Generic Name: asparaginase (a-SPARE-a-ji-naze), l-asparaginase, erwinia l-asparaginase
Trade Name: Elspar®, Kidrolase®
For which conditions is Kidrolase approved for? Kidrolase is FDA approved for the treatment of acute lymphocytic leukemia. It is recommended that Kidrolase be used in conjunction with other agents, if not contraindicated in patients, in a regimen for the induction of remission, not as maintenance therapy for acute lymphocytic leukemia.
What is the mechanism of action? Kidrolase is an enzyme. Kidrolase produces its anti-cancer effects by “breaking down” asparagine, a substance normally found in the body that is involved in biological processes that are essential for cells to maintain life. Healthy cells are able to create asparagine for themselves; however, cancer cells are not able to create asparagine. Therefore, the depletion of asparagine by Kidrolase kills cancer cells, while healthy cells are not as affected.
How is Kidrolase typically given (administered)? Kidrolase may be given in a vein (intravenous) or as an injection into a muscle (intramuscular), and the dose depends on several factors, including the condition being treated, the size of the patient, the particular regimen being used, and the overall health of the patient. Patients will often receive a small “test” dose under the skin (intradermal) prior to therapy to detect an allergic reaction to Kidrolase. During administration of Kidrolase, patients will be closely monitored as they may experience a serious allergic reaction. If patients experience difficulty in breathing, wheezing, itching, agitation, lightheadedness, or swelling of the face during administration of Kidrolase, they should notify their healthcare provider immediately.
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Kidrolase. Typically, blood will be drawn to check levels of blood sugar, levels of electrolytes, functions of organs, such as the pancreas, liver and kidneys, function of blood clotting and levels of blood cells. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.
What are the common (occur in 30% or more of patients) side effects of treatment with Kidrolase?
- Nausea and vomiting
- Allergic reaction during administration consisting of difficulty breathing, wheezing, itching, rash, swelling of face, agitation, fever, low blood pressure
- Loss of appetite
- Abdominal cramping
- Excessive fatigue or sleepiness
- Disorientation or confusion
What are the less common (occur in 10% to 29% of patients) side effects of treatment with Kidrolase?
- Mouth sores
- Pancreatitis (inflammation of the pancreas) in up to 10% of patients
- Increased levels of sugar in the blood
- Abnormalities of liver or kidney function tests
- Increased risk of bleeding
- Increased risk of blood clotting
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
FDA Grants Orphan Drug Designation to LYT-200 for Pancreatic Cancer and being evaluated in Cholangiocarcinoma
Pancreatic Cancer - Cholangiocarcinoma Clinical Trial
What can patients do to help alleviate or prevent discomfort and side effects?
- Pay careful attention to the physician’s instructions and inform the physician of any side effects.
- Maintain adequate rest and nutrition.
- Wear sunscreen and protective clothing and try to minimize sun exposure.
- Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
- Eat small meals frequently to help alleviate nausea.
- Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
- For mouth sores, patients should rinse their mouth three times a day with a salt and sod solution (8 ounces of water mixed with ½ to 1 tsp baking soda and/or ½ to 1 tsp salt) and brush their teeth with a soft toothbrush to help prevent the development of mouth sores.
Are there any special precautions patients should be aware of before starting treatment?
- Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
- It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
- Patients should inform their physician of any history of pancreatitis.
- Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
- Patients should check with their physician before starting any new drug or nutritional supplement.
- Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
When should patients notify their physician?
- Allergic reaction (hives, itching, tightness of chest, difficulty breathing, swelling)
- Severe nausea
- Prolonged vomiting
- Fever or chills
- Signs of infection
- Prolonged upper abdominal pain or pain that increases after eating
- Itching, rash
- Abdominal swelling
- Severe or prolonged diarrhea
- Unusual bleeding or bruising
- Swelling, redness and/or pain in one leg or arm
- Extreme fatigue
- Yellowing of the skin or eyes
- Unusual thirst, need to urinate frequently
- Confusion, excessive sleepiness, hallucinations, agitation, anxiety, or disorientation
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.
As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.
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