Cyclophosphamide (Systemic)

Cyclophosphamide (Systemic)

US Brand Names

• Cytoxan

• Neosar

Canadian Brand Names

• Cytoxan

• Procytox

Description

Cyclophosphamide (sye-kloe-FOSS-fa-mide) belongs to the group of medicines called alkylating agents. It is used to treat cancer of the ovaries, breast, blood and lymph system, nerves (found primarily in children), retinoblastoma (a cancer of the eye found primarily in children), multiple myeloma (cancer in the bone marrow), and mycosis fungoides (tumors on the skin).

Cyclophosphamide is also used for treatment of some kinds of kidney disease.

Cyclophosphamide may also be used for other conditions as determined by your doctor.

Cyclophosphamide interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by cyclophosphamide, other effects will 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 not occur for months or years after the medicine is used.

Before you begin treatment with cyclophosphamide, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Cyclophosphamide is available only with your doctor's prescription, in the following dosage forms:

Oral

• Oral solution (U.S. and Canada)

• Tablets (U.S. and Canada)

Parenteral

• Injection (U.S. and Canada)

Special Considerations

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 cyclophosphamide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to cyclophosphamide.

Pregnancy

This medicine may cause several different birth defects if either the male or female is taking it at the time of conception or if it is taken during pregnancy. In addition, many cancer medicines may cause sterility. Although sterility occurs commonly with cyclophosphamide, it is usually only temporary.

Be sure that you have discussed this with your doctor before taking this medicine. It is best to use some kind of birth control while you are taking cyclophosphamide. Tell your doctor right away if you think you have become pregnant while taking cyclophosphamide.

Breast-feeding

Cyclophosphamide passes into the breast milk. Because this medicine may cause serious side effects, breast-feeding is generally not recommended while you are taking it.

Children

This medicine has been tested in children and has not been shown to cause different side effects or problems than it does in adults.

Older adults

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of cyclophosphamide in the elderly with use in other age groups, it is not expected to cause different side effects or problems in older people than it does in younger adults.

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 taking or receiving cyclophosphamide, it is especially important that your health care professional know if you are taking any of the following:

• Amphotericin B by injection (e.g., Fungizone) or

• Antithyroid agents (medicine for overactive thyroid) or

• Chloramphenicol (e.g., Chloromycetin) or

• Colchicine or

• Flucytosine (e.g., Ancobon) or

• Ganciclovir (e.g., Cytovene) or

• Interferon (e.g., Intron A, Roferon-A) or

• Methotrexate or

• Plicamycin (e.g., Mithracin) or

• Zidovudine (e.g., AZT, Retrovir) or

• If you have ever been treated with radiation or cancer medicines-Cyclophosphamide may increase the effects of these medicines or radiation therapy on the blood

• Cocaine-Cyclophosphamide may increase the effects and toxicity of this medicine

• Cytarabine-Cyclophosphamide may increase the effects of this medicine on the heart and blood

• Azathioprine (e.g., Imuran) or

• Chlorambucil (e.g., Leukeran) or

• Corticosteroids (cortisone-like medicine) or

• Cyclosporine (e.g., Sandimmune) or

• Mercaptopurine (e.g., Purinethol) or

• Muromonab-CD3 (monoclonal antibody) (e.g., Orthoclone OKT3)-There may be an increased risk of infection and development of cancer because cyclophosphamide reduces the body's ability to fight them

• Probenecid (e.g., Benemid) or

• Sulfinpyrazone (e.g., Anturane)-Cyclophosphamide may increase the amount of uric acid in the blood. Since these medicines are used to lower uric acid levels, they may not work as well in patients taking cyclophosphamide

Other medical problems

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

• Chickenpox (including recent exposure) or

• Herpes zoster (shingles)-Risk of severe disease affecting other parts of the body

• Gout (history of) or

• Kidney stones (history of)-Cyclophosphamide may increase levels of uric acid in the body, which can cause gout or kidney stones

• Infection-Cyclophosphamide can decrease your body's ability to fight infection

• Kidney disease-Effects of cyclophosphamide may be increased because of slower removal from the body

• Liver disease-The effect of cyclophosphamide may be decreased

• Prior removal of adrenal gland(s)-Toxic effects of cyclophosphamide may be increased, dosage adjustment may be necessary

• Tumor cell accumulation-Increased risk of tumor cells entering the bone marrow, due to bone marrow depression from high doses of cyclophosphamide

Administration

Take this medicine only as directed by your doctor . Do not take more or less of it, and do not take it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition.

Cyclophosphamide is sometimes given together with certain other medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your health care professional to help you plan a way to remember to take your medicines at the right times.

