Kepivance

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

This product is available in the following dosage forms:

• Powder for Solution

Before Using

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.

Pediatric

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.

Geriatric

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

Breastfeeding

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.

Drug Interactions

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)a€”May be worsened by palifermin

Proper Use

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:
    
    
    
    • Adultsa€”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.
    
    
    • Childrena€”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

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

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 .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.