaccinations are up to date, since live vaccines should be avoided while on Cosentyx 150 mg/ml Injection.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.
