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Cosentyx

Generic Name: Secukinumab
Class: Skin and Mucous Membrane Agents, Miscellaneous
Chemical Name: Anti-(human interleukin-17A (IL-17, cytotoxic T-lymphocyte-associated antigen 8)) immunoglobulin G1; human monoclonal AIN457 γ1 heavy chain (230-215′)-disulfide with human monoclonal AIN457 κ light chain dimer (236-236″:239-239″)-bisdisulfide
Molecular Formula: C6584H10134N1754O2042S44
CAS Number: 1229022-83-6

Introduction

Inhibitor of interleukin-17A (IL-17A), a proinflammatory cytokine; a recombinant human IgG1 kappa monoclonal antibody specific for IL-17A.1 2 3 4 7 8 10

Uses for Cosentyx

Plaque Psoriasis

Management of moderate to severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy.1 2 3 7 8

Cosentyx Dosage and Administration

Administration

Administer by sub-Q injection; IV use not recommended by manufacturer.1

Sub-Q Administration

Available as injection pen, prefilled syringe, and lyophilized drug in vial.1 Lyophilized drug intended for institutional use only.1

Administer by sub-Q injection into the upper arms, thighs, or any quadrant of the abdomen; do not make abdominal injections within 2 inches of the navel.1 Rotate injection sites.1 Do not make injections into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis.1

Intended for use under the guidance and supervision of a clinician, but may be self-administered if clinician determines the patient and/or their caregiver is competent to safely administer the drug after appropriate training.1

Use of injection pen may result in higher trough concentrations.1 10 (See Bioavailability under Pharmacokinetics.)

Use of Injection Pen or Prefilled Syringe

Remove injection pen or prefilled syringe from refrigerator and allow to sit at room temperature in the unopened carton for 15–30 minutes prior to injection.1 Do not remove needle cap while pen or prefilled syringe is warming to room temperature.1 Administer within 1 hour after removal from refrigerator.1

Do not shake the solution.1

Discard any unused portions of solution.1

Reconstitution of Lyophilized Secukinumab

Reconstitution of secukinumab lyophilized powder must proceed without interruption.1 Preparation time from piercing the stopper until end of reconstitution on average is 20 minutes, not to exceed 90 minutes.1

Remove the appropriate number of vials containing secukinumab lyophilized powder from refrigerator and allow drug to sit for 15–30 minutes to reach room temperature prior to reconstitution.1

Reconstitute drug by slowly adding 1 mL of sterile water for injection (also at room temperature) to a vial containing 150 mg of secukinumab to provide a solution containing 150 mg/mL; direct stream of diluent onto the lyophilized powder.1

Tilt vial at an angle of approximately 45 degrees and gently rotate between the fingertips for approximately 1 minute; do not shake or invert vial.1 Allow vial to sit for approximately 10 minutes at room temperature to allow for dissolution; foaming may occur.1

Tilt vial again at an angle of approximately 45 degrees and gently rotate between the fingertips for approximately 1 minute; do not shake or invert vial.1 Allow vial to sit undisturbed for approximately 5 minutes at room temperature.1

Administer solution immediately following reconstitution or refrigerate for up to 24 hours.1 (See Powder for Injection under Stability.) If stored in refrigerator, allow solution to sit for 15–30 minutes to reach room temperature prior to administration; administer within 1 hour following removal from refrigerator.1

Do not invert vial when withdrawing solution for administration.1

Discard any unused portions of solution.1

Dosage

Adults

Plaque Psoriasis
Sub-Q

300 mg at weeks 0, 1, 2, 3, and 4, followed by 300 mg every 4 weeks.1 Doses of 150 mg may be acceptable for some patients (e.g., those with lower body weight and less severe disease).1

Special Populations

Hepatic Impairment

Manufacturer makes no specific dosage recommendations.1

Renal Impairment

Manufacturer makes no specific dosage recommendations.1

Geriatric Patients

Manufacturer makes no specific dosage recommendations.1

Cautions for Cosentyx

Contraindications

  • Known hypersensitivity to secukinumab or any ingredient in the formulation.1

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity

Anaphylaxis and urticaria reported.1 If an anaphylactic or other serious allergic reaction occurs, discontinue drug immediately and administer appropriate supportive treatment.1

