Ukoniq

Indicated For

marginal zone lymphoma, follicular lymphoma

About This Medication

# TG Therapeutics Patient Assistance Program Guide: How to Get Ukoniq (umbralisib) at Low or No Cost **Important Safety Notice:** Ukoniq (umbralisib) is no longer available through standard channels. The FDA withdrew approval on June 1, 2022, due to safety concerns including increased risk of death observed in clinical trials. TG Therapeutics voluntarily withdrew it from the market for approved indications (relapsed or refractory marginal zone lymphoma after one prior anti-CD20 regimen and follicular lymphoma after three prior therapies).[3][4] Healthcare providers should not prescribe it, and patients should switch to alternatives. In rare cases of ongoing benefit, expanded access may be possible—consult your doctor immediately.[3] This guide covers the former TG Patient Assistance Program (PAP) for historical reference only, as the drug is discontinued. ## About Ukoniq (Umbralisib) Ukoniq was an oral kinase inhibitor used to treat certain blood cancers, specifically **relapsed or refractory marginal zone lymphoma (MZL)** in adults who had at least one prior anti-CD20-based therapy, and **relapsed or refractory follicular lymphoma (FL)** in adults after at least three prior systemic therapies.[1][4] It targeted PI3K-delta to slow cancer cell growth. Clinical data showed response rates like 43% in R/R FL patients with a median follow-up of 20.1 months.[1] However, common side effects included diarrhea/colitis (up to 50%+), fatigue (41%), nausea, musculoskeletal pain (27-29%), infections, neutropenia, and increased liver enzymes.[1][4] Serious reactions affected 18% of patients, leading to discontinuation in 14%.[4] Due to safety issues, including survival imbalances in trials, it's no longer approved or sold.[3][4] **Why was the PAP relevant?** Before withdrawal, TG Therapeutics offered support for eligible patients struggling with costs.[1][2][5] ## Who Qualifies for Assistance? The **TG Therapeutics Patient Assistance Program** provided free medication to those unable to afford it, focusing on uninsured or underinsured patients meeting financial need.[5] Qualification typically required: - U.S. residency. - Prescription for Ukoniq from a licensed provider. - Proof of financial hardship (e.g., low income, lack of insurance coverage). Since Ukoniq is withdrawn, no new assistance is available. Previously, it included commercial co-pay help, quick start/bridge programs, and PAP via independent charities.[1][2] ## Income Eligibility Breakdown Specific income thresholds were not publicly detailed in available sources, often based on **Federal Poverty Level (FPL)** (e.g., 400-500% FPL for many PAPs), but varied by household size.[5] Here's a general table based on standard PAP structures (consult program for exacts pre-withdrawal): | Household Size | Estimated Annual Income Limit (e.g., 400% FPL, 2022) | |----------------|-----------------------------------------------------| | 1 (Individual) | ~$54,360 | | 2 (Couple) | ~$73,240 | | 3 | ~$92,120 | | 4 | ~$111,000 | *Notes:* Limits could adjust yearly; assets, expenses, and insurance status factored in. Medicare patients often ineligible for free drug but could get co-pay aid.[1][5] Post-withdrawal, irrelevant. ## Insurance Requirements Pre-withdrawal, patients needed to explore insurance first. TG Patient Support verified coverage, co-pays, and prior authorizations.[1][2] - **Commercial insurance:** Co-pay assistance, bridge programs for delays. - **Medicare/Medicaid:** Often excluded from free PAP drug; separate co-pay funds or charities.[1] - **Uninsured:** Primary PAP candidates.[5] Services: Insurance verification, financial option info, education.[2] ## Step-by-Step Application Process 1. **Consult your doctor:** Discuss Ukoniq risks/alternatives; get prescription (now discontinued).[3] 2. **Visit UKONIQ.com/patientsupport** (archived): Download enrollment form.[1] 3. **Gather documents:** Proof of income (tax returns, pay stubs), ID, prescription, insurance denial (if applicable).[5] 4. **Call 1-877-TGTXPSP (1-877-848-9777):** Speak to case manager for enrollment, insurance help.[1][2] 5. **Submit via fax/website/specialty pharmacy** (e.g., Onco360: 1-877-662-6633).[2] 6. **Approval wait:** Processed quickly for bridges; full PAP variable.[1] **Specialty pharmacy:** Onco360 handled distribution.[2] ## Timeline and Delivery - **Processing:** Co-pay/bridge: days; PAP: 2-4 weeks typically.[1] - **Delivery:** Shipped to home/doctor via specialty pharmacy.[2] - **Refills:** Annual reauthorization with updated docs.[1] Post-withdrawal, no shipments occur.[4] ## Alternatives if Denied or Discontinued **Primary advice:** Do not seek Ukoniq—switch therapies per FDA.[3] - **Other PAPs:** RxAssist.org lists lymphoma options.[5] - **Charities:** Independent foundations for B-cell cancers (e.g., via TG referrals pre-withdrawal).[1] - **Newer TG drugs:** Briumvi (ublituximab) for MS has support, but not lymphoma.[7][8] - **Clinical trials:** Search ClinicalTrials.gov for MZL/FL. - **Medicare Extra Help:** For low-income seniors. Consult oncologist for approved alternatives like rituximab combos, lenalidomide, or CAR-T. ## Disclaimer This guide is for informational purposes only and reflects pre-2022 program details.[1][2][5] Ukoniq is **discontinued and not recommended** due to safety risks—**stop use and seek alternatives**.[3][4] Not medical/financial advice. Contact healthcare provider or 1-877-848-9777 for legacy questions. Programs change; verify via official sources. TG Therapeutics not liable for reliance on this info. Word count: 942.

Program information last verified: March 25, 2026