Cosentyx

Antipsoriatic Monoclonal Antibodies and Others
Interleukin-17A (IL-17A) Inhibitors

The removable caps of the 75 mg/0.5 mL and 150 mg/mL prefilled syringes and the Sensoready pen contain natural rubber latex. Persons with a hypersensitivity to latex should not handle the cap.
Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. The solution should be free of visible particles, clear to slightly opalescent, and colorless to slightly yellow.

Secukinumab is available as a prefilled syringe (75 mg/0.5 mL, 150 mg/mL, and 300 mg/2 mL), UnoReady pen (300 mg/2 mL), and Sensoready pen (150 mg/mL). All formulations are single-dose. Patients requiring a 300 mg dose may receive either a single 300 mg subcutaneous injection or two 150 mg subcutaneous injections.
The prefilled syringes, UnoReady pen, and Sensoready pen may be self-administered by adult patients after proper training. Self-administration is not recommended for pediatric patients; a properly trained adult caregiver should prepare and inject the pediatric patient.
Injections should be administered at a different location than was used for the previous injection.
Administration sites for self-administration include upper arms, thighs, and any quadrant of the abdomen. Caregivers and health care professionals may inject in the upper, outer arm.
Do not administer into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis.
 
Preparation for use of the prefilled syringes, Sensoready pen, or UnoReady pen:
Prior to administration, remove the product from the refrigerator and allow time to reach room temperature (i.e., 15 to 30 minutes for Sensoready pen, 75 mg/0.5 mL or 150 mg/mL prefilled syringe; 30 to 45 minutes for UnoReady pen or the 300 mg/2 mL prefilled syringe). Do not remove the needle cap.
Storage: If necessary, the Sensoready pen and the 75 mg/0.5 mL and 150 mg/mL prefilled syringe(s) may be stored for up to 4 days at room temperature not to exceed 30 degrees C (86 degrees F). Discard if the pen or syringe(s) have been kept out of the refrigerator and not used in over 4 days. Within the 4 days window, if unused and not stored above 30 degrees C (86 degrees F), the pen or syringe(s) may be returned to the refrigerator only 1 time and must be stored at 2 to 8 degrees C (36 to 46 degrees F) until used or expired. Write the date removed from and returned to the refrigerator in the space provided on the carton. The 300 mg/2 mL prefilled syringe and the Unoready pen do not supply information for extended storage once removed from refrigeration.

anaphylactoid reactions / Rapid / Incidence not known

neutropenia / Delayed / 0-11.0
oral ulceration / Delayed / 0.1-1.3
conjunctivitis / Delayed / 0-1.0
candidiasis / Delayed / 0-1.0
elevated hepatic enzymes / Delayed / 0-1.0
antibody formation / Delayed / 0-1.0
atopic dermatitis / Delayed / Incidence not known
ocular infection / Delayed / Incidence not known
colitis / Delayed / Incidence not known
gastritis / Delayed / Incidence not known
inflammatory bowel disease / Delayed / Incidence not known

infection / Delayed / 28.7-47.5
pharyngitis / Delayed / 1.0-12.3
diarrhea / Early / 2.6-4.1
rhinitis / Early / 1.4-1.4
urticaria / Rapid / 0.6-1.2
rhinorrhea / Early / 0.3-1.2
sinusitis / Delayed / 0-1.0
rash / Early / Incidence not known
abdominal pain / Early / Incidence not known

Cosentyx

Rx

Subcutaneous IgG1 monoclonal antibody that inhibits interleukin-17A (IL-17A)
Used for plaque psoriasis, psoriatic arthritis, enthesitis-related arthritis, ankylosing spondylitis, and active non-radiographic axial spondyloarthritis
May increase risk for serious infection and may cause hypersensitivity reactions

300 mg subcutaneously at weeks 0, 1, 2, 3, and 4, then 300 mg subcutaneously every 4 weeks. A dose of 150 mg may be acceptable for some.

