Ukoniq

Indicated For

follicular lymphoma, marginal zone lymphoma

About This Medication

# TG Therapeutics Patient Assistance Program: Important Information About Ukoniq ## Critical Safety Notice Ukoniq (umbralisib) has been **withdrawn from the market** by the FDA due to safety concerns. The FDA determined that the risks of treatment with Ukoniq outweigh its benefits based on findings from clinical trials showing a possible increased risk of death in patients receiving the medication. **If you are currently taking Ukoniq, you should stop taking this medicine and contact your healthcare provider immediately to discuss alternative treatment options.** TG Therapeutics has voluntarily withdrawn Ukoniq from the market for its approved uses in marginal zone lymphoma and follicular lymphoma. In limited circumstances where a patient may be receiving benefit from Ukoniq, TG Therapeutics plans to make it available under expanded access through your healthcare provider. ## About This Program Before Ukoniq's withdrawal, TG Therapeutics offered patient support services through its TG Patient Support program. This information is provided for historical reference and for patients who may qualify for expanded access. ## What Was TG Patient Support? TG Patient Support was a comprehensive program designed to help patients navigate treatment with Ukoniq by providing: - Insurance verification and coverage support - Information about financial assistance options - Educational resources about the medication - Copay and coinsurance assistance for eligible patients - Support navigating the reimbursement process ## Program Contact Information For patients who may qualify for expanded access or have questions about previous assistance: - **Phone:** 1-877-TGTXPSP (1-877-848-9777) - **Fax:** 1-877-778-1329 - **Website:** Ukoniq.com/patientsupport ## Income Eligibility Specific income thresholds for the TG Therapeutics patient assistance program were not publicly detailed in available materials. Eligibility was determined on a case-by-case basis considering individual financial circumstances. ## Insurance Requirements The program worked with patients regardless of insurance status. Services included helping patients understand their insurance coverage and identifying financial assistance options for those with or without insurance. ## How to Apply (Historical Information) Patients seeking assistance would contact TG Patient Support directly using the phone number, fax, or website listed above. Representatives would: 1. Verify insurance coverage and copay/coinsurance responsibility 2. Assess financial need 3. Explain available assistance options 4. Guide patients through the application process 5. Provide educational materials about treatment ## What Happens If Your Application Is Denied If you were denied assistance under the previous program, you should contact TG Patient Support to understand the reason and explore alternative options. Given Ukoniq's market withdrawal, your healthcare provider can discuss alternative treatments that may be covered by your insurance or have their own patient assistance programs. ## Reauthorization Reauthorization requirements were not specified in publicly available program materials. ## Important Disclaimer **This guide is provided for informational purposes only and reflects the status of the TG Therapeutics patient assistance program as of the date of this writing. Ukoniq has been withdrawn from the market due to safety concerns identified by the FDA. Patients currently taking or considering Ukoniq should consult with their healthcare provider immediately.** This information does not constitute medical advice. Always consult with your healthcare provider about your treatment options, eligibility for assistance programs, and any questions about your medications. ## Reporting Side Effects If you experienced side effects while taking Ukoniq, you can report them to the FDA's MedWatch program: - **Online:** FDA MedWatch website - **Phone:** 1-800-332-1088 - **Fax:** 1-800-FDA-0178 ## Next Steps If you were taking Ukoniq or considering it as a treatment option: 1. **Contact your healthcare provider** to discuss alternative treatments 2. **Do not stop taking Ukoniq without medical guidance** if you are currently on the medication 3. **Ask about other patient assistance programs** for alternative medications your doctor recommends 4. **Contact TG Patient Support** if you have questions about previous assistance or expanded access options

Program information last verified: March 30, 2026