While you are using cyclophosphamide, it is important that you drink extra fluids so that you will pass more urine . Also, empty your bladder frequently, including at least once during the night. This will help prevent kidney and bladder problems and keep your kidneys working well. Cyclophosphamide passes from the body in the urine. If too much of it appears in the urine or if the urine stays in the bladder too long, it can cause dangerous irritation. Follow your doctor's instructions carefully about how much fluid to drink every day . Some patients may have to drink up to 7 to 12 cups (3 quarts) of fluid a day.

Usually it is best to take cyclophosphamide first thing in the morning, to reduce the risk of bladder problems. However, your doctor may want you to take it with food in smaller doses over the day, to lessen stomach upset or help the medicine work better. Follow your doctor's instructions carefully about when to take cyclophosphamide.

Cyclophosphamide often causes nausea, vomiting, and loss of appetite. However, it is very important that you continue to use the medicine even if you begin to feel ill. Do not stop taking this medicine without first checking with your doctor . Ask your health care professional for ways to lessen these effects.

If you vomit shortly after taking a dose of cyclophosphamide, check with your doctor. You will be told whether to take the dose again or to wait until the next scheduled dose.

Dosing

The dose of cyclophosphamide will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for, the patient's weight, whether the medicine is being given by mouth or by injection, and whether or not other medicines are also being taken. If you are taking or receiving cyclophosphamide at home, follow your doctor's orders or the directions on the label . If you have any questions about the proper dose of cyclophosphamide, ask your doctor.

Missed dose

If you miss a dose of this medicine, do not take the missed dose at all and do not double the next one. Instead, go back to your regular dosing schedule and check with your doctor.

Storage

To store this medicine:

• Keep out of the reach of children.

• Store away from heat and direct light.

• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.

• Store the oral solution form of this medicine in the refrigerator. Keep it from freezing.

• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

While you are being treated with cyclophosphamide, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval . Cyclophosphamide may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your house 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 recently taken oral polio vaccine within the last 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.

Before having any kind of surgery, including dental surgery, or emergency treatment, make sure the medical doctor or dentist in charge knows that you are taking this medicine, especially if you have taken it within the last 10 days.

Cyclophosphamide 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 necessary 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, or painful or difficult urination.

• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in 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. 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.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Side 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.

Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These may include certain types of cancer, such as leukemia or bladder cancer. Discuss these possible effects with your doctor.

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

More common

Cough or hoarseness; fever or chills; lower back or side pain; missing menstrual periods; painful or difficult urination.

With high doses and/or long-term treatment

Blood in urine; dizziness, confusion, or agitation; fast heartbeat; joint pain; shortness of breath; swelling of feet or lower legs; unusual tiredness or weakness.

Less common

Black, tarry stools or blood in stools; pinpoint red spots on skin; unusual bleeding or bruising.

Rare

Frequent urination; redness, swelling, or pain at site of injection; sores in mouth and on lips; sudden shortness of breath; unusual thirst; yellow eyes or skin.

Other 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:

More common

Darkening of skin and fingernails; loss of appetite; nausea or vomiting.

Less common

Diarrhea or stomach pain; flushing or redness of face; headache; increased sweating; skin rash, hives, or itching; swollen lips.

Cyclophosphamide may cause a temporary loss of hair in some people. After treatment has ended, normal hair growth should return, although the new hair may be a slightly different color or texture.

After you stop using cyclophosphamide, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effect:

Blood in urine.

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

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, cyclophosphamide is used in certain patients with the following medical conditions:

• Cancer of the bladder

• Cancer in the bones

• Cancer of the cervix

• Cancer of the endometrium

• Cancers of the lungs

• Cancer of the prostate

• Cancer of the testicles

• Cancer of the adrenal cortex (the outside layer of the adrenal gland)

• Ewing's sarcoma (a certain type of bone cancer)

• Germ cell tumors in the ovaries (a cancer in the egg-making cells in the ovary)

• Gestational trophoblastic tumors (a certain type of tumor in the uterus/womb)

• Soft tissue sarcomas (a cancer of the muscles, tendons, vessels that carry blood or lymph, joints, and fat)

• Thymoma (a cancer in the thymus, a small organ beneath the breastbone)

• Tumors in the brain

• Waldenstr�m's macroglobulinemia (a certain type of cancer of the blood)

• Wilms' tumor (a cancer of the kidney found primarily in children)

• Histiocytosis X (a certain type of cancer found primarily in children)

• Organ transplant rejection (prevention)

• Rheumatoid arthritis

• Wegener's granulomatosis

• Systemic lupus erythematosus

• Systemic dermatomyositis or

• Multiple sclerosis (a disease of the nervous system)

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

May 22, 2002