Hycamtin 4mg Inj, 1 Vial
WARNING: Low blood cell counts may happen with this drug. Low blood cell counts may raise the chance of needing a blood transfusion or getting an infection or bleeding. If you have questions, talk with the doctor.Have your blood work and other lab tests checked as you have been told by your doctor. @ COMMON USES: It is used to treat cancer.
Drug Class
Antineoplastic agent
Pharmacologic Class
Topoisomerase I inhibitor
Pregnancy Category
Category D
FDA Approved
May 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Topotecan is a chemotherapy drug used to treat certain types of cancer, including ovarian, lung, and cervical cancer. It works by stopping cancer cells from growing and multiplying, which helps to shrink tumors.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and adhere to all guidelines provided. This drug is administered as an intravenous infusion, which means it is given into a vein over a specified period of time.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
If you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
If you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
Lifestyle & Tips
- Avoid contact with people who are sick or have infections, as your immune system will be weakened.
- Practice good hand hygiene.
- Report any signs of infection (fever, chills, sore throat) immediately.
- Avoid activities that could cause cuts or bruises due to increased bleeding risk.
- Maintain good oral hygiene to prevent mouth sores.
- Stay well-hydrated and eat a balanced diet as tolerated.
- Discuss any planned vaccinations with your doctor, as live vaccines should be avoided.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Ovarian Cancer: 1.5 mg/m² IV infusion over 30 minutes daily for 5 consecutive days, starting on day 1 of a 21-day cycle. Small Cell Lung Cancer: 1.5 mg/m² IV infusion over 30 minutes daily for 5 consecutive days, starting on day 1 of a 21-day cycle. Cervical Cancer (with cisplatin): 0.75 mg/m² IV infusion over 30 minutes daily for 3 consecutive days, starting on day 1 of a 21-day cycle.
Dose Range:
0.75 - 1.5 mg
Condition-Specific Dosing:
Ovarian Cancer (metastatic):
1.5 mg/m² IV daily for 5 days, repeat every 21 days.
Small Cell Lung Cancer (SCLC):
1.5 mg/m² IV daily for 5 days, repeat every 21 days.
Cervical Cancer (with cisplatin):
0.75 mg/m² IV daily for 3 days, repeat every 21 days.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (safety and efficacy not established in pediatric patients)
Adolescent:
Not established (safety and efficacy not established in pediatric patients)
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment required for CrCl 40-60 mL/min.
Moderate:
For CrCl 20-39 mL/min: Reduce dose to 0.75 mg/m² IV daily for 5 days (for ovarian/SCLC) or 0.6 mg/m² IV daily for 3 days (for cervical cancer).
Severe:
Not recommended for CrCl < 20 mL/min due to insufficient data and potential for increased toxicity.
Dialysis:
Not recommended. Topotecan is not significantly removed by hemodialysis.
Hepatic Impairment:
Mild:
No dose adjustment required for bilirubin < 1.5 times ULN.
Moderate:
No specific dose adjustment recommended for bilirubin 1.5-3 times ULN, but caution is advised. Monitor closely for myelosuppression.
Severe:
Not recommended for bilirubin > 3 times ULN due to lack of data and potential for increased toxicity.
Pharmacology
Mechanism of Action
Topotecan is a topoisomerase I inhibitor. It binds to the topoisomerase I-DNA complex, preventing religation of the DNA strand after cleavage. This leads to accumulation of DNA single-strand breaks, which are converted to double-strand breaks during DNA replication, ultimately leading to cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (IV administration)
Tmax:
Not applicable (IV administration)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 60-100 L/m²
ProteinBinding:
Approximately 35% (primarily to albumin)
CnssPenetration:
Limited (low penetration into CSF)
Elimination:
HalfLife:
Approximately 2-3 hours (lactone form)
Clearance:
Approximately 67 L/h/m²
ExcretionRoute:
Renal (approximately 30-50% as unchanged drug and metabolites), fecal (approximately 20-30%)
Unchanged:
Approximately 30-50% (renal excretion)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of infusion)
PeakEffect:
Not directly applicable for antineoplastic effect; myelosuppression typically peaks 11-15 days after treatment.