150 mg subcutaneously at weeks 0, 1, 2, 3, and 4, then 150 mg subcutaneously every 4 weeks.

75 mg subcutaneously at weeks 0, 1, 2, 3, and 4, then 75 mg subcutaneously every 4 weeks.

300 mg subcutaneously at weeks 0, 1, 2, 3, and 4, then 300 mg subcutaneously every 4 weeks. A dose of 150 mg may be acceptable for some.

150 mg subcutaneously at weeks 0, 1, 2, 3, and 4, then 150 mg subcutaneously every 4 weeks.

75 mg subcutaneously at weeks 0, 1, 2, 3, and 4, then 75 mg subcutaneously every 4 weeks.

150 mg subcutaneously every 4 weeks, or may initiate with a loading dose of 150 mg subcutaneously at weeks 0, 1, 2, 3, and 4, then 150 mg subcutaneously every 4 weeks. Consider increasing the dose to 300 mg subcutaneously every 4 weeks if active disease persists.

150 mg subcutaneously at weeks 0, 1, 2, 3, and 4, then 150 mg subcutaneously every 4 weeks.

75 mg subcutaneously at weeks 0, 1, 2, 3, and 4, then 75 mg subcutaneously every 4 weeks.

May initiate with or without a loading dose. WITH LOADING DOSE: 150 mg subcutaneously at weeks 0, 1, 2, 3, and 4, then every 4 weeks thereafter. WITHOUT A LOADING DOSE: 150 mg subcutaneously every 4 weeks. TITRATION: Consider 300 mg subcutaneously every 4 weeks if the patient continues to have active disease. In clinical studies, patients were allowed to continue any of the following medications: sulfasalazine, weekly methotrexate, prednisone or prednisone equivalent (up to 10 mg/day), and any non-steroidal anti-inflammatory medications (NSAIDs).

May initiate with or without a loading dose. WITH LOADING DOSE: 150 mg subcutaneously at weeks 0, 1, 2, 3, and 4, then follow with 150 mg subcutaneously every 4 weeks for maintenance. WITHOUT LOADING DOSE: 150 mg subcutaneously every 4 weeks. In a clinical trial, patients with active non-radiographical axial spondyloarthritis were allowed to received concomitant therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and disease-modifying antirheumatic drugs (DMARDs).

150 mg subcutaneously at Weeks 0, 1, 2, 3, and 4. Then give 150 mg subcutaneously every 4 weeks thereafter.

