Drug: Cosentyx

Secukinumab is a recombinant human monoclonal IgG1/κ antibody that binds specifically to IL-17A. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution. COSENTYX is supplied in a single-use Sensoready pen with a 27 gauge fixed ½ inch needle, or a single-use prefilled syringe with a 27 gauge fixed ½ inch needle. The removable cap of the COSENTYX Sensoready pen or prefilled syringe contains natural rubber latex. Each COSENTYX Sensoready pen or prefilled syringe contains 150 mg of secukinumab formulated in: Lhistidine/ histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX for Injection COSENTYX for injection is supplied as a sterile, preservative free, white to slightly yellow, lyophilized powder in singleuse vials. Each COSENTYX vial contains 150 mg of secukinumab formulated in L-histidine/L-histidine hydrochloride monohydrate (4.656 mg), polysorbate 80 (0.6 mg), and sucrose (92.43 mg). Following reconstitution with 1 mL Sterile Water for Injection, USP, the resulting pH is approximately 5.8. Last reviewed on RxList: 1/29/2015
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

The following adverse reactions are discussed in greater detail elsewhere in the labeling:
  • Infections [see WARNINGS AND PRECAUTIONS]
  • Exacerbations of Crohn's Disease [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 3430 plaque psoriasis subjects were treated with COSENTYX in controlled and uncontrolled clinical trials. Of these, 1641 subjects were exposed for at least 1 year. Four placebo-controlled phase 3 trials in plaque psoriasis subjects were pooled to evaluate the safety of COSENTYX in comparison to placebo up to 12 weeks after treatment initiation, in Trials 1, 2, 3 and 4. In total, 2077 subjects were evaluated (691 to COSENTYX 300 mg group, 692 to COSENTYX 150 mg group, and 694 to placebo group) [see Clinical Studies]. Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the COSENTYX groups than the placebo group during the 12-week placebo-controlled period of the placebo-controlled trials. Table 1 : Adverse Reactions Reported by Greater Than 1% of Subjects with Plaque Psoriasis Through Week 12 in Trials 1, 2, 3 and 4
Adverse Reactions COSENTYX Placebo
(N=694)
n (%) 300 mg
(N=691)
n (%) 150 mg
(N=692)
n (%) Nasopharyngitis 79 (11.4) 85 (12.3) 60 (8.6) Diarrhea 28 (4.1) 18 (2.6) 10 (1.4) Upper respiratory tract infection 17 (2.5) 22 (3.2) 5 (0.7) Rhinitis 10 (1.4) 10 (1.4) 5 (0.7) Oral herpes 9 (1.3) 1 (0.1) 2 (0.3) Pharyngitis 8 (1.2) 7 (1.0) 0 (0) Urticaria 4 (0.6) 8 (1.2) 1 (0.1) Rhinorrhea 8 (1.2) 2 (0.3) 1 (0.1) Adverse reactions that occurred at rates less than 1% in the placebo-controlled period of Trials 1, 2, 3, and 4 through week 12 included: sinusitis, tinea pedis, conjunctivitis, tonsillitis, oral candidiasis, impetigo, otitis media, otitis externa, inflammatory bowel disease, increased liver transaminases and neutropenia. Infections In the placebo-controlled period of the clinical trials in plaque psoriasis (a total of 1382 subjects treated with COSENTYX and 694 subjects treated with placebo up to 12 weeks), infections were reported in 28.7% of subjects treated with COSENTYX compared with 18.9% of subjects treated with placebo. Serious infections occurred in 0.14% of patients treated with COSENTYX and in 0.3% of patients treated with placebo [see WARNINGS AND PRECAUTIONS]. Over the entire treatment period (a total of 3430 plaque psoriasis subjects treated with COSENTYX for up to 52 weeks for the majority of subjects), infections were reported in 47.5% of subjects treated with COSENTYX (0.9 per patient-year of follow-up). Serious infections were reported in 1.2% of subjects treated with COSENTYX (0.015 per patient-year of follow-up). Phase 3 data showed an increasing trend for some types of infection with increasing serum concentration of secukinumab. Candida infections, herpes viral infections, staphylococcal skin infections, and infections requiring treatment increased as serum concentration of secukinumab increased. Neutropenia was observed in clinical trials. Most cases of secukinumab-associated neutropenia were transient and reversible. No serious infections were associated with cases of neutropenia. Exacerbation of Crohn's Disease Exacerbations of Crohn's disease, in some cases serious, were observed in clinical trials in both COSENTYX and placebo treated patients. In the psoriasis program, with 3430 patients exposed to COSENTYX there were 3 cases of exacerbation of Crohn's disease [see WARNINGS AND PRECAUTIONS]. Hypersensitivity Reactions Anaphylaxis and cases of urticaria occurred in COSENTYX-treated patients in clinical trials [see WARNINGS AND PRECAUTIONS]. Immunogenicity As with all therapeutic proteins, there is the potential for immunogenicity. The immunogenicity of COSENTYX was evaluated using an electrochemiluminescence-based bridging immunoassay. Less than 1% of subjects treated with COSENTYX developed antibodies to secukinumab in up to 52 weeks of treatment. However, this assay has limitations in detecting anti-secukinumab antibodies in the presence of secukinumab; therefore the incidence of antibody development might not have been reliably determined. Of the subjects who developed antidrug antibodies, approximately one-half had antibodies that were classified as neutralizing. Neutralizing antibodies were not associated with loss of efficacy. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to COSENTYX with the incidences of antibodies to other products may be misleading. Read the Cosentyx (secukinumab injection) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

