Hycamtin

Generic Name: Topotecan Hydrochloride
Class: Antineoplastic Agents
VA Class: AN900
Chemical Name: (S) - 10 - [(Dimethylamino)methyl] - 4 - ethyl - 4,9 - dihydroxy - 1H - pyrano[3′,4′:6,7]indolizino[1,2 - b]quinoline - 3,14(4H,12H) - dione monohydrochloride
Molecular Formula: C₂₃H₂₃N₃O₅•ClH
CAS Number: 119413-54-6

• Experience of Supervising Clinician


• 
  

  Administer only under supervision of qualified clinicians experienced in use of cytotoxic therapy.¹ Adequate diagnostic and treatment facilities should be readily available to manage complications.¹

  
  

• Myelosuppression


• 
  

  Severe myelosuppression (neutropenia) resulting in infection and death may occur.¹ (See Hematologic Effects under Cautions.)

  
  


• 
  

  Do not administer to patients with baseline neutrophil counts <1500/mm³ and a platelet count <100,000/mm³ . ^{1 c}

  
  


• 
  

  Monitor peripheral blood cell counts frequently.^{1 c}

  
  

Introduction

Antineoplastic agent; a semisynthetic derivative of camptothecin.^{1 3 5 6 7 9 10 11 13 17 21 24 c}

Uses for Hycamtin

Ovarian Cancer

Treatment of advanced ovarian cancer in patients with disease that has recurred or progressed following therapy with platinum-based (i.e., cisplatin, carboplatin) regimens.^{1 2 5 7 16 18 19 20 24 27 28 29 34 35 36 37 38}

Small Cell Lung Cancer

Second-line therapy for treatment-sensitive small cell lung cancer^{1 34 39 40 c} (defined as disease initially responding to first-line chemotherapy with subsequent relapse no sooner than 60–90 days following completion of first-line therapy when topotecan is administered IV^{1 40} or at least 45 days following completion of first-line therapy when topotecan is administered orally).^c

Cervical Cancer

Used in combination with cisplatin for the treatment of stage IV-B, recurrent, or persistent cervical cancer not amenable to curative treatment with surgery and/or radiation therapy.¹

Hycamtin Dosage and Administration

General

• 
  

  Consult specialized references for procedures for proper handling and disposal of antineoplastic drugs.

  
  


• 
  

  Individualize dosage based on body surface area and patient tolerance.^{1 2 c}

  
  

Administration

Administer orally or by IV infusion.^{1 c}

Oral Administration

Administer topotecan capsules orally, with or without food.^c (See Food under Pharmacokinetics).

Capsules should be swallowed whole; do not crush, chew, divide, or open.^c

IV Administration

Administer by IV infusion only.^{1 2 3 33}

Handle cautiously (by trained nonpregnant personnel); use protective equipment (e.g., vertical laminar flow hood, goggles, gloves, and protective gowns).^{1 22} Immediately treat accidental contact with the skin by copious lavage with soap and water; flush mucosa with copious amounts of water.^{1 22}

Reconstitution

Reconstitute vial containing 4 mg of topotecan with 4 mL of sterile water for injection to provide a solution containing 1 mg/mL.^{1 3}

Dilution

Must be diluted in 5% dextrose or 0.9% sodium chloride injection prior to IV administration.³³

Dilute calculated daily dose in a suitable volume (e.g., 50–250 mL) of 5% dextrose or 0.9% sodium chloride injection.^{1 3 6 12 16 22 33}

Lyophilized drug contains no preservatives; prepare solutions immediately before use.^{1 33}

Rate of Administration

Administer by IV infusion over a period of 30 minutes.^{1 3 6 12 16 22 33}

Dosage

Available as topotecan hydrochloride; dosage expressed in terms of topotecan.^{1 22 c}

Prior to administration of the initial course of therapy, patient must have a baseline neutrophil count ≥1500/mm³ and a platelet count ≥100,000/mm³.^{1 c}

