August 28, 2015
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Hycamtin

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Hycamtin




Hycamtin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 6/16/2015

Hycamtin (topotecan) is a cancer (antineoplastic) medication used to treat ovarian cancer, small cell lung cancer, and certain types of cervical cancer. 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.

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

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.

Ovarian Cancer

Table 1 shows the Grade 3/4 hematologic and major non-hematologic adverse reactions in the topotecan/paclitaxel comparator trial in ovarian cancer.

Table 1: 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/mm ) 80 21
Grade 3/4 anemia (Hgb < 8 g/dL) 41 6
Grade 4 thrombocytopenia ( < 25,000 plts/mm³) 27 3
Febrile neutropenia 23 4
Non-hematologic Grade 3/4 % %
Infections and infestations
  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
aDeath related to sepsis occurred in 2% of patients receiving HYCAMTIN and 0% of patients receiving paclitaxel.
bPain includes body pain, skeletal pain, and back pain.

Small Cell Lung Cancer

Table 2 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 2: 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
Febrile neutropenia 28 26
Non-hematologic Grade 3/4 % %
Infections and infestations
  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
aDeath related to sepsis occurred in 3% of patients receiving HYCAMTIN and 1% of patients receiving CAV.
bPain includes body pain, skeletal pain, and back pain.

Hepatobiliary Disorders in Ovarian and Small Cell Lung Cancer Patients Receiving HYCAMTIN: Based on the combined experience of 453 patients with metastatic ovarian carcinoma, and 426 patients with small cell lung cancer treated with HYCAMTIN, Grade 1 transient elevations in hepatic enzymes occurred in 8% of patients. Grade 3/4 elevations occurred in 4%. Grade 3/4 elevated bilirubin occurred in less than 2% of patients.

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 3 shows the hematologic and non-hematologic adverse reactions in patients with cervical cancer.

Table 3: Adverse Reactions Experienced by ≥ 5% of Patients with Cervical Cancer Randomized to Receive HYCAMTIN plus Cisplatin or Cisplatin Monotherapy (Between-Arm Difference ≥ 2%)a

Adverse Reaction HYCAMTIN plus Cisplatin
(n = 140) %
Cisplatin
(n = 144) %
Hematologic
Neutropenia
  Grade 3 ( < 1,000-500 cells/mm³) 26 1
  Grade 4 ( < 500 cells/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 cells/mm³) 26 3
  Grade 4 ( < 10,000 cells/mm³) 7 0
Non-hematologicb,c
General disorders and administrative site conditions
  Constitutionald 69 62
  Paine 59 50
Gastrointestinal disorders
  Vomiting 40 37
  Stomatitis-pharyngitis 6 0
  Other 63 56
Dermatologyf 48 20
Infection-febrile neutropeniaf 28 18
Cardiovascularf 25 15
aIncludes patients who were eligible and treated.
bData were collected using NCI Common Toxicity Criteria, v. 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.
dConstitutional includes fatigue (lethargy, malaise, asthenia), fever (in the absence of neutropenia), rigors, chills, sweating, and weight gain or loss.
ePain 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.
fHigh-level terms were included if the between-arm difference was ≥ 10%.

Postmarketing Experience

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 enterocolitis [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 Extravasation [see WARNINGS AND PRECAUTIONS].

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

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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