Glucarpidase – Uses, Dosage, Side Effects, Interaction

Last updated: February 8, 2026Reviewed date: February 8, 2026Reading time: 10 min read
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Glucarpidase is the recombinant form of the Pseudomonas sp. (strain RS-16) enzyme carboxypeptidase G2 that is produced in Escherichia coli. In patients, glucarpidase inactivates methotrexate, and other antifolates, by hydrolyzing glutamate on the carboxyl-terminal of these compounds. Therefore since methotrexate is eliminated enzymatically and not by the kidneys, glucarpidase...

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Article Summary

Glucarpidase is the recombinant form of the Pseudomonas sp. (strain RS-16) enzyme carboxypeptidase G2 that is produced in Escherichia coli. In patients, glucarpidase inactivates methotrexate, and other antifolates, by hydrolyzing glutamate on the carboxyl-terminal of these compounds. Therefore since methotrexate is eliminated enzymatically and not by the kidneys, glucarpidase is indicated in patients on methotrexate treatment who have kidney dysfunction, and are experiencing an abnormally high plasma concentration of methotrexate (>1 micromole per...

Key Takeaways

  • This article explains Mechanism of action in simple medical language.
  • This article explains Indications in simple medical language.
  • This article explains Contraindications in simple medical language.
  • This article explains Dosage in simple medical language.
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Glucarpidase is the recombinant form of the Pseudomonas sp. (tendon. সহজ বাংলা: মাংসপেশি/টেনডনে টান।" data-rx-term="strain" data-rx-definition="A strain is injury to a muscle or tendon. সহজ বাংলা: মাংসপেশি/টেনডনে টান।">strain RS-16) enzyme carboxypeptidase G2 that is produced in Escherichia coli. In patients, glucarpidase inactivates methotrexate, and other antifolates, by hydrolyzing glutamate on the carboxyl-terminal of these compounds. Therefore since methotrexate is eliminated enzymatically and not by the kidneys, glucarpidase is indicated in patients on methotrexate treatment who have kidney dysfunction, and are experiencing an abnormally high plasma concentration of methotrexate (>1 micromole per liter). Glucarpidase is marketed under the brand name Voraxaze®.

Glucarpidase is a recombinant carboxypeptidase G2 produced by genetically modified Escherichia coli bacteria. It is a 390 amino acid homodimer protein.[rx] High-dose methotrexate, an antifolate agent, has been widely and safely used for many decades in treating various cancers; however, even with aggressive hydration, urine alkalinization, and leucovorin rescue, some patients still develop high-dose methotrexate-induced nephrotoxicity. This can lead to delayed renal clearance of methotrexate and elevated drug plasma levels, increasing the risk of methotrexate toxicity.[rx,rx]

After the discovery of certain bacteria with the capacity to inactivate folate analogs such as methotrexate, carboxypeptidase G was identified and Carboxypeptidase G1 was first isolated from Pseudomonas stutzeri in 1967. In 1983, the gene for carboxypeptidase G2, or glucarpidase, was derived from Pseudomonas sp. tendon. সহজ বাংলা: মাংসপেশি/টেনডনে টান।" data-rx-term="strain" data-rx-definition="A strain is injury to a muscle or tendon. সহজ বাংলা: মাংসপেশি/টেনডনে টান।">strain RS-16 to be cloned into Escherichia coli, allowing the enzyme to be produced in sufficient quantities for therapeutic purposes.[rx] Glucarpidase is an enzyme that can rapidly hydrolyze methotrexate into its nontoxic metabolites. It prevents methotrexate toxicity in patients with renal dysfunction who are undergoing high-dose methotrexate treatment, as it provides an alternative non-renal pathway for methotrexate elimination.[rx] Glucarpidase was first approved by the FDA in January 2012,[rx] followed by the European Commission’s approval in January 2022.[rx] It is marketed as VORAXAZE.

Glucarpidase (Voraxaze) is a medication used for the treatment of elevated levels of methotrexate (defined as 1 micromol/L) during the treatment of cancer patients who have impaired kidney function (and thus cannot reduce the drug to safe levels sufficiently after the drug has been given). Glucarpidase is an enzyme that inactivates methotrexate rapidly after injection. Because this agent reduces systemic levels of methotrexate and could therefore interfere with efficacy, it is not recommended for use in patients with normal or only slightly impaired kidney function or in whom serum levels are normal. The main antidote for methotrexate overdoses prior to the approval of this drug was high doses of folinic acid. However, this agent was not always sufficient at preventing kidney failure due to methotrexate. Glucarpidase also degrades folinic acid so the two should not be used together (within two hours of one another).

