Topotecan

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Generic Name: Topotecan Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: D

Uses

What is Topotecan used for?

Topotecan is used to treat small cell lung cancer. It works by killing cancer cells or slowing their growth.

How should I take Topotecan?

Take this medication by mouth, usually once daily for 5 days or as directed by your doctor. Each 5-day treatment period is called a cycle. You will usually repeat this cycle every 21 days. The dosage is based on your body size, medical condition, laboratory tests, and response to treatment.

Take this medication with or without food. Swallow the capsules whole. Do not open, crush, or chew the capsules. If the capsule contents touch your skin, wash the skin right away and completely with soap and water. If the contents get into your eyes, mouth, or nose, flush right away with water for at least 15 minutes. Consult your doctor if you have redness/burning/swelling on the area of skin the contents touched or if the contents get into your eyes.

If you vomit after taking a dose, do not take another dose at that time. Take your next dose on your usual dosing schedule.

All people should wash their hands carefully after handling this drug. Women who are pregnant or who may become pregnant should not handle this medication.

How do I store Topotecan?

Topotecan is best stored in the refrigerator. To prevent drug damage, do not freeze. There may be different brands of Topotecan that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Topotecan down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Topotecan?

Before using topotecan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bone marrow disorders, kidney problems.

This drug may make you feel weak or tired. Alcohol or marijuana can make you more tired. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

Topotecan can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Older adults may be more sensitive to the effects of this drug, especially diarrhea and decreased bone marrow function.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Discuss reliable forms of birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away. Female patients should use reliable forms of birth control during and for 1 month after treatment with topotecan. Male patients and their female partner should use reliable forms of birth control during and for 3 months after treatment with topotecan since this medication may damage sperm.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Topotecan during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Topotecan. Topotecan is pregnancy risk category D according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Topotecan?

Nausea, vomiting, diarrhea, tiredness, loss of appetite, weakness, and fever may occur. If these effects persist or worsen, tell your doctor or pharmacist promptly. 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.

Diarrhea can also be severe and may require treatment in a hospital. Tell your doctor right away if you have any diarrhea with fever, diarrhea with stomach pain, or diarrhea 3 or more times a day.

Temporary hair loss may occur. However, 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: lung problems (such as cough, shortness of breath).

This medication may affect male and female fertility. Consult your doctor for more details.

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.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Topotecan?

Other medications can affect the removal of topotecan from your body, which may affect how topotecan works. Examples include azole antifungals (such as ketoconazole), cyclosporine, macrolide antibiotics (such as erythromycin), HIV protease inhibitors (such as ritonavir), among others.

Topotecan may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Topotecan?

Topotecan may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Topotecan?

Topotecan may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Topotecan.

What is the dose of Topotecan for an adult?

Usual Adult Dose for Ovarian Cancer

1.5 mg/m(2) IV over 30 minutes once a day for 5 consecutive days, starting on day 1 of a 21 day course

Comments:

-In the absence of tumor progression, a minimum of 4 courses is recommended because tumor response may be delayed.

-The median time to response was 9 to 12 weeks.

-Recommended dosage should generally not exceed 4 mg.

Use: Metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy.

Usual Adult Dose for Cervical Cancer

0.75 mg/m(2) IV over 30 minutes on days 1, 2, and 3 of each 21 day cycle

Comments:

-Administer cisplatin 50 mg/m(2) IV on day 1 of each 21 day cycle.

-Consult cisplatin manufacturer product information for administration and hydration guidelines, and for dose adjustments.

-Recommended dosage should generally not exceed 4 mg.

Use: In combination with cisplatin, treatment of stage IVB, recurrent or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.

Usual Adult Dose for Small Cell Lung Cancer

IV formulation: 1.5 mg/m(2) IV over 30 minutes once a day for 5 consecutive days, starting on day 1 of a 21 day course

Oral capsules: 2.3 mg/m(2) orally once a day for 5 consecutive days, starting on day 1 of a 21 day course (round dose to nearest 0.25 mg)

Duration of therapy: Until disease progression

Comments:

-In the absence of tumor progression, a minimum of 4 courses is recommended because tumor response may be delayed.

-The median time to response was 5 to 7 weeks.

-Recommended IV dosage should generally not exceed 4 mg.

-Do not prescribe a replacement oral capsule dose for emesis.

Uses:

IV formulation: Small cell lung cancer sensitive disease after failure of first-line chemotherapy. Sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 to 90 days after chemotherapy.

Capsule formulation: Treatment of relapsed small cell lung cancer in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy.

