Data from FDA - Curated by EPG Health - Last updated 22 November 2019

Indication(s)

1 INDICATIONS AND USAGE Topotecan hydrochloride is indicated for the treatment of: small cell lung cancer sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the Phase 3 study) or at least 90 days (in the Phase 2 studies) after chemotherapy [see Clinical Studies (14)] . Topotecan hydrochloride in combination with cisplatin is indicated for the treatment of: stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy. Topotecan Hydrochloride for Injection is a topoisomerase inhibitor indicated for: small cell lung cancer sensitive disease after failure of first-line chemotherapy. ( 1) combination therapy with cisplatin for stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy. ( 1)

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Advisory information

contraindications
4 CONTRAINDICATIONS Topotecan hydrochloride is contraindicated in patients who have a history of severe hypersensitivity reactions (e.g., anaphylactoid reactions) to topotecan or to any of its ingredients. Topotecan hydrochloride should not be used in patients with severe bone marrow depression. History of severe hypersensitivity reactions (e.g., anaphylactoid reactions) to topotecan or any of its ingredients. ( 4) Severe bone marrow depression. ( 4)
Adverse reactions
6 ADVERSE REACTIONS Small cell lung cancer: The most common hematologic adverse reactions were: neutropenia (97%), leukopenia (97%), anemia (89%), and thrombocytopenia (69%). ( 6.1) The most common (>25%) non-hematologic adverse reactions (all grades) were: nausea, alopecia, vomiting, sepsis or pyrexia/infection with neutropenia, diarrhea, constipation, fatigue, and pyrexia. ( 6.1) Cervical cancer (Topotecan hydrochloride plus cisplatin): The most common hematologic adverse reactions (all grades) were: anemia (94%), leukopenia (91%), neutropenia (89%), and thrombocytopenia (74%). ( 6.1) The most common (>25%) non-hematologic adverse reactions (all grades) were: pain, nausea, vomiting, and infection/febrile neutropenia. ( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC, Medical Affairs at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Small Cell Lung Cancer Data in the following section are based on the combined experiences of the 879 patients studied, including 426 patients with small cell lung cancer treated with topotecan hydrochloride injection. Table 1 lists the principal hematologic adverse reactions and Table 2 lists non-hematologic adverse reactions occurring in at least 15% of patients. Table 1. Hematologic Adverse Reactions Experienced in ≥ 15% of Patients Receiving Topotecan Hydrochloride Hematologic Adverse Reaction Patients (n = 879) % Incidence Neutropenia <1,500 cells/mm 3 <500 cells/mm 3 97 78 Leukopenia <3,000 cells/mm 3 <1,000 cells/mm 3 97 32 Thrombocytopenia <75,000/mm 3 <25,000/mm 3 69 27 Anemia <10 g/dL <8 g/dL 89 37 Table 2. Non-hematologic Adverse Reactions Experienced by ≥ 15% of Patients Receiving Topotecan Hydrochloride Non-hematologic Adverse Reaction Percentage of Patients with Adverse Reaction (879 Patients) All Grades Grade 3 Grade 4 Infections and infestations Sepsis or pyrexia/infection with neutropenia a 43 NR 23 Metabolism and nutrition disorders Anorexia 19 2 <1 Nervous system disorders Headache 18 1 <1 Respiratory, thoracic, and mediastinal disorders Dyspnea Coughing 22 15 5 1 3 0 Gastrointestinal disorders Nausea Vomiting Diarrhea Constipation Abdominal pain Stomatitis 64 45 32 29 22 18 7 4 3 2 2 1 1 1 1 1 2 <1 Skin and subcutaneous tissue disorders Alopecia Rash b 49 16 NA 1 NA 0 General disorders and administrative site conditions Fatigue Pyrexia Pain c Asthenia 29 28 23 25 5 1 2 4 0 <1 1 2 NA=Not applicable NR=Not reported separately a Does not include Grade 1 sepsis or pyrexia. b Rash also includes pruritus, rash erythematous, urticaria, dermatitis, bullous eruption, and maculopapular rash. c Pain includes body pain, back pain, and skeletal pain. Nervous System Disorders Paresthesia occurred in 7% of patients but was generally grade 1. Hepatobiliary Disorders Grade 1 transient elevations in hepatic enzymes occurred in 8% of patients. Greater elevations, grade 3/4, occurred in 4%. Grade 3/4 elevated bilirubin occurred in <2% of patients. Table 4 shows the grade 3/4 hematologic and major non-hematologic adverse reactions in the topotecan/CAV comparator trial in small cell lung cancer. Table 4. Adverse Reactions Experienced by ≥ 5% of Small Cell Lung Cancer Patients Randomized to Receive Topotecan Hydrochloride or CAV Adverse Reaction Topotecan Hydrochloride (n=107) CAV (n=104) Hematologic Grade 3/4 % % Grade 4 neutropenia (<500 cells/mm 3) 70 72 Grade 3/4 anemia (Hgb <8g dL) 42 20 Grade 4 thrombocytopenia (<25,000 plts/mm 3) 29 5 Pyrexia/Grade 4 neutropenia 28 26 Non-hematologic Grade 3/4 % % Infections and infestations Documented sepsis a 5 5 Respiratory, thoracic, and mediastinal disorders Dyspnea Pneumonia 9 8 14 6 Gastrointestinal disorders