DurationOfAction:
Antineoplastic effects are cumulative over cycles; myelosuppression is transient.
Safety & Warnings
BLACK BOX WARNING
Topotecan can cause severe myelosuppression, including neutropenia, thrombocytopenia, and anemia. Febrile neutropenia has occurred. Monitor complete blood counts frequently. Do not administer topotecan to patients with baseline neutrophil counts less than 1,500 cells/mm³ or platelet counts less than 100,000 cells/mm³.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction: rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or discolored sputum, painful urination, mouth sores, or a wound that won't heal.
Signs of bleeding: vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, gum bleeding, abnormal vaginal bleeding, unexplained bruises, or uncontrollable bleeding.
Severe diarrhea or diarrhea accompanied by stomach cramps, nausea, vomiting, fever, or fluid loss.
Lung problems: shortness of breath, difficulty breathing, new or worsening cough, or fever.
Severe bowel problems: stomach pain (with or without fever), tender abdomen, or diarrhea. These conditions can be life-threatening and may occur as early as the first day of symptoms.
Tissue damage: if the medication leaks from the vein, it can cause damage. Inform your nurse immediately if you experience redness, burning, pain, swelling, blisters, skin sores, or fluid leakage at the injection site.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor for guidance:
Fatigue or weakness
Hair loss
Mouth irritation or mouth sores
Constipation
Stomach pain
* Diarrhea, vomiting, nausea, upset stomach, and decreased appetite are common side effects. If these occur, consult your doctor for ways to manage them. If they persist, worsen, or become severe, seek immediate medical attention.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction: rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or discolored sputum, painful urination, mouth sores, or a wound that won't heal.
Signs of bleeding: vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, gum bleeding, abnormal vaginal bleeding, unexplained bruises, or uncontrollable bleeding.
Severe diarrhea or diarrhea accompanied by stomach cramps, nausea, vomiting, fever, or fluid loss.
Lung problems: shortness of breath, difficulty breathing, new or worsening cough, or fever.
Severe bowel problems: stomach pain (with or without fever), tender abdomen, or diarrhea. These conditions can be life-threatening and may occur as early as the first day of symptoms.
Tissue damage: if the medication leaks from the vein, it can cause damage. Inform your nurse immediately if you experience redness, burning, pain, swelling, blisters, skin sores, or fluid leakage at the injection site.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor for guidance:
Fatigue or weakness
Hair loss
Mouth irritation or mouth sores
Constipation
Stomach pain
* Diarrhea, vomiting, nausea, upset stomach, and decreased appetite are common side effects. If these occur, consult your doctor for ways to manage them. If they persist, worsen, or become severe, seek immediate medical attention.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Fever (100.4°F or higher) or chills
- Unusual bleeding or bruising (nosebleeds, bleeding gums, petechiae)
- Severe fatigue or weakness
- Shortness of breath
- Severe nausea, vomiting, or diarrhea that doesn't improve
- Severe mouth sores
- Signs of allergic reaction (rash, itching, swelling, dizziness, trouble breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ Low white blood cell count (leukopenia)
+ Low platelet count (thrombocytopenia)
+ Low red blood cell count (anemia)
* If you are breastfeeding, as you should not breastfeed while taking this medication and for 1 week after your last dose.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ Low white blood cell count (leukopenia)
+ Low platelet count (thrombocytopenia)
+ Low red blood cell count (anemia)
* If you are breastfeeding, as you should not breastfeed while taking this medication and for 1 week after your last dose.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When starting this medication, be cautious and avoid driving or engaging in activities that require alertness until you understand how it affects you.
You are at a higher risk of developing infections, some of which can be severe or life-threatening. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
This medication may increase your risk of bleeding easily. To reduce this risk, be careful to avoid injuries, use a soft-bristled toothbrush, and consider using an electric razor for shaving.
