(toe-poe-tee-kan) ,


(trade name)


Therapeutic: antineoplastics
Pharmacologic: enzyme inhibitors
Pregnancy Category: D


Intravenous: Metastatic ovarian cancer that has not responded to previous chemotherapy.Small cell lung cancer unresponsive to first line therapy. Oral: Relapsed small cell lung cancer in patients with a complete or partial prior response and who are at least 45 days from the end of first-line chemotherapy.Stage IV-B persistent or recurrent cervical cancer not amenable to treatment with surgery or radiation (with cisplatin).


Interferes with DNA synthesis by inhibiting the enzyme topoisomerase.

Therapeutic effects

Death of rapidly replicating cells, particularly malignant ones.


Absorption: IV administration results in complete bioavailability.
Distribution: Unknown.
Metabolism and Excretion: 30% excreted in urine; small amounts metabolized by the liver.
Half-life: PO—3–6 hr; IV—2–3 hr.

Time/action profile (effects on WBCs)

POunknown1–2 hr24 hr
IVwithin days11 days7 days


Contraindicated in: Hypersensitivity;Pre-existing severe myelosuppression; Obstetric / Lactation: Pregnancy or lactation.
Use Cautiously in: Impaired renal function (↓ dose if CCr <40 mL/min);Platelet count <25,000 cells/mm3 (↓ dose);History of interstitial lung disease, pulmonary fibrosis, lung cancer, thoracic radiation, or use of pneumotoxic drugs or colony stimulating factors; Geriatric: May require dose ↓ due to age-related ↓ in renal function.

Adverse Reactions/Side Effects

Central nervous system

  • headache (most frequent)
  • fatigue
  • weakness


  • interstitial lung disease (life-threatening)
  • dyspnea (most frequent)


  • abdominal pain (most frequent)
  • diarrhea (most frequent)
  • nausea (most frequent)
  • vomiting (most frequent)
  • anorexia
  • constipation
  • ↑ liver enzymes
  • stomatitis


  • alopecia (most frequent)


  • anemia (most frequent)
  • leukopenia (most frequent)
  • thrombocytopenia (most frequent)


  • arthralgia


Drug-Drug interaction

Neutropenia 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.


Oral (Adults) 2.3 mg/m2/day for 5 days repeated every 21 days (round calculated oral dose to nearest 0.25 mg and prescribe the minimum number of 1 mg and 0.25 mg capsules with the same number of capsules prescribed for each of the 5 days).
Intravenous (Adults) Ovarian and Small Cell Lung Cancer—1.5 mg/m2/day for 5 days starting on day 1 of a 21-day course; Cervical Cancer—75 mg/m2 on Days 1, 2, and 3 followed by cisplatin on Day 1 and repeated every 21 days.

Renal Impairment

Oral (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.
Intravenous (Adults) CCr 20–39 mL/min—0.75mg/m2/day for 5 days starting on day 1 of a 21-day course. Cervical Cancer—Administer at standard doses only if serum creatinine is ≤1.5 mg/dL. Do not administer if serum creatinine >1.5 mg/dL.

Availability (generic available)

Capsules: 0.25 mg, 1 mg
Powder for injection: 4 mg/vial

Nursing implications

Nursing assessment

  • 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 Diagnoses

Risk 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.
  • Intravenous Administration
  • 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

Patient/Family Teaching

  • 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.

Evaluation/Desired Outcomes

  • Decrease in size and spread of malignancy.


A water-soluble derivative of camptothecin, obtained from the Chinese tree Camptotheca accuminata. It is a topoisomerase inhibitor which is FDA-approved for treating ovarian, cervical and small cell carcinoma of the lung.


A brand name for TOPOTECAN.
References in periodicals archive ?
In-depth analysis of Hycamtin including efficacy, safety, pricing, competition and other details which influence its sales potential
Hycamtin is one of the first of a new kind of anti-cancer drugs that kills cancer cells by inhibiting an enzyme essential to the replication of human DNA.
Gemzar, ovarian cancer, gemcitabine, cytotoxic chemotherapy, second line treatment, locally advanced and metastatic ovarian cancer, platinum-based, first line therapy,Eli Lilly, sales forecast, phase III/pipeline, generic gemcitabine, competitors to Gemzar Hycamtin carboplatin
The patent expires of major branded products, such as Taxol (paclitaxel), Paraplatin (carboplatin), Gemzar (gemcitabine), Hycamtin (topotecan hydrochloride) and the subsequent launch of generics, have acted as restraining factors to the market.
Growth in the cervical cancer therapeutics market is expected to decline in the forecast period until 2018, primarily due to the generic erosion of Hycamtin, the only approved therapeutic treatment option available in the market for advanced and recurrent cervical cancer patients.
The report studies eight off-patent and patented drugs including Navelbine, Hycamtin, Taxotere, Gemzar, Alimta, Iressa, Avastin, and Tarceva.
The initial stage of the study will establish the maximum tolerated dose (MTD) of ME-344 in combination with Hycamtin in up to 24 patients.
Paclitaxel, ovarian cancer, Taxol, first and second line treatment of advanced ovarian cancer, Bristol Myers Squibb, combination with carboplatin, standard treatment of advanced ovarian cancer, microtubule assembly, sales forecast, phase III/pipeline, competitors to paclitaxel EC145, Olaparib , Opaxio, Gemzar, Hycamtin, Hexalen, Doxil , Yondelis.
The growth during 2005-2010 is primarily attributed to the launch of an oral form of Hycamtin (topotecan).
Similarly, the major marketed drugs after 1990 approved for ovarian cancer were Altretamine (Hexalen), Gemcitabine (Gemzar), Hycamtin (Topotecan hydrochloride) and Yondelis (trabectedin).
The patent expiries of major branded products, such as Taxol (paclitaxel), Paraplatin (carboplatin), Gemzar (gemcitabine), Hycamtin (topotecan hydrochloride) and the subsequent launch of generics, have acted as restraining factors to the market.