The name of this medicine is Docetaxel. Its common name is docetaxel. Docetaxel is a substance derived from the needles of yew trees. Docetaxel belongs to the group of anti-cancer medicines called taxoids.

Docetaxel has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer:

-   For the treatment of advanced breast cancer, Docetaxel could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.

-   For the treatment of early breast cancer with or without lymph node involvement, Docetaxel could be administered in combination with doxorubicin and cyclophosphamide.

-   For the treatment of lung cancer, Docetaxel could be administered either alone or in combination with cisplatin.

-   For the treatment of prostate cancer, Docetaxel is administered in combination with prednisone or prednisolone.

-    For the treatment of metastatic gastric cancer, Docetaxel is administered in combination with cisplatin and 5-fluorouracil.

-     For the treatment of head and neck cancer, Docetaxel is administered in combination with cisplatin and 5-fluorouracil.

You must not be given Docetaxel: 

-   if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel (listed in section 6).

-  if the number of white blood cells is too low.

-  if you have a severe liver disease.

Warnings and precautions

Before each treatment with Docetaxel, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel. In case of white blood cells disturbances, you may experience associated fever or infections.

Tell your doctor, hospital pharmacist, or nurse immediately if you have abdominal pain or tenderness, diarrhoea, rectal haemorrhage, blood in stool or fever. These symptoms may be the first signs of a serious gastrointestinal toxicity, which could be fatal. Your doctor should address them immediately.

Tell your doctor, hospital pharmacist or nurse if you have vision problems. In case of vision problems, in particular blurred vision, you should immediately have your eyes and vision examined.

Tell your doctor, hospital pharmacist or nurse if you have experienced an allergic reaction to previous paclitaxel therapy.

Tell your doctor, hospital pharmacist or nurse if you have heart problems.

If you develop acute or worsening problems with your lungs (fever, shortness of breath or cough), please tell your doctor, hospital pharmacist or nurse immediately. Your doctor may stop your treatment immediately.

You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Docetaxel administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of Docetaxel in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).

During treatment, you may be given other medicines to maintain the number of your blood cells.

Docetaxel contains alcohol. Discuss with your doctor if you suffer from alcohol dependency, epilepsy or liver impairment. See also section “Docetaxel contains ethanol (alcohol)” below.

Other medicines and Docetaxel

Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription. This is because Docetaxel or the

other medicine may not work as well as expected and you may be more likely to get a side effect. The amount of alcohol in this medicinal product may alter the effects of other medicines.

Pregnancy, breast-feeding and fertility

Ask your doctor for advice before being given any medicine.

Docetaxel must NOT be administered if you are pregnant unless clearly indicated by your doctor. You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy, because Docetaxel may be harmful for the unborn baby. If pregnancy occurs during your treatment, you must immediately inform your doctor.

You must not breast-feed while you are treated with Docetaxel.

If you are a man being treated with Docetaxel you are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because docetaxel may alter male fertility.

Driving and using machines

The amount of alcohol in this medicinal product may impair your ability to drive or use machines. You may experience side effects of this medicine that may impair your ability to drive, use tools or operate machines (see section 4 Possible side effects). If this happens, do not drive or use any tools or machines before discussing with your doctor, nurse or hospital pharmacist.

Docetaxel contains ethanol (alcohol)

This medicinal product contains 326 mg of alcohol (ethanol) in each 1 ml which is equivalent to

41.3 volume %. The amount in 1 ml of this medicine is equivalent to 8.25 ml beer or 3.30 ml wine;

1.304 g of alcohol (ethanol) in each 4 ml which is equivalent to 41.3 volume %. The amount in 4 ml of this medicine is equivalent to 33 ml beer or 13.1 ml wine.

The alcohol in this preparation is likely to affect children. These effects may include feeling sleepy and changes in behaviour. It may also affect their ability to concentrate and take part in physical activities.

The amount of alcohol in this medicine can affect your ability to drive or use machines. This is because it may affect your judgement and how fast you react.

