What is levoleucovorin?

Levoleucovorin is a folate analog and the pharmacologically active levo-isomer of d,l- leucovorin. The chemical name is (2S)-2-[[4-[[(6S)-2-amino-5-formyl-4-oxo-1,6,7,8-tetrahydropteridin-6- yl] methylamino] benzoyl] amino] pentanedioate. The molecular formula is C 20 H 23 N 7 O 7 and the molecular weight is 473.45. The molecular structure is: 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. Levoleucovorin Chemical Structure

Can you take levoleucovorin with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run levoleucovorin against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What brand names is levoleucovorin sold under?

We track 2 levoleucovorin-containing products in the U.S.: Fusilev and Khapzory. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

What forms does levoleucovorin come in?

Across the brands we track, levoleucovorin is currently marketed as solution, powder and injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic levoleucovorin?

We do not currently list a generic-labelled levoleucovorin product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Levoleucovorin: uses, dosing, side effects & brands

Levoleucovorin is a medicine sold in the U.S. under 2 brand and generic names, for drug-related side effects and adverse reactions. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesHow we research

Key facts

Treats: Drug-Related Side Effects and Adverse Reactions
Available as: Solution · Powder · Injectable
Sold as: 2 products — Fusilev and Khapzory
Prescription?: Prescription only
Generic available?: Not in our catalog

How levoleucovorin is dosed

From the FDA label for Khapzory (application NDA211226). Other levoleucovorin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

For intravenous administration only. Do not administer intrathecally. ( 2.1 ) Rescue After High-Dose Methotrexate Therapy Rescue recommendations are based on a methotrexate dose of 12 grams/ m 2 administered by intravenous infusion over 4 hours. Initiate rescue at a dose of 7.5 mg (approximately 5 mg/m 2 ) every 6 hours, 24 hours after the beginning of the methotrexate infusion. ( 2.2 ) Continue until the methotrexate level is below 5 x 10 -8 M (0.05 micromolar). Adjust dose if necessary, based on methotrexate elimination; refer to Full Prescribing Information. ( 2.2 ) Overdosage of Folic Acid Antagonists or Impaired Methotrexate Elimination Start as soon as possible after methotrexate overdosage or within 24 hours of delayed methotrexate elimination. ( 2.3 ) Administer KHAPZORY 7.5 mg (approximately 5 mg/m 2 ) intravenously every 6 hours until methotrexate level is less than 5 x 10 -8 M (0.05 micromolar). ( 2.3 ) Metastatic Colorectal Cancer in Combination with Fluorouracil The following regimens have been used for the treatment of colorectal cancer. o KHAPZORY 100 mg/m 2 by intravenous injection over a minimum of 3 minutes, followed by fluorouracil 370 mg/m 2 once daily for 5 consecutive days. ( 2.4 ) o KHAPZORY 10 mg/m 2 by intravenous injection followed by fluorouracil 425 mg/m 2 once daily for 5 consecutive days. ( 2.4 ) The above five-day courses may be repeated every 4…

Levoleucovorin side effects

The following clinical significant adverse reactions are described elsewhere in the labeling: • Increased gastrointestinal toxicities with fluorouracil [see Warnings and Precautions ( 5.1 )] The most common adverse reactions (≥ 20%) in patients receiving high-dose methotrexate therapy with levoleucovorin rescue are stomatitis and vomiting. ( 6.1 ) The most common adverse reactions (>50%) in patients receiving levoleucovorin in combination with fluorouracil for metastatic colorectal cancer are stomatitis, diarrhea, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Acrotech Biopharma Inc at 1-888-292-9617 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical 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/m 2 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. Table 2…

Every levoleucovorin product we track (2)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Levoleucovorin products
#	Drug	Rating	Type	Form	Generic?	Typical price
1	Fusilev	Not yet rated	Prescription	Solution	—	—	View →
2	Khapzory	Not yet rated	Prescription	Injectable	—	—	View →

Frequently asked questions

What is levoleucovorin?: Levoleucovorin is a folate analog and the pharmacologically active levo-isomer of d,l- leucovorin. The chemical name is (2S)-2-[[4-[[(6S)-2-amino-5-formyl-4-oxo-1,6,7,8-tetrahydropteridin-6- yl] methylamino] benzoyl] amino] pentanedioate. The molecular formula is C 20 H 23 N 7 O 7 and the molecular weight is 473.45. The molecular structure is: 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. Levoleucovorin Chemical Structure
Can you take levoleucovorin with other medicines?: It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run levoleucovorin against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is levoleucovorin sold under?: We track 2 levoleucovorin-containing products in the U.S.: Fusilev and Khapzory. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does levoleucovorin come in?: Across the brands we track, levoleucovorin is currently marketed as solution, powder and injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic levoleucovorin?: We do not currently list a generic-labelled levoleucovorin product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.