Docetaxel Adco 20 mg/1 ml Solution

DOCETAXEL ADCO is indicated for the treatment of various cancers, including metastatic cancer (i.e. cancer that has spread to other organs) either alone or in combination with other medicines.

You should not be administered DOCETAXEL ADCO if you:

• Are known to be hypersensitive (allergic) to DOCETAXEL ADCO, or to any components of the formulation, including polysorbate 80;
• Have neutrophil (type of white blood cell) counts below 1 500 cells/mm 3; Your doctor will be able to tell you if this is so;
• Are pregnant or breastfeeding;
• Suffer from severe impairment of liver function.

It has not been established if DOCETAXEL ADCO is safe to use in children.

DOCETAXEL ADCO will be administered to you by a healthcare professional. Your doctor will tell you how long your treatment with DOCETAXEL ADCO will last.

Usual dosage

The dose will depend on your weight and your general condition. Your doctor will calculate your body surface area in square meters (m 2) and will determine the dose you should receive.

Method and route of administration

You will not be expected to give yourself DOCETAXEL ADCO. It will be given to you by a person who is qualified to do so. DOCETAXEL ADCO will be given by infusion into one of your veins. The infusion will last approximately one hour during which you will be in the hospital.

Frequency of administration

You should usually receive your infusion once every 3 weeks. Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to DOCETAXEL ADCO. In particular, please inform your doctor in case of diarrhoea, sores in the mouth, feeling of numbness or pins and needles, fever and give her/him results of your blood tests. Such information will allow her/him to decide whether a dose reduction is needed. If you have any further questions on the use of this product, ask your doctor, or hospital pharmacist.

For single use only, discard any unused portions. If you have the impression that DOCETAXEL ADCO is too strong or too weak for you, please discuss this with your treating doctor.

DOCETAXEL ADCO can have side effects. Your doctor will discuss these with you and will explain the potential risks of your treatment. The severity of adverse events of DOCETAXEL ADCO may be increased when DOCETAXEL ADCO is given in combination with other chemotherapeutic medicines.

During the infusion at the hospital the following allergic reactions may occur:

• Flushing, skin reactions, itching;
• Chest tightness; difficulty in breathing;
• Fever or chills;
• Back pain;
• Low blood pressure.

More severe reactions may occur. The hospital staff will monitor your condition closely during treatment. Tell them immediately if you notice any of these effects.

Between infusions of DOCETAXEL ADCO the following may occur, and the frequency may vary with the combinations of drugs that are received:

• Infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets;
• Loss of appetite (anorexia);
• Insomnia;
• Feeling of numbness or pins and needles or pain in the joints of muscles;
• Headache;
• Alteration in sense of taste;
• Inflammation of the eye or increased tearing of the eyes;
• Swelling caused by faulty lymphatic drainage;
• Shortness of breath;
• Nasal drainage; inflammation of the throat and nose; cough;
• Bleeding from the nose;
• Sores in the mouth;
• Stomach upsets including nausea, vomiting and diarrhea, constipation;
• Abdominal pain;
• Indigestion;
• Short term hair loss (in most cases normal hair growth should return);
• Redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body);
• Change in the color of your nails, which may detach;
• Muscle aches and pains; back pain or bone pain;
• Change or absence of menstrual period;
• Swelling of the hands, feet, legs;
• Tiredness; or flu-like symptoms;
• Weight gain or loss;
• Oral thrush (fungal infection of the mouth);
• Dehydration;
• Hearing impaired;
• Decrease in blood pressure; irregular or rapid heartbeat;
• Heart failure;
• Oesophagitis (acid reflux);
• Dry mouth;
• Difficulty or painful swallowing;
• Haemorrhage;
• Raised liver enzymes (hence the need for regular blood tests);
• Fainting;
• At the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling;
• Inflammation of the colon, small intestine; intestinal perforation;
• Blood clots.

Not all side-effects reported for DOCETAXEL ADCO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while this medicine is being administered, please consult your doctor, pharmacist or other health care professional for advice.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. 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 DOCETAXEL ADCO.

For reporting of side effects directly to the HCR, contact +27 11 635 0134 or email [email protected].

Store at or below 25 °C. Do not refrigerate or freeze. Store in the original package in order to protect from light. Store all medicines out of reach of children. DOCETAXEL ADCO should not be used after the expiry date shown on the carton and vial. The diluted solution should be used immediately after preparation. If not used immediately the in-use storage times and conditions are the responsibility of the user and would not normally be longer than 8 hours at room temperature (about 25 °C) including the one-hour infusion. Discard any unused solution.