Hycamtin

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 6/9/2022
Hycamtin Side Effects Center

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 Slideshow
Hycamtin Consumer Information

Get 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 Answer
Hycamtin Professional Information

SIDE 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.

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%.

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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