6 mg / ml concentrate for solution for infusion
paclitaxel
What Paclitaxel Fresenius Kabi is and what it is used for
Paclitaxel Fresenius Kabi belongs to a group of anticancer medicines called taxanes. These drugs prevent the growth of cancer cells.
Paclitaxel Fresenius Kabi is used to treat:
Ovarian cancer:
- as first-line treatment (after initial surgery in combination with the platinum drug cisplatin).
- when standard treatment with platinum drugs has been tried but has not worked.
Breast cancer:
- as first-line treatment for advanced disease or when the disease has spread to other parts of the body (metastatic disease). Paclitaxel Fresenius Kabi is given in combination with either an anthracycline preparation (eg doxorubicin) or the drug trastuzumab (in patients where anthracycline preparations are not suitable, and where the tumor cells have protein et HER 2 on the surface; see package leaflet for trastuzumab).
- as adjunctive therapy to anthracycline and cyclophosphamide (AC).
- as a secondary treatment to patients who have not responded to standard anthracycline treatment, or where such treatment is not possible.
Advanced non-small-cell lung cancer:
- in combination with cisplatin in patients where surgery and/or radiation therapy are not appropriate.
AIDS-related Kaposi’s sarcoma:
- when other treatment (ie liposomal anthracycline ) has been tried but has not worked
Paclitaxel Fresenius Kabi may also be approved for the treatment of other conditions not mentioned in this leaflet. If you have any further questions, ask your doctor, pharmacist, or other healthcare professional.
What you need to know before you use Paclitaxel Fresenius Kabi
You should not receive Paclitaxel Fresenius Kabi:
- if you are allergic to Paclitaxel Fresenius Kabi or any of the other ingredients of this medicine (listed in section 6), in particular macrogol glycerol castin oil (polyoxyethylated castor oil).
- if you are breastfeeding.
- if the number of white blood cells in the blood is too low ( neutrophil before treatment <1.5 x 10 9 / l or <1.0 x 10 9 / l for patients with Kaposi’s sarcoma – this will be checked by your doctor). Blood tests will be taken to check this.
- if you get Paclitaxel Fresenius Kabi for Kaposi’s sarcoma and at the same time have a severe and uncontrolled infection.
If any of these apply to you, talk to your doctor before starting treatment with Paclitaxel Fresenius Kabi.
Paclitaxel Fresenius Kabi is not recommended for use in children (under 18 years of age).
Warnings and cautions
Talk to your doctor before using Paclitaxel Fresenius Kabi.
To reduce the risk of allergic reactions, you will be given other medicines before you receive Paclitaxel Fresenius Kabi.
- If you get allergic reactions (eg difficulty breathing, shortness of breath, pressure over the chest, drop in blood pressure, dizziness, fainting, skin reactions such as rash or swelling)
- If you get a fever, severe chills, sore throat, or cold sores (signs of bone marrow suppression).
- If you experience numbness, tingling, itching, increased sensitivity to touch, or weakness in the arms and legs (signs of peripheral neuropathy ); a reduction in the paclitaxel dose may be required.
- If you have severe liver problems; in such cases, the use of Paclitaxel Fresenius Kabi is not recommended.
- If you have heart problems
- If you get severe or persistent diarrhea with fever and abdominal pain during or shortly after treatment with Paclitaxel Fresenius Kabi. Your colon may be inflamed (pseudomembranous colitis ).
- If you have previously undergone radiation therapy to your chest (this may increase the risk of pneumonia ).
- If you are being treated for Kaposi’s sarcoma and cold sores or reddening of the mouth (signs of mucositis ), you may need a lower dose.
Given the risk of the drug entering the surrounding tissue, it is advisable to closely monitor the infusion site for any leakage during drug administration.
If any of these apply to you, tell your doctor immediately.
Paclitaxel Fresenius Kabi must always be given in a vein. If Paclitaxel Fresenius Kabi is given in an artery, this can lead to inflammation in the artery with pain, swelling, reddening of the skin, and a feeling of heat.
Other medicines and Paclitaxel Fresenius Kabi
Talk to your doctor while taking Paclitaxel Fresenius Kabi 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.
The alcohol in this medicine may affect the effectiveness of other medicines. Tell your doctor or pharmacist if you are taking other medicines.
Pregnancy, breastfeeding, and fertility
You must tell your doctor if you are pregnant or think you may be pregnant before starting treatment with Paclitaxel Fresenius Kabi. If there is a possibility that you may become pregnant, you must use an effective and safe contraceptive during treatment. Paclitaxel Fresenius Kabi should be used during pregnancy only if needed.