Latex Sensitivity

Some packaging components (i.e., removable cap) of injection pen and prefilled syringe contain natural rubber latex1 and should not be handled by individuals sensitive to latex.1 14 15 16

Some individuals may be hypersensitive to natural latex proteins;14 15 16 rarely, hypersensitivity reactions to natural latex proteins have been fatal.15 16

Manufacturer states safety of using secukinumab injection pen or prefilled syringe in latex-sensitive individuals not established.1

Infectious Complications

Increased risk of infections.1 Higher rates of common infections (e.g., nasopharyngitis, upper respiratory tract infection, mucocutaneous candidiasis) observed in patients receiving secukinumab compared with those receiving placebo.1 Serious infections also reported.1 Incidence of some types of infections appeared to be dose dependent.1

Secukinumab-associated neutropenia, generally transient and reversible, reported; no serious neutropenia-associated infections reported.1

Exercise caution when considering use in patients with chronic or recurrent infections.1

If a serious infection develops, monitor patient closely and discontinue drug until infection resolves.1

Evaluate patients for tuberculosis before initiating secukinumab.1 Do not administer to patients with active tuberculosis infection.1 When indicated, initiate appropriate antimycobacterial regimen for treatment of latent tuberculosis infection before initiating secukinumab.1 Also consider antimycobacterial therapy for patients with a history of latent or active tuberculosis in whom an adequate course of antimycobacterial treatment cannot be confirmed.1 Closely monitor patients for active tuberculosis during and after secukinumab treatment.1

Exacerbation of Crohn's Disease

Use with caution and close monitoring in patients with coexisting active Crohn's disease.1 Exacerbations of Crohn's disease, some serious, reported.1 19

Immunization

Consider administering all age-appropriate vaccines recommended by current immunization guidelines before initiating secukinumab.1

Avoid live vaccines during therapy.1 Patients may receive inactivated vaccines.1 (See Interactions.)

Immunogenicity

Formation of antisecukinumab antibodies, including neutralizing antibodies, reported; neutralizing antibodies were not associated with loss of efficacy.1

Specific Populations

Pregnancy

Category B.1

Lactation

Not known whether secukinumab is distributed into human milk or absorbed systemically after ingestion.1 Use caution.1

Pediatric Use

Safety and efficacy not established in pediatric patients <18 years of age.1

Geriatric Use

No apparent differences in safety or efficacy between geriatric patients and younger adults with psoriasis; however, insufficient experience in patients ≥65 years of age to determine whether they respond differently than younger adults.1

Hepatic Impairment

No formal studies to date.1

Renal Impairment

No formal studies to date.1

Common Adverse Effects

Nasopharyngitis,1 2 3 8 diarrhea,1 2 7 upper respiratory tract infection,1 2 rhinitis,1 7 oral herpes,1 pharyngitis,1 3 rhinorrhea,1 urticaria.1

Interactions for Cosentyx

No formal drug interaction studies to date.1 4 10

Drugs Metabolized by Hepatic Microsomal Enzymes

Manufacturer states role of IL-17A in the regulation of CYP isoenzymes not elucidated.1 Because elevated levels of certain cytokines during chronic inflammation may alter formation of CYP isoenzymes, antagonism of IL-17A activity by secukinumab could normalize formation of CYP enzymes.1

CYP substrates: Upon initiation or discontinuance of secukinumab, consider monitoring for therapeutic effect or drug concentration and consider dosage adjustment of the CYP substrate, especially if substrate has a narrow therapeutic index.1

Vaccines

Inactivated vaccines: Patients may receive inactivated vaccines.1 Inactivated vaccines administered during secukinumab therapy may not elicit an immune response sufficient to prevent disease.1

Live vaccines: Avoid live vaccines.1

Specific Drugs

Drug

Interaction

Comments

Cyclosporine

Possible effect on cyclosporine metabolism; because increased levels of cytokines during chronic inflammation may alter formation of CYP isoenzymes, secukinumab could normalize enzyme formation1

Consider monitoring cyclosporine concentrations and consider cyclosporine dosage adjustment upon initiation or discontinuance of secukinumab1

Influenza virus vaccine inactivated (non-US preparation)

Single secukinumab dose given 2 weeks before immunization in healthy individuals did not alter immune response to vaccine;1 17 vaccine effectiveness in patients receiving secukinumab therapy not established1

