Recommended Topic Related To:

Levoleucovorin

"Dec. 20, 2012 -- Single tests that measure intelligence quotient, or IQ, may become a thing of the past.

A new study of more than 100,000 participants suggests that there may be at least three distinct components of intelligence. So y"...

Levoleucovorin

Levoleucovorin

Levoleucovorin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

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. It is also used in combination chemotherapy with fluorouracil to treat colorectal cancer that has spread to other parts of the body. Common side effects include nausea, vomiting, diarrhea, stomach pain, numbness or tingling, loss of appetite, unusual or unpleasant taste in your mouth, weakness, tired feeling, hair loss, or mild skin rash.

The dose of Levoleucovorin is determined based on the dose of methotrexate. 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. 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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Levoleucovorin in Detail - Patient Information: Side Effects

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

Tell your doctor or caregivers at once if you have a serious side effect such as:

  • white patches or sores inside your mouth or on your lips;
  • urinating more or less than usual;
  • severe or ongoing diarrhea;
  • feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
  • fever, chills;
  • confusion; or
  • trouble breathing.

Less serious side effects may include:

  • nausea, vomiting, diarrhea;
  • stomach pain, upset stomach;
  • numbness or tingling;
  • loss of appetite, unusual or unpleasant taste in your mouth;
  • weakness, tired feeling;
  • hair loss; or
  • mild skin rash.

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 (Levoleucovorin) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Levoleucovorin FDA Prescribing Information: Side Effects
(Adverse Reactions)

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)
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) »

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


WebMD Daily

Get breaking medical news.

advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations