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Fusilev
Overview
What is Fusilev?
Levoleucovorin is the levo isomeric form of racemic -leucovorin, present as the calcium salt. Levoleucovorin is the pharmacologically active isomer of leucovorin [(6-S)-leucovorin].
Fusilev for Injection and Fusilev Injection contain levoleucovorin calcium, which is one of several active, chemically reduced derivatives of folic acid. It is useful as antidote to the inhibition of dihydrofolate reductase by methotrexate. This compound has the chemical designation calcium (6S)-N-{4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl}-L-glutamate pentahydrate. The molecular weight is 601.6 and the structural formula is:
Its molecular formula is: CHCaNO
5 HO.
Fusilev for Injection is supplied as a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium pentahydrate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol per 50 mg vial. Sodium hydroxide and/or hydrochloric acid are used to adjust the pH during manufacture. It is intended for intravenous administration after reconstitution with 5.3 mL of sterile 0.9% Sodium Chloride Injection, USP []
Fusilev Injection is supplied as a sterile solution of either 175 mg levoleucovorin in 17.5 mL or 250 mg levoleucovorin in 25 mL. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. Sodium hydroxide is used for pH adjustment to pH 8.0 (6.5 to 8.5).
What does Fusilev look like?
What are the available doses of Fusilev?
Fusilev for Injection: Each 50 mg single-use vial of Fusilev contains a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium pentahydrate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. (3, 11, 16) It is intended for intravenous administration after reconstitution with 5.3 mL of sterile 0.9% Sodium Chloride Injection, USP. (2.6, 11)
Fusilev Injection: 17.5 mL of a sterile solution containing levoleucovorin calcium pentahydrate equivalent to 175 mg levoleucovorin and 0.83% sodium chloride. (3, 11, 16)
Fusilev Injection: 25 mL of a sterile solution containing levoleucovorin calcium pentahydrate equivalent to 250 mg levoleucovorin and 0.83% sodium chloride. (3, 11, 16)
What should I talk to my health care provider before I take Fusilev?
How should I use Fusilev?
Fusilev is a folate analog indicated for:
Limitations of Use
Fusilev is not approved for pernicious anemia and megaloblastic anemias. Improper use may cause a hematologic remission while neurologic manifestations continue to progress. (1.1)
Fusilev is dosed at the usual dose of racemic -leucovorin.
Fusilev is indicated for intravenous administration only
Do not administer intrathecally.
What interacts with Fusilev?
Sorry No Records found
What are the warnings of Fusilev?
Sorry No Records found
What are the precautions of Fusilev?
Sorry No Records found
What are the side effects of Fusilev?
Sorry No records found
What should I look out for while using Fusilev?
Fusilev is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid.
What might happen if I take too much Fusilev?
No data are available for overdosage with levoleucovorin.
How should I store and handle Fusilev?
