Cyclophosphamide Injection

WHY is this medicine prescribed?

Cyclophosphamide is used to treat Hodgkin's lymphoma (Hodgkin's disease) and non-Hodgkin's lymphoma (types of cancer that begin in a type of white blood cells that normally fights infection); mycosis fungoides (a type of blood cancer that first appears as skin rashes); multiple myeloma (a type of cancer of the bone marrow); and certain types of leukemia (cancer of the white blood cells), including chronic lymphocytic leukemia (CLL), chronic myelogenous leukemia (CML), acute myeloid leukemia (AML, ANLL), and acute lymphoblastic leukemia (ALL). It is also used to treat retinoblastoma (cancer in the eye), neuroblastoma (a cancer that begins in nerve cells and occurs mainly in children), ovarian cancer (cancer that begins in the female reproductive organs where eggs are formed), and breast cancer. Cyclophosphamide is also used to treat nephrotic syndrome (a disease that is caused by damage to the kidneys) in certain children. Cyclophosphamide is in a class of medications called alkylating agents. When cyclophosphamide is used to treat cancer, it works by slowing or stopping the growth of cancer cells in your body. When cyclophosphamide is used to treat nephrotic syndrome, it works by suppressing your body's immune system.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Cyclophosphamide injection comes as a powder to be added to fluid and injected intravenously (into a vein) by a doctor or nurse in a medical office or hospital outpatient clinic. Your doctor will tell you how often you will receive cyclophosphamide. The schedule depends on the condition you have and on how your body responds to the medication.

Your doctor may need to delay your treatment or adjust your dose if you experience certain side effects. It is important for you to tell your doctor how you are feeling during your treatment with cyclophosphamide injection.

What SPECIAL PRECAUTIONS should I follow?

Before receiving cyclophosphamide injection,

• tell your doctor and pharmacist if you are allergic to cyclophosphamide, other alkylating agents such as bendamustine, busulfan, carumustine, chlorambucil, ifosfamide, lomustine, melphalan, procarbazine, or temozolomide, any other medications, or any of the ingredients in cyclophosphamide injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving cyclophosphamide injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had urinary obstruction (a blockage of urine flowingout of the bladder). Your doctor may not want you not to receive cyclophosphamide injection.

• tell your doctor if you have previously received treatment with other chemotherapy medications or if you have had radiation therapy to your chest or stomach area. Also tell your doctor if you have an open or healing wound or if you have or have ever had heart failure, a fast or irregular heartbeat, or any other heart problems; low blood levels of sodium; or kidney or liver disease.

• tell your doctor if you are pregnant or plan to become pregnant. You or your partner should not become pregnant while you are receiving cyclophosphamide injection. Cyclophosphamide may interfere with the normal menstrual cycle (period) in women and may stop sperm production in men. However, you should not assume that you cannot get pregnant or that you cannotget someone else pregnant. If you can become pregnant, your doctor may order a pregnancy test before you start treatment. If you can become pregnant, you should use effective birth control during therapy and for 1 year after receiving the last dose. If your partner can become pregnant, you should use birth control during therapy and for 4 months after receiving the last dose. Talk to your doctor about birth control methods that will work for you. If you or your partner becomes pregnant while receivingcyclophosphamide injection, call your doctor immediately. Cyclophosphamide may harm the fetus.

• tell your doctor if you are breastfeeding. You should not breastfeed during therapy or for 1 week after receiving the last dose.

• you should know that this medication may cause permanent infertility in men and women. Talkto your doctor about the risks of receiving cyclophosphamide injection.

• you should know that cyclophosphamide may make you dizzy, or cause vision problems. Do notdrive a car or operate machinery until you know how this medication affects you.

• you should know that cyclophosphamide may cause severe or life-threatening urinary problems.Tell your doctor if you have problems urinating of if you have a bladder infection. Call yourdoctor immediately if you experience any of the following: pink or red colored urine or blood inthe urine; or frequent, urgent, or painful urination. You should also drink plenty of fluids andurinate frequently during your treatment to help reduce urinary side effects.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Cyclophosphamide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea, vomiting, or diarrhea
• loss of appetite or weight
• stomach pain
• hair loss
• sores in the mouth or throat
• changes in skin color
• changes in color or growth of finger or toenails

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:

• sore throat, fever, chills, or other signs of infection
• poor or slow wound healing
• black, tarry stools, or other unusual bruising or bleeding
• rash, hives, itching, or difficulty breathing or swallowing
• shortness of breath; swelling of the legs, ankles, or feet; fast, irregular, or poundingheartbeat; weight gain (more than 5 pounds [about 2.3 kilograms] in 24 hours)
• new or worsening cough, chest pain, or shortness of breath
• yellowing of the skin or eyes, extreme tiredness, nausea or vomiting, right-sided stomachpain, dark colored urine, decreased appetite

Cyclophosphamide may increase the risk that you will develop other cancers. Talk to your doctor about the risks of receiving cyclophosphamide injection.

Cyclophosphamide may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to cyclophosphamide injection.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.