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Lomustine: Drug information

Lomustine: Drug information
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For additional information see "Lomustine: Patient drug information" and "Lomustine: Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
ALERT: US Boxed Warning
Bone marrow suppression:

Lomustine causes myelosuppression, including fatal myelosuppression. Myelosuppression is delayed, dose-related, and cumulative, occurring 4 to 6 weeks after drug administration and persisting for 1 to 2 weeks. Thrombocytopenia is generally more severe than leukopenia. Cumulative myelosuppression from lomustine is manifested by greater severity and longer duration of cytopenias. Monitor blood counts for at least 6 weeks after each dose. Do not give lomustine more frequently than every 6 weeks.

Medication error prevention:

Prescribe, dispense, and administer only enough capsules for one dose. Fatal toxicity occurs with overdosage of lomustine. Both health care provider and pharmacist should emphasize to the patient that only one dose of lomustine is taken every 6 weeks.

Brand Names: US
  • Gleostine
Brand Names: Canada
  • CeeNU
Pharmacologic Category
  • Antineoplastic Agent, Alkylating Agent;
  • Antineoplastic Agent, Alkylating Agent (Nitrosourea)
Dosing: Adult

Dosage guidance:

Safety: Do not administer courses of lomustine more frequently than every 6 weeks. Dispense only enough capsules for a single dose; do not dispense more than one dose at a time (Ref). Repeat courses should only be administered after adequate recovery of leukocytes to >4,000/mm3 and platelets to >100,000/mm3.

Dosing : Round doses to the nearest 10 mg.

Clinical considerations: Lomustine is associated with a moderate or high emetic potential; antiemetics are recommended to prevent nausea and vomiting (Ref).

Brain tumors

Brain tumors: Note: Doses should be rounded to the nearest 10 mg.

Astrocytomas:

Glioblastoma, adjuvant therapy, MGMT-methylated tumors (off-label combination): Adults ≤70 years: Oral: 100 mg/m2 on day 1 every 6 weeks for 6 cycles (in combination with temozolomide and concurrent radiation therapy) (Ref). Refer to protocol for dosage modification details.

Glioblastoma:

PCV regimen (off-label combination): Oral: 110 mg/m2 on day 1 every 6 weeks for 7 cycles (following radiation therapy and in combination with procarbazine and vincristine) (Ref).

Single-agent therapy, recurrent glioblastoma: Oral: 100 to 130 mg/m2 once every 6 weeks until disease progression or unacceptable toxicity (Ref) or 110 mg/m2 on day 1 every 6 weeks (maximum dose: 200 mg) for a maximum of 6 cycles (Ref).

Glioma, low grade, adjuvant therapy: PCV regimen (off-label combination): Note: Patients with grade 2 astrocytoma, oligodendroglioma, or oligoastrocytoma were included in these trials.

Oral: 110 mg/m2 on day 1 of each 8-week cycle for 6 cycles (following radiation therapy and in combination with procarbazine and vincristine) (Ref).

Medulloblastomas:

Medulloblastoma, newly-diagnosed, average risk, adjuvant therapy (off-label combination): Adults ≤21 years: Oral: 75 mg/m2 once every 6 weeks for 8 cycles (following radiation therapy and in combination with cisplatin and vincristine) (Ref).

Oligodendrogliomas:

Anaplastic oligodendroglioma, IDH-mutant and 1p/19q-codeleted: PCV regimen (off-label combination):

Oral: 130 mg/m2 on day 1 every 6 weeks for up to 4 cycles prior to radiation therapy (in combination with procarbazine and vincristine) (Ref).

Oral: 110 mg/m2 on day 1 every 6 weeks for 6 cycles (following radiation therapy and in combination with procarbazine and vincristine) (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. The following adjustments have been recommended:

Kintzel 1995:

CrCl 46 to 60 mL/minute: Reduce dose to 75% of normal dose.

CrCl 31 to 45 mL/minute: Reduce dose to 70% of normal dose.

CrCl ≤30 mL/minute: Avoid use.