Mechanism of action

Methotrexate is an anticancer agent widely used to treat various cancers: it is often used in higher doses in leukemias and lymphomas. As methotrexate and its metabolites are primarily excreted in the kidneys, patients with reduced renal function are at an elevated risk for increased drug exposure and methotrexate toxicity. Methotrexate itself can cause renal toxicity at high doses: methotrexate-induced renal damage can occur by precipitation of methotrexate and its breakdown products in the renal tubules, or from a direct toxic effect of the drug.[rx]

Glucarpidase is a recombinant bacterial enzyme that hydrolyzes the carboxyl-terminal glutamate residue from folic acid and classical antifolates such as methotrexate. Glucarpidase converts methotrexate to its inactive metabolites glutamate and 2,4-diamino-N10-methylpteroic acid (DAMPA),[rx] which is a nontoxic metabolite. DAMPA is later excreted in urine or further metabolized by the liver into hydroxyl-DAMPA, DAMPA-glucuronide, and hydroxy-DAMPA-glucuronide.[rx] Glucarpidase provides an alternate non-renal pathway for methotrexate elimination in patients with renal dysfunction during high-dose methotrexate treatment.[rx]

Glucarpidase acts as an antidote to toxic methotrexate levels by eliminating methotrexate by a non-kidney route. In one study, methotrexate concentration measured by a chromatographic method was reduced by more than 97% within 15 minutes in all 22 treatment-evaluable patients who received glucarpidase 50 Units/kg: this effect was maintained at a >95% reduction up to 8 days in 20 of the 22 patients.[rx] It reduced the circulating levels of methotrexate in pediatric and adult patients, as well as patients with delayed methotrexate elimination.[rx]

Indications

  • Glucarpidase is indicated to reduce toxic plasma methotrexate concentration (greater than 1 micromole per liter) in adult and pediatric patients with delayed methotrexate clearance (plasma methotrexate concentrations greater than 2 standard deviations of the mean methotrexate excretion curve specific for the dose of methotrexate administered) due to impaired renal function.[rx] In the European prescribing information, glucarpidase is specified for use in adults and children aged 28 days and older.[rx]
  • Glucarpidase is not recommended for use in patients who exhibit the expected clearance and expected plasma methotrexate concentration. Reducing plasma methotrexate concentration in these patients may result in subtherapeutic exposure to methotrexate.[rx]
  • Glucarpidase is a carboxypeptidase enzyme used to reduce plasma concentrations of methotrexate in patients with impaired renal function.
  • Treatment of toxic plasma methotrexate concentrations (greater than 1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function.

Use in Cancer

Glucarpidase is approved to treat:

  • Toxic blood levels of the anticancer drug methotrexate. Glucarpidase is used to remove methotrexate from the body in adults and children whose kidneys are not working as they should.

Contraindications

  • Glucarpidase is not indicated for use in patients who exhibit the expected clearance of methotrexate (plasma methotrexate concentrations within 2 standard deviations of the mean methotrexate excretion curve specifically for the dose of methotrexate administered) or those with
    normal or mildly impaired renal function because of the potential risk of subtherapeutic exposure to methotrexate.

Dosage

Strengths: 1000 units

Methotrexate Overdosage

  • Single IV injection of 50 Units/kg

Pediatric Dose for Methotrexate Overdosage

  • Children 1 month of age or older: Single IV injection of 50 units/kg

Administration advice:

  • Administer intravenously as a bolus injection over 5 minutes.
  • Flush the intravenous line before and after administration.

Side Effects

The Most Common

  • nausea
  • vomiting
  • fever
  • chills
  • flushing or feeling hot
  • rash
  • hives
  • itching
  • throat tightness or difficulty breathing
  • feelings of numbness, tingling, pricking, burning or creeping on the skin
  • pain in the head or upper neck. সহজ বাংলা: মাথাব্যথা।" data-rx-term="headache" data-rx-definition="Headache means pain in the head or upper neck. সহজ বাংলা: মাথাব্যথা।">headache

More Common

  • Blurred vision
  • confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • sweating
  • unusual tiredness or weakness
  • Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
  • feeling of warmth
  • nausea
  • redness of the face, neck, arms, and occasionally, upper chest
  • vomiting
  • Diarrhea
  • shakiness in the legs, arms, hands, or feet
  • sore throat
  • trembling or shaking of the hands or feet

Rare

  • Cough
  • difficulty with swallowing
  • dizziness
  • fever
  • pain in the head or upper neck. সহজ বাংলা: মাথাব্যথা।" data-rx-term="headache" data-rx-definition="Headache means pain in the head or upper neck. সহজ বাংলা: মাথাব্যথা।">headache
  • hives
  • hoarseness
  • irritation
  • itching
  • joint pain, stiffness, or swelling
  • nervousness
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rash
  • redness of the skin
  • shortness of breath
  • slow or fast heartbeat
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness in the chest
  • troubled breathing or swallowing
  • wheezing

