Kepivance is a manmade form of a human protein that affects growth of cells within the tissues lining your mouth and digestive tract (esophagus, stomach, and intestines).

Kepivance is used to help prevent or heal mouth sores and ulcers in people being treated with chemotherapy and stem cell treatment.

Kepivance is used in people receiving chemotherapy to treat blood cancers (Hodgkin's disease, multiple myeloma, leukemia). This medicine is not a treatment for the cancer itself.

You should not use Kepivance if you are allergic to palifermin.

Kepivance is given as an I .V. (in the vein) infusion for three days before you get chemotherapy and then three days after. It should not be given to you within 24 hours of your chemotherapy treatment.

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.

Before taking this medicine

You should not use Kepivance if you are allergic to palifermin.

Kepivance may cause growth in tumors that are not related to a blood cancer. Talk to your doctor if you have a history of any type of tumor.

Palifermin may harm an unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

Palifermin may affect fertility (your ability to have children), whether you are a man or a woman.

Do not breastfeed while using Kepivance, and for at least 2 weeks after your last dose.

Kepivance is not approved for use by anyone younger than 1 year old.

Kepivance given as an IV infusion into a vein. A healthcare provider will give you this injection before and after your chemotherapy treatment.

Your injections are timed to take place at certain intervals as part of your treatment. Carefully follow your doctor's instructions about when to receive each injection.

Kepivance should not be given within 24 hours before you receive your chemotherapy.

Usual Adult Dose for Mucositis:

60 mcg/kg IV bolus daily for 6 doses administered on 3 consecutive days prior to and 3 consecutive days after myelotoxic therapy

Prior to myelotoxic therapy, administer the third dose no later than 24 to 48 hours prior to initiation of myelotoxic therapy.

Following myelotoxic therapy, administer the first dose no sooner than 4 days after the most recent Kepivance administration and on the same day of hematopoietic stem cell infusion.

You should not use Kepivance if you are allergic to palifermin.

Kepivance may cause growth in tumors that are not related to a blood cancer. Talk to your doctor if you have a history of any type of tumor.

Palifermin may harm an unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

Palifermin may affect fertility (your ability to have children), whether you are a man or a woman.

Do not breastfeed while using Kepivance, and for at least 2 weeks after your last dose.

Kepivance is not approved for use by anyone younger than 1 year old.

Call your doctor for instructions if you miss an appointment for your Kepivance injection.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have any signs of an allergic reaction to Kepivance: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• blurred vision, tunnel vision, eye pain, or seeing halos around lights.

Common Kepivance side effects may include:

• fever;

• swelling or redness of your skin;

• itching or rash; or

• abnormal blood test.

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 interact with palifermin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.