Topotecan

Topotecan is a prescription medication used for the treatment of small-cell lung cancer, cervical cancer, and ovarian cancer.

• Topotecan is available under the following different brand names: Hycamtin

Adult dosage

Powder for injection

• 4mg/vial

Capsule

• 0.25mg
• 1mg

Small Cell Lung Cancer

Adult dosage

IV Infusion

• 1.5mg/m² IV every day for 5 days; repeat at 21-day cycles  
• See Administration

Capsules

• 2.3mg/m² orally every day for 5days; repeat at 21-day cycles

Cervical Cancer

Adult dosage

• 0.75 mg/m² IV infused over 30 min on Days 1,2, & 3 (with cisplatin 50 mg/m² on Day 1); repeat at 21-day cycles

Ovarian Cancer

Adult dosage

• 1.5mg/m² IV every day for 5 days; repeat at 21-day cycles

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of the Topotecan include:

• low blood cell counts,
• trouble bleeding,
• pneumonia,
• nausea,
• diarrhea,
• vomiting,
• stomach pain,
• loss of appetite,
• hair loss,
• weakness, and
• tiredness

Serious side effects of the Topotecan include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• new or worsening cough,
• fever,
• diarrhea with fever and stomach cramps,
• pain or burning when you urinate,
• chills,
• cough with mucus,
• chest pain,
• shortness of breath,
• flu-like symptoms,
• mouth sores,
• skin sores,
• pale skin,
• cold hands and feet,
• bruising,
• bleeding, and
• lightheadedness

Rare side effects of the Topotecan include:

• none

This is not a complete list of side effects and other serious side effects or health problems that may occur due to the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Topotecan has severe interactions with no other drugs.
• Topotecan has serious interactions with at least 57 other drugs.
• Topotecan has moderate interactions with at least 43 other drugs.
• Topotecan has minor interactions with the following drugs:
  • vitamin A
  • vitamin E

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity reactions to the drug or any components

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Topotecan?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Topotecan?”

Cautions

• Administer to patients with bone marrow suppression only if the patient has adequate bone marrow reserves; monitor peripheral blood counts and adjust the dose as needed
• Oral: Do NOT redose if ANC is below 1500/mm³; Plt 100,000
• Avoid use in pregnancy; can cause fetal harm; advise women of the potential risk to the fetus
• Neutropenia: pancytopenia has been reported
• Grade 4 thrombocytopenia and grade 3-4 anemia were reported; withhold and reduce dose based on neutrophil counts, platelet counts, and hemoglobin levels
• Fatal cases of interstitial lung disease have occurred; permanently discontinue for confirmed ILD
• If extravasation occurs, immediately stop administration and institute recommended management procedures; severe cases reported
• Oral: If the patient vomits after taking a capsule, do NOT repeat the dose
• Oral: If diarrhea occurs, treat aggressively, potentially life-threatening
• Monitor patients presenting with neutropenia, fever, and abdominal pain; fatal typhlitis reported in patients with neutropenic enterocolitisas
• Monitor patients presenting with cough, fever, dyspnea, and/or hypoxia and a history of lung disease as fatalities due to interstitial lung disease have been reported
• Combination with cisplatin
  • Administer the first cycle of topotecan for injection only to patients with a baseline neutrophil count above 1,500/mm³ and a platelet count above 100,000/mm³; monitor blood counts frequently during treatment; withhold and reduce dose based on neutrophil counts, platelet counts, and hemoglobin levels

Pregnancy and Lactation

• Based on animal data and its mechanism of action, therapy can cause fetal harm when administered to a pregnant woman; there are no available clinical data on the use of therapy in pregnancy; the drug caused embryolethality, fetotoxicity, and teratogenicity in rats and rabbits when administered during organogenesis at doses similar to the clinical dose.); advise pregnant women of the potential risk to the fetus
• Verify pregnancy status of females of reproductive potential before initiating therapy
• Contraception
  • Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose
• Infertility
  • Females: Therapy can have both acute and long-term effects on fertility
  • Males: Effects on spermatogenesis occurred in animals administered topotecan; therapy may damage spermatozoa, resulting in possible genetic and fetal abnormalities; advise males with a female partner of reproductive potential to use effective contraception during treatment and for 3 months after the last dose
• Lactation
  • There are no data on the presence of drugs or their metabolites in human milk or their effects on the breastfed infant or milk production; lactating rats excrete high concentrations of drugs in milk
  • Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for 1 week after the last dose