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Topotecan Hydrochloride 4 mg/4mL Injection, Powder, Lyophilized, For Solution

by Bedford Laboratories · 1 VIAL in 1 CARTON (55390-370-10) / 4 mL in 1 VIAL

NDC 55390-0370-10

🏷️ FDA NDC (as labeled) 55390-370-10 billing pads the product segment with a zero

Rx only Generic Discontinued Non-controlled ⚠ Inactivated by FDA

🗂️ Data synced Jul 14, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️

Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2023. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 55390-370-10

Product NDC 55390-370

11-digit billing NDC 55390037010

NCPDP billing unit EA — each (per item)

Application # ANDA201191

SPL Set ID a439bf07-53db-0352-846a-99d9da772f9b

Mechanism of action Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors

DEA schedule Non-controlled

Marketing category ANDA

Marketing status Discontinued

FDA listing status Inactivated by FDA (certified through Dec 2023)

Route INTRAVENOUS

Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Substance TOPOTECAN HYDROCHLORIDE

GCN Seq No 026807

GCN 22661

HICL code 011381

Ingredient (HICL) Topotecan Hcl

HIC1 code V

Therapeutic class — broad (HIC1) Neoplasms

HIC2 code V3

Therapeutic class — intermediate (HIC2) Antineoplastic Drugs (Continued 1)

HIC3 code V3E

Therapeutic class — specific (HIC3) Antineoplastic - Topoisomerase I Inhibitors

AHFS code 10:00.00.00

AHFS class Antineoplastic Agents

FDB label name TOPOTECAN HCL 4 MG VIAL

FDB brand name Topotecan Hcl

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AP · RLD · RS

Why two NDCs? The FDA registers this code as 55390-370-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 55390-0370-10. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerBedford Laboratories

Application holderDR REDDYS LABORATORIES LTD

FDA applicationANDA201191 (ANDA)

Labeler code55390

Product typeHuman Prescription Drug

🔎 All NDCs from Bedford Laboratories

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name TOPOTECAN HCL 4 MG VIAL Ingredient Topotecan Hcl

📗 Our plain-language guide HelloPharmacist

Topotecan is a chemotherapy used for three types of cancer: small cell lung cancer (SCLC), metastatic ovarian cancer, and advanced cervical cancer. The IV form covers all three, de...
What exactly is topotecan used to treat?
The most common effects are drops in blood counts — low white blood cells, red blood cells, and platelets — along with nausea, vomiting, hair loss, fatigue, and bowel changes. Most...
What side effects should I expect, and which ones should make me call someone right away?

📖 Read our full Topotecan guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
UNII W4888I119H
Tartaric acid is a natural organic acid found in grapes and tamarinds. In medicines, it works as a buffer to control acidity, an antioxidant to prevent spoilage, and sometimes a flavoring or binding agent.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Topotecan Hydrochloride 4 mg/4mLthis 55390-0370-10	Bedford	1 vial	—	AP	Discontinued	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

📍

2026

Currently FDA-listed

listed with the FDA

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Topotecan hydrochloride — the ingredient across all brands.

Top reported reactions

Death384

Febrile Neutropenia257

Anaemia235

White Blood Cell Count Decreased204

Pyrexia202

Nausea188

Platelet Count Decreased184

Age at onset

Neonate1

Infant6

Child32

Adolescent7

Adult46

Elderly11

Reporter sex

Male · 41%

Female · 57%

Unknown · 1%

Serious outcomes

Hospitalization921

Death720

Life-threatening151

Disabling58

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
55390-0370-10 You're viewing this	1 VIAL in 1 CARTON (55390-370-10) / 4 mL in 1 VIAL	2020-12-01	Inactivated by FDA

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	— Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

What does the discontinued status mean for this NDC?

The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 55390-370-10, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 55390-0370-10, written without dashes as 55390037010. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 55390-0370-10, the first segment (55390) is the labeler code FDA assigned to Bedford Laboratories; the middle segment (0370) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) identifies this exact package size and type. Together they name one specific package of one specific product.

Who lists this product with the FDA?

Bedford Laboratories is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🚨 Boxed Warning 129 words ▾

WARNING: BONE MARROW SUPPRESSION Do not give topotecan hydrochloride for injection to patients with baseline neutrophil counts less than 1,500 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection and death, monitor peripheral blood counts frequently on all patients receiving topotecan hydrochloride for injection [see Warnings and Precautions (5.1) ]. WARNING: BONE MARROW SUPPRESSION See full prescribing information for complete boxed warning.

Do not give topotecan hydrochloride for injection to patients with baseline neutrophil counts less than 1,500 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection and death, monitor peripheral blood cell counts frequently on all patients receiving topotecan hydrochloride for injection. ( 5.1)

🎯 Indications and Usage 155 words ▾

1 INDICATIONS AND USAGE Topotecan hydrochloride for injection is indicated for the treatment of: Small cell lung cancer sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the Phase 3 study) or at least 90 days (in the Phase 2 studies) after chemotherapy [see Clinical Studies (14 ) ]. Topotecan hydrochloride for injection in combination with cisplatin is indicated for the treatment of: stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.

Topotecan hydrochloride for injection is a topoisomerase inhibitor indicated for: Small cell lung cancer sensitive disease after failure of first-line chemotherapy. (1) Combination therapy with cisplatin for stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy. (1)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Verify dose using body surface area prior to dispensing. Recommended dosage should generally not exceed 4 mg intravenously [ see Overdosage ( 10 )]. Prior to administration of the first course of topotecan hydrochloride for injection, patients must have a baseline neutrophil count of >1,500 cells/mm 3 and a platelet count of >100,000 cells/mm 3 .

Small cell lung cancer: 1.5mg/m 2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on day one of a 21-day course. (2.1) Cervical cancer: 0.75mg/m 2 by intravenous infusion over 30 minutes on days 1, 2, and 3 followed by cisplatin 50mg/m 2 by intravenous infusion on day 1 repeated every 21 days. ( 2.2) See Dosage Modification Guidelines for patients with neutropenia or reduced platelets.

( 2.1 , 2.2) See Dosage Adjustment in Renal Impairment. (2.3)

2.1Small Cell Lung Cancer Recommended Dosage: The recommended dose of topotecan hydrochloride for injection is 1.5 mg/m 2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on day 1 of a 21-day course. In the absence of tumor progression, a minimum of 4 courses is recommended because tumor response may be delayed and median time to response in 4 small cell lung cancer trials was 5 to 7 weeks. Dosage Modification Guidelines: In the event of severe neutropenia (defined as <500 cells/mm 3 ) during any course, reduce the dose by 0.25 mg/m 2 (to 1.25 mg/m 2 ) for subsequent courses.

Alternatively, in the event of severe neutropenia, administer G-CSF (granulocyte-colony stimulating factor) following the subsequent course (before resorting to dose reduction) starting from day 6 of the course (24 hours after completion of topotecan administration).In the event the platelet count falls below 25,000 cells/mm 3 , reduce doses by 0.25 mg/m 2 (to 1.25 mg/m 2 ) for subsequent courses.

2.2Cervical Cancer Recommended Dosage: The recommended dose of topotecan hydrochloride for injection is 0.75 mg/m 2 by intravenous infusion over 30 minutes daily on days 1, 2, and 3; followed by cisplatin 50 mg/m2 by intravenous infusion on day 1 repeated every 21 days (a 21-day course). Dosage Modification Guidelines: Dosage adjustments for subsequent courses of topotecan hydrochloride for injection in combination with cisplatin are specific for each drug. See manufacturer’s prescribing information for cisplatin administration and hydration guidelines and for cisplatin dosage adjustment in the event of hematologic toxicity.

In the event of severe febrile neutropenia (defined as <1000 cells/mm 3 with temperature of 38.0°C or 100.4°F), reduce the dose of topotecan hydrochloride for injection to 0.60 mg/m 2 for subsequent courses. Alternatively, in the event of severe febrile neutropenia, administer G-CSF following the subsequent course (before resorting to dose reduction) starting from day 4 of the course (24 hours after completion of administration of topotecan hydrochloride for injection). If febrile neutropenia occurs despite the use of G-CSF, reduce the dose of topotecan hydrochloride for injection to 0.45 mg/m 2 for subsequent courses.

In the event the platelet count falls below 25,000 cells/mm 3 , reduce doses to 0.60 mg/m 2 for subsequent courses.

