10,000 U powder to concentrate to infusion liquid, solution
asparaginase
What Spectral is and what it is used for
Spectral contains asparaginase, which is an enzyme that interferes with natural substances that are necessary for cancer cells to grow. All cells need an amino acid called asparagine to continue living. Normal cells can produce their asparagine, but this is not the case for some cancer cells. Asparaginase lowers the level of asparagine in blood cancer cells and stops cancer growth.
Spectrila is used to treat adults and children with acute lymphoblastic leukemia (ALL), which is a form of blood cancer. Spectrila is used as a component of combination therapy.
What you need to know before you are given Spectrila
Spectrila must not be used
- if you are allergic to asparaginase or the other ingredients of this medicine (listed in section 6)
- if you have or have had inflammation of the pancreas ( pancreatitis )
- if you have serious problems with liver function
- if you have a blood clotting disorder (e.g. hemophilia )
- if you have had serious bleeding or serious blood clots ( thrombosis ) during previous treatment with asparaginase.
Warnings and precautions
Talk to your doctor or nurse before you are given Spectrila.
The following life-threatening situations may occur during treatment with Spectrila:
- severe inflammation of the pancreas ( acute pancreatitis )
- liver problems
- a severe allergic reaction that causes difficulty breathing or dizziness
- blood coagulation disorders (bleeding or blood clot formation)
- high blood sugar levels.
Before and during treatment with Spectrila, the doctor takes blood samples.
If serious liver problems occur, treatment with Spectrila must be stopped immediately.
If allergic symptoms occur, intravenous infusion with Spectrila must be stopped immediately. You may be given medication for allergies and, if necessary, medication to stabilize circulation. In most cases, treatment can be continued by changing to other medicines that contain other forms of asparaginase.
Disorders of blood clotting may require you to receive fresh blood plasma or a certain type of protein (antithrombin III) to reduce the risk of bleeding or blood clot formation ( thrombosis ).
High blood sugar levels may require treatment with intravenous fluids and/or insulin.
Reversible posterior leukoencephalopathy syndrome (characterized by headache, confusion, epileptic seizures, and loss of vision) may require antihypertensive drugs and, in cases of epileptic seizures, antiepileptic treatment.
Other medicines and Spectrila
Tell your doctor if you are using, have recently used, or might be using other medicines. This is important because Spectrila can increase the side effects of other medicines through its effect on the liver, which plays an important role in removing medicines from the body.
In addition, you must tell the doctor if you are using any of the following medicines:
- Vincristine (used to treat certain types of cancer) because the simultaneous use of vincristine and asparaginase may increase the risk of certain side effects. To avoid this, vincristine is usually given 3–24 hours before asparaginase.
- Glucocorticoid er (“cortisone”, anti-inflammatory drugs that inhibit the immune system) because the simultaneous use of glucocorticoid er and asparaginase can increase blood clot formation ( thrombosis ).
- Medicines that reduce the blood’s ability to coagulate, e.g. anticoagulants (eg warfarin and heparin ), dipyridamole, aspirin, or medicines to treat pain and inflammation as the use of these medicines together with asparaginase may increase the risk of bleeding.
- Medicines that are broken down in the liver (e.g. paracetamol, acetylsalicylic acid, tetracycline ), the risk of side effects, may increase.
- Asparaginase can affect the effect of methotrexate or cytarabine (used to treat certain types of cancer):
- if asparaginase is given after these drugs, their effect may be enhanced.
- if asparaginase is given before these drugs, their effect may be weakened.
- Medicines that can hurt liver function (eg paracetamol, acetylsalicylic acid, tetracycline ) because these negative effects can be aggravated by parallel treatment with asparaginase.
- Medicines that can inhibit bone marrow function (eg cyclophosphamide, doxorubicin, methotrexate) as these effects may be enhanced by the parallel use of asparaginase. You may become more prone to infection.
- Other anticancer drugs because can contribute to the release of too much uric acid when tumor cells are destroyed by asparaginase.
Vaccination
Simultaneous vaccination with live vaccines can increase the risk of a serious infection. Therefore, you should not be vaccinated with live vaccines until at least 3 months after finishing treatment with Spectrila.
Pregnancy and breastfeeding
There is a lack of information on the use of asparaginase in pregnant women. Spectrila must not be used during pregnancy unless the woman’s condition requires treatment with asparaginase. It is not known whether asparaginase is present in breast milk. Therefore, Spectrila should not be used during breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
If you are sexually mature, you must use contraception or be abstinent during chemotherapy treatment and for 3 months after the end of treatment. Since an indirect effect between oral contraceptives and asparaginase cannot be excluded, oral contraceptives (taken by mouth) are not considered sufficiently safe. Women of childbearing age should use a contraceptive method other than oral contraceptives.
Driving ability and use of machinery
Do not drive or operate machinery while taking this medicine as it may make you feel drowsy, tired, or confused.
How Spectrila is used
Spectrila is prepared and given by healthcare professionals. The doctor decides what dose you will receive. The dose you receive depends on your body surface area, which is calculated from your height and weight.
Spectrila is given into a vein. It is usually given together with other anticancer drugs. The length of treatment depends on the specific chemotherapy protocol used to treat your disease.
Use for adults
The recommended dose of Spectrila for adults is 5,000 U (units) per square meter of the body surface and is given every three days.
Use for children and adolescents
The recommended dose for children and adolescents aged 1–18 years is 5,000 E per square meter of the body surface and is given every three days.
The recommended dose for infants aged 0–12 months is as follows:
- younger than 6 months: 6,700 E per square meter of body surface
- 6-12 months: 7,500 E per square meter of the body surface.
If you have been given too much Spectrila
If you think you have received too much Spectrila, tell the doctor or nurse as soon as possible.
So far, an overdose of asparaginase is not known to have led to any signs of an overdose. If necessary, the doctor treats your symptoms and provides supportive care.
If you have any further questions about this medicine, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately and stop taking Spectrila if you get:
- inflammation of the pancreas, causing severe pain in the abdomen and back
- serious abnormalities in liver function (determined by laboratory tests)
- allergic reactions including severe allergic reaction (anaphylactic shock ), flushing, rash, low blood pressure, swelling of the face and throat, hives, shortness of breath
- disorders of blood coagulation such as bleeding, an acute condition with uncontrolled activation of blood coagulation (disseminated intravascular coagulation, DIC ), or blood clot formation ( thrombosis )
- high blood sugar levels (hyperglycemia).
A list of all other side effects can be found below in order of how common they are:
Very common side effects (may affect more than 1 in 10 users)
- nausea, vomiting, stomach pain, or loose stools (diarrhea)
- accumulation of fluid ( edema )
- feeling of fatigue
- abnormal laboratory tests including changes in protein levels in the blood, changes in blood lipid levels or liver enzyme levels, or high levels of blood urea
Common side effects (may affect up to 1 in 10 users)
- mild to moderately reduced numbers of all blood cells
- allergic reactions including wheezing (spasm in the airways) or difficulty breathing
- low blood sugar ( hypoglycemia )
- loss of appetite or weight loss
- depression, hallucination, or confusion
- nervousness (worry) or sleepiness
- changes in electroencephalogram (EEG; a graph that shows the electrical activity of the brain)
- high blood levels of amylase and lipase
- pain (back pain, joint pain, stomach pain)
Uncommon side effects (may affect up to 1 in 100 users)
- high blood levels of uric acid (hyperuricemia)
- high levels of ammonia in the blood (hyperammonemia)
- headache
Rare side effects (may affect up to 1 in 1,000 users)
- diabetic ketoacidosis (complication due to uncontrolled blood sugar)
- epileptic seizures, severe loss of consciousness including coma and stroke
- reversible posterior leukoencephalopathy syndrome (a condition characterized by headache, confusion, seizures, and vision loss)
- inflammation of the salivary glands (parotitis)
- cholestasis (blocked flow of bile from the liver)
- jaundice
- breakdown of liver cells (liver cell necrosis)
- liver failure that can lead to death
Very rare side effects (may affect up to 1 in 10,000 users)
- reduced function of the thyroid or parathyroid glands
- the slight tremor in the fingers
- pancreatic pseudocysts (accumulation of fluid after acute inflammation of the pancreas)
Has been reported (occurring in an unknown number of users)
- infection _
- fatty liver
How to store Spectrila
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton. The expiration date is the last day of the specified month.
Store in a refrigerator (2 °C–8 °C).
Store the vial in the outer carton. Light sensitive.
The reconstituted solution is stable for 2 days when stored at 2°C–8°C.
If the finished medicine is not used immediately, the user who prepares this medicine is responsible for storage times and storage conditions to ensure the sterility of the product. Storage should not normally exceed 24 hours at 2 °C–8 °C.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is asparaginase. One vial of powder contains 10,000 units of asparaginase. After preparation, one milliliter of solution contains 2,500 units of asparaginase.
- The other ingredient is sucrose.
Appearance and package sizes of the medicine
Spectrila is supplied as a powder to concentrate for solution for infusion.
The powder is white and supplied in a clear glass vial with a rubber stopper, an aluminum seal, and a plastic flip cap.
Spectrila is available in packs of 1 or 5 vials.
Not all pack sizes may be marketed.
medac
Gesellschaft für klinische Spezialpräparate mbH
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22880 Wedel
Germany
Tel.: +49-4103-8006-0
Fax: +49-4103-8006-100
Email: contact@medac.de