Women and men of childbearing potential and their partners must use contraception for at least 6 months after stopping treatment with Paclitaxel Fresenius Kabi. Men should investigate the possibility of freezing semen before paclitaxel treatment due to the risk of incurable infertility.
Tell your doctor if you are breastfeeding. It is not known whether Paclitaxel Fresenius Kabi is excreted in human milk. You must stop breastfeeding during treatment with Paclitaxel Fresenius Kabi due to the possible risk of injury to your baby. Do not resume breastfeeding until your doctor gives the go-ahead.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There is no reason why you can not continue driving between treatments with Paclitaxel Fresenius Kabi, but as this medicine contains some alcohol, it may be unwise to drive or use machines immediately after treatment due to possible effects on the central nervous system. You should not drive or use machines if you feel dizzy and faint.
The alcohol in this medicine may affect the ability to drive and use machines. This is because your judgment and ability to react can be affected.
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 Fresenius Kabi contains castor oil (macrogol glycerol ricinoleate) and alcohol
Paclitaxel Fresenius Kabi contains castor oil which can cause severe allergic reactions. Tell your doctor if you are allergic to castor oil before starting treatment with Paclitaxel Fresenius Kabi.
This medicine contains 393 mg of alcohol ( ethanol ) in each 1 ml corresponding to 39.3% w / v. The amount in 52.5 ml of this medicine corresponds to 515.8 ml of beer or 206.3 ml of wine.
If you have epilepsy or liver problems, consult your doctor or pharmacist before using this medicine.
If you are or have been addicted to alcohol, consult your doctor or pharmacist before using this medicine.
How to use Paclitaxel Fresenius Kabi
- To reduce the risk of allergic reactions, you will need to take other medicines before receiving Paclitaxel Fresenius Kabi. These drugs can be given either in tablet form or as an infusion into a vein, or both.
- You will receive Paclitaxel Fresenius Kabi as a drip into a vein ( intravenous infusion ), via an in-line filter. Paclitaxel Fresenius Kabi will be given to you by healthcare professionals. They will prepare the infusion solution before you receive it. The dose you receive will also depend on the answers to your blood tests. Depending on the type of cancer you have and the severity of your illness, you will be given Paclitaxel Fresenius Kabi either alone or with another cancer medicine.
- Paclitaxel Fresenius Kabi should always be given in a vein over a 3- or 24-hour period. Treatment is usually every two or three weeks unless your doctor prescribes otherwise. Your doctor will tell you how many treatments with Paclitaxel Fresenius Kabi you will need.
If you use more Paclitaxel Fresenius Kabi than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately if you experience symptoms of an allergic reaction. Examples of these symptoms can be:
- hot flashes,
- skin reactions,
- itching,
- tight across the chest,
- shortness of breath or difficulty breathing,
- swelling.
All of these can indicate serious side effects.
Contact a doctor immediately if you experience:
- fever, severe chills, sore throat, or cold sores (signs of bone marrow suppression).
- numbness or weakness in the arms and legs (signs of peripheral neuropathy ).
- severe or persistent diarrhea with fever and abdominal pain.
Very common may occur in more than 1 in 10 users
- Mild allergic reactions, such as redness, rash, and itching
- Infections: mainly upper respiratory tract infections and urinary tract infection
- Sore throat and cold sores, sore mouth, reddening of the mouth, diarrhea, nausea, vomiting.
- Hair loss (most cases of hair loss occurred less than a month after paclitaxel insertion. When this happens, hair loss is pronounced (over 50%) in most patients).
- Muscle pain, cramps, joint pain
- Numbness, tingling, weakness in arms and legs (all symptoms of peripheral neuropathy ) ** May persist for more than six months after stopping paclitaxel use.
- Sampling may show: decreased platelet count, which may lead to bleeding and increased tendency to get bruises and white or red blood cells, low blood pressure
Common can occur in up to 1 in 10 users
- Transient slight changes in nails and skin, reactions at the injection site (local swelling, pain, and redness of the skin)
- Sampling may show: a slower heart rate, a sharp increase in liver enzymes (alkaline phosphatase and AST )
Uncommon may occur in up to 1 in 100 users
- Shock condition caused by blood poisoning ( septic shock )
- Palpitations, severe cardiac arrest (AV block, cardiomyopathy ), high heart rate, heart attack, difficulty breathing
- Fatigue, sweating, fainting ( syncope ), severe allergic reactions, phlebitis ( inflammation of a vein), swelling of the face, lips, mouth, tongue, or throat
- Pain in the back, chest, around hands and feet, chills, abdominal pain
- Sampling may show Severely elevated bilirubin levels (jaundice), high blood pressure, blood clots.