If you experience diarrhea, consult your doctor before attempting to treat it, as some treatments may not be suitable for you while taking this medication.
Before receiving any vaccinations, discuss the potential risks and benefits with your doctor, as certain vaccines may not be effective or may increase your risk of infection when taken with this medication.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
This medication may affect fertility, potentially making it more difficult to conceive or father a child. If you plan to become pregnant or father a child, consult your doctor before starting this medication to discuss the potential risks and alternatives.
Women of childbearing age should be aware that this medication may harm an unborn baby. A pregnancy test will be conducted before initiating treatment to confirm that you are not pregnant. If you may become pregnant, use effective birth control throughout the treatment period and for 6 months after the last dose, unless otherwise advised by your doctor. It is crucial to understand the duration for which you need to use birth control. If you become pregnant while taking this medication, notify your doctor immediately.
Additionally, if your partner may become pregnant, you may need to use birth control during treatment and for a period after the last dose. Consult your doctor to determine the necessary precautions to take.
When starting this medication, be cautious and avoid driving or engaging in activities that require alertness until you understand how it affects you.
You are at a higher risk of developing infections, some of which can be severe or life-threatening. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
This medication may increase your risk of bleeding easily. To reduce this risk, be careful to avoid injuries, use a soft-bristled toothbrush, and consider using an electric razor for shaving.
If you experience diarrhea, consult your doctor before attempting to treat it, as some treatments may not be suitable for you while taking this medication.
Before receiving any vaccinations, discuss the potential risks and benefits with your doctor, as certain vaccines may not be effective or may increase your risk of infection when taken with this medication.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
This medication may affect fertility, potentially making it more difficult to conceive or father a child. If you plan to become pregnant or father a child, consult your doctor before starting this medication to discuss the potential risks and alternatives.
Women of childbearing age should be aware that this medication may harm an unborn baby. A pregnancy test will be conducted before initiating treatment to confirm that you are not pregnant. If you may become pregnant, use effective birth control throughout the treatment period and for 6 months after the last dose, unless otherwise advised by your doctor. It is crucial to understand the duration for which you need to use birth control. If you become pregnant while taking this medication, notify your doctor immediately.
Additionally, if your partner may become pregnant, you may need to use birth control during treatment and for a period after the last dose. Consult your doctor to determine the necessary precautions to take.
Overdose Information
Overdose Symptoms:
- Severe myelosuppression (very low white blood cell count, platelet count, red blood cell count)
- Severe gastrointestinal toxicity (nausea, vomiting, diarrhea, mucositis)
What to Do:
There is no known antidote for topotecan overdose. Management is supportive, including transfusions (blood, platelets), antiemetics, antidiarrheals, and granulocyte colony-stimulating factors (G-CSF) to manage myelosuppression. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
Major Interactions
- Myelosuppressive agents (e.g., other chemotherapy, radiation therapy): Increased risk of severe myelosuppression.
- Live vaccines: Risk of severe infection in immunocompromised patients.
Moderate Interactions
- Cisplatin: Used in combination for cervical cancer, but requires dose adjustment of topotecan due to increased myelosuppression.
- G-CSF (Filgrastim, Pegfilgrastim): Should not be administered concurrently with topotecan during the 5-day treatment period to avoid masking myelosuppression and potentially increasing toxicity. Administer after completion of topotecan course.
- Phenytoin, Carbamazepine, Rifampin (CYP3A4 inducers): May decrease topotecan exposure, potentially reducing efficacy (though CYP3A4 metabolism is minor).
Minor Interactions
- Ketoconazole, Itraconazole (CYP3A4 inhibitors): May slightly increase topotecan exposure (minor effect).
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential and platelets
Rationale: To establish baseline hematologic status and ensure adequate bone marrow reserve before initiating therapy, as myelosuppression is the dose-limiting toxicity.
Timing: Within 24 hours prior to first dose of each cycle.
Renal function tests (Serum Creatinine, CrCl)
Rationale: Topotecan is primarily renally excreted; dose adjustments are necessary for impaired renal function.
Timing: Prior to initiation of therapy and periodically during treatment.
