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Hycamtin Capsules

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Hycamtin Capsules

Hycamtin Capsules

Hycamtin Capsules Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Hycamtin (topotecan) is a cancer medication used to treat ovarian cancer, small cell lung cancer, and certain types of cervical cancer. Common side effects include nausea, diarrhea, vomiting, tired feeling, or temporary hair loss.

The recommended dose of Hycamtin capsules is 2.3 mg/mē/day once daily for 5 consecutive days repeated every 21 days. Hycamtin may interact with filgrastim, pegfilgrastim, sargramostim, cisplatin, carboplatin, oxaliplatin, or "live" vaccines. Tell your doctor all medications and supplements you use and all vaccines you recently received. Do not use Hycamtin if you are pregnant. It could harm a fetus. Use birth control, and tell your doctor if you become pregnant during treatment. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Breastfeeding while using Hycamtin is not recommended.

Our Hycamtin (topotecan) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Hycamtin Capsules in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • wheezing, feeling short of breath, chest pain, dry cough;
  • fever, chills, flu symptoms, mouth and throat ulcers, rapid and shallow breathing, fainting;
  • pale skin, feeling light-headed, rapid heart rate, trouble concentrating;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • diarrhea with fever and stomach cramps;
  • pain or burning when you urinate; or
  • skin changes or severe irritation where the needle is placed.

Less serious side effects may include:

  • nausea, diarrhea, vomiting;
  • tired feeling; or
  • temporary hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Hycamtin Capsules (Topotecan Capsules) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Hycamtin Capsules FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in the labeling:

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 safety of HYCAMTIN capsules was evaluated in 682 patients with lung cancer (3 recurrent small cell lung cancer [SCLC] trials and 1 recurrent non-small cell lung cancer [NSCLC] trial) who received at least one dose of HYCAMTIN capsules. Patients in all four trials had advanced lung malignancies and received prior chemotherapy in the first-line setting. The dose regimen for HYCAMTIN capsules was 2.3 mg/m²/day for five consecutive days every 21 days. The median number of courses was 3 (range: 1 to 20) in these four trials. Table 2 describes the hematologic and non-hematologic adverse reactions in recurrent SCLC patients treated with HYCAMTIN capsules in the overall lung cancer patient population. | HYCAMTIN [see Use in Specific Populations].

Table 2: Incidence ( ≥ 5%) of Adverse Reactions in Small Cell Lung Cancer Patients Treated With HYCAMTIN Capsules Plus BSC and in Four Lung Cancer Trials

Adverse Reaction HYCAMTIN Capsules + BSC
(N = 70)
HYCAMTIN Capsules Lung Cancer Population
[N = 682)
All Grades (%) Grade 3 (%) Grade 4 (%) All Grades (%) Grade 3 (%) Grade 4 (%)
Hematologic
  Anemia 94 15 10 98 18 7
  Neutropenia 91 28 33 83 24 32
  Thromb ocy topenia 81 30 7 81 29 6
Non-hematologic
  Nausea 27 1 0 33 3 0
  Diarrhea 14 4 1 22 4 0.4
  Vomiting 19 1 0 21 3 0.4
  Alopecia 10 0 0 20 0.1 0
  Fatigue 11 0 0 19 4 0.1
  Anorexia 7 0 0 14 2 0
  Asthenia 3 0 0 7 2 0
  Pyrexia 7 1 0 5 1 1
BSC = Best Supportive Care.
N = Total number of patients treated.

Adverse reactions were graded using NCI Common Toxicity Criteria Version 2.0.

On-Study Death Due to Toxicity of HYCAMTIN

In the 682 patients who received HYCAMTIN capsules in the four lung cancer trials, 39 deaths (6%) occurred within 30 days after the last dose for a reason other than progressive disease: 13 due to hematologic toxicity, 5 due to non-hematologic toxicity (2 from diarrhea), and 21 due to other causes.

Read the entire FDA prescribing information for Hycamtin Capsules (Topotecan Capsules) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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