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Topotecan Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 9, 2023.

Applies to topotecan: oral capsule. Other dosage forms:

Warning

Oral route (Capsule)

Topotecan can cause severe myelosuppression. Administer first cycle only to patients with neutrophil counts greater than or equal to 1500/mm(3) and platelet counts greater than or equal to 100,000/mm(3). Monitor blood cell counts.

Serious side effects of Topotecan

Along with its needed effects, topotecan may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking topotecan:

More common

Incidence not known

Other side effects of Topotecan

Some side effects of topotecan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

For Healthcare Professionals

Applies to topotecan: intravenous powder for injection, intravenous solution, oral capsule.

General

The most common adverse events were hematologic: neutropenia, leukopenia, anemia, and thrombocytopenia.[Ref]

Hematologic

Very common (10% or more): Neutropenia (up to 97%), leukopenia (97%), anemia (up to 94%), thrombocytopenia (up to 74%), pyrexia/grade 4 neutropenia (28%), febrile neutropenia (28%), hemorrhage (15%)

Common (1% to 10%): Pancytopenia, coagulation adverse event

Postmarketing reports: Severe bleeding (in association with thrombocytopenia)[Ref]

Gastrointestinal

Very common (10% or more): Nausea (64%), other gastrointestinal adverse event (63%), vomiting (45%), diarrhea (32%), constipation (29%), abdominal pain (22%), stomatitis (18%)

Common (1% to 10%): Abdominal pain, intestinal obstruction, dyspepsia

Frequency not reported: Neutropenic colitis

Postmarketing reports: Abdominal pain potentially associated with neutropenic colitis[Ref]

Dermatologic

Rash includes pruritus, rash erythematous, urticaria, dermatitis, bullous eruption, and maculopapular rash.[Ref]

Very common (10% or more): Alopecia (49%), dermatologic adverse reaction (48%), rash (16%)

Common (1% to 10%): Pruritus

Frequency not reported: Urticaria

Postmarketing reports: Angioedema, severe dermatitis, severe pruritus[Ref]

Immunologic

Very common (10% or more): Sepsis or pyrexia/infection with neutropenia (43%), infection-febrile neutropenia (28%), infection (27%)

Common (1% to 10%): Pneumonia, allergy-immunology adverse event, pharyngitis, rhinitis, sepsis

Other

Pain includes abdominal pain or cramping, arthralgia, bone pain, chest pain (non-cardiac and non-pleuritic), dysmenorrhea, dyspareunia, earache, headache, hepatic pain, myalgia, neuropathic pain, pain due to radiation, pelvic pain, pleuritic pain, rectal or perirectal pain, tumor pain, body pain, back pain, and skeletal pain.

"Constitutional" is a composite term that includes fatigue (lethargy, malaise, asthenia), fever (in the absence of neutropenia), rigors, chills, sweating, and weight gain or loss.

Very common (10% or more): Constitutional (69%), pain (up to 59%), fatigue (29%), pyrexia (28%), asthenia (25%), mucositis (14%)

Common (1% to 10%): Treatment related death, malaise

Respiratory

Very common (10% or more): Dyspnea (22%), pulmonary adverse event (17%), coughing (15%)

Common (1% to 10%): Epistaxis, respiratory disorder

Rare (less than 0.1%): Interstitial lung disease

Postmarketing reports: Fatal interstitial lung disease[Ref]

Hepatic

Very common (10% or more): Hepatic adverse event (24%)

Common (1% to 10%): Transient elevations in hepatic enzymes, hyperbilirubinemia, elevated ALT, elevated AST[Ref]

Nervous system

Very common (10% or more): Non-neuropathy neurologic adverse event (35%), headache (18%)

Common (1% to 10%): Paresthesia, neuropathy, dizziness

Uncommon (0.1% to 1%): Hypoesthesia, peripheral neuropathy, paresis[Ref]

Cardiovascular

Very common (10% or more): Cardiovascular adverse event (25%)[Ref]

Metabolic

Very common (10% or more): Metabolic-laboratory adverse event (39%), anorexia (19%)

Frequency not reported: Dehydration

Musculoskeletal

Very common (10% or more): Musculoskeletal adverse event (14%)[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity (including rash)

Postmarketing reports: Allergic manifestations, anaphylactoid reactions[Ref]

Genitourinary

Very common (10% or more): Genitourinary adverse event (36%)

Common (1% to 10%): Sexual reproduction function adverse event[Ref]

Local

Rare (less than 0.1%): Extravasation

Postmarketing reports: Inadvertent extravasation

Endocrine

Common (1% to 10%): Endocrine adverse event

Ocular

Common (1% to 10%): Ocular-visual adverse event

References

1. Kantarjian HM, Beran M, Ellis A, Zwelling L, O'Brien S, Cazenave L, Koller C, Rios MB, Plunkett W, Keating MJ, et al. Phase I study of Topotecan, a new topoisomerase I inhibitor, in patients with refractory or relapsed acute leukemia. Blood. 1993;81:1146-51.

