YONDELIS or its combination with PLD can have side effects. Not all side effects reported for YONDELIS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using YONDELIS, please consult your doctor, pharmacist or other healthcare professional for advice.
Side effects caused by the single treatment with YONDELIS:
Frequent
- You may: feel tired, feel short of breath (dyspnoea), bruise more easily, have nose bleeds, be more prone to infections like chest infection (pneumonia), catheter site infection and infection in the blood (sepsis). An infection could also give you a raised temperature (fever). If you develop any of these symptoms you should seek medical attention immediately.
- Your doctor may require blood tests in certain situations in order to avoid that you develop muscle damage (rhabdomyolysis). In very severe cases this could lead to kidney failure. If you experience severe muscle pain or weakness, you should seek medical attention immediately.
- You could have increased levels of the yellow pigment bilirubin in the blood which might cause jaundice (a yellowing of the skin, mucous membranes and eyes).
- You may experience headache and a loss of strength.
- You may also lose your appetite, feel sick (nausea) or vomit, and become constipated. If you still feel sick, vomit or are unable to drink fluids and therefore pass less urine, despite being given anti-sickness medication, you should immediately seek medical help.
- Your doctor will order regular blood tests to detect any abnormalities in the blood.
- You may have fever. If you have a raised temperature you should seek medical attention immediately.
- You could also feel pain in your back, muscles and joints. There could be damage to your nerves which may result in muscle pain, weakness and numbness. You could experience general swelling or swelling of the limbs and a sensation of creeping on the skin.
- You may experience diarrhoea, loss of water from the body, inflammation of the mouth (stomatitis), pain in the abdomen, weight loss, digestive discomfort and a change in your sense of taste.
- You may lose hair (alopecia).
- You could also experience dizziness, sleeping problems, low blood pressure and flushing.
- You may have a reaction at the site of injection. YONDELIS infusion may leak out of your vein while you are being given it, leading to damage and death of your tissue cells around the injection site (tissue necrosis, see also TAKE SPECIAL CARE WITH YONDELIS), which may require surgery.
Less frequent
- You may experience difficulty in breathing, irregular heartbeat, decreased urine output, abrupt change in mental status, areas of mottled skin, extremely low blood pressure associated with abnormal laboratory tests results (decrease in platelet count). If you get any of the above symptoms or signs, seek medical care immediately.
- You may experience yellowing of your skin and eyeballs (jaundice), pain in the upper right area of your abdomen, nausea, vomiting, a general sense of not feeling well, difficulty in concentrating, disorientation or confusion, sleepiness. These signs could be indicative of the inability of the liver to perform its normal function. If you get any of the previous described symptoms or signs, seek medical care immediately.
- You may experience fever, difficulty in breathing, redness or flushing of the skin or a rash, feeling sick (nausea) or being sick (vomiting).
- You may notice that YONDELIS infusion leaks out of your vein (extravasation) while you are being given it. Then you will notice some redness, swelling, itchiness and discomfort at the injection site. If you get any of these symptoms or signs, tell your nurse or doctor immediately. It could lead to damage and death of your tissue cells around the injection site (tissue necrosis) which may require surgery. Some of the symptoms or signs of extravasation may not be visible until several hours after it occurred. There may be blistering, peeling and darkening of the skin over the site. It is possible for it to take a few days before the full extent of tissue damage is visible. If you get any of the previous described symptoms or signs, seek medical care immediately.
Other side effects that may occur with the combination of YONDELIS and PLD: When YONDELIS is used in combination with PLD some of these side effects are more likely to occur and some may occur in a more severe way.
Frequent
- You may have the hand and foot syndrome. It may present as red skin of the palms, fingers, and soles of the feet that later may become swelling and violaceous. The lesions may either dry out and desquamate or blister with ulceration.
- You may have a higher skin pigmentation and rash.
- You could have mucosal inflammation as a swelling redness of the inside of the mouth leading to painful ulcers and mouth sores or as an inflammation of the gastrointestinal tract.
- You may also have blood infections (neutropenic infection and neutropenic sepsis). Your doctor will order regular blood tests to detect any abnormalities in the blood.
- You may have syncope also called fainting.
- You could have a weakness in the ventricles, the heart's major pumping chambers (left ventricular dysfunction), sudden blockage in a lung artery (pulmonary embolism) and an abnormal buildup of fluid in the lungs, which leads to swelling (pulmonary oedema).
Less frequent:
- You may experience difficulty in breathing, irregular heartbeat, decreased urine output, abrupt change in mental status, areas of mottled skin, extremely low blood pressure associated with abnormal laboratory tests results (decrease in platelet count). If you get any of the above symptoms or signs, seek medical care immediately.
- You may experience fever, difficulty in breathing, redness or flushing of the skin or a rash, feeling sick (nausea) or being sick (vomiting).
- You may feel severe muscle aches and pains (myalgia), stiffness and muscle weakness. You also may experience a darkening of the urine colour. All of the previously described, could be a sign of damage to your muscles (rhabdomyolysis).
You may notice that YONDELIS infusion leaks out of your vein (extravasation) while you are being given it. Then you will notice some redness, swelling, itchiness and discomfort at the injection site. If you get any of these symptoms or signs, tell your nurse or doctor immediately. It could lead to damage and death of your tissue cells around the injection site (tissue necrosis) which may require surgery. Some of the symptoms or signs of extravasation may not be visible until several hours after it occurred. There may be blistering, peeling and darkening of the skin over the site. It is possible for it to take a few days before the full extent of tissue damage is visible. If you get any of the previous described symptoms or signs, seek medical care immediately.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Reporting of side effects: If you get side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/. By reporting side effects, you can help provide more information on the safety of YONDELIS.