Do not administer a subsequent course of therapy until recovery of patient's hematologic function (neutrophil count >1000/mm³, platelet count >100,000/mm³, and hemoglobin ≥9 g/dL [with transfusion if necessary]).^{1 2 c}

Adults

Ovarian Cancer

IV

1.5 mg/m² daily for 5 consecutive days every 21 days.^{1 2 3 6 7 11 14 16 17 24}

A minimum of 4 courses of therapy is recommended in patients without progression of disease, provided intolerable toxicity does not develop.^{1 2 33} Median time to response averages 9–12 weeks; response may not be achieved if therapy is discontinued prematurely.^{1 2 33}

Small Cell Lung Cancer

Oral

2.3 mg/m² once daily for 5 consecutive days every 21 days.^c

Round calculated daily dosage to the nearest 0.25 mg and prescribe the minimum number of 1-mg and 0.25-mg capsules; use the same number of capsules for each of the 5 days.^c

IV

1.5 mg/m² daily for 5 consecutive days every 21 days.^{1 40}

A minimum of 4 courses of therapy is recommended in patients without progression of disease, provided intolerable toxicity does not develop.^{1 2 33} Median time to response averages 5–7 weeks; response may not be achieved if therapy is discontinued prematurely.¹

Cervical Cancer

IV

0.75 mg/m² daily for 3 consecutive days (days 1, 2, and 3) every 21 days; administer cisplatin 50 mg/m² by IV infusion on day 1¹ of each 21-day cycle (after the topotecan dose).¹

Dosage Modification for Toxicity

Ovarian Cancer

IV

If severe neutropenia occurs (i.e., neutrophil count <500/mm³),¹⁵ reduce dose in subsequent courses to 1.25 mg/m²; alternatively, administer granulocyte colony stimulation factor (G-CSF; filgrastim) 24 hours after the final dose of topotecan in the subsequent treatment course (i.e., beginning on day 6 of the 21-day treatment course).^{1 2 12 14 16 33}

If platelet count is <25,000/mm³, reduce dose in subsequent courses to 1.25 mg/m².¹

Small Cell Lung Cancer

Oral

If severe neutropenia (i.e., neutrophil count <500/mm³ associated with fever or infection or lasting for ≥7 days) or neutropenia (neutrophils 500–1000/mm³ lasting beyond day 21 of the treatment course) occurs, reduce dose in subsequent courses to 1.9 mg/m² daily.^c

If platelet count is <25,000/mm³, reduce dose in subsequent courses to 1.9 mg/m² daily.^c

If grade 3 or 4 diarrhea occurs, reduce dose in subsequent courses to 1.9 mg/m² daily.^c If necessary, consider the same dose reduction to 1.9 mg/m² daily for grade 2 diarrhea.^c

IV

If severe neutropenia occurs (i.e., neutrophil count <500/mm³),¹⁵ reduce dose in subsequent courses to 1.25 mg/m²; alternatively, administer granulocyte colony stimulation factor (G-CSF; filgrastim) 24 hours after the final dose of topotecan in the subsequent treatment course (i.e., beginning on day 6 of the 21-day treatment course).^{1 2 12 14 16 33}

If platelet count is <25,000/mm³, reduce dose in subsequent courses to 1.25 mg/m².¹

Cervical Cancer

IV

If severe febrile neutropenia occurs (i.e., neutrophil count <1000/mm³ with a temperature of 38°C), reduce dose to 0.6 mg/m² for subsequent courses.¹ Alternatively, administer G-CSF 24 hours after the final dose of topotecan in the subsequent treatment course (i.e., beginning on day 4 of the 21-day treatment course).¹ If febrile neutropenia still occurs with G-CSF, reduce topotecan dosage to 0.45 mg/m² for subsequent courses.¹

If platelet count is <10,000/mm³, reduce dose in subsequent courses to 0.6 mg/m².¹

Special Populations

Hepatic Impairment

No dosage adjustment required in patients with plasma bilirubin >1.5 but <10 mg/dL.¹

Renal Impairment

Ovarian Cancer

IV

Reduce dosage in patients with Cl_cr of 20–39 mL/minute to 0.75 mg/m² daily for 5 consecutive days every 21 days.^{1 2 24 30}

