Accord Paclitaxel Solution

ACCORD PACLITAXEL is used for the treatment of cancer. It can be cancer in the ovaries or breast cancer (advanced or spreading), after failure of other standardised prescribed treatment. ACCORD PACLITAXEL may also be used for a certain cancer in the lungs (advanced non-small cell lung cancer, NSCLC) in patients who cannot be treated with surgery and/or radiotherapy.

You should not be administered ACCORD PACLITAXEL:

• if you are allergic (hypersensitive) to paclitaxel or to any of the other ingredients listed in section 6, especially polyoxyl castor oil.
• if you are pregnant or breastfeeding.
• If you are a child
• if your number of white blood cells (neutrophils) is too low. This is measured by a doctor or nurse.

If you are unsure about anything, ask your doctor or pharmacist.

Warnings and precautions

Take special care and tell your doctor:

• if ACCORD PACLITAXEL was given to you before, and you experienced severe allergic reactions characterised by dyspnoea (shortness of breath), flushing, chest pain and tachycardia (increased heartbeat) and hypotension (low blood pressure) requiring treatment, angioedema (rapid swelling under the skin), and generalised urticaria (rash), inform your medical practitioner
• if you experience fever, fatigue or sore throat. These may be signs of changes in your white blood cell count and may make you more prone to infection.
• if you experience high or low blood pressure or changes in your heart rate.
• if you experience chest pain, shortness of breath or swelling in your ankles and feet.
• if you have had nerve problems in your hands or in feet, such as numbness, tingling or burning (peripheral neuropathy)
• if you have any liver disease
• if you experience severe diarrhoea during or after your treatment
• if you experience any changes in your vision.

Children and adolescents

ACCORD PACLITAXEL should not be used in children and as safety has not been established.

Other medicines and ACCORD PACLITAXEL

Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicine.) Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines you have obtained without a prescription. When used in combination, ACCORD PACLITAXEL should be given before cisplatin. ACCORD PACLITAXEL should be given 24 hours after doxorubicin. Special care should be observed if you are taking medicines which influence the metabolism of paclitaxel such as: ketoconazole (treats fungal infections), erythromycin (antibiotic), fluoxetine (anti-depressant), gemfibrozil (cholesterol medication), clopidogrel (to prevent blood clots), cimetidine (for treatment of stomach ulcers), rifampicin (TB medication), epilepsy treatment such as carbamazepine, phenytoin, phenobarbital, or HIV treatment such as efavirenz, and nevirapine and for HIV patients receiving protease inhibitors (ritonavir, nelfinavir) as concomitant therapy.

Pregnancy, breastfeeding and fertility:

• Do not use ACCORD PACLITAXEL if you think you are pregnant or you are trying to become pregnant. ACCORD PACLITAXEL can damage the unborn baby.
• You and your partner should use effective contraception for at least 6 months after treatment with ACCORD PACLITAXEL.
• ACCORD PACLITAXEL should not be used when you are breastfeeding. You should stop breastfeeding while you are being treated with ACCORD PACLITAXEL. Do not restart breastfeeding until your doctor tells you it is safe to do so. Ask your doctor or pharmacist for advice before taking any medicine.
• ACCORD PACLITAXEL can cause infertility in men. If you are a male patient, speak to your doctor about freezing and storing your sperm before treatment with ACCORD PACLITAXEL.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare professional for advice before receiving ACCORD PACLITAXEL.

You will not be expected to give yourself ACCORD PACLITAXEL. It will be given to you by a person who is qualified to do so. Your healthcare professional will administer ACCORD PACLITAXEL. Your doctor will advise you on how ACCORD PACLITAXEL will be administered to you. Read the Patient Information Leaflet available from your pharmacist before you start receiving ACCORD PACLITAXEL. If you have any questions, consult your doctor or pharmacist. ACCORD PACLITAXEL is given by injection into a vein by a healthcare professional. It is given on a schedule as directed by your doctor. If you have any questions about the use of ACCORD PACLITAXEL, consult your doctor or pharmacist. Dosage is based on your medical condition, body size, and response to treatment. If you are given more ACCORD PACLITAXEL than you should:

Your dose will be carefully calculated by the doctors, so overdose is unlikely. However, if too much is given this is likely to make the usual side effects worse, particularly blood disorders, numbness/tingling especially of the arms, hands, legs or feet, and stomach upsets including vomiting and diarrhoea. Since a healthcare professional will administer ACCORD PACLITAXEL, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

ACCORD PACLITAXEL can have side effects. Not all side effects reported for ACCORD PACLITAXEL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving ACCORD PACLITAXEL, please consult your health care provider for advice. If any of the following happens, tell your doctor to stop treatment immediately or go to the casualty department at your nearest hospital:

• sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint
• decreased or increased blood pressure, chills, back pain, chest pain, fast heartbeat, abdominal pain, pain in arms and legs, sweating.

These are all very serious side effects. If you have them, you may have had a serious reaction to ACCORD PACLITAXEL. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Any abnormal bruising, bleeding, or signs of infections such as a sore throat and high temperature.
• Breathlessness and dry cough due to damage to the lung.
• Reaction at the injection site, e.g. local swelling, pain, redness.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects

• Unexplained bruising and bleeding.
• Milder allergic (hypersensitivity) reactions, such as flushing and rash.
• Nerve problems affecting the hands and/or feet (peripheral neuropathy), which can cause tingling feelings in the skin, numbness and/or pain.
• Low or high blood pressure.
• Pain, swelling, tenderness in leg due to blood clot formation
• Feeling sick (nausea), being sick (vomiting) and diarrhoea.
• Hair loss.
• Muscle or joint pain.
• Inflammation of areas such as the lining of the mouth.
• Slow heart beat (pulse).
• Mild changes in nail and skin which soon disappear.
• Painful swelling and inflammation where the injection is given which may cause tissue hardening (occasionally cellulitis, thickening and scarring of the skin (skin fibrosis), death of skin cells (skin necrosis).

Less frequent side effects:

• Septic shock (a life-threatening condition that happens when your blood pressure drops to a dangerously low level after an infection. You may experience low blood pressure, chills, fatigue, fever, or low body temperature.
• Serious heart problems like heart muscle degeneration (cardiomyopathy), serious changes in your heart’s rhythm even with fainting. Heart attack.
• Blood clot (thrombosis), inflammation of a vein in connection with blood clots.
• Yellowing of the skin (jaundice).
• Pneumonia
• Reduced number of a type of white blood cell with fever (febrile neutropenia)
• Effects on the nerves, which can cause muscle weakness in the arms and legs.
• Difficulty in breathing, fluid on the lungs, inflammation of the lungs and other lung problems (lung fibrosis, pulmonary embolism), markedly impaired pulmonary function (respiratory failure).
• Itching, rash and reddened skin.
• Weakness, high temperature (fever), dehydration, oedema, feeling ill.
• Blockage of the intestines, penetration of the wall of the small intestine or large bowel, inflammation of the lining of the belly (peritoneum), inflammation of the intestine caused by inadequate blood supply, inflammation of the pancreas.
• Loss of appetite, shock due to decreased blood pressure, cough.
• Effects on the nervous system which can cause paralysis of the intestines (gut) and a decrease in blood pressure when standing up or sitting up from a lying down position, fits (epileptic seizures), cramps, confusion, dizziness, alteration in brain function or structure, headache, loss of the ability to coordinate muscular movement.
• Problems with eyesight and visual disturbances, usually in patients given larger doses.
• Reduction or loss of hearing, ringing in the ears (tinnitus), vertigo.
• Abnormal heart rhythm (atrial fibrillation, supraventricular tachycardia).
• A blood clot in the mesenteric artery, pseudomembranous colitis (an infection of the colon caused by specific bacteria), inflammation of the oesophagus, constipation. Collection of fluid in the abdomen (belly).
• Severe inflammation of the large bowel presenting with fever, watery or bloody diarrhoea, and crampy abdominal pain (neutropenic colitis).
• Death of liver cells (necrosis of the liver) - you may experience abrupt onset of nausea, weakness, fatigue and abdominal pain; tiredness and confusion
• Nausea with or without vomiting accompanied by lack of appetite and fatigue, dark urine or reduced urine output (tumour lysis syndrome)

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, 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/Publications/Index/8 By reporting side effects, you can help provide more information on the safety of ACCORD PACLITAXEL.

Store at or below 25 °C. To be kept in outer container until required. Protect from light. Discard any unused portion. Do not refrigerate. STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Store in original package. Do not use after the expiry date stated on the carton. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).