Pharmacologic class: DNA topoisomerase inhibitor
Therapeutic class: Antineoplastic
Pregnancy risk category D
FDA Box Warning
Give under supervision of physician experienced in cancer chemotherapy, in facility with adequate diagnostic and treatment resources.
Don't administer to patients with baseline neutrophil counts below 1,500 cells/mm3. Obtain frequent peripheral blood cell counts on all patients to monitor for bone marrow depression.
Regulates DNA replication and repair of broken DNA strands, relieving torsional strain; exerts cytotoxic effects during DNA synthesis
Capsules: 0.25 mg, 1 mg
Injection: 4 mg in 4-ml single-dose vials
Injection (powder for solution): 4 mg in single-dose vials
Indications and dosages
➣ Metastatic ovarian cancer or small-cell lung cancer after first-line chemotherapy fails
Adults: 1.5 mg/m2 daily by I.V. infusion given over 30 minutes for 5 consecutive days, starting on day 1 of 21-day cycle
➣ Relapsed small-cell lung cancer
Adults: 2.3 mg/m2 P.O. daily for 5 consecutive days; repeat every 21 days
➣ Stage IV-B, recurrent, or persistent cervical carcinoma not amenable to curative treatment with surgery or radiation therapy (in combination with cisplatin)
Adults: 0.75 mg/m2 I.V. daily over 30 minutes on days 1, 2, and 3; followed by cisplatin 50 mg/m2 by I.V. infusion on day 1, repeated every 21 days
• Renal impairment
• Grade 3 or 4 diarrhea (capsules)
• History of severe hypersensitivity to drug or its components
• Severe bone marrow depression
Use cautiously in:
• pregnant or breastfeeding patients
• children (safety and efficacy not established).
Before starting therapy, check blood counts. Patient must have baseline neutrophil count above 1,500 cells/mm3 and platelet count above 100,000 cells/mm3 to receive drug.
Prepare drug under vertical laminar-flow hood, wearing gloves and protective clothing. Follow facility policy for discarding used drug containers and I.V. equipment.
• If skin contacts drug, wash immediately with soap and water.
• To reconstitute, add 4 ml of sterile water to 4-mg vial. Dilute further in normal saline solution or dextrose 5% in water. Give immediately over 30 minutes using infusion pump.
• Round calculated oral daily dose to nearest 0.25 mg, and administer minimum number of 1-mg and 0.25-mg capsules. Know that the same number of capsules should be prescribed for each of the 5 dosing days.
CNS: asthenia, fatigue, paresthesia
GI: nausea, diarrhea, constipation, abdominal pain, stomatitis, anorexia, severe diarrhea, neutropenic colitis
Hematologic: anemia, leukopenia, thrombocytopenia, neutropenia
Musculoskeletal: back pain, skeletal pain
Respiratory: coughing, dyspnea, interstitial lung disease
Skin: erythematous or maculopapular rash, pruritus, urticaria, dermatitis, bullous eruption, alopecia
Other: fever, body pain, sepsis
Drug-drug. Cisplatin: severe bone marrow depression
Granulocyte colony-stimulating factor: prolonged neutropenia
Live-virus vaccines: increased risk of infection from vaccine
Drug-diagnostic tests. Alanine aminotransferase, aspartate aminotransferase, bilirubin: increased levels
• Closely monitor CBC with white cell differential.
Assess for signs and symptoms of bleeding tendency, severe diarrhea (with capsule use), and neutropenic colitis (fever, neutropenia, and compatible pattern of abdominal pain).
Monitor patient for signs and symptoms of interstitial lung disease (cough, fever, dyspnea, or hypoxia); discontinue drug if diagnosis is confirmed.
• Monitor closely for sepsis, other infections, and increased hepatic enzyme levels.
• Tell patient to take capsules whole with or without food and not to break, divide, chew, or crush them.
Advise patient to immediately report unusual bleeding or bruising, diarrhea, abdominal pain, cough, difficulty breathing, sore throat, fever, or chills.
• Teach patient safety measures to avoid bruising and bleeding.
• Tell patient to minimize GI upset by eating small, frequent servings of food and drinking plenty of fluids.
Advise female patient to notify prescriber of suspected pregnancy. Caution her not to breastfeed during therapy.
• Inform patient that drug may cause hair loss.
• Tell patient he'll undergo regular blood testing during therapy.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.
Pharmacologic: enzyme inhibitors
Time/action profile (effects on WBCs)
|PO||unknown||1–2 hr||24 hr|
|IV||within days||11 days||7 days|
Adverse Reactions/Side Effects
Central nervous system
- headache (most frequent)
- interstitial lung disease (life-threatening)
- dyspnea (most frequent)
- abdominal pain (most frequent)
- diarrhea (most frequent)
- nausea (most frequent)
- vomiting (most frequent)
- ↑ liver enzymes
- alopecia (most frequent)
- anemia (most frequent)
- leukopenia (most frequent)
- thrombocytopenia (most frequent)
Drug-Drug interactionNeutropenia is prolonged by concurrent use of filgrastim (do not use until day 6; 24 hr following completion of topotecan).↑ myelosuppression with other antineoplastics (especially cisplatin ) or radiation therapy.May ↓ antibody response to and ↑ risk of adverse reactions from live virus vaccines.