Krens 2019:

CrCl >50 mL/minute: No dosage adjustment necessary.

CrCl 30 to 50 mL/minute: Reduce dose to 75% of normal dose.

CrCl <30 mL/minute: Use is not recommended.

Hemodialysis: Use is not recommended (Ref). Due to its lipophilic nature, lomustine is not dialyzable (Ref).

CAPD: Reduce dose to 25% to 50% of normal dose (Ref).

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. However, lomustine is hepatically metabolized and caution should be used in patients with hepatic dysfunction.

The following adjustments have been recommended (Ref):

Mild to moderate impairment: No dosage adjustment necessary.

Severe impairment: Use is not recommended.

Dosing: Obesity: Adult

American Society of Clinical Oncology guidelines for appropriate chemotherapy dosing in adults with cancer with a BMI ≥30 kg/m2 : Utilize patient's actual body weight (full weight) for calculation of BSA- or weight-based dosing; manage regimen-related toxicities in the same manner as for patients with a BMI <30 kg/m2; if a dose reduction is utilized due to toxicity, may consider resumption of full weight-based dosing (or previously tolerated dose level) with subsequent cycles only if dose escalations are allowed in the prescribing information, if contributing underlying factors (eg, hepatic or kidney impairment) are sufficiently resolved, AND if performance status has markedly improved or is considered adequate (Ref).

Dosing: Adjustment for Toxicity: Adult

Hematologic toxicity: Dosing adjustment for subsequent cycles:

Note: Dose adjustments should be based on nadir counts from prior dose.

Leukocytes ≥3,000/mm3, platelets ≥75,000/mm3: No dosage adjustment required.

Leukocytes 2,000 to 2,999/mm3, platelets 25,000 to 74,999/mm3: Reduce dose to 70% of prior dose.

Leukocytes <2,000/mm3, platelets <25,000/mm3: Reduce dose to 50% of prior dose.

Nonhematologic toxicity: Pulmonary fibrosis: Discontinue permanently.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Lomustine: Pediatric drug information")

Note: At FDA approved dosages, lomustine should only be dispensed and administered as a single dose once every 6 weeks due to delayed myelotoxicity; serious errors have occurred when lomustine was inadvertently administered daily. Repeat courses should only be administered after adequate recovery of leukocytes to >4,000/mm3 and platelets to >100,000/mm3. Details concerning dosage in combination regimens should also be consulted; dose, frequency, number of doses, and start date may vary by protocol and treatment phase.

Note: Round doses to the nearest 10 mg. Lomustine is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Ref).

Brain tumors

Brain tumors:

General dosing: Manufacturer's labeling: Infants, Children, and Adolescents: Oral: Initial: 130 mg/m2 as a single dose every 6 weeks (dosage reductions may be recommended for combination chemotherapy regimens).

Compromised marrow function: Reduce initial dose to 100 mg/m2 as a single dose once every 6 weeks; Note: Subsequent doses may require adjustment after initial treatment according to platelet and leukocyte counts.

Medulloblastoma: Children ≥3 years and Adolescents: Limited data available: Oral: 75 mg/m2 on day 0 of each chemotherapy cycle in combination with cisplatin, vincristine, and radiotherapy (Ref).

Gliomas: Limited data available:

Low grade: Infants, Children, and Adolescents: Oral: 110 mg/m2 on day 3 of a 6-week cycle in combination with thioguanine, vincristine, and procarbazine for up to 8 cycles for low grade, nonoperable (usually) gliomas (including astrocytomas) (Ref).

High grade: Jakacki 2016: Astrocytoma, glioblastoma: Children ≥3 years and Adolescents: Oral: 90 mg/m2 on day 1 every 42 days (or repeated when counts recovered) in combination with temozolomide and following radiotherapy for a total of 6 cycles (Ref).

Hodgkin lymphoma

Hodgkin lymphoma: Note: Although FDA approved (Gleostine prescribing information), other contemporary therapies have replaced the use of lomustine in the treatment of progressive Hodgkin lymphoma. Hodgkin lymphoma guidelines do not include lomustine as a treatment component for Hodgkin lymphoma management (Ref).