Recommended Dosage The recommended dose is 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks. Each 300 mg dose is given as 2 subcutaneous injections of 150 mg. For some patients, a dose of 150 mg may be acceptable. Important Administration Instructions There are three presentations for COSENTYX (i.e., Sensoready pen, prefilled syringe, and lyophilized powder in vial for reconstitution). The COSENTYX “Instructions for Use” for each presentation contains more detailed instructions on the preparation and administration of COSENTYX [see Instructions For Use]. COSENTYX is intended for use under the guidance and supervision of a physician. Patients may self-inject after proper training in subcutaneous injection technique using the Sensoready pen or prefilled syringe and when deemed appropriate. The lyophilized powder for reconstitution is for healthcare provider use only. Administer each injection at a different anatomic location (such as upper arms, thighs or any quadrant of abdomen) than the previous injection, and not into areas where the skin is tender, bruised, erythematous, indurated or affected by psoriasis. Administration of COSENTYX in the upper, outer arm may be performed by a caregiver or healthcare provider. Preparation For Use Of COSENTYX Sensoready® Pen And Prefilled Syringe Before injection, remove COSENTYX Sensoready pen or COSENTYX prefilled syringe from the refrigerator and allow COSENTYX to reach room temperature (15 to 30 minutes) without removing the needle cap. The removable cap of the COSENTYX Sensoready pen and the COSENTYX prefilled syringe contains natural rubber latex and should not be handled by latex-sensitive individuals [see WARNINGS AND PRECAUTIONS]. Inspect COSENTYX visually for particulate matter and discoloration prior to administration. COSENTYX injection is a clear to slightly opalescent, colorless to slightly yellow solution. Do not use if the liquid contains visible particles, is discolored or cloudy. COSENTYX does not contain preservatives; therefore, administer the Sensoready pen or prefilled syringe within 1 hour after removal from the refrigerator. Discard any unused product remaining in the Sensoready pen or prefilled syringe. Reconstitution And Preparation Of COSENTYX Lyophilized Powder COSENTYX lyophilized powder should be prepared and reconstituted with Sterile Water for Injection 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.
  1. Remove the vial of COSENTYX lyophilized powder from the refrigerator and allow to stand for 15 to 30 minutes to reach room temperature. Ensure the Sterile Water for Injection is at room temperature.
  2. Slowly inject 1 mL of Sterile Water for Injection into the vial containing COSENTYX lyophilized powder and direct the stream of Sterile Water for Injection onto the lyophilized powder.
  3. 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.
  4. Allow the vial to stand for about 10 minutes at room temperature to allow for dissolution. Note that foaming may occur.
  5. 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.
  6. Allow the vial to stand undisturbed at room temperature for approximately 5 minutes. The reconstituted COSENTYX 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.
  7. Prepare the required number of vials (1 vial for the 150 mg dose or 2 vials for the 300 mg dose).
  8. The COSENTYX reconstituted solution contains 150 mg of secukinumab in 1 mL of solution. After reconstitution, use the solution immediately or store in the refrigerator at 2°C to 8°C (36°F to 46°F) for up to 24 hours. Do not freeze.
  9. If stored at 2°C to 8°C (36°F to 46°F), allow the reconstituted COSENTYX solution to reach room temperature (15 to 30 minutes) before administration. COSENTYX does not contain preservatives; therefore, administer within 1 hour after removal from 2°C to 8°C (36°F to 46°F) storage.

