secukinumab

A monoclonal antibody that acts as an antagonist of interleukin (IL)-17A by selectively binding to it and preventing its interaction with the IL-17 receptor. Antagonism prevents the production of inflammatory cytokines and chemokines.

Therapeutic effects:

Decreased plaque formation and spread in plaque psoriasis.
Decreased progression of and decreased structural damage associated with psoriatic arthritis.
Decreased signs and symptoms in ankylosing spondylitis.
Decreased disease activity in non-radiographic axial spondyloarthritis.
Decreased risk of disease flare in juvenile psoriatic arthritis and enthesitis-related arthritis.
Reduction in abscesses and inflammatory nodules in hidradenitis suppurativa.

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed following SUBQ administration. IV administration results in complete bioavailability.

Distribution: Levels in interstitial fluid of skin (lesional and nonlesional) are 27–40% those of serum.

Metabolism/Excretion: Catabolized into small peptides and amino acids.

Half-Life: 22–31 days.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	6 hr	unknown
IV	rapid	end of infusion	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Acute viral hepatitis.

Use Cautiously in:

Chronic infection/history recurrent infection (including tuberculosis [TB]);
Inflammatory bowel disease (exacerbation may occur);
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children <18 yr (psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and hidradenitis suppurativa) or <6 yr (plaque psoriasis).

Adv. Reactions/Side Effects ⬆ ⬇

Derm: eczematous eruptions

GI: diarrhea, inflammatory bowel disease

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS OR ANGIOEDEMA) , INFECTION(INCLUDING HEPATITIS B VIRUS REACTIVATION)

Interactions ⬆ ⬇

Drug-drug:

↑risk of adverse reactions with live vaccines; avoid concurrent use.
Administration of non-live vaccines may not elicit antibody response sufficient to produce protection.
May affect activity of CYP450 enzymes and may alter the effectiveness/toxicity of CYP450 substrate, including warfarin and cyclosporine; close monitoring is recommended and necessary dose modifications undertaken.

Route/Dosage ⬆ ⬇

Plaque Psoriasis

SC (Adults ): 300 mg once weekly for 5 wk, then 300 mg every 4 wk; for select patients, a dose of 150 mg may be sufficient.
SC (Children ≥6 yr and ≥50 kg): 150 mg once weekly for 5 wk, then 150 mg every 4 wk.
SC (Children ≥6 yr and <50 kg): 75 mg once weekly for 5 wk, then 75 mg every 4 wk.

Psoriatic Arthritis

SC (Adults ): Initiate therapy with or without a loading dose. With loading dose: 150 mg once weekly for 5 wk; then 150 mg every 4 wk; if patient continues to have symptoms, may ↑ dose to 300 mg. Without loading dose: 150 mg every 4 wk; if patient continues to have symptoms, may ↑ dose to 300 mg.
IV (Adults ): Initiate therapy with or without a loading dose. With loading dose: 6 mg/kg initially; then 1.75 mg/kg (max dose = 300 mg) every 4 wk. Without loading dose: 1.75 mg/kg (max dose = 300 mg) every 4 wk.
SC (Children ≥2 yr and ≥50 kg): 150 mg once weekly for 5 wk; then 150 mg every 4 wk.
SC (Children ≥2 yr and 15–<50 kg): 75 mg once weekly for 5 wk; then 150 mg every 4 wk.

Ankylosing Spondylitis

SC (Adults ): Initiate therapy with or without a loading dose. With loading dose: 150 mg once weekly for 5 wk; then 150 mg every 4 wk; if patient continues to have symptoms, may ↑ dose to 300 mg; Without loading dose: 150 mg every 4 wk; if patient continues to have symptoms, may ↑ dose to 300 mg.
IV (Adults ): Initiate therapy with or without a loading dose. With loading dose: 6 mg/kg initially; then 1.75 mg/kg (max dose = 300 mg) every 4 wk. Without loading dose: 1.75 mg/kg (max dose = 300 mg) every 4 wk.