Experience in patients with Cl_cr ≤19 mL/minute is too limited to make dosage recommendations.^{1 2}

Small Cell Lung Cancer

Oral

Reduce dosage in patients with Cl_cr of 30–49 mL/minute to 1.8 mg/m²daily for 5 consecutive days every 21 days.^c

Insufficient experience in patients with Cl_cr of <30 mL/minute to make dosage recommendations.^c

IV

Reduce dosage in patients with Cl_cr of 20–39 mL/minute to 0.75 mg/m² daily for 5 consecutive days every 21 days.^{1 2 30}

Experience in patients with Cl_cr ≤19 mL/minute is too limited to make dosage recommendations.^{1 2}

Cervical Cancer

IV

Initiate treatment in combination with cisplatin only if S_Cr ≤1.5 mg/dL.¹ In clinical trials, cisplatin was discontinued if S_Cr >1.5 mg/dL; insufficient data available regarding continuing topotecan therapy after cisplatin is discontinued.¹

Geriatric Patients

No dosage adjustments required except those related to renal impairment.^{1 29} (See Renal Impairment under Dosage and Administration.)

Cautions for Hycamtin

Contraindications

• 
  

  Known or suspected pregnancy.^{1 c} (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

  
  


• 
  

  Nursing women.^{1 c}

  
  


• 
  

  Severe bone marrow depression.^{1 c}

  
  


• 
  

  Known hypersensitivity to topotecan or any ingredient in the formulation.^{1 c}

  
  

Warnings/Precautions

Warnings

Hematologic Effects

Risk of dose-limiting and potentially fatal myelosuppression, manifested commonly as neutropenia, thrombocytopenia, and anemia.^{1 36 40 c} Pancytopenia reported.^d Myelosuppression occurs frequently, may be severe,^{1 2 3 4 5 6 7 8 11 12 13 14 16 17 19 21 24 27 28 34 c} and may require transfusions.¹

Neutrophil nadirs usually occur at day 12 and 15 with IV and oral administration, respectively.^{1 c} Platelet nadirs usually occur at day 15 with IV and oral administration.^{1 c} Median duration of neutropenia is 7 days with IV and oral administration and median duration of thrombocytopenia is 5 and 3 days with IV and oral administration, respectively.^{1 c} Median nadir for anemia occurs at day 15.^{1 c}

Careful hematologic monitoring required; perform peripheral blood cell counts prior to and at frequent intervals during therapy.^{1 2 3 5 6 7 11 12 14 16 c} Withhold subsequent courses of therapy until neutrophil count is >1000/mm³, platelet count is >100,000/mm³, and hemoglobin is ≥9 g/dL (with transfusion if necessary).^{1 2}

Neutropenic Colitis

Neutropenic colitis, a sequela of drug-induced neutropenia, has been reported and can be fatal.^{c d}

Consider possibility of neutropenic colitis if patients present with fever, neutropenia, and abdominal pain.^{c d}

Diarrhea

Diarrhea occurs commonly in patients receiving topotecan capsules; may be severe, life-threatening, and require hospitalization..^c

Diarrhea may occur at the same time as neutropenia and its sequelae.^c (See Neutropenic Colitis under Cautions.)

If diarrhea occurs, manage aggressively (e.g., antidiarrheal and anti-infective therapy, changes in fluid and diet requirements, hospitalization).^c

Other GI Effects

Nausea, vomiting, abdominal pain, constipation, intestinal obstruction, and stomatitis reported.^{1 c}

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; teratogenicity and embryolethality demonstrated in animals.^{1 c} Avoid pregnancy during therapy.^{1 c} If used during pregnancy or patient becomes pregnant, apprise of potential fetal hazard.^{1 c}

General Precautions

Local Effects

Extravasation may result in mild local effects (e.g., erythema, bruising).¹

Nervous System Effects

Possible asthenia or fatigue.^{1 c}

Specific Populations

Pregnancy

Category D.^{1 c} (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Distributed in high concentrations into milk in rats;^c not known whether topotecan is distributed into human milk.^{1 c} Discontinue nursing because of potential risk to nursing infants.^{1 c} (See Contraindications under Cautions.)

