Hycamtin Intravenous

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.

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.

Pediatric

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.

Geriatric

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 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.

Interactions with 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.

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

• Abiraterone
• 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
• Sofosbuvir
• Sunitinib
• Telaprevir
• Ticagrelor
• Tocophersolan
• Typhoid Vaccine
• Velpatasvir
• Verapamil
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

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

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.

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:

• Abdominal or stomach pain
• black, tarry stools
• blood in the urine or stools
• cough or hoarseness (accompanied by fever or chills)
• fever or chills
• lower back or side pain (accompanied by fever or chills)
• painful or difficult urination (accompanied by fever or chills)
• pinpoint red spots on the skin
• troubled breathing
• unusual bleeding or bruising
• unusual tiredness or weakness

• Changes in the skin color of the face
• fast or irregular breathing
• large, hive-like swellings on the face, eyelids, mouth, lips, or tongue
• puffiness or swelling of the eyelids or around the eyes
• skin rash, hives, or itching
• tightness in the chest

• Bleeding gums
• difficulty with swallowing
• dizziness
• fast heartbeat
• skin rash or itching, severe

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:

• Burning or tingling in the hands or feet
• constipation
• diarrhea
• headache
• loss of appetite
• muscle weakness
• nausea or vomiting
• sores, ulcers, or white spots on the lips or tongue or inside the mouth

Topotecan sometimes causes bruising or redness at the place of injection. Check with your doctor or nurse if these effects are especially bothersome.

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.

See also Warning section.

Nausea, vomiting, constipation, diarrhea, abdominal pain, weakness, tiredness, or mouth sores may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk ofside effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: pain/redness/bruising at injection site, signs of 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.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.