HYCAMTIN

Product NDC
66758-101
11-digit product format
667580101
Labeler code
66758
Product ID
66758-101_b23b46f5-c276-47f5-8bbd-940680b3f579
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topotecan
Dosage form
CAPSULE
Route
ORAL
Labeler
Sandoz Inc
Application
NDA020981
Marketing category
NDA
Marketing start
2017-07-07
Substance
TOPOTECAN HYDROCHLORIDE
Active strength
.25 mg/1
Pharmacologic classes
Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020981-001HYCAMTINTOPOTECAN HYDROCHLORIDEEQ 0.25MG BASECAPSULE / ORALRLD2007-10-11
N020981-002HYCAMTINTOPOTECAN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALRLD, RS2007-10-11

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYCAMTINTOPOTECANSandoz Incb23b46f5-c276-47f5-8bbd-940680b3f5792023-09-18Boxed warning, Warnings, Adverse reactionsExact identifier

Boxed warning cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

boxed warning

WARNING: 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 of greater than or equal to 1,500/mm 3 and platelet counts of greater than or equal to 100,000/mm 3 . Monitor blood cell counts ( 2.2 , 5.1 ).

Warnings cross-check#

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warnings and cautions

5 WARNINGS AND PRECAUTIONS • Diarrhea: Severe diarrhea can occur. Withhold and reduce dose as recommended. ( 2.2 , 5.2 ) • Interstitial Lung Disease (ILD): Fatal cases have occurred. Permanently discontinue if confirmed ILD. ( 5.3 ) • Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of potential risk to the fetus and to use effective contraception. ( 5.4 , 8.1 , 8.3 ) 5.1 Myelosuppression HYCAMTIN can cause severe myelosuppression. The following safety data are based on an integrated safety database from four trials in patients with lung cancer (N = 682) who received HYCAMTIN capsules at a dose of 2.3 mg/m 2 orally once daily for 5 consecutive days, starting on Day 1 of a 21-day cycle. The median day for neutrophil and platelet nadirs occurred on Day 15. Grade 4 neutropenia occurred in 32% of the 682 patients, with a median duration of 7 days. Grade 4 neutropenia most commonly occurred during cycle 1 (20% of patients). Clinical sequelae of neutropenia included infection (17%), febrile neutropenia (4%), sepsis (2%), and septic death (1%). Grade 4 thrombocytopenia occurred in 6%, with a median duration of 3 days. Grade 3 or 4 anemia occurred in 25%. HYCAMTIN can cause fatal typhlitis (neutropenic enterocolitis). Consider the possibility of typhlitis in patients presenting with fever, neutropenia, and abdominal pain. Administer the first cycle of HYCAMTIN capsules only to patients with a baseline neutrophil count greater than or equal to 1,500/mm 3 and a platelet count greater than or equal to 100,000/mm 3 . Monitor blood cell counts frequently during treatment. Withhold and reduce dose of HYCAMTIN capsules based on neutrophil counts, platelet counts and hemoglobin levels [see Dosage and Administration (2.2)] . 5.2 Diarrhea Diarrhea, including severe and life-threatening diarrhea requiring hospitalization, can occur with HYCAMTIN capsules. Diarrhea can occur at the same time as drug-induced neutropenia and its sequelae. In the 682 patients who received HYCAMTIN capsules in the four lung cancer trials, the incidence of diarrhea caused by HYCAMTIN capsules was 22%, including Grade 3 (4%) and Grade 4 (0.4%). The incidence of Grade 3 or 4 diarrhea proximate (within 5 days) to Grade 3 or 4 neutropenia was 5%. The median time to onset of Grade 2 to 4 diarrhea was 9 days in the group receiving HYCAMTIN capsules. Monitor patients for diarrhea and treat w...

Adverse reactions cross-check#

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adverse reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Myelosuppression [see Warnings and Precautions (5.1)] • Diarrhea [see Warnings and Precautions (5.2)] • Interstitial Lung Disease (ILD) [see Warnings and Precautions (5.3)] • The most common Grade 3 or 4 hematologic adverse reactions (incidence > 20%) were neutropenia, anemia, and thrombocytopenia. • The most common (incidence > 10%) non-hematologic adverse reactions (all Grades) were nausea, diarrhea, vomiting, alopecia, fatigue, and anorexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical 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. The data in the Warnings and Precautions and below reflects exposure to HYCAMTIN capsules in 682 patients with recurrent lung cancer enrolled in four randomized, open label trials, including 275 patients with small lung cell lung cancer (SCLC) (Studies 478, 065 and 396), and 407 patients with non-small cell lung cancer (NSCLC) (Study 387), who received at least one dose of HYCAMTIN capsules. Patients in these trials had advanced lung cancer and received prior chemotherapy in the first-line setting. Patients received HYCAMTIN capsules 2.3 mg/m 2 orally once daily for 5 consecutive days, starting on Day 1 of a 21-day cycle. The median number of cycles was 3 (range: 1 to 20). The safety of HYCAMTIN capsules was evaluated in a randomized trial (Study 478) conducted in 70 patients with recurrent SCLC [see Clinical Studies (14)] . In the 682 patients who received HYCAMTIN capsules in the four lung cancer trials, 39 deaths (6%) occurred within 30 days after the last dose for a reason other than progressive disease: 13 due to hematologic toxicity, 5 due to non-hematologic toxicity (2 from diarrhea), and 21 due to other causes. Table 1 describes the hematologic and non-hematologic adverse reactions that occurred in greater than 5% of patients treated with HYCAMTIN capsules in these trials. Table 1. Adverse Reactions Occurring in Greater than or Equal to 5% of Patients With Lung Cancer Adverse React...

adverse reactions table

Table 1. Adverse Reactions Occurring in Greater than or Equal to 5% of Patients With Lung Cancer Adverse ReactionsAdverse reactions were graded using National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 2.0. HYCAMTIN Capsules With Best Supportive Care (Study 478) HYCAMTIN Capsules Lung Cancer Population (Studies 478, 065, 396 and 387)N = 70N = 682All Grades(%)Grade 3(%)Grade 4(%)All Grades(%)Grade 3(%)Grade 4(%)Hematologic Anemia94151098187 Neutropenia912833832432 Thrombocytopenia8130781296Non-hematologic Nausea27103330 Vomiting19102130.4 Diarrhea14412240.4 Fatigue11001940.1 Alopecia1000200.10 Pyrexia710511 Anorexia7001420 Asthenia300720

Additional Listing Data#

Finished product
Yes
Brand name base
HYCAMTIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPOTECAN HYDROCHLORIDE.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii956S425ZCY
Rxcui747193, 747195, 748738, 748740

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cbf6bf79-4ea9-419f-b7df-eefa780730bfProduct name220180125
19c78384-80c8-23c8-a4e6-c197ed91c59eProduct name120140508
302dcbc5-1902-d63c-93ac-bac5e14c2822Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66758-101-11HYCAMTIN10 in 1 BOTTLECAPSULE101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66758-101-11EA - Each66758-101b93685b1-bd56-4a6c-af25-49b2ff0ec31d12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66758-101HYCAMTIN (TOPOTECAN) CAPSULE [SANDOZ INC]1Current NDC, 1 package rows20241031_b23b46f5-c276-47f5-8bbd-940680b3f579.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
748738Hycamtin 0.25 MG Oral CapsulePSNb23b46f5-c276-47f5-8bbd-940680b3f5791
748740Hycamtin 1 MG Oral CapsulePSNb23b46f5-c276-47f5-8bbd-940680b3f5791
747195topotecan HCl 0.25 MG Oral CapsulePSNb23b46f5-c276-47f5-8bbd-940680b3f5791
747193topotecan HCl 1 MG Oral CapsulePSNb23b46f5-c276-47f5-8bbd-940680b3f5791
748738topotecan 0.25 MG Oral Capsule [Hycamtin]SBDb23b46f5-c276-47f5-8bbd-940680b3f5791
748740topotecan 1 MG Oral Capsule [Hycamtin]SBDb23b46f5-c276-47f5-8bbd-940680b3f5791
747195topotecan 0.25 MG Oral CapsuleSCDb23b46f5-c276-47f5-8bbd-940680b3f5791
747193topotecan 1 MG Oral CapsuleSCDb23b46f5-c276-47f5-8bbd-940680b3f5791
748738Hycamtin 0.25 MG Oral CapsuleSYb23b46f5-c276-47f5-8bbd-940680b3f5791
748740Hycamtin 1 MG Oral CapsuleSYb23b46f5-c276-47f5-8bbd-940680b3f5791
747195topotecan 250 MCG Oral CapsuleSYb23b46f5-c276-47f5-8bbd-940680b3f5791

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66758-101-116675801011110 CAPSULE in 1 BOTTLE (66758-101-11) 10 capsule2025-01-06NoNoCurrent