Ilaris(canakinumab)
NO BOXED WARNING
Dosage & Administration
• CAPS: Recommended weight-based dosage is:
- For patients > 40 kg: 150 mg subcutaneously, every 8 weeks
- For patients ≥ 15 kg and < 40 kg: 2 mg/kg subcutaneously, every 8 weeks. For pediatric patients 15 kg to 40 kg with an inadequate response, the dose can be increased to 3 mg/kg.
• TRAPS, HIDS/MKD, and FMF: Recommended weight-based dosage is:
- For patients > 40 kg: Starting dosage is 150 mg subcutaneously every 4 weeks. The dosage can be increased to 300 mg every 4 weeks if the clinical response is not adequate.
- For patients ≤ 40 kg: Starting dosage is 2 mg/kg subcutaneously every 4 weeks. The dosage can be increased to 4 mg/kg every 4 weeks if the clinical response is not adequate.
Get Your Patient on Ilaris
See your patient's specific prior authorization requirements including coverage restrictions and step therapies
Or select your Insurance from the list below:
Ilaris Prescribing Information
Ilaris Prior Authorization Resources
Most recent state uniform prior authorization forms
Verified: Oct 24, 2024Arizona - Uniform Prior Authorization Form
Verified: Oct 24, 2024Colorado - Uniform Prior Authorization Form
Verified: Oct 24, 2024Hawaii - Uniform Prior Authorization Form
Verified: Oct 24, 2024Illinois - Uniform Prior Authorization Form
Verified: Oct 24, 2024Indiana - Uniform Prior Authorization Form
Verified: Oct 24, 2024Louisiana - Uniform Prior Authorization Form
Verified: Oct 24, 2024Minnesota - Uniform Prior Authorization Form
Verified: Oct 24, 2024New Hampshire - Uniform Prior Authorization Form
Verified: Oct 24, 2024New Mexico - Uniform Prior Authorization Form
Verified: Oct 24, 2024Oregon - Uniform Prior Authorization Form
Verified: Oct 24, 2024Texas - Uniform Prior Authorization Form
Verified: Oct 05, 2024Washington - Uniform Prior Authorization Form
Verified: Oct 05, 2024Wisconsin - Uniform Prior Authorization Form
Ilaris Preferred Pharmacy
Ilaris Financial Assistance Options
Copay savings program
Learn More
Overview
- Reduce patient OOP costs for drug (and occasionally for drug administration/infusion costs or drug-related test costs)
Patient benefit
- A portion (or all) of patient OOP (deductible, copay), typically up to monthly and/or annual max
Patient eligibility
- Patient must enroll or activate (may permit HCPs to enroll on patient’s behalf for HCP-administered drugs)
- Generally, must have commercial insurance (rarely, may permit uninsured patients to use)
- May never be used with government insurance
How to sign up
- Cards may be downloadable digital cards or hard copies
- Some pharmacos offer debit cards with pre-loaded copay benefit
- Typically, available through multiple channels (e.g., rep to HCP to patient; pharmacy to patient; patient via website, Hub live agent, or copay vendor (live agent or IVR); patient and HCP via Hub enrollment form)
- Some HCP-administered product programs permit HCPs to enroll on a patient’s behalf through via Hub form
Bridge program
Learn More
Overview
- Provide patient immediate access to therapy during an insurance delay (typically new starts; some may cover change in insurance)
- Limited time/ fill (typically 7-30 days; some may offer additional fill for continued delay up to certain limit)
Patient benefit
- 100% free (outside of insurance)
Patient eligibility
- HCP must enroll patient
- May be limited to commercially insured patients (i.e., no government beneficiaries); some programs may allow government beneficiaries
How to sign up
- Typically HCP assisted enrollment (via form)
Foundation programs
Learn More
Overview
- Charitable 501(c)(3) organizations provide direct cost-sharing and other support (e.g., travel, counseling) through disease-state funds to indigent patients on first-come first-served basis
- These organizations may receive financial contributions from drug manaufacturers for particular disease-state funds that cannot provide funds directly to patients - the foundation must be independent/unaligned
Patient benefit
- Patients apply for grants that cover a portion (or all) of their out-of-pocket costs (deductibles and copays) until the grant is exhausted
Patient eligibility
- Patients must apply and meet eligibility criteria including income level (typically a multiple of federal poverty line), specific diagnosis, insurance status, etc.
How to sign up
- Patients submit proof of out-of-pocket drug costs to charities for reimbursement
Ilaris PubMed™ News
Ilaris Patient Education
To share resource; ask patient to:
1.Pull out phone
2.Open camera
3.Scan QR code with camera
4.Tap link
Patient toolkit
Safety Considerations: CAPS (FCAS & MWS)
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
Open Camera on Phone
Scan QR Code & Tap Link
Doctor Discussion Guide: CAPS (FCAS & MWS)
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
Open Camera on Phone
Scan QR Code & Tap Link
Ilaris FAQs
Available human data from postmarketing experience and published case reports on ILARIS use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, and adverse maternal or fetal outcomes. Canakinumab, like other monoclonal antibodies, is actively transported across the placenta mainly during the third trimester of pregnancy and may cause immunosuppression in the in utero exposed infant. In animal embryo-fetal development studies with marmoset monkeys, there was no evidence of embryotoxicity or fetal malformations with subcutaneous administration of canakinumab during the period of organogenesis and later in gestation at doses that produced exposures approximately 11 times the exposure at the maximum recommended human dose (MRHD) and greater. However, delays in fetal skeletal development were observed in marmoset monkeys following prenatal exposure to ILARIS at concentrations approximately 11 times the MRHD and greater. Similar delays in fetal skeletal development were observed in mice administered a murine analog of ILARIS during the period of organogenesis. The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
There is no information regarding the presence of canakinumab in human milk or the effects on milk production. There are a small number of published case reports that do not establish an association between maternal canakinumab use during lactation and adverse effects on breastfed infants. Maternal IgG is known to be present in human milk. The effects of canakinumab in breast milk and possible systemic exposure in the breastfed infant are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ILARIS and any potential adverse effects on the breastfed infant from ILARIS or from the underlying maternal condition.
The CAPS trials with ILARIS included a total of 23 pediatric patients with an age range from 4 years to 17 years. The majority of patients achieved improvement in clinical symptoms and objective markers of inflammation.
Overall, the efficacy and safety of ILARIS in pediatric and adult patients were comparable. In the TRAPS, HIDS/MKD, and FMF trial, which included a total of 102 pediatric patients, there were no clinically meaningful differences in the efficacy, safety, and tolerability profile of ILARIS in pediatric patients compared to the overall TRAPS, HIDS/MKD, and FMF populations. The majority of pediatric patients achieved improvement in clinical symptoms and objective markers of inflammation.
The safety and effectiveness of ILARIS in CAPS patients under 4 years of age has not been established.
The safety and efficacy of ILARIS in SJIA patients under 2 years of age have not been established.
Yes, because IL-1 blockade may interfere with immune response to infections, it is recommended that prior to initiation of therapy with ILARIS, pediatric patients receive all recommended vaccinations. Live virus vaccines should be avoided concurrently with ILARIS treatment in pediatric patients or in infants exposed in utero following maternal administration.
No formal studies have been conducted to examine the pharmacokinetics of ILARIS administered subcutaneously in patients with renal impairment.
No formal studies have been conducted to examine the pharmacokinetics of ILARIS administered subcutaneously in patients with hepatic impairment.
Clinical studies of ILARIS did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects.
We receive information directly from the FDA and PrescriberPoint is updated as frequently as change are made available