2.3Dosage Adjustment in Specific Populations Renal Impairment: No dosage adjustment of topotecan hydrochloride for injection appears to be required for patients with mild renal impairment (Cl cr 40 to 60 mL/min.). Dosage adjustment of topotecan hydrochloride for injection to 0.75 mg/m 2 is recommended for patients with moderate renal impairment (20 to 39 mL/min.). Insufficient data are available in patients with severe renal impairment to provide a dosage recommendation for topotecan hydrochloride for injection [see Use in Specific Populations (8.6) and Clinical Pharmacology ( 12.3) ].

Topotecan hydrochloride for injection in combination with cisplatin for the treatment of cervical cancer should only be initiated in patients with serum cr…

💊 Dosage Forms and Strengths 23 words ▾

3 DOSAGE FORMS AND STRENGTHS 4 mg (free base) single-dose vial, light yellow to greenish powder 4 mg (free base) single-dose vial. (3)

⛔ Contraindications 65 words ▾

4 CONTRAINDICATIONS Topotecan hydrochloride for injection is contraindicated in patients who have a history of severe hypersensitivity reactions (e.g., anaphylactoid reactions) to topotecan or to any of its ingredients. Topotecan hydrochloride for injection should not be used in patients with severe bone marrow depression. History of severe hypersensitivity reactions (e.g., anaphylactoid reactions) to topotecan or any of its ingredients (4) Severe bone marrow depression (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Bone marrow suppression: Administer topotecan hydrochloride for injection only to patients with adequate bone marrow reserves. Monitor peripheral blood counts and adjust the dose if needed. (5.1) Topotecan-induced neutropenia can lead to neutropenic colitis.

(5.2) Interstitial lung disease: Topotecan hydrochloride for injection has been associated with reports of interstitial lung disease. Monitor patients for symptoms and discontinue topotecan hydrochloride for injection if the diagnosis is confirmed. (5.3) Pregnancy: Can cause fetal harm.

Advise women of potential risk to the fetus. (5.4, 8.1)

5.1Bone Marrow Suppression Bone marrow suppression (primarily neutropenia) is the dose-limiting toxicity of topotecan hydrochloride for injection. Neutropenia is not cumulative over time. In the comparative trial in small cell lung cancer, however, the treatment-related death rates were 5% for topotecan hydrochloride for injection and 4% for CAV (cyclophosphamide-doxorubicin-vincristine).

Neutropenia: Small cell lung cancer experience: Grade 4 neutropenia (<500 cells/mm 3 ) was most common during course 1 of treatment (60% of patients) and occurred in 39% of all courses, with a median duration of 7 days. The nadir neutrophil count occurred at a median of 12 days. Therapy-related sepsis or febrile neutropenia occurred in 23% of patients, and sepsis was fatal in 1%.

Pancytopenia has been reported. Cervical cancer experience: Grade 3 and Grade 4 neutropenia affected 26% and 48% of patients, respectively. Thrombocytopenia: Small cell lung cancer experience: Grade 4 thrombocytopenia (<25,000/mm 3 ) occurred in 27% of patients and in 9% of courses, with a median duration of 5 days and platelet nadir at a median of 15 days.

Platelet transfusions were given to 15% of patients in 4% of courses. Cervical cancer experience: Grade 3 and Grade 4 thrombocytopenia affected 26% and 7% of patients, respectively. Anemia: Small cell lung cancer experience: Grade 3/4 anemia (<8 g/dL) occurred in 37% of patients and in 14% of courses.

Median nadir was at day 15. Transfusions were needed in 52% of patients in 22% of courses. Cervical cancer experience: Grade 3 and Grade 4 anemia affected 34% and 6% of patients, respectively.

Monitoring of Bone Marrow Function: Administer topotecan hydrochloride for injection only in patients with adequate bone marrow reserves, including baseline neutrophil count of at least 1,500 cells/mm 3 and platelet count at least 100,000/mm 3 . Monitor peripheral blood counts frequently during treatment with topotecan hydrochloride for injection. Do not treat patients with subsequent courses of topotecan hydrochloride for injection until neutrophils recover to >1,000 cells/mm 3 , platelets recover to >100,000 cells/mm 3 , and hemoglobin levels recover to 9.0 g/dL (with transfusion if necessary).

