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IRINOTECAN
IRINOTECAN is a drug. It is currently FDA-approved (first approved 1996).
Irinotecan is a small molecule that inhibits DNA topoisomerase 1, a type of enzyme involved in DNA replication. It is used to treat various types of pancreatic cancer, including pancreatic cancer, pancreas neoplasms, and neoplasms.
At a glance
| Generic name | IRINOTECAN |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1996 |
Approved indications
Boxed warnings
- WARNING FULL PRESCRIBING INFORMATION WARNING: DIARRHEA and MYELOSUPPRESSION Early and late forms of diarrhea can occur. Early diarrhea may be accompanied by cholinergic symptoms which may be prevented or ameliorated by atropine. Late diarrhea can be life threatening and should be treated promptly with loperamide. Monitor patients with diarrhea and give fluid and electrolytes as needed. Institute antibiotic therapy if patients develop ileus, fever, or severe neutropenia. Interrupt Irinotecan hydrochloride injection and reduce subsequent doses if severe diarrhea occurs. Severe myelosuppression may occur. WARNING: DIARRHEA and MYELOSUPPRESSION See full prescribing information for complete boxed warning . • Early and late forms of diarrhea can occur. Early diarrhea may be accompanied by cholinergic symptoms which may be prevented or ameliorated by atropine. Late diarrhea can be life threatening and should be treated promptly with loperamide. Monitor patients with diarrhea and give fluid and electrolytes as needed. Institute antibiotic therapy if patients develop ileus, fever, or severe neutropenia. Interrupt irinotecan hydrochloride injection and reduce subsequent doses if severe diarrhea occurs. • Severe myelosuppression may occur.
Common side effects
- Nausea
- Vomiting
- Abdominal pain
- Diarrhea
- Constipation
- Anorexia
- Neutropenia
- Leukopenia
- Anemia
- Asthenia
- Fever
- Alopecia
Serious adverse events
- Neutropenic fever/sepsis
- Neutropenic sepsis
- CNS bleeding during thrombocytopenia
Key clinical trials
- Erlotinib Hydrochloride and Irinotecan Hydrochloride in Treating Patients With Advanced Solid Tumors (PHASE1)
- A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20) (PHASE3)
- Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma (PHASE3)
- M6620 and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery (PHASE1)
- Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma (PANDAS-PRODIGE 44) (PHASE2)
- Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma (PHASE3)
- Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer (PHASE3)
- Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer (PHASE2)
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:
- IRINOTECAN CI brief — competitive landscape report
- IRINOTECAN updates RSS · CI watch RSS
Frequently asked questions about IRINOTECAN
What is IRINOTECAN?
IRINOTECAN is a Small molecule drug.
When was IRINOTECAN approved?
IRINOTECAN was first approved on 1996.
What development phase is IRINOTECAN in?
IRINOTECAN is FDA-approved (marketed).
What are the side effects of IRINOTECAN?
Common side effects of IRINOTECAN include Nausea, Vomiting, Abdominal pain, Diarrhea, Constipation, Anorexia. Serious adverse events: Neutropenic fever/sepsis, Neutropenic sepsis, CNS bleeding during thrombocytopenia.
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing