6 mg / ml concentrate for solution for infusion
paclitaxel
WHAT PACLITAXEL ACCORD IS AND WHAT IT IS USED FOR
The full name of the medicine you received is ‘Paclitaxel 6 mg/ml, concentrate for solution for infusion ‘, but for the rest of this leaflet it will be called ‘Paclitaxel Accord’.
Paclitaxel belongs to a group of anti-cancer drugs called taxanes. These drugs prevent the growth of cancer cells.
Paclitaxel Accord is used to treat:
Ovarian cancer:
- as first 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 Accord is given in combination with either an anthracycline preparation (eg doxorubicin) or with the drug trastuzumab (for 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).
- after initial surgery after treatment with anthracycline and cyclophosphamide (AC) as adjunctive therapy.
- as a second-line treatment for patients who have not responded to standard anthracycline therapy, 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 contained in the Paclitaxel Accord 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 another healthcare professional, and always follow their instructions.
WHAT YOU NEED TO KNOW BEFORE TAKING PACLITAXEL ACCORD
Do not use Paclitaxel Accord
- if you are allergic (hypersensitive) to paclitaxel or any of the other ingredients of this medicine (listed in section 6), in particular, polyoxyethylated castor oil (macrogol glycerol castinoleate);
- 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 – this will be checked by your doctor). Blood tests will be taken to check this.
- if you get Paclitaxel Accord for Kaposi’s sarcoma and at the same time have a severe uncontrolled infection.
If any of these apply to you, talk to your doctor before starting treatment with Paclitaxel Accord.
Paclitaxel Accord is not recommended for use in children (under 18 years of age).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Paclitaxel Accord.
To reduce the risk of allergic reactions, you will need to take other medicines before receiving Paclitaxel Accord.
- If you have severe allergic reactions (eg difficulty breathing, shortness of breath, tightness of the chest, drop in blood pressure, dizziness, dizziness, 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; it may be necessary to reduce the dose of Paclitaxel Accord.
- If you have severe liver problems; in this case, it is not recommended that Paclitaxel Accord be given.
- If you have problems with the heart’s conduction system.
- If you get severe or persistent diarrhea, with fever and abdominal pain, during or shortly after treatment with Paclitaxel Accord. This may indicate inflammation of the colon (pseudomembranous colitis ).
- If you have previously undergone radiation therapy to your chest (as this may increase the risk of pneumonia ).
- If you are treated for Kaposi’s sarcoma and cold sores or reddening of the skin in the mouth (signs of inflammation of the mucous membranes) occur. Dose one may need to be reduced.
If any of these apply to you, tell your doctor immediately.
Paclitaxel Accord must always be given in a vein. If Paclitaxel Accord is given in an artery, this can lead to inflammation in the artery with pain, swelling, redness of the skin, and a feeling of warmth.
Other medicines and Paclitaxel Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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 )
- medicines used to help lower blood fat levels (eg gemfibrozil)
- medicines used to treat heartburn or stomach ulcers (eg cimetidine)
- medicines to treat HIV and AIDS (eg ritonavir, saquvinavir, indinavir, nelfinavir, efavirenz, nevirapine)
- a drug called clopidogrel, which is used to prevent blood clots.
Use of Paclitaxel Accord food, drink, and alcohol
Paclitaxel Accord is not affected by concomitant intake of food and drink
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.
Paclitaxel Accord should not be used during pregnancy unless necessary.
This medicine can cause congenital malformations. Therefore, you must not become pregnant while taking paclitaxel and you and/or your partner must use an effective method of contraception while receiving paclitaxel and for six months after stopping treatment. If you become pregnant during treatment, or within six months of stopping treatment, tell your doctor immediately.
If you are a man and are being treated with paclitaxel, you are advised not to have children during and up to six months after treatment.
Tell your doctor if you are breastfeeding. It is not known whether paclitaxel is excreted in human milk. You must stop breastfeeding during treatment with Paclitaxel Accord due to the potential risk of harm to your baby. Do not resume breastfeeding until your doctor gives the go-ahead.
Fertility
Treatment with paclitaxel may lead to irreversible infertility. Men should therefore seek advice regarding sperm preservation before treatment.
Driving and using machines
Paclitaxel Accord can cause side effects such as fatigue (very common) and dizziness (common) which may affect your ability to drive and use machines. Avoid driving and using machines if you experience these symptoms until they are completely gone. If your treatment includes additional drugs, discuss driving and using machines with your doctor.
This medicine contains alcohol. You should therefore avoid driving immediately after treatment.
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.
Important information about some of the ingredients of Paclitaxel Accord
Paclitaxel Accord contains castor oil which can cause severe allergic reactions. Tell your doctor if you are allergic to castor oil (50% polyethoxylated castor oil) before starting treatment with Paclitaxel Accord.
Paclitaxel Accord contains alcohol (approximately 50% ethanol ) – one milliliter of Paclitaxel Accord contains 0.391 g of alcohol. A 300 mg / 50 ml dose of Paclitaxel Accord contains 20 g of anhydrous ethanol, equivalent to 429 ml of strong beer or 179 ml of wine.