Severe myelotoxicity has been reported when topotecan hydrochloride for injection is used in combination with cisplatin [see Drug Interactions (7) ].

5.2Neutropenic Colitis Topotecan-induced neutropenia can lead to neutropenic colitis. Fatalities due to neutropenic colitis have been reported in clinical trials with topotecan hydrochloride for injection. In patients presenting with fever, neutropenia, and a compatible pattern of abdominal pain, consider the possibility of neutropenic colitis.

5.3Interstitial Lung Disease Topotecan hydrochloride for injection has been associated with reports of interstitial lung disease (ILD), some of which have been fatal [see Adverse Reactions (6.2) ]. Underlying risk factors include history of ILD, pulmonary fibrosis, lung cancer, thoracic exposure to radiation, and use of pneumotoxic drugs and/or colony stimulating factors. Monitor patients for pulmonary symptoms indicative of interstitial lung disease (e.g., cough, fever, dyspnea, and/or hypoxia), and discontinue topotecan hydrochloride for injection if a new diagnosis of ILD is confirmed.

5.4 Pregnancy Pregnancy Category D Topo…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Small cell lung cancer: The most common hematologic adverse reactions were: neutropenia (97%), leukopenia (97%), anemia (89%), and thrombocytopenia (69%). (6.1) The most common (>25%) non-hematologic adverse reactions (all grades) were: nausea, alopecia, vomiting, sepsis or pyrexia/infection with neutropenia, diarrhea, constipation, fatigue, and pyrexia. (6.1) Cervical cancer (topotecan hydrochloride for injection plus cisplatin): The most common hematologic adverse reactions (all grades) were: anemia (94%), leukopenia (91%), neutropenia (89%), and thrombocytopenia (74%).

(6.1) The most common (>25%) non-hematologic adverse reactions (all grades) were: pain, nausea, vomiting, and infection/febrile neutropenia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Limited Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Small Cell Lung Cancer: Data in the following section are based on the 426 patients with small cell lung cancer treated with topotecan hydrochloride for injection. Table 1 lists the principal hematologic adverse reactions and Table 2 lists non-hematologic adverse reactions occurring in at least 15% of patients.

Table 1. Hematologic Adverse Reactions Experienced in ≥ 15% Small Cell Lung Cancer Patients Receiving Topotecan Hydrochloride For Injection Hematologic Adverse Reaction Patients (n = 879) % Incidence Neutropenia <1,500 cells/mm 3 <500 cells/mm 3 97 78 Leukopenia <3,000 cells/mm 3 <1,000 cells/mm 3 97 32 Thrombocytopenia <75,000/mm 3 <25,000/mm 3 69 27 Anemia <10 g/dL <8 g/dL 89 37 Table 2. Non-hematologic Adverse Reactions Experienced by ≥ 15% of Small Cell Lung Cancer Patients Receiving Topotecan Hydrochloride For Injection Non-hematologic Adverse Reaction Percentage of Patients with Adverse Reaction (879 Patients) All Grades Grade 3 Grade 4 Infections and infestations Sepsis or pyrexia/infection with neutropenia a 43 NR 23 Metabolism and nutrition disorders Anorexia 19 2 <1 Nervous system disorders Headache 18 1 <1 Respiratory, thoracic, and mediastinal disorders Dyspnea Coughing 22 15 5 1 3 0 Gastrointestinal disorders Nausea Vomiting Diarrhea Constipation Abdominal pain Stomatitis 64 45 32 29 22 18 7 4 3 2 2 1 1 1 1 1 2 <1 Skin and subcutaneous tissue disorders Alopecia Rash b 49 16 NA 1 NA 0 General disorders and administrative site conditions Fatigue Pyrexia Pain c Asthenia 29 28 23 25 5 1 2 4 0 <1 1 2 NA = Not applicable NR = Not reported separately a Does not include Grade 1 sepsis or pyrexia. b Rash also includes pruritus, rash erythematous, urticaria, dermatitis, bullous eruption, and maculopapular rash. c Pain includes body pain, back pain, and skeletal pain.

