Hycamtin Side Effects
Generic name: topotecan
Medically reviewed by Drugs.com. Last updated on May 14, 2023.
Note: This document contains side effect information about topotecan. Some dosage forms listed on this page may not apply to the brand name Hycamtin.
Summary
Common side effects of Hycamtin include: febrile neutropenia, sepsis, infection, abdominal pain, alopecia, anemia, asthenia, constipation, dyspnea, fatigue, fever, headache, leukopenia, nausea, neutropenia, stomatitis, thrombocytopenia, vomiting, granulocytopenia, diarrhea, and anorexia. Other side effects include: increased serum alanine aminotransferase, increased serum aspartate aminotransferase, intestinal obstruction, pain, and paresthesia. Continue reading for a comprehensive list of adverse effects.
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 Hycamtin
Along with its needed effects, topotecan (the active ingredient contained in Hycamtin) 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
- 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
- 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
Incidence not known
- Cracked lips
- diarrhea
- difficulty in swallowing
- dizziness
- fast heartbeat
- heartburn
- hives, itching, skin rash
- indigestion
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- nausea
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- severe abdominal pain, cramping, or burning
- tightness in the chest
- trouble breathing
- vomiting of material that looks like coffee grounds, severe and continuing
Other side effects of Hycamtin
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
- Diarrhea
- hair loss or thinning of the hair
- lack or loss of strength
- loss of appetite
- 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
More about Hycamtin (topotecan)
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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 81 (1993): 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 13 (1995): 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 12 (1994): 553-9
4. Betcher DL, Burnham N "Topotecan." J Pediatr Oncol Nurs 9 (1992): 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 34 (1993): 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 11 (1992): 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 85 (1993): 1499-507
8. "Product Information. Hycamtin (topotecan)." SmithKline Beecham (2001):
9. O'Brien S, Kantarjian H, Ellis A, Zwelling L, Estey E, Keating M "Topotecan in chronic lymphocytic leukemia." Cancer 75 (1995): 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 10 (1992): 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 13 (1995): 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 12 (1994): 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 12 (1994): 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 12 (1994): 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 33 (1992): 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 10 (1991): 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 12 (1993): 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 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
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.