Non-radiographic Axial Spondyloarthritis

SC (Adults ): Initiate therapy with or without a loading dose. With loading dose: 150 mg once weekly for 5 wk; then 150 mg every 4 wk; Without loading dose: 150 mg every 4 wk.
IV (Adults ): Initiate therapy with or without a loading dose. With loading dose: 6 mg/kg initially; then 1.75 mg/kg (max dose = 300 mg) every 4 wk. Without loading dose: 1.75 mg/kg (max dose = 300 mg) every 4 wk.

Enthesitis-Related Arthritis

SC (Adults and Children ≥4 yr and ≥50 kg): 150 mg once weekly for 5 wk; then 150 mg every 4 wk.
SC (Adults and Children ≥4 yr and 15–<50 kg): 75 mg once weekly for 5 wk; then 150 mg every 4 wk.

Hidradenitis Suppurativa

SC (Adults ): 300 mg once weekly for 5 wk; then 300 mg every 4 wk; if patient does not adequately respond, may ↑ dose to 300 mg every 2 wk.

Availability ⬆ ⬇

Solution for SUBQ injection (caps contain latex) (prefilled syringes): 75 mg/0.5 mL; 150 mg/mL
Solution for SUBQ injection (caps contain latex) (Sensoready pen): 150 mg/mL
Solution for SUBQ injection (UnoReady pen): 150 mg/mL
Solution for IV injection: 25 mg/mL

Assessment ⬆ ⬇

Assess skin lesions periodically during therapy for psoriasis.
For patients with arthritis, assess pain, joint swelling and stiffness, and limitations of movement during therapy.
For patients with hidradenitis suppurativa, assess armpits, groin, buttocks, and under breasts for new or worsening cysts or abscesses (including cellulitis) during therapy.
Assess for signs/symptoms of infection (fever; dyspnea; sweats; chills; muscle aches; cough; blood in phlegm; weight loss; frequent or painful urination; warm, red, or painful skin or sores; diarrhea; stomach pain), including TB, prior to and periodically during therapy. New infections should be monitored closely; most common are upper respiratory tract infections, bronchitis, and urinary tract infections. Infections may be fatal, especially in patients taking immunosuppressive therapy.
Assess for latex allergy. Needle cover of syringe contains latex and should not be handled by persons sensitive to latex.
Monitor for signs/symptoms of anaphylaxis (urticaria, dyspnea, wheezing) and angioedema (facial or throat swelling, hoarseness) following injection. Provide necessary emergency care. Medications (antihistamines, corticosteroids, epinephrine) and equipment should be readily available in the event of a severe reaction. If anaphylaxis or other severe allergic reaction occurs, discontinue secukinumab.
Assess for history of hepatitis B, which can be reactivated during therapy.
Monitor patients with inflammatory bowel disease closely; may cause exacerbations.

Implementation ⬆ ⬇

Administer a tuberculin skin test prior to administration of secukinumab. Patients with active latent TB should be treated for TB prior to therapy.
- Immunizations should be current prior to initiating therapy. Patients on secukinumab may receive concurrent vaccinations, except for live vaccines.
- Administer initial injection under supervision of a health care provider.
- Vial is for institutional use only. With training, patient may use pen and prefilled syringes at home.
- Solution is clear to slightly opalescent and colorless to slightly yellow. Do not administer solutions that are cloudy, discolored, or contain particulate matter. Discard unused solution.
SC: Administer at a 45° angle in upper thighs or abdomen, avoiding the 2 inches around navel. Upper outer arm may be used if administered by caregiver. Put pressure on injection site for 10 sec; do not rub. Administer two injections at different sites for 300-mg dose. Rotate injection sites; avoid areas that are tender, bruised, hard, red, or affected by psoriasis. Refrigerate prefilled syringes and pens.
Y-Site Incompatibility:
- Do not administer other drugs through same IV line

IV Administration:

