6 mg / ml concentrate for solution for infusion
paclitaxel
What Paclitaxel Actavis is and what it is used for
Paclitaxel Actavis concentrate for solution for infusion is only given by healthcare professionals who can answer any questions you may have after reading this leaflet.
Paclitaxel Actavis is used in the treatment of cancer, for example in certain types of breast and ovarian cancer and a certain type of lung cancer (advanced non-small cell lung cancer, NSCLC) in patients where surgery and or radiation therapy is not appropriate.
Paclitaxel Actavis is also used to treat a type of cancer, AIDS-related Kaposi’s sarcoma when other treatments have not worked.
Paclitaxel Actavis works by inhibiting cell division and preventing the growth of cancer cells.
What you need to know before you use Paclitaxel Actavis
Do not use Paclitaxel Actavis
- if you are allergic (hypersensitive) to paclitaxel or any of the other ingredients of this medicine (listed in section 6). One of the ingredients, macrogol glycerol ricinoleate, can cause severe allergic reactions.
- if you are breastfeeding.
- if the number of white blood cells ( neutrophilia ) is too low. This is checked by healthcare professionals.
- if you have Kaposi’s sarcoma and at the same time have a severe uncontrolled infection.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Warnings and cautions
Talk to your doctor before using Paclitaxel Actavis.
- if you have heart disease or liver problems.
- if you get diarrhea (pseudomembranous colitis ) during or shortly after treatment with paclitaxel.
- if you have Kaposi’s sarcoma and severe inflammation of the mucous membranes occurs.
- if you have previously had neurological problems in your hands or feet, with numbness and ant crawling or burning sensation ( peripheral neuropathy ).
- if you have a change in the number of cells in your blood.
- if Paclitaxel Actavis is given in combination with radiation therapy to the lungs.
Other medicines and Paclitaxel Actavis
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Paclitaxel Actavis should be given before cisplatin when combined. Paclitaxel Actavis should be given 24 hours after doxorubicin.
Talk to your doctor while taking paclitaxel while taking any of the following:
- medicines to treat your infections (ie antibiotics such as erythromycin, rifampicin, etc., ask your doctor, nurse, or pharmacist if you are unsure whether the medicine you are taking are antibiotics ), and medicines to treat fungal infections (eg ketoconazole )
- drugs used to help stabilize your mood, also called antidepressants (eg fluoxetine )
- medicines for seizures ( epilepsy ) (eg carbamazepine, phenytoin )
- drugs used to help lower blood lipid levels (eg gemfibrozil)
- medicines used to treat heartburn or stomach ulcers (eg cimetidine)
- medicines for HIV and AIDS (eg ritonavir, saquvinavir, indinavir, nelfinavir, efavirenz, nevirapine)
- a drug called clopidogrel, which is used to prevent blood clots.
Children and young people
This medicine should not be given to children and adolescents under 18 years of age.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Paclitaxel Actavis should only be used during pregnancy if necessary. Paclitaxel can harm the fetus.
Pregnancy must be avoided and both parties must use effective contraception during treatment with Paclitaxel Actavis and for at least 6 months after stopping treatment.
If you become pregnant during treatment or within 6 months after stopping treatment, tell your doctor immediately.
Breast-feeding
Do not use Paclitaxel Actavis if you are breastfeeding. You must stop breastfeeding while you are being treated with Paclitaxel Actavis. Do not start breastfeeding until your doctor tells you that it is safe to start again.
Fertility
Male patients may be consulted about sperm preservation before treatment, as treatment with Paclitaxel may lead to irreversible infertility. Both male and women of childbearing potential and/or their partners should use effective contraception for at least 6 months after stopping treatment with Paclitaxel.
Driving and using machines
You can drive between treatments with Paclitaxel Actavis, but remember that this medicine contains alcohol, and driving and the use of machines immediately after a course of treatment should be avoided. Do not drive or use machines if you feel dizzy or dizzy.
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.
Paclitaxel Actavis contains alcohol and macrogol glycerol ricinoleate:
- Alcohol ( ethanol ) about 50% (volume), ie up to 20 g per dose. This is equivalent to half a liter of beer or a large glass of wine (210 ml) per dose. This amount can be dangerous for people suffering from alcoholism as well as for high-risk patients including patients with liver problems or epilepsy. The alcohol in this medicine may affect the effectiveness of other medicines.
