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topotecan (Rx)Brand and Other Names:Hycamtin

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 4mg/vial

capsule

  • 0.25mg
  • 1mg
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Small Cell Lung Cancer

Indicated for SCLC sensitive disease after failure of first-line chemotherapy

IV Infusion

  • Administer 1.5mg/m² IV infused over 30 min qDay x5 days; repeat at 21-day cycles 
  • Absence of tumor progresssion: ≥ 4 courses is recommended
  • Severe neutropenia or thrombocytopenia (Plt <25K/mm³): reduce to 1.25 mg/m² for subsequent courses

Capsules

  • Administer 2.3mg/m² PO QD x5days; repeat at 21-day cycles 
  • Severe febrile neutropenia (ANC <500/mm³ with fever x7 days)/neutropenia (ANC<1000/mm³ x21 days)/thrombocytopenia (Plt<25K/mm³): Reduce by 0.4 mg/m²/day
  • Grade 3/4 diarrhea: reduce by 0.4 mg/m²/day

Dosage Modifications (SCLC)

Renal impairment

  • CrCl 30-49 mL/min: Decrease dose to 1.5 mg/m² PO qDay
  • CrCl <30 mL/min: Decrease dose to 0.6 mg/m² PO qDay
  • Renal impairment dosage modification: Dose can be increased after the first course by 0.4 mg/m²/day if no severe hematologic or GI toxicities occur

Hematologic toxicities

  • Do not administer subsequent courses of until neutrophils recover to >1,000 cells/mm³, platelets recover to >100,000 cells/mm³, hemoglobin levels recover to ≥9.0 g/dL (with transfusion if necessary)
  • Reduce dose by 0.4 mg/m²/day PO (0.25 mg/m² IV) if: - neutrophil counts <500 cells/mm³ with fever or infection or lasting for ≥7 days - neutrophil counts of 500-1,000 cells/mm³ lasting beyond day 21 of treatment cycle - platelet counts <25,000 cells/mm³
  • Also, consider G-CSF for severe neutropenia

Diarrhea

  • Do not administer to patients with Grade 3 or 4 diarrhea
  • After recovery to ≤Grade 1, reduce the dose by 0.4 mg/m²/day PO for subsequent courses

Cervical Cancer

Indicated for combination therapy with cisplatin for stage IV-B, recurrent or persistent cervical carcinoma which cannot be treated with surgery and/or radiation therapy

Administer 0.75 mg/m² IV infused over 30 min on Days 1,2, & 3 (with cisplatin 50 mg/m² on Day 1); repeat at 21-day cycles 

Severe febrile neutropenia (<1000 cells/mm³) or thrombocytopenia (Plt <25K/mm³)

  • Reduce all subsequent doses to 0.6 mg/m²
  • Alternatively, G-CSF may be administered for febrile neutropenia starting on Day 4 of the course (24 hours after toptecan administration has been completed)

Ovarian Cancer

Indicated for metastatic ovarian cancer after failure of initial or subsequent chemotherapy

Administer 1.5mg/m² IV infused over 30 min qDay x5 days; repeat at 21-day cycles 

Absence of tumor progresssion: ≥4 courses is recommended

Severe neutropenia or thrombocytopenia (Plt <25K/mm³): Reduce to 1.25 mg/m² for subsequent courses

Dosing Considerations

Verify dose using body surface area prior to dispensing

Recommended dosage should generally not exceed 4 mg IV

Prior to administration of the first treatment course, baseline counts for neutrophils should be >1,500/mm³ and platelets >100,000/mm³

Other Information

Monitor: CBC

Safety and effectiveness not established

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Interactions

Interaction Checker

topotecan and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Neutropenia (97%)

            Leukopenia (97%)

            Anemia (89%)

            Thrombocytopenia (69%)

            Nausea (64%)

            Alopecia (49%)

            Sepsis or pyrexia/ infection with neutropenia (43%)

            Vomiting (45%)

            Diarrhea (32%)

            Fatigue (29%)

            Constipation (29%)

            Fever (28%)

            Asthenia (25%)

            Body/ back/ skeletal pain (23%)

            Abdominal pain (22%)

            Dyspnea (22%)

            Anorexia (19%)

            Stomatitis (18%)

            Headache (18%)

            Rash (16%)

            Cough (15%)

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            Warnings

            Black Box Warnings

            Administer only to patients with baseline neutrophil counts of 1500 cells/mm³or higher and a platelet count of 100,000 cells/mm³ or higher

            To assess the occurrence of bone marrow suppression, blood cell counts should be monitored

            Contraindications

            Hypersensitivity reactions to drug or any components

            Cautions

            Administer to patients with bone marrow suppression only if patient has adequate bone marrow reserves; monitor peripheral blood counts and adjust dose as needed

            PO: Do NOT redose if ANC <1500/mm³; Plt 100,000 <mm³; Hgb <9 g/dL

            Avoid use in pregnancy; can cause fetal harm; advise women of potential risk to fetus

            Neutropenia: pancytopenia has been reported

            Fatal cases of interstitial lung disease have occurred; permanently discontinue for confirmed ILD

            If extravasation occurs, immediately stop administration and institute recommended management procedures; severe cases reported

            PO: If patient vomits after taking capsule, do NOT repeat dose

            PO: If diarrhea occurs, treat aggressively, potentially life-threatening

            Monitor patients presenting with neutropenia, fever and abdominal pain; fatal typhlitis reported in patients with neutropenic enterocolitisas

            Monitor patients presenting with cough, fever, dyspnea and/or hypoxia and a histroy of lung disease as fatalities due to interstitial lung disease have been reported

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: not known if excreted in breast milk, do not breast feed

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Binds to topoisomerase I to produce double-strand breaks in DNA

            Absorption

            Bioavailability: 40% (PO)

            Peak plasma time: 1-2 hr (PO)

            Distribution

            Protein Bound: 35%

            Metabolism

            Hepatic

            Excretion

            Half-life, terminal: 2-3 hr (IV); 3-6 hr (PO)

            Excretion, PO: 35% feces; 22% urine

            Excretion, IV: 20% feces; 54% urine

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            Administration

            IV Incompatibilities

            Y-site: dexamethasone sodium phosphate, fluorouracil, mitomycin, ticarcillin-clavulanate(?)

            IV Compatibilities

            Solution: D5W, NS

            Y-site: carbopolatin, cisplatin, cimetidine, cyclophosphamide, doxorubicin, etoposide, gemcitabine, granisetron, ifosfamide, methylprednisolone Na-succinate, metoclopramide, ondansetro, paclitaxel, prochlorperazine, vincristine

            IV Preparation

            No preservatives-reconstitute immediately prior to use

            Reconstitute in 4 mL SWI to obtain a 1 mg/mL solution

            No preservatives-use immediately

            Dilute in 50-250 mL NS or D5W; stability is pH dependent although topotecan may be further diluted in NS

            IV Administration

            Infuse over 30 min

            Storage

            Store intact vials at room temp protected from light

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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

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            • Compare formulary status to other drugs in the same class.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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