Drug Interactions

Pregnancy and Lactation

US FDA pregnancy category Not Assigned

Pregnancy

The manufacturer makes no recommendation regarding use during pregnancy. There is no data on use in pregnant women or animal studies to know the risks of this drug, including the risk of fetal harm, major birth defects, miscarriage, or adverse maternal or fetal effects. This drug is administered in combination with methotrexate which may cause embryo-fetal harm; the methotrexate manufacturer product information should be consulted.

Lactation

The manufacturer makes no recommendation regarding use during lactation. There is no information regarding this drug on its presence in human milk, its effects on a breastfed infant, or its effects on milk production. This drug is administered in combination with methotrexate; the methotrexate manufacturer’s product information should be consulted.

How should this medicine be used?

Glucarpidase comes as a powder to be mixed with liquid and injected intravenously (into a vein). It is usually given over 5 minutes as a one-time dose. Glucarpidase is given along with leucovorin (another medication used to prevent the harmful effects of methotrexate) until laboratory tests show treatment is no longer needed.

What special precautions should I follow?

Before taking glucarpidase,

  • tell your doctor and pharmacist if you are allergic to glucarpidase, any other medications, or any of the ingredients in glucarpidase injection. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: folic acid (Folicet, in multivitamins); levoleucovorin (Fusilev); or pemetrexed (Alimta). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • if you are receiving leucovorin, it should be given at least 2 hours before or 2 hours after glucarpidase.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding . If you become pregnant while taking glucarpidase, call your doctor.

References

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Safety note: This is not a prescription or diagnosis. For severe symptoms, pregnancy danger signs, children with serious illness, chest pain, breathing difficulty, stroke-like weakness, or major injury, seek urgent care.

Which doctor may help?

Start with a registered doctor or the nearest qualified health center.

What to tell the doctor

  • Write when the problem started and how it changed.
  • Bring old prescriptions, investigation reports, and current medicines.
  • Write allergies, pregnancy status, diabetes, kidney/liver disease, and major past illnesses.
  • Bring one family member if the patient is weak, elderly, confused, or a child.

Questions to ask

  • What is the most likely cause of my symptoms?
  • Which danger signs mean I should go to hospital quickly?
  • Which tests are necessary now, and which can wait?
  • How should I take medicines safely and what side effects should I watch for?
  • When should I come for follow-up?

Tests to discuss

  • Vital signs: temperature, pulse, blood pressure, oxygen saturation
  • Basic physical examination by a clinician
  • CBC, urine test, blood sugar, or imaging only when clinically needed

Avoid these mistakes

  • Do not use antibiotics, steroid tablets/injections, or strong painkillers without proper medical advice.
  • Do not hide pregnancy, kidney disease, ulcer, allergy, or blood thinner use.
  • Do not delay emergency care when danger signs are present.

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This section is for patient education only. It does not replace a doctor, pharmacist, or emergency care.

Safe first steps

  • Avoid heavy lifting, sudden bending, and prolonged bed rest.
  • Use comfortable posture and gentle movement as tolerated.
  • Discuss physiotherapy, X-ray, or MRI only when clinically needed.

OTC medicine safety

  • For mild back pain, pain-relief medicine may be discussed with a doctor or pharmacist.
  • Avoid repeated painkiller use if you have kidney disease, stomach ulcer, uncontrolled blood pressure, or are taking blood thinners.

Avoid these mistakes

  • Do not start antibiotics without a proper medical decision.
  • Do not use steroid tablets or injections casually for quick relief.
  • Do not delay emergency care because of home remedies.

Get urgent help if

  • Back pain with leg weakness, numbness around private area, loss of urine/stool control, fever, cancer history, or major injury needs urgent care.
Medicine names, dose, and timing must be decided by a qualified clinician or pharmacist after checking age, pregnancy, allergy, other diseases, and current medicines.

For rural patients and family caregivers

Patient health record and symptom diary

Write your symptoms, medicines already taken, test results, and questions before visiting a doctor. This note stays on your device unless you print or copy it.

Doctor to discuss: Medicine doctor / pediatrician for children / qualified clinician
Tests to discuss with doctor
  • Temperature chart and hydration assessment
  • CBC with platelet count if fever persists or dengue/other infection is possible
  • Urine test, malaria/dengue tests, chest evaluation, or blood culture only when clinically indicated
Questions to ask
  • What is the most likely cause of my symptoms?
  • Which warning signs mean I should go to emergency care?
  • Which tests are really needed now?
  • Which medicines are safe for my age, pregnancy status, allergy, kidney/liver/stomach condition, and current medicines?
  • Do I need antibiotics, or is this more likely viral?

Emergency warning signs such as chest pain, severe breathing difficulty, sudden weakness, confusion, severe dehydration, major injury, or loss of bladder/bowel control need urgent medical care. Do not wait for online information.

Safe pathway to proper treatment

Care roadmap for: Glucarpidase – Uses, Dosage, Side Effects, Interaction

Use this simple roadmap to understand the next safe steps. It is educational and does not replace examination by a doctor.

Go to emergency care if you notice:
  • Severe or rapidly worsening symptoms
  • Breathing difficulty, chest pain, fainting, confusion, severe weakness, major injury, or severe dehydration
Doctor / service to discuss: Qualified healthcare provider; specialist depends on symptoms and examination.
  1. Step 1

    Check danger signs first

    If danger signs are present, seek emergency care and do not wait for online information.

  2. Step 2

    Record the symptom story

    Write when symptoms started, severity, medicines already taken, allergies, pregnancy status, and test results.

  3. Step 3

    Visit a qualified clinician

    A doctor, nurse, or qualified healthcare provider can examine you and decide which tests or treatment are needed.

  4. Step 4

    Do only useful tests

    Do tests after clinical assessment. Avoid unnecessary tests, random antibiotics, or repeated medicines without diagnosis.

  5. Step 5

    Follow up and return early if worse

    If symptoms worsen, new warning signs appear, or treatment is not helping, return for review quickly.

Rural patient practical tips
  • Take a written symptom diary and all previous prescriptions/test reports.
  • Do not hide medicines already taken, even herbal or over-the-counter medicines.
  • Ask which warning signs mean urgent referral to hospital.

This roadmap is for education. A real diagnosis and treatment plan requires history, examination, and clinical judgment.

RX Patient Help

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Write your symptom story. A health professional or site editor can review it before any answer is prepared. This box is not for emergency care.

Emergency first: Severe chest pain, breathing trouble, unconsciousness, stroke signs, severe injury, heavy bleeding, or rapidly worsening symptoms need urgent local medical care now.

