J3247: Permanent J-code for the intravenous (IV) formulation of COSENTYX® (secukinumab)*
Effective July 1, 2024, for all sites of care
J3247:
Permanent J-code for the intravenous (IV) formulation of COSENTYX® (secukinumab)*
Effective July 1, 2024, for all sites of care
*If COSENTYX is administered on or after July 1, 2024, the permanent J-code replaces the miscellaneous J-code, J3590.
It is the sole responsibility of the healthcare provider to select the proper codes and ensure the accuracy of all statements used in seeking coverage and reimbursement for an individual patient. Novartis cannot guarantee insurance coverage or reimbursement.
Reference: CMS, HCPCS Quarterly Update, April 2024.
IV Dosing Information
The FIRST and ONLY IL-17A
antagonist available in IV form
for adult patients with active PsA, AS, or nr-axSpA1-6
The FIRST and ONLY IL-17A antagonist available in IV form for adult patients with active PsA, AS, or nr-axSpA1-6
IV Dosing
Information
The FIRST and ONLY IL-17A antagonist available in IV form for adult patients with active PsA, AS, or nr-axSpA1-6
3 steps for IV dosing calculation
Use the guide† below to determine the proper IV dose, number of vials, and total volume of COSENTYX® required for each adult patient.
Enter the patient’s weight in pounds or kilograms. Be sure to enter weight using the proper measurement unit.
Select for loading dose or maintenance dose based on the patient’s needs.
Click or tap the “Submit” button. The appropriate dose, number of vials, and total volume will populate below.
Enter patient’s weight (in whole numbers)
Error, please make sure field is appropriately filled out
Error, please make sure one option is selected
Total dose
Number of
single-use vials required
Number of single-use vials required
Total volume
to be withdrawn
Total volume to be withdrawn
Total doses exceeding 300 mg per infusion are not recommended for the 1.75 mg/kg maintenance dose in patients
1 vial contains 5 mL or 125 mg of COSENTYX solution.
You can also review the following predetermined fields for loading dose and maintenance dose.
†In using this guide, you are agreeing to the following: This guide is intended for use by qualified healthcare providers only and is not a substitute for clinical judgment. Novartis Pharmaceuticals Corporation makes no claims pertaining to the accuracy of the information contained within the guide. All calculations should be confirmed prior to administration of COSENTYX for IV use. Neither Novartis Pharmaceuticals Corporation nor any party involved in the creation of this website is liable to you or others for any actions taken or decisions made in reliance on this guide.
The effectiveness and safety of COSENTYX you’re familiar with,
in an IV formulation1‡
The effectiveness and safety of COSENTYX you’re familiar with, in an IV formulation1‡
§This is not intended to compare the relative safety or efficacy of these treatments for PsA and AS. Please refer to the full Prescribing Information of each agent for dosage and administration.
Dosing information
Recommended IV dosage regimen of COSENTYX for adults with PsA, AS, or nr-axSpA1:
6mg/kg
given at Week 0
as a loading dose
1.75mg/kg
every 4 weeks
thereafter
COSENTYX IV formulation can also be administered without a loading dose at 1.75 mg/kg every 4 weeks.1
COSENTYX solution in vials requires dilution prior to administration. Total doses exceeding 300 mg per infusion are not recommended for the 1.75-mg/kg maintenance dose in patients with PsA, AS, or nr-axSpA.1
‡The effectiveness and safety of COSENTYX IV formulation are based on the pharmacokinetic exposure and extrapolation of the established effectiveness and safety of SC COSENTYX in adult patients with active PsA, AS, or nr-axSpA. 1
COSENTYX (for IV use) must be diluted prior to infusion. Using aseptic technique, prepare COSENTYX (for IV use) as follows:
Step 1:
Volume calculation
Step 2:
Dilution
Recommended infusion bags for dilution and preparation of COSENTYX for IV use based on body weight and dose
Body weight at time of dosing | For loading dose (6 mg/kg) recommended infusion bag | For maintenance dose (1.75 mg/kg) recommended infusion bag |
---|---|---|
>52 kg | 100 mL | 100 mL |
≤52 kg | 100 mL | 50 mL* |
*If a 50-mL infusion bag is unavailable, then use a 100-mL infusion bag and withdraw and discard 50 mL of saline using aseptic technique and continue to follow the preparation and administration steps.
Step 3:
Administration
Getting started with the IV formulation of COSENTYX
An overview of the preparation and administration of the IV formulation of COSENTYX to help you infuse.
