6 mg / ml concentrate for solution for infusion
paclitaxel
What Pacligen is and what it is used for
Paclitaxel is a cancer medicine. It inhibits the growth and division of cancer cells.
Pacligen is used to treat different types of cancer ie:
- Breast cancer:
- Treatment of early breast cancer after surgery when the primary tumor has been removed, followed by additional treatment with anthracycline and cyclophosphamide (AC).
- As a first-line treatment for advanced breast cancer or for breast cancer that has spread to other parts of the body. Pauly is combined either with anthracycline (eg doxorubicin) or with a substance called trastuzumab (for patients for whom an anthracycline is not suitable and for patients whose cancer cells have a protein on their surface called HER2, see the package leaflet for trastuzumab).
- As secondary treatment for patients who have not responded to standard anthracycline therapy or where such treatment should not be used
- Ovarian cancer:
- As a first-line treatment for advanced ovarian cancer or in patients with a residual tumor larger than 1 cm after an initial operation, in combination with cisplatin.
- After standard treatment with platinum-containing drugs has been tried but has not given effect.
- A type of lung cancer (advanced non-small cell lung cancer):
- In combination with cisplatin when surgery and/or radiation therapy are not appropriate.
It is also used to treat a specific AIDS-related form of cancer that develops in the connective tissue ( Kaposi’s sarcoma ) when other treatments (ie liposomal anthracyclines ) have been tried but have not yielded results.
Paclitaxel contained in Pacligen may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Pacligen
Do not use Pacligen
- if you are allergic to paclitaxel or any of the other ingredients of this medicine (listed in section 6), especially macrogol glycerol ricinoleate.
- if you are breast-feeding
- if the number of white blood cells ( neutrophils ) is below 1500 cells per microliter (for cancer patients) or below 1000 