Cosmegen is used to treat different types of cancers that affect the kidneys, uterus, testicles, bones, muscles, joints, and soft tissues. This medicine is also used to treat solid tumors.

Cosmegen may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Cosmegen is given as an infusion into a vein. A healthcare provider will give you this injection.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when Cosmegen is injected.

For most conditions, Cosmegen is given once every 3 weeks for several months, or up to 2 years or longer. You may receive this medicine more often or less often, depending on the type of cancer you have. For solid tumors, you may only receive one dose.

Your doctor will determine how long to treat you.

Cosmegen can lower your blood cell counts. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results.

Using Cosmegen may increase your risk of developing other cancers, such as leukemia. Ask your doctor about this risk.

Tell your doctor if you have ever had:

• liver disease; or

• radiation treatment.

Cosmegen can harm an unborn baby or cause birth defects if the mother or the father is using Cosmegen.

• If you are a woman, do not use Cosmegen if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Cosmegen.

You should not breastfeed while you are using Cosmegen.

Call your doctor for instructions if you miss an appointment for your Cosmegen.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine while using Cosmegen. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Cosmegen may cause serious side effects. Call your doctor at once if you have:

• swelling or tenderness in your stomach (upper right side), rapid weight gain;

• swelling in your arms or legs;

• dark urine, jaundice (yellowing of the skin or eyes);

• redness of your skin or the inside of your mouth and throat (if you are also receiving radiation treatment);

• sores or white patches in or around your mouth, trouble swallowing or talking, dry mouth, bad breath, altered sense of taste;

• blisters, ulcers, or other skin changes where an injection was given; or

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects of Cosmegen may include:

• hair loss;

• fever, infections, low blood cell counts;

• rash;

• trouble swallowing;

• nausea, vomiting; or

• tiredness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect Cosmegen, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.