May be used concomitantly1

Meningococcal (group C) oligosaccharide diphtheria CRM197 conjugate vaccine (not commercially available in US)

Single secukinumab dose given 2 weeks before immunization in healthy individuals did not alter immune response to vaccine;1 17 vaccine effectiveness in patients receiving secukinumab therapy not established1

May be used concomitantly1

Warfarin

Possible effect on warfarin metabolism; because increased levels of cytokines during chronic inflammation may alter formation of CYP isoenzymes, secukinumab could normalize enzyme formation1

Consider monitoring therapeutic effect of warfarin and consider warfarin dosage adjustment upon initiation or discontinuance of secukinumab1

Cosentyx Pharmacokinetics

Absorption

Bioavailability

Bioavailability is 55–77% following sub-Q administration.1

Peak serum concentrations achieved by approximately 6 days following sub-Q administration of secukinumab 150 or 300 mg.1

Steady-state concentrations achieved by week 24 following sub-Q administration of secukinumab every 4 weeks.1

Cross-study comparisons suggest that administration by injection pen may result in higher trough concentrations (23–26% higher compared with prefilled syringe or 23–30% higher compared with sub-Q injection of reconstituted powder).1 10

Concentrations in interstitial fluid in lesional and nonlesional skin of patients with plaque psoriasis were 27–40% of those in serum at 1 and 2 weeks after a single 300-mg sub-Q dose.1

Pharmacokinetics are dose proportional over a sub-Q dose range of 25–300 mg.1

Special Populations

Serum concentrations higher in patients with lower body weight than in those with higher body weight.10

Distribution

Extent

Not known whether distributed into human milk.1

Special Populations

Volume of distribution increases as body weight increases.1

Elimination

Metabolism

Metabolic pathway not characterized.1

Expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.1

Half-life

22–31 days.1

Special Populations

Pharmacokinetics not formally studied in renal or hepatic impairment.1

Population analysis suggests age does not substantially affect clearance in adults with plaque psoriasis.1 Clearance appears to be similar in patients ≥65 years of age and younger adults.1

Clearance increases as body weight increases.1

Stability

Storage

Parenteral

Injection

Injection pen or prefilled syringe: 2–8°C.1 Keep in original carton and protect from light.1 Do not freeze.1

Powder for Injection

2–8°C.1 Keep in original package and protect from light.1 Do not freeze.1

Reconstituted solution: 2–8°C for up to 24 hours.1 Do not freeze.1

Actions

  • Binds to IL-17A and inhibits interaction with the IL-17 receptor.1 2 4 11

  • Neutralizes biologic activity of IL-17A and inhibits release of proinflammatory cytokines, chemokines, and mediators of tissue damage.1 2 4 11

  • Elevated levels of IL-17A found in psoriatic lesions and blood of individuals with psoriasis.1 4 7 13

Advice to Patients

  • Provide all patients with a copy of the manufacturer's patient information (medication guide) with each prescription of the drug.1 Importance of advising patients about potential benefits and risks of secukinumab.1 Importance of patients reading the medication guide prior to initiation of therapy and each time the prescription is refilled.1

  • Instruct patient and/or caregiver regarding proper storage, dosage, and administration of secukinumab, including the use of aseptic technique, and proper disposal of needles and syringes if it is determined the patient and/or caregiver is competent to safely administer the drug.1

  • Increased susceptibility to infection.1 Importance of promptly informing clinician if any signs or symptoms of infection (e.g., fever, sweats, or chills; muscle aches; cough or shortness of breath; blood in phlegm; weight loss; warm, red or painful sores on the body; diarrhea or stomach pain; burning upon urination or increased urination) occur.1

  • Advise patients with coexisting Crohn's disease to inform clinician if they experience worsening of Crohn's disease symptoms during secukinumab therapy.1

  • Importance of reviewing vaccination status with clinician and receiving all appropriate vaccinations prior to initiation of secukinumab.1

  • Importance of alerting clinician if allergy to latex exists.1

  • Importance of seeking immediate medical attention if symptoms of a serious allergic reaction (e.g., feeling faint; swelling of eyelids, face, lips, mouth, tongue, or throat; dyspnea or throat tightness; chest tightness; rash) occur.1

  • Importance of informing clinicians of existing or contemplated therapy, including prescription or OTC drugs, as well as any concomitant illnesses (e.g., active infection, Crohn's disease) or any history of tuberculosis or other infections.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Secukinumab

