Medical Editor: John P. Cunha, DO, FACOEP
What Is Hycamtin?
Hycamtin (topotecan) is a cancer (antineoplastic) medication used to treat ovarian cancer, small cell lung cancer, and certain types of cervical cancer.
What Are Side Effects of Hycamtin?
Common side effects of Hycamtin include:
- weakness,
- tiredness,
- headache,
- cough,
- nausea and vomiting (may be severe),
- diarrhea,
- constipation,
- abdominal pain,
- loss of appetite,
- temporary hair loss, and
- mouth sores
Dosage for Hycamtin
The recommended dose of Hycamtin capsules is 2.3 mg/m²/day once daily for 5 consecutive days repeated every 21 days.
What Drugs, Substances, or Supplements Interact with Hycamtin?
Hycamtin may interact with cyclosporine. Tell your doctor all medications and supplements you use.
Hycamtin During Pregnancy or Breastfeeding
Hycamtin is not recommended for use during pregnancy. It may harm a fetus. Consult your doctor to discuss using 2 forms of birth control (e.g., condoms, birth control pills) while taking this medication. If you become pregnant or think you may be pregnant, tell your doctor. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug is not recommended.
Additional Information
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.
SLIDESHOW
Lung Cancer: Early Signs, Symptoms, Stages See SlideshowGet emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- new or worsening cough, fever, trouble breathing;
- diarrhea with fever and stomach cramps;
- pain or burning when you urinate;
- signs of pneumonia--fever, chills, cough with mucus, chest pain, feeling short of breath; or
- low blood cell counts--fever, chills, flu-like symptoms, mouth sores, skin sores, pale skin, cold hands and feet, bruising or bleeding, feeling light-headed.
Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
- low blood cell counts;
- trouble breathing, pneumonia
- nausea, diarrhea, vomiting, stomach pain;
- loss of appetite;
- hair loss; or
- feeling weak or tired.
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 (Topotecan Hydrochloride)
QUESTION
Lung cancer is a disease in which lung cells grow abnormally in an uncontrolled way. See AnswerSIDE EFFECTS
The following serious adverse reactions are described elsewhere in the labeling:
- Myelosuppression [see WARNINGS AND PRECAUTIONS]
- Interstitial Lung Disease [see WARNINGS AND PRECAUTIONS]
- Extravasation and Tissue Injury [see WARNINGS AND PRECAUTIONS]
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 Warnings and Precautions reflect exposure to HYCAMTIN for injection from eight trials in which 879 patients with ovarian cancer or small cell lung cancer (SCLC) received HYCAMTIN for injection 1.5 mg/m² by intravenous infusion daily for 5 consecutive days, starting on Day 1 of a 21 day cycle and from one trial (Study GOG 0179) in which 147 patients with cervical cancer received HYCAMTIN for injection 0.75 mg/m² by intravenous infusion daily on Days 1, 2, and 3, with cisplatin 50 mg/m² by intravenous infusion on Day 1, of a 21-day cycle.
Ovarian Cancer
The safety of HYCAMTIN for injection was evaluated in a randomized trial conducted in 226 patients with metastatic ovarian cancer (Study 039) [see Clinical Studies]. Table 1 shows the incidence of Grade 3 and 4 hematologic and non-hematologic adverse reactions that occurred in patients receiving HYCAMTIN for injection.
Table 1: Adverse Reactions Occurring in Greater than
or Equal to 5% of Patients with Ovarian Cancer in Study 039
| Adverse Reaction | HYCAMTIN for injection (n = 112) |
Paclitaxel (n = 114) |
| Grade 3-4 (%) | Grade 3-4 (%) | |
| Hematologic | ||
| Grade 4 neutropenia (< 500/mm³) | 80 | 21 |
| Grade 3 or 4 anemia (Hgb < 8 g/dL) | 41 | 6 |
| Grade 4 thrombocytopenia (< 25,000/mm³) | 27 | 3 |
| Febrile neutropenia | 23 | 4 |
| Non-Hematologic | ||
| Infections | ||
| Sepsisa | 5 | 2 |
| Respiratory, thoracic, and mediastinal | ||
| Dyspnea | 6 | 5 |
| Gastrointestinal | ||
| Vomiting | 10 | 3 |
| Nausea | 10 | 2 |
| Diarrhea | 6 | 1 |
| Abdominal pain | 5 | 4 |
| Intestinal obstruction | 5 | 4 |
| Constipation | 5 | 0 |
| General and administrative site conditions | ||
| Fatigue | 7 | 6 |
| Painb | 5 | 7 |
| Asthenia | 5 | 3 |
| a Death related to sepsis occurred in 2% of
patients receiving HYCAMTIN and 0% of patients receiving paclitaxel. b Pain includes body pain, skeletal pain, and back pain. |
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Small Cell Lung Cancer (SCLC)
The safety of HYCAMTIN for injection was evaluated in randomized, comparative trial in patients with recurrent or progressive SCLC (Study 090) [see Clinical Studies]. Table 2 shows the Grade 3 or 4 hematologic and non-hematologic adverse reactions in patients with SCLC.
Table 2: Adverse Reactions Occurring in Greater than
or Equal to 5% of Patients with Small Cell Lung Cancer in Study 090
| Adverse Reactions | HYCAMTIN for injection (n = 107) |
CAVc (n = 104) |
| Grade 3-4 (%) | Grade 3-4 (%) | |
| Hematologic | ||
| Grade 4 neutropenia (< 500/mm³) | 70 | 72 |
| Grade 3 or 4 anemia (Hgb < 8 g/dL) | 42 | 20 |
| Grade 4 thrombocytopenia (< 25,000/mm³) | 29 | 5 |
| Febrile neutropenia | 28 | 26 |
| Non-Hematologic | ||
| Infections | ||
| Sepsisa | 5 | 5 |
| Respiratory, thoracic, and mediastinal | ||
| Dyspnea | 9 | 14 |
| Pneumonia | 8 | 6 |
| Gastrointestinal | ||
| Nausea | 8 | 6 |
| Abdominal pain | 6 | 4 |
| General and administrative site conditions | ||
| Asthenia | 9 | 7 |
| Fatigue | 6 | 10 |
| Painb | 5 | 7 |
| a Death related to sepsis occurred in 3% of
patients receiving HYCAMTIN and 1% of patients receiving CAV. b Pain includes body pain, skeletal pain, and back pain. c CAV = cyclophosphamide, doxorubicin and vincristine. |
||
Hepatobiliary Disorders In Ovarian And Small Cell Lung Cancer
Based on the combined experience of 453 patients with metastatic ovarian cancer and 426 patients with SCLC treated with HYCAMTIN for injection, Grade 3 or 4 increases aspartate transaminase (AST) or alanine transaminase (ALT) occurred in 4% and Grade 3 or 4 elevated bilirubin occurred in less than 2%.
Cervical Cancer
The safety of HYCAMTIN for injection was evaluated in a comparative trial of HYCAMTIN with cisplatin versus cisplatin as a single agent in patients with cervical cancer (Study GOG 0179). Table 3 shows the hematologic and non-hematologic adverse reactions in patients with cervical cancer.
Table 3: Adverse Reactions Occurring in Greater than
or Equal to 5% of Patients with Cervical Cancer (Between-Arm Difference ≥
2%)a in Study GOG 0179
| Adverse Reaction | HYCAMTIN for injection with Cisplatin (n = 140) % |
Cisplatin (n = 144) % |
| Hematologic | ||
| Neutropenia | ||
| Grade 3 (< 1,000-500/mm³) | 26 | 1 |
| Grade 4 (< 500/mm³) | 48 | 1 |
| Anemia | ||
| Grade 3 (Hgb < 8-6.5 g/dL) | 34 | 19 |
| Grade 4 (Hgb < 6.5 g/dL) | 6 | 3 |
| Thrombocytopenia | ||
| Grade 3 (< 50,000-10,000/mm³) | 26 | 3 |
| Grade 4 (< 10,000/mm³) | 7 | 0 |
| Non-Hematologicb,c | ||
| General and administrative site conditions | ||
| Constitutionald | 69 | 62 |
| Paine | 59 | 50 |
| Gastrointestinal | ||
| Vomiting | 40 | 37 |
| Stomatitis-pharyngitis | 6 | 0 |
| Other | 63 | 56 |
| Dermatologyf | 48 | 20 |
| Infection | ||
| Febrile neutropeniaf | 28 | 18 |
| Cardiovascularf | 25 | 15 |
| a Includes patients who were eligible and
treated. b Severity based on using National Cancer Institute (NCI) Common Toxicity Criteria (CTC), Version 2.0. CGrades 1 through 4 only. There were 3 patients who experienced deaths with investigator-designated attribution. The first patient experienced a Grade 5 hemorrhage in which the drug-related thrombocytopenia aggravated the event. A second patient experienced bowel obstruction, cardiac arrest, pleural effusion, and respiratory failure which were not treatment-related but probably aggravated by treatment. A third patient experienced a pulmonary embolism and adult respiratory distress syndrome; the latter was indirectly treatment-related. d Constitutional includes fatigue (lethargy, malaise, asthenia), fever (in the absence of neutropenia), rigors, chills, sweating, and weight gain or loss. e Pain includes abdominal pain or cramping, arthralgia, bone pain, chest pain (non-cardiac and non-pleuritic), dysmenorrhea, dyspareunia, earache, headache, hepatic pain, myalgia, neuropathic pain, pain due to radiation, pelvic pain, pleuritic pain, rectal or perirectal pain, and tumor pain. f High-level terms were included if the between-arm difference was ≥ 10%. |
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Postmarketing Experience
The following reactions have been identified during post approval use of HYCAMTIN. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System: severe bleeding (in association with thrombocytopenia)
Hypersensitivity: allergic manifestations, anaphylactoid reactions, angioedema
Gastrointestinal: abdominal pain potentially associated with neutropenic enterocolitis, gastrointestinal perforation
Pulmonary: interstitial lung disease
Skin and Subcutaneous Tissue: severe dermatitis, severe pruritus
General and Administration Site Conditions: extravasation, mucosal inflammation
Read the entire FDA prescribing information for Hycamtin (Topotecan Hydrochloride)
© Hycamtin Patient Information is supplied by Cerner Multum, Inc. and Hycamtin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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