75 mg subcutaneously at Weeks 0, 1, 2, 3, and 4. Then give 75 mg subcutaneously every 4 weeks thereafter.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Abatacept: (Major) Concomitant use of abatacept with biological DMARDs, such as secukinumab, is not recommended because of the possibility of additive immunosuppression and increased risk of infection. There is insufficient experience to assess the safety and efficacy of abatacept administered concurrently with secukinumab.
Alfentanil: (Moderate) If secukinumab is initiated or discontinued in a patient taking alfentanil, monitor for altered patient response to alfentanil; alfentanil dose adjustments may be needed. The formation of CYP450 enzymes may be altered by increased concentrations of cytokines during chronic inflammation. Thus, the formation of CYP450 enzymes could be normalized during secukinumab administration. In theory, clinically relevant drug interactions may occur with CYP450 substrates that have a narrow therapeutic index such as alfentanil.
Bacillus Calmette-Guerin Vaccine, BCG: (Major) Do not administer live vaccines to secukinumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving secukinumab. Before initiation of secukinumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Secukinumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. Similar antibody responses were seen when healthy individuals who received a single 150 mg dose of secukinumab 2 weeks before vaccination with a non-US approved group C meningococcal polysaccharide conjugate vaccine and a non-US approved inactivated seasonal influenza vaccine. The efficacy of meningococcal and influenza vaccines has not been evaluated in patients undergoing treatment with secukinumab.
Baricitinib: (Major) Concomitant use of baricitinib with biologic DMARDs, such as secukinumab, is not recommended because of the possibility of additive immunosuppression and increased infection risk. Baricitinib may be used as monotherapy or concomitantly with methotrexate or other nonbiologic DMARDs.
Canakinumab: (Major) Avoid the concomitant use of canakinumab with other interleukin inhibitors, such as secukinumab; coadministration has not been studied and may result in additive immunosuppression and increased risk of infection.
Carbamazepine: (Moderate) If secukinumab is initiated or discontinued in a patient taking carbamazepine, monitor carbamazepine concentrations; carbamazepine dose adjustments may be needed. The formation of CYP450 enzymes may be altered by increased concentrations of cytokines during chronic inflammation. Thus, the formation of CYP450 enzymes could be normalized during secukinumab administration. In theory, clinically relevant drug interactions may occur with CYP450 substrates that have a narrow therapeutic index such as carbamazepine. These interactions remain theoretical. Results from a drug-drug interaction study in subjects with moderate to severe psoriasis showed no clinically relevant interaction for drugs metabolized by CYP3A4.
Cholera Vaccine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the live cholera vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to cholera bacteria after receiving the vaccine.
Cisapride: (Moderate) If secukinumab is initiated or discontinued in a patient taking cisapride, monitor for altered patient response to cisapride; cisapride dose adjustments may be needed. The formation of CYP450 enzymes may be altered by increased concentrations of cytokines during chronic inflammation. Thus, the formation of CYP450 enzymes could be normalized during secukinumab administration. In theory, clinically relevant drug interactions may occur with CYP450 substrates that have a narrow therapeutic index such as cisapride.
Cyclosporine: (Moderate) If secukinumab is initiated or discontinued in a patient taking cyclosporine, monitor cyclosporine concentrations; cyclosporine dose adjustments may be needed. The formation of CYP450 enzymes may be altered by increased concentrations of cytokines during chronic inflammation. Thus, the formation of CYP450 enzymes could be normalized during secukinumab administration. In theory, clinically relevant drug interactions may occur with CYP450 substrates that have a narrow therapeutic index such as cyclosporine. These interactions remain theoretical. Results from a drug-drug interaction study in subjects with moderate to severe psoriasis showed no clinically relevant interaction for drugs metabolized by CYP3A4.
Dextromethorphan; Quinidine: (Moderate) If secukinumab is initiated or discontinued in a patient taking quinidine, monitor for altered patient response to quinidine; quinidine dose adjustments may be needed. The formation of CYP450 enzymes may be altered by increased concentrations of cytokines during chronic inflammation. Thus, the formation of CYP450 enzymes could be normalized during secukinumab administration. In theory, clinically relevant drug interactions may occur with CYP450 substrates that have a narrow therapeutic index such as quinidine.