Infants, Children, and Adolescents: Oral: Initial: 130 mg/m2 as a single dose every 6 weeks (dosage reductions may be recommended for combination chemotherapy regimens) (Ref): Note: Subsequent doses may require adjustment after initial treatment according to platelet and leukocyte counts.

Compromised marrow function: Reduce initial dose to 100 mg/m2 as a single dose once every 6 weeks.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosage adjustment based on toxicity: Infants, Children, and Adolescents:

Hematologic toxicity (nadir for subsequent cycles):

Leukocytes ≥3,000/mm3, platelets ≥75,000/mm3: No adjustment required.

Leukocytes 2,000 to 2,999/mm3, platelets 25,000 to 74,999/mm3: Administer 70% of prior dose.

Leukocytes <2,000/mm3, platelets <25,000/mm3: Administer 50% of prior dose.

Nonhematologic toxicity: Pulmonary fibrosis: Discontinue permanently.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling; based on experience in adult patients, dosing adjustment suggested.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling; however, lomustine is hepatically metabolized and caution should be used in patients with hepatic dysfunction.

Adverse Reactions

The following adverse drug reactions are derived from product labeling unless otherwise specified.

Frequency not defined:

Dermatologic: Alopecia

Gastrointestinal: Nausea, stomatitis, vomiting

Hematologic & oncologic: Bone marrow depression, leukopenia, second primary malignant neoplasm (including acute leukemia and myelodysplastic syndrome), thrombocytopenia

Hepatic: Hepatotoxicity, increased serum alkaline phosphatase, increased serum bilirubin, increased serum transaminases

Nervous system: Ataxia, disorientation, dysarthria, lethargy

Ophthalmic: Blindness, optic atrophy, visual disturbance

Renal: Nephron atrophy, renal failure syndrome

Respiratory: Pulmonary infiltrates

Postmarketing: Respiratory: Pulmonary fibrosis (Dent 1982)

Contraindications

US labeling: There are no contraindications listed in the manufacturer’s labeling.

Canadian labeling: Hypersensitivity to lomustine or any component of the formulation; severe leukopenia and/or thrombocytopenia.

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: Lomustine causes myelosuppression, which may result in fatal infections or bleeding. Hematologic toxicity is dose-related, delayed (occurring 4 to 6 weeks after drug administration and persisting for 1 to 2 weeks), and cumulative. Thrombocytopenia is generally more severe than leukopenia. Cumulative myelosuppression from lomustine is manifested by greater severity and longer duration of cytopenias. Do not administer lomustine more frequently than once every 6 weeks.

• Hepatotoxicity: Hepatotoxicity (transaminase, alkaline phosphatase and bilirubin elevations) has been reported.

• Pulmonary toxicity: May cause pulmonary toxicity (infiltrates and/or fibrosis). Pulmonary toxicity is usually related to cumulative doses >1,100 mg/m2. May be delayed 6 months or longer after treatment initiation. Patients with baseline below 70% of predicted forced vital capacity or carbon monoxide diffusing capacity are at increased risk. Patients treated at a younger age may also be at increased risk for pulmonary toxicity.

• Renal toxicity: Progressive renal failure with a decrease in kidney size has been reported. Use with caution in patients with renal impairment.

• Secondary malignancies: Long-term use of nitrosoureas is associated with the development of secondary malignancies, including acute leukemia and myelodysplasia.

Other warnings/precautions:

• Medication error prevention: Lomustine should only be prescribed/dispensed as a single dose once every 6 weeks. Serious and fatal adverse events have occurred with overdosage (when lomustine was inadvertently administered daily). Health care providers should emphasize to the patient that only 1 dose of lomustine is taken every 6 weeks. The Institute for Safe Medication Practices (ISMP) recommends that prescribers only prescribe one dose at a time and pharmacies dispense only enough capsules for a single dose; in addition, patients should receive both verbal counseling and written instructions regarding proper dose and administration (ISMP 2014).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Gleostine: 10 mg, 40 mg, 100 mg

Generic Equivalent Available: US

No

Pricing: US

Capsules (Gleostine Oral)

10 mg (per each): $145.79

40 mg (per each): $583.14

100 mg (per each): $1,609.75

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

CeeNU: 10 mg, 40 mg

Administration: Adult

Lomustine is associated with a moderate or high emetic potential; antiemetics are recommended to prevent nausea and vomiting (Ref).

