Description
Asparaginase Erwinia chrysanthemi is used together with other cancer medicines to treat a certain type of blood cancer called acute lymphoblastic leukemia (ALL). This medicine is used in patients who have had an allergic reaction to E. coli-derived asparaginase.
Asparaginase Erwinia chrysanthemi belongs to the group of medicines known as antineoplastic agents. It interferes with the growth of the cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by this medicine, other effects will also occur. Some of these may be serious and must be reported to your doctor.
Before you begin treatment with Erwinase®, you and your doctor should talk about the benefits of this medicine as well as the risks of using it.
This medicine is to be given only by or under the immediate supervision of your doctor.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
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 this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Erwinase® in children 4 months of age and older.
Geriatric
Appropriate studies have not been performed on the relationship of age to the effects of Erwinase® in the geriatric population. Safety and efficacy have not been established.
Breastfeeding
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine 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.
- Cytarabine
- Methotrexate
- Prednisolone
- Prednisone
- Vincristine
- Vincristine Sulfate Liposome
Other Interactions
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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Pancreatitis, active or
- Pancreatitis caused by L-asparaginase treatment, active or history of—Should not be given to patients with these conditions.
- Bleeding problems or
- Blood clotting problems or
- Diabetes or
- Hyperglycemia (high blood sugar) or
- Kidney disease or
- Pancreatitis (inflammation of the pancreas)—Use with caution. May make these conditions worse.
Proper Use
A doctor or other trained health professional will give you or your child this medicine in a hospital or cancer treatment center. This medicine is given as a shot into a muscle or a vein.
Missed Dose
This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you or your child have chills, fever, lightheadedness, dizziness, or fainting, fast, pounding heartbeat, swelling of the face, tongue, and throat, or trouble breathing after you receive the medicine.
Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.
Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Tell your doctor right away if you have seizures, headache, confusion, vision problems, unusual drowsiness, tiredness, or weakness. These could be symptoms of a serious nervous system problem called posterior reversible encephalopathy syndrome (PRES).
Erwinase® can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever, chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
Check with your doctor right away if you or your child start having increased thirst or hunger, increased urination, pale skin, nausea, sweating, or faintness. These may be signs that you are having problems with the amount of blood sugar in your body.
Tell your doctor right away if you or your child develop confusion, headache, nausea and vomiting, numbness or tingling in the arms or legs, or chest pain after receiving this medicine. These may be symptoms of a serious bleeding or blood clotting problem.
This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Agitation
- back pain
- black, tarry stools
- bleeding gums
- bloating
- blood in the urine or stools
- blurred vision
- chest pain
- chills
- coma
- confusion
- constipation
- cough or hoarseness
- difficulty in walking
- dizziness
- drooping eyelids
- drowsiness
- dry mouth
- lightheadedness
- fainting
- fast heartbeat
- fever
- flushed, dry skin
- fruit-like breath odor
- hallucinations
- headache
- increased hunger
- increased menstrual flow or vaginal bleeding
- increased thirst
- increased urination
- indigestion
- irritability
- jaw pain
- lower back or side pain
- mood or mental changes
- nosebleeds
- numbness or tingling in the fingers and toes
- pain in the fingers and toes
- pain in the testicles
- pains in the chest, groin, or legs, especially calves of the legs
- pains in stomach, side, or abdomen, possibly radiating to the back
- painful or difficult urination
- pale skin
- paralysis
- pinpoint red spots on the skin
- prolonged bleeding from cuts
- rapid, shallow breathing
- seizures
- severe headaches of sudden onset
- sleepiness or unusual drowsiness
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stiff neck
- stomach pain
- sudden loss of coordination
- sudden onset of slurred speech
- sudden vision changes
- sweating
- swollen glands
- trouble breathing
- unexplained weight loss
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
- yellow eyes or skin
Less common
- Chest tightness
- difficulty swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- hives, itching, skin rash
- increase in frequency of seizures
- loss of appetite
- loss of consciousness
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
Incidence not known
- Diarrhea
- nervousness
- pounding in the ears
- slow or fast heartbeat
- unpleasant breath odor
- vomiting of blood
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
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
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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