Hycamtin (Topotecan Hydrochloride) – Malignancies | HongKong DengYue Medicine

Topotecan Hydrochloride Application Scope

Topotecan Hydrochloride is a chemotherapeutic agent indicated for the treatment of:

• Small Cell Lung Cancer (SCLC): For patients with chemotherapy-sensitive disease who have progressed at least 60 days after first-line chemotherapy.

• Ovarian Cancer: For patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy.

• Cervical Cancer: In combination with cisplatin, for the treatment of patients with Stage IV-B, recurrent, or persistent cervical cancer not amenable to curative treatment.

  

Topotecan Hydrochloride Characteristics

• Ingredients: Topotecan Hydrochloride

• Properties:​ Oral capsules, light yellow to greenish capsules

• Packaging Specification: 4 capsules / blister × 1 blister / box

• Storage:​ Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F)

• Expiry Date: Refer to the packaging for the specific expiry date

• Executive Standard: ​Complies with relevant pharmacopoeial standards and regulatory guidelines

• Approval Number: FDA Approval Number: 20-671/S-004

• Date of Revision: Refer to the product labeling for the most recent revision date

• Manufacturer: Novartis Pharmaceuticals Corporation

Guidelines for the Use of Topotecan Hydrochloride

• Dosage and Administration:

  • Recommended Dose:

    • Ovarian Cancer: 2.3 mg/m²/day orally for 5 consecutive days every 21-day cycle.

    • Small Cell Lung Cancer: 2.3 mg/m²/day orally for 5 consecutive days every 21-day cycle.

    • Cervical Cancer: 0.75 mg/m² orally on Days 1–3, in combination with cisplatin, every 21-day cycle.

  • Administration:

    • Take on an empty stomach or at least 1 hour before or 2 hours after meals to ensure consistent absorption.

    • Swallow capsules whole; do not crush or chew.

    • If a dose is missed, take as soon as remembered unless it is close to the next scheduled dose; do not double the dose.

  • Missed Dose:​ Take as soon as remembered unless it is near the next scheduled dose; do not double dose

• Adverse Reactions:

  • Common Adverse Reactions:

    • Bone marrow suppression: neutropenia, anemia, thrombocytopenia

    • Gastrointestinal: nausea, vomiting, diarrhea

    • Fatigue, hair thinning

  • Serious Adverse Reactions:

    • Severe myelosuppression

    • Neutropenic infections

    • Rare hypersensitivity reactions

    ​

• Contraindications:

  • Hypersensitivity to topotecan or any component of the formulation

  • Severe bone marrow suppression

• Precautions:

  • Monitor blood counts and liver/renal function regularly.

  • Avoid pregnancy; effective contraception is recommended.

  • Patients with pre-existing bone marrow suppression should be carefully evaluated.

Topotecan Hydrochloride Interactions

• Avoid concurrent use with live vaccines

• Monitor for increased toxicity with P-glycoprotein inhibitors

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
•  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.