Hepatic function tests (Bilirubin, AST, ALT)
Rationale: To assess baseline liver function, although hepatic impairment typically does not require dose adjustment unless severe.
Timing: Prior to initiation of therapy.
Routine Monitoring
Complete Blood Count (CBC) with differential and platelets
Frequency: Prior to each cycle and periodically during the cycle (e.g., weekly or twice weekly during the first cycle, then as clinically indicated).
Target: Absolute Neutrophil Count (ANC) ≥ 1,500 cells/mm³, Platelets ≥ 100,000 cells/mm³ for subsequent doses/cycles.
Action Threshold: Hold dose if ANC < 1,500 cells/mm³ or platelets < 100,000 cells/mm³. Reduce dose for subsequent cycles if severe neutropenia (ANC < 500 cells/mm³ for ≥ 7 days) or febrile neutropenia occurs, or if platelet count < 25,000 cells/mm³.
Renal function tests (Serum Creatinine)
Frequency: Periodically during treatment, especially if renal function changes are suspected.
Target: Within normal limits or stable for patient.
Action Threshold: Re-evaluate dose if CrCl falls below 40 mL/min.
Symptom Monitoring
- Signs of infection (fever, chills, sore throat, cough)
- Unusual bleeding or bruising
- Severe nausea, vomiting, or diarrhea
- Fatigue or weakness
- Mouth sores (mucositis)
- Hair loss (alopecia)
Special Patient Groups
Pregnancy
Topotecan can cause fetal harm when administered to a pregnant woman. It is classified as Pregnancy Category D. Advise pregnant women of the potential risk to the fetus. Women of childbearing potential should be advised to use effective contraception during treatment and for at least 6 months after the last dose.
Trimester-Specific Risks:
First Trimester:
High risk of major birth defects and fetal death due to rapid cell division and organogenesis.
Second Trimester:
Risk of fetal growth restriction, myelosuppression, and other developmental abnormalities.
Third Trimester:
Risk of myelosuppression in the neonate, premature birth, and other complications.
Lactation
It is not known whether topotecan is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, breastfeeding is contraindicated during topotecan therapy and for at least 1 month after the last dose.
Infant Risk:
High risk of serious adverse effects, including myelosuppression, growth inhibition, and potential carcinogenicity.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. While some studies have been conducted in pediatric oncology, topotecan is not routinely used in this population outside of specific protocols or clinical trials. Severe myelosuppression is a significant concern.
Geriatric Use
No overall differences in effectiveness were observed between elderly (≥65 years) and younger patients. However, elderly patients are more likely to have decreased renal function, which may necessitate dose adjustment. Monitor renal function closely.
Clinical Information
Clinical Pearls
- Topotecan is a potent myelosuppressive agent; careful monitoring of CBC is crucial before and during each cycle.
- Dose reductions are frequently required due to myelosuppression, especially neutropenia.
- Administer antiemetics proactively to manage nausea and vomiting.
- Ensure adequate hydration to prevent renal complications, although topotecan itself is not nephrotoxic.
- The lactone ring of topotecan is pH-sensitive; ensure proper storage and preparation to maintain drug stability and activity.
- Do not administer G-CSF concurrently with topotecan during the 5-day treatment period; administer after the last dose of topotecan in a cycle.
Alternative Therapies
- Paclitaxel (for ovarian cancer, SCLC)
- Docetaxel (for ovarian cancer, SCLC)
- Gemcitabine (for ovarian cancer, SCLC)
- Pemetrexed (for SCLC)
- Etoposide (for SCLC)
- Platinum-based chemotherapy (carboplatin, cisplatin) for ovarian, SCLC, cervical cancer
- Bevacizumab (for ovarian, cervical cancer)
- Immunotherapy agents (e.g., pembrolizumab, nivolumab) for SCLC, cervical cancer
Cost & Coverage
Average Cost:
Varies widely, typically $500 - $1500+ per 4mg vial
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (often requires prior authorization and is covered under medical benefit for IV administration)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.