Renal Dose Adjustments

Small cell lung cancer or Ovarian cancer, IV formulation:

-Mild renal impairment (CrCl 40 to 60 mL/min): No adjustment recommended

-Moderate renal impairment (CrCl 20 to 39 mL/min): Decrease dose to 0.75 mg/m(2)

-Severe renal impairment: Insufficient data to provide a dosage recommendation

Small cell lung cancer, oral capsules:

-Mild renal impairment (CrCl 50 to 79 mL/min): No adjustment recommended

-Moderate renal impairment (CrCl 30 to 49 mL/min): Decrease dose to 1.5 mg/m(2)

-Severe renal impairment (CrCl less than 30): Decrease dose to 0.6 mg/m(2)

-Doses for moderate to severe renal impairment can be increased by 0.4 mg/m(2) after the first course if no severe hematologic or gastrointestinal toxicities occur.

Cervical cancer:

-Only initiate treatment if serum creatinine is less than 1.5 mg/dL

-Serum creatinine greater than 1.5 mg/dL on day 1 of first cycle: Delay initiation of treatment until renal recovery

-Serum creatinine greater than 1.5 mg/dL on day 1 of subsequent cycles: Delay cycle until renal recovery

-Serum creatinine greater than 1.5 mg/dL in subsequent cycles: Permanently discontinue

Dose Adjustments

All cancer types:

On day 1 of first cycle, delay therapy initiation until hematologic or renal recovery IF:

-Neutrophil count is less than 1,500 cells/mm(3) OR

-Platelet count 100,000 cells/mm(3) or less OR

-Serum creatinine less than 1.5 mg/dL

On day 1 of subsequent cycles, delay treatment cycle until hematologic or renal recovery IF:

-Neutrophil count is less than 1000 cells/mm(3) OR

-Platelet count 100,000 cells/mm(3) or less OR

-Serum creatinine less than 1.5 mg/dL OR

-Hemoglobin less than 9 gm/dL

Small cell lung cancer or Ovarian cancer:

IV formulation:

Severe neutropenia [less than 500 cells/mm(3)] in preceding cycle:

-Permanently reduce IV dose by 0.25 mg [to 1.25 mg/m(2)] or oral dose by 0.4 mg/m(2) for subsequent courses OR

-Administer granulocyte-colony stimulating factor (G-CSF) following the subsequent course (before resorting to dose reduction) starting from day 6 of the course (24 hours after completion of topotecan administration).

Platelet count below 25,000 cells/mm(3): Reduce dose to 1.25 mg/m(2) for subsequent courses .

Oral capsules (Small cell lung cancer only):

Permanently reduce dose by 0.4 mg/m(2) for subsequent courses for:

-Neutrophil counts less than 500 cells/mm(3)] with fever or infection lasting 7 or more days

-Neutrophil counts of 500 to 1,000 cells/mm(3) lasting beyond day 21 of treatment course

-Platelet count below 25,000 cells/mm(3)

Do not give oral formulation to patients with Grade 3 or 4 diarrhea

-After recovery to Grade 1 or less, reduce dose by 0.4 mg/m(2) for subsequent courses

Cervical cancer:

First occurrence of febrile neutropenia [less than 1,000 neutrophils/mm(3) with fever of 38 C/100.4F or higher] in preceding cycle:

-Permanently reduce dose to 0.60 mg/m(2) OR

-Administer prophylactic G-CSF during subsequent cycles

Re-occurrence of febrile neutropenia in preceding cycle despite use of G-CSF:

-Permanently reduce dose to 0.45 mg/m(2)

Platelet nadir less than 25,000 cells/mm(3) in preceding cycle:

-Permanently reduce dose to 0.60 mg/m(2)

Serum creatinine greater than 1.5 mg/dL in subsequent cycles:

-Permanently discontinue topotecan

Other Comments

Administration advice:

-Verify dose using body surface area.

-Oral capsules should be swallowed whole: do not crush, chew, or divide the capsules.

-Oral capsules can be taken with or without food.

Reconstitution/preparation techniques:

-Prepare in a laminar flow hood while wearing gloves and protective clothing.

-If solution contacts skin, wash skin immediately and thoroughly with soap and water.

-If solution contacts mucous membranes, flush thoroughly with water.

What is the dose of Topotecan for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Topotecan available?

Topotecan is available in the following dosage forms and strengths:

  • Intravenous powder for injection,
  • Oral capsule,
  • Intravenous solution.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Topotecan, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: November 8, 2018 | Last Modified: November 8, 2018

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