Topotecan Side Effects

It is possible that some side effects of topotecan may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to topotecan: oral capsule

As well as its needed effects, topotecan may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking topotecan, check with your doctor immediately:

More common
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • chest pain
  • chills
  • cough
  • fever
  • lower back or side pain
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • shortness of breath
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Some topotecan side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Diarrhea
  • hair loss or thinning of the hair
  • lack or loss of strength
  • loss of appetite
  • nausea
  • vomiting
  • weight loss

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. 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 13 (1995): 2230-7

2. Betcher DL, Burnham N "Topotecan." J Pediatr Oncol Nurs 9 (1992): 31-2

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 12 (1994): 553-9

4. 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 11 (1992): a3731992

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 34 (1993): a25411993

6. 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 85 (1993): 1499-507

7. 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 81 (1993): 1146-51

8. "Product Information. Hycamtin (topotecan)." SmithKline Beecham, Philadelphia, PA.

9. 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 13 (1995): 1768-76

10. 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 12 (1994): 1946-54

11. 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 10 (1991): a2611991

12. 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 12 (1993): a15071993

13. 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 12 (1994): 2743-50

14. 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 10 (1992): 647-56

15. 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 12 (1994): 539-43

16. 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 33 (1992): a31281992

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

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 12 (1994): 2193-203

19. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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

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