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Hycamtin

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Hycamtin

Hycamtin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Hycamtin (topotecan) is used to treat ovarian cancer, small cell lung cancer, and certain types of cervical cancer. It is a cancer (antineoplastic) medication. Common side effects include weakness, tiredness, headache, cough, nausea and vomiting (may be severe), diarrhea, constipation, abdominal pain, loss of appetite, and mouth sores.

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 cyclosporine. Tell your doctor all medications and supplements you use. 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.

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 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 (Topotecan Hydrochloride) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Hycamtin Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Weakness, tiredness, headache, cough, nausea, vomiting, diarrhea, constipation, abdominal pain, loss of appetite, and mouth sores may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: pain/redness/bruising at injection site, numbness/tingling of the arms/legs, yellowing eyes/skin, dark urine, lung problems (such as cough, shortness of breath).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Hycamtin (Topotecan Hydrochloride)»

What is Prescribing information?

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

Hycamtin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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.

Ovarian Cancer and Small Cell Lung Cancer

Data in the following section are based on the combined experience of 453 patients with metastatic ovarian carcinoma, and 426 patients with small cell lung cancer treated with HYCAMTIN. Table 1 lists the principal hematologic adverse reactions and Table 2 lists non-hematologic adverse reactions occurring in at least 15% of patients.

Table 1: Hematologic Adverse Reactions Experienced in ≥ 15% Ovarian Cancer and Small Cell Lung Cancer Patients Receiving HYCAMTIN

Hematologic Adverse Reaction Patients
(n = 879) % Incidence
Neutropenia
   < 1,500 cells/mm³ 97
   < 500 cells/mm³ 78
Leukopenia
   < 3,000 cells/mm³ 97
   < 1,000 cells/mm³ 32
Thrombocytopenia
   < 75,000/mm³ 69
   < 25,000/mm³ 27
Anemia
   < 10 g/dL 89
   < 8 g/dL 37

Table 2: Non-hematologic Adverse Reactions Experienced by ≥ 15% of Ovarian Cancer and Small Cell Lung Cancer Patients Receiving HYCAMTIN

Non-hematologic Adverse Reaction Percentage of Patients With Adverse Reaction (879 Patients)
All Grades Grade 3 Grade 4
Infections and infestations
  Sepsis or pyrexia/infection with neutropeniaa 43 NR 23
Metabolism and nutrition disorders
  Anorexia 19 2 < 1
Nervous system disorders
  Headache 18 1 < 1
Respiratory, thoracic, and mediastinal disorders
  Dyspnea 22 5 3
  Coughing 15 1 0
Gastrointestinal disorders
  Nausea 64 7 1
  Vomiting 45 4 1
  Diarrhea 32 3 1
  Constipation 29 2 1
  Abdominal pain 22 2 2
  Stomatitis 18 1 < 1
Skin and subcutaneous tissue disorders
  Alopecia 49 NA NA
  Rashb 16 1 0
General disorders and administrative site conditions
  Fatigue 29 5 0
  Pyrexia 28 1 < 1
  Painc 23 2 1
  Asthenia 25 4 2
NA = Not applicable.
NR = Not reported separately.
a Does not include Grade 1 sepsis or pyrexia.
b Rash also includes pruritus, rash erythematous, urticaria, dermatitis, bullous eruption, and maculopapular rash.
c Pain includes body pain, back pain, and skeletal pain.

Nervous System Disorders

Paresthesia occurred in 7% of patients but was generally Grade 1.

Hepatobiliary Disorders

Grade 1 transient elevations in hepatic enzymes occurred in 8% of patients. Greater elevations, Grade 3/4, occurred in 4%. Grade 3/4 elevated bilirubin occurred in < 2% of patients.

Table 3 shows the Grade 3/4 hematologic and major non-hematologic adverse reactions in the topotecan/paclitaxel comparator trial in ovarian cancer.

Table 3: Adverse Reactions Experienced by > 5% of Ovarian Cancer Patients Randomized to Receive HYCAMTIN or Paclitaxel

Adverse Reaction HYCAMTIN
(n = 112)
Paclitaxel
(n = 114)
Hematologic Grade 3/4 % %
Grade 4 neutropenia ( < 500 cells/mm³) 80 21
Grade 3/4 anemia (Hgb < 8 g/dL) 41 6
Grade 4 thrombocytopenia ( < 25,000 plts/mm³) 27 3
Pyrexia/Grade 4 neutropenia 23 4
Non-hematologic Grade 3/4 % %
Infections and infestations
  Documented sepsisa 5 2
Respiratory, thoracic, and mediastinal disorders
  Dyspnea 6 5
Gastrointestinal disorders
  Abdominal pain 5 4
  Constipation 5 0
  Diarrhea 6 1
  Intestinal obstruction 5 4
  Nausea 10 2
  Vomiting 10 3
General disorders and administrative site conditions
  Fatigue 7 6
  Asthenia  5 3
  Painb 5 7
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.

Table 4 shows the Grade 3/4 hematologic and major non-hematologic adverse reactions in the topotecan/CAV (cyclophosphamide-doxorubicin-vincristine) comparator trial in small cell lung cancer.

Table 4: Adverse Reactions Experienced by ≥ 5% of Small Cell Lung Cancer Patients Randomized to Receive HYCAMTIN or CAV

Adverse Reaction HYCAMTIN
(n = 107)
CAV
(n = 104)
Hematologic Grade 3/4 % %
Grade 4 neutropenia ( < 500 cells/mm³) 70 72
Grade 3/4 anemia(Hgb < 8 g/dL) 42 20
Grade 4 thrombocytopenia ( < 25,000 plts/mm³) 29 5
Pyrexia/Grade 4 neutropenia 28 26
Non-hematologic Grade 3/4 % %
Infections and infestations
  Documented sepsisa 5 5
Respiratory, thoracic, and mediastinal disorders
  Dyspnea 9 14
  Pneumonia 8 6
Gastrointestinal disorders
  Abdominal pain 6 4
  Nausea 8 6
General disorders and administrative site conditions
  Fatigue 6 10
  Asthenia 9 7
  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.

Cervical Cancer

In the comparative trial with HYCAMTIN plus cisplatin versus cisplatin in patients with cervical cancer, the most common dose-limiting adverse reaction was myelosuppression. Table 5 shows the hematologic adverse reactions and Table 6 shows the non-hematologic adverse reactions in patients with cervical cancer.

Table 5: Hematologic Adverse Reactions in Patients with Cervical Cancer Treated with HYCAMTIN Plus Cisplatin or Cisplatin Monotherapya

Hematologic Adverse Reaction HYCAMTIN Plus Cisplatin
(n = 140)
Cisplatin
(n = 144)
Anemia
  All Grades (Hgb < 12 g/dL) 131 (94%) 130 (90%)
  Grade 3 (Hgb < 8-6.5 g/dL) 47 (34%) 28 (19%)
  Grade 4 (Hgb < 6.5 g/dL) 9 (6%) 5 (3%)
Leukopenia
  All Grades ( < 3,800 cells/mm³) 128 (91%) 43 (30%)
  Grade 3 ( < 2,000-1,000 cells/mm³) 58 (41%) 1 (1%)
  Grade 4 ( < 1,000 cells/mm³) 35 (25%) 0 (0%)
Neutropenia
  All Grades ( < 2,000 cells/mm³) 125 (89%) 28 (19%)
  Grade 3 ( < 1,000-500 cells/mm³) 36 (26%) 1 (1%)
  Grade 4 ( < 500 cells/mm³) 67 (48%) 1 (1%)
Thrombocytopenia
  All Grades ( < 130,000 cells/mm³) 104 (74%) 21 (15%)
  Grade 3 ( < 50,000-10,000 cells/mm³) 36 (26%) 5 (3%)
  Grade 4 ( < 10,000 cells/mm³) 10 (7%) 0 (0%)
a Includes patients who were eligible and treated.

