Tremfya(guselkumab)
Tremfya 100 MG in 1 ML Auto-Injector
NO BOXED WARNING
Dosage & Administration
Recommended Dosage
Plaque Psoriasis
Psoriatic Arthritis
Ulcerative Colitis
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Tremfya Prescribing Information
Tremfya Prior Authorization Resources
Most recent state uniform prior authorization forms
Verified: Sep 24, 2024Arizona - Uniform Prior Authorization Form
Verified: Sep 24, 2024Colorado - Uniform Prior Authorization Form
Verified: Sep 24, 2024Hawaii - Uniform Prior Authorization Form
Verified: Sep 24, 2024Illinois - Uniform Prior Authorization Form
Verified: Sep 24, 2024Indiana - Uniform Prior Authorization Form
Verified: Sep 24, 2024Louisiana - Uniform Prior Authorization Form
Verified: Sep 24, 2024Minnesota - Uniform Prior Authorization Form
Verified: Sep 24, 2024New Hampshire - Uniform Prior Authorization Form
Verified: Sep 24, 2024New Mexico - Uniform Prior Authorization Form
Verified: Sep 24, 2024Oregon - Uniform Prior Authorization Form
Verified: Sep 24, 2024Texas - Uniform Prior Authorization Form
Verified: Sep 05, 2024Washington - Uniform Prior Authorization Form
Verified: Sep 05, 2024Wisconsin - Uniform Prior Authorization Form
Tremfya Preferred Pharmacy
Tremfya Financial Assistance Options
Copay savings program
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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
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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
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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
Tremfya PubMed™ News
Tremfya Patient Education
Getting started on Tremfya
Instructions For Use: Psoriatic Arthritis
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
Open Camera on Phone
Scan QR Code & Tap Link
To share resource; ask patient to:
1.Pull out phone
2.Open camera
3.Scan QR code with camera
4.Tap link
Patient toolkit
View How to Take Tremfya: Plaque Psoriasis
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
Open Camera on Phone
Scan QR Code & Tap Link
View How to Take Tremfya: Psoriatic Arthritis
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
Open Camera on Phone
Scan QR Code & Tap Link
Other resources
Tremfya FAQs
Is TREMFYA safe to use during pregnancy?
There are no available data on TREMFYA use in pregnant women to inform a drug associated risk of adverse developmental outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, TREMFYA may be transmitted from the mother to the developing fetus. In a combined embryofetal development and pre- and post-natal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of guselkumab during organogenesis through parturition at doses up to 30 times the maximum recommended human dose (MRHD). Neonatal deaths were observed at 6- to 30-times the MRHD. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Pregnant women should discuss the potential risks and benefits of TREMFYA with their healthcare provider.
Is there a pregnancy exposure registry for TREMFYA?
Yes, there is a pregnancy registry that monitors pregnancy outcomes in women exposed to TREMFYA during pregnancy. Patients should be encouraged to enroll by calling 1-877-311-8972.
What is the estimated background risk of major birth defects and miscarriage in the general population?
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.
What animal data is available for TREMFYA use during pregnancy?
In a combined embryofetal development and pre- and post-natal development study, pregnant cynomolgus monkeys were administered weekly subcutaneous doses of guselkumab up to 50 mg/kg (30 times the MRHD based on a mg/kg comparison) from the beginning of organogenesis to parturition. Neonatal deaths occurred in the offspring of one control monkey, three monkeys administered guselkumab at 10 mg/kg/week (6 times the MRHD based on a mg/kg comparison) and three monkeys administered guselkumab at 50 mg/kg/week (30 times the MRHD based on a mg/kg comparison). The clinical significance of these findings is unknown. No guselkumab-related effects on functional or immunological development were observed in the infants from birth through 6 months of age.
What are the risks associated with guselkumab use during lactation?
There is no data on the presence of guselkumab in human milk or the effects on the breastfed infant or milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TREMFYA and any potential adverse effects on the breastfed infant from TREMFYA or from the underlying maternal condition.
Is TREMFYA safe and effective for use in pediatric patients?
The safety and efficacy of TREMFYA in pediatric patients (less than 18 years of age) have not been established.
Are there differences in safety or effectiveness of TREMFYA in geriatric patients?
No overall differences in safety or effectiveness were observed between older and younger subjects who received TREMFYA. However, the number of subjects aged 65 years and older was not sufficient to determine whether they respond differently from younger subjects.
FAQ Data Source
We receive information directly from the FDA and PrescriberPoint is updated as frequently as change are made available