Levoleucovorin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Levoleucovorin?

Levoleucovorin Injection, Powder, Lyophilized, for Solution for Intravenous use is used to treat or prevent toxic effects of methotrexate in people who have received methotrexate to treat bone cancer, or in people whose bodies do not eliminate methotrexate properly after the drug is metabolized, or to treat toxic effects of an accidental overdose of methotrexate. Levoleucovorin Injection is also used in combination chemotherapy with fluorouracil to treat colorectal cancer that has spread to other parts of the body.

What Are Side Effects of Levoleucovorin?

Common side effects of Levoleucovorin Injection include:

nausea
vomiting
diarrhea
stomach pain or upset
numbness or tingling
loss of appetite
unusual or unpleasant taste in your mouth
weakness
tired feeling
hair loss
mild skin rash
swelling of the mouth and lips
indigestion
shortness of breath, or
confusion

Dosage for Levoleucovorin/h4>
The dose of Levoleucovorin is determined based on the dose of methotrexate.

What Drugs, Substances, or Supplements Interact with Levoleucovorin?

Levoleucovorin may interact with sulfa drugs, seizure medications, or multivitamin or mineral supplements containing folic acid. Tell your doctor all medications and supplements you use.

Levoleucovorin During Pregnancy or Breastfeeding

During pregnancy, Levoleucovorin should be used only if prescribed. It is unknown if this drug is excreted in human milk. Consult your doctor before breastfeeding.

Additional Information

Our Levoleucovorin 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 Consumer Information

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.

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Levoleucovorin Professional Information

SIDE EFFECTS

Clinical Studies Experience

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/m²followed by levoleucovorin rescue for osteosarcoma in 16 patients age 6-21. Most patients received levoleucovorin 7.5 mg every 6 hours for 60 hours or longer beginning 24 hours after completion of methotrexate.

Table 2: Adverse Reactions

Body System/Adverse Reactions	Number (%) of Patients with Adverse Reactions (N =16)		Number (%) of Courses with Adverse Reactions (N = 58)
Body System/Adverse Reactions	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 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 reaction.”

Read the entire FDA prescribing information for Levoleucovorin (Levoleucovorin)