Pediatric Use

Safety and efficacy not established.^{1 c}

Geriatric Use

Oral administration: increased risk of diarrhea relative to younger patients.^c

IV administration: No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.¹

Substantially eliminated by kidneys; assess renal function periodically and select dosage with caution since geriatric patients more likely to have decreased renal function.^{1 c}

Hepatic Impairment

Pharmacokinetics not substantially altered in patients with impaired hepatic function (i.e., plasma bilirubin >1.5 to <10 mg/dL).^{1 2 6 26 29 c}

Renal Impairment

Decreased clearance; increased risk of toxicity in patients with renal impairment.^{1 c} Dosage adjustments recommended depending on degree of renal impairment.^{1 c} (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Neutropenia, leukopenia, thrombocytopenia, anemia, nausea, vomiting, diarrhea, constipation, abdominal pain, stomatitis, anorexia, fatigue, fever, pain, asthenia, alopecia, rash, dyspnea, cough, headache, infection/sepsis.¹

Interactions for Hycamtin

Does not inhibit CYP isoenzymes 1A2, 2A6, 2C8, 2C9, 2C19, 2D6, 2E, 3A, or 4A or dihydropyrimidine dehydrogenase in vitro.^{1 c}

Specific Drugs

Drug	Interaction	Comments
Antineoplastic agents (paclitaxel)	Increased myelosuppression1 2 25 29 31	Dose reduction may be necessary1 (see Dosage Modification for Toxicity under Dosage and Administration)
Antineoplastic agents, platinum (cisplatin, carboplatin)	Possible sequence-dependent myelosuppression 1	Lower doses of each drug required with administration of cisplatin on day 1 compared with day 5 of the topotecan dosing schedule1
G-CSF (filgrastim)	Prolonged duration of neutropenia if administered concomitantly1	Initiate G-CSF 24 hours after completion of the last topotecan dose in a course of therapy1 (see Dosage under Dosage and Administration)
P-glycoprotein inhibitors (e.g., cyclosporine A, ketoconazole, ritonavir, saquinavir)	Insignificant increased topotecan exposurec	Avoid concomitant usec If used concomitantly, closely monitor for adverse effectsc

Hycamtin Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed following oral administration, with peak plasma concentrations attained within 1–2 hours. ^c

Bioavailability is approximately 40%.^c

Food

Extent of absorption following oral administration similar in fed and fasted states, however t_max delayed; capsules can be given without regard to food.^c

Distribution

Plasma Protein Binding

Approximately 35%.^{1 c}

Elimination

Metabolism

Principally undergoes reversible pH-dependent hydrolysis.^{1 c} Minor metabolic pathway in the liver to an N-demethylated metabolite.^{1 c}

Elimination Route

Following IV administration, excreted in urine (51%) and in feces (18%) mainly as total topotecan.¹

Following oral administration, excreted in urine (20%) and in feces (33%) mainly as total topotecan.^c

Half-life

Terminal elimination half-life following IV administration: 2–3 hours.¹

Terminal elimination half-life following oral administration: 3–6 hours.^c

Special Populations

In male patients, increased clearance.¹

In patients with renal impairment, clearance is decreased and half-life is 5 hours.¹

In patients with hepatic impairment, clearance is decreased; however, half-life is increased only slightly.¹

Stability

Storage

Oral

Capsules

20–25°C (may be exposed to 15–30°C); protect from light.^c

Parenteral

Powder for Injection

20–25°C; protect from light.¹ Use immediately after reconstitution.¹ Following dilution with infusion solution, use drug within 24 hours.¹