Ethosuximide: (Moderate) If secukinumab is initiated or discontinued in a patient taking ethosuximide, monitor ethosuximide concentrations; ethosuximide dose adjustments may be needed. The formation of CYP450 enzymes may be altered by increased concentrations of cytokines during chronic inflammation. Thus, the formation of CYP450 enzymes could be normalized during secukinumab administration. In theory, clinically relevant drug interactions may occur with CYP450 substrates that have a narrow therapeutic index such as ethosuximide. These interactions remain theoretical. Results from a drug-drug interaction study in subjects with moderate to severe psoriasis showed no clinically relevant interaction for drugs metabolized by CYP3A4.
Everolimus: (Moderate) Monitor everolimus whole blood trough concentrations as appropriate if treatment with secukinumab is initiated for a patient on chronic everolimus therapy. The dose of everolimus may need to be increased. Everolimus is a sensitive CYP3A4 substrate. During chronic inflammation, increased levels of certain cytokines can decrease the formation of CYP450 enzymes. Thus, the formation of CYP3A4 could be normalized during secukinumab administration. The addition of secukinumab to everolimus therapy may increase the metabolism of everolimus and decrease everolimus blood concentrations.
Fentanyl: (Moderate) If secukinumab is initiated or discontinued in a patient taking fentanyl, monitor for altered patient response to fentanyl; fentanyl dose adjustments may be needed. The formation of CYP450 enzymes may be altered by increased concentrations of cytokines during chronic inflammation. Thus, the formation of CYP450 enzymes could be normalized during secukinumab administration. In theory, clinically relevant drug interactions may occur with CYP450 substrates that have a narrow therapeutic index such as fentanyl.
Fosphenytoin: (Moderate) If secukinumab is initiated or discontinued in a patient taking fosphenytoin, monitor phenytoin concentrations; fosphenytoin dose adjustments may be needed. The formation of CYP450 enzymes may be altered by increased concentrations of cytokines during chronic inflammation. Thus, the formation of CYP450 enzymes could be normalized during secukinumab administration. In theory, clinically relevant drug interactions may occur with CYP450 substrates that have a narrow therapeutic index such as fosphenytoin.
Intranasal Influenza Vaccine: (Major) Do not administer live vaccines to secukinumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving secukinumab. Before initiation of secukinumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Secukinumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. Similar antibody responses were seen when healthy individuals who received a single 150 mg dose of secukinumab 2 weeks before vaccination with a non-US approved group C meningococcal polysaccharide conjugate vaccine and a non-US approved inactivated seasonal influenza vaccine. The efficacy of meningococcal and influenza vaccines has not been evaluated in patients undergoing treatment with secukinumab.
Live Vaccines: (Major) Do not administer live vaccines to secukinumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving secukinumab. Before initiation of secukinumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Secukinumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. Similar antibody responses were seen when healthy individuals who received a single 150 mg dose of secukinumab 2 weeks before vaccination with a non-US approved group C meningococcal polysaccharide conjugate vaccine and a non-US approved inactivated seasonal influenza vaccine. The efficacy of meningococcal and influenza vaccines has not been evaluated in patients undergoing treatment with secukinumab.
Macitentan: (Major) Avoid coadministration of macitentan with secukinumab due to the potential for increases in macitentan exposure and adverse effects. Macitentan is a CYP3A4 and CYP2C9 substrate and secukinumab is a dual moderate CYP3A4 and CYP2C9 inhibitor. Concomitant use is predicted to increase macitentan exposure approximately 4-fold.
Measles Virus; Mumps Virus; Rubella Virus; Varicella Virus Vaccine, Live: (Major) Do not administer live vaccines to secukinumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving secukinumab. Before initiation of secukinumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Secukinumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. Similar antibody responses were seen when healthy individuals who received a single 150 mg dose of secukinumab 2 weeks before vaccination with a non-US approved group C meningococcal polysaccharide conjugate vaccine and a non-US approved inactivated seasonal influenza vaccine. The efficacy of meningococcal and influenza vaccines has not been evaluated in patients undergoing treatment with secukinumab.
Measles/Mumps/Rubella Vaccines, MMR: (Major) Do not administer live vaccines to secukinumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving secukinumab. Before initiation of secukinumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Secukinumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. Similar antibody responses were seen when healthy individuals who received a single 150 mg dose of secukinumab 2 weeks before vaccination with a non-US approved group C meningococcal polysaccharide conjugate vaccine and a non-US approved inactivated seasonal influenza vaccine. The efficacy of meningococcal and influenza vaccines has not been evaluated in patients undergoing treatment with secukinumab.
