HYCAMTIN 4 mg/4mL
topotecan hydrochloride · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Novartis Pharmaceuticals Corporation
Hycamtin (topotecan hydrochloride) is a chemotherapy medication given by injection that is used to treat certain types of cancer, including ovarian cancer and small cell lung cancer. It works by interfering with cancer cell growth and division.
Key Facts
- Brand Name
- HYCAMTIN
- Generic Name
- topotecan hydrochloride
- NDC Code (Product)
0078-0674- Manufacturer
- Novartis Pharmaceuticals Corporation
- Strength
- 4 mg/4mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA020671
- Marketing Start
- 12/21/2016
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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). ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • The recommended dosage is 2.3 mg/m 2 /day orally once daily for 5 consecutive days starting on Day 1 of a 21-day cycle. ( 2.1 ) • Renal Impairment: Reduce dose if creatinine clearance (CLcr) less than 50 mL/min. ( 2.3 ) 2.1 Recommended Dosage The recommended dosage of HYCAMTIN capsules is 2.3 mg/m 2 /day orally once daily, with or without food, for 5 consecutive days, starting on Day 1 of a 21-day cycle. Round the dose to the nearest 0.25 mg and prescribe the minimum number of 1 mg and 0.25 mg capsules. Prescribe the same number of capsules for each of the 5 dosing days. Swallow capsules whole. Do not chew, crush, or divide the capsules. If a dose of HYCAMTIN capsules is missed or vomiting occurs after taking a dose, do not administer an additional dose and take the next dose at the scheduled time. 2.2 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 [see Warnings and Precautions (5.2)] . Hematologic Do not administer subsequent cycles of HYCAMTIN capsules until neutrophils recover t…
Contraindications
4 CONTRAINDICATIONS HYCAMTIN is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan. Reactions have included anaphylactoid reactions [see Adverse Reactions (6.2)] . • History of severe hypersensitivity reactions to topotecan ( 4 )
Drug Interactions
7 DRUG INTERACTIONS • Avoid concomitant use of P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) inhibitors with HYCAMTIN capsules. ( 7.1 , 12.3 ) 7.1 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 [see Clinical Pharmacology (12.3)] , which may increase the risk of adverse reactions. Avoid concomitant use HYCAMTIN capsules with P-gp inhibitors or BCRP inhibitors.
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Myelosuppression [see Warnings and Precautions (5.1)] • Diarrhea [see Warnings and Precautions (5.2)] • Interstitial Lung Disease (ILD) [see Warnings and Precautions (5.3)] • The most common Grade 3 or 4 hematologic adverse reactions (incidence > 20%) were neutropenia, anemia, and thrombocytopenia. • The most common (incidence > 10%) non-hematologic adverse reactions (all Grades) were nausea, diarrhea, vomiting, alopecia, fatigue, and anorexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 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 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 …
Frequently Asked Questions
What is HYCAMTIN used for?
Hycamtin (topotecan hydrochloride) is a chemotherapy medication given by injection that is used to treat certain types of cancer, including ovarian cancer and small cell lung cancer. It works by interfering with cancer cell growth and division.
Is HYCAMTIN a controlled substance?
HYCAMTIN is not classified as a controlled substance by the DEA.
What is the generic name for HYCAMTIN?
The generic name for HYCAMTIN is topotecan hydrochloride. There are 3 other brand versions of topotecan hydrochloride.
What is the NDC code for HYCAMTIN 4 mg/4mL?
The NDC (National Drug Code) for HYCAMTIN 4 mg/4mL is 0078-0674, listed by Novartis Pharmaceuticals Corporation.