Summary

Commonly reported side effects of topotecan 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:

• intravenous powder for solution, intravenous solution

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

• 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 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

• 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