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility^HID

Compatible

Dextrose 5% in water

Sodium chloride 0.9%

Drug Compatibility

Y-Site CompatibilityHID

Compatible

Carboplatin

Cimetidine HCl

Cisplatin

Cyclophosphamide

Doxorubicin HCl

Etoposide

Gemcitabine HCl

Granisetron HCl

Ifosfamide

Methylprednisolone sodium succinate

Metoclopramide HCl

Ondansetron HCl

Oxaliplatin

Paclitaxel

Palonosetron HCl

Prochlorperazine edisylate

Vincristine sulfate

Incompatible

Dexamethasone sodium phosphate

Fluorouracil

Mitomycin

Pemetrexed disodium

Variable

Ticarcillin disodium–clavulanate potassium

ActionsActions

• 
  

  A type I DNA topoisomerase inhibitor.^{1 3 4 5 6 7 8 9 10 11 13 17}

  
  


• 
  

  Exerts cytotoxic effects during the S-phase of DNA synthesis through an interaction with the DNA-DNA topoisomerase cleavable complex.^{1 2 3 5 7 8 9 11 13 17 21 23 24}

  
  


• 
  

  Stabilizes cleavable complex and prevents the topoisomerase from religating the single-strand breaks.^{2 3 5 7 8 11 13 17 21 23}

  
  


• 
  

  Interferes with the moving replication fork, inducing replication arrest and lethal double-stranded breaks in DNA.^{1 2 4 7 8 9 10 11 13 17 23} This DNA damage is not efficiently repaired and apparently leads to apoptosis (programmed cell death).^{9 23}

  
  

Advice to Patients

• 
  

  Importance of recognizing and reporting adverse effects including myelosuppressive effects and infectious complications.¹

  
  


• 
  

  Risk of weakness or fatigue; use caution when driving or operating machinery until effects on individual are known.¹

  
  


• 
  

  Importance of not chewing, crushing, dividing, or opening the capsule.^c Capsules must be swallowed whole.^c

  
  


• 
  

  Risk of potentially severe diarrhea with oral topotecan.^c Importance of contacting clinician if severe diarrhea occurs.^c

  
  


• 
  

  If vomiting occurs following a dose of oral topotecan, do not take a replacement dose.^c

  
  


• 
  

  Importance of women informing clinicians immediately if they are or plan to become pregnant or plan to breast-feed; necessity for clinicians to advise women to avoid pregnancy during therapy and advise pregnant women of risk to the fetus.¹

  
  


• 
  

  Importance of patients informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Topotecan Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	0.25 mg (of topotecan)	Hycamtin	GlaxoSmithKline
		1 mg (of topotecan)	Hycamtin	GlaxoSmithKline
Parenteral	For injection, for IV infusion only	4 mg (of topotecan)	Hycamtin	GlaxoSmithKline

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions April 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. GlaxoSmithKline. Hycamtin (topotecan hydrochloride) injection for intravenous use prescribing information. Research Triangle Park, NC; 2006 Jul.

2. SmithKline Beecham Pharmaceuticals. Hycamtin (topotecan hydrochloride) injection for intravenous use product information. Philadelphia, PA; 1996 Aug.

3. Rowinsky EK, Grochow LB, Hendricks CB et al. Phase I and pharmacologic study of topotecan: a novel topoisomerase I inhibitor. J Clin Oncol. 1992; 10:657-56. [PubMed 1285731]

4. Sinha BK. Topoisomerase inhibitors: a review of their therapeutic potential in cancer. Drugs. 1995; 49:11-9. [PubMed 7705211]

5. Burris HA, Rothenberg ML, Kuhn JG et al. Clinical trials with the topoisomerase I inhibitors. Semin Oncol. 1992; 19:663-9. [PubMed 1334279]

6. Herben WMM, ten Bokkel Huinink WW, Beijnen JH. Clinical pharmacokinetics of topotecan. Clin Pharmacokinet. 1996; 31:85-102. [PubMed 8853931]

7. Fields Jones S, Burris HA III. Topoisomerase I inhibitors: topotecan irinotecan. Cancer Pract. 1996; 4:51-3. [PubMed 8788772]