Phenytoin: (Moderate) If secukinumab is initiated or discontinued in a patient taking phenytoin, monitor phenytoin concentrations; phenytoin dose adjustments may be needed. The formation of CYP450 enzymes may be altered by increased concentrations of cytokines during chronic inflammation. Thus, the formation of CYP450 enzymes could be normalized during secukinumab administration. In theory, clinically relevant drug interactions may occur with CYP450 substrates that have a narrow therapeutic index such as phenytoin.
Pimozide: (Moderate) If secukinumab is initiated or discontinued in a patient taking pimozide, monitor for altered patient response to pimozide; pimozide dose adjustments may be needed. The formation of CYP450 enzymes may be altered by increased concentrations of cytokines during chronic inflammation. Thus, the formation of CYP450 enzymes could be normalized during secukinumab administration. In theory, clinically relevant drug interactions may occur with CYP450 substrates that have a narrow therapeutic index such as pimozide.
Quinidine: (Moderate) If secukinumab is initiated or discontinued in a patient taking quinidine, monitor for altered patient response to quinidine; quinidine dose adjustments may be needed. The formation of CYP450 enzymes may be altered by increased concentrations of cytokines during chronic inflammation. Thus, the formation of CYP450 enzymes could be normalized during secukinumab administration. In theory, clinically relevant drug interactions may occur with CYP450 substrates that have a narrow therapeutic index such as quinidine.
Rotavirus Vaccine: (Major) Do not administer live vaccines to secukinumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving secukinumab. Before initiation of secukinumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Secukinumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. Similar antibody responses were seen when healthy individuals who received a single 150 mg dose of secukinumab 2 weeks before vaccination with a non-US approved group C meningococcal polysaccharide conjugate vaccine and a non-US approved inactivated seasonal influenza vaccine. The efficacy of meningococcal and influenza vaccines has not been evaluated in patients undergoing treatment with secukinumab.
Sarilumab: (Major) Avoid using sarilumab with other biological DMARDs, such as secukinumab; coadministration has not been studied and may result in additive immunosuppression and increased risk of infection.
SARS-CoV-2 (COVID-19) vaccines: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine.
Smallpox and Monkeypox Vaccine, Live, Nonreplicating: (Major) Do not administer live vaccines to secukinumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving secukinumab. Before initiation of secukinumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Secukinumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. Similar antibody responses were seen when healthy individuals who received a single 150 mg dose of secukinumab 2 weeks before vaccination with a non-US approved group C meningococcal polysaccharide conjugate vaccine and a non-US approved inactivated seasonal influenza vaccine. The efficacy of meningococcal and influenza vaccines has not been evaluated in patients undergoing treatment with secukinumab.
Smallpox Vaccine, Vaccinia Vaccine: (Major) Do not administer live vaccines to secukinumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving secukinumab. Before initiation of secukinumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Secukinumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. Similar antibody responses were seen when healthy individuals who received a single 150 mg dose of secukinumab 2 weeks before vaccination with a non-US approved group C meningococcal polysaccharide conjugate vaccine and a non-US approved inactivated seasonal influenza vaccine. The efficacy of meningococcal and influenza vaccines has not been evaluated in patients undergoing treatment with secukinumab.
Tacrolimus: (Moderate) If secukinumab is initiated or discontinued in a patient taking tacrolimus, monitor tacrolimus concentrations; tacrolimus dose adjustments may be needed. The formation of CYP450 enzymes may be altered by increased concentrations of cytokines during chronic inflammation. Thus, the formation of CYP450 enzymes could be normalized during secukinumab administration. In theory, clinically relevant drug interactions may occur with CYP450 substrates that have a narrow therapeutic index such as tacrolimus. These interactions remain theoretical. Results from a drug-drug interaction study in subjects with moderate to severe psoriasis showed no clinically relevant interaction for drugs metabolized by CYP3A4.