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.Each 50 mg single-use vial of Fusilev for Injection contains a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium pentahydrate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. 50 mg vial of freeze-dried powder – NDC 68152-101-00.Store at 25° C (77 °F) in carton until contents are used. Excursions permitted from 15-30° C (59-86 °F). [See USP Controlled Room Temperature]. Protect from light.Fusilev Injection, 175 mg contains 17.5 mL sterile solution in a single-use vial. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. 175 mg/17.5 mL solution – NDC 68152-102-01Fusilev Injection, 250 mg contains 25 mL sterile solution in a single-use vial. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. 250 mg/25 mL solution – NDC 68152-102-02Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until contents are used.Manufactured for Spectrum Pharmaceuticals, Inc. Irvine, CA 92618Fusilev is a registered trademark of Spectrum Pharmaceuticals, Inc.Each 50 mg single-use vial of Fusilev for Injection contains a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium pentahydrate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. 50 mg vial of freeze-dried powder – NDC 68152-101-00.Store at 25° C (77 °F) in carton until contents are used. Excursions permitted from 15-30° C (59-86 °F). [See USP Controlled Room Temperature]. Protect from light.Fusilev Injection, 175 mg contains 17.5 mL sterile solution in a single-use vial. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. 175 mg/17.5 mL solution – NDC 68152-102-01Fusilev Injection, 250 mg contains 25 mL sterile solution in a single-use vial. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. 250 mg/25 mL solution – NDC 68152-102-02Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until contents are used.Manufactured for Spectrum Pharmaceuticals, Inc. Irvine, CA 92618Fusilev is a registered trademark of Spectrum Pharmaceuticals, Inc.Each 50 mg single-use vial of Fusilev for Injection contains a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium pentahydrate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. 50 mg vial of freeze-dried powder – NDC 68152-101-00.Store at 25° C (77 °F) in carton until contents are used. Excursions permitted from 15-30° C (59-86 °F). [See USP Controlled Room Temperature]. Protect from light.Fusilev Injection, 175 mg contains 17.5 mL sterile solution in a single-use vial. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. 175 mg/17.5 mL solution – NDC 68152-102-01Fusilev Injection, 250 mg contains 25 mL sterile solution in a single-use vial. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. 250 mg/25 mL solution – NDC 68152-102-02Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until contents are used.Manufactured for Spectrum Pharmaceuticals, Inc. Irvine, CA 92618Fusilev is a registered trademark of Spectrum Pharmaceuticals, Inc.Each 50 mg single-use vial of Fusilev for Injection contains a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium pentahydrate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. 50 mg vial of freeze-dried powder – NDC 68152-101-00.Store at 25° C (77 °F) in carton until contents are used. Excursions permitted from 15-30° C (59-86 °F). [See USP Controlled Room Temperature]. Protect from light.Fusilev Injection, 175 mg contains 17.5 mL sterile solution in a single-use vial. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. 175 mg/17.5 mL solution – NDC 68152-102-01Fusilev Injection, 250 mg contains 25 mL sterile solution in a single-use vial. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. 250 mg/25 mL solution – NDC 68152-102-02Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until contents are used.Manufactured for Spectrum Pharmaceuticals, Inc. Irvine, CA 92618Fusilev is a registered trademark of Spectrum Pharmaceuticals, Inc.Each 50 mg single-use vial of Fusilev for Injection contains a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium pentahydrate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. 50 mg vial of freeze-dried powder – NDC 68152-101-00.Store at 25° C (77 °F) in carton until contents are used. Excursions permitted from 15-30° C (59-86 °F). [See USP Controlled Room Temperature]. Protect from light.Fusilev Injection, 175 mg contains 17.5 mL sterile solution in a single-use vial. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. 175 mg/17.5 mL solution – NDC 68152-102-01Fusilev Injection, 250 mg contains 25 mL sterile solution in a single-use vial. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. 250 mg/25 mL solution – NDC 68152-102-02Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until contents are used.Manufactured for Spectrum Pharmaceuticals, Inc. Irvine, CA 92618Fusilev is a registered trademark of Spectrum Pharmaceuticals, Inc.Each 50 mg single-use vial of Fusilev for Injection contains a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium pentahydrate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. 50 mg vial of freeze-dried powder – NDC 68152-101-00.Store at 25° C (77 °F) in carton until contents are used. Excursions permitted from 15-30° C (59-86 °F). [See USP Controlled Room Temperature]. Protect from light.Fusilev Injection, 175 mg contains 17.5 mL sterile solution in a single-use vial. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. 175 mg/17.5 mL solution – NDC 68152-102-01Fusilev Injection, 250 mg contains 25 mL sterile solution in a single-use vial. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. 250 mg/25 mL solution – NDC 68152-102-02Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until contents are used.Manufactured for Spectrum Pharmaceuticals, Inc. Irvine, CA 92618Fusilev is a registered trademark of Spectrum Pharmaceuticals, Inc.Each 50 mg single-use vial of Fusilev for Injection contains a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium pentahydrate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. 50 mg vial of freeze-dried powder – NDC 68152-101-00.Store at 25° C (77 °F) in carton until contents are used. Excursions permitted from 15-30° C (59-86 °F). [See USP Controlled Room Temperature]. Protect from light.Fusilev Injection, 175 mg contains 17.5 mL sterile solution in a single-use vial. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. 175 mg/17.5 mL solution – NDC 68152-102-01Fusilev Injection, 250 mg contains 25 mL sterile solution in a single-use vial. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. 250 mg/25 mL solution – NDC 68152-102-02Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until contents are used.Manufactured for Spectrum Pharmaceuticals, Inc. Irvine, CA 92618Fusilev is a registered trademark of Spectrum Pharmaceuticals, Inc.Each 50 mg single-use vial of Fusilev for Injection contains a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium pentahydrate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. 50 mg vial of freeze-dried powder – NDC 68152-101-00.Store at 25° C (77 °F) in carton until contents are used. Excursions permitted from 15-30° C (59-86 °F). [See USP Controlled Room Temperature]. Protect from light.Fusilev Injection, 175 mg contains 17.5 mL sterile solution in a single-use vial. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. 175 mg/17.5 mL solution – NDC 68152-102-01Fusilev Injection, 250 mg contains 25 mL sterile solution in a single-use vial. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. 250 mg/25 mL solution – NDC 68152-102-02Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until contents are used.Manufactured for Spectrum Pharmaceuticals, Inc. Irvine, CA 92618Fusilev is a registered trademark of Spectrum Pharmaceuticals, Inc.Each 50 mg single-use vial of Fusilev for Injection contains a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium pentahydrate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. 50 mg vial of freeze-dried powder – NDC 68152-101-00.Store at 25° C (77 °F) in carton until contents are used. Excursions permitted from 15-30° C (59-86 °F). [See USP Controlled Room Temperature]. Protect from light.Fusilev Injection, 175 mg contains 17.5 mL sterile solution in a single-use vial. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. 175 mg/17.5 mL solution – NDC 68152-102-01Fusilev Injection, 250 mg contains 25 mL sterile solution in a single-use vial. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. 250 mg/25 mL solution – NDC 68152-102-02Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until contents are used.Manufactured for Spectrum Pharmaceuticals, Inc. Irvine, CA 92618Fusilev is a registered trademark of Spectrum Pharmaceuticals, Inc.Each 50 mg single-use vial of Fusilev for Injection contains a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium pentahydrate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. 50 mg vial of freeze-dried powder – NDC 68152-101-00.Store at 25° C (77 °F) in carton until contents are used. Excursions permitted from 15-30° C (59-86 °F). [See USP Controlled Room Temperature]. Protect from light.Fusilev Injection, 175 mg contains 17.5 mL sterile solution in a single-use vial. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. 175 mg/17.5 mL solution – NDC 68152-102-01Fusilev Injection, 250 mg contains 25 mL sterile solution in a single-use vial. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. 250 mg/25 mL solution – NDC 68152-102-02Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until contents are used.Manufactured for Spectrum Pharmaceuticals, Inc. Irvine, CA 92618Fusilev is a registered trademark of Spectrum Pharmaceuticals, Inc.Each 50 mg single-use vial of Fusilev for Injection contains a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium pentahydrate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. 50 mg vial of freeze-dried powder – NDC 68152-101-00.Store at 25° C (77 °F) in carton until contents are used. Excursions permitted from 15-30° C (59-86 °F). [See USP Controlled Room Temperature]. Protect from light.Fusilev Injection, 175 mg contains 17.5 mL sterile solution in a single-use vial. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. 175 mg/17.5 mL solution – NDC 68152-102-01Fusilev Injection, 250 mg contains 25 mL sterile solution in a single-use vial. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. 250 mg/25 mL solution – NDC 68152-102-02Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until contents are used.Manufactured for Spectrum Pharmaceuticals, Inc. Irvine, CA 92618Fusilev is a registered trademark of Spectrum Pharmaceuticals, Inc.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
12.1.1 Levoleucovorin effects during high-dose methotrexate therapy
Levoleucovorin is the pharmacologically active isomer of 5-formyl tetrahydrofolic acid. Levoleucovorin does not require reduction by the enzyme dihydrofolate reductase in order to participate in reactions utilizing folates as a source of “one-carbon” moieties. Administration of levoleucovorin can counteract the therapeutic and toxic effects of folic acid antagonists such as methotrexate, which act by inhibiting dihydrofolate reductase.
