Docetere 20 mg/1 ml Solution

Docetaxel belongs to the group of anticancer medicines called taxoids. DOCETERE RTU has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, ovarian cancer, head and neck cancer, or the palliative treatment of gastric cancer.

You must not be given DOCETERE RTU if:

• You are hypersensitive (allergic) to docetaxel or any of the other ingredients of DOCETERE RTU (see section 6).
• The number of your white blood cells is too low.
• You have a severe liver disease.
• You are pregnant or breastfeeding.
• You are a child.

Warnings and Precautions

Tell your doctor or healthcare professional before being given the infusion with DOCETERE RTU if:

• You have vision problems. In case of vision problems, in particular blurred vision, you should immediately have your eyes and vision examined.
• You have experienced an allergic reaction to paclitaxel therapy previously, as you may also be allergic to DOCETERE RTU.
• You have heart problems. Report any irregular and/or rapid heartbeat, severe shortness of breath, dizziness, and/or fainting to your doctor.
• You suffer from alcohol dependency, epilepsy or liver impairment, since DOCETERE RTU contains alcohol (see DOCETERE RTU contains alcohol, below and section 6).
• You have kidney problems or high levels of uric acid in your blood.

Take special care with DOCETERE RTU:

• Before treatment - Before each treatment with DOCETERE RTU, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive DOCETERE RTU. In case of white blood cell disturbances, you may experience associated fever or infections.
• You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to DOCETERE RTU administration and to continue for one or two days afterwards in order to minimise certain undesirable effects which may occur after the infusion of DOCETERE RTU, in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).

During treatment - DOCETERE RTU may cause serious adverse reactions such as allergic reactions, severe skin reactions, or diarrhoea (especially if you also suffer from a low white blood cell count [neutropenia]). You may need to stop your treatment and seek urgent medical care. Please see section 4 for more information on these side effects.

• If you develop acute or worsening problems with your lungs (fever, shortness of breath and cough), please tell your doctor, hospital pharmacist or nurse immediately. Your doctor may stop your treatment immediately.
• If you suffer from pain in your side, or reduced amount or darkening of urine after DOCETERE RTU infusion, tell your doctor immediately.
• If you are elderly (above the age of 60 years) and you are receiving treatment with DOCETERE RTU, the severity of side effects of DOCETERE RTU may be increased when compared to younger patients and you may need to be monitored closely.
• During treatment, you may be given medication to maintain the number of your blood cells.

Do not share DOCETERE RTU prescribed for you with any other person. DOCETERE RTU will be administered to you by a healthcare professional.

Usual dosage: The dose will depend on your weight and your general condition. Your doctor will calculate your body surface area in square meters (m²) and will determine the dose you should receive.

Method and route of administration: DOCETERE RTU 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 DOCETERE RTU. In particular, please inform your doctor in case of diarrhoea, sores in the mouth, feeling of numbness or pins and needles, or fever, and give her/him the results of your blood tests. Such information will allow her/him to decide whether a dose reduction is needed.

If you receive more DOCETERE RTU than you should: Since a healthcare professional will administer DOCETERE RTU, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you experience any unexpected or worrying side effects after being given DOCETERE RTU, tell your doctor immediately or go to your nearest hospital.

If you missed a dose of DOCETERE RTU: DOCETERE RTU needs to be given on a fixed schedule. If you miss an appointment, call your doctor for instructions.

DOCETERE RTU can have side effects. Not all side effects reported for DOCETERE RTU are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving DOCETERE RTU, please consult your doctor, pharmacist, or other health care professional for advice. Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.

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

• Frequent: flushing, skin reactions, itching
• chest tightness, difficulty in breathing
• fever or chills
• back pain
• low blood pressure.

More severe reactions (difficulty in breathing or wheezing, generalised rash/redness of the skin, requiring therapeutic intervention) 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 DOCETERE RTU the side effects listed below may occur, and the frequency and severity may vary with the combinations of medicines that are received. If any of the following happens, tell your doctor immediately, or go to your nearest hospital:

• Frequent: sudden signs of allergy such as flushing, skin reactions, itching, swelling of the face, tongue or other parts of the body, chest tightness, shortness of breath, wheezing or trouble breathing
• difficulty in breathing.

