levoleucovorin (Rx)Brand and Other Names:Fusilev

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 50mg
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Methotrexate Inadvertent Overdose

7.5 mg (approximately 5 mg/m²) intravenously (IV) every 6 hours until the serum methotrexate level is less than 0.01 micromolar 

Measure methotrexate and creatinine levels at 24 hours interval; increase dose of levoleucovorin to 50 mg/m² IV every 3 hours until the methotrexate is less than 0.01 micromolar if methotrexate level is > 5 micromolar or serum creatinine has increased 50% over baseline after 24 hr of initiating treatment or if the 48 hr methotreaxate level is >0.9 micromolar

Aggressive hydration and urinary alkalinization (with sodium bicarbonate) should be maintained during the treatment period

High Dose Methotrexate Rescue

7.5 mg or 5 mg/m² IV q6hr for 10 doses starting 24 hr after initiating methotrexate infusion 

Renal failure may occur in patients with delayed early methotrexate elimination; such patients require continuing hydration and urinary alkalization (with sodium bicarbonate); fluid and electrolyte monitoring is necessary until serum methotrexate has fallen to below 0.05 micromolar and renal failure has resolved

Advanced Colorectal Cancer

Indicated in combination with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer

100 mg/m² by slow IV injection over a minimum of 3 minutes, followed by 5-FU at 370 mg/m² by IV injection, OR 

10 mg/m² by slow IV injection followed by 5-FU at 425 mg/m² by IV injection

Repeat daily for 5 days at 4-week intervals for 2 cycles, and then repeat at 4-5 week intervals provided that the patient has completely recovered from the toxic effects of the prior treatment course

5-FU dose may need to be adjusted downward by 20-30% according to toxicities or upward by 10% if no toxicities experienced

Administer levoleucovorin separate from 5-FU to avoid precipitant

Dosage Forms & Strengths

powder for injection

  • 50mg
more...

Methotrexate Inadvertent Overdose

7.5 mg (approximately 5 mg/m²) intravenously (IV) every 6 hours until the serum methotrexate level is less than 0.01 micromolar 

Measure methotrexate and creatinine levels at 24 hours interval; increase dose of levoleucovorin to 50 mg/m² IV every 3 hours until the methotrexate is less than 0.01 micromolar if methotrexate level is > 5 micromolar or serum creatinine has increased 50% over baseline after 24 hr of initiating treatment or if the 48 hr methotreaxate level is >0.9 micromolar

Aggressive hydration and urinary alkalinization (with sodium bicarbonate) should be maintained during the treatment period

High Dose Methotrexate Rescue

7.5 mg or 5 mg/m² IV q6hr for 10 doses starting 24 hr after initiating methotrexate infusion 

Renal failure may occur in patients with delayed early methotrexate elimination; such patients require continuing hydration and urinary alkalization (with sodium bicarbonate); fluid and electrolyte monitoring is necessary until serum methotrexate has fallen to below 0.05 micromolar and renal failure has resolved

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Interactions

Interaction Checker

levoleucovorin and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            Fatigue

            Dermatitis

            Alopecia

            Diarrhea

            Nausea

            Vomiting

            Abdominal pain

            Stomatitis

            Weakness/malaise

            Confusion

            Neuropathy

            Dyspnea

            Thrombocytosis

            Anaphylaxis

            Wheezing

            Urticaria

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            Warnings

            Contraindications

            Documented hypersensitivity to drug or related products

            Cautions

            Seizures and/or syncope reported

            May increase toxicity of 5-fluorouracil

            May increase treatment failure of sulfamethoxazole-trimethoprim therapies

            Should not be used to treat pernicious anemia or megaloblastic anemia secondary to vitamin B12 deficiency

            Risk of severe neurological complications in patients with undiagnosed anemia

            Administer as soon as possible following accidental folinic acid antagonist overdose

            Monitor methotrexate serum concentrations to determine appropriate dose and duration of levoleucovorin therapy

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Not known whether distributed in breast milk; 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

            Levoleucovorin does not require reduction by dihydrofolate reductase. Counteracts the toxic effects of folic acid antagonists. Supplies the necessary cofactor blocked by methotrexate.

            Stabilizes the binding of 5-fluoro-2-deoxyuridine-5-monophosphate to thymidylate synthetase resulting in its inhibition.

            Pharmacokinetics

            Peak plasma time: 0.9 hr (IV)

            Half-life elimination: 5-7 hr (15mg); 16-30 hr (300mg)

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            Administration

            IV Incompatibilities

            Coadministration with other agents could cause precipitation

            Administer 5-FU and levoleucovorin separately to avoid formation of precipitate

            IV Compatibilities

            NS, D5W

            Y-site: Granisetron

            IV Preparation

            Lyphilized powder: Reconstitute 50 mg vial w/ 5.3 mL NS to obtain 10 mg/mL solution

            May further dilute to 0.5 mg/mL w/ NS or D5W

            Stable 12 hr in NS & 4 hr in D5W at room temp

            Ready-to-use solution: 10 mg/mL; may dilute further with NS

            IV Administration

            IV injection not to exceed 160 mg/min

            Not for intrathecal use

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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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