12.1.2 Levoleucovorin effects in combination with 5-fluorouracil
Levoleucovorin can enhance the therapeutic and toxic effects of fluoropyrimidines used in cancer therapy such as 5-fluorouracil. 5-fluorouracil is metabolized to 5-fluoro-2'-deoxyuridine-5'-monophosphate (FdUMP), which binds to and inhibits thymidylate synthase (an enzyme important in DNA repair and replication). Levoleucovorin is readily converted to another reduced folate, 5,10-methylenetetrahydrofolate, which acts to stabilize the binding of FdUMP to thymidylate synthase and thereby enhances the inhibition of this enzyme.
Non-Clinical Toxicology
Fusilev is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid.Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors and angiotensin II antagonists. These interactions should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors or angiotensin II antagonists. In some patients with compromised renal function, the co-administration of an NSAID and an ACE-inhibitor or an angiotensin II antagonist may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Acetaminophen had no effect on the plasma levels of sulindac or its sulfide metabolite.
The concomitant administration of aspirin with sulindac significantly depressed the plasma levels of the active sulfide metabolite. A double-blind study compared the safety and efficacy of sulindac 300 or 400 mg daily given alone or with aspirin 2.4 g/day for the treatment of osteoarthritis. The addition of aspirin did not alter the types of clinical or laboratory adverse experiences for sulindac; however, the combination showed an increase in the incidence of gastrointestinal adverse experiences. Since the addition of aspirin did not have a favorable effect on the therapeutic response to sulindac, the combination is not recommended.
Administration of non-steroidal anti-inflammatory drugs concomitantly with cyclosporine has been associated with an increase in cyclosporine-induced toxicity, possibly due to decreased synthesis of renal prostacyclin. NSAIDs should be used with caution in patients taking cyclosporine, and renal function should be carefully monitored.
The concomitant administration of sulindac and diflunisal in normal volunteers resulted in lowering of the plasma levels of the active sulindac sulfide metabolite by approximately one-third.
Clinical studies, as well as post marketing observations, have shown that sulindac can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see ), as well as to assure diuretic efficacy.
DMSO should not be used with sulindac. Concomitant administration has been reported to reduce the plasma levels of the active sulfide metabolite and potentially reduce efficacy. In addition, this combination has been reported to cause peripheral neuropathy.
NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.
NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.
The concomitant use of sulindac with other NSAIDs is not recommended due to the increased possibility of gastrointestinal toxicity, with little or no increase in efficacy.
Although sulindac and its sulfide metabolite are highly bound to protein, studies in which sulindac was given at a dose of 400 mg daily have shown no clinically significant interaction with oral anticoagulants. However, patients should be monitored carefully until it is certain that no change in their anticoagulant dosage is required. Special attention should be paid to patients taking higher doses than those recommended and to patients with renal impairment or other metabolic defects that might increase sulindac blood levels. The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.
Although sulindac and its sulfide metabolite are highly bound to protein, studies in which sulindac was given at a dose of 400 mg daily, have shown no clinically significant interaction with oral hypoglycemic agents. However, patients should be monitored carefully until it is certain that no change in their hypoglycemic dosage is required. Special attention should be paid to patients taking higher doses than those recommended and to patients with renal impairment or other metabolic defects that might increase sulindac blood levels.
Probenecid given concomitantly with sulindac had only a slight effect on plasma sulfide levels, while plasma levels of sulindac and sulfone were increased. Sulindac was shown to produce a modest reduction in the uricosuric action of probenecid, which probably is not significant under most circumstances.
Propoxyphene hydrochloride had no effect on the plasma levels of sulindac or its sulfide metabolite.
Because of the Cacontent of the levoleucovorin solution, no more than 16 mL (160 mg of levoleucovorin) should be injected intravenously per minute.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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