Brand Name
Khapzory
Generic Name
Levoleucovorin
View Brand Information FDA approval date: July 07, 2016
Classification: Folate Analog
Form: Injection
What is Khapzory (Levoleucovorin)?
Levoleucovorin injection is indicated for: rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. the treatment of adults with metastatic colorectal cancer in combination with fluorouracil. Limitations of Use: Levoleucovorin injection is not indicated for pernicious anemia and megaloblastic anemia secondary to the lack of vitamin B 12, because of the risk of progression of neurologic manifestations despite hematologic remission. Levoleucovorin injection is a folate analog indicated for: Rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. Treatment of adults with metastatic colorectal cancer in combination with fluorouracil. Limitations of Use: Levoleucovorin injection is not indicated for the treatment of pernicious anemia and megaloblastic anemia secondary to lack of vitamin B 12, because of the risk of progression of neurologic manifestations despite hematologic remission.
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Brand Information
KHAPZORY (levoleucovorin)
1INDICATIONS AND USAGE
KHAPZORY is indicated for:
- rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma.
- diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination adult and pediatric patients.
- The treatment of adults with metastatic colorectal cancer in combination with fluorouracil.
Limitations of Use
KHAPZORY is not indicated for pernicious anemia and megaloblastic anemia secondary to lack the of vitamin B
2DOSAGE FORMS AND STRENGTHS
For Injection: 175 mg of levoleucovorin as a sterile, white to yellowish lyophilized powder in a single-dose vial for reconstitution.
3CONTRAINDICATIONS
KHAPZORY is contraindicated in patients who have had severe hypersensitivity to leucovorin products, folic acid, or folinic acid
4ADVERSE REACTIONS
The following clinical significant adverse reactions are described elsewhere in the labeling:
- Increased gastrointestinal toxicities with fluorouracil
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
High-Dose Methotrexate Therapy
Table 2 presents the frequency of adverse reactions which occurred during the administration of 58 courses of high-dose methotrexate 12 grams/m2 followed by levoleucovorin rescue, for osteosarcoma, in 16 patients aged 6 to 21 years. Most patients received levoleucovorin 7.5 mg every 6 hours for 60 hours or longer, beginning 24 hours after completion of methotrexate administration.
Combination with Fluorouracil in Colorectal Cancer
Table 3 presents the frequency of adverse reactions which occurred in 2 arms of a randomized controlled trial conducted by the North Central Cancer Treatment Group (NCCTG) in patients with metastatic colorectal cancer. The trial failed to show superior overall survival with fluorouracil + levoleucovorin compared to fluorouracil + d,l-leucovorin. Patients were randomized to fluorouracil 370 mg/m2 intravenously and levoleucovorin 100 mg/m2 intravenously, both daily for 5 days, or to fluorouracil 370 mg/m2 intravenously and d,l-leucovorin 200 mg/m2 intravenously, both daily for 5 days. Treatment was repeated week 4 and week 8, and then every 5 weeks until disease progression or unacceptable toxicity.
*Includes abdominal pain, upper abdominal pain, lower abdominal pain, and abdominal tenderness
4.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of levoleucovorin products. Because these adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following have been reported:
- Dermatologic: pruritus, rash
- Respiratory: dyspnea
- Other Clinical Events: temperature change, rigors, allergic reactions
5DESCRIPTION
Levoleucovorin is a folate analog and the pharmacologically active levo-isomer of
Levoleucovorin is a slightly hygroscopic, crystalline, yellow powder which is soluble in water when pH is at or above 8.
KHAPZORY 175 mg is a sterile lyophilized powder consisting of 175 mg levoleucovorin, 29.6 mg sodium hydroxide, and 105 mg mannitol in each vial. Additional sodium hydroxide and/or hydrochloric acid may be used to adjust the pH during manufacture. It is intended for intravenous administration after reconstitution with 3.6 mL of sterile 0.9% Sodium Chloride Injection, USP.
6HOW SUPPLIED/STORAGE AND HANDLING
KHAPZORY (levoleucovorin) for injection is a sterile, preservative-free, white to yellowish lyophilized powder in a single-dose vial. It is available as:
175 mg vial –NDC 72893-004-01.
Distributed by:
KHAPZORY is a registered trademark of Acrotech Biopharma Inc.
7PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Carton Label
NDC 72893-004-01
175 mg/vial
For Intravenous use only
Single-dose vial
Vial Label
NDC 72893-004-01
175 mg/vial
For Intravenous use only
Single-dose vial