Patient Medication Information: uses, side effects, how to take - Cytarabine Injection BP
ABOUT THIS MEDICATION
What the medication is used for:
Cytarabine Injection BP is used to treat patients with cancer of the blood (leukemia) or cancer of the lymph nodes (lymphoma). It is used alone or in combination with other medicines.
What it does:
Cytarabine Injection BP slows or stops the growth of cancer cells.
When it should not be used:
Do not take Cytarabine Injection BP:
- If you/the child in your care are allergic (hypersensitive) to cytarabine or any of the other ingredients in Cytarabine Injection BP (see “What the nonmedicinal ingredients are” section of this leaflet).
What the medicinal ingredient is:
Cytarabine.
What the nonmedicinal ingredients are:
Hydrochloric acid solution and/or sodium hydroxide solution to adjust the pH, water for injection.
What dosage forms it comes in:
Cytarabine Injection BP is supplied in single use vials of 100 mg / 1 mL (5 vials per box), 500 mg/5 mL (5 vials per box), 1000 mg / 10 mL (1 vial per box) and 2000 mg / 20 mL (1 vial per box).
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions Cytarabine Injection BP should be prescribed and monitored only by doctors with experience with cancer medicines.
The following are serious side effects of Cytarabine Injection BP :
- Serious Allergic Reaction: Symptoms include sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body), hives.
- Cytarabine Injection BP can cause damage to the heart. Tell your doctor right away if you/the child in your care have chest pain, shortness of breath, swelling of the legs or irregular heartbeat.
Cytarabine Injection BP can cause changes to the lungs. Tell
your doctor right away if you/the child in your care develop wheezing, cough, fever or feeling of breathlessness, or if existing breathing problems get worse.
- Cytarabine Injection BP can have harmful effects on the nervous system. Tell your doctor right away if you/the child in your care feel drowsy or confused, dizzy or unsteady, get headaches or personality changes.
- Cytarabine Injection BP can have harmful effects on the stomach and gut that can sometimes be fatal. Tell your doctor right away if you/the child in your care feel sick or vomit, have diarrhea, a loss of appetite or abdominal pain.
- Cytarabine Injection BP can cause a decrease in the number of white blood cells, red blood cells, and platelets (low blood cell counts). This means that you/the child in your care may bruise or bleed more easily. Tell your doctor right away if you/the child in your care get infection, bleeding, fever, or chills with shivering, bruising or rash.
While you/the child in your care are being given Cytarabine Injection BP your doctor will monitor your blood counts (white blood cells, red blood cells, platelets) as well as your liver and kidney function by doing regular blood tests.
A preservative called benzyl alcohol is sometimes added to Cytarabine Injection BP. This preservative should not be given to low birth weight or premature babies.
Cytarabine Injection BP may cause Tumour Lysis Syndrome (TLS). This happens when cytarabine makes the cancer cells break down very quickly. This releases uric acid (a waste product) into the blood. The kidneys usually get rid of uric acid but may not be able to cope with large amounts. This can cause serious imbalances in the blood that affect the kidneys and the heart. Tell your doctor immediately if you/the child in your care 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.
Vaccination with a live vaccine should be avoided while being treated with Cytarabine Injection BP. Tell your doctor that you/the child in your care are on Cytarabine Injection BP before getting any vaccine.
Cases of sudden inflammation of the pancreas and cases of paralysis, at times fatal in children, have been reported with the use of cytarabine in combination with other drugs.
Serious nervous system side effects that ranged from headache to paralysis, coma and stroke-like episodes have been reported mostly in children (under 18 years of age) given intravenous (injected into the vein) cytarabine in combination with intrathecal (injected into the spinal cord) methotrexate.
The safety of Cytarabine Injection BP in infants (under 1 year of age) is not known.
Before you start treatment with Cytarabine Injection BP, tell your doctor if you, or the child in your care, have any of the following:
- Liver or kidney problems;
- Heart problems;
- Lung problems;
- Stomach or gut problems
- Low blood cell counts;
- Skin problems.
Pregnancy, Breastfeeding and Fertility:
Cytarabine Injection BP may harm your baby/unborn baby.
Do not become pregnant while being treated with Cytarabine Injection BP. Women who may become pregnant must use effective birth control during treatment and for 3 months after treatment has finished.
If you are pregnant, think you might be pregnant or are planning to have a baby, ask your doctor for advice before starting treatment with Cytarabine Injection BP.
Tell your doctor immediately if you become pregnant.
Do not breastfeed while you are being treated with Cytarabine Injection BP.
Male Fertility:
Do not father a child while being treated with Cytarabine Injection BP and for 3 months after stopping treatment. Use condoms and do not donate sperm during treatment and for 3 months after your treatment has finished. If you plan to father a child, talk to your doctor before starting treatment with Cytarabine Injection BP.
Driving and using machines:
If you feel drowsy or dizzy, do not drive or use machinery.
INTERACTIONS WITH THIS MEDICATION
Serious Drug Interactions If Cytarabine Injection BP is given to you/the child in your care with methotrexate (another drug used to treat cancer), you have more chances of having serious side effects on your nervous system such as headache, paralysis, coma and stroke-like episodes.
Tell your doctor or pharmacist about any medicines you or the child in your care are on or have taken (including the ones you don’t need a prescription for), especially the following:
- 5-Fluorocytosine (a medicine used to treat fungal infections)
- Digoxin (a heart medicine)
- Gentamicin (an antibiotic)
- Cyclophosphamide, vincristine and prednisone
PROPER USE OF THIS MEDICATION
Cytarabine Injection BP will be given to you or the child in your care as an injection or an infusion. It can be given:
- Into the spinal cord
- Into a vein (through a “drip”)
Under the skin
Chemotherapy is usually given during several cycles of treatment over a few months. The length of your/the child in your care’s treatment and the number of cycles you or the child in your care need will depend on the type of cancer you/they have. Your doctor will discuss your treatment plan with you.
