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Gliadel (CARMUSTINE)
Gliadel works by attaching an alkyl group to the DNA of cancer cells, interfering with their ability to replicate and grow.
Gliadel (Carmustine) is a small molecule alkylating drug originally developed by EMCURE PHARMS LTD and currently owned by Avet Lifesciences. It targets glutathione reductase in the mitochondria and has been FDA-approved since 1977 for various cancer indications, including glioblastoma multiforme, non-Hodgkin's lymphoma, and multiple myeloma. Gliadel is available as a generic medication due to its off-patent status, with multiple manufacturers. Key safety considerations include its short half-life of 0.37 hours and limited bioavailability of 12%. It is used to treat various types of cancer, including brain tumors and blood cancers.
At a glance
| Generic name | CARMUSTINE |
|---|---|
| Sponsor | Avet Lifesciences |
| Drug class | Alkylating Drug |
| Target | Glutathione reductase, mitochondrial |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1977 |
Mechanism of action
The activity of GLIADEL Wafer is due to release of cytotoxic concentrations of carmustine, DNA and RNA alkylating agent, into the tumor resection cavity. On exposure to the aqueous environment of the resection cavity, the anhydride bonds in the copolymer are hydrolyzed, releasing carmustine, carboxyphenoxypropane, and sebacic acid into the surrounding brain tissue.
Approved indications
- Diffuse non-Hodgkin's lymphoma, large cell
- Glioblastoma multiforme of brain
- Glioma, malignant
- Hodgkin's disease
- Malignant neoplasm of brain
- Multiple myeloma
- Non-Hodgkin's lymphoma
Boxed warnings
- WARNING: MYELOSUPPRESSION and PULMONARY TOXICITY Myelosuppression Carmustine for injection, USP causes suppression of marrow function (including thrombocytopenia and leukopenia), which may contribute to bleeding and overwhelming infections. [ see Warnings and Precautions (5.1) and Adverse Reactions (6) ]. Monitor blood counts weekly for at least 6 weeks after each dose. Adjust dosage based on nadir blood counts from the prior dose [ see Dosage and Administration (2.1) ]. Do not administer a repeat course of carmustine for injection, USP until blood counts recover. Pulmonary Toxicity Carmustine for injection, USP causes dose-related pulmonary toxicity. Patients receiving greater than 1400 mg/m 2 cumulative dose are at significantly higher risk than those receiving less. Delayed pulmonary toxicity can occur years after treatment, and can result in death, particularly in patients treated in childhood [see Adverse Reactions (6) and Use in Specific Populations (8.4) ] . WARNING: MYELOSUPPRESSION and PULMONARY TOXICITY See full prescribing information for complete boxed warning Suppression of marrow function, notably thrombocytopenia and leukopenia, is the most common and severe of the toxic effects of carmustine for injection, USP. Monitor blood counts. (5, 6). Pulmonary toxicity from carmustine for injection, USP appears to be dose related. Patients receiving greater than 1400 mg/m 2 cumulative dose are at significantly higher risk than those receiving less (5, 6).
Common side effects
- Cerebral edema
- Wound healing abnormalities
- Nausea
- Vomiting
- Constipation
- Asthenia
- Fever
- Urinary tract infections
- Chest pain
- Back pain
- Depression
- Intracranial hypertension
Drug interactions
- cimetidine
Key clinical trials
- Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (PHASE3)
- A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma (PHASE2)
- Ruxolitinib-Decitabine Intensified Conditioning Regimen for AML: A Randomized Trial (PHASE4)
- Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma (PHASE2)
- A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant (PHASE1)
- Comprehensive Analysis of Chemotherapy and Targeted Therapy Outcomes in Recurrent Malignant Gliomas
- Autologous Stem Cell Transplant for Neurologic Autoimmune Diseases (PHASE2)
- Genetically Modified T-cells (CMV-Specific CD19-CAR T-cells) Plus a Vaccine (CMV-MVA Triplex) Following Stem Cell Transplantation for the Treatment of Intermediate or High Grade B-cell Non-Hodgkin Lymphoma (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Gliadel CI brief — competitive landscape report
- Gliadel updates RSS · CI watch RSS
- Avet Lifesciences portfolio CI