Nervous System Disorders: Paresthesia occurred in 7% of patients but was generally Grade 1. Hepatobiliary Disorders: Grade 1 transient elevations in hepatic enzymes occurred in 8% of patients. Greater elevations, Grade 3/4, occurred in 4%.

Grade 3/4 elevated bilirubin occurred in <2% of patients. Table 3 shows the Grade 3/4 hematologic and major non-hematologic adverse reactions in the topotecan/CAV (cyclophosphamide-doxorubicin-vincristine) comparator trial in small cell lung cancer. Table 3.

Adverse Reactions Experienced by ≥ 5 % of Small Cell Lung Cancer Patients Randomized to Receive Topotecan Hydrochloride For Injection or CAV Adverse Reaction Topotecan Hydrochloride For Injection (n = 107) CAV (n = 104) Hematologic Grade 3/4 % % Grade 4 neutropenia (<500 cells/mm 3 ) 70 72 Grade 3/4 anemia (Hgb <8 g/dL) 42 20 Grade 4 thrombocytopenia (<25,000 plts/mm 3 ) 29 5 Pyrexia/Grade 4 neutropenia 28 26 Non-hematologic Grade 3/4 % % Infections and infestationsDocumented sepsis a 5 5 Res…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS G-CSF: Concomitant administration of G-CSF can prolong the duration of neutropenia, so if G-CSF is to be used, do not initiate it until day 6 of the course of therapy, 24 hours after completion of treatment with topotecan hydrochloride for injection. Platinum and Other Cytotoxic Agents: Myelosuppression was more severe when topotecan hydrochloride for injection, at a dose of 1.25 mg/m 2 /day for 5 days, was given in combination with cisplatin at a dose of 50 mg/m 2 in Phase 1 trials. In one trial, 1 of 3 patients had severe neutropenia for 12 days and a second patient died with neutropenic sepsis.

Greater myelosuppression is also likely to be seen when topotecan hydrochloride for injection is used in combination with other cytotoxic agents, thereby necessitating a dose reduction. However, when combining topotecan hydrochloride for injection with platinum agents (e.g., cisplatin or carboplatin), a distinct sequence-dependent interaction on myelosuppression has been reported. Coadministration of a platinum agent on day 1 of dosing with topotecan hydrochloride for injection required lower doses of each agent compared to coadministration on day 5 of the dosing schedule for topotecan hydrochloride for injection.

For information on the pharmacokinetics, efficacy, safety, and dosing of topotecan hydrochloride for injection at a dose of 0.75 mg/m 2 /day on days 1, 2, and 3 in combination with cisplatin 50 mg/m 2 on day 1 for cervical cancer, see Dosage and Administration (2) , Adverse Reactions ( 6) , Clinical Pharmacology (12.3) , and Clinical Studies (14) . Do not initiate G-CSF until 24 hours after completion of treatment with topotecan hydrochloride for injection. Concomitant administration can prolong duration of neutropenia.

(7) Greater myelosuppression is likely to be seen when used in combination with other cytotoxic agents. (7)

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Nursing Mothers: Discontinue nursing when receiving topotecan hydrochloride for injection. (8.3)

8.1Pregnancy Pregnancy Category D [see Warnings and Precautions (5.4) ]. Topotecan hydrochloride for injection can cause fetal harm when administered to a pregnant woman. In rabbits, a dose of 0.10 mg/kg/day (about equal to the clinical dose on a mg/m 2 basis) given on days 6 through 20 of gestation caused maternal toxicity, embryolethality, and reduced fetal body weight.

In the rat, a dose of 0.23 mg/kg/day (about equal to the clinical dose on a mg/m 2 basis) given for 14 days before mating through gestation day 6 caused fetal resorption, microphthalmia, pre-implant loss, and mild maternal toxicity. A dose of 0.10 mg/kg/day (about half the clinical dose on a mg/m 2 basis) given to rats on days 6 through 17 of gestation caused an increase in post-implantation mortality. This dose also caused an increase in total fetal malformations.

The most frequent malformations were of the eye (microphthalmia, anophthalmia, rosette formation of the retina, coloboma of the retina, ectopic orbit), brain (dilated lateral and third ventricles), skull, and vertebrae. There are no adequate and well-controlled studies of topotecan hydrochloride for injection in pregnant women. If this drug is used during pregnancy, or if a patient becomes pregnant while receiving topotecan hydrochloride for injection, the patient should be apprised of the potential hazard to the fetus. [see Warnings and Precautions (5.4) ].