Oral: Administering on an empty stomach may reduce the incidence of nausea and vomiting.

Varying strengths of capsules may be required to obtain necessary dose. Dispense only enough capsules for a single dose; do not dispense more than one dose at a time (ISMP 2014). Do not break capsules. If contact with skin occurs, immediately wash area (thoroughly). Avoid exposure to broken capsules.

Administration: Pediatric

Lomustine is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Ref).

Oral: Administering on an empty stomach may reduce the incidence of nausea and vomiting.

Varying strengths of capsules may be required to obtain necessary dose. Dispense only enough capsules for a single dose; do not dispense more than one dose at a time (Ref). Do not break capsules. If contact with skin occurs, immediately wash area thoroughly; avoid exposure to broken capsules.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2024 [table 1]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).

Use: Labeled Indications

Brain tumors: Treatment of primary and metastatic brain tumors (after appropriate surgical and/or radiotherapeutic procedures).

Medication Safety Issues
Sound-alike/look-alike issues:

Lomustine may be confused with bendamustine, carmustine

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).

Administration issues:

Lomustine should only be administered as a single dose once every 6 weeks; serious and fatal adverse events have occurred when lomustine was inadvertently administered daily. The manufacturer and the Institute for Safe Medication Practices (ISMP) recommend prescribing, dispensing, and administering only enough capsules for a single dose (ISMP 2014).

Metabolism/Transport Effects

Substrate of CYP2D6 (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Antithymocyte Globulin (Equine): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of cytotoxic chemotherapy is reduced. Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor

Baricitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid

BCG Products: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of BCG Products. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Brincidofovir: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor

Brivudine: May increase adverse/toxic effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Chikungunya Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid

Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor

Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid

Cladribine: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Cladribine. Risk X: Avoid

CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor

Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Cytotoxic Chemotherapy) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing cytotoxic chemotherapy several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor

COVID-19 Vaccine (mRNA): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor

Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Denosumab: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and cytotoxic chemotherapy. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification

Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid

Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Inebilizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor

Influenza Virus Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating chemotherapy if possible. If vaccination occurs less than 2 weeks prior to or during chemotherapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification

Leflunomide: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents, such as cytotoxic chemotherapy. Risk D: Consider Therapy Modification

Lenograstim: Antineoplastic Agents may decrease therapeutic effects of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider Therapy Modification

Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Lipegfilgrastim: Antineoplastic Agents may decrease therapeutic effects of Lipegfilgrastim. Management: Avoid concomitant use of lipegfilgrastim and myelosuppressive cytotoxic chemotherapy. Lipegfilgrastim should be administered at least 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider Therapy Modification

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Nadofaragene Firadenovec: Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid

Natalizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid

Ocrelizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor

Ofatumumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor

Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor

Palifermin: May increase adverse/toxic effects of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Risk D: Consider Therapy Modification

Pidotimod: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Pidotimod. Risk C: Monitor

Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Piperacillin: May increase hypokalemic effects of Antineoplastic Agents. Risk C: Monitor

Pneumococcal Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Polymethylmethacrylate: Immunosuppressants (Cytotoxic Chemotherapy) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification

Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Rabies Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification

Ritlecitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid

Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification

Ruxolitinib (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid

Sipuleucel-T: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants, such as cytotoxic chemotherapy, prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification

Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk C: Monitor

Tacrolimus (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid

Talimogene Laherparepvec: Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid

Tertomotide: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Tertomotide. Risk X: Avoid

Tofacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid

Typhoid Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Ublituximab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor

Upadacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid

Vaccines (Live): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may decrease therapeutic effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting chemotherapy when possible. Patients vaccinated less than 14 days before or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification

Yellow Fever Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Zoster Vaccine (Live/Attenuated): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

Reproductive Considerations

Patients who could become pregnant should use effective contraception during treatment and for 2 weeks after the final lomustine dose. Patients with partners who may become pregnant should use effective contraception during treatment and for 3.5 months after the final lomustine dose.

