Patient Medication Information: uses, side effects, how to take - AJ-Cytarabine
ABOUT THIS MEDICATION
What the medication is used for:
CYTARABINE INJECTION is used alone or in combination with other anticancer medicines in the treatment of patients with certain types of leukaemia (cancer of the blood) and lymphomas (cancer of the lymph glands).
What it does:
Cytarabine is a cytotoxic drug that interferes with cell growth and causes cell death.
When it should not be used:
Do not take CYTARABINE INJECTION:
If you are allergic (hypersensitive) to cytarabine
or any of the other ingredients in CYTARABINE INJECTION
What the medicinal ingredient is:
Cytarabine.
What the important nonmedicinal ingredients are:
Hydrochloric acid solution and/or sodium hydroxide solution to adjust the pH.
What dosage forms it comes in:
CYTARABINE INJECTION (cytarabine) is available in single use vials of 2 g/20 mL (single pack).
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
CYTARABINE INJECTION should be used only by doctors with experience in cancer medicines.
Serious side effects with CYTARABINE INJECTION include:
- Decreased production of blood cells
- (myelosuppression)
- Heart muscle disorders (cardiomyopathy).
- Anaphylactic reactions
- Tumour Lysis Syndrome (TLS)
- Secondary cancers (other cancers)
In patients on a high dose schedule of
CYTARABINE INJECTION, severe gastrointestinal toxicity, central nervous system toxicity, pulmonary toxicity, at times fatal, and eye toxicity have been reported. Vaccination with a live vaccine should be avoided while taking CYTARABINE INJECTION.
CYTARABINE INJECTION may cause Tumour Lysis Syndrome [TLS]. TLS is a metabolic condition that results from dying cancer cells and involves changes in blood chemistry that can lead to kidney failure and abnormal heart rhythm, which may be fatal. Tell your doctor immediately if you have palpitations/irregular heartbeats; vomiting; fatigue/weakness; difficulty concentrating/trouble thinking; swelling, numbness or tingling in hands, face or feet; back pain; muscle cramps; fainting or trouble breathing.
Cases of acute pancreatitis, and cases of paralysis, at time fatal in children have been reported with the use of CYTARABINE INJECTION in combination with other drugs.
Tell your doctor before taking CYTARABINE INJECTION, if any of the following apply to you:
- Liver or kidney problems;
- Heart problems;
- Lung problems;
- Low blood cell counts;
- Skin problems;
Pregnant or think you may be pregnant;
- Breast-feeding;
- Are male patient and plan to father a child.
The safety of CYTARABINE INJECTION in infants (under 1 year of age) is not known.
Contraception
CYTARABINE INJECTION may cause harm to an unborn child. Female patients who might get pregnant must use effective contraception during treatment with CYTARABINE INJECTION. Since CYTARABINE INJECTION may present in the semen, male patients who are not surgically sterile must agree to use effective contraception during treatment with CYTARABINE INJECTION to prevent pregnancy in female partners. If pregnancy is suspected during treatment with CYTARABINE INJECTION, inform your doctor immediately.
Driving and using machines:
If you experience (feel) dizziness, do not drive or use machinery.
INTERACTIONS WITH THIS MEDICATION
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed, especially the following:
- 5-Fluorocytosine (a medicine used to treat fungal
- infections).
- Digoxin.
- Gentamicin (an antibiotic).
- Cyclophosphamide, vincristine and prednisone
PROPER USE OF THIS MEDICATION
Cytarabine will be given to you as an injection or an infusion into a vein (through a ‘drip’).
The dose of Cytarabine will be decided by your doctor based on your condition being treated for and your body surface area (your body weight and height will be used to calculate your body surface area).
Overdose:
In case of drug overdose, contact a healthcare practitioner, hospital emergency department or regional poison control centre, even if there are no symptoms.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, CYTARABINE INJECTION can have side effects.
Tell your doctor or nursing staff immediately, if you experience the following side effects:
- An allergic reaction such as sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body), hives.
- Feeling tired and lethargic.
- Flu like symptoms e.g. raised temperature or fever and chills.
- Bruise more easily or bleed more than usual if you hurt yourself.
Other side effects include:
- Reactions at Injection site: inflammation to your veins (caused by a blood clot) and infection.
- Headaches or feeling dizzy, feeling of pins and needles, shaking and fits, drowsiness, experience problems in walking, speech problems, involuntary muscular movement, changes in your personality, tiredness, weakness, fainting.
- Hair loss, a skin rash or ulceration, peeling of the skin, itching or increased freckles.
- Infections
- Feeling sick, being sick, diarrhoea, loss of appetite, abdominal pain. Abdominal swelling and bloody stool.
- Inflammation of the gullet, heartburn, sores and bleeding in the mouth, lips, or on the anus (back passage).
- Pancreatitis (pain in the upper abdomen) often accompanied by feeling sick or vomiting.
- Liver damage (seen as yellowing of the skin and whites of the eye).
- Difficulty or pain when passing urine. Blood in your urine and impaired kidney function.
- Feeling hot and feverish, conjunctivitis, and pain and numbness in joints, fingers, toes or face, swelling of the abdomen, legs, ankles and feet.
- May cause paralysis
- Shortness of breath, pneumonia, short or stabbing chest pain, build up of fluid in the lungs, sore throat.
- Muscle pain, bone pain.
- Fast heart beat
Eye infection, irritation, pain and blurred vision.
Visual loss. Intolerance to light.
Cytarabine Syndrome can happen between 6
to12 hours after receiving Cytarabine. The syndrome includes feeling generally unwell with a high temperature, pain in bone, muscle and sometimes the chest, blistery rash, sore eyes.
If any of the side effects get serious or if you notice any side effect not listed in this leaflet, please tell your doctor or nursing staff immediately.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | |||||
| HAPPEN AND WHAT TO DO ABOUT THEM | |||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |||
Only if severe | In all cases | ||||
Pancreatitis (inflammation of the pancreas) with symptoms such as abdominal pain, fever, nausea, vomiting | √ | ||||
Decreased white blood cell and platelet counts with symptoms such as infection, fever, bleeding, bruising, and rash | √ | ||||
This is not a complete list of side effects. For any unexpected effects while taking CYTARABINE INJECTION, contact your doctor or pharmacist.
HOW TO STORE IT
- Keep out of reach and sight of children.
Store CYTARABINE INJECTION between 15°-
30°C. Protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
Report online at www.healthcanada.gc.ca/medeffect Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and: Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full Product Monograph, prepared for health professionals can be obtained by contacting the sponsor:
Onco Therapies Limited