8.3Nursing Mothers Rats excrete high concentrations of topotecan into milk. Lactating female rats given 4.72 mg/m 2 IV (about twice the clinical dose on a mg/m 2 basis) excreted topotecan into milk at concentrations up to 48-fold higher than those in plasma. It is not known whether the drug is excreted in human milk.

Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from topotecan hydrochloride for injection, discontinue breastfeeding when women are receiving topotecan hydrochloride for injection.

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.5Geriatric Use Of the 879 patients with small cell lung cancer in clinical trials of topotecan hydrochloride for injection, 32% (n = 281) were 65 years of age and older, while 3.8% (n = 33) were 75 years of age and older. Of the 140 patients with stage IV-B, relapsed, or refractory cervical cancer in clinical studies of topotecan hydrochloride for injection who received topotecan hydrochloride for injection plus cisplatin in the randomized clinical trial, 6% (n = 9) were 65 years of age and older, while 3% (n = 4) were 75 years of age and older.

No overall differences in effectiveness or safety were observed between these patients and younger adult patients, and other reported clinical experience has not identified differences in responses between the elderly and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out. There were no apparent differences in the pharmacokinetics of topotecan in elderly patients, once the age-related decrease in renal function was considered [see Clinical Pharmacology (12.3) ]. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Dosage and Administration (2.3) ].

8.6Renal Impairment No dosage adjustment of topotecan hydrochloride for injection appears to be required for patients with mild renal impairment (Cl cr 40 to 60 mL/min.). Dosage reduction is recommended for patients with moderate renal impairment (Cl cr 20 to 39 mL/min.). Insufficient data are available in patients with severe renal impairment to provide a…

🤰 Pregnancy ~1 min read ▾

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use ~1 min read ▾

🆘 Overdosage 144 words ▾

10 OVERDOSAGE Overdoses (up to 10-fold of the prescribed dose) occurred in patients treated with intravenous topotecan. The primary complication of overdosage is bone marrow suppression. The observed signs and symptoms of overdose are consistent with the known adverse reactionsassociated with topotecan hydrochloride for injection for intravenous use [see Adverse Reactions ( 6.1 , 6.2)].

In addition, elevated hepatic enzymes and mucositis have been reported following overdose. One patient received a single dose of 40 mg/m 2 of intravenous topotecan and developed gastrointestinal toxicity, skin toxicity, and myelosuppresion leading to septic shock. Another patient received a single dose of 35 mg/m 2 and experienced severe, reversible neutropenia.

There is no known antidote for overdosage with topotecan hydrochloride for injection. If an overdose is suspected, monitor the patient for bone marrow suppression and institute supportive-care measures (such as prophylactic G-CSF and antibiotic therapy) as appropriate.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Topoisomerase I relieves torsional strain in DNA by inducing reversible single-strand breaks. Topotecan binds to the topoisomerase I-DNA complex and prevents religation of these single-strand breaks. The cytotoxicity of topotecan is thought to be due to double-strand DNA damage produced during DNA synthesis, when replication enzymes interact with the ternary complex formed by topotecan, topoisomerase I, and DNA.

Mammalian cells cannot efficiently repair these double-strand breaks.

12.2Pharmacodynamics The dose-limiting toxicity of topotecan is leukopenia. White blood cell count decreases with increasing topotecan dose or topotecan AUC. When topotecan is administered at a dose of 1.5 mg/m 2 /day for 5 days, an 80% to 90% decrease in white blood cell count at nadir is typically observed after the first cycle of therapy.

12.3Pharmacokinetics The pharmacokinetics of topotecan have been evaluated in cancer patients following doses of 0.5 to 1.5 mg/m 2 administered as a 30-minute infusion. Topotecan exhibits multiexponential pharmacokinetics with a terminal half-life of 2 to 3 hours. Total exposure (AUC) is approximately dose-proportional.

Distribution: Binding of topotecan to plasma proteins is about 35%. Metabolism: Topotecan undergoes a reversible pH-dependent hydrolysis of its lactone moiety; it is the lactone form that is pharmacologically active. At pH ≤4, the lactone is exclusively present, whereas the ring-opened hydroxy-acid form predominates at physiologic pH.

