Leucovorin

What is Leucovorin?

• Leucovorin (Wellcovorin) is one of several active, chemically reduced derivatives of folic acid used as a medicine to help prevent or treat severe side effects of some chemotherapy drugs (such as methotrexate, which makes a cell unable to use folic acid, preventing DNA from being made, and stopping cells from dividing).
• Leucovorin also is used in the prevention or treatment of some types of anemia and in the treatment of colorectal cancer.
• Leucovorin is also known as Folinic acid.

Leucovorin2DACS

Leucovorin molecule ball

Leucovorin molecule spacefill

What are the uses of this medicine?

Leucovorin (Wellcovorin) is:

• used to prevent harmful effects of methotrexate (Rheumatrex, Trexall; cancer chemotherapy medication) when methotrexate is used to to treat certain types of cancer.
• used to treat people who have accidentally received an overdose of methotrexate or similar medications.
• used to treat anemia (low level of red blood cells) caused by low levels of folic acid in the body.
• also used with 5-fluorouracil (a chemotherapy medication) to treat colorectal cancer (cancer that begins in the large intestine).

How does this medicine work?

• Leucovorin is a mixture of the diastereoisomers of the 5-formyl derivative of tetrahydrofolic acid (THF).
• Administration of leucovorin can counteract the therapeutic and toxic effects of folic acid antagonists such as methotrexate, which act by inhibiting dihydrofolate reductase.
• It treats people who are receiving methotrexate by protecting healthy cells from the effects of methotrexate.
• It treats anemia by supplying folic acid that is needed for red blood cell formation.
• It treats colorectal cancer by increasing the effects of 5-fluorouracil.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• pernicious anemia and other megaloblastic anemias secondary to the lack of vitamin B12.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• certain medications for seizures such as phenobarbital, phenytoin (Dilantin), and primidone (Mysoline); and trimethoprim-sulfamethoxazole (Bactrim, Septra)

Is this medicine FDA approved?

• Folinic acid was first made in 1945.
• It is on the World Health Organization's List of Essential Medicines

How should this medicine be used?

Recommended dosage: Advanced Colorectal Cancer:

• Leucovorin calcium for injection is administered at 200 mg/m2 by slow intravenous injection over a minimum of 3 minutes, followed by 5-fluorouracil at 370 mg/m2 by intravenous injection.
• Leucovorin calcium for injection is administered at 20 mg/m2 by intravenous injection followed by 5-fluorouracil at 425 mg/m2 by intravenous injection.
• Treatment is repeated daily for five days. This five-day treatment course may be repeated at 4 week (28-day) intervals, for 2 courses and then repeated at 4 to 5 week (28 to 35 day) intervals provided that the patient has completely recovered from the toxic effects of the prior treatment course.
• 5-Fluorouracil and leucovorin should be administered separately to avoid the formation of a precipitate.

Leucovorin Rescue After High-Dose Methotrexate Therapy:

• The recommendations for leucovorin rescue are based on a methotrexate dose of 12 to 15 grams/m2 administered by intravenous infusion over 4 hours.
• Leucovorin rescue at a dose of 15 mg (approximately 10 mg/m2) every 6 hours for 10 doses starts 24 hours after the beginning of the methotrexate infusion.
• Leucovorin rescue at a dose of 15 mg (approximately 10 mg/m2) every 6 hours for 10 doses starts 24 hours after the beginning of the methotrexate infusion. In the presence of gastrointestinal toxicity, nausea or vomiting, leucovorin calcium for injection should be administered parenterally. Do not administer leucovorin calcium for injection intrathecally.

Megaloblastic Anemia Due to Folic Acid Deficiency:

• Up to 1 mg daily.
• There is no evidence that doses greater than 1 mg/day have greater efficacy than those of 1 mg.

Administration:

• It is taken by mouth, injection into a muscle, or injection into a vein.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Leucovorin Calcium for Injection, USP
• Leucovorin calcium tablets USP contain either 5 mg, 10 mg, 15 mg or 25 mg leucovorin

This medicine is available in fallowing brand namesː

• Wellcovorin

What side effects can this medication cause?

The most common side effects of this medicine include:

• anaphylactoid reactions
• urticaria
• diarrhea
• difficulty breathing or swallowing

What special precautions should I follow?

• In the treatment of accidental overdosage of folic acid antagonists, leucovorin should be administered as promptly as possible.
• Monitoring of the serum methotrexate concentration is essential in determining the optimal dose and duration of treatment with leucovorin.
• Parenteral administration is preferable to oral dosing if there is a possibility that the patient may vomit or not absorb the leucovorin.
• Delayed methotrexate excretion may be caused by a third space fluid accumulation (i.e., ascites, pleural effusion), renal insufficiency, or inadequate hydration. Under such circumstances, higher doses of leucovorin or prolonged administration may be indicated.
• Doses higher than those recommended for oral use must be given intravenously.
• Leucovorin may enhance the toxicity of fluorouracil. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly leucovorin and fluorouracil.
• The concomitant use of leucovorin with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection was associated with increased rates of treatment failure and mortality.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• Excessive amounts of leucovorin may nullify the chemotherapeutic effect of folic acid antagonists.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• It is also not known whether leucovorin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
• Leucovorin should be given to a pregnant woman only if clearly needed.

Can this medicine be used in children?

• Folic acid in large amounts may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible children.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• leucovorin calcium

Inactive ingredients:

• sodium chloride
• sodium hydroxide
• hydrochloric acid

Who manufactures and distributes this medicine?

• Mfd. for SAGENT Pharmaceuticals
• Schaumburg, IL (USA)
• Made in Italy
• ©2019 Sagent Pharmaceuticals, Inc.

Leucovorin Calcium Tablets: Distr. by:

• West-WardPharmaceuticals Corp.
• Eatontown, NJ

What should I know about storage and disposal of this medication?

• Store dry product and reconstituted solution at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F).
• Protect from light.
• Retain in carton until time of use.

• Dailymed label info on Leucovorin
• FDA Leucovorin

Leucovorin Resources
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