Consumer Information for: PMS-CYTARABINE
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
pms-CYTARABINE 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
pms-CYTARABINE slows or stops the growth of cancer cells.
When it should not be used
Do not take pms-CYTARABINE:
- If you/the child in your care are allergic (hypersensitive) to cytarabine or any of the other ingredients in pms-CYTARABINE (see “What the nonmedicinal ingredients are” section of this leaflet).
What the medicinal ingredient is
Cytarabine.
What the non-medicinal ingredients are
Solution (20 mg/mL): Sodium chloride, hydrochloride acid and/or sodium hydroxide to adjust pH, water for Injection.
Solution (100 mg/mL): hydrochloride acid and/or sodium hydroxide to adjust pH, water for Injection.
What dosage form it comes in
pms-CYTARABINE is supplied as:
- Solution (20 mg/mL) in vials of 100 mg/5 mL and 500 mg/25 mL
- Solution (100 mg/mL) in vials of 1000 mg/10 mL and 2000 mg/20 mL
Warnings and precautions
Serious Warnings and Precautions
pms-CYTARABINE should be prescribed and monitored only by
doctors with experience with cancer medicines.
The following are serious side effects of pms-CYTARABINE:
- 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.
- pms-CYTARABINE 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.
- pms-CYTARABINE 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.
- pms-CYTARABINE 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.
- pms-CYTARABINE 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.
- pms-CYTARABINE 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 pms-CYTARABINE 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.
pms-CYTARABINE may cause Tumour Lysis Syndrome (TLS). This
happens when pms-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 pms-CYTARABINE. Tell your doctor that you/the
child in your care are on pms-CYTARABINE 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 pms-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) pms-CYTARABINE in combination with
intrathecal (injected into the spinal cord) methotrexate.
The safety of pms-CYTARABINE in infants (under 1 year of age) is
not known.
Before starting treatment with pms-CYTARABINE, 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:
pms-CYTARABINE may harm your baby/unborn baby.
Do not become pregnant while being treated with pms-CYTARABINE.
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 pms-CYTARABINE.
Tell your doctor immediately if you become pregnant.
Do not breastfeed while you are being treated with pms-CYTARABINE.
Male Fertility:
Do not father a child while being treated with pms-CYTARABINE 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 pms-CYTARABINE.
Driving and using machines:
If you feel drowsy or dizzy, do not drive or use machinery.
Interactions with this medication
Serious Drug Interactions
If pms-CYTARABINE 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 that 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
pms-CYTARABINE 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 pms-CYTARABINE 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 pms-CYTARABINE injection.
Side effects and what to do about them
Side effects of pms-CYTARABINE 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.
- pms-CYTARABINE Syndrome: pms-CYTARABINE may cause a reaction called pms-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.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop treatment with pms-CYTARABINE and seek immediate medical help |
|---|---|---|---|
| Very common | |||
| 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. | ✔ | ||
| Frequency not known | |||
| 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. | ✔ | ||
| Edema: 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. | ✔ | ||
| 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. | ✔ | ||
How to store
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 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 1908C
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 Pharmascience Inc., at 1-888-550-6060.
This leaflet was prepared by
Pharmascience Inc.
Montréal, Canada
H4P 2T4
www.pharmascience.com
Last revised: February 14, 2017
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