In vitro studies in human liver microsomes indicate topotecan is metabolized to an N-demethylated metabolite. The mean metabolite:parent AUC ratio was about 3% for total topotecan and topotecan lactone following IV administration. Excretion: Renal clearance is an important determinant of topotecan elimination.

In a mass balance/excretion trial in 4 patients with solid tumors, the overall recovery of total topotecan and its N-desmethyl metabolite in urine and feces over 9 days averaged 73.4% ± 2.3% of the administered IV dose. Mean values of 50.8% ± 2.9% as total topotecan and 3.1% ± 1.0% as N-desmethyl topotecan were excreted in the urine following IV administration. Fecal elimination of total topotecan accounted for 17.9% ± 3.6% while fecal elimination of N desmethyl topotecan was 1.7% ± 0.6%.

An O-glucuronidation metabolite of topotecan and Ndesmethyl topotecan has been identified in the urine. These metabolites, topotecan-O glucuronide and N-desmethyl topotecan-O-glucuronide, were less than 2% of the administered dose. Effect of Gender: The overall mean topotecan plasma clearance in male patients was approximately 24% higher than that in female patients, largely reflecting difference in body size.

Effect of Age: Topotecan pharmacokinetics have not been specifically studied in an elderly population, but population pharmacokinetic analysis in female patients did not identify age as a significant factor. Decreased renal clearance, which is common in the elderly, is a more important determinant of topotecan clearance [see Dosage and Administration (2.3) and Use in Specific Populations (8.5 ) ]. Effect of Race: The effect of race on topotecan pharmacokinetics has not been studied.

Effect of Renal Impairment: In patients with mild renal impairment (creatinine clearance of 40 to 60 mL/min.), topotecan plasma clearance was decreased to about 67% of the value in patients with normal renal function. In patients with moderate renal impairment (Cl cr of 20 to 39 mL/min.), topotecan plasma clearance was reduced to about 34% of the value in control patients, with an increase in half-life. Mean half-life, estimated in 3 patients with renal impairment, was about 5.0 hours.

Dosage adjustment is recommended for these patients [see Dosage and Administration (2.3 ) ]. Effect of Hepatic Impairment: Plasma clearance in patients with hepatic impairment (serum bilirubin levels between 1.7 and 15.0 mg/dL) was decreased to about 67% of…

🧬 Mechanism of Action 70 words ▾

Mammalian cells cannot efficiently repair these double-strand breaks.

📦 How Supplied / Storage and Handling 45 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Topotecan hydrochloride for injection is supplied in 4 mg (free base) single-dose vials packaged in a carton containing 1vial NDC 55390-370-10 Storage: Store the vials protected from light in the original cartons at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature].

📋 Description 163 words ▾

11 DESCRIPTION Topotecan hydrochloride for injection is a semi-synthetic derivative of camptothecin and is an anti-tumor drug with topoisomerase I-inhibitory activity. Topotecan hydrochloride for Injection is supplied as a sterile lyophilized, buffered, light yellow to greenish powder available in single-dose vials. Each vial contains topotecan hydrochloride equivalent to 4 mg of topotecan as free base.

The reconstituted solution ranges in color from yellow to yellow-green and is intended for administration by intravenous infusion. Inactive ingredients are mannitol 48 mg and tartaric acid 20 mg. Hydrochloric acid and sodium hydroxide may be used to adjust the pH.

The solution pH ranges from 2.5 to 3.5. The chemical name for topotecan hydrochloride is (S)-10-[(dimethylamino)methyl]-4ethyl-4,9-dihydroxy-1 H -pyrano[3’,4’:6,7] indolizino [1,2- b ]quinoline-3,14-(4 H ,12 H )-dione monohydrochloride. It has the molecular formula C 23 H 23 N 3 O 5 •HCl and a molecular weight of 457.9.

Topotecan hydrochloride has the following structural formula: It is soluble in water and melts with decomposition at 213° to 218°C.