- Macrogol glycerol ricinoleate may cause severe allergic (hypersensitivity) reactions.
How to use Paclitaxel Actavis
Your doctor will decide what dose you should receive. It is given under the supervision of a doctor, who can give you more information. Dose one depends on the type and severity of cancer as well as your weight and height that the doctor uses to calculate your body surface area (m 2 ). Does one also depend on the results of your blood tests?
Paclitaxel Actavis must be diluted before it is given to you.
Paclitaxel Actavis is given as an infusion (drip) into a vein for 3 or 24 hours. The treatment is usually repeated every three weeks. Treatment of AIDS-related Kaposi sarcoma is repeated every two weeks.
Depending on the type and severity of cancer, you will receive Paclitaxel Actavis alone or in combination with other anticancer medicines.
Before each treatment with Paclitaxel Actavis, you will be given other medicines (premedication) such as dexamethasone, diphenhydramine, and cimetidine or ranitidine. This is necessary to reduce the risk of severe allergic (hypersensitivity) reactions (see section 4. Possible side effects, uncommon).
Use for children and adolescents
This medicine should not be given to children and adolescents under 18 years of age.
If you take more Paclitaxel Actavis than you should
Dose one is carefully calculated by a doctor, so overdose is unlikely. However, if you take too much medicine, the usual side effects will probably be more severe, especially blood effects, numbness/ant crawling especially in the arms, hands, legs, and feet, and upset stomach with vomiting and diarrhea.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur after treatment with Paclitaxel Actavis.
The most common side effects are hair loss and decreased blood cells. After treatment, your hair grows back and blood levels return to normal.
Tell your doctor immediately if you notice any of the following:
- Abnormal bruising, bleeding, or signs of infection such as sore throat and high fever.
- Severe allergic reaction – you may suddenly have a rash with itching ( urticaria ), swelling of the hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing and breathing), and you may feel faint.
- Shortness of breath and dry cough caused by damage to the lungs.
- Injection site reaction, such as local swelling, pain, and redness.
Very common (may affect more than 1 user in 10):
- Bone marrow effects can lead to a decrease in the number of blood cells, which can cause anemia. This can also lead to infection, especially in the urinary tract and over the respiratory tract (with reported fatal cases).
- Reduced platelet counts and bleeding.
- Mild allergic (hypersensitivity) reactions, such as redness and rash.
- Nerve damage in the hands and/or feet ( peripheral neuropathy ), which is characterized by ant crawling, numbness, and/or pain. *
- Low blood pressure.
- Nausea, vomiting, and diarrhea.
- Muscle or joint pain.
- Mucositis, for example around the mouth.
- Hair loss (most cases occurred within one month after starting paclitaxel treatment. When it does occur, hair loss is pronounced (over 50%) in most patients)
* May persist for more than six months after stopping paclitaxel use.
Common (may affect up to 1 in 10 people):
- Slow heartbeat ( pulse ).
- Transient minor nail and skin changes.
- Painful swelling and inflammation at the injection site may cause tissue hardening (sometimes cellulite, hardening and scarred skin ( fibrosis ), skin cell death ( necrosis )).
- Changes in blood tests show how the liver works.
Uncommon (may affect up to 1 in 100 people):
- Shock condition caused by blood poisoning.
- Severe allergic (hypersensitivity) reaction with, for example, lowered or elevated blood pressure, swelling of the face, difficulty breathing, rash, chills, back pain, chest pain, rapid heartbeat, abdominal pain, pain in arms and legs, sweating.
- Serious heart problems such as cardiomyopathy, severe changes in heart rhythm, and fainting. Myocardial infarction.
- High blood pressure.
- Blood clot ( thrombosis ), inflammation of the vein in connection with a blood clot.
- Yellowing of the skin (jaundice).
Rare (may affect up to 1 in 1,000 people):
- Pneumonia.
- Decreased number of a certain type of white blood cells and fever (febrile neutropenia ).
- Severe allergic (anaphylactic) reaction.