AS, ankylosing spondylitis; nr-axSpA, non-radiographic axial spondyloarthritis; PsA, psoriatic arthritis; Q4W, every 4 weeks; SC, subcutaneous; USP, United States Pharmacopeia.
References: 1. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp. 2. Remicade. Prescribing information. Janssen Biotech Inc. 3. Simponi Aria. Prescribing information. Janssen Biotech Inc. 4. Orencia. Prescribing information. Bristol-Myers Squibb Co. 5. Taltz. Prescribing information. Eli Lilly & Co. 6. Siliq. Prescribing information. Bausch Health US LLC.
INDICATIONS
COSENTYX® (secukinumab) is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in patients 6 years and older who are candidates for systemic therapy or phototherapy.
COSENTYX is indicated for the treatment of active psoriatic arthritis (PsA) in patients 2 years of age and older.
COSENTYX is indicated for the treatment of adult patients with active ankylosing spondylitis (AS).
COSENTYX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.
COSENTYX is indicated for the treatment of active enthesitis-related arthritis (ERA) in patients 4 years of age and older.
COSENTYX is indicated for the treatment of adult patients with moderate to severe hidradenitis suppurativa (HS).
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
COSENTYX is contraindicated in patients with a
previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of
anaphylaxis have been reported during treatment with COSENTYX.
WARNINGS AND PRECAUTIONS
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 in subjects with moderate to severe PsO, 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 in subjects treated with COSENTYX compared to placebo-treated subjects. A similar increase in risk of infection in subjects treated with COSENTYX was seen in placebo-controlled trials in subjects with PsA, AS and nr-axSpA. The incidence of some types of infections, including fungal infections, appeared to be dose-dependent in clinical trials.
In the postmarketing setting, serious and some fatal infections have been reported in patients treated with COSENTYX.
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, monitor the patient closely and discontinue COSENTYX until the infection resolves.
Pre-treatment Evaluation for Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with COSENTYX. Avoid administration of 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. Monitor patients closely for signs and symptoms of active TB during and after treatment.
Inflammatory Bowel Disease
Inflammatory Bowel Disease (IBD) exacerbations, in some cases serious and/or leading to discontinuation of COSENTYX, occurred in COSENTYX treated subjects during clinical trials in PsO, PsA, AS, nr-axSpA, and HS. In adult subjects with HS, the incidence of IBD was higher in subjects who received COSENTYX 300 mg every 2 weeks (Ulcerative Colitis [UC] 1 case, EAIR 0.2/100 subject-years; Crohn’s Disease [CD] 1 case, EAIR 0.2/100 subject-years) compared to subjects who received COSENTYX 300 mg every 4 weeks (IBD 1 case, EAIR 0.2/100 subject-years). In addition, new onset IBD cases occurred in subjects treated with COSENTYX in clinical trials. In an exploratory trial in 59 subjects with active Crohn’s disease [COSENTYX is not approved for the treatment of Crohn’s disease], there were trends toward greater disease activity and increased adverse reactions in subjects treated with COSENTYX as compared to placebo-treated subjects.
Exercise caution when prescribing COSENTYX to patients with IBD. Patients treated with COSENTYX should be monitored for signs and symptoms of IBD.
Eczematous Eruptions
In postmarketing reports, cases of severe eczematous eruptions, including atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma, were reported in patients receiving COSENTYX; some cases resulted in hospitalization. The onset of eczematous eruptions was variable, ranging from days to months after the first dose of COSENTYX.
Treatment may need to be discontinued to resolve the eczematous eruption. Some patients were successfully treated for eczematous eruptions while continuing COSENTYX.
Hypersensitivity Reactions
Anaphylaxis and cases of urticaria occurred in COSENTYX treated subjects in clinical trials. If an anaphylactic or other serious allergic reaction occurs, administration of COSENTYX should be discontinued immediately and appropriate therapy initiated.
The removable caps of the COSENTYX Sensoready® pen and the COSENTYX 1 mL and 0.5 mL prefilled syringes contain natural rubber latex, which may cause an allergic reaction in latex-sensitive individuals. The safe use of the COSENTYX Sensoready pen or prefilled syringe in latex-sensitive individuals has not been studied.
Immunizations
Prior to initiating therapy with COSENTYX, consider completion of all age-appropriate immunizations according to current immunization guidelines. COSENTYX may alter a patient’s immune response to live vaccines. Avoid use of live vaccines in patients treated with COSENTYX.
MOST COMMON ADVERSE REACTIONS
Most common adverse reactions (>1%) are nasopharyngitis, diarrhea, and upper respiratory tract infection.
Please see full Prescribing Information, including Medication Guide.
COSENTYX is a registered trademark of Novartis AG.
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