Dosing and uses of Cosentyx (secukinumab)
Adult dosage forms and strengths
lyophilized powder for reconstitution
- 150mg/vial
solution for injection
- 150mg/prefilled syringe
- 150mg/Sensoready pen
Psoriasis
Indicated for moderate-to-severe plaque psoriasis in patients who are candidates for systemic therapy or phototherapy
Initial: 300 mg SC at weeks 0, 1, 2, 3, and 4
Monthly maintenance: Beginning at week 8, give 300 mg SC once monthly
For some patients, a dose of 150 mg may be acceptable
Psoriatic Arthritis
Indicated for adults with active psoriatic arthritis
For psoriatic arthritis patients with coexistent moderate-to-severe plaque psoriasis, use the dosing and administration recommendations for plaque psoriasis
Recommended dosage
- For other patients with psoriatic arthritis, administer with or without a loading dosage by SC injection
- With loading dose: 150 mg SC at weeks 0, 1, 2, 3, and 4 and q4wk thereafter
- Without loading dose: 150 mg SC q4wk
- If a patient continues to have active psoriatic arthritis, consider a dosage of 300 mg
- May be administered with or without methotrexate
Ankylosing Spondylitis
Indicated for adults with active ankylosing spondylitis
Administer with or without a loading dosage by SC injection
With loading dose: 150 mg SC at weeks 0, 1, 2, 3, and 4 and q4wk thereafter
Without a loading dose: 150 mg SC q4wk
Dosing Considerations
Evaluate patients for tuberculosis infection prior to initiating treatment (see Cautions)
Pediatric dosage forms and strengths
Safety and efficacy not established
Cosentyx (secukinumab) adverse (side) effects
>10%
Infections (28.7%)
Nasopharyngitis (11.4-12.3%)
1-10%
Diarrhea (2.6-4.1%)
URT infection (2.5-3.2%)
Rhinitis (1.4%)
Oral herpes (0.1-1.3%)
Pharyngitis (1-1.2%)
Urticaria (0.6-1.2%)
Rhinorrhea (0.3-1.2%)
Warnings
Contraindications
Hypersensitivity
Cautions
May increase risk of infections; caution when considering use in patients with chronic infection or a history of recurrent infection
Evaluate patients for tuberculosis (TB) infection before initiating; do not administer with active TB; for latent TB, initiate anti-TB therapy prior to initiation of secukinumab in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed
May exacerbate Crohn disease
Anaphylaxis and cases of urticaria reported; if this occurs, discontinue secukinumab immediately and initiate anaphylaxis treatment
Caution if latex allergic; the removable cap on the Sensoready pen and prefilled syringe contains natural rubber
Immunizations
- Prior to initiating therapy, consider completion of all age-appropriate immunizations according to current immunization guidelines
- Patients treated with secukinumab should not receive live vaccines
- Nonlive vaccines received during a course of secukinumab may not elicit an immune response sufficient to prevent disease
Pregnancy and lactation
Pregnancy category: B
Lactation: Unknown if distributed in human breast milk
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Cosentyx (secukinumab)
Mechanism of action
Human IgG1 monoclonal antibody that selectively binds to and neutralizes the proinflammatory cytokine interleukin 17A (IL-17A)
IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses and plays a key role in the pathogenesis of plaque psoriasis
Absorption
Peak plasma time: 6 days (single dose); 31-34 days (weekly dosing during first month)
Peak plasma concentration (single dose, day 6): 13.7 mcg/mL (150 mg) and 27.3 mcg/mL (300 mg)
Steady-state: By 24 weeks with monthly dosing
Steady-state trough levels: 16.7 mcg/mL (150 mg) to 34.4 mcg/mL (300 mg)
At the 300-mg dose at week 4 and week 12, the mean trough concentrations resulting from the Sensoready pen were 23-30% higher than those from the lyophilized powder and 23-26% higher than those from the prefilled syringe based on cross-study comparisons
Distribution
Vd: Low; 7.1-8.6 L (IV administration)
Concentrations in interstitial fluid in lesional and nonlesional skin: 27-40% of those in serum at weeks 1 and 2
Metabolism
Expected to be metabolized in the same manner as any endogenous IgG via intracellular catabolism, following fluid phase or receptor-mediated endocytosis and degraded into small peptides and amino acids
Elimination
Half-life: 22-31 days
Systemic clearance: Slow; 0.14-0.22 L/day
Clearance and distribution increases with body weight
Administration
SC Preparation
Lyophilized powder for injection
- Prepared and reconstitute with sterile water for injection (SWI) by a trained healthcare provider using aseptic technique and without interruption
- The preparation time from piercing the stopper until end of reconstitution on average takes 20 minutes and should not exceed 90 minutes
- Prepare the required number of vials (1 vial for the 150-mg dose or 2 vials for the 300-mg dose)
- Remove vial and SWI from refrigerator for 15-30 minutes to reach room temperature
- Slowly inject 1 mL of SWI into the vial and direct the stream of SWI into the lyophilized powder
- Tilt the vial at an angle of approximately 45 degrees and gently rotate between the fingertips for approximately 1 minute
- Do not shake or invert the vial
- Allow the vial to stand for ~10 minutes at room temperature to allow for dissolution
- Note that foaming may occur
- Once again, tilt the vial at an angle of approximately 45 degrees and gently rotate between the fingertips for approximately 1 minute; do not shake or invert the vial
- Allow the vial to stand undisturbed at room temperature for ~5 minutes
- Reconstituted solution contains 150 mg/mL
- 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 is discolored
Sensoready pen and prefilled syringe
- Before injection, remove Sensoready pen or prefilled syringe from the refrigerator and allow reach room temperature (15-30 minutes) without removing the needle cap
- The removable cap of the Sensoready pen and the prefilled syringe contains natural rubber latex and should not be handled by latex-sensitive individuals
- Inspect visually for particulate matter and discoloration prior to administration
- Solution should be clear to slightly opalescent, colorless to slightly yellow solution
- Do not use if the liquid contains visible particles, is discolored, or is cloudy
- Does not contain preservatives; therefore, administer the Sensoready pen or prefilled syringe within 1 hr after removal from the refrigerator
- Discard any unused product
SC Administration
Patient self-administration
- Patients may self-inject after proper training in SC injection technique using the Sensoready pen or prefilled syringe and when deemed appropriate
- Rotate administration site between the thighs or any quadrant of abdomen (or upper, outer arm if administered by a caregiver)
- Do not inject into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis
Administration by healthcare professionaL
- The lyophilized powder for reconstitution is for healthcare provider use only
- Administer each injection at a different anatomic location (eg, upper arms, thighs, or any quadrant of abdomen) from the previous injection, and not into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis
Storage
Store vials, Sensoready pens, and prefilled pens refrigerated at 2-8ºC (36-46ºF)
Keep in the original carton to protect from light until the time of use
Do not freeze
To avoid foaming, do not shake
Does not contain a preservative; discard any unused portion
Reconstituted viaL
- After reconstitution, use the solution immediately or store in the refrigerator at 2-8ºC (36-46ºF) for up to 24 hr
- Do not freeze
- Allow to reach room temperature (15-30 minutes) before administration
- Does not contain preservatives; therefore, administer within 1 hr after removal from refrigerator
