Written By: Jeremiah Moore, PharmD, BCOP
Description: This PQI will provide background information on umbralisib’s novel mechanism of action and discuss effective practices to maximize the use of umbralisib therapy in the management of relapsed refractory follicular lymphoma.
Background: Phosphatidylinositol-3-kinase (PI3K) dysregulation is thought to be a driver of B cell malignancies. Multiple PI3K inhibitors (idelalisib, duvelisib, copanlisib) have shown efficacy in non-Hodgkin lymphoma (NHL) however, toxicities have limited their use. Umbralisib (Ukoniq®) is an oral medication indicated for patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. Umbralisib is a novel dual inhibitor of (PI3K) δ-isoform and casein kinase-1ε (CK1ε) with an improved side effect profile. In the phase IIb UNITY-NHL trial involving patients with marginal zone and follicular lymphoma, umbralisib showed a favorable response rate with a manageable side effect profile.1-3
Upon receiving a new prescription for umbralisib:
- Confirm appropriate dose of umbralisib 800 mg (4 x 200 mg tablet) by mouth once daily with food
- Confirm that patient does not have a history of allergic reactions due to FD&C Yellow No. 5. If the patient does have a history of allergic reactions to FD&C Yellow No. 5 contact prescribers office before dispensing
- Verify that the patient has prophylaxis for Pneumocystis jirovecii (PJP) during treatment with Interrupt umbralisib therapy in patients with suspected PJP and discontinue in patients with confirmed PJP3
- Consider prophylactic antivirals during treatment to prevent cytomegalovirus (CMV) infection, including CMV reactivation. Hold umbralisib therapy until CMV infection or viremia resolves, then resume at same or reduced dose. If umbralisib is resumed, monitor CMV reactivation by PCR or antigen test at least monthly3
- Verify monitoring parameters:
- CBC with differential – at least every 2 weeks for the first 2 months and at least weekly in patients with neutrophil counts <1 x 109/L
- CMP at baseline and as clinically necessary
- Consider monitoring CMV PCR or antigen test monthly
Patient Centered Activities:
- Provide Oncology Chemotherapy Education (OCE) sheet
- Provide patient with the umbralisib (Ukoniq®) medication guide
- Ensure patients understand how to take their umbralisib dose
- Administer once daily with food and a glass of water
Patient Centered Activities Continued:
- Medication should not be crushed, broken or chewed, but should be swallowed whole
- If a dose of umbralisib is missed, take a missed dose unless it is less than 12 hours until the next scheduled dose
- Verify PJP prophylaxis and review importance with patient
- Ensure patients understand how to monitor for signs and symptoms of side effects of umbralisib, including: Infections, diarrhea or non-infectious colitis, hepatotoxicity, and skin rash and when to call their provider
- Monitor for adherence and adverse effects throughout treatment
- Patients with commercial or private insurance may be eligible to receive umbralisib for $5 per prescription
- Quick start/bridge program
- Provides free umbralisib to eligible patients who experience delays of at least 5 business days
- No insurance or underinsured
- Provides free umbralisib to eligible patients
- Fowler NH, Samaniego F, Jurczak W, et al. Umbralisib, a dual PI3Kδ/CK1ε inhibitor in patients with relapsed or refractory indolent lymphoma. Journal of Clinical Oncology. 2021; 39:1609-1618.
- Hanlon A and Brander DM. Managing toxicities of phosphatidylinositol-3-kinase (PI3K) inhibitors. 2020; 346-56.
- Ukoniq (umbralisib) [package insert]. Edison, NJ: TG Therapeutics, Inc; 2021.