20 mg / mL concentrate for infusion solution
docetaxel
1. What Docetaxel Actavis is and what it is used for
The name of this medicine is Docetaxel Actavis. The generic name is docetaxel. Docetaxel is a substance that originates in the needles of the yew tree.
Docetaxel belongs to the group of cancer drugs called taxoids.
Your doctor has prescribed Docetaxel Actavis 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:
- For the treatment of advanced breast cancer, Docetaxel Actavis can be given either alone or in combination with doxorubicin, trastuzumab, or capecitabine.
- For the treatment of early-stage breast cancer that has or has not spread to the lymph nodes, Docetaxel Actavis can be given in combination with doxorubicin and cyclophosphamide.
- For the treatment of lung cancer, Docetaxel Actavis can be given either alone or in combination with cisplatin.
- In the treatment of prostate cancer, Docetaxel Actavis is given in combination with prednisone or prednisolone.
- In the treatment of gastric cancer, Docetaxel Actavis is given in combination with cisplatin and fluorouracil.
- In the treatment of head and neck cancer, Docetaxel Actavis is given in combination with cisplatin and fluorouracil
Docetaxel contained in Docetaxel Actavis may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Docetaxel Actavis
You should not be prescribed Docetaxel Actavis
- 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 Actavis, blood samples will be taken from you to check if you have enough blood cells and sufficient liver function to get Docetaxel Actavis. 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, clinician, 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 treatment with Docetaxel Actavis. You will take the cortisone tablets for an additional 1 or 2 days after the day of treatment with Docetaxel Actavis to minimize the risk of certain side effects that may occur after Docetaxel Actavis infusion, especially allergic reactions and fluid retention (swelling of hands, feet, legs or weight gain).
During your treatment, you may be given 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 Actavis:
- 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.
Docetaxel Actavis contains alcohol. Talk to your doctor if you have alcohol abuse. See also section “Docetaxel Actavis contains alcohol ( ethanol )” below.
Other medicines and Docetaxel Actavis
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because Docetaxel Actavis or the other medicine may not work as well as expected and because the risk of you getting a side effect is higher.
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 for advice before taking this medicine.
Pregnancy
Docetaxel Actavis must 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 Actavis may be harmful to the unborn baby.
If you become pregnant during Docetaxel Actavis treatment, you must inform your doctor immediately.
If you are a man and being treated with Docetaxel Actavis, you are advised not to have children during and up to 6 months after treatment and to seek advice on sperm preservation before treatment, as docetaxel may affect male fertility.
Breast-feeding
You must not breast-feed while you are being treated with Docetaxel Actavis.
Fertility
If you are a man and being treated with Docetaxel Actavis, you are advised not to have children during and up to 6 months after treatment and to seek advice on sperm preservation before treatment, as docetaxel may affect male fertility.
Driving and using machines
The amount of alcohol in this medicine may impair your ability to drive or use machines. This medicine can 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.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Docetaxel Actavis contains alcohol (ethanol)
This medicine contains 400 mg of alcohol ( ethanol ) in each 1 ml vial corresponding to 40% w / v.
The amount in a vial of this medicine corresponds to 10 ml of beer or 4 ml of wine.
This medicine contains 1600 mg alcohol ( ethanol ) in each 4 ml vial corresponding to 40% w / v.
The amount in a vial of this medicine corresponds to 40 ml of beer or 16 ml of wine.
This medicine contains 2800 mg of alcohol ( ethanol ) in each 7 ml vial corresponding to 40% w / v.
The amount in a vial of this medicine corresponds to 70 ml of beer or 28 ml of wine.
This medicine contains 3200 mg of alcohol ( ethanol ) in each 8 ml vial corresponding to 40% w / v.
The amount in a vial of this medicine corresponds to 80 ml of beer or 32 ml of wine.
The amount of alcohol in this medicine is unlikely to have any effects on adults and adolescents and its effect in children is probably not noticeable. It can have some effect on younger children, e.g. somnolence.
