Patient Safety Information
What you need to know about taking Oyavas®
Some side effects may require you to stop taking Oyavas®. But as long as your cancer is under control and the side effects remain manageable, your doctor may advise you to keep taking Oyavas®.
YOU ARE LIKELY TO EXPERIENCE THESE PROBLEMS/ SIDE EFFECTS (very common side effects)
These side effects occur in more than 10 out of 100 patients (10%). You may experience one or more of them. They include:
· High blood pressure
· Feeling of numbness or tingling in hands or feet (peripheral neuropathy)
· An increased risk of infection
· An increased risk of bruising and bleeding
· Feeling weak and lacking energy
· Tiredness (fatigue)
· Feeling or being sick
· Tummy (abdominal) pain
· Loss of appetite and weight
· High temperature (fever)
· Eye problems, including watery eyes
· Changes to your voice
· Taste changes
· Runny nose
· Protein in urine
· Skin problems
· Muscle and joint pain.
YOU MAY EXPERIENCE THESE PROBLEMS/SIDE EFFECTS (less common side effects)
These side effects occur in 1 to 10 out of every 100 patients (1-10%). You may experience one or more of them. They include:
· Life-threatening blood clots; signs are pain, swelling, and redness where a clot is situated. Feeling breathless can be a sign of a blood clot in the lung.
→ Contact your doctor immediately if you experience any of these symptoms
· Damage to your gut or bowel, such as a blockage or hole
· Heart failure
· Redness, peeling, tenderness, pain, or blistering on the fingers or feet
· Breathlessness and paleness
· Thirst and dry mouth
· Passing less urine and dark urine
· Inflammation of the mouth, gut, airway, lungs, and other parts of the body
· Sores in the mouth, throat, and food pipe (esophagus)
· Pain including headache, back pain, pain between the hips (pelvis) and back passage (anus)
· Feeling sleepy
· Increased heart rate
· An abnormal opening (fistula) between internal organs and skin or other tissues that are not usually connected.
WHEN TO CONSULT YOUR DOCTOR
OTHER MEDICINES, FOODS, AND DRINK
Please inform your doctor or pharmacist if you are taking any other medicines, including vitamins, herbal supplements, and over-the-counter remedies.
LOSS OF FERTILITY
Talk to your doctor before starting treatment with Oyavas® if you think you may want to have a baby in the future.
Treatment with this drug could affect your chances of becoming pregnant or of fathering a child.
You may decide to store your eggs or sperm before starting treatment. Please ask your doctor for more information about this.
Do not have live vaccines during treatment and for several months afterward.
Please consult your doctor on how long you should avoid live vaccinations - this may vary depending on the duration of your treatment. You can be in direct contact with people who have had live vaccines as injections, but contact with people who have recently had live oral vaccines (for example, the typhoid vaccine) should be avoided. You should avoid contact with children who have had the flu vaccine as a nasal spray for two weeks following their vaccinations. You may come into contact with a live virus while changing the diapers of babies who have had the live rotavirus vaccine. You should wear gloves, wash your hands well after changing diapers or ask someone to help you.
Please talk to your doctor about the following conditions:
• surgery: Oyavas® can cause wounds to heal more slowly. You cannot start treatment with Oyavas® until at least 28 days after surgery or until any wounds have completely healed.
• pregnancy, pregnancy planning, and contraception: it is essential not to become pregnant or father a child while undergoing treatment with this drug and for at least six months afterward. This drug may be dangerous for child development. Please talk to your doctor about contraception.
• breastfeeding: do not breastfeed during your treatment and for six months afterward. Oyavas® may be passed to your baby in your breast milk.
Reporting of side effects
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. You can report any suspected adverse reactions via
HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2
Phone: +353 1 6764971 Fax: +353 1 6762517
E-mail: firstname.lastname@example.org Website: www.hpra.ie
You can also report a side effect concerning a Clonmel Healthcare Ltd. medicinal product directly to Clonmel Healthcare Ltd.
Post: Clonmel Healthcare Ltd. Pharmacovigilance, Waterford Road, Clonmel, Co. Tipperary, E91 D768
Phone: +353 52 6177777 Fax: +353 52 6177791