If you have epilepsy or liver problems, talk to your doctor or pharmacist before taking this medicine.

The amount of alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.

If you are pregnant or breast-feeding, talk to your doctor or pharmacist before taking this medicine.

If you are addicted to alcohol, talk to your doctor or pharmacist before taking this medicine.

Docetaxel will be administered to you by a healthcare professional.

Usual dose

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

Docetaxel will be given by infusion into one of your veins (intravenous use). 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. 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 medicine, ask your doctor, or hospital pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.

The most commonly reported adverse reactions of Docetaxel alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.

The severity of adverse events of Docetaxel may be increased when Docetaxel is given in combination with other chemotherapeutic agents.

During the infusion at the hospital the following allergic reactions may occur (may affect more than 1 in 10 people):

·       flushing, skin reactions, itching

·       chest tightness; difficulty in breathing

·       fever or chills

·       back pain

·       low blood pressure.

More severe reactions may occur.

If you had an allergic reaction to paclitaxel, you may also experience an allergic reaction to docetaxel, which may be more severe.

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

Between infusions of Docetaxel the following may occur, and the frequency may vary with the combinations of medicines that are received

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

·                 infections, decrease in the number of red (anaemia), or white blood cells (which are important in        fighting infection) and platelets

·                 fever: if this happens you must tell your doctor immediately

·                 allergic reactions as described above

·                 loss of appetite (anorexia)

·                 insomnia

·                 feeling of numbness or pins and needles or pain in the joints or 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 diarrhoea, constipation

·                 abdominal pain

·                 indigestion

·                 hair loss: in most cases normal hair growth should return. In some cases (frequency not known)         permanent hair loss has been observed

·                 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 colour 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.

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

·                 oral candidiasis

·                 dehydration

·                 dizziness

·                 hearing impaired

·                 decrease in blood pressure; irregular or rapid heart beat

·                 heart failure

·                 oesophagitis

·                 dry mouth

·                 difficulty or painful swallowing

·                 haemorrhage

·                 raised liver enzymes (hence the need for regular blood tests).

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

·                 fainting

·                 at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling

·                 blood clots

·                 acute myeloid leukaemia and myelodysplastic syndrome (types of blood cancer) may occur in patients who are treated with docetaxel together with certain other anticancer treatments.

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

·                 inflammation of the colon, small intestine, which could be fatal (frequency not known); intestinal perforation.

Frequency not known (cannot be estimated from the available data):

·                 interstitial lung disease (inflammation of the lungs causing coughing and difficulty breathing.

·                 Inflammation of the lungs can also develop when docetaxel therapy is used with radiotherapy)

·                 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)

·                 ventricular arrhythmia or ventricular tachycardia (manifested as irregular and/or rapid heartbeat,   severe shortness of breath, dizziness, and/or fainting). Some of these symptoms can be serious. If this happens, you must tell your doctor immediately

·                 injection site reactions at the site of a previous reaction

·                 non-Hodgkin lymphoma (a cancer affecting the immune system) and other cancers may occur in          patients who are treated with docetaxel together with certain other anticancer treatments.

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.

To report any side effect(s):
• Saudi Arabia:

The National Pharmacovigilance Center (NPC):
• Fax: +966-11-205-7662
• SFDA Call Center: 19999
• E-mail: npc.drug@sfda.gov.sa
• Website: https://ade.sfda.gov.sa/

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer carton and on the label of the vial after EXP. The expiry date refers to the last day of that month.

Store below 25^oC.

Store in the original package in order to protect from light.

Chemical and physical in-use stability has been demonstrated in non-PVC bags for 6 hours at 25°C and for 48 hours at 2 to 8°C. It should be used within 6 hours (including the one-hour infusion intravenous administration).

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Docetaxel infusion solution is supersaturated, therefore may crystallize over time. If crystals appear, the solution must no longer be used and shall be discarded.

Do not throw away any medicines via waste water. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.