20 mg / 1 ml, 80 mg / 4 ml and 160 mg / 8 ml concentrate for solution for infusion 
docetaxel

1. What Docetaxel Accord is and what it is used for

The name of this medicine is Docetaxel Accord. The generic name is docetaxel. Docetaxel is a substance that originates in the needles of the yew tree. Docetaxel belongs to a group of anti-cancer medicines called taxoids.

Your doctor has prescribed Docetaxel Accord for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer ), prostate cancer, stomach cancer, or head and neck cancer:

  • In the treatment of advanced breast cancer, docetaxel can be given either alone or in combination with doxorubicin or trastuzumab, or capecitabine.
  • For the treatment of early-stage breast cancer with or without lymph node involvement, Docetaxel can be given in combination with doxorubicin and cyclophosphamide.
  • In the treatment of lung cancer, docetaxel can be given either alone or in combination with cisplatin.
  • In the treatment of prostate cancer, docetaxel is given in combination with prednisone or prednisolone.
  • In the treatment of gastric cancer, docetaxel is given in combination with cisplatin and 5-fluorouracil.
  • In the treatment of head and neck cancer, docetaxel is given in combination with cisplatin and 5-fluorouracil

2. What you need to know before using Docetaxel Accord

You should not be prescribed Docetaxel Accord:

  • if you are allergic to docetaxel or any of the other ingredients of this medicine (listed in section 6).
  • if the white blood cell count is too low.
  • if you have severe liver disease.

Warnings and cautions

Before each treatment with Docetaxel Accord, blood samples will be taken from you to check if you have enough blood cells and sufficient liver function to get Docetaxel Accord. When the number of white blood cells is disturbed, you can get a fever or infection.

Talk to a doctor, pharmacist, or nurse immediately if you experience abdominal pain or soreness, diarrhea, rectal bleeding, blood in the stool, or fever. These symptoms can be the first signs of a serious injury to the stomach and intestines, which can be fatal. Your doctor should treat these symptoms immediately.

Talk to your doctor, pharmacist, or nurse if you have vision problems. In case of vision problems, especially blurred vision, have your eyes and eyesight examined immediately.

Tell your doctor, pharmacist, or nurse if you have experienced an allergic reaction during previous paclitaxel treatment.

Talk to your doctor, pharmacist, or nurse if you have heart problems.

If you develop acute or worsening problems with your lungs (fever, shortness of breath, or cough), tell your doctor, pharmacist,t or nurse immediately. Your doctor may choose to end your treatment immediately.

You will be pre-medicated with an oral corticosteroid (taken by mouth) such as dexamethasone the day before Docetaxel Accord treatment. You will take the cortisone tablets for an additional 1 or 2 days after the day of treatment with Docetaxel Accord to minimize the risk of certain side effects that may occur after Docetaxel Accord infusion, especially allergic reactions and fluid retention (swelling of hands, feet, legs or weight gain).

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

Serious skin problems such as Stevens-Johnson Syndrome (SJS), Toxic epidermal necrolysis (TEN), Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with docetaxel:

  • SJS / TEN symptoms may include blistering, flaking, 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.
  • AGEP symptoms may include a red, scaly, widespread rash with bumps under the swollen skin (including skin folds, torso, and upper extremities ) and blisters accompanied by fever.

If you develop severe skin reactions or any of the above, contact your doctor or healthcare professional immediately.

Tell your doctor, pharmacist, or nurse if you have kidney problems or high levels of uric acid in your blood before starting Docetaxel Accord.

Docetaxel Accord contains alcohol. Talk to your doctor if you have alcohol abuse, epilepsy, or impaired liver function. See also section Docetaxel Accord contains ethanol (alcohol) below.

Other medicines and Docetaxel Accord

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription because Docetaxel Accord or the other medicine may not work as well as expected and because you are more likely to get a side effect.

The amount of alcohol in this medicine may affect the effectiveness of other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Docetaxel Accord should NOT be given during pregnancy unless your doctor has told you to.

You must not become pregnant during treatment with this medicine and should use a reliable contraceptive during treatment as docetaxel may be harmful to the unborn baby.

If you become pregnant during docetaxel treatment, you must inform your doctor immediately.

If you are a man and being treated with docetaxel, you are advised not to have children for and up to 6 months after treatment and to seek advice on sperm preservation before treatment as docetaxel may affect male fertility.

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

Driving and using machines

The amount of alcohol in this medicine may impair your ability to drive or use machines. This medicine may give you side effects that may affect your ability to drive and use machines (see section 4 Possible side effects ). If this happens, do not drive or use machines until you have discussed this with your doctor, pharmacist, or nurse.