💬 Information for Patients 180 words ▾

17 PATIENT COUNSELING INFORMATION

17.1Bone Marrow Suppression Inform patients that topotecan hydrochloride for injection decreases blood cell counts such as white blood cells, platelets, and red blood cells. Patients who develop fever, other signs of infection (e.g., chills, cough, or burning pain on urination), or bleeding while on therapy should notify their physician promptly. Inform patients that frequent blood tests will be performed while taking topotecan hydrochloride for injection to monitor for the occurrence of bone marrow suppression.

17.2Pregnancy and Breastfeeding Advise patients to use effective contraceptive measures to prevent pregnancy and to avoid breastfeeding during treatment with topotecan hydrochloride for injection.

17.3Asthenia and Fatigue Inform patients that topotecan hydrochloride for injection may cause asthenia or fatigue. If these symptoms occur, caution should be observed when driving or operating machinery. Topotecan hydrochloride for injection is a registered trademark of GlaxoSmithKline.

Rx only Manufactured for: Dr. Reddy’s Laboratories Limited By: Cipla Limited, at S-103 to S-105 & S-107 to S-112, Verna Industrial Estate, Verna Goa – 403722, INDIA Distributed by: Bedford Laboratories TM Bedford, OH 44146 Issued: 0414

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

alopecia: Loss of hair from the scalp or body.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

asthenia: Unusual weakness or lack of physical strength and energy.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

bilirubin: A yellow substance the liver normally clears from the blood; high levels can turn the skin or the whites of the eyes yellow.

bone marrow suppression: Slowed production of blood cells by the soft tissue inside bones, causing low counts of red cells, white cells, or platelets.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

colitis: Swelling and irritation of the inner lining of the large intestine, or colon.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

cytotoxic: Describing a substance that kills cells, especially fast-growing ones such as cancer cells.

depression: A lasting low mood with loss of interest that affects everyday life.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

dose-limiting toxicity: A side effect severe enough that it prevents giving a higher dose of a medicine.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

febrile: Having a fever, or relating to a fever.

febrile neutropenia: A fever that happens when infection-fighting white blood cells are very low, which can be a sign of serious infection.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

glucuronidation: The process where enzymes attach a sugar-like molecule to a drug so it dissolves in water and leaves the body.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemoglobin: The iron-containing protein inside red blood cells that carries oxygen throughout the body.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypoxia: A condition in which the body's tissues do not get enough oxygen.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

interstitial lung disease: A group of conditions in which the tissue around the lungs' air sacs becomes scarred or inflamed, making breathing harder.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

lyophilized: Freeze-dried into a powder that is mixed with liquid before it is given.

maculopapular rash: A common rash made up of flat red patches mixed with small raised bumps.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

mucositis: Painful swelling and sores in the moist lining of the mouth, throat, or digestive tract.

myelosuppression: A slowing of the bone marrow's job of making blood cells, which can lower red cells, white cells, or platelets.

nadir: The point when a blood cell count falls to its lowest level after treatment, before it starts to recover.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neutropenia: A low level of neutrophils, a type of white blood cell that fights infection, which can make it easier to catch infections.

neutrophil: A type of white blood cell that is one of the body's main defenders against infection.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

pancytopenia: A low level of all three main blood cell types at once: red cells, white cells, and platelets.

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

pregnancy category: An older letter rating (A, B, C, D, or X) once used to describe a medicine's possible risk during pregnancy.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

pruritus: Itching of the skin.

pulmonary fibrosis: Scarring and thickening of lung tissue that makes the lungs stiff and breathing harder over time.

pyrexia: A raised body temperature; a fever.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

refractory: Describing a disease that does not respond to, or improve with, treatment.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

Rx only: A label marking meaning the medicine can be obtained only with a prescription from a licensed health professional.

sepsis: A serious, body-wide reaction to an infection in which the body's own response can start to injure its tissues and organs.

single-dose vial: A small container holding one dose of medicine, meant to be used once and then thrown away.

stomatitis: Soreness, swelling, or sores on the lining inside the mouth.

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

terminal half-life: The time it takes blood levels to fall by half during the final, slowest stage of removal.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 55370-0827-00 · Patheon 55404-0002-01 · Lessors, →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

Topotecan Hydrochloride 4 mg/4mL Injection, Powder, Lyophilized, For Solution

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5.4 Pregnancy Pregnancy Category D Topo…

12 CLINICAL PHARMACOLOGY

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