Palifermin

What is Palifermin?

• Palifermin (Kepivance) is a truncated recombinant keratinocyte growth factor (KGF) produced by recombinant DNA technology in E coli used to treat Oral mucositis that is severe.

Limitations of Use:

• The safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies.
• Kepivance was not effective in decreasing the incidence of severe mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of allogeneic hematopoietic stem cell support.
• Kepivance is not recommended for use with melphalan 200 mg/m 2 as a conditioning regimen.

What are the uses of this medicine?

• Palifermin (Kepivance) to decrease the incidence and duration of severe oral mucositis in patients with blood cancers (leukemia and lymphoma) receive high dose chemotherapy and radiation therapy to undergo bone marrow transplantation.
• They usually get severe oral mucositis.
• Palifermin reduces the incidence and duration of severe oral mucositis by protecting those cells and stimulating the growth of new epithelial cells to build up the mucosal barrier.

How does this medicine work?

• Keratinocyte growth factor (KGF) resides in the family of fibroblast growth factor (FGF).
• The drug’s target is the KGF receptor.
• Through the binding of this drug to the aforementioned receptor, Palifermin stimulates epithelial cell proliferation, differentiation, and upregulation of cytoprotective mechanisms to reduce the symptoms of oral mucositis.

Who Should Not Use this medicine ?

Limitations of Use:

• The safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies.
• Kepivance was not effective in decreasing the incidence of severe mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of allogeneic hematopoietic stem cell support.
• Kepivance is not recommended for use with melphalan 200 mg/m 2 as a conditioning regimen.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take.

Be sure to mention any of the following:

• dalteparin (Fragmin)
• enoxaparin (Lovenox)
• heparin
• tinzaparin (Innohep)

• Drug interactions with Heparin include a significantly increased systemic exposure to Palifermin.
• Avoid administration of Palifermin within 24 hours of myeltoxic chemotherapy, as this could result in increased oral mucositis.

Is this medicine FDA approved?

• Initial U.S. Approval: 2004

How should this medicine be used?

Recommended dosage:

• The recommended dose of Kepivance is 60 mcg/kg/day, administered as an intravenous bolus injection for 3 consecutive days before and 3 consecutive days after myelotoxic therapy, for a total of 6 doses.
• The recommended dose of Kepivance is 60 mcg/kg/day, administered as an intravenous bolus injection for 3 consecutive days before and 3 consecutive days after myelotoxic therapy, for a total of 6 doses.
• Administer the first 3 doses prior to myelotoxic therapy. Administer the third dose 24 to 48 hours prior to beginning myelotoxic therapy.
• Administer the last 3 doses after myelotoxic therapy is complete with the first of these doses on the day of hematopoietic stem cell infusion after the infusion is completed, and at least 7 days after the most recent administration of Kepivance.

Administration:

• Palifermin comes as a powder to be mixed with liquid to be injected intravenously (into a vein).
• It is usually given once a day for 3 days in a row before you receive your chemotherapy treatment and then once a day for 3 days in a row after you receive your chemotherapy for a total of 6 doses.
• You will not be given palifermin on the same day that you are given your cancer chemotherapy treatment.
• Palifermin must be given at least 24 hours before and at least 24 hours after you receive your chemotherapy treatment.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 6.25 mg lyophilized powder in single-dose vials

This medicine is available in fallowing brand namesː

• Kepivance

What side effects can this medication cause?

The most common side effects of this medicine include:

• rash
• fever
• elevated serum amylase
• pruritus
• erythema
• edema

Kepivance may cause some of the serious side effects:

• Difficulty breathing
• Changes in cutaneous or mucous membrane appearance/feel (redness/rash, swelling, itching, change in color or thickness of tongue, changes in taste)
• Fever

What special precautions should I follow?

That the safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies. Advise patients to report the following to healthcare providers:

• Rashes and reddening of skin
• Itchiness
• Swelling of tongue
• Changes in mouth and tongue sensation
• Alteration in taste

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• thick tongue
• change in color of tongue
• change in ability to taste food
• increased or decreased feelings when touched, especially in and around the mouth
• burning or tingling, especially in and around the mouth
• joint pain
• rash
• red or itching skin
• swelling of the hands, feet, ankles, or lower legs
• fever

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on findings in animal studies, Kepivance may cause fetal harm when administered to pregnant women.
• There are no data available on Kepivance use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• Information on the dosing and safety of Kepivance in the pediatric population is limited.
• However, use of Kepivance in pediatric patients ages 1 to 16 years is supported by evidence from adequate and well-controlled studies of Kepivance in adults and a phase 1 study that included 27 pediatric patients with acute leukemia undergoing hematopoietic stem cell transplant.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• PALIFERMIN

Inactive ingredients:

• MANNITOL
• SUCROSE
• HISTIDINE
• POLYSORBATE 20

Who manufactures and distributes this medicine?

Manufactured by:

• Swedish Orphan Biovitrum AB (publ)
• SE-112 76 Stockholm, Sweden

What should I know about storage and disposal of this medication?

• Store Kepivance vials in the dispensing pack in its carton refrigerated at 2° to 8°C (36° to 46°F) until time of use.
• Protect from light.

• Dailymed label info on Palifermin
• FDA Palifermin

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