Kepivance

DRUG DESCRIPTION

Kepivance (palifermin) is a truncated human KGF produced by recombinant DNA technology in E coli. Kepivance is a water soluble, 140 amino acid protein with a molecular weight of 16.3 kilodaltons. It differs from endogenous human KGF in that the first 23 N terminal amino acids have been deleted to improve protein stability.

Kepivance is supplied as a sterile, white, preservative-free, lyophilized powder for intravenous injection after reconstitution with 1.2 mL of Sterile Water for Injection, USP. Reconstitution yields a clear, colorless solution of Kepivance (5 mg/mL) with a pH of6.5. Each single use vial of Kepi vance contains palifermin (6.25 mg),with L histidine (1.94 mg), mannitol (50 mg), polysorbate 20 (0.13 mg or 0.01% w/v), and sucrose (25 mg).

What are the possible side effects of palifermin (Kepivance)?

If you experience any of the following serious side effects from palifermin, seek emergency medical attention or contact your doctor immediately:

  • fever;
  • breathing problems;
  • skin and mucus membrane side effects such as rash, redness, swelling, itching, unusual sensations in the mouth, tongue color change, tongue thickening and changes in taste.

Other common side effects include:

  • swelling;
  • pain;
  • joint pain;
  • increases in blood pancreas...

Read All Potential Side Effects and See Pictures of Kepivance


Kepivance Patient Information Including Side Effects

Brand Names: Kepivance

Generic Name: palifermin (Pronunciation: PAL ee FER min)

  • What is palifermin (Kepivance)?
  • What are the possible side effects of palifermin (Kepivance)?
  • What is the most important information I should know about palifermin (Kepivance)?
  • What should I discuss with my healthcare provider before receiving palifermin (Kepivance)?
  • How should I use palifermin (Kepivance)?
  • What happens if I miss a dose (Kepivance)?
  • What happens if I overdose (Kepivance)?
  • What should I avoid while using palifermin (Kepivance)?
  • What other drugs will affect palifermin (Kepivance)?
  • Where can I get more information?

What is palifermin (Kepivance)?

Palifermin is a human keratinocyte growth factor (KGF) produced by recombinant DNA technology.

Palifermin is used to reduce the chance of developing sores and ulcers in the mouth and to shorten the time with sores or ulcers in patients with blood cancers who receive high doses of chemotherapy and radiation therapy before bone marrow transplants.

Palifermin may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of palifermin (Kepivance)?

If you experience any of the following serious side effects from palifermin, seek emergency medical attention or contact your doctor immediately:

  • fever;
  • breathing problems;
  • skin and mucus membrane side effects such as rash, redness, swelling, itching, unusual sensations in the mouth, tongue color change, tongue thickening and changes in taste.

Other common side effects include:

  • swelling;
  • pain;
  • joint pain;
  • increases in blood pancreas enzymes;
  • increased blood pressure; or
  • protein in the urine.

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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about palifermin (Kepivance)?

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

If you experience any of the following serious side effects from palifermin, seek emergency medical attention or contact your doctor immediately:

  • fever;
  • breathing problems;
  • skin and mucus membrane side effects such as rash, redness, swelling, itching, unusual sensations in the mouth, tongue color change, tongue thickening and changes in taste.
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