2. Lilenbaum RC, Ratain MJ, Miller AA, Hargis JB, Hollis DR, Rosner GL, O'Brien SM, Brewster L, Green MR, Schilsky RL. Phase I study of paclitaxel and topotecan in patients with advanced tumors: a cancer and leukemia group B study. J Clin Oncol. 1995;13:2230-7.

3. Hochster H, Liebes L, Speyer J, Sorich J, Taubes B, Oratz R, Wernz J, Chachoua A, Raphael B, Vinci RZ, et al. Phase I trial of low-dose continuous topotecan infusion in patients with cancer: an active and well-tolerated regimen. J Clin Oncol. 1994;12:553-9.

4. Betcher DL, Burnham N. Topotecan. J Pediatr Oncol Nurs. 1992;9:31-2.

5. Sabiers JH, Berger NA, Berger SJ, Haaga JR, Hoppel CL, Willson JK. Phase I trial of topotecan administered as a 72-hr infusion (Meeting abstract). Proc Annu Meet Am Assoc Cancer Res. 1993;34:a25411993.

6. Eckardt J, Burris H, Kuhn J, Smith S, Rodriguez G, Weiss G, Smith L, Shaffer D, Johnson R, Von Hoff D. PHASE I AND PHARMACOKINETIC TRIAL OF CONTINUOUS INFUSION TOPOTECAN IN PATIENTS WITH REFRACTORY SOLID TUMORS (MEETING ABSTRACT). Proc Annu Meet Am Soc Clin Oncol. 1992;11:a3731992.

7. 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.

8. Product Information. Hycamtin (topotecan). SmithKline Beecham. 2001;PROD.

9. O'Brien S, Kantarjian H, Ellis A, Zwelling L, Estey E, Keating M. Topotecan in chronic lymphocytic leukemia. Cancer. 1995;75:1104-8.

10. Rowinsky EK, Grochow LB, Hendricks CB, Ettinger DS, Forastiere AA, Hurowitz LA, McGuire WP, Sartorius SE, Lubejko BG, Kaufmann SH, et al. Phase I and pharmacologic study of topotecan: a novel topoisomerase I inhibitor. J Clin Oncol. 1992;10:647-56.

11. van Warmerdam LJ, ten Bokkel Huinink WW, Rodenhuis S, Koier I, Davies BE, Rosing H, Maes RA, Beijnen JH. Phase I clinical and pharmacokinetic study of topotecan administered by a 24-hour continuous infusion. J Clin Oncol. 1995;13:1768-76.

12. Miller AA, Hargis JB, Lilenbaum RC, Fields SZ, Rosner GL, Schilsky RL. 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.

13. Stewart CF, Baker SD, Heideman RL, Jones D, Crom WR, Pratt CB. Clinical pharmacodynamics of continuous infusion topotecan in children: systemic exposure predicts hematologic toxicity. J Clin Oncol. 1994;12:1946-54.

14. Pratt CB, Stewart C, Santana VM, Bowman L, Furman W, Ochs J, Marina N, Kuttesch JF, Heideman R, Sandlund JT, et al. Phase I study of topotecan for pediatric patients with malignant solid tumors. J Clin Oncol. 1994;12:539-43.

15. Haas NB, LaCreta FP, Walczak J, Hudes GR, Brennan J, Ozols RF, O'Dwyer PJ. PHASE I/PHARMACOKINETIC TRIAL OF TOPOTECAN ON A WEEKLY 24-HOUR INFUSION SCHEDULE (MEETING ABSTRACT). Proc Annu Meet Am Assoc Cancer Res. 1992;33:a31281992.

16. Wall J, Burris H, Rodriguez G, Brown T, Weiss G, Kuhn J, Brown J, Johnson R, Friedman C, Mann W, et al. PHASE I TRIAL OF TOPOTECAN (SK AND F 104864) IN PATIENTS WITH REFRACTORY SOLID TUMORS (MEETING ABSTRACT). Proc Annu Meet Am Soc Clin Oncol. 1991;10:a2611991.

17. Janik J, Miller L, Smith J, Kopp W, Alvord G, Gause B, Curti B, Urba WJ, Longo DL. Prechemotherapy granulocyte-macrophage colony stimulating factor (GM- CSF) prevents topotecan-induced neutropenia (Meeting abstract). Proc Annu Meet Am Soc Clin Oncol. 1993;12:a15071993.

18. Rowinsky EK, Adjei A, Donehower RC, Gore SD, Jones RJ, Burke PJ, Cheng YC, Grochow LB, Kaufmann SH. Phase I and pharmacodynamic study of the topoisomerase I-inhibitor topotecan in patients with refractory acute leukemia. J Clin Oncol. 1994;12:2193-203.

19. Cerner Multum, Inc. UK Summary of Product Characteristics.

20. Edgerton CC, Gilman M, Roth BJ. Topotecan-induced bronchiolitis. South Med J. 2004;97:699-701.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.