What is Hycamtin?

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• Blackbox Warning
• Overview
• Proper Use
• Before Using
• Allergies
• Pediatric
• Geriatric
• Breast Feeding
• Drug Interactions
• Other Interactions
• Other Medical Problems
• Precautions

Blackbox WarningTOP

OverviewTOP

Topotecan injection is used to treat patients with metastatic cancer (a cancer that has already spread) of the ovaries after other treatments have failed. This medicine is also used to treat a certain type of lung cancer called small cell lung cancer. It is also used in combination with cisplatin to treat cancer of the cervix which cannot be treated with surgery or radiation therapy.

Topotecan belongs to the group of medicines called antineoplastics. It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other effects may also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may occur after treatment with topotecan has been stopped.

This medicine is available only with your doctor's prescription.

Proper UseTOP

You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

Topotecan is usually given every day for 3 to 5 days. This 3-day or 5-day treatment is given again every 21 days until your body responds to the medicine. Each treatment usually takes about 30 minutes.

Topotecan often causes nausea and vomiting. It is very important that you continue to receive the medicine even if it makes you feel ill. Ask your doctor for ways to lessen these effects.

Before UsingTOP

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

AllergiesTOP

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

PediatricTOP

Appropriate studies have not been performed on the relationship of age to the effects of topotecan injection in the pediatric population. Safety and efficacy have not been established.

GeriatricTOP

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of topotecan injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving topotecan injection.

Breast FeedingTOP

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug InteractionsTOP

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine
• Amiodarone
• Azithromycin
• Bacillus of Calmette and Guerin Vaccine, Live
• Captopril
• Carboplatin
• Carvedilol
• Cholera Vaccine, Live
• Cisplatin
• Clarithromycin
• Cobicistat
• Conivaptan
• Diltiazem
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Dronedarone
• Eliglustat
• Eltrombopag
• Erythromycin
• Felodipine
• Filgrastim
• Influenza Virus Vaccine, Live
• Itraconazole
• Ivacaftor
• Ketoconazole
• Lomitapide
• Lopinavir
• Nilotinib
• Poliovirus Vaccine, Live
• Quercetin
• Quinidine
• Ranolazine
• Ritonavir
• Simeprevir
• Smallpox Vaccine
• Sunitinib
• Telaprevir
• Ticagrelor
• Tocophersolan
• Tolvaptan
• Typhoid Vaccine
• Velpatasvir
• Verapamil
• Voxilaprevir
• Yellow Fever Vaccine

Other InteractionsTOP

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical ProblemsTOP

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection—May decrease your body's ability to fight infection.

• Kidney disease, moderate—Higher blood levels of topotecan can occur, which increases the risk of serious side effects.

• Lung disease (eg, interstitial lung disease), or history of or
• Neutropenia (low white blood cells)—Use with caution. May make these conditions worse.

PrecautionsTOP

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 1 month after your last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. He must use an effective form of birth control during treatment and for 3 months after receiving this medicine.

Talk with your doctor before using this medicine if you plan to have children. Some men and women who use this medicine have become infertile (unable to have children).

While you are being treated with topotecan, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Topotecan may lower your body's resistance, and there is a chance you might get the infection the vaccine is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine, since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the past several months. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Topotecan can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are needed for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, painful or difficult urination, severe diarrhea, or stomach pain.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Also, check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause a bowel problem called typhlitis (neutropenic enterocolitis). Tell your doctor right away if you have a fever, abdominal or stomach pain, or low count of white blood cells after receiving this medicine.

This medicine may cause some people to become tired or weak than they are normally. If any of these side effects occur, avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.

If you develop a skin rash or any allergic reaction to this medicine, check with your doctor as soon as possible.

Check with your doctor right away if you start having breathing problems, cough, fast heartbeat, fever, or shortness of breath. These could be symptoms of a serious lung problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.