Pronunciation:

pal-ee-FER-min

Brand Names:

• Kepivance

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Protectant, Dental

Pharmacologic—

Keratinocyte Growth Factor

Uses of This Medicine:

Palifermin injection is used to prevent or lessen side effects (such as swelling, irritation, sores or ulcers on the lining of the mouth) caused by cancer medicines that are used to treat blood or bone marrow problems. This medicine is used in patients who will be needing hematopoietic stem cell support.

This medicine is to be given only by or under the direct supervision of a doctor.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional 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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of palifermin injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Although appropriate studies on the relationship of age to the effects of palifermin injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased 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.

• Heparin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

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

• Other types of cancer or tumors—It is not known if this medicine will work in patients with these conditions.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

This medicine is given for 3 consecutive days before and 3 consecutive days after cancer treatment, for a total of 6 doses.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

This medicine may cause some tumors (not blood or bone marrow tumors) to grow. Tell your doctor right away if you have had any other types of tumor or cancer.

Tell your doctor right away if you have the following symptoms after receiving this medicine: a rash, itching, reddening of the skin, swelling of the tongue, or unusual taste in your mouth.

Side Effects of This Medicine:

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 or nurse immediately if any of the following side effects occur:

More common

Fever

Rare

Skin rash (severe)

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

Bad, unusual, or unpleasant (after) taste

blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in taste

difficulty with moving

discoloration of the tongue

dizziness

flushing or redness of the skin

headache

increased sensitivity to pain

increased sensitivity to touch

itching skin

muscle pain or stiffness

nervousness

pain

pain in the joints

pounding in the ears

rash (mild)

slow or fast heartbeat

swelling

thickening of the tongue

tingling in the hands and feet

unusually warm skin

Incidence not known

redness or swelling of the vagina

redness, swelling, or pain of the skin

scaling of the skin on the hands and feet

ulceration of the skin

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.