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DBL™ Docetaxel Concentrated Injection docetaxel Consumer Medicine Information

What is in this leaflet It works by stopping cells from • wheezing or difficulty breathing growing and multiplying. or a tight feeling in your chest This leaflet answers some common Ask your doctor if you have any • swelling of the face, lips, tongue questions about DBL Docetaxel, questions about why this medicine or other parts of the body Concentrated Injection. has been prescribed for you. • rash, itching, hives or flushed, red It does not contain all the available Your doctor may have prescribed it skin information. It does not take the for another reason. • dizziness or light-headedness place of talking to your doctor or This medicine is not addictive. • back pain pharmacist. This medicine is available only with Do not use DBL Docetaxel, All medicines have risks and a doctor’s prescription. benefits. Your doctor has weighed Concentrated Injection if you have, You may have taken another the risks of you taking DBL or have had, any of the following Docetaxel, Concentrated Injection medicine to treat your breast, non medical conditions: small cell lung , ovarian, against the benefits they expect it • severe problems or . will have for you. • blood disorder with a reduced However, your doctor has now number of white blood cells If you have any concerns about decided to treat you with docetaxel. taking this medicine, ask your There is not enough information to Do not use this medicine if you are doctor or pharmacist. recommend the use of this medicine pregnant or intend to become Keep this leaflet with the medicine. for children. pregnant either during treatment You may need to read it again. or in the three months following the last dose of docetaxel. Like most medicines used to treat Before you are given cancer, docetaxel is not What DBL Docetaxel, DBL Docetaxel, recommended for use during Concentrated Concentrated , unless you and your Injection is used for Injection doctor have discussed the risks and benefits involved.

Docetaxel is used to treat: When you must not be given Do not breast-feed if you are using this medicine. • it • non small cell It is not known if docetaxel passes Do not use DBL Docetaxel, into breast milk and there is a • Concentrated Injection if you have possibility that your baby may be • an to: affected. • any medicine containing • head and neck cancer If you are not sure whether you docetaxel or This medicine belongs to a group of should start using this medicine, medicines called antineoplastic or • any of the ingredients listed at the talk to your doctor. cytotoxic medicines. You may also end of this leaflet. hear of these being called Some of the symptoms of an allergic Before you are given it medicines. reaction may include: Tell your doctor if you have • shortness of breath to any other medicines, foods, preservatives or dyes.

DBL™ DOCETAXEL CONCENTRATED INJECTION 1 Docetaxel is not recommended for , clarithromycin and • prescribe you an oral use in children. telithromycin. corticosteroid (eg Safety and effectiveness in children • , itraconazole and ) to help stop or have not been established. voriconazole, medicines used to reduce the severity of certain side treat fungal infections effects. For breast, lung, ovarian Tell your doctor if you have or and head and neck cancer, this • , a medicine used to have had any of the following medicine is usually taken for treat high blood pressure and medical conditions: three days (one day before, the angina • blood disorder with a reduced day of and the day after your • some medicines called number of white blood cells infusion). These medicines are corticosteroids, such as very important. For prostate • hearing problems dexamethasone cancer, this is usually taken on • heart problems • medicines used to treat people the day of the infusion (12 hours, • high uric acid levels with epilepsy, such as 3 hours and 1 hour before your infusion). • kidney problems phenobarbitone • • test your blood to see how many • liver problems medicines used to treat or prevent HIV or Hepatitis C viral white blood cells you have. If infections, such as , they are too low, your infusion Tell your doctor if you have an , nelfinavir and may be delayed. infection or high temperature. saquinavir. • test your blood for levels of liver Your doctor may decide to delay • medicines used to treat people enzymes. If these levels are high your treatment until the infection has with depression such as your doctor may reduce your dose gone. A mild illness, such as a cold, or decide you should not have a docetaxel infusion at that time. is not usually a reason to delay These medicines may be affected by treatment. DBL Docetaxel, Concentrated Ask your doctor or pharmacist if Tell your doctor if you are Injection or may affect how well it you have any questions on these pregnant or plan to become works. You may need different medicines or tests. pregnant or are breast-feeding. amounts of your medicines, or you How much is given Your doctor can discuss with you the may need to take different medicines. risks and benefits involved. Your doctor and pharmacist have Your doctor will decide what dose more information on medicines to be you will receive. This depends on If you have not told your doctor your condition and other factors, careful with or avoid while taking about any of the above, tell such as your weight, kidney function this medicine. him/her before you start using and other chemotherapy medicines DBL Docetaxel, Concentrated you are being given. Injection. The usual dose of docetaxel is 75 to 100mg/m2 which is based on your Taking other medicines How DBL Docetaxel, 2 Concentrated body size (m ). Tell your doctor or pharmacist if you are taking any other Injection is given When docetaxel is given in medicines, including any that you combination with Follow all directions given to you (another medicine used for the get without a prescription from by your doctor or pharmacist treatment of breast cancer) the usual your pharmacy, supermarket or carefully. dose of docetaxel is 75 mg/m2. health food shop. They may differ from the Some medicines and DBL Docetaxel, Docetaxel may be given alone or in information contained in this leaflet. Concentrated Injection may interfere combination with other drugs. with each other. These include: Docetaxel should only be administered by trained Several courses of docetaxel therapy • other medicines used to treat may be needed depending on your professionals, with appropriate cancer, radiation therapy or any response to treatment. handling, in a hospital or clinic other treatment which lowers environment. your immune system, including Additional treatment may not be repeated until your blood cell Before you are given your docetaxel infusion your doctor numbers return to acceptable levels • some medicines used to treat and any uncontrolled effects have should: bacterial infections, including been controlled.

