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Topotecan Hydrochloride for Injection by Accord Healthcare Inc.
Topotecan belongs to the group of cancer-fighting medications known as antineoplastics. It kills cancer cells by interfering with the genetic material DNA, which is necessary for their growth and reproduction. Topotecan is used to treat metastatic cancer of the ovary after other treatment(s) have failed. It is also used to treat small cell lung cancer that has returned after initial treatment.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are receiving this medication, speak to your doctor.
Each single dose vial of a sterile lyophilized, buffered, yellow powder contains topotecan HCl equivalent to 4 mg of topotecan as free base. Nonmedicinal ingredients: mannitol and tartaric acid. Hydrochloric acid and sodium hydroxide may be used to adjust to a pH of 3. The solution pH ranges from 2.5 to 3.5.
The recommended dose and dosing schedule of topotecan varies according to body size and the results of blood tests carried out before your treatment. It is injected into a vein through a specially prepared site on your skin. The appropriate dose is usually injected over 30 minutes, once daily for 5 consecutive days followed by 16 days without medication. This cycle is then repeated at least 3 more times.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. Your doctor may choose a schedule different from the one listed here.
Very careful handling of this medication is required. It is always given under the supervision of a doctor in a hospital or similar setting with access to sterile equipment for preparation.
As well as interfering with the genetic material DNA of cancer cells, topotecan can interfere with some of your normal cells. This can cause a number of side effects such as hair loss and mouth sores. Topotecan often causes nausea and vomiting, but you will be given medications to help control this. Your doctor, nurse, or pharmacist can advise you on how to reduce the effects of nausea and vomiting. Keep track of any side effects and report them to your doctor as suggested in the section, "What side effects are possible with this medication?"
It is important this medication be given exactly as recommended by your doctor. If you miss an appointment to receive topotecan, contact your doctor as soon as possible to reschedule your appointment.
This medication is stored at room temperature and protected from light.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Topotecan should not be used by anyone who:
- is allergic to topotecan or to any of the ingredients of the medication
- is breast-feeding
- is pregnant
- has severe depletion of neutrophils (white blood cells) or platelets
- has severely reduced kidney function
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is used in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people receiving this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- appetite loss
- burning or tingling in the hands or feet
- general feeling of being unwell
- hair loss
- redness or bruising at site of the injection
- swelling and pain of the mouth, tongue, or gums
- temporary hair loss
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- abdominal or stomach pain
- sores or white spots on the lips, tongue, or inside the mouth
- signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
- signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
- unusual fatigue or weakness
Stop taking the medication and seek immediate medical attention if any of the following occur:
- irregular or fast breathing
- wheezing or tightness in chest
- signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
- signs of bowel inflammation (e.g., fever that appears after starting the medication, watery and severe diarrhea [may also be bloody])
- signs of breathing problems (e.g., shortness of breath, troubled breathing, wheezing, or tightness in chest, fast or irregular breathing)
- signs of severe infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
- signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
- symptoms of gastrointestinal perforation (e.g., severe stomach pain, nausea, vomiting, bloody stool)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are receiving this medication.
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Anemia: Topotecan may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.
Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.
Blood clotting: This medication can reduce the number of platelet cells in the blood. Platelets help the blood to clot, and a shortage could make you bleed more easily. Tell your doctor of any signs that your blood is not clotting as quickly. Such symptoms may include black and tarry stools, blood in the urine, easy bruising, or cuts that won't stop bleeding.
Extravasation: This medication may be irritating to your veins while it is being administered. Please let your nurse know immediately if you feel any burning or pain at the injection site while the medication is being given.
Infection: As well as killing cancer cells, this medication can reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people who have contagious infections. Tell your doctor immediately if you begin to notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.
Lung inflammation: Topotecan can cause lung inflammation, especially for people with a history of lung problems (e.g., fibrosis, lung cancer, chest radiation). This can be serious and sometimes fatal. If you experience cough, fever, or shortness of breath, contact your doctor immediately.
Neutropenic colitis: This medication can cause neutropenic colitis, which is an inflammation of the colon associated with a decrease in white blood cells. If you experience abdominal pain with fever, seek immediate medical attention.
Weakness/tiredness: This medication is not expected to make you drowsy and impair your ability to drive or use machinery. However, it may make some people feel weak or tired. Do not drive or use machinery if you feel weak or tired.
Pregnancy: There is a possibility of birth defects with topotecan if it is taken during pregnancy. Effective birth control should be practiced while using this medication. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if topotecan passes into breast milk. Women who are receiving this medication should not breast-feed.
Children: The safety and effectiveness of using this medication have not been established for children.
There may be an interaction between topotecan and any of the following:
- antiarrythmics (e.g., amiodarone, dronedarone, quinidine)
- "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
- BCG vaccine
- grapefruit juice
- hepatitis C antivirals (e.g., daclatasvir, dasabuvir, ledipasvir, velpatasvir)
- HIV protease inhibitors (e.g., darunavir, indinavir, lopinavir, saquinavir, tipranavir)
- macrolide antibiotics (e.g., azithromycin, clarithromycin)
- other cancer medications (e.g., cisplatin, carboplatin, oxaliplatin, trastuzumab)
- protein kinase inhibitors (e.g., crizotinib, dasatinib, imatinib, nilotinib)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Topotecan-Hydrochloride-for-Injection-by-Accord-Healthcare-Inc
All material © 1996-2020 MediResource Inc. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.