This amount can be dangerous for people suffering from alcoholism. Consideration must be given to the treatment of pregnant and lactating women, children, and high-risk patients with liver problems or epilepsy.
The alcohol in this medicine may affect the effectiveness of other medicines.
HOW TO TAKE PACLITAXEL ACCORD
- To reduce the risk of allergic reactions, you will need to take other medicines before receiving Paclitaxel Accord. These drugs can be given either in tablet form or as an infusion into a vein, or both.
- You will receive Paclitaxel Accord as a drip into a vein ( intravenous infusion ), via a multi-way tap. Paclitaxel Accord will be administered 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 Accord either alone or with another cancer medicine.
- Paclitaxel Accord 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 Paclitaxel Accord treatments you will need.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you take more Paclitaxel Accord than you should
There is no treatment for Paclitaxel Accord overdose. You will receive symptomatic treatment.
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 a dose of Paclitaxel Accord has been missed
If you think a dose may have been missed, talk to your doctor or nurse.
A double dose should not be given to compensate for the missed dose.
If you stop using Paclitaxel Accord
Your doctor will decide when to stop paclitaxel treatment.
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 get symptoms of an allergic reaction. Examples of these symptoms can be:
- hot flashes
- skin reactions
- itching
- crowded across the chest
- shortness of breath or difficulty breathing
- swelling
All of these can indicate serious side effects.
Contact a doctor immediately:
- If you get a fever, severe chills, sore throat, or cold sores (signs of bone marrow suppression).
- If you get numbness or weakness in the arms and legs (signs of peripheral neuropathy ).
- If you get severe or persistent diarrhea with fever and abdominal pain.
Very common ( may affect more than 1 user in 10):
- Mild allergic reactions, such as redness, rash, and itching
- Infections: mainly upper respiratory tract infections and urinary tract infection
- Respiratory distress
- Sore throat and cold sores, sore mouth, reddening of the mouth, diarrhea, nausea, vomiting.
- Hair loss (when this happens, hair loss is pronounced [over 50%] in most patients)
- Muscle pain, cramps, joint pain
- Fever, severe chills, headache, dizziness, tiredness, pallor, bleeding, increased tendency to bruise
- Numbness, tingling, weakness in arms and legs (all symptoms of peripheral neuropathy ) *
- Sampling may show: Decreased platelets and white or red blood cells, low blood pressure
* May persist for more than six months after stopping paclitaxel use.
Common ( may affect up to 1 in 10 people):
- Transient slight changes in nails and skin, reactions at the injection site (local swelling, pain, and redness of the skin)
- Sampling may show: Slower heart rate, a sharp increase in liver enzymes (alkaline phosphatase and AST )
Uncommon ( may affect up to 1 in 100 people):
- Shock condition caused by blood poisoning
- Palpitations, severe cardiac arrest (AV block), 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 (may affect up to 1 in 1,000 people)
- Decreased white blood cell count with fever and increased risk of infection (febrile neutropenia i)
- Nerve damage with muscle weakness in arms and legs (motor neuropathy)
- 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
- 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
- Heart failure
Very rare (may affect up to 1 in 10,000 people)
- 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, 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 inflammation of the eyes ( Stevens-Johnson syndrome ), scaly skin ( epidermal necrolysis ), reddening of the skin with irregular rash (erythema multiforme), inflammation of the skin with blisters and exfoliation (exfoliative dermatitis ) hives, 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.
Has been reported (may occur in an unknown number of users):
- Thickened skin ( scleroderma )
- Tumor light syndrome
- Macular edema, photos, spots in the visual field
- Phlebitis
- Systemic lupus erythematosus
- 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 can lead to the skin flaking.
HOW TO STORE PACLITAXEL 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 outer carton after EXP. dat. and on the vial after EXP. The expiration date is the last day of the specified month.
Before opening the package
Do not store above 25 ° C. Keep the vial in the outer carton. Sensitive to light.
The product can be frozen without being adversely affected.
Opened package before preparation (description of conditions)
From a microbiological point of view, opened packages should be stored at a maximum of 25 ° C for a maximum of 28 days. Other storage conditions after opening are the responsibility of the user.
Prepared solution (description of conditions)
From a microbiological perspective, the product should be used immediately. If not used immediately, in the refrigerator (2 ° C to 8 ° C) for a maximum of 24 hours, unless the preparation has been carried out in a controlled and validated manner under aseptic conditions. For further information on the sustainability of the prepared solution, see the section for healthcare professionals.
Do not use this medicine if the solution is cloudy or has a visible precipitate.
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. FURTHER INFORMATION
Content declaration
- The active substance is paclitaxel. 1 ml concentrate for solution for infusion contains 6 mg paclitaxel. One vial contains 5, 16.7, 25, 50 and 100 ml (equivalent to 30, 100, 150, 300 and 600 mg paclitaxel respectively).
- The other ingredients are polyoxyl 35 castor oil (macrogol glycerol castor oil 35) and anhydrous ethanol.
What the medicine looks like and the contents of the pack
Paclitaxel Accord is a clear, unstained to the pale yellow solution, free from visible particles.
Packed in vials of 5 ml, 16.7 ml, 25 ml, 50 ml, and 100 ml concentrate for infusion solution.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 kV Utrecht
Netherlands
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