Theophylline, Aminophylline: (Moderate) If secukinumab is initiated or discontinued in a patient taking aminophylline, monitor theophylline concentrations; aminophylline dose adjustments may be needed. The formation of CYP450 enzymes may be altered by increased concentrations of cytokines during chronic inflammation. Thus, the formation of CYP450 enzymes could be normalized during secukinumab administration. In theory, clinically relevant drug interactions may occur with CYP450 substrates that have a narrow therapeutic index such as aminophylline. (Moderate) If secukinumab is initiated or discontinued in a patient taking theophylline, monitor theophylline concentrations; theophylline dose adjustments may be needed. The formation of CYP450 enzymes may be altered by increased concentrations of cytokines during chronic inflammation. Thus, the formation of CYP450 enzymes could be normalized during secukinumab administration. In theory, clinically relevant drug interactions may occur with CYP450 substrates that have a narrow therapeutic index such as theophylline.
Thioridazine: (Moderate) Monitor for an altered patient response to thioridazine if coadministration with secukinumab is necessary. Secukinumab therapy may restore CYP450 activities to higher levels than pretreatment, leading to increased metabolism of CYP450 substrates as compared to metabolism prior to treatment. Therefore, CYP450 substrates with a narrow therapeutic index may have fluctuations in drug levels and therapeutic effect. Thioridazine is a CYP2D6 substrate and narrow therapeutic index drug.
Tizanidine: (Moderate) If secukinumab is initiated or discontinued in a patient taking tizanidine, monitor for altered patient response to tizanidine; tizanidine dose adjustments may be needed. The formation of CYP450 enzymes may be altered by increased concentrations of cytokines during chronic inflammation. Thus, the formation of CYP450 enzymes could be normalized during secukinumab administration. In theory, clinically relevant drug interactions may occur with CYP450 substrates that have a narrow therapeutic index such as tizanidine.
Tocilizumab: (Major) Avoid using tocilizumab with other biological DMARDs, such as secukinumab; coadministration has not been studied and may result in additive immunosuppression and increased risk of infection.
Tofacitinib: (Major) Concomitant use of tofacitinib with biologic DMARDs, such as secukinumab, is not recommended because of the possibility of additive immunosuppression and increased infection risk. Tofacitinib may be used as monotherapy or concomitantly with methotrexate or other nonbiologic DMARDs.
Typhoid Vaccine: (Major) Do not administer live vaccines to secukinumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving secukinumab. Before initiation of secukinumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Secukinumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. Similar antibody responses were seen when healthy individuals who received a single 150 mg dose of secukinumab 2 weeks before vaccination with a non-US approved group C meningococcal polysaccharide conjugate vaccine and a non-US approved inactivated seasonal influenza vaccine. The efficacy of meningococcal and influenza vaccines has not been evaluated in patients undergoing treatment with secukinumab.
Upadacitinib: (Major) Concomitant use of upadacitinib with biologic DMARDs, such as secukinumab, is not recommended because of the possibility of increased immunosuppression and increased infection risk. Upadacitinib may be used as monotherapy or concomitantly with methotrexate or other nonbiologic DMARDs.
Varicella-Zoster Virus Vaccine, Live: (Major) Do not administer live vaccines to secukinumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving secukinumab. Before initiation of secukinumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Secukinumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. Similar antibody responses were seen when healthy individuals who received a single 150 mg dose of secukinumab 2 weeks before vaccination with a non-US approved group C meningococcal polysaccharide conjugate vaccine and a non-US approved inactivated seasonal influenza vaccine. The efficacy of meningococcal and influenza vaccines has not been evaluated in patients undergoing treatment with secukinumab.
Warfarin: (Moderate) Closely monitor the INR if coadministration of warfarin with secukinumab is necessary as concurrent use may increase the exposure of warfarin leading to increased bleeding risk. Secukinumab is a moderate CYP3A4/CYP2C9/CYP1A2 inhibitor and warfarin is a CYP3A4/CYP2C9/CYP1A2 substrate.
Yellow Fever Vaccine, Live: (Major) Do not administer live vaccines to secukinumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving secukinumab. Before initiation of secukinumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Secukinumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. Similar antibody responses were seen when healthy individuals who received a single 150 mg dose of secukinumab 2 weeks before vaccination with a non-US approved group C meningococcal polysaccharide conjugate vaccine and a non-US approved inactivated seasonal influenza vaccine. The efficacy of meningococcal and influenza vaccines has not been evaluated in patients undergoing treatment with secukinumab.

