Asparaginase Injection

as-PAR-a-jin-ase

Injection routePowder for Solution

It is recommended that asparaginase be administered to patients only in a hospital setting under the supervision of a physician who is qualified by training and experience to administer cancer chemotherapeutic agents, because of the possibility of severe reactions, including anaphylaxis and sudden death. The physician must be prepared to treat anaphylaxis at each administration of the drug. In the treatment of each patient the physician must weigh carefully the possibility of achieving therapeutic benefit versus the risk of toxicity.

Special handling procedures should be followed .

Administer to patients only in a hospital setting because of the possibility of severe reactions, including anaphylaxis and sudden death. The physician must be prepared to treat anaphylaxis at each administration of the drug. Special handling procedures should be followed .

Commonly used brand name(s):

In the U.S.

  • Elspar

Available Dosage Forms:

  • Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Asparaginase (class)

Uses For asparaginase

Asparaginase belongs to the group of medicines known as enzymes. It is used to treat some kinds of cancer of the blood. It may also be used to treat other kinds of cancer, as determined by your doctor.

All cells need a chemical called asparagine to stay alive. Normal cells can make this chemical for themselves, while cancer cells cannot. Asparaginase breaks down asparagine in the body. Since the cancer cells cannot make more asparagine, they die.

Before you begin treatment with asparaginase, you and your doctor should talk about the good asparaginase will do as well as the risks of using it.

Asparaginase is to be administered only by or under the supervision of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, asparaginase is used in certain patients with the following condition:

  • Cancer of the lymph system (certain types)

Before Using asparaginase

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For asparaginase, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to asparaginase or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

asparaginase has been tested in children and has not been shown to cause different side effects or problems than it does in adults. In fact, the side effects of asparaginase seem to be less severe in children than in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of asparaginase in the elderly with use in other age groups.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using asparaginase with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Rotavirus Vaccine, Live

Using asparaginase with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Bacillus of Calmette and Guerin Vaccine, Live
  • Influenza Virus Vaccine, Live
  • Measles Virus Vaccine, Live
  • Methotrexate
  • Mumps Virus Vaccine, Live
  • Poliovirus Vaccine, Live
  • Prednisolone
  • Prednisone
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Smallpox Vaccine
  • Typhoid Vaccine
  • Varicella Virus Vaccine
  • Vincristine
  • Vincristine Liposome
  • Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of asparaginase. Make sure you tell your doctor if you have any other medical problems, especially:

  • Chickenpox (including recent exposure) or
  • Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body
  • Type 2 diabetes mellitus—Asparaginase may increase glucose (sugar) in the blood
  • Gout or
  • Kidney stones—Asparaginase may increase levels of uric acid in the body, which can cause gout or kidney stones
  • Infection—Asparaginase can reduce your body's ability to fight infection
  • Liver disease—Asparaginase may worsen the condition
  • Pancreatitis (inflammation of the pancreas)—Asparaginase may cause pancreatitis

Proper Use of asparaginase

asparaginase is usually given together with certain other medicines. If you are using a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to remember to take them at the right times.

While you are using asparaginase, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.

asparaginase often causes nausea, vomiting, and loss of appetite. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. After several doses, your stomach upset should lessen. Ask your health care professional for ways to lessen these effects.

Dosing

The dose of asparaginase will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of asparaginase. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Precautions While Using asparaginase

It is very important that your doctor check your progress at regular visits to make sure that asparaginase is working properly and to check for unwanted effects.

While you are being treated with asparaginase, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Asparaginase may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Before you have any medical tests, tell the medical doctor in charge that you are receiving asparaginase. The results of thyroid tests may be affected by asparaginase.

asparaginase Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Some side effects will have signs or symptoms that you can see or feel. Your doctor may watch for others by doing certain tests. Some of the unwanted effects that may be caused by asparaginase are listed below. Although not all of these effects may occur, if they do occur, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Joint pain
  • puffy face
  • skin rash or itching
  • stomach pain (severe) with nausea and vomiting
  • trouble in breathing
Less common
  • Confusion
  • convulsions
  • frequent urination
  • headache, sudden or severe
  • loss of bladder control
  • muscle spasm or jerking of all extremities
  • nausea and vomiting
  • numbness or tingling in hands, arms, or legs
  • severe weakness
  • sudden loss of consciousness
  • swelling of feet or lower legs
  • unusual bleeding or bruising
  • unusual thirst
Rare
  • Fever or chills
  • inability to move arm or leg
  • infection
  • pain in lower legs

Check with your doctor as soon as possible if any of the following side effects occur:

Less common
  • Drowsiness
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • lower back or side pain
  • mental depression
  • nervousness
  • sores in mouth or on lips
  • unusual tiredness

asparaginase may also cause the following side effect that your doctor will watch for:

More common
  • Bleeding problems
  • liver problems

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Headache (mild)
  • loss of appetite
  • stomach cramps
  • weight loss

After you stop using asparaginase, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

  • Headache (severe)
  • inability to move arm or leg
  • stomach pain (severe) with nausea and vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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