palifermin (Rx)

Brand and Other Names:Kepivance
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 6.25mg
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Oral Mucositis

Indicated for severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support

Also indicated as supportive care for preparative regimens predicted to result in WHO Grade 3 or greater mucositis in the majority of patients

60 mcg/kg IV bolus 3 consecutive days before and 3 consecutive days after myelotoxic therapy (6 doses total) 

Dosage schedule

  • Premyelotoxic therapy
    • Administer the first 3 doses prior to myelotoxic therapy
    • Administer the third dose 24-48 hr prior to beginning myelotoxic therapy
  • Postmyelotoxic therapy
    • Administer the last 3 doses after myelotoxic therapy is complete
    • Administer 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 palifermin (ie, 3rd premyelotoxic dose)

Dosage Modification

Renal or hepatic impairment: Dose adjustment not necessary

Limitation of Use

The safety and efficacy of not established in patients with non-hematologic malignancies

Not effective in decreasing incidence of severe mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of allogeneic hematopoietic stem cell support

Not recommended for use with melphalan 200 mg/m² as a conditioning regimen

Safety and efficacy not established

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Interactions

Interaction Checker

and palifermin

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Elevated serum amylase (62%)

            Rash (62%)

            Fever (39%)

            Pruritus (35%)

            Erythema (32%)

            Edema (28%)

            Elevated serum lipase (28%)

            Mouth/tongue thickness/discoloration (17%)

            proteinuria (17%)

            Pain (16%)

            Taste altered (16%)

            Dysesthesia (12%)

            1-10%

            Arthralgia (10%)

            Hypertension (7%)

            Antibody formation (2%)

            <1%

            Cough

            Vaginal erythema

            Vaginal edema

            Cataracts

            Perianal pain

            Rhinitis

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            Warnings

            Contraindications

            Hypersensitivity to palifermin or E coli-derived proteins

            Cautions

            Do not administer <24 hr before, during, or <24 hr after myelotoxic treatment; may worsen mucositis

            Potential for tumor growth stimulation

            Safety/efficacy not established for nonhematologic malignancies

            Do not freeze reconstituted solution

            Not recommended for use with melphalan 200 mg/m² as a conditioning regimen

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Not recommended

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Recombinant human keratinocyte growth factor, stimulates epithelial cell differentiation, proliferation, and migration in many tissues

            Pharmacokinetics

            Half-Life, Elimination: 3.3-5.7 hr

            Onset: 48 hr

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            Administration

            IV Preparation

            Reconstitute aseptically by injecting 1.2 mL sterile water for injection to yield a concentration of 5 mg/mL

            Gently swirl to mix - do not shake vigorously

            Reconstituted solution should be clear & colorless - do not use if discolored or turbid, do not filter

            IV Administration

            IV bolus

            If heparin is used to maintain an IV line, rinse with saline before & after palifermin administration

            Storage

            Reconstituted IV solution may be stored at 2-8°C for up to 24 hr

            Do not freeze reconstituted solution

            Do not let reconstituted solution sit at room temp >1 hr

            Protect from light

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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