Prescription medicine
Topotecan Brand names: Hycamtin
Topotecan (Hycamtin) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 4 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the topotecan FDA label on DailyMed (effective July 7, 2022, Novartis Pharmaceuticals Corporation); the NDA 20671 record on Drugs@FDA; every topotecan label on DailyMed.
Highlights of the record
FDA label of July 7, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
MYELOSUPPRESSION.
HYCAMTIN can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts of greater than or equal to 1,500/mm 3 and platelet counts greater than or equal to 100,000/mm 3 . Monitor blood cell counts [see Warnings and Precautions ( 5.1 )]. WARNING: MYELOSUPPRESSION See full prescribing information for complete boxed warning. HYCAMTIN can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts greater than or equal to 1,500/mm 3 and platelet counts greater than or equal to 100,000/mm 3 . Monitor blood cell counts ( 2.4 , 5.1 ).
Used for
From the label: indications and usageHYCAMTIN for injection is a topoisomerase inhibitor indicated for treatment of: Patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as a single agent ( 1.1 ) Patients with small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy, as a single agent ( 1.2 ) Patients with Stage IV-B,
Forms and strengths
- 0.25 mg
- 1 mg
- 1 mg/ml
- 4 mg/4ml
Injection (powder) (lyophilized) for solution; capsule; injection; injection (solution) (concentrate).
On the market
- Earliest approval on file
- May 28, 1996 Hycamtin, Sandoz; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first November 29, 2010; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 7 of which 4 under generic applications, 3 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2019 1 Class I among all firms' recalls; latest June 12, 2019; 1 more by firms not listed as its makers
- FAERS reports
- 6,854 through July 30, 2026
What is topotecan used for?
From the label: indications and usageHYCAMTIN for injection is a topoisomerase inhibitor indicated for treatment of: Patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as a single agent ( 1.1 ) Patients with small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy, as a single agent ( 1.2 ) Patients with Stage IV-B, recurrent, or persistent cervical cancer which is not amenable to curative treatment, in combination with cisplatin ( 1.3 ) 1.1 Ovarian Cancer HYCAMTIN ® for injection, as a single agent, is indicated for the treatment of patients with metastatic ovarian cancer after disease […]
Conditions named in the indications of topotecan's FDA labels, with every medicine labeled for each:
From other topotecan labelsLung cancer: Small Cell Lung Cancer HYCAMTIN for injection, as a single agent, is indicated for the treatment of patients with small cell lung cancer (SCLC) with platinum-sensitive disease who progressed at least 60 days after initiation of first‑line …
FDA pharmacologic class: Topoisomerase Inhibitor.
Source: FDA drug label (HYCAMTIN), NDA020671 (Sandoz), as published by Novartis Pharmaceuticals Corporation, effective July 7, 2022 (SPL set eeee060c-a9ec-423e-a374-8484009f8524), via openFDA; the full label on DailyMed
What does the patient leaflet for topotecan say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about HYCAMTIN?HYCAMTIN may cause serious side effects, including: • Bone marrow problems. HYCAMTIN can affect your bone marrow and can cause a severe decrease in your white blood cell, red blood cell, and platelet counts. Decreased blood cell counts can make you more likely to develop bleeding, bruising, anemia, or infections which may be life-threatening. Your healthcare provider will do blood tests regularly to check your blood cell counts during treatment with HYCAMTIN. Tell your healthcare provider right away if you have any signs of infection, including: o fever (temperature of 100.5°F or greater) o chills o cough o burning or pain on urination • Diarrhea. HYCAMTIN can cause severe and life-threatening diarrhea that may need to be treated in a hospital. Tell your healthcare provider right away if you develop: o diarrhea with fever o diarrhea 3 or more times a day o diarrhea with stomach-area pain or cramps See “What are the possible side effects of HYCAMTIN?” for more information about side effects.
From the patient leaflet: How should I store HYCAMTIN?Store HYCAMTIN in a refrigerator between 36°F to 46°F (2°C to 8°C). • Keep the bottle of HYCAMTIN in the carton that it comes in to protect it from light. • Ask your healthcare provider or pharmacist how to safely throw away any unused or expired HYCAMTIN. Keep HYCAMTIN and all medicines out of the reach of children.
Source: FDA drug label (HYCAMTIN), Sandoz Inc, effective September 18, 2023 (SPL set b23b46f5-c276-47f5-8bbd-940680b3f579), via openFDA; the full label on DailyMed
Is there a generic for topotecan (Hycamtin)?
The FDA approved the first generic topotecan on November 29, 2010. 13 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists topotecan from 4 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1996 earliest approval on file
- 2010 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has topotecan been recalled?
The FDA's Enforcement Report lists 2 recalls naming topotecan since 2019: 1 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of topotecan and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 18, 2021 | Class I | Teva Pharmaceuticals USA not a listed maker | Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two … |
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the topotecan label say about other medicines?
The topotecan label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 6 other medicines name topotecan. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cisplatin | warnings and precautions | Combination with Cisplatin Grade 4 neutropenia occurred in 48% and Grade 4 thrombocytopenia occurred in 7% of 147 patients. |
Other labels that name topotecan
Source: FDA drug label (HYCAMTIN), NDA020671 (Sandoz), as published by Novartis Pharmaceuticals Corporation, effective July 7, 2022 (SPL set eeee060c-a9ec-423e-a374-8484009f8524), via openFDA; the full label on DailyMed
What do FAERS reports show for topotecan?
The FDA Adverse Event Reporting System holds 6,854 reports that list topotecan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,640 are coded as a death and 2,591 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as topotecan?
16 other medicines are given the same way (intravenous) and in the same FDA class as topotecan or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Etoposide | Lung cancer | 5 labelers | n/a | No current entry |
| Pemetrexed | Lung cancer | 15 labelers | n/a | A presentation being discontinued |
| Nivolumab | Lung cancer | none listed | n/a | No current entry |
| Atezolizumab | Lung cancer | none listed | n/a | No current entry |
| Durvalumab | Lung cancer | none listed | n/a | No current entry |
| Ipilimumab | Lung cancer | none listed | n/a | No current entry |
| Ramucirumab | Lung cancer | none listed | n/a | No current entry |
| Telisotuzumab vedotin | Lung cancer | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to topotecan
- 16 medicines for the same use
- Other topoisomerase inhibitors
- the pharmacologic class, with prices and generics
- Topotecan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other