Table 6: Non-hematologic Adverse Reactions Experienced by ≥ 5% of Patients with Cervical Cancer Treated with HYCAMTIN Plus Cisplatin or Cisplatin Monotherapya

Adverse Reaction HYCAMTIN Plus Cisplatin
(n = 140)
Cisplatin
(n = 144)
All Gradesb Grade 3 Grade 4 All Gradesb Grade 3 Grade 4
General disorders and administrative site conditions
  Constitutionalc 96 (69%) 11 (8%) 0 89 (62%) 17 (12%) 0
  Paind 82 (59%) 28 (20%) 3 (2%) 72 (50%) 18 (13%) 5 (3%)
Gastrointestinal disorders
  Vomiting 56 (40%) 20 (14%) 2 (1%) 53 (37%) 13 (9%) 0
  Nausea 77 (55%) 18 (13%) 2 (1%) 79 (55%) 13 (9%) 0
  Stomatitis-pharyngitis 8 (6%) 1 ( < 1%) 0 0 0 0
  Other 88 (63%) 16 (11%) 4 (3%) 80 (56%) 12 (8%) 3 (2%)
Dermatology 67 (48%) 1 ( < 1%) 0 29 (20%) 0 0
Metabolic-Laboratory 55 (39%) 13 (9%) 7 (5%) 44 (31%) 14 (10%) 1 ( < 1%)
Genitourinary 51 (36%) 9 (6%) 9 (6%) 49 (34%) 7 (5%) 7 (5%)
Nervous system disorders
  Neuropathy 4 (3%) 1 ( < 1%) 0 3 (2%) 1 ( < 1%) 0
  Other 49 (35%) 3 (2%) 1 ( < 1%) 43 (30%) 7 (5%) 2 (1%)
Infection-febrile neutropenia 39 (28%) 21 (15%) 5 (4%) 26 (18%) 11 (8%) 0
Cardiovascular 35 (25%) 7 (5%) 6 (4%) 22 (15%) 8 (6%) 3 (2%)
Hepatic 34 (24%) 5 (4%) 2 (1%) 23 (16%) 2 (1%) 0
Pulmonary 24 (17%) 4 (3%) 0 23 (16%) 5 (3%) 3 (2%)
Vascular disorders
  Hemorrhage 21 (15%) 8 (6%) 1 ( < 1%) 20 (14%) 3 (2%) 1 ( < 1%)
  Coagulation 8 (6%) 4 (3%) 3 (2%) 10 (7%) 7 (5%) 0
Musculoskeletal 19 (14%) 3 (2%) 0 7 (5%) 1 ( < 1%) 1 ( < 1%)
Allergy-Immunology 8 (6%) 2 (1%) 1 ( < 1%) 4 (3%) 0 1 (<1%)
Endocrine 8 (6%) 0 0 4 (3%) 2 (1%) 0
Sexual reproduction function 7 (5%) 0 0 10 (7%) 1 ( < 1%) 0
Ocular-visual 7 (5%) 0 0 7 (5%) 1 ( < 1%) 0
Data were collected using NCI Common Toxicity Criteria, v. 2.0.
a Includes patients who were eligible and treated.
b Grades 1 through 4 only. There were 3 patients who experienced Grade 5 deaths with investigatordesignated attribution. One was 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.
c Constitutional includes fatigue (lethargy, malaise, asthenia), fever (in the absence of neutropenia), rigors, chills, sweating, and weight gain or loss.
d Pain includes abdominal pain or cramping, arthralgia, bone pain, chest pain (non-cardiac and nonpleuritic), dysmenorrhea, dyspareunia, earache, headache, hepatic pain, myalgia, neuropathic pain, pain due to radiation, pelvic pain, pleuritic pain, rectal or perirectal pain, and tumor pain.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials or listed in other sections of the prescribing information, the following reactions have been identified during postmarketing use of HYCAMTIN. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to HYCAMTIN.

Blood and Lymphatic System Disorders: Severe bleeding (in association with thrombocytopenia) [see WARNINGS AND PRECAUTIONS].

Immune System Disorders: Allergic manifestations, anaphylactoid reactions.

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

Pulmonary Disorders: Interstitial lung disease [see WARNINGS AND PRECAUTIONS].

Skin and Subcutaneous Tissue Disorders: Angioedema, severe dermatitis, severe pruritus.

General Disorders and Administration Site Conditions: Inadvertent extravasation [see WARNINGS AND PRECAUTIONS].

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

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Hycamtin - User Reviews

Hycamtin User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Hycamtin sorted by most helpful. Patient Discussions FAQs

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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