Less frequent:

• ulcers or inflammation in the stomach, small intestine or colon; intestinal perforation – symptoms may include vomiting blood, bleeding from the back passage (rectum) or bloody or severe diarrhoea
• sudden swelling of the leg/arm which may be due to blood clots.

Frequency unknown:

• Irregular or rapid heartbeat, severe shortness of breath, dizziness, and/or fainting.
• Severe skin problems such as: - Stevens - Johnson syndrome (SJS), toxic epidermal necrolysis (TEN). Symptoms may include blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash. You may also have flu-like symptoms at the same time, such as fever, chills or aching muscles.

- Acute generalised exanthematous pustulosis (AGEP). Symptoms may include a red, scaly, widespread rash with bumps under the skin (including your skin folds, trunk, and upper extremities) and blisters accompanied by fever.

- Tumour lysis syndrome which may manifest as pain in your side, seizures, or a reduced amount or darkening of urine. This can cause life-threatening kidney failure and heart problems.

- Myositis (inflammation of the muscles (hot, red and swollen muscles) which produces muscle pain and weakness). These are very serious side effects. 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:

• Frequent: high temperature (fever) or chills
• decrease in the number of red blood cells or white blood cells (manifested as frequent infections) and platelets
• bleeding (haemorrhage)
• frequent infections with fever, severe chills, sore throat or mouth ulcers (sores in the mouth) or upper respiratory tract
• inflammation of and bleeding from the nose
• sore, red mouth or swelling in this area (thrush)
• severe diarrhoea
• breathing problems, shortness of breath or difficulty in breathing
• coughing
• irregular or rapid heartbeat
• pain in muscles

passing little or no urine (abnormal kidney function), drowsiness, nausea, vomiting and breathlessness

abnormal liver function (yellowing of the skin or eyes, also called jaundice, and raised liver enzymes)

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)

chest pain/heart failure

inflammation of the eye or increased tearing of the eyes

high blood pressure (hypertension)

impaired hearing or some loss of hearing

swelling of the hands, feet or legs

feeling of numbness, pins and needles or a burning or tingling feeling in hands or feet

joint pain or swelling

sudden and severe swelling or pain in the joints, or rash.

Less frequent:

• acute myeloid leukaemia and myelodysplastic syndrome (types of blood cancer), may occur (when DOCETERE RTU is used together with certain other anticancer treatments)
• fainting.

Frequency unknown:

• interstitial lung disease (inflammation of the lungs causing coughing and difficulty breathing)
• pneumonia (infection of the lungs)
• pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath)
• blurred vision due to swelling of the retina within the eye (cystoid macular oedema)
• decrease of the sodium, potassium, magnesium and/or calcium in your blood (electrolyte balance disorders)

non-Hodgkin lymphoma (a cancer affecting the immune system), renal cancer and other cancers (when DOCETERE RTU is used together with certain other anticancer treatments). These may be serious side effects. You may need medical attention.

Tell your doctor, nurse or pharmacist if you notice any of the following:

• Frequent: abdominal (stomach) pain or discomfort, indigestion
• stomach upsets including nausea (feeling sick), vomiting and mild diarrhoea
• constipation
• tiredness
• headaches
• dizziness and looking pale
• piles (haemorrhoids)
• inflammation of the food pipe (oesophagitis) and food pipe ulcers
• difficulty or painful swallowing
• change in the colour of your nails and loosening of the nails (may detach)
• short term hair loss (in most cases hair growth should return)
• muscle aches and pains
• tiredness or weakness (flu-like symptoms)
• dehydration, dry mouth
• weight gain or loss
• back pain
• loss of appetite (anorexia)
• low blood pressure (hypotension)
• insomnia (inability to sleep)
• alteration in sense of taste
• change or absence of menstrual period.

Less frequent:

• irritation, pain, swelling or discolouration around the injection site.

Frequency unknown:

• permanent hair loss
• injection site reactions at the site of a previous reaction.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can report any side effects directly to Sanofi’s Pharmacovigilance Unit at [email protected] (email) or 011 256 3700 (tel). 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

Store all medicine out of reach of children. Store at or below 25 °C. Store in the original package in order to protect from light. Do not use after the expiry date stated on the carton and vial. Do not use DOCETERE RTU if you notice that a precipitate (visible particles) has formed in the solution or at the bottom of the container. The infusion solution should be used within 4 hours at room temperature (below 25 °C) including a one-hour infusion. Return all unused medicine to your pharmacist.