DBL™ DOCETAXEL CONCENTRATED INJECTION 2 check on your progress and detect be life threatening. In most cases, Ask your doctor if you want to know any unwanted side effects. fluid retention will go away within more about the dose of docetaxel you weeks or months after your receive. Tell any other doctors, dentists, treatments are completed. and pharmacists who treat you How it is given that you are taking this medicine. Things you must not do

If you are about to be started on Do not use DBL Docetaxel, DBL Docetaxel, Concentrated any new medicine, tell your doctor, Concentrated Injection to treat any Injection is given as an infusion dentist or pharmacist that you are other complaints unless your (drip) into your veins, over 1 hour. having DBL Docetaxel, doctor tells you to. Concentrated Injection. How long it is given for If you plan to have surgery that Things to be careful of Docetaxel is given every 3 weeks. needs a general anaesthetic, tell Be careful driving or operating your doctor or dentist that you are machinery until you know how This is called one cycle of having docetaxel. DBL Docetaxel, Concentrated chemotherapy. Your doctor will Injection affects you. decide how many of these cycles you If you become pregnant while will need. having docetaxel, tell your doctor Docetaxel may cause dizziness, light- immediately. headedness, tiredness, drowsiness in

If you are given too much some people. Make sure you know DBL Docetaxel, Concentrated how you react to docetaxel before (overdose) Injection can lower the number of you drive a car, operate machinery, white blood cells and platelets in As DBL Docetaxel, Concentrated or do anything else that could be Injection is given to you under the your blood. This means that you dangerous if you are dizzy or light- supervision of your doctor, it is have an increased chance of getting very unlikely that you will receive an infection or bleeding. headed. If this occurs do not drive. too much. However, if you If you drink alcohol, dizziness or experience any severe side effects The following precautions should light-headedness may be worse. after being given DBL Docetaxel, be taken to reduce your risk of Concentrated Injection, tell your infection or bleeding: doctor immediately or contact the • Avoid people who have National Poisons Centre (telephone infections. Check with your 0800 POISON or 0800 doctor immediately if you think Side effects 764 766) or go to Accident and you may be getting an infection, Emergency at the nearest hospital. or if you get a , chills, Tell your doctor or pharmacist as cough, hoarse throat, lower soon as possible if you do not feel back or side pain or find it You may need urgent medical well while you are taking DBL painful or difficult to urinate. attention. Docetaxel, Concentrated Injection. • Be careful when using a toothbrush, toothpick or dental It helps most people with breast, non floss. Your doctor, dentist, small cell lung cancer, ovarian, nurse or pharmacist may prostate or head and neck cancer, but While you are using recommend other ways to it may have unwanted side effects in clean your teeth and gums. a few people. DBL Docetaxel, Check with your doctor before Concentrated having any dental work. All medicines can have side effects. Injection • Be careful not to cut yourself Sometimes they are serious, most of when you are using sharp the time they are not. You may need Things you must do objects such as a razor or nail medical attention if you get some of cutters. the side effects. Keep follow up appointments with • Avoid contact sports or other your doctor. situations where you may bruise Do not be alarmed by the following or get injured. lists of side effects. You may not It is important to have your follow-up If you notice swelling in the feet experience any of them. doses/cycles/infusions of docetaxel at and legs or a slight weight gain, If you are over 60 years of age you the appropriate times to get the best inform your doctor or nurse. may have an increased chance of effects from your treatments. Docetaxel may cause fluid retention getting side effects. Your doctor may want to check your which means the body is holding Ask your doctor or pharmacist to blood pressure and do some blood extra water. If this fluid retention is answer any questions you may and other tests from time to time to in the chest or around the heart it can have.

