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Khapzory Generic Name & Formulations
Legal Class
Rx
General Description
Levoleucovorin 175mg, 300mg; per vial; lyophilized pwd for IV inj after reconstitution and dilution; preservative-free.
Pharmacological Class
Folate analogue.
How Supplied
Single-dose vial—1
Manufacturer
Generic Availability
NO
Khapzory Indications
Indications
Treatment of metastatic colorectal cancer in combination with fluorouracil.
Limitations of Use
Not for treatment of pernicious anemia and megaloblastic anemia secondary to lack of Vit. B12 due to risk of progression of neurologic manifestations despite hematologic remission.
Khapzory Dosage and Administration
Adult
Administer levoleucovorin and fluorouracil separately to avoid precipitate formation. Regimen 1: give levoleucovorin 100mg/m2 by IV inj over a minimum of 3 minutes, followed by fluorouracil at 370mg/m2. Regimen 2: give levoleucovorin 10mg/m2 IV inj, followed by fluorouracil at 425mg/m2. Both: treat once daily for 5 days. The five-day treatment course may be repeated at 4 week intervals for 2 courses, and then every 4–5 weeks provided that patient recovered from toxicity from prior treatment course. Do not adjust dosage for toxicity.
Children
Not established.
Khapzory Contraindications
Not Applicable
Khapzory Boxed Warnings
Not Applicable
Khapzory Warnings/Precautions
Warnings/Precautions
Increased GI toxicity (w. fluorouracil): do not initiate or continue therapy until symptoms resolved. Monitor patients with diarrhea until resolved. Pregnancy. Nursing mothers.
Khapzory Pharmacokinetics
See Literature
Khapzory Interactions
Interactions
Monitor with antiepileptics (eg, phenobarbital, phenytoin, primidone). Potentiates fluorouracil toxicity: monitor for GI effects. Antagonizes TMP/SMZ.
Khapzory Adverse Reactions
Adverse Reactions
Stomatitis, diarrhea, nausea, vomiting, asthenia/fatigue/malaise, dermatitis, alopecia, anorexia/decreased appetite, abdominal pain.
Khapzory Clinical Trials
See Literature
Khapzory Note
Not Applicable
Khapzory Patient Counseling
See Literature
Khapzory Generic Name & Formulations
Legal Class
Rx
General Description
Levoleucovorin 175mg, 300mg; per vial; lyophilized pwd for IV inj after reconstitution and dilution; preservative-free.
Pharmacological Class
Folate analogue.
How Supplied
Single-dose vial—1
Manufacturer
Generic Availability
NO
Khapzory Indications
Indications
In osteosarcoma, as rescue after high-dose methotrexate (MTX) therapy. To reduce toxicity associated with overdose of folic acid antagonists or impaired MTX elimination.
Limitations of Use
Not for treatment of pernicious anemia and megaloblastic anemia secondary to lack of Vit. B12 due to risk of progression of neurologic manifestations despite hematologic remission.
Khapzory Dosage and Administration
Adults and Children
<6yrs: see full labeling. ≥6yrs: Give by IV inj. High-dose MTX rescue: Start 24hrs after the beginning of MTX infusion (based on MTX dose of 12g/m2 over 4hrs). Normal MTX elimination: give levoleucovorin 7.5mg (approx. 5mg/m2) every 6hrs for 10 doses. Delayed late MTX elimination: continue levoleucovorin 7.5mg every 6hrs until MTX <0.05micromolar; delayed early MTX elimination and/or evidence of acute renal injury: levoleucovorin 75mg every 3hrs until MTX <1micromolar, then 7.5mg every 3hrs until MTX <0.05micromolar. May continue another 24hrs for subsequent courses in cases of significant clinical toxicity. Folic acid antagonist overdose or impaired MTX elimination: Start as soon as possible or within 24hrs if MTX elimination impaired; give levoleucovorin 7.5mg every 6hrs until MTX <0.05micromolar. Adjustments: see full labeling.
Khapzory Contraindications
Not Applicable
Khapzory Boxed Warnings
Not Applicable
Khapzory Warnings/Precautions
Warnings/Precautions
Monitor serum creatinine and MTX levels at least once daily. Delayed early MTX elimination may cause reversible renal failure; provide hydration, alkalinize urine with sodium bicarbonate, closely monitor fluid and electrolytes until serum MTX <0.05micromolar and renal failure resolves. Pregnancy. Nursing mothers.
Khapzory Pharmacokinetics
See Literature
Khapzory Interactions
Interactions
Monitor with antiepileptics (eg, phenobarbital, phenytoin, primidone). Potentiates fluorouracil toxicity: monitor for GI effects. Antagonizes TMP/SMZ.
Khapzory Adverse Reactions
Adverse Reactions
Stomatitis, vomiting, nausea.
Khapzory Clinical Trials
See Literature
Khapzory Note
Not Applicable
Khapzory Patient Counseling
See Literature