Patient/Family Teaching ⬆ ⬇

Explain the purpose and side effects of secukinumab to patient. If an appointment is missed, contact health care provider as soon as possible to reschedule. Instruct patient on the correct technique for administering secukinumab. Review Medication Guide, preparation of dose, administration sites and technique, and disposal of equipment into a puncture-resistant container. Advise patient to review Medication Guide with each Rx in case of changes.
Caution patient to notify health care provider immediately if signs of infection, severe rash, swollen face, or difficulty breathing occur while taking secukinumab.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care provider before taking other medications.
Advise patient to avoid live vaccines during therapy.
Instruct patient to notify health care provider of medication regimen prior to treatment or surgery.
Sensoready Pen and UnoReady Pen: Adults may self-administer, if appropriate. Pediatric patients should not self-administer; a caregiver should inject pen. Use the UnoReady or Sensoready pen within 5 min of removing the cap. Allow refrigerated product to return to room temperature before administering. Clean area for injection with alcohol swab. Hold pen with cap pointing up. Check solution through window; if discolored, cloudy, or contains flakes, discard solution. Remove cap. Place pen, with window visible, against skin at a 90° angle and press button until 2 clicks are heard. 1st click indicates injection started; 2nd click indicates injection is almost complete. Hold pen in place until all solution is injected (10 sec) and green marker is visible in window and has filled window. Remove needle and press with a gauze pad or cotton ball for 10 sec. Do not rub injection site. Dispose of pen into a puncture-resistant container.
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes ⬆ ⬇

Reduced severity of plaques in patients with severe chronic plaque psoriasis.
Reduction in abscesses and inflammatory nodules in hidradenitis suppurativa.
Decreased progression of and decreased structural damage associated with psoriatic arthritis.
Decreased risk of disease flare in juvenile psoriatic arthritis and enthesitis-related arthritis.
Decreased signs and symptoms in ankylosing spondylitis.
Decreased disease activity in non-radiographic axial spondyloarthritis.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

0078- Novartis Pharmaceuticals Corporation
- 0078-0639- COSENTYX
  - 0078-0639-41- 2 mL in 1 CARTON (0078-0639-41)

0078- Novartis Pharmaceuticals Corporation
- 0078-0639- COSENTYX
  - 0078-0639-68- 1 mL in 1 CARTON (0078-0639-68)

0078- Novartis Pharmaceuticals Corporation
- 0078-0639- COSENTYX
  - 0078-0639-97- 1 mL in 1 CARTON (0078-0639-97)

0078- Novartis Pharmaceuticals Corporation
- 0078-0639- COSENTYX
  - 0078-0639-98- 2 mL in 1 CARTON (0078-0639-98)

0078- Novartis Pharmaceuticals Corporation
- 0078-1056- COSENTYX
  - 0078-1056-97- 1 SYRINGE, GLASS in 1 CARTON (0078-1056-97) / .5 mL in 1 SYRINGE, GLASS

0078- Novartis Pharmaceuticals Corporation
- 0078-1056- COSENTYX
  - 0078-1056-99- 1 SYRINGE, GLASS in 1 CARTON (0078-1056-99) / .5 mL in 1 SYRINGE, GLASS

0078- Novartis Pharmaceuticals Corporation
- 0078-1070- COSENTYX
  - 0078-1070-68- 1 SYRINGE, GLASS in 1 CARTON (0078-1070-68) / 2 mL in 1 SYRINGE, GLASS

0078- Novartis Pharmaceuticals Corporation
- 0078-1070- COSENTYX
  - 0078-1070-96- 1 SYRINGE, GLASS in 1 CARTON (0078-1070-96) / 2 mL in 1 SYRINGE, GLASS

0078- Novartis Pharmaceuticals Corporation
- 0078-1168- COSENTYX
  - 0078-1168-61- 5 mL in 1 VIAL, GLASS (0078-1168-61)

0078- Novartis Pharmaceuticals Corporation
- 0078-1322-
  - 0078-1322-09- 2 kg in 1 BOTTLE (0078-1322-09)

66447- NOVARTIS PHARMA SAS
- 66447-0103-
  - 66447-0103-9- 2 kg in 1 BOTTLE (66447-0103-9)

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