August 4, 2015
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Hycamtin

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Hycamtin




Side Effects
Interactions

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 Hycamtin (topotecan hydrochloride) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

G-CSF

Concomitant administration with G-CSF can prolong the duration of neutropenia. If G-CSF is used, it should be started no sooner than 24 hours following the last dose of HYCAMTIN.

Read the Hycamtin Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 6/19/2015
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions

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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