Levoleucovorin calcium

Last updated on RxList: 3/1/2017
Levoleucovorin calcium Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 03/02/2017

Levoleucovorin calcium injection, solution for intravenous use is a folate analogue indicated for rescue after high-dose methotrexate therapy in osteosarcoma; and diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonist. Levoleucovorin calcium is available in generic form. Common side effects of levoleucovorin calcium include:

  • vomiting,
  • swelling of the lips and mouth,
  • nausea,
  • diarrhea,
  • indigestion,
  • typhlitis,
  • shortness of breath,
  • skin inflammation,
  • confusion,
  • nerve pain, and
  • abnormal kidney function.

Levoleucovorin injection rescue recommendations are based on a methotrexate dose of 12 grams/m2 administered by intravenous infusion over 4 hours. Levoleucovorin injection rescue at a dose of 7.5 mg (approximately 5 mg/m2) every 6 hours for 10 doses starts 24 hours after the beginning of the methotrexate infusion. Levoleucovorin calcium may interact with phenobarbital, phenytoin, and primidone. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using levoleucovorin calcium; it is unknown how it will affect a fetus. It is unknown if levoleucovorin calcium passes into breast milk. Breastfeeding while using levoleucovorin calcium is not recommended.

Our Levoleucovorin Calcium Injection, Solution for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Levoleucovorin calcium Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor or caregivers at once if you have:

  • blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
  • severe or ongoing diarrhea;
  • a light-headed feeling, like you might pass out;
  • seizure (convulsions);
  • dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin; or
  • kidney problems--little or no urination; painful or difficult urination; swelling in your feet or ankles.

Common side effects may include:

  • diarrhea, nausea, vomiting; or
  • pain or sores in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Levoleucovorin calcium (Levoleucovorin calcium Injection)

Levoleucovorin calcium Professional Information

SIDE EFFECTS

Clinical Studies In High-Dose Methotrexate Therapy

Since 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. The following table presents the frequency of adverse reactions which occurred during the administration of 58 courses of high-dose methotrexate 12 grams/m² followed by levoleucovorin injection rescue for osteosarcoma in 16 patients age 6 to 21. Most patients received levoleucovorin injection 7.5 mg every 6 hours for 60 hours or longer beginning 24 hours after completion of methotrexate.

Table 2: Adverse Reactions with High-Dose Methotrexate Therapy

Body System/Adverse Reactions Number (%) of Patients with Adverse Reactions
(N = 16)
Number (%) of Courses with Adverse Reactions
(N = 58)
All Grade 3+ All Grade 3+
Gastrointestinal
Stomatitis 6 (37.5) 1 (6.3) 10 (17.2) 1 (1.7)
Vomiting 6 (37.5) 0 14 (24.1) 0
Nausea 3 (18.8) 0 3 (5.2) 0
Diarrhea 1 (6.3) 0 1 (1.7) 0
Dyspepsia 1 (6.3) 0 1 (1.7) 0
Typhlitis 1 (6.3) 1 (6.3) 1 (1.7) 1 (1.7)
Respiratory
Dyspnea 1 (6.3) 0 1 (1.7) 0
Skin and Appendages
Dermatitis 1 (6.3) 0 1 (1.7) 0
Other
Confusion 1 (6.3) 0 1 (1.7) 0
Neuropathy 1 (6.3) 0 1 (1.7) 0
Renal function abnormal 1 (6.3) 0 3 (5.2) 0
Taste perversion 1 (6.3) 0 1 (1.7) 0
Total number of patients 9 (56.3) 2 (12.5)
Total number of courses 25 (43.1) 2 (3.4)

The incidence of adverse reactions may be underestimated because not all patients were fully evaluable for toxicity for all cycles in the clinical trials. Leukopenia and thrombocytopenia were observed, but could not be attributed to high-dose methotrexate with levoleucovorin injection rescue because patients were receiving other myelosuppressive chemotherapy.

Postmarketing Experience

Since adverse reactions from spontaneous reports are provided voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. Spontaneously reported adverse reactions collected by the WHO Collaborating Center for International Drug Monitoring in Uppsala Sweden have yielded seven cases where levoleucovorin was administered with a regimen of methotrexate. The events were dyspnea, pruritus, rash, temperature change and rigors. For 217 adverse reactions (108 reports) where levoleucovorin was a suspected or interacting medication, there were 40 occurrences of “possible allergic reactions.”

In an analysis where calcium levoleucovorin was reported as the primary suspect drug and fluorouracil (FU) was reported as a concomitant medication, possible allergic reactions were reported among 47 cases (67 events).

Read the entire FDA prescribing information for Levoleucovorin calcium (Levoleucovorin calcium Injection)

© Levoleucovorin calcium Patient Information is supplied by Cerner Multum, Inc. and Levoleucovorin calcium Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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