Hycamtin Drug Information

    Generic name: TOPOTECAN

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    Uses of Hycamtin

    HYCAMTIN ® capsules are indicated for the treatment of relapsed small cell lung cancer (SCLC) in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy. HYCAMTIN capsules is a topoisomerase inhibitor indicated for treatment of patients with relapsed small cell lung cancer (SCLC).

    Dosage & Administration of Hycamtin

    Dosage Modifications for Adverse Reactions Diarrhea

    Do not administer HYCAMTIN capsules to patients with Grade 3 or 4 diarrhea. After recovery to Grade 1 or less, reduce the dose by 0.4 mg/m 2 /day for subsequent courses. Hematologic Do not administer subsequent cycles of HYCAMTIN capsules until neutrophils recover to greater than 1,000/mm 3, platelets recover to greater than 100,000/mm 3, and hemoglobin levels recover to greater than or equal to 9 g/dL (with transfusion if necessary).

    Side Effects of Hycamtin

    Clinical Trials Experience

    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data in the Warnings and Precautions and below reflects exposure to HYCAMTIN capsules in 682 patients with recurrent lung cancer enrolled in four randomized, open label trials, including 275 patients with small lung cell lung cancer (SCLC) Studies patients with non-small cell lung cancer (NSCLC) (Study 387), who received at least one dose of HYCAMTIN capsules. Patients in these trials had advanced lung cancer and received prior chemotherapy in the first-line setting.

    The median number of cycles was 3 (range: 1 to 20). The safety of HYCAMTIN capsules was evaluated in a randomized trial (Study 478) conducted in 70 patients with recurrent SCLC. Table 1 describes the hematologic and non-hematologic adverse reactions that occurred in greater than 5% of patients treated with HYCAMTIN capsules in these trials.

    Table 1. Adverse Reactions Occurring in Greater than or Equal to 5% of Patients With Lung Cancer Postmarketing Experience The following reactions have been identified during post approval use of HYCAMTIN. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

    Gastrointestinal: Gastrointestinal perforation General and Administration Site Conditions: Mucosal inflammation Hypersensitivity: Allergic manifestations, anaphylactoid reactions, angioedema

    Table 1. Adverse Reactions Occurring in Greater than or Equal to 5% of Patients With Lung Cancer
    Adverse Reactions Adverse reactions were graded using National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 2.0.HYCAMTIN Capsules With Best Supportive Care (Study 478)HYCAMTIN Capsules Lung Cancer Population (Studies 478, 065, 396 and 387)
    N = 70N = 682
    All Grades (%)Grade 3 (%)Grade 4 (%)All Grades (%)Grade 3 (%)Grade 4 (%)
    Hematologic
    Anemia94151098187
    Neutropenia912833832432
    Thrombocytopenia8130781296
    Non-hematologic
    Nausea27103330
    Vomiting19102130.4
    Diarrhea14412240.4
    Fatigue11001940.1
    Alopecia1000200.10
    Pyrexia710511
    Anorexia7001420
    Asthenia300720

    Warnings & Cautions for Hycamtin

    Myelosuppression HYCAMTIN can cause severe myelosuppression

    The following safety data are based on an integrated safety database from four trials in patients with lung cancer (N = 682) who received HYCAMTIN capsules at a dose of 2.3 mg/m 2 orally once daily for 5 consecutive days, starting on Day 1 of a 21-day cycle. The median day for neutrophil and platelet nadirs occurred on Day 15. Grade 4 neutropenia most commonly occurred during cycle 1 (20% of patients).

    Grade 4 thrombocytopenia occurred in 6%, with a median duration of 3 days. Grade 3 or 4 anemia occurred in 25%. HYCAMTIN can cause fatal typhlitis (neutropenic enterocolitis).

    Consider the possibility of typhlitis in patients presenting with fever, neutropenia, and abdominal pain. Administer the first cycle of HYCAMTIN capsules only to patients with a baseline neutrophil count greater than or equal to 1,500/mm 3 and a platelet count greater than or equal to 100,000/mm 3. Monitor blood cell counts frequently during treatment.

    Withhold and reduce dose of HYCAMTIN capsules based on neutrophil counts, platelet counts and hemoglobin levels.

    Diarrhea

    Diarrhea, including severe and life-threatening diarrhea requiring hospitalization, can occur with HYCAMTIN capsules. Diarrhea can occur at the same time as drug-induced neutropenia and its sequelae. The median time to onset of Grade 2 to 4 diarrhea was 9 days in the group receiving HYCAMTIN capsules.

    Monitor patients for diarrhea and treat with antidiarrheals at the first sign of diarrhea. Withhold and dose reduce as recommended based on severity.

    Interstitial Lung Disease

    Interstitial lung disease (ILD), including fatalities, can occur with HYCAMTIN. Underlying risk factors include history of ILD, pulmonary fibrosis, lung cancer, thoracic radiation, and use of pneumotoxic drugs or colony stimulating factors. Monitor for pulmonary symptoms indicative of ILD.

    Permanently discontinue HYCAMTIN capsules if ILD is confirmed.

    Embryo-Fetal Toxicity Based on animal data, HYCAMTIN can cause fetal harm when administered to a pregnant woman. Topotecan caused embryolethality, fetotoxicity, and teratogenicity in rats and rabbits when administered during organogenesis. Advise women of the potential risk to fetus.

    Advise females of reproductive potential to use effective contraception during treatment and for at least 6 months after the last dose of HYCAMTIN capsules. Advise males with a female partner of reproductive potential to use effective contraception during treatment with HYCAMTIN capsules and for 3 months after the last dose.

    Drug Interactions with Hycamtin

    Effect of Other Drugs on HYCAMTIN P-glycoprotein or Breast Cancer Resistance Protein Inhibitor Concomitant use of a P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) inhibitor increases topotecan AUC, which may increase the risk of adverse reactions. Avoid concomitant use HYCAMTIN capsules with P-gp inhibitors or BCRP inhibitors.

    Pregnancy Safety for Hycamtin

    Pregnancy Risk Summary Based on animal data and its mechanism of action, HYCAMTIN can cause fetal harm when administered to a pregnant woman. There are no available clinical data on the use of HYCAMTIN in pregnancy. Topotecan caused embryolethality, fetotoxicity, and teratogenicity in rats and rabbits when administered during organogenesis at doses similar to the clinical dose (see Data).

    Advise pregnant women of the potential risk to a fetus. Data Animal Data In rabbits, an intravenous dose of 0.10 mg/kg/day given on days 6 through 20 of gestation caused maternal toxicity, embryolethality, and reduced fetal body weight. In the rat, an intravenous dose of 0.23 mg/kg/day (about equal to the 1.5 mg/m 2 clinical intravenous dose based on BSA) given for 14 days before mating through gestation day 6 caused fetal resorption, microphthalmia, pre-implant loss, and mild maternal toxicity.

    This dose also caused an increase in total fetal malformations. The most frequent malformations were of the eye (microphthalmia, anophthalmia, rosette formation of the retina, coloboma of the retina, ectopic orbit), brain (dilated lateral and third ventricles), skull, and vertebrae.

    Pediatric Use of Hycamtin

    Pediatric Use Safety and effectiveness in pediatric patients have not been established.

    Contraindications for Hycamtin

    • HYCAMTIN is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan. Reactions have included anaphylactoid reactions.
    • History of severe hypersensitivity reactions to topotecan

    Overdosage Information for Hycamtin

    Overdoses (up to 5-fold of the prescribed dose) have occurred in patients receiving HYCAMTIN capsules. The primary complication of overdosage is myelosuppression. Mucositis have occurred with overdosages.

    If an overdose is suspected, monitor the patient closely for myelosuppression and institute supportive-care measures as appropriate.

    Clinical Studies of Hycamtin

    Small Cell Lung Cancer (SCLC)

    The efficacy of HYCAMTIN capsules was studied in 141 patients with relapsed SCLC in a randomized, controlled, open-label trial (Study 478). The patients were prior responders (complete or partial) to first-line chemotherapy, were not considered candidates for standard intravenous chemotherapy and had relapsed at least 45 days from the end of first-line chemotherapy. The major efficacy outcome measure was overall survival (OS).

    The majority of patients were White (99%) and male (73%). In the HYCAMTIN capsules with BSC arm, 68% of patients had extensive disease and 28% had liver metastasis. In the BSC alone arm, 61% had extensive disease and 20% had liver metastases.

    Eighty percent of patients receiving HYCAMTIN capsules with BSC previously received carboplatin or cisplatin and 77% of patients in the BSC alone arm received prior carboplatin or cisplatin. In the arm receiving HYCAMTIN capsules with BSC, 18% of patients had prior carboplatin and 62% had prior cisplatin. In the BSC-alone arm, 26% of patients had prior carboplatin and 51% had prior cisplatin.

    The arm receiving HYCAMTIN capsules with BSC showed a statistically significant improvement in OS compared with the BSC-alone arm (Log-rank P = 0.0104). Efficacy results are shown in Table 3 and Figure 1. Table 3.

    Efficacy Results in Small Cell Lung Cancer in Study 478, Best Supportive Care; N, Total number of patients randomized; CI, Confidence Interval. Figure 1. Kaplan-Meier Curves for Overall Survival in Small Cell Lung Cancer in Study 478 Figure 1.

    Table 3. Efficacy Results in Small Cell Lung Cancer in Study 478
    ParametersTreatment Group
    HYCAMTIN Capsules with BSCBSC
    (N = 71)(N = 70)
    Median Overall Survival (months) (95% CI)6.0 (4.2, 7.3)3.2 (2.6, 4.3)
    Hazard ratio (95% CI)0.64 (0.45, 0.90)
    Log-rank P -value0.0104

    Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.

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