Lomustine Shortage: What Providers and Prescribers Need to Know in 2026

Lomustine (Gleostine; CCNU) remains a critical component of the neuro-oncology armamentarium — standard of care for recurrent glioblastoma in many guidelines, an essential component of the PCV regimen for lower-grade gliomas, and a second-line option for Hodgkin's lymphoma. Yet the drug's access landscape is uniquely challenging: sole-source supply, a 1,400–1,900% price increase over the past decade, and withdrawal from Medicare Part D and Medicaid rebate programs in 2021. This guide helps oncology providers navigate these barriers and ensure patients receive timely treatment.

Current Supply Status (2026)

Lomustine is not currently on the FDA Drug Shortage Database as of 2026. NextSource Biotechnology remains the sole U.S. manufacturer, distributing the drug as Gleostine through authorized specialty distributors. Physical supply is available, but constrained to specialty pharmacies and oncology-affiliated dispensing.

Key supply facts for providers:

Available as 5 mg, 10 mg, 40 mg, and 100 mg capsules (Gleostine brand)

Generic FDA-approved but market availability at retail pharmacies is limited

Sole-source dependency means any manufacturing disruption could rapidly create a shortage

Brand-name retail cost: $600–$2,950 per dose depending on strength and quantity

Insurance Coverage Landscape

Since 2021, lomustine is NOT covered under:

Medicare Part D — NextSource voluntarily withdrew from this program

Medicaid rebate program — states cannot receive federal funding reimbursement; state Medicaid programs may still cover it with own funds

Private commercial insurance coverage varies widely. Prior authorization is typically required, and some plans may not cover it. When initiating lomustine, consider having your practice's financial counselors or patient navigators engage proactively with payers to minimize delays in the critical cycle 1 dose.

Prescribing Considerations and Safety Protocols

Lomustine carries an FDA boxed warning for delayed, cumulative, and potentially fatal myelosuppression. Key prescribing safeguards include:

Dosing interval: Never administer more frequently than every 6 weeks due to delayed (28–42 day onset) cumulative myelosuppression

Blood count monitoring: Weekly CBC for at least 6 weeks after each dose; withhold next dose until platelets >100,000/mm³ and leukocytes >4,000/mm³

Dispense one dose at a time: Overdose can be fatal; dispense only enough for one dose per 6-week cycle

Cumulative dose limit: Pulmonary toxicity risk increases significantly at cumulative doses >1,100 mg/m²; monitor pulmonary function

Renal monitoring: Progressive renal failure has been reported; monitor renal function throughout treatment

Drug interaction — cimetidine: Co-administration with cimetidine decreases lomustine metabolism, enhancing myelotoxicity

Dose Adjustment Schedule

The standard starting dose is 130 mg/m² every 6 weeks (reduced to 100 mg/m² for patients with compromised bone marrow). Subsequent doses should be adjusted based on nadir counts from the preceding cycle per the manufacturer's dosing adjustment table. Do not proceed to the next cycle until blood counts recover to acceptable levels.

Clinical Alternatives When Lomustine Is Inaccessible

If a patient cannot obtain lomustine due to cost or access barriers, the following clinical alternatives may be considered — always on a patient-specific basis:

Temozolomide (Temodar): For MGMT-methylated GBM at recurrence; Medicare and most insurers cover it; generic widely available

Bevacizumab (Avastin): FDA-approved for recurrent GBM; administered IV; covered under Medicare Part B; often used in combination with lomustine but can be used as monotherapy

Carmustine (BiCNU): Nitrosourea with similar mechanism; IV administration; cross-resistance with lomustine may limit efficacy in patients who have progressed on lomustine

Resources for Patients Who Cannot Afford Lomustine

Prescription Hope: Advocacy program offering lomustine for approximately $70/month to qualifying patients regardless of insurance status

GoodRx/SingleCare: Discount cards may reduce generic lomustine to $672 or less at participating pharmacies

Social work/financial counseling: Oncology social workers can help identify state-specific assistance programs and cancer foundation grants

For providers who want to help patients find lomustine at pharmacies in their area, medfinder for providers offers a service that calls local pharmacies to check real-time availability, saving your care team hours of phone time and reducing treatment delays.