8. Verweij J. Topoisomerase I inhibitors and other new cytotoxic drugs. Eur J Cancer. 1995; 31A:828-30. [PubMed 7640070]

9. Pommier Y. Eukaryotic DNA topoisomerase I: genome gatekeeper and its intruders, camptothecins. Semin Oncol. 1996; 23(Suppl 3):3-10. [PubMed 8633251]

10. Tanizawa A, Fujimori A, Fujimori Y et al. Comparison of topoisomerase I inhibition, DNA damage, and cytotoxicity of camptothecin derivatives presently in clinical trials. J Natl Cancer Inst. 1994; 86:836-42. [IDIS 329876] [PubMed 8182764]

11. Slichenmyer WJ, Rowinsky EK, Donehower RC et al. The current status of camptothecin analogues as antitumor agents. J Natl Cancer Inst. 1993; 85:271-91. [PubMed 8381186]

12. Rowinsky EK, Grochow LB, Sartorius SE et al. Phase I and pharmacologic study of high doses of the topoisomerase I inhibitor topotecan with granulocyte colony-stimulating factor in patients with solid tumors. J Clin Oncol. 1996; 14:1224-35. [IDIS 366510] [PubMed 8648378]

13. Hawkins MJ. Topoisomerase I inhibitors. In: DeVita VT Jr, Hellman S, Rosenberg SA, eds. Cancer: principles and practice of oncology. 4th ed. Philadelphia, PA: J. B. Lippincott; 1993:351-3.

14. Saltz L, Sirott M, Young C et al. Phase I clinical and pharmacology study of topotecan given daily for 5 consecutive days to patients with advanced solid tumors, with attempt at dose intensification using recombinant granulocyte colony-stimulating factor. J Natl Cancer Inst. 1993; 85:1499-507. [PubMed 7689654]

15. National Cancer Institute Division of Cancer Treatment. Investigational agent adverse drug reaction reporting chart (attachment 3). In: National Institutes of Health, National Cancer Institute. Investigators handbook: a manual for participation in clinical trials of investigational agents. Bethesda, MD; 1993 Oct:153-7.

16. Creemers GJ, Lund B, Verweij J. Topoisomerase I inhibitors: topotecan and irenotecan. Cancer Treat Rev. 1994; 20:73-96. [PubMed 8293429]

17. Burris HA III, Fields SM. Topoisomerase I inhibitors: an overview of the camptothecin analogs. New Drug Ther. 1994; 8:333-55.

18. Carmichael J, Gordon A, Malfetano J et al et al. Topotecan, a new active drug, vs paclitaxel in advanced epithelial ovarian carcinoma: international topotecan study group trial. Proceedings of the American Society of Clinical Oncologists (ASCO). J Clin Oncol. 1996; 15:Abstract No.

19. ten Bokkel Huinink W, Gore M, Bolis G et al et al. A phase II trial of topotecan for the treatment of relapsed advanced ovarian carcinoma. Proceedings of the American Society of Clinical Oncologists (ASCO). J Clin Oncol. 1996; 15:Abstract No.

20. Gordon A, Bookman M, Malmstrom H et al et al. Efficacy of topotecan in advanced epithelial ovarian cancer after failure of platinum and paclitaxel: international topotecan study group trial. Proceedings of the American Society of Clinical Oncologists (ASCO). J Clin Oncol. 1996; 15:Abstract No.

21. Capranico G, Giaccone G, Zunino F et al. DNA topoisomerase inhibitors. Cancer Chemother Biol Response Modif. 1994; 15:67-86. [PubMed 7779607]

22. SmithKline Beecham Pharmaceuticals. Product information brochure (HY7111) for Hycamtin (topotecan HCl) for injection. Philadelphia, PA; 1996 Aug.

23. Traganos F, Seiter K, Feldman E et al. Induction of apoptosis by camptothecin and topotecan. Ann NY Acad Sci. 1996; 803:101-10. [PubMed 8993504]

24. Anon. Topotecan hydrochloride for metastatic ovarian cancer. Med Lett Drugs Ther. 1996; 38:96-7. [PubMed 8906133]

25. SmithKline Beecham Pharmaceuticals. AHFS Product information form on Hycamtin (topotecan HCl) for injection. Philadelphia, PA; undated.