Cosentyx/Secukinumab Subcutaneous Inj Sol: 0.5mL, 1mL, 2mL, 75mg, 150mg, 300mg

150 mg/dose subcutaneously for non-radiographic axial spondyloarthritis; 300 mg/dose subcutaneously for all other indications.

150 mg/dose subcutaneously for non-radiographic axial spondyloarthritis; 300 mg/dose subcutaneously for all other indications.

weighing 50 kg or more: 150 mg/dose subcutaneously.
weighing less than 50 kg: 75 mg/dose subcutaneously.

2 to 12 years weighing 50 kg or more: 150 mg/dose subcutaneously.
2 to 12 years weighing 15 to 49 kg: 75 mg/dose subcutaneously.
1 year or weighing less than 15 kg: Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Secukinumab is a human IgG1 monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine, inhibiting its interaction with the IL-17 receptor. A naturally occurring cytokine, IL-17A is involved in normal inflammatory and immune responses. IL-17A stimulates keratinocytes to secrete chemokines and other proinflammatory cells. Elevated concentrations of IL-17A are found in psoriatic plaques. Treatment with secukinumab inhibits the release of proinflammatory cytokines and chemokines and may reduce epidermal neutrophils and IL-17A concentrations in psoriatic plaques.

Secukinumab is administered subcutaneously. The mean volume of distribution following a single intravenous dose in patients with plaque psoriasis ranges from 7.1 to 8.6 L. Secukinumab concentrations in the interstitial fluid in lesional and non-lesional skin of patients with plaque psoriasis ranges from 27% to 40% of serum concentrations at 1 and 2 weeks following a 300-mg subcutaneous dose. Although the metabolic pathway is not fully elucidated, secukinumab is expected to be degraded to small peptides and amino acids in the same manner as endogenous human IgG. Mean systemic clearance ranges from 0.14 to 0.22 L/day, and the mean half-life ranges from 22 to 31 days following intravenous and subcutaneous administration. Secukinumab exhibits dose-proportional pharmacokinetics.
 
Affected cytochrome P450 (CYP450) isoenzymes and drug transporters: None known
The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNF-alpha, IFN) during chronic inflammation. In theory, treatment with secukinumab might cause alteration of the formation of CYP450 enzymes. Upon initiation or discontinuation of secukinumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect or drug concentration and consider dosage adjustment as needed. Results from drug-drug interaction studies showed no clinically relevant interactions of secukinumab with drugs metabolized by CYP3A4.

Secukinumab bioavailability ranges from 55% to 77% following subcutaneous administration of the 150 mg or 300 mg dose (administered as two 150 mg injections). The peak mean (+/- SD) serum concentrations of secukinumab after subcutaneous doses of 150 mg and 300 mg are 13.7 +/- 4.8 mcg/mL and 27.3 +/- 9.5 mcg/mL, respectively, and are reached in approximately 6 days. Following multiple subcutaneous doses of secukinumab (administered as 1 or 2 injections of 150 mg), the mean (+/- SD) serum trough concentrations at Week 12 are 22.8 +/- 10.2 mcg/mL for the 150 mg dose and 45.4 +/- 21.2 mcg/mL for the 300 mg dose. Evaluations of the 300 mg dose at Week 4 and Week 12 show the mean trough concentrations of the Sensoready pen were 23% to 26% higher than those from the prefilled syringe. Following multiple subcutaneous doses of 300 mg administered via the UnoReady pen, the mean serum trough concentrations were generally consistent with those observed with the Sensoready pen study used to deliver 300 mg doses. Steady-state concentrations are achieved by Week 24 following every 4 week administration. The mean (+/- SD) steady-state trough concentrations range from 16.7 +/- 8.2 mcg/mL (150 mg) to 34.4 +/- 16.6 mcg/mL (300 mg).

There are no adequate or well-controlled studies of secukinumab in pregnant women. A study in pregnant cynomolgus monkeys given weekly secukinumab doses up to 30 times the maximum recommended human dose found no evidence of malformations or embryo-fetal toxicity. Secukinumab should only be used during pregnancy if the benefit justifies the potential risk to the fetus.

It is not known whether secukinumab is excreted in human milk or absorbed systemically after ingestion. Use caution when administering secukinumab to a nursing woman. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.