Usual dose:
The dose of Cytarabine Injection BP you or the child in your care will be given will be calculated by your doctor based on your/the child’s weight and height.
Overdose:
In case of drug overdose, contact a healthcare practitioner, hospital emergency department or regional poison control centre, even if there are no symptoms.
Missed dose:
Call your doctor for instructions if you/the child in your care miss an appointment for your cytarabine injection.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Side effects of Cytarabine Injection BP may include:
- Viral, bacterial, or fungal infections: Infections can be serious and may lead to death. Contact your doctor if you or the child in your care have fever, chills, or any other signs or symptoms of a possible infection.
- Cytarabine Syndrome: Cytarabine Injection BP may cause a reaction called Cytarabine Syndrome 6 to12 hours after it has been given. Contact your doctor if you or the child in your care develop fever, muscle pain, bone pain, chest pain, rash, eye problems (pain, itching, redness, discharge, blurred vision), or generally feel unwell.
- Feeling tired or weak.
- Headaches or feeling dizzy, fainting.
- Feeling of pins and needles.
- Nausea, vomiting, diarrhea, loss of appetite, abdominal pain.
- Eye infection, irritation, pain and blurred vision.
- Hair loss, skin rash or open sores, peeling of the skin, itching or increased freckles.
- Swelling of the throat, heartburn, sores and bleeding in the mouth, lips, or on the anus.
- Feeling hot and feverish.
- Sore throat.
- Muscle pain, bone pain.
- Fast heartbeat.
- Rash or blisters on the palms of the hands and soles of the feet.
If any of these affects you severely, tell your doctor, nurse or pharmacist.
During treatment, you or the child in your care will need to have regular blood tests. Your doctor will tell you how often this should be done. It is important that you do not miss any of these tests.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN | ||
| AND WHAT TO DO ABOUT THEM |
| Symptom / effect | Talk with your doctor or pharmacist | Stop treatment and seek immediat e medical help | ||
Only if severe | In all cases | |||
| Anemia: symptoms include fatigue, loss of energy, weakness, shortness of breath. | ✓ | |||
| Decreased platelets: symptoms include bruising, bleeding, fatigue and weakness. | ✓ | |||
| Decreased white blood cells: symptoms include infections, fever, chills with shivering, fatigue, aches pains and flu-like symptoms. | ✓ | |||
| Infection of the blood: symptoms include feeling dizzy or faint, confusion or disorientation, diarrhea, nausea, vomiting, slurred speech, severe muscle pain. | ✓ | |||
Megaloblastic anemia: symptoms include fatigue, weakness, loss of appetite, nausea, diarrhea, fast heartbeat, smooth or tender tongue, tingling or numbness in hands and feet. | ✓ | |||
| Pneumonia: symptoms include cough with or without mucus, fever, chills, shortness of breath. | ✓ | |||
| Serious stomach or gut problems: symptoms include severe vomiting, severe diarrhea (increased number of bowel movements, watery or bloody stool, stomach pain and/or cramps. | ✓ | |||
| Serious allergic reaction: symptoms include rash, hives, swelling of the face, lips tongue or throat, difficulty swallowing or breathing. It may lead to a heart attack. | ✓ | |||
| Oedema: symptoms include swelling of the stomach, legs, ankles or feet. | ✓ | |||
| Inflammation of the pancreas: symptoms include abdominal pain that lasts and gets worse when you lie down, fever, nausea, vomiting. | ✓ | |||
Injection site reaction: symptoms include pain, redness, warmth, swelling at the injection site or along the vein. | ✓ | |||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN | ||||||
| AND WHAT TO DO ABOUT THEM | ||||||
Symptom / effect Kidney disorder: symptoms include decreased urination, nausea, vomiting, swelling of extremities, fatigue, difficulty or pain when urinating, blood in the urine. Liver disorder: symptoms include yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite. Serious bleeding problems: symptoms include blood in your stool or urine, bleeding that lasts for a long time or that you cannot control, coughing up blood or blood clots, increased bruising, feel dizzy or weak, confusion, change in your speech, or a headache that lasts a long time. Serious eye problems: symptoms include sensitivity to light, blurry vision, eye pain, tearing, feeling like there is something stuck in your eye. Serious heart problems: symptoms include shortness of breath, swelling of the legs, irregular heartbeat, chest pain. Serious nervous system problems: symptoms include headache, paralysis, coma, stroke-like episodes, drowsiness or confusion, dizziness or unsteadiness, personality changes, shaking and fits, speech problems, involuntary movements. Tumor Lysis Syndrome: symptoms include nausea, vomiting, decreased urination, irregular heartbeat, confusion, delirium, seizures. | Talk with your doctor or pharmacist | Stop treatment and seek immediat e medical help | ||||
Only if severe | In all cases | |||||
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This is not a complete list of side effects. For any unexpected effects while taking Cytarabine Injection BP, contact your doctor or pharmacist.
HOW TO STORE IT
Keep out of reach and sight of children.
This drug will be given to you in a hospital or doctor’s office. You will not store it at home.
Medicines should not be thrown down the drain or in the garbage. Ask your pharmacist how to dispose of medicines you no longer need. This will help to protect the environment.
REPORTING SIDE EFFECTS
You can report any suspected side effects associated with the use of health products to Health Canada by:
Visiting the Web page on Adverse Reaction
Reporting (http://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Sandoz Canada Inc., at:
1-800-361-3062
or by written request at:
145 Jules-Léger
Boucherville QC
J4B 7K8
Or by e-mail at:
medinfo@sandoz.com