26. O’Reilly S, Rowinsky E, Slichenmyer W et al. Phase I and pharmacologic studies of topotecan in patients with impaired hepatic function. J Natl Cancer Inst. 1996; 88:817-24. [IDIS 369444] [PubMed 8637048]

27. Kudelka AP, Tresukosol D, Edwards CL et al. Phase II study of intravenous topotecan as a 5-day infusion for refractory epithelial ovarian carcinoma. J Clin Oncol. 1996; 14:1552-7. [IDIS 366397] [PubMed 8622071]

28. Creemers GJ, Bolis G, Gore M et al. Topotecan, an active drug in the second-line treatment of epithelial ovarian cancer: results of a large European phase II study. J Clin Oncol. 1996; 14:3056-61. [IDIS 386167] [PubMed 8955650]

29. Lynch T. Topotecan today. J Clin Oncol. 1996; 14:3053-55. [IDIS 386166] [PubMed 8955649]

30. O’Reilly S, Rowinsky EK, Slichenmyer W et al. Phase I and pharmacologic study of topotecan in patients with impaired renal function. J Clin Oncol. 1996; 14:3062-73. [IDIS 386168] [PubMed 8955651]

31. Miller AA, Lilenbaum RC, Lynch TJ et al. Treatment-related fatal sepsis from topotecan/cisplatin and topotecan/paclitaxel. J Clin Oncol. 1996; 14:1964-5. [IDIS 369597] [PubMed 8656268]

32. Miller AA, Hargis JB, Lilenbaum RC et al. Phase I study of topotecan and cisplatin in patients with advanced solid tumors: a Cancer and Leukemia Group B study. J Clin Oncol. 1994; 12:2743-50. [IDIS 339640] [PubMed 7527456]

33. SmithKline Beecham Pharmaceuticals, Philadelphia, PA: Personal communication.

34. Anon. Drugs of choice for cancer chemotherapy. Med Lett Drugs Ther. 2000; 42:83-92. [PubMed 10994034]

35. ten Bokkel Huinink W, Gore M, Carmichael J et al. Topotecan versus paclitaxel for the treatment of recurrent epithelial ovarian cancer. J Clin Oncol. 1997; 15:2183-93. [IDIS 388883] [PubMed 9196130]

36. Gordon A, Carmichael J, Malfetano J et al. Final analysis of a phase III, randomized study of topotecan (T) vs paclitaxel (P) in advanced epithelial ovarian carcinoma (OC): International Topotecan Study Group. Proc Am Soc Clin Oncol. 1998; 17:A1374.

37. Brogden RN, Wiseman LR. Topotecan: a review of its potential in advanced ovarian cancer. Drugs. 1998; 56:709-23. [PubMed 9806112]

38. Ozols RF. Treatment of recurrent ovarian cancer: increasing options—“recurrent” results. J Clin Oncol. 1997; 15:2177-80. [IDIS 388882] [PubMed 9196128]

39. Small cell lung cancer. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2007 May 3.

40. von Pawel J, Schiller JH, Shepherd FA et al. Topotecan versus cyclophosphamide, doxorubicin, and vincristine for the treatment of recurrent small-cell lung cancer. J Clin Oncol. 1999; 17:658-67. [IDIS 422583] [PubMed 10080612]

HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1578-81.

b. AHFS drug information 2006. McEvoy GK, ed. Topotecan. Bethesda, MD: American Society of Health-System Pharmacists;1201-3.

c. GlaxoSmithKline. Hycamtin (topotecan hydrochloride) capsules prescribing information. Research Triangle Park, NC; 2007 Oct.

d. GlaxoSmithKline. Hycamtin(topotecan hydrochloride) injection for intravenous use prescribing information. Research Triangle, Park, NC; 2007 Aug.

More Hycamtin resources

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Compare Hycamtin with other medications

• Cancer
• Cervical Cancer
• Ovarian Cancer
• Small Cell Lung Cancer