Abdominal pain Nausea 6 8 4 6 General disorders and administrative site conditions Fatigue Asthenia Pain b 6 9 5 10 7 7 a Death related to sepsis occurred in 3% of patients receiving topotecan hydrochloride, and 1% of patients receiving CAV. b Pain includes body pain, skeletal pain, and back pain. Cervical Cancer In the comparative trial with topotecan hydrochloride plus cisplatin versus cisplatin in patients with cervical cancer, the most common dose-limiting adverse reaction was myelosuppression. Table 5 shows the hematologic adverse reactions and Table 6 shows the non-hematologic adverse reactions in patients with cervical cancer. Table 5. Hematologic Adverse Reactions in Patients with Cervical Cancer Treated with Topotecan Hydrochloride Plus Cisplatin or Cisplatin Monotherapy a Hematologic Adverse Reaction Topotecan Hydrochloride Plus Cisplatin (n=140) Cisplatin (n=144) Anemia All grades (Hgb <12 g/dL) Grade 3 (Hgb <8 to 6.5 g/dL) Grade 4 (Hgb <6.5 g/dL) 131 (94%) 47 (34%) 9 (6%) 130 (90%) 28 (19%) 5 (3%) Leukopenia All grades (<3,800 cells/mm 3) Grade 3 (<2,000 to 1,000 cells/mm 3) Grade 4 (<1,000 cells/mm 3) 128 (91%) 58 (41%) 35 (25%) 43 (30%) 1 (1%) 0 (0%) Neutropenia All grades (<2,000 cells/mm 3) Grade 3 (<1,000 to 500 cells/mm 3) Grade 4 (<500 cells/mm 3) 125 (89%) 36 (26%) 67 (48%) 28 (19%) 1 (1%) 1 (1%) Thrombocytopenia All grades (<130,000 cells/mm 3) Grade 3 (<50,000 to 10,000 cells/mm 3) Grade 4 (<10,000 cells/mm 3) 104 (74%) 36 (26%) 10 (7%) 21 (15%) 5 (3%) 0 (0%) a Includes patients who were eligible and treated. Table 6. Non-hematologic Adverse Reactions Experienced by ≥ 5% of Patients with Cervical Cancer Treated with Topotecan Hydrochloride Plus Cisplatin or Cisplatin Monotherapy a Adverse Reaction Topotecan Hydrochloride Plus Cisplatin (n=140) Cisplatin (n=144) All Grades b Grade 3 Grade 4 All Grades b Grade 3 Grade 4 General disorders and administrative site conditions Constitutional c Pain d 96 (69%) 82 (59%) 11 (8%) 28 (20%) 0 3 (2%) 89 (62%) 72 (50%) 17 (12%) 18 (13%) 0 5 (3%) Gastrointestinal disorders Vomiting Nausea Stomatitis-pharyngitis Other 56 (40%) 77 (55%) 8 (6%) 88 (63%) 20 (14%) 18 (13%) 1 (<1%) 16 (11%) 2 (1%) 2 (1%) 0 4 (3%) 53 (37%) 79 (55%) 0 80 (56%) 13 (9%) 13 (9%) 0 12 (8%) 0 0 0 3 (2%) Dermatology 67 (48%) 1 (<1%) 0 29 (20%) 0 0 Metabolic-Laboratory 55 (39%) 13 (9%) 7 (5%) 44 (31%) 14 (10%) 1 (<1%) Genitourinary 51 (36%) 9 (6%) 9 (6%) 49 (34%) 7 (5%) 7 (5%) Nervous system disorders Neuropathy Other 4 (3%) 49 (35%) 1 (<1%) 3 (2%) 0 1 (<1%) 3 (2%) 43 (30%) 1 (<1%) 7 (5%) 0 2 (1%) Infection-febrile neutropenia 39 (28%) 21 (15%) 5 (4%) 26 (18%) 11 (8%) 0 Cardiovascular 35 (25%) 7 (5%) 6 (4%) 22 (15%) 8 (6%) 3 (2%) Hepatic 34 (24%) 5 (4%) 2 (1%) 23 (16%) 2 (1%) 0 Pulmonary 24 (17%) 4 (3%) 0 23 (16%) 5 (3%) 3 (2%) Vascular disorders Hemorrhage Coagulation 21 (15%) 8 (6%) 8 (6%) 4 (3%) 1 (<1%) 3 (2%) 20 (14%) 10 (7%) 3 (2%) 7 (5%) 1 (<1%) 0 Musculoskeletal 19 (14%) 3 (2%) 0 7 (5%) 1 (<1%) 1 (<1%) Allergy-Immunology 8 (6%) 2 (1%) 1 (<1%) 4 (3%) 0 1 (<1%) Endocrine 8 (6%) 0 0 4 (3%) 2 (1%) 0 Sexual reproduction function 7 (5%) 0 0 10 (7%) 1 (<1%) 0 Ocular-visual 7 (5%) 0 0 7 (5%) 1 (<1%) 0 Data were collected using NCI Common Toxicity Criteria, v. 2.0. a Includes patients who were eligible and treated. b Grades 1 through 4 only. There were 3 patients who experienced grade 5 deaths with investigator-designated attribution. One was a grade 5 hemorrhage in which the drug-related thrombocytopenia aggravated the event. A second patient experienced bowel obstruction, cardiac arrest, pleural effusion and respiratory failure which were not treatment-related but probably aggravated by treatment. A third patient experienced a pulmonary embolism and adult respiratory distress syndrome, the latter was indirectly treatment-related. c Constitutional includes fatigue (lethargy, malaise, asthenia), fever (in the absence of neutropenia), rigors, chills, sweating, and weight gain or loss. d 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, and tumor pain. 6.2 Postmarketing Experience In addition to adverse reactions reported from clinical trials or listed in other sections of the prescribing information, the following reactions have been identified during post-marketing use of topotecan hydrochloride. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to topotecan hydrochloride. Blood and Lymphatic System Disorders: Severe bleeding (in association with thrombocytopenia) [see Warnings and Precautions (5.1)] . Immune System Disorders: Allergic manifestations; Anaphylactoid reactions. Gastrointestinal Disorders: Abdominal pain potentially associated with neutropenic colitis [see Warnings and Precautions (5.2) ]. Pulmonary Disorders: Interstitial lung disease [see Warnings and Precautions (5.3) ]. Skin and Subcutaneous Tissue Disorders: Angioedema, severe dermatitis, severe pruritus. General Disorders and Administration Site Conditions: Inadvertent extravasation [see Warnings and Precautions (5.5) ].

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION Prior to administration of the first course of topotecan hydrochloride, patients must have a baseline neutrophil count of >1,500 cells/mm 3 and a platelet count of >100,000 cells/mm 3. Small cell lung cancer: 1.5 mg/m 2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on day one of a 21-day course. ( 2.1) Cervical cancer: 0.75 mg/m 2 by intravenous infusion over 30 minutes on days 1, 2, and 3 followed by cisplatin 50 mg/m 2 by intravenous infusion on day 1 repeated every 21 days. ( 2.2) See Dosage Modification Guidelines for patients with neutropenia or reduced platelets. ( 2.1, 2.2) See Dosage Adjustment in Renal Impairment. ( 2.3) 2.1 Small Cell Lung Cancer Recommended Dosage The recommended dose of topotecan hydrochloride is 1.5 mg/m 2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on day 1 of a 21-day course. In the absence of tumor progression, a minimum of 4 courses is recommended because tumor response may be delayed. The median time to response in 4 small cell lung cancer trials was 5 to 7 weeks. Dosage Modification Guidelines In the event of severe neutropenia (defined as <500 cells/ mm 3) during any course, reduce the dose by 0.25 mg/m 2 (to 1.25 mg/m 2) for subsequent courses. Alternatively, in the event of severe neutropenia, administer G-CSF (granulocyte-colony stimulating factor) following the subsequent course (before resorting to dose reduction) starting from day 6 of the course (24 hours after completion of topotecan administration). In the event the platelet count falls below 25,000 cells/mm 3, reduce doses by 0.25 mg/m 2 (to 1.25 mg/m 2) for subsequent courses. 2.2 Cervical Cancer Recommended Dosage The recommended dose of topotecan hydrochloride is 0.75 mg/m 2 by intravenous infusion over 30 minutes daily on days 1, 2, and 3; followed by cisplatin 50 mg/m 2 by intravenous infusion on day 1 repeated every 21 days (a 21-day course). Dosage Modification Guidelines Dosage adjustments for subsequent courses of topotecan hydrochloride in combination with cisplatin are specific for each drug. See manufacturer’s prescribing information for cisplatin administration and hydration guidelines and for cisplatin dosage adjustment in the event of hematologic toxicity. In the event of severe febrile neutropenia (defined as <1,000 cells/mm 3 with temperature of 38°C or 100.4°F), reduce the dose of topotecan hydrochloride to 0.6 mg/m 2 for subsequent courses. Alternatively, in the event of severe febrile neutropenia, administer G-CSF following the subsequent course (before resorting to dose reduction) starting from day 4 of the course (24 hours after completion of administration of topotecan hydrochloride). If febrile neutropenia occurs despite the use of G-CSF, reduce the dose of topotecan hydrochloride to 0.45 mg/m 2 for subsequent courses. In the event the platelet count falls below 25,000 cells/mm 3, reduce doses to 0.6 mg/m 2 for subsequent courses. 2.3 Dosage Adjustment in Specific Populations Renal Impairment No dosage adjustment of topotecan hydrochloride appears to be required for patients with mild renal impairment (Cl cr 40 to 60 mL/min). Dosage adjustment of topotecan hydrochloride to 0.75 mg/m 2 is recommended for patients with moderate renal impairment (20 to 39 mL/min). Insufficient data are available in patients with severe renal impairment to provide a dosage recommendation for topotecan hydrochloride [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ]. Topotecan hydrochloride in combination with cisplatin for the treatment of cervical cancer should only be initiated in patients with serum creatinine ≤1.5 mg/dL. In the clinical trial, cisplatin was discontinued for a serum creatinine >1.5 mg/dL. Insufficient data are available regarding continuing monotherapy with topotecan hydrochloride after cisplatin discontinuation in patients with cervical cancer. 2.4 Instructions for Handling, Preparation and Intravenous Administration Handling Topotecan hydrochloride is a cytotoxic anticancer drug. Prepare topotecan hydrochloride under a vertical laminar flow hood while wearing gloves and protective clothing. If topotecan hydrochloride solution contacts the skin, wash the skin immediately and thoroughly with soap and water. If topotecan hydrochloride contacts mucous membranes, flush thoroughly with water. Use procedures for proper handling and disposal of anticancer drugs. Several guidelines on this subject have been published. 1-4 Preparation and Administration Each 4 mg vial of topotecan hydrochloride is reconstituted with 4 mL Sterile Water for Injection. Then the appropriate volume of the reconstituted solution is diluted in either 0.9% Sodium Chloride Intravenous Infusion or 5% Dextrose Intravenous Infusion prior to administration. Stability Unopened vials of topotecan hydrochloride are stable until the date indicated on the package when stored between 20° and 25°C (68° and 77°F) [see USP Controlled Room Temperature] and protected from light in the original package. Because the vials contain no preservative, contents should be used immediately after reconstitution. Reconstituted vials of topotecan hydrochloride diluted for infusion are stable at approximately 20° to 25°C (68° to 77°F) and ambient lighting conditions for 24 hours.
Use in special populations
8 USE IN SPECIFIC POPULATIONS Nursing Mothers: Discontinue nursing when receiving topotecan hydrochloride. ( 8.3) 8.1 Pregnancy Pregnancy Category D [see Warnings and Precautions (5.4) ]. Topotecan hydrochloride can cause fetal harm when administered to a pregnant woman. In rabbits, a dose of 0.1 mg/kg/day (about equal to the clinical dose on a mg/m 2 basis) given on days 6 through 20 of gestation caused maternal toxicity, embryolethality, and reduced fetal body weight. In the rat, a dose of 0.23 mg/kg/day (about equal to the clinical dose on a mg/m 2 basis) given for 14 days before mating through gestation day 6 caused fetal resorption, microphthalmia, pre-implant loss, and mild maternal toxicity. A dose of 0.1 mg/kg/day (about half the clinical dose on a mg/m 2 basis) given to rats on days 6 through 17 of gestation caused an increase in post-implantation mortality. 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. There are no adequate and well controlled studies of topotecan hydrochloride in pregnant women. If this drug is used during pregnancy, or if a patient becomes pregnant while receiving topotecan hydrochloride, the patient should be apprised of the potential hazard to the fetus [see Warnings and Precautions (5.4) ]. 8.3 Nursing Mothers Rats excrete high concentrations of topotecan into milk. Lactating female rats given 4.72 mg/m 2 IV (about twice the clinical dose on a mg/m 2 basis) excreted topotecan into milk at concentrations up to 48-fold higher than those in plasma. It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from topotecan hydrochloride, discontinue breastfeeding when women are receiving topotecan hydrochloride. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Of the 879 patients with cancer in clinical studies of topotecan hydrochloride, 32% (n = 281) were 65 years of age and older, while 3.8% (n = 33) were 75 years of age and older. Of the 140 patients with stage IV-B, relapsed, or refractory cervical cancer in clinical studies of topotecan hydrochloride who received topotecan hydrochloride plus cisplatin in the randomized clinical trial, 6% (n = 9) were 65 years of age and older, while 3% (n = 4) were 75 years of age and older. No overall differences in effectiveness or safety were observed between these patients and younger adult patients, and other reported clinical experience has not identified differences in responses between the elderly and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out. There were no apparent differences in the pharmacokinetics of topotecan in elderly patients, once the age-related decrease in renal function was considered [see Clinical Pharmacology (12.3) ]. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Dosage and Administration (2.3) ]. 8.6 Renal Impairment No dosage adjustment of topotecan hydrochloride appears to be required for patients with mild renal impairment (Cl cr 40 to 60 mL/min). Dosage reduction is recommended for patients with moderate renal impairment (Cl cr 20 to 39 mL/min). Insufficient data are available in patients with severe renal impairment to provide a dosage recommendation for topotecan hydrochloride [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3) ].
Pregnancy and lactation
8.3 Nursing Mothers Rats excrete high concentrations of topotecan into milk. Lactating female rats given 4.72 mg/m 2 IV (about twice the clinical dose on a mg/m 2 basis) excreted topotecan into milk at concentrations up to 48-fold higher than those in plasma. It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from topotecan hydrochloride, discontinue breastfeeding when women are receiving topotecan hydrochloride.

Interactions

7 DRUG INTERACTIONS G-CSF Concomitant administration of G-CSF can prolong the duration of neutropenia, so if G-CSF is to be used, do not initiate it until day 6 of the course of therapy, 24 hours after completion of treatment with topotecan hydrochloride. Platinum and Other Cytotoxic Agents Myelosuppression was more severe when topotecan hydrochloride, at a dose of 1.25 mg/m 2/day for 5 days, was given in combination with cisplatin at a dose of 50 mg/m 2 in Phase 1 studies. In one study, 1 of 3 patients had severe neutropenia for 12 days and a second patient died with neutropenic sepsis. Greater myelosuppression is also likely to be seen when topotecan hydrochloride is used in combination with other cytotoxic agents, thereby necessitating a dose reduction. However, when combining topotecan hydrochloride with platinum agents (e.g., cisplatin or carboplatin), a distinct sequence-dependent interaction on myelosuppression has been reported. Co-administration of a platinum agent on day 1 of dosing with topotecan hydrochloride required lower doses of each agent compared to co-administration on day 5 of the dosing schedule for topotecan hydrochloride. For information on the pharmacokinetics, efficacy, safety, and dosing of topotecan hydrochloride at a dose of 0.75 mg/m 2/day on days 1, 2, and 3 in combination with cisplatin 50 mg/m 2 on day 1 for cervical cancer [see Dosage and Administration (2), Adverse Reactions (6), Clinical Pharmacology (12.3), and Clinical Studies (14)] . Do not initiate G-CSF until 24 hours after completion of treatment with topotecan hydrochloride. Concomitant administration can prolong duration of neutropenia. ( 7) Greater myelosuppression is likely to be seen when used in combination with other cytotoxic agents. ( 7)

More information

Category Value
Authorisation number ANDA091089
Agency product number 956S425ZCY
Orphan designation No
Product NDC 63323-762
Date Last Revised 11-10-2019
Type HUMAN PRESCRIPTION DRUG
RXCUI 1799416
Marketing authorisation holder Fresenius Kabi USA, LLC
Warnings BOXED WARNING BONE MARROW SUPPRESSION Do not give topotecan hydrochloride to patients with baseline neutrophil counts less than 1,500 cells/mm 3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection and death, monitor peripheral blood counts frequently on all patients receiving topotecan hydrochloride [see Warnings and Precautions (5.1) ]. WARNING: BONE MARROW SUPPRESSION See full prescribing information for complete boxed warning. Do not give topotecan hydrochloride to patients with baseline neutrophil counts less than 1,500 cells/mm 3 . In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection and death, monitor peripheral blood cell counts frequently on all patients receiving topotecan hydrochloride. ( 5.1)