Hycamtin Side Effects

Please note - some side effects for Hycamtin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Hycamtin - for the Consumer

Hycamtin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Hycamtin:

Constipation; diarrhea; fatigue; hair loss; loss of appetite; nausea; stomach pain; tiredness; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blue or unusually pale skin or nails; fever, chills, or persistent sore throat; painful or burning urination; persistent or severe cough; persistent or severe pain, redness, or swelling at the injection site; persistent or severe stomach pain or cramps; persistent or severe tiredness or weakness; shortness of breath; unusual or unexplained bruising or bleeding; yellowing of the eyes or skin.

Hycamtin Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Hycamtin Capsules:

Constipation; diarrhea; fatigue; hair loss; loss of appetite; nausea; stomach pain; tiredness; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blue or unusually pale skin or nails; chest pain; fever, chills, or persistent sore throat; painful or burning urination; severe or persistent cough; severe or persistent diarrhea, stomach pain, or cramps; severe or persistent tiredness or weakness; shortness of breath; swelling or soreness of the mouth or tongue; unusual or unexplained bruising or bleeding; yellowing of the eyes or skin.

Hycamtin Side Effects - for the Professional

Hycamtin Capsules

The most common Grade 3 or 4 hematologic adverse reactions with Hycamtin capsules were neutropenia (61%), anemia (25%), and thrombocytopenia (37%). The most common (≥10%) non-hematologic adverse reactions (all grades) were nausea (27%), diarrhea (14%), vomiting (19%), fatigue (11%), and alopecia (10%).

Side Effects by Body System

Hematologic

Use of granulocyte colony stimulating factor (G-CSF) may be useful. Alternatively, dose reductions could be considered, especially if topotecan is used for palliative effects.

Risk of myelosuppression is increased in cases of pretreatment chemotherapy and/or radiation therapy.

Hematologic side effects have been the most profound and dose-limiting toxicity. Virtually all patients have developed neutropenia (80% to 98% less than 1,500/mm3), leukopenia (98% less than 3,000/mm3), anemia (85% to 95% less than 10 g/dL), and thrombocytopenia (44% to 63% less than 100,000/mm3). Twenty-five percent to 80% of patients developed severe pancytopenia. Nadirs have typically been observed 8 to 15 days after administration, with recovery often noted by day 21.

Gastrointestinal

Gastrointestinal side effects have been reported to usually be mild to moderate in severity, observed seven to fourteen days after administration, and last for two to five days. Protracted cases of nausea, vomiting, or diarrhea have been reported infrequently. However, these data are from studies where antiemetic therapy was not routinely used, and effective antiemetic therapy is now available.

Abdominal pain potentially associated with neutropenic colitis has been reported.

Gastrointestinal side effects have been common, but rarely severe, and can usually be controlled with antiemetic therapy. Gastrointestinal side effects have included nausea (64%), vomiting (45%), diarrhea (32%), constipation (29%), abdominal pain (22%), stomatitis (18%), and anorexia (19%).

General

Pain includes body pain, back pain, an skeletal pain.

General side effects have included fatigue (29%), fever (28%), pain (23%), and asthenia (25%).

Dermatologic

Rash also includes pruritus, rash erythematous, urticaria, dermatitis, bullous eruption, and rash maculopapular.

Dermatologic side effects have included alopecia (49%) and rash (16%).

Respiratory

Respiratory side effects have included dyspnea (22%), coughing (15%), and interstitial lung disease. A case of bronchiolitis has also been reported.

Nervous system

Nervous system side effects have included headache (18%).

Musculoskeletal

Musculoskeletal side effects have included arthralgias and myalgias.

Genitourinary

Genitourinary side effects have been limited to rare cases of acute renal failure, microscopic hematuria, proteinuria, and dysuria.

Cases of acute renal failure have been associated with myelosuppression and sepsis. They are not necessarily directly caused by topotecan therapy.

Local

Local side effects including erythema and bruising have resulted from inadvertent extravasation.

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