The alcohol in this medicine may affect the effectiveness of other medicines. Tell your doctor or pharmacist if you are taking any other medicines.
If you are pregnant or breast-feeding, talk to your doctor or pharmacist before taking this medicine.
If you are or have been addicted to alcohol, consult your doctor or pharmacist before using this medicine.
The amount of alcohol in this medicine may have effects on the central nervous system (the part of the nervous system that includes the brain and spinal cord).
How to use Docetaxel Actavis
Docetaxel Actavis will be given to you by healthcare professionals
Usual 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 Actavis 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 Actavis 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 Actavis treatment. You must inform your doctor if you get diarrhea, mouth sores, loss of sensation, tingling, or fever and inform him/her of your blood test results. Such information helps him/her to decide if a dose needs to be reduced. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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 Actavis when used alone are reduction in red or white blood cell count, hair loss, nausea, vomiting, mouth sores, diarrhea, and fatigue.
If you are given Docetaxel Actavis in combination with other anticancer medicines, the severity of the side effects may increase.
During ongoing hospital treatment, the following allergic reactions may occur (may affect more than 1 in 10 people):
- redness, skin reactions, itching
- pressure over the chest, difficulty breathing
- fever or chills
- back pain
- low blood pressure.
More severe reactions may 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 condition will be closely monitored during treatment by healthcare professionals.
Notify staff immediately if you notice any of these reactions.
Between the infusions of Docetaxel Actavis, the following side effects may occur and the frequency may vary between different combinations of medicines:
Very common (may affect more than 1 user in 10):
- infection, a decrease in the number of red blood cells ( anemia ) or white blood cells (which are important for fighting infections ) and platelets
- fever: if you get a fever, 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
- eye inflammation or increased tear flow
- swelling caused by deficient lymphatic drainage
- shortness of breath
- runny nose, 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: after the end of treatment, normal hair growth should in most cases return. 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 or missed periods
- 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
- decreased blood pressure, irregular or increased heart rate
- high blood pressure
- 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
- skin reactions, venous inflammation, and swelling locally at the injection site.
Uncommon (may affect up to 1 in 100 people):
- fainting
- blood clots
- 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)
- kidney diseases
- hepatitis
- burn-like appearance at the injection site can occur several days after the last dose of a
- 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 and/or 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 a 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.).
5. How to store Docetaxel Actavis
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 vial.
Do not store above 25 ° C.
Store in the original package. Sensitive to light.
Store in a cold place. Do not freeze.
After opening the vial:
Each vial is for single use only and should be used immediately after opening. If not used immediately, in-use storage times and conditions before use is the responsibility of the user.
When added to the infusion bag:
The diluted solution should be used immediately after reconstitution. If not used immediately, in-use storage times and conditions before use are the responsibility of the user and would normally not be longer than 3 days. C).
Any unused product or waste material should be disposed of by local requirements.
Medicines should not be disposed of via wastewater or household waste. 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
Content declaration
- The active substance is docetaxel. 1 ml docetaxel solution contains 20 mg docetaxel.
- The other ingredients are citric acid, povidone, absolute ethanol, and polysorbate 80.
What the medicine looks like and the contents of the pack
Docetaxel Actavis concentrate for solution for infusion is a clear pale yellow solution.
Docetaxel Actavis is provided in a colorless vial of glass sealed with a “flip-off” -work with a rubber stopper and polypropylene. The vial is packaged with or without a protective plastic cover.
Pack sizes:
1 x 1 ml vial, the single dose
1 x 4 mL vial, the single dose
1 x 7 mL vial, the single dose
1 x 8 mL vial, the single dose
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Actavis Group PTC ehf.
Reykjavikurvegur 76-78
IS-220 Hafnarfjordur
Iceland
Manufacturer
SC Sinden-Pharma SRL
11 Ion Mihalache Blvd
011171 Bucharest
Romania
Actavis Italy SpA
Viale Pasteur 10
20014 Nerviano (MI)