Docetaxel Accord contains ethanol (alcohol)

Docetaxel Accord 20 mg / 1 ml contains:

50 vol% anhydrous ethanol (alcohol), i.e. up to 395 mg of anhydrous ethanol per vial, equivalent to 10 ml of beer or 4 ml of wine.

Docetaxel Accord 80 mg / 4 ml contains:

50 vol% anhydrous ethanol (alcohol), i.e. up to 1.58 g of anhydrous ethanol per vial, equivalent to 40 ml of beer or 17 ml of wine.

Docetaxel Accord 160 mg / 8 ml contains

50 vol% anhydrous ethanol (alcohol), i.e. up to 3.16 g of anhydrous ethanol per vial, equivalent to 80 ml of beer or 33 ml of wine.

Harmful to people suffering from alcoholism.

Should be included in the calculation of pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.

The amount of alcohol in this medicine can affect the central nervous system (the part of the nervous system that consists of the brain and spinal cord).

3. How to use Docetaxel Accord

Docetaxel Accord will be given to you by healthcare professionals.

Recommended dose

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

Method of administration and route of administration

Docetaxel Accord will be given as an infusion into one of your veins ( intravenous use). Infusion one will last for about an hour and is given in the hospital.

Administration interval

Docetaxel Accord infusion is usually given once every three weeks.

Your doctor may change the dose and dosing interval depending on how your blood tests are, how you feel and how you react to Docetaxel Accord treatment. Inform your doctor especially if you get diarrhea, mouth sores, loss of sensation or tingling, fever and give your blood test results to the doctor. Such information helps the doctor decide if the dose needs to be reduced. If you have any further questions on the use of this product, ask your doctor or hospital staff.

4. Possible side effects

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

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

The most commonly reported side effects of docetaxel, when used alone, are reduction in red or white blood cell count, hair loss, nausea, vomiting, mouth ulcers, diarrhea, and fatigue.

If you receive docetaxel in combination with other cytostatic agents, the severity of side effects may increase.

During ongoing hospital treatment, the following allergic reactions may occur (may affect more than 1 in 10 people):

  • redness of the face, skin reactions, itching
  • the feeling of heaviness over the chest, difficulty breathing
  • fever or chills
  • back pain
  • low blood pressure.

Several serious reactions can occur.

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

Your general condition will be closely monitored during the treatment of hospital staff. Notify staff immediately if you notice any of these reactions.

Between docetaxel infusions, the following may occur and the frequency may vary between given combinations of drugs:

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

  • Infections, decrease in red blood cell count ( anemia ) or white blood cells (which are important in fighting infections ), and platelets
  • fever: if this happens you must contact your doctor immediately
  • allergic reactions described above
  • loss of appetite ( anorexia )
  • insomnia
  • numbness or tingling or pain in joints or muscles
  • headache
  • taste change
  • inflammation of the eye or increased tear flow
  • swelling caused by deficient lymphatic drainage
  • shortness of breath
  • nasal congestion; inflammation of the throat and nose; cough
  • nosebleeds
  • sores in the mouth
  • upset stomach including nausea, vomiting, and diarrhea, constipation
  • abdominal pain
  • indigestion
  • hair loss: normal hair growth should return in most cases. In some cases (no known frequency), permanent hair loss has been observed
  • redness and swelling of the palms and soles of the feet, which may cause skin flaking (this can also occur on the arms, face, or body)
  • change in the color of your nails and any subsequent nail detachment
  • muscle pain or ache; back pain or skeletal pain
  • menstrual disorders
  • swelling of hands, feet, legs
  • fatigue; or flu-like symptoms
  • weight gain or weight loss
  • infection of the upper airways.

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

  • fungal infection in the mouth
  • dehydration
  • dizziness
  • impaired hearing
  • lowered blood pressure; irregular or increased heart rate
  • heart failure
  • inflammation of the esophagus
  • dry mouth
  • difficulty swallowing or swallowing pain
  • increased tendency to bleed
  • elevated liver enzyme levels (hence the need for regular blood tests)
  • increase in blood sugar levels ( diabetes )
  • reduction of potassium, calcium, and/or phosphate in the blood.

ess common (may affect up to 1 in 100):

  • fainting
  • skin reactions, vascular inflammation, and swelling locally at the injection site
  • blood clot
  • Acute myeloid leukemia and myelodysplastic syndrome (types of blood cancer) may occur in patients treated with docetaxel in combination with certain other cancers.

