Colorectal and other GI cancers:
Indications for: KHAPZORY
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.
Adult Dosage:
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 Dosage:
Not established.
KHAPZORY 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 Classification:
Folate analogue.
KHAPZORY Interactions:
Monitor with antiepileptics (eg, phenobarbital, phenytoin, primidone). Potentiates fluorouracil toxicity: monitor for GI effects. Antagonizes TMP/SMZ.
Adverse Reactions:
Stomatitis, diarrhea, nausea, vomiting, asthenia/fatigue/malaise, dermatitis, alopecia, anorexia/decreased appetite, abdominal pain.
Generic Drug Availability:
NO
How Supplied:
Single-dose vial—1
Cytoprotective and supportive care agents:
Indications for: KHAPZORY
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.
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 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 Classification:
Folate analogue.
KHAPZORY Interactions:
Monitor with antiepileptics (eg, phenobarbital, phenytoin, primidone). Potentiates fluorouracil toxicity: monitor for GI effects. Antagonizes TMP/SMZ.
Adverse Reactions:
Stomatitis, vomiting, nausea.
Generic Drug Availability:
NO
How Supplied:
Single-dose vial—1