Frequently Asked Questions

Mechanism of action Methotrexate is an anticancer agent widely used to treat various cancers: it is often used in higher doses in leukemias and lymphomas. As methotrexate and its metabolites are primarily excreted in the kidneys, patients with reduced renal function are at an elevated risk for increased drug exposure and methotrexate toxicity. Methotrexate itself can cause renal toxicity at high doses: methotrexate-induced renal damage can occur by precipitation of methotrexate and its breakdown products in the renal tubules, or from a direct toxic effect of the drug.[rx] Glucarpidase is a recombinant bacterial enzyme that hydrolyzes the carboxyl-terminal glutamate residue from folic acid and classical antifolates such as methotrexate. Glucarpidase converts methotrexate to its inactive metabolites glutamate and 2,4-diamino-N10-methylpteroic acid (DAMPA),[rx] which is a nontoxic metabolite. DAMPA is later excreted in urine or further metabolized by the liver into hydroxyl-DAMPA, DAMPA-glucuronide, and hydroxy-DAMPA-glucuronide.[rx] Glucarpidase provides an alternate non-renal pathway for methotrexate elimination in patients with renal dysfunction during high-dose methotrexate treatment.[rx] Glucarpidase acts as an antidote to toxic methotrexate levels by eliminating methotrexate by a non-kidney route. In one study, methotrexate concentration measured by a chromatographic method was reduced by more than 97% within 15 minutes in all 22 treatment-evaluable patients who received glucarpidase 50 Units/kg: this effect was maintained at a >95% reduction up to 8 days in 20 of the 22 patients.[rx] It reduced the circulating levels of methotrexate in pediatric and adult patients, as well as patients with delayed methotrexate elimination.[rx] Indications Glucarpidase is indicated to reduce toxic plasma methotrexate concentration (greater than 1 micromole per liter) in adult and pediatric patients with delayed methotrexate clearance (plasma methotrexate concentrations greater than 2 standard deviations of the mean methotrexate excretion curve specific for the dose of methotrexate administered) due to impaired renal function.[rx] In the European prescribing information, glucarpidase is specified for use in adults and children aged 28 days and older.[rx] Glucarpidase is not recommended for use in patients who exhibit the expected clearance and expected plasma methotrexate concentration. Reducing plasma methotrexate concentration in these patients may result in subtherapeutic exposure to methotrexate.[rx] Glucarpidase is a carboxypeptidase enzyme used to reduce plasma concentrations of methotrexate in patients with impaired renal function. Treatment of toxic plasma methotrexate concentrations (greater than 1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function. Use in Cancer Glucarpidase is approved to treat: Toxic blood levels of the anticancer drug methotrexate. Glucarpidase is used to remove methotrexate from the body in adults and children whose kidneys are not working as they should. Contraindications Glucarpidase is not indicated for use in patients who exhibit the expected clearance of methotrexate (plasma methotrexate concentrations within 2 standard deviations of the mean methotrexate excretion curve specifically for the dose of methotrexate administered) or those with normal or mildly impaired renal function because of the potential risk of subtherapeutic exposure to methotrexate. Dosage Strengths: 1000 units Methotrexate Overdosage Single IV injection of 50 Units/kg Pediatric Dose for Methotrexate Overdosage Children 1 month of age or older: Single IV injection of 50 units/kg Administration advice: Administer intravenously as a bolus injection over 5 minutes. Flush the intravenous line before and after administration. Side Effects The Most Common nausea vomiting fever chills flushing or feeling hot rash hives itching throat tightness or difficulty breathing feelings of numbness, tingling, pricking, burning or creeping on the skin headache More Common Blurred vision confusion dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position sweating unusual tiredness or weakness Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings feeling of warmth nausea redness of the face, neck, arms, and occasionally, upper chest vomiting Diarrhea shakiness in the legs, arms, hands, or feet sore throat trembling or shaking of the hands or feet Rare Cough difficulty with swallowing dizziness fever headache hives hoarseness irritation itching joint pain, stiffness, or swelling nervousness pounding in the ears puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue rash redness of the skin shortness of breath slow or fast heartbeat swelling of the eyelids, face, lips, hands, or feet tightness in the chest troubled breathing or swallowing wheezing Drug Interactions DRUG INTERACTION Folic acid The serum concentration of the active metabolites of Folic acid can be reduced when Folic acid is used in combination with Glucarpidase resulting in a loss in efficacy. Leucovorin The serum concentration of the active metabolites of Leucovorin can be reduced when Leucovorin is used in combination with Glucarpidase resulting in a loss in efficacy. Levoleucovorin The serum concentration of the active metabolites of Levoleucovorin can be reduced when Levoleucovorin is used in combination with Glucarpidase resulting in a loss in efficacy. Levomefolic acid The serum concentration of the active metabolites of Levomefolic acid can be reduced when Levomefolic acid is used in combination with Glucarpidase resulting in a loss in efficacy. Methotrexate The serum concentration of the active metabolites of Methotrexate can be reduced when Methotrexate is used in combination with Glucarpidase resulting in a loss in efficacy. Pafolacianine The serum concentration of the active metabolites of Pafolacianine can be reduced when Pafolacianine is used in combination with Glucarpidase resulting in a loss in efficacy. Pemetrexed The serum concentration of the active metabolites of Pemetrexed can be reduced when Pemetrexed is used in combination with Glucarpidase resulting in a loss in efficacy. Pralatrexate The serum concentration of the active metabolites of Pralatrexate can be reduced when Pralatrexate is used in combination with Glucarpidase resulting in a loss in efficacy. Raltitrexed The serum concentration of the active metabolites of Raltitrexed can be reduced when Raltitrexed is used in combination with Glucarpidase resulting in a loss in efficacy. Pregnancy and Lactation US FDA pregnancy category Not Assigned Pregnancy The manufacturer makes no recommendation regarding use during pregnancy. There is no data on use in pregnant women or animal studies to know the risks of this drug, including the risk of fetal harm, major birth defects, miscarriage, or adverse maternal or fetal effects. This drug is administered in combination with methotrexate which may cause embryo-fetal harm; the methotrexate manufacturer product information should be consulted. Lactation The manufacturer makes no recommendation regarding use during lactation. There is no information regarding this drug on its presence in human milk, its effects on a breastfed infant, or its effects on milk production. This drug is administered in combination with methotrexate; the methotrexate manufacturer's product information should be consulted. How should this medicine be used?

Glucarpidase comes as a powder to be mixed with liquid and injected intravenously (into a vein). It is usually given over 5 minutes as a one-time dose. Glucarpidase is given along with leucovorin (another medication used to prevent the harmful effects of methotrexate) until laboratory tests show treatment is no longer needed.

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    Mirogabalin has been used in trials studying the treatment of Post-herpetic Neuralgia, Pain? Associated With Fibromyalgia, and Diabetic peripheral neuropathic pain. Mirogabalin is a medication designed...

    August 12, 2023 • Drugs (A - Z)