Source: http://www.rxlist.com

Drug interaction trials have not been conducted with COSENTYX. Live Vaccines Patients treated with COSENTYX may not receive live vaccinations [see WARNINGS AND PRECAUTIONS]. Non-Live Vaccines Patients treated with COSENTYX may receive non-live vaccinations. Healthy individuals who received a single 150 mg dose of COSENTYX 2 weeks prior to vaccination with a non-U.S. approved group C meningococcal polysaccharide conjugate vaccine and a non-U.S. approved inactivated seasonal influenza vaccine had similar antibody responses compared to individuals who did not receive COSENTYX prior to vaccination. The clinical effectiveness of meningococcal and influenza vaccines has not been assessed in patients undergoing treatment with COSENTYX [see WARNINGS AND PRECAUTIONS]. CYP450 Substrates A role for IL-17A in the regulation of CYP450 enzymes has not been reported. The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation. Thus, COSENTYX, an antagonist of IL-17A, could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of COSENTYX in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate. Last reviewed on RxList: 1/29/2015
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

COSENTYX™ is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

Source: http://www.rxlist.com

COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients [see WARNINGS AND PRECAUTIONS]. Last reviewed on RxList: 1/29/2015
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Doses up to 30 mg/kg intravenously (i.e., approximately 2000 to 3000 mg) have been administered in clinical trials without dose-limiting toxicity. In the event of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.

Source: http://www.rxlist.com

Dosage Forms And Strengths
  • Injection: 150 mg/mL solution in a single-use Sensoready pen
  • Injection: 150 mg/mL solution in a single-use prefilled syringe
  • For Injection: 150 mg, lyophilized powder in a single-use vial for reconstitution (for healthcare professional use only)
COSENTYX Sensoready pen NDC 0078-0639-41: Carton of two 150 mg/mL (300 mg dose) Sensoready pens (injection) NDC 0078-0639-68: Carton of one 150 mg/mL single-use Sensoready pen (injection) COSENTYX prefilled syringe NDC 0078-0639-98: Carton of two 150 mg/mL (300 mg dose) single-use prefilled syringes (injection) NDC 0078-0639-97: Carton of one 150 mg/mL single-use prefilled syringe (injection) The removable cap of the COSENTYX Sensoready pen and prefilled syringe contains natural rubber latex. Each Sensoready pen and prefilled syringe is equipped with a needle safety guard. COSENTYX vial (for healthcare professional use only) NDC 0078-0657-61: Carton of one 150 mg lyophilized powder in a single-use vial (for injection) Storage And Handling COSENTYX Sensoready pens, prefilled syringes and vials must be refrigerated at 2°C to 8°C (36°F to 46°F). Keep the product in the original carton to protect from light until the time of use. Do not freeze. To avoid foaming do not shake. COSENTYX does not contain a preservative; discard any unused portion. Manufactured by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. Revised: Jan 2015 Last reviewed on RxList: 1/29/2015
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Infections COSENTYX may increase the risk of infections. In clinical trials, a higher rate of infections was observed in COSENTYX-treated subjects compared to placebo-treated subjects. In placebo-controlled clinical trials, higher rates of common infections such as nasopharyngitis (11.4% versus 8.6%), upper respiratory tract infection (2.5% versus 0.7%) and mucocutaneous infections with candida (1.2% versus 0.3%) were observed with COSENTYX compared with placebo. The incidence of some types of infections appeared to be dose-dependent in clinical studies [see ADVERSE REACTIONS]. Exercise caution when considering the use of COSENTYX in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, the patient should be closely monitored and COSENTYX should be discontinued until the infection resolves. Pre-treatment Evaluation For Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with COSENTYX. Do not administer COSENTYX to patients with active TB infection. Initiate treatment of latent TB prior to administering COSENTYX. Consider anti-TB therapy prior to initiation of COSENTYX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving COSENTYX should be monitored closely for signs and symptoms of active TB during and after treatment. Exacerbations Of Crohn's Disease Exercise caution when prescribing COSENTYX to patients with active Crohn's disease, as exacerbations of Crohn's disease, in some cases serious, were observed in COSENTYX-treated patients during clinical trials. Patients who are treated with COSENTYX and have active Crohn's disease should be monitored closely [see ADVERSE REACTIONS]. Hypersensitivity Reactions Anaphylaxis and cases of urticaria occurred in COSENTYX-treated patients in the clinical trials. If an anaphylactic or other serious allergic reaction occurs, administration of COSENTYX should be discontinued immediately and appropriate therapy initiated [see ADVERSE REACTIONS]. Risk Of Hypersensitivity In Latex-sensitive Individuals The removable cap of the COSENTYX Sensoready pen and the COSENTYX prefilled syringe contains natural rubber latex which may cause an allergic reaction in latex-sensitive individuals. The safe use of COSENTYX Sensoready pen or prefilled syringe in latex-sensitive individuals has not been studied. Vaccinations Prior to initiating therapy with COSENTYX, consider completion of all age appropriate immunizations according to current immunization guidelines. Patients treated with COSENTYX should not receive live vaccines. Non-live vaccinations received during a course of COSENTYX may not elicit an immune response sufficient to prevent disease. Patient Counseling Information Advise the patient to read FDA-approved patient labeling [Medication Guide and Instructions for Use]. Patient Counseling Instruct patients to read the Medication Guide before starting COSENTYX therapy and to reread the Medication Guide each time the prescription is renewed. Advise patients of the potential benefits and risks of COSENTYX. Infections Inform patients that COSENTYX may lower the ability of their immune system to fight infections. Instruct patients of the importance of communicating any history of infections to the doctor and contacting their doctor if they develop any symptoms of infection [see WARNINGS AND PRECAUTIONS]. Hypersensitivity Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]. Instruction on Injection Technique Perform the first self-injection under the supervision of a qualified healthcare professional. If a patient or caregiver is to administer COSENTYX, instruct him/her in injection techniques and assess their ability to inject subcutaneously to ensure the proper administration of COSENTYX [see Medication Guide and Instructions for Use]. Instruct patients or caregivers in the technique of proper syringe and needle disposal, and advise them not to reuse these items. Instruct patients to inject the full amount of COSENTYX (1 or 2 subcutaneous injections of 150 mg) according to the directions provided in the Medication Guide and Instructions for Use. Dispose of needles, syringes and pens in a puncture-resistant container. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of Fertility Animal studies have not been conducted to evaluate the carcinogenic or mutagenic potential of COSENTYX. Some published literature suggests that IL-17A directly promotes cancer cell invasion in vitro, whereas other reports indicate IL- 17A promotes T-cell mediated tumor rejection. Depletion of IL-17A with a neutralizing antibody inhibited tumor development in mice. The relevance of experimental findings in mouse models for malignancy risk in humans is unknown. No effects on fertility were observed in male and female mice that were administered a murine analog of secukinumab at subcutaneous doses up to 150 mg/kg once weekly prior to and during the mating period. Use In Specific Populations Pregnancy Pregnancy Category B There are no adequate and well controlled trials of COSENTYX in pregnant women. Developmental toxicity studies conducted with monkeys found no evidence of harm to the fetus due to secukinumab. COSENTYX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. An embryofetal development study was performed in cynomolgus monkeys with secukinumab. No malformations or embryofetal toxicity were observed in fetuses from pregnant monkeys that were administered secukinumab weekly by the subcutaneous route during the period of organogenesis at doses up to 30 times the maximum recommended human dose (MRHD; on a mg/kg basis at a maternal dose of 150 mg/kg). A pre- and postnatal development toxicity study was performed in mice with a murine analog of secukinumab. No treatment related effects on functional, morphological or immunological development were observed in fetuses from pregnant mice that were administered the murine analog of secukinumab on gestation days 6, 11, and 17 and on postpartum days 4, 10, and 16 at doses up to 150 mg/kg/dose. Nursing Mothers It is not known whether secukinumab is excreted in human milk or absorbed systemically after ingestion. Because many drugs are excreted in human milk, caution should be exercised when COSENTYX is administered to a nursing woman. Pediatric Use Safety and effectiveness of COSENTYX in pediatric patients have not been evaluated. Geriatric Use Of the 3430 plaque psoriasis subjects exposed to COSENTYX in clinical trials, a total of 230 were 65 years or older, and 32 subjects were 75 years or older. Although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 years and older was not sufficient to determine whether they responded differently from younger subjects. Last reviewed on RxList: 1/29/2015
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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