Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You must contact your doctor immediately if you notice any of the following:

• Fever or infection; if you have a temperature of 38ºC or greater, sweating or other signs of infection (since you might have less white blood cells than normal which is very common). Infection (sepsis) may be severe and could lead to death
• If you start feeling chest pain or having a fast heart rate
• If you have pain, redness, swelling or sores in your mouth
• Allergic reaction; if you develop skin rash/ burning or prickling sensation or fever. Rarely, skin reactions may be severe and could lead to death Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson Syndrome or Toxic epidermal necrolysis)
• If you experience tiredness, feeling faint,

becoming easily breathless or if you look pale (since you might have less hemoglobin than normal which is very common)

• If you experience bleeding from the gums, nose or mouth or any bleeding that would not stop reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is very common)
• If you experience sudden breathlessness, intense chest pain or cough with bloody sputum (may indicate a blood clot in the blood vessels of the lungs)

Side effects with Pemaxa may include:

Very common side effects (may affect more than 1 in 10 people):

• Low white blood cells
• Low hemoglobin level (anemia)
• Low platelet count
• Diarrhea
• Vomiting
• Pain, redness, swelling or sores in your mouth
• Nausea
• Loss of appetite, Fatigue (tiredness)
• Skin rash
• Hair loss
• Constipation
• Loss of sensation
• Kidney: abnormal blood tests

Common side effects (may affect up to 1 in 10 people):

• Allergic reaction: skin rash/ burning or prickling sensation
• Infection including sepsis
• Fever
• Dehydration
• Kidney failure
• Irritation of the skin and itching
• Chest pain
• Muscle weakness
• Conjunctivitis (inflamed eye)
• Upset stomach
• Pain in the abdomen
• Taste change
• Watery eye
• Increased skin pigmentation
• Liver: abnormal blood tests

Uncommon side effects (may affect up to 1 in 100 people):

• Acute renal failure
• Fast heart rate
• Inflammation of the lining of the esophagus (gullet) (experienced with Pemaxa / radiation therapy)
• Colitis (may be accompanied by intestinal or rectal bleeding)
• Interstitial pneumonitis
• Edema (excess fluid in body tissue, causing swelling). Some patients have experienced heart attack, stroke or “mini-stroke” (while receiving in combination with another anticancer therapy)
• Pancytopenia
• Radiation pneumonitis (occur in patients treated with radiation either before, during or after their Pemaxa therapy)
• Extremity pain, low temperature and discoloration
• Blood clots in the lung blood vessels (pulmonary embolism)

Rare side effects (may affect up to 1 in 1,000 people):

• Radiation recall (a skin rash like severe sunburn) (occurs on skin exposed to radiotherapy, from days to years after the radiation)
• Bullous conditions (blistering skin diseases),

including Stevens-Johnson syndrome and toxic epidermal necrolysis

• Immune mediated haemolytic anaemia
• Hepatitis
• Anaphylactic shock

Not known side effects (frequency cannot be estimated from the available data):

• Lower limb swelling with pain and redness
• Increased urine output
• Thirst and increased water consumption
• Hypernatraemia: increased sodium in blood
• Inflammation of the skin, mainly of the lower limb with swelling, pain and redness

You might have any of these symptoms and/or conditions. You must tell your doctor as soon as possible when you start experiencing any of these side effects.