Pregnancy Considerations

Based on the mechanism of action and data from animal reproduction studies, in utero exposure to lomustine may cause fetal harm.

Breastfeeding Considerations

It is not known if lomustine is present in breast milk.

Due to the potential for serious adverse reactions in the nursing infant, the manufacturer does not recommend breastfeeding during treatment and for 2 weeks after the final lomustine dose.

Monitoring Parameters

CBC with differential and platelet count (weekly for at least 6 weeks after a dose), hepatic and renal function tests (periodic). Monitor pulmonary function tests (baseline and periodic). Monitor for secondary malignancies. Monitor adherence.

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Lomustine inhibits DNA, RNA, and protein synthesis via alkylation and carbamylation of DNA and RNA; lomustine is cell cycle non-specific (Perry 2012).

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Crosses blood-brain barrier; CNS concentrations are high (Perry 2012)

Metabolism: Hepatic to active metabolites (Perry 2012)

Half-life elimination: Metabolites: 16 to 48 hours

Time to peak, serum: ~3 hours (Perry 2012)

Excretion: Urine (~50%, as metabolites)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Ceenu | Lomustina eczane;
  • (AT) Austria: Ccnu schoeller | Lomustin (Ccnu);
  • (AU) Australia: Ceenu;
  • (BE) Belgium: Cecenu;
  • (BG) Bulgaria: Ccnu | Ceenu | Lomoother;
  • (BR) Brazil: Citostal;
  • (CH) Switzerland: Ceenu | Prava;
  • (CL) Chile: Ceenu;
  • (CZ) Czech Republic: Belustine;
  • (DE) Germany: Cecenu;
  • (EE) Estonia: Ccnu | Cecenu | Ceenu | Lomustine medac;
  • (EG) Egypt: Lomustine medac;
  • (ES) Spain: Belustine;
  • (FI) Finland: Lomustine medac | Lucostine;
  • (FR) France: Belustine | Cecenu | Lomustine medac;
  • (GR) Greece: Cecenu;
  • (HK) Hong Kong: Ceenu;
  • (IN) India: Lomtin;
  • (KR) Korea, Republic of: Ccnu | Ceenu;
  • (LT) Lithuania: Belustine | Cecenu | Lomoother;
  • (LV) Latvia: Belustine | Cecenu | Ceenu | Lomustine medac;
  • (MX) Mexico: Ceenu;
  • (MY) Malaysia: Ceenu;
  • (NL) Netherlands: Cecenu | Lomustine eureco pharma | Lomustine medcor;
  • (NO) Norway: Ceenu | Gleostine | Lomustine medac;
  • (NZ) New Zealand: Ceenu;
  • (PH) Philippines: Ceenu combo;
  • (PL) Poland: Belustine | Cecenu | Ceenu | Lomustin;
  • (PR) Puerto Rico: Ceenu | Gleostine;
  • (PT) Portugal: Cecenu | Ceenu;
  • (QA) Qatar: Cecenu | CeeNU;
  • (RO) Romania: Cecenu | Ceenu;
  • (RU) Russian Federation: Ceenu | Lomustine medac;
  • (SE) Sweden: Lomustine medac;
  • (SG) Singapore: Ceenu;
  • (SI) Slovenia: Ccnu | Ceenu | Lomustine medac;
  • (TH) Thailand: Ccnu | Ceenu;
  • (TN) Tunisia: Belustine | Lomustine medac;
  • (TR) Turkey: Ccnu;
  • (TW) Taiwan: Cecenu | Ceenu;
  • (UA) Ukraine: Ceenu | Lomustin;
  • (UY) Uruguay: Ceenu;
  • (ZA) South Africa: Ceenu
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