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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

Clinical Trials Experience

The safety of HYCAMTIN capsules (topotecan capsules) has been evaluated in 682 patients with thoracic cancer (3 recurrent small cell lung cancer [SCLC] studies and 1 recurrent non-small cell lung cancer [NSCLC] study) who received at least one dose of HYCAMTIN capsules (topotecan capsules) . 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.

Table 1 describes the hematologic and non-hematologic adverse reactions in recurrent SCLC patients treated with HYCAMTIN capsules (topotecan capsules) plus best supportive care (BSC) and in the overall thoracic cancer patient population.

Table 1: Incidence ( ≥ 5%) of Adverse Reactions in Small Cell Lung Cancer Patients Treated With HYCAMTIN Capsules (topotecan capsules) Plus BSC and in 4 Thoracic Cancer Studies

Adverse Reaction HYCAMTIN Capsules + BSC (N = 70) HYCAMTIN Capsules Thoracic Cancer Population (N = 682)
All Grades
(%)
Grade 3
(%)
Grade 4
(%)
All Grades
(%)
Grade 3
(%)
Grade 4
(%)
Hematologic
  Anemia 94 15 10 98 18 7
  Leukopenia 90 25 16 86 29 15
  Neutropenia 91 28 33 83 24 32
  Thrombocytopenia 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.

Diarrhea Adverse Reactions

Of the 70 patients who received HYCAMTIN capsules (topotecan capsules) plus BSC, the incidence of drug-related diarrhea was 14%, with 4% Grade 3 and 1% Grade 4.

In the 682 patients who received HYCAMTIN capsules (topotecan capsules) in the 4 thoracic cancer studies, the incidence of drug-related diarrhea was 22%, with 4% Grade 3 and 0.4% Grade 4. The overall incidence of drug-related diarrhea was more frequent in patients ≥ 65 years of age (28%, n = 225) with 10% Grade 1, 9% Grade 2, 7% Grade 3, and 1% Grade 4 compared to those < 65 years of age (19%, n = 457) with 7% Grade 1, 9% Grade 2, 3% Grade 3, and 0% Grade 4. The incidence of Grade 3 or 4 diarrhea proximate (within 5 days) to Grade 3 or 4 neutropenia events in the HYCAMTIN capsules (topotecan capsules) treatment group was 5%. The median time to onset of Grade 2 or worse diarrhea was 9 days in the HYCAMTIN capsules (topotecan capsules) group.

Deaths Occurring Within 30 Days Following the Last Dose of Study Medication

In the 682 patients who received HYCAMTIN capsules (topotecan capsules) in the 4 thoracic cancer studies, 39 deaths occurred within 30 days after the last dose of study medication for a reason other than progressive disease; 13 of these deaths were attributed to hematologic toxicity, 5 were attributed to non-hematologic toxicity, and 21 were attributed to other causes. One patient death (68 years of age) was attributed to treatment-related diarrhea and one death (68 years of age) attributed diarrhea as a contributory event; both patients received HYCAMTIN capsules (topotecan capsules) .

In addition to the adverse reactions listed previously, the following adverse reactions have been reported with HYCAMTIN for Injection:

Postmarketing Experience

There is no postmarketing experience with HYCAMTIN capsules (topotecan capsules) . The following adverse reactions have been identified during post-approval use of HYCAMTIN for Injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and lymphatic system disorders: Severe bleeding (in association with thrombocytopenia).

Immune system disorders: Allergic manifestations, anaphylactoid reactions.

Respiratory, thoracic, and mediastinal disorders: Interstitial lung disease.

Gastrointestinal disorders: Abdominal pain potentially associated with neutropenic colitis [see WARNINGS AND PRECAUTIONS].

Skin and subcutaneous tissue disorders: Angioedema, severe dermatitis, severe pruritus.

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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