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for subcutaneous use

150 mg/mL

Cosentyx (available as single-use prefilled syringes and single-use pens)

Novartis

For injection, for subcutaneous use

150 mg

Cosentyx

Novartis

AHFS DI Essentials. © Copyright, 2016, American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

Date published: July 15, 2015
Last reviewed: July 15, 2015
Date modified: February 08, 2016

References

1. Novartis Pharmaceuticals. Cosentyx (secukinumab) injection prescribing information. East Hanover, NJ; 2015 Jan.

2. Langley RG, Elewski BE, Lebwohl M et al. Secukinumab in plaque psoriasis--results of two phase 3 trials. N Engl J Med. 2014; 371:326-38. [PubMed 25007392]

3. Ohtsuki M, Morita A, Abe M et al. Secukinumab efficacy and safety in Japanese patients with moderate-to-severe plaque psoriasis: subanalysis from ERASURE, a randomized, placebo-controlled, phase 3 study. J Dermatol. 2014; 41:1039-46. [PubMed 25354738]

4. US Food and Drug Administration. Center for Drug Evaluation and Research. Application number125504Orig1s000: Summary Review. From FDA website.

5. Langley RG, Feldman SR, Nyirady J et al. The 5-point Investigator's Global Assessment (IGA) Scale: A modified tool for evaluating plaque psoriasis severity in clinical trials. J Dermatolog Treat. 2013; :. [PubMed 24354461]

6. Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis. 2005; 64 Suppl 2:ii65-8; discussion ii69-73. [PubMed 15708941]

7. Blauvelt A, Prinz JC, Gottlieb AB et al. Secukinumab administration by pre-filled syringe: efficacy, safety and usability results from a randomized controlled trial in psoriasis (FEATURE). Br J Dermatol. 2015; 172:484-93. [PubMed 25132411]

8. Paul C, Lacour JP, Tedremets L et al. Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol. 2014; :. [PubMed 25243910]

9. Lebwohl M, Swensen AR, Nyirady J et al. The Psoriasis Symptom Diary: development and content validity of a novel patient-reported outcome instrument. Int J Dermatol. 2014; 53:714-22. [PubMed 23557000]

10. US Food and Drug Administration. Center for Drug Evaluation and Research. Application number125504Orig1s000: Clinical pharmacology and biopharmaceutics review(s). From FDA website.

11. US Food and Drug Administration. Center for Drug Evaluation and Research. Application number125504Orig1s000: Pharmacology review(s). From FDA website.

12. Adami S, Cavani A, Rossi F et al. The role of interleukin-17A in psoriatic disease. BioDrugs. 2014; 28:487-97. [PubMed 24890029]

13. Lønnberg AS, Zachariae C, Skov L. Targeting of interleukin-17 in the treatment of psoriasis. Clin Cosmet Investig Dermatol. 2014; 7:251-9. [PubMed 25246805]

14. Food and Drug Administration. Amended economic impact analysis of final rule requiring use of labeling on natural rubber containing devices. 21 CFR Part 801. Final rule. (Docket No. 96N-0119) Fed Regist. 1998; 63:50660-704.

15. Food and Drug Administration. Latex-containing devices; user labeling. 21 CFR Part 801. Proposed rule. (Docket No. 96N-0119) Fed Regist. 1996; 61:32617-21.

16. Food and Drug Administration. Natural rubber-containing medical devices; user labeling. 21 CFR Part 801. Final rule. (Docket No. 96N-0119) Fed Regist. 1997; 62:51021-30.

17. Chioato A, Noseda E, Stevens M et al. Treatment with the interleukin-17A-blocking antibody secukinumab does not interfere with the efficacy of influenza and meningococcal vaccinations in healthy subjects: results of an open-label, parallel-group, randomized single-center study. Clin Vaccine Immunol. 2012; 19:1597-602. [PubMed 22875601]

18. Novartis. Cosentyx 150 mg solution for injection summary of product characteristics. Frimley, UK; 2015 Feb 9.

19. Hueber W, Sands BE, Lewitzky S et al. Secukinumab, a human anti-IL-17A monoclonal antibody, for moderate to severe Crohn's disease: unexpected results of a randomised, double-blind placebo-controlled trial. Gut. 2012; 61:1693-700. [PubMed 22595313]

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