Pronunciation:

toe-poe-TEE-kan

Brand Names:

• Hycamtin

Dosage Forms:

• Solution
• Powder for Solution

Warnings:

Topotecan can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts greater than or equal to 1500/mm(3) and platelet counts greater than or equal to 100,000/mm(3). Monitor blood cell counts .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Topoisomerase I Inhibitor

Uses of This Medicine:

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 that has come back and cannot be treated with surgery or radiation.

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 to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

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:

Allergies—

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.

Children—

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.

Older adults—

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 caution for patients receiving topotecan injection.

Breast-feeding—

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.

Other medicines—

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.

• Bacillus of Calmette and Guerin Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

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 Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Asciminib
• Berotralstat
• Capmatinib
• Cholera Vaccine
• Danicopan
• Darolutamide
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Leflunomide
• Leniolisib
• Midostaurin
• Pacritinib
• Rotavirus Vaccine, Live
• Tafamidis
• Vadadustat
• Venetoclax

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Rolapitant

Other interactions—

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 problems—

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

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into 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 at least 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.

Precautions While Using This Medicine:

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. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use an effective form of birth control to keep from getting pregnant during treatment and for at least 6 months after your last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

Talk with your doctor before receiving this medicine if you plan to have children. Some men and women who receive 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 serious bowel problem called typhlitis (neutropenic enterocolitis), which could be life-threatening. Tell your doctor right away if you have a fever, abdominal or stomach pain, or a 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. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

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, or fever. 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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

bleeding gums

blood in the urine or stools

body aches or pain

chest pain

chills

congestion

cough

difficult or labored breathing

dryness or soreness of the throat

fever

hoarseness

lower back or side pain

painful or difficult urination

pale skin

pinpoint red spots on the skin

runny nose

sneezing

tender, swollen glands in the neck

tightness in the chest

trouble in swallowing

troubled breathing with exertion

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

voice changes

Less common

Confusion

diarrhea

dizziness

fainting

fast heartbeat

lightheadedness

nausea

pain or cramping in the abdomen

rapid, shallow breathing

stomach pain

vomiting

Incidence not known

Cracked lips

dizziness

hives, itching, skin rash

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

pale skin, pain, or redness at the site of injection

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

severe bleeding

severe itching, skin rash

severe stomach pain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Bone or back pain

constipation

lack or loss of strength

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.