- Nerve impact can cause muscle weakness in the arms and legs.
- Breathing difficulties, fluid in the lungs, inflammation of the lungs and other lung problems ( pulmonary fibrosis, pulmonary embolism), markedly impaired lung function ( respiratory failure).
- Itching, rash, and redness of the skin.
- Weakness, high temperature (fever), dehydration, swelling ( edema ), general malaise.
- Blood poisoning.
- Intestinal obstruction, ulcers in the small and large intestine, inflammation of the peritoneum, inflammation of the intestines caused by insufficient blood supply, inflammation of the pancreas.
- Increased levels of the substance creatinine in the blood.
Very rare (may affect up to 1 in 10,000 users):
- Acute leukemia (a type of blood cancer), myelodysplastic syndrome (a mixture of blood cell diseases).
- Life-threatening allergic reaction (anaphylactic shock ).
- Loss of appetite, shock caused by decreased blood pressure, cough.
- Effects on the nervous system that can cause paralysis of the intestines and drops in blood pressure when standing or sitting up from a supine position, epileptic seizures, seizures, confusion, dizziness, effects on brain function, headaches, inability to coordinate movements.
- Eye problems and visual disturbances, usually at higher doses.
- Impaired hearing or hearing loss, ringing in the ears ( tinnitus ), dizziness.
- Abnormal heart rhythm ( atrial fibrillation, supraventricular tachycardia).
- Blood clot in an artery at the intestines, pseudomembranous colitis ( infection of the large intestine caused by a special bacterium ), inflammation of the esophagus, constipation. Accumulation of fluid in the abdomen.
- Severe inflammation of the colon with symptoms such as fever, watery or bloody diarrhea, and cramping abdominal pain ( neutropenic colitis ).
- Liver cell death (liver necrosis), confusion, and other symptoms ( hepatic encephalopathy ) are caused by impaired liver function (with reported fatalities).
- Urticaria, scaly and flaky skin in combination with redness.
- Severe inflammatory cracking of the skin and mucous membranes (severity from erythema multiforme to Stevens-Johnson syndrome and the most severe toxic epidermal necrolysis (TEN)).
- Nail resolution. Hands and feet should be protected from sunlight during the treatment period.
No known frequency (can not be calculated from the available data):
- Tumor light syndrome (complications caused by degradation products from dying cancer cells). May cause symptoms such as muscle weakness due to increased potassium levels in the blood, acute kidney failure due to increased phosphate levels in the blood, muscle cramps, and movement disorders due to lower calcium levels in the blood.
- Eye complications (macular edema, appearance of flashes of light and dots/spots in the field of vision )
- Inflammation of the vein
- Hardening of the skin ( scleroderma )
- Redness and swelling of the palms and soles of the feet can lead to skin flaking.
- Systemic lupus erythematosus, SLE, is mainly characterized by recurrent red spots on the skin that are usually accompanied by infections of inflammation in joints, tendons, and other connective tissue and organs.
- Disseminated intravascular coagulation or “DIC” has been reported. This is a serious condition that causes people to bleed too easily, get blood clots too easily or both.
How to store Paclitaxel Actavis
Keep this medicine out of the sight and reach of children.
Keep the vial in the outer carton. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
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.
Contents of the pack and other information
What Paclitaxel Actavis contains
- The active substance is paclitaxel.
- 1 ml concentrate for solution for infusion contains 6 mg paclitaxel.
- The other ingredients are citric acid (anhydrous), macrogol glycerol ricinoleate, and ethanol (anhydrous).
What the medicine looks like and the contents of the pack
Paclitaxel Actavis 6 mg/ml concentrate for solution for infusion is a clear, colorless to pale yellow, slightly viscous solution that is packaged in vials.
Pack sizes:
1 x 5 ml vial (30 mg / 5 ml)
1 x 16.7 ml vial (100 mg / 16.7 ml)
1 x 25 ml vial (150 mg / 25 ml)
1 x 50 ml vial (300 mg / 50 ml)
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 SRL
11 Ion Mihalache Blvd
011171 Bucharest
Romania
or
Actavis Italy SpA-Nerviano Plant
Viale Pasteur 10
20014 Nerviano (MI)
Italy