Rare can occur in up to 1 in 1,000 users
- Decreased white blood cell count with fever and increased risk of infection (febrile neutropenia )
- Nerve damage with muscle weakness in arms and legs (motor neuropathy)
- Heart failure
- Breathing difficulties, pulmonary embolism, pulmonary fibrosis, inflammation of the lungs, shortness of breath, fluid in the lungs
- Bowel obstruction, ulcers on the intestines, inflammation of the colon (ischemic colitis ), inflammation of the pancreas ( pancreatitis )
- Itching, rash, redness of the skin ( erythema )
- Blood poisoning ( sepsis ), peritonitis, pneumonia
- High temperature (fever), dehydration, weakness, swelling ( edema ), general malaise
- Severe, potentially fatal allergic (anaphylactic) reaction
- Sampling may show: an increase in creatinine levels in the blood which is a sign of impaired kidney function
Very rare can occur in up to 1 in 10,000 users
- Irregular heartbeat ( atrial fibrillation, supraventricular tachycardia )
- Sudden conditions of blood-forming cells ( acute myeloid leukemia, myelodysplastic syndrome )
- Problems with optic nerve and/or visual disturbances (visual phenomena)
- Impaired hearing or hearing loss (ototoxicity), ringing in the ears ( tinnitus ), dizziness
- Cough
- Blood clots in blood vessels in the abdomen or intestines (mesenteric thrombosis ), colitis, possibly with persistent severe diarrhea (pseudomembranous colitis, neutropenic colitis ), accumulation of fluid in the abdomen ( ascites ), inflammation of the esophagus, constipation.
- Severe hypersensitivity reactions include fever, reddening of the skin, joint pain and/or eye inflammation (Stevens-Johnson syndrome), scaly skin ( epidermal necrolysis ), reddening of the skin with irregular red (liquid) rash (erythema multiforme), dermatitis with blisters and exfoliative rash ( exfoliative rash ), nail solution (hands and feet should be protected from sunlight during the treatment period).
- Loss of appetite ( anorexia ).
- Severe, potentially fatal hypersensitivity reaction with shock (anaphylactic shock ).
- Failure of liver function ( hepatic necrosis, hepatic encephalopathy [fatal cases have been reported for both]).
- Confusion state.
- Epileptic seizures, effects on the nervous system (autonomic neuropathy, this can lead to intestinal upset and low blood pressure ), seizures, brain disease ( encephalopathy ), dizziness, headache, problems with coordination ( ataxia ).
No known frequency (can not be calculated from the available data)
- Rapid disintegration of tumor cells (tumor lysis syndrome)
- Fluid accumulation in the eye (macular edema ), the experience of flashes of light in the eye ( photos ), spots in the field of vision et
- Inflammation of the veins ( phlebitis )
- Thickening of the skin, blood vessels, and internal organs (scleroderma)
- A disease of the immune system that attacks many organs in the body ( SLE, Systemic lupus erythematosus)
- The formation of blood clots in the small blood vessels can lead to bleeding in various parts of the body (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. )
- Redness and swelling of the palms and soles of the feet, which can lead to the skin flaking
How to store Paclitaxel Fresenius Kabi
Keep out of sight and reach of children.
Do not store above 25 ° C.
Keep the vial in the original package. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
The expiration date is the last day of the specified month.
Do not use this medicine if you notice turbidity or precipitation in the solution.
The medicine 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
Content declaration
- The active substance is paclitaxel. Each ml of concentrate for solution for infusion contains 6 mg paclitaxel.One 5 ml vial contains 30 mg paclitaxel.One 16.7 ml vial contains 100 mg paclitaxel.One 25 ml vial contains 150 mg paclitaxel.One 50 ml vial contains 300 mg paclitaxel.One 100 ml vial contains 600 mg paclitaxel.
- The other ingredients are anhydrous ethanol, macrogol glycerol ricinoleate, and anhydrous citric acid (for pH adjustment).
What the medicine looks like and the contents of the pack
Concentrate for solution for infusion
Paclitaxel Fresenius Kabi is a clear, slightly yellowish solution.
Paclitaxel Fresenius Kabi is supplied in glass vials. The vials are closed with Teflon-coated rubber stoppers.
Pack sizes:
Packs containing 1 or 5 glass vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Fresenius Kabi AB
75174 Uppsala
Manufacturer
Fresenius Kabi Deutschland GmbH
Pfingstweide 53
611 69 Friedberg
Germany
or
Corden Pharma Latina SpA
Via Murillo No. 7
04013 Sermoneta (LT)
Italy