Cyclophosphamide (Oral, Intravenous)

Cyclophosphamide is used to treat cancer of the ovaries, breast, blood and lymph system, and nerves (mainly in children). Cyclophosphamide is also used for retinoblastoma (a type of eye cancer mainly in children), multiple myeloma (cancer in the bone marrow), and mycosis fungoides (tumors on the skin). It belongs to the group of cancer medicines called alkylating agents.

Cyclophosphamide is also used for some kinds of kidney disease.

Cyclophosphamide interferes with the growth of cancer cells, which are then destroyed by the body. 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 benefits of this medicine as well as the risks of using it.

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

It is very important that your doctor checks your progress at regular visits to ensure that this medicine is working properly and to look for unwanted effects.

While you are being treated with cyclophosphamide, and after you stop treatment with it, do not get any immunizations (vaccines) without your doctor's approval. Cyclophosphamide may lower your body's resistance, and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. Additionally, you should avoid being around other people in your household who receive live virus vaccines because they could pass the virus to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Stay away from them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

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

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 happens, 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 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 suggest 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 clippers.
• Avoid contact sports or other situations where bruising or injury could happen.

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.

In deciding to use a medicine, you and your doctor will need to think about the risks of taking the medicine compared to the benefits it will provide. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know 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

This medicine has been tested in children and has not shown different side effects or problems compared to adults.

Geriatric

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

Breast Feeding

Studies in breastfeeding women have shown harmful effects on infants. An alternative to this medication should be prescribed, or you should stop breastfeeding while using this medicine.

Interactions with Medicines

While some medicines should not be used together at all, in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. When you are taking this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or adjust some of the other medicines you are taking.

• 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 necessary in some situations. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Adenovirus Vaccine
• Amprenavir
• Atazanavir
• Bacillus of Calmette and Guerin Vaccine, Live
• Boceprevir
• Carbamazepine
• Ceritinib
• Cholera Vaccine, Live
• Cobicistat
• Cyclosporine
• Darunavir
• Dengue Tetravalent Vaccine, Live
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Eslicarbazepine Acetate
• Etanercept
• Fexinidazole
• Fosamprenavir
• Fosphenytoin
• Idarubicin
• Indinavir
• Influenza Virus Vaccine, Live
• Lemborexant
• Lopinavir
• Nelfinavir
• Nevirapine
• Nilotinib
• Pentostatin
• Phenobarbital
• Phenytoin
• Poliovirus Vaccine, Live
• Primidone
• Ritonavir
• Ruxolitinib
• Saquinavir
• Smallpox Vaccine
• Sparsentan
• St John's Wort
• Tamoxifen
• Telaprevir
• Tipranavir
• Typhoid Vaccine, Live
• Warfarin
• Yellow Fever Vaccine

Using this medicine with any of the following medicines may increase the 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.

• Ondansetron
• Thiotepa

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or around mealtime or with specific types of food, as interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, 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 raise uric acid levels in the body, which can lead to gout or kidney stones.

• Infection—May reduce the body's ability to fight infection.

• Kidney disease—The effects of cyclophosphamide may be increased due to slower removal from the body.

• Liver disease—The effect of cyclophosphamide may be reduced.

• Prior removal of adrenal gland(s)—Toxic effects of cyclophosphamide may be heightened, and dosage adjustment may be needed.

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

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 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 the urine
• Dizziness, confusion, or agitation
• Fast heartbeat
• Joint pain
• Shortness of breath
• Swelling of the feet or lower legs
• Unusual tiredness or weakness

Less common

• Black, tarry stools
• Pinpoint red spots on the skin
• Unusual bleeding or bruising

Rare

• Frequent urination
• Redness, swelling, or pain at the injection site
• Sores in the mouth and on the lips
• Sudden shortness of breath
• Unusual thirst
• Yellow eyes or skin

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:

More common

• Darkening of the skin and fingernails
• Loss of appetite
• Nausea or vomiting

Less common

• Diarrhea
• Flushing or redness of the face
• Headache
• Increased sweating
• Skin rash, hives, or itching
• Stomach pain
• Swollen lips

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.

In the U.S.

• Cytoxan
• Cytoxan Lyophilized

Available Dosage Forms:

• Capsule
• Powder for Solution
• Tablet
• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Alkylating Agent

Chemical Class: Nitrogen Mustard

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 doctor 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 doctor 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 this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For the treatment of cancer: Adults—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 5 milligrams (mg) per kilogram (kg) of body weight per day. Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 5 mg per kg of body weight per day.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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