DBL™ DOCETAXEL CONCENTRATED INJECTION 3 • frequent infections with fever, • sudden signs of allergy such as Tell your doctor or pharmacist if severe chills, sore throat or mouth rash, itching, hives on the skin, you notice any of the following and ulcers - especially 5-7 days after swelling of the face, tongue or they worry you: receiving a docetaxel infusion other parts of the body, shortness of breath, wheezing or trouble • irritation, pain, swelling or • sore red mouth or vagina or breathing colouring around the needle swelling in these areas • during infusion • severe diarrhoea Redness of the skin studded with pimples containing fluid or pus • high temperature • tiredness, headaches, being short • convulsions, fits or seizures • stomach pain or discomfort of breath when exercising, dizziness and looking pale • hallucinations or delirium • feeling sick, upset stomach or • coughing • ulcer in the stomach or intestine - • vomiting blood or material that • mild diarrhoea change in the rhythm or rate of your heart beats (palpitations) looks like coffee grounds, • constipation bleeding from the back passage, • muscle pain or cramps • inflammation of the food pipe black sticky bowel motions or (oesophagus) • flushed, dry skin, irritability and bloody diarrhoea confusion • whitening or darkening of the • difficulty in breathing, rapid skin or nails • passing little or no urine, and/or shallow breathing drowsiness, nausea, vomiting and • loosening of the nails • sudden swelling of the leg/arm breathlessness which may be due to blood clots • unusual or thinning • yellowing of the skin or eyes, also • pain, pressure or tightness in the • joint pain or swelling called jaundice chest, arms, neck, jaw or back • aching muscles, muscle • flaking of the skin that may occur together with tenderness, swelling or weakness • red, scaly patches of the skin nausea, dizziness or cold sweats not caused by exercise especially around the cheeks and • fainting • unusual tiredness or weakness nose • fever with diarrhoea and or • mild swelling of hands, ankles • raised lumps on the skin which vomiting, painful cramping. and feet looks like scalding The above list includes very serious • weight gain/loss • hardening of the skin side effects. You may need urgent • pins and needles or a burning or • excessive watery discharge from medical attention or hospitalisation. tingling feeling in hands or feet the eyes These side effects may differ when • redness or rash around previous • trouble with your hearing, or using docetaxel in combination with radiation site (if you have had some loss of hearing another chemotherapy agent. radiotherapy) • sudden and severe swelling or Please consult your doctor for • back pain pain in the joints or rash. possible side effects that may be caused by using docetaxel with • decreased appetite • Blurry or “wavy” vision or another chemotherapy agent. • high blood pressure disturbances to colour vision. Tell your doctor or pharmacist if (hypertension) • Widening and rounding of the you notice anything that is making tips of the fingers or toes • low blood pressure (hypotension) you feel unwell. (clubbing). • temporary visual disturbances, or Other side effects not listed above • Leg pain, tenderness or swelling. feeling that you are about to faint, may also occur in some people. which mostly occur when you are • Skin that is red and warm. The benefits and side effects of being infused with docetaxel. The above list includes serious side docetaxel may take some time to The above list includes the more effects that may require medical occur. Therefore, even after you common side effects of your attention. have finished your docetaxel medicine. If any of the following happen, tell treatment you should tell your doctor Tell your doctor as soon as possible your doctor immediately or go to immediately if you notice any of the if you notice any of the following: Accident and Emergency at your side effects listed in this section. • infections nearest hospital:

DBL™ DOCETAXEL CONCENTRATED INJECTION 4 After using DBL DBL Docetaxel, Concentrated Docetaxel, Injection is available in the following Concentrated strengths: Injection • 20 mg/2 mL vials • 80 mg/8mL vials • 160 mg/16mL vials Storage DBL Docetaxel, Concentrated ™ = Trademark Injection will be stored in the This leaflet was prepared in pharmacy or on the ward. The December 2020. injection is kept in a cool dry place, protected from light, where the temperature stays below 25℃.

Product description

What it looks like DBL Docetaxel, Concentrated Injection in single dose vials is a clear, colourless to pale yellow solution, which is diluted prior to intravenous administration.

Ingredients Active ingredients:

DBL Docetaxel, Concentrated Injection contains 10mg/mL of docetaxel as the active ingredient.

Inactive Ingredients:

It also contains: • ethanol • citric acid • Polysorbate 80 • Macrogol 300

DBL Docetaxel, Concentrated Injection does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Supplier

Pfizer New Zealand Limited PO Box 3998 Auckland Toll Free Number: 0800 736 363

DBL™ DOCETAXEL CONCENTRATED INJECTION 5