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

  • inflammation of the colon, small intestine which can be fatal (has been reported); perforation of the intestine

Has been reported (occurs in an unknown number of users):

  • interstitial lung disease ( inflammation of the lungs that causes coughing and difficulty breathing. Inflammation of the lungs can also develop when docetaxel treatment is given with radiotherapy ).
  • pneumonia ( pneumonia )
  • pulmonary fibrosis (scarring and thickening of the lungs with shortness of breath)
  • blurred vision due to swelling of the retina of the eye (cystic macular edema)
  • decreased levels of sodium and/or magnesium in the blood (disturbances in the electrolyte balance)
  • ventricular arrhythmia or ventricular tachycardia (manifests as irregular anand/rapid heartbeat, severe shortness of breath, dizziness, and/or fainting). Some of these symptoms can be severe. If this happens, tell your doctor immediately
  • injection site reactions at the site of the previous reaction
  • Non-Hodgkin’s lymphoma (cancer that affects the immune system) and other cancers can occur in patients treated with docetaxel in combination with certain other cancers
  • Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) (blistering, flaking, or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands, or feet) with or without rash. also have flu-like symptoms at the same time, such as fever, chills, or aching muscles.)
  • Acute generalized exanthematous pustulosis (AGEP) (red, scaly, widespread rash with bumps under the swollen skin (including skin folds, torso, and upper extremities ) and blisters accompanied by fever.)
  • Tumor lysis syndrome is a serious condition that can be detected by changes in blood tests such as increased levels of uric acid, potassium, phosphorus, and decreased calcium levels; and results in symptoms such as seizures, kidney failure( reduced amount or dark urine), and heart rhythm disturbances. If this happens, tell your doctor immediately
  • myositis (muscle inflammation – heat, redness, and swelling – which causes muscle pain and weakness).

5. How to store Docetaxel Accord

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 carton and the vial label after EXP. The expiration date is the last day of the specified month.

Do not store above + 25 ° C.

Store in the original package. Sensitive to light.

Use the vial immediately after opening. If not used immediately, in-use storage times and conditions before use is the responsibility of the user.

From a microbiological point of view, dilution must take place under controlled and aseptic conditions.

Use the medicine immediately after adding it to the infusion bag. If not used immediately, in-use storage times and conditions before use is the responsibility of the user and should not be longer than 6 hours at a temperature of not more than 25 ° C including one hour of infusion.

Physical and chemical stability during use, for infusion prepared as recommended, shown in bags (not PVC) for up to 48 hours when stored between 2 ° C -8 ° C.

Prepare the infusion solution as recommended. The infusion solution must not be connected to the infusion set for more than 6 hours at 25 ºC.

The docetaxel infusion solution is supersaturated and can therefore crystallize over time. If crystals appear, the solution should no longer be used and should be discarded.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

What Docetaxel Accord contains:

  • The active substance is docetaxel (as trihydrate). One ml of concentrate for solution for infusion contains 20 mg docetaxel.
  • One vial of 1 ml concentrates containing 20 mg docetaxel.
  • One vial of 4 ml concentrates containing 80 mg docetaxel.
  • One vial of 8 ml concentrates containing 160 mg docetaxel.
  • The other ingredients are polysorbate 80, anhydrous ethanol (see section 2), and anhydrous citric acid.

What the medicine looks like and the contents of the pack

Docetaxel Accord concentrate for solution for infusion is a clear pale yellow to the yellow-brown solution.

Docetaxel Accord 20 mg / 1 ml is supplied in a 5 ml glass bottle with a rubber stopper made of fluoroplastic and aluminum closure and an orange easy-to-open cap.

Docetaxel Accord 80 mg / 4 ml is supplied in a 5 ml glass bottle with a rubber stopper made of fluoroplastic and aluminum closure and a red easy-to-open cap.

Docetaxel Accord 160 mg / 4 ml is supplied in a 10 ml glass bottle with a rubber stopper made of fluoroplastic and aluminum closure and a red easy-to-open cap.

Each carton contains one vial of 1 ml concentrate.

Each carton contains a vial of 4 ml of concentrate.

Each carton contains one vial of 8 ml of concentrate.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare SLU

World Trade Center, Moll de Barcelona, ​​s / n,

Edifici Est 6ª planta,

08039 Barcelona,

Spain

Manufacturer

Accord Healthcare Limited

Sage House

319, Pinner Road

North Harrow, Middlesex HA1 4HF

UK

Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice, Poland

Muhammad Nadeem

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