Renal ImpairmentOral (Adults) Ovarian and Small Cell Lung Cancer—CCr 30–49 mL/min—1.8 mg/m2/day starting on day 1 of a 21-day course.
Availability (generic available)
- Monitor vital signs frequently during administration.
- Monitor for bone marrow depression. Assess for bleeding (bleeding gums, bruising, petechiae; guaiac stools, urine, and emesis) and avoid IM injections and taking rectal temperatures if platelet count is low. Apply pressure to venipuncture sites for 10 min. Assess for signs of infection during neutropenia. Anemia may occur. Monitor for increased fatigue, dyspnea, and orthostatic hypotension.
- Nausea and vomiting are common. Pretreatment with antiemetics should be considered.
- Assess IV site frequently for extravasation, which causes mild local erythema and bruising.
- Monitor for signs and symptoms of interstitial lung disease (cough, fever, dyspnea, hypoxia). Discontinue topotecan if interstitial lung disease is confirmed.
- Lab Test Considerations: Monitor CBC with differential and platelet count prior to administration and frequently during therapy. Baseline neutrophil count of ≥1500 cells/mm3 and platelet count of ≥100,000 cells/mm3 are required before first dose. The nadir of neutropenia occurs in 11 days, with a duration of 7 days. The nadir of thrombocytopenia occurs in 15 days, with a duration of 5 days. The nadir of anemia occurs in 15 days. Subsequent doses should not be administered until neutrophils recover to >1000 cells/mm3, platelets recover to >100,000 cells/mm3, and hemoglobin levels recover to 9.0 mg/dL. If severe neutropenia occurs during any course, subsequent doses should be reduced by 0.25 mg/m2 or filgrastim may be administered following the subsequent course of therapy starting on day 6, 24 hr after the completion of topotecan.
- Monitor liver function. May cause transient ↑ in AST, ALT, and bilirubin concentrations.
Potential Nursing DiagnosesRisk for infection (Adverse Reactions)
- high alert: Fatalities have occurred with chemotherapeutic agents. Before administering, clarify all ambiguous orders; double check single, daily, and course-of-therapy dose limits; have second practitioner independently double check original order, dose calculations and infusion pump settings.
- Oral: May be taken without regard to food. Capsules must be swallowed whole; do not open, crush, or chew. If patient vomits after taking dose, do not replace dose.
- pH: 2.5–3.5.
- Solution should be prepared in a biologic cabinet. Wear gloves, gown, and mask while handling IV medication. Discard IV equipment in specially designated containers.
- Intermittent Infusion: Reconstitute each vial with 4 mL of sterile water for injection. Diluent: Dilute further in D5W or 0.9% NaCl. Infusion is stable for 24 hr at room temperature or up to 7 days if refrigerated. Solution is yellow to yellow-green.Concentration: 10–50 mcg/mL.
- Rate: Infuse over 30 min.
- Y-Site Compatibility: alemtuzumab, anidulafungin, argatroban, bivalirudin, carboplatin, caspofungin, cisplatin, cyclophosphamide, dactinomycin, daptomycin, dexmedetomidine, doxorubicin, etoposide, fenoldopam, gemcitabine, granisetron, ifosfamide, levofloxacin, meperidine, methylprednisolone, metoclopramide, nesiritide, octreotide, ondansetron, oxaliplatin, paclitaxel, palonosetron, pamidronate, prochlorperazine, teniposide, thiotepa, tigecycline, tirofiban, vincristine, voriconazole, zoledronic acid
- Y-Site Incompatibility: amphotericin B lipid complex, dexamethasone sodium phosphate, ertapenem, fluorouracil, mitomycin, pantoprazole, pemetrexed, rituximab, trastuzumab
- Instruct patient to take as directed. If patient vomits after taking, do not replace dose; notify health care professional. Do not take missed doses; take next scheduled dose and notify health care professional. If any capsules are broken or leaking, do not touch with bare hands; dispose of capsules and wash hands with soap and water. Patient should be instructed to read the Patient Information guide prior to first dose and with each refill; new information may be available.
- May cause drowsiness or sleepiness during and for several days after therapy. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.
- Instruct patient to notify health care professional if fever; chills; sore throat; signs of infection; bleeding gums; bruising; petechiae; blood in urine, stool, emesis or signs and symptoms of interstitial lung disease occur. Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor. Patient should be cautioned not to drink alcoholic beverages or take products containing aspirin or NSAIDs.
- May cause diarrhea. Advise patient to notify health care professional if diarrhea with fever or stomach pain or cramps or diarrhea that occurs more than 3 times/day.
- Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
- Discuss with patient the possibility of hair loss. Explore methods of coping.
- Instruct patient not to receive any vaccinations without advice of health care professional.
- Advise patient that this medication may have teratogenic effects. Contraception should be used during therapy and breast feeding avoided.
- Emphasize the need for periodic lab tests to monitor for side effects.
- Decrease in size and spread of malignancy.