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 is used to help prevent or lessen some side effects caused by other medicines or radiation therapy that are used to treat cancer.

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

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—

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of palifermin in children with use in other age groups.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of palifermin in the elderly with use in other age groups.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Non-hematologic malignancies (e.g., other cancerous tumors)—May be worsened by palifermin

Proper Use of This Medicine:

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 parenteral dosage form (injection):
  • For preventing or lessening side effects caused by medicines used to treat cancer:
    • Adults—60 milligrams (mg) per square meter of body surface area, injected into a vein for 3 consecutive days before and 3 consecutive days after myelotoxic therapy for a total of 6 doses.
    • Children—Use and dose must be determined by your doctor.

Storage—

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

Your doctor will want to check your progress at regular visits.

This medicine may cause some other tumors (not bone marrow tumors) to grow in animal models.Make sure your doctor knows if you have had any other type of tumor or cancer.

The importance of reporting any side effects to your doctor

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 immediately if any of the following side effects occur:

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 in moving

dizziness

elevated serum amylase

elevated serum lipase

fever

flushing, redness of skin

headache

increased sensitivity to pain

increased sensitivity to touch

itching skin

muscle pain or stiffness

nervousness

pain

pain in joints

pounding in the ears

rash

slow or fast heartbeat

swelling

tingling in the hands and feet

tongue discoloration

tongue thickening

unusually warm skin

Frequency unknown

Body produces substance that can bind to drug making it less effective or cause side effects

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.