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Hycamtin (Topotecan Hydrochloride) - Drug Interactions, Contraindications, Overdosage, etc

 
 



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 HYCAMTIN.

Platinum and Other Cytotoxic Agents: Myelosuppression was more severe when HYCAMTIN, at a dose of 1.25 mg/m2/day for 5 days, was given in combination with cisplatin at a dose of 50 mg/m2 in Phase 1 trials. In one trial, 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 HYCAMTIN is used in combination with other cytotoxic agents, thereby necessitating a dose reduction. However, when combining HYCAMTIN with platinum agents (e.g., cisplatin or carboplatin), a distinct sequence-dependent interaction on myelosuppression has been reported. Coadministration of a platinum agent on day 1 of dosing with HYCAMTIN required lower doses of each agent compared to coadministration on day 5 of the dosing schedule for HYCAMTIN.

For information on the pharmacokinetics, efficacy, safety, and dosing of HYCAMTIN at a dose of 0.75 mg/m2/day on days 1, 2, and 3 in combination with cisplatin 50 mg/m2 on day 1 for cervical cancer, see Dosage and Administration (2), Adverse Reactions (6), Clinical Pharmacology (12.3), and Clinical Studies (14).

OVERDOSAGE

Overdoses (up to 10-fold of the prescribed dose) occurred in patients treated with intravenous topotecan. The primary complication of overdosage is bone marrow suppression. The observed signs and symptoms of overdose are consistent with the known adverse reactions associated with HYCAMTIN for intravenous use [see Adverse Reactions (6.1, 6.2)]. In addition, elevated hepatic enzymes and mucositis have been reported following overdose. One patient received a single dose of 40 mg/m2 of intravenous topotecan and developed gastrointestinal toxicity, skin toxicity, and myelosuppresion leading to septic shock. Another patient received a single dose of 35 mg/m2 and experienced severe, reversible neutropenia.

There is no known antidote for overdosage with HYCAMTIN. If an overdose is suspected, monitor the patient for bone marrow suppression and institute supportive-care measures (such as prophylactic G-CSF and antibiotic therapy) as appropriate.

CONTRAINDICATIONS

HYCAMTIN is contraindicated in patients who have a history of severe hypersensitivity reactions (e.g., anaphylactoid reactions) to topotecan or to any of its ingredients. HYCAMTIN should not be used in patients with severe bone marrow depression.

REFERENCES

  1. 1.Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. NIOSH Alert 2004-165.
  2. 2.OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
  3. 3.American Society of Health-System Pharmacists. ASHP Guidelines on Handling Hazardous Drugs. Am J Health-Syst Pharm. 2006;63:1172-1193.
  4. 4.Polovich M, White JM, Kelleher LO (eds.) 2005. Chemotherapy and Biotherapy Guidelines and Recommendations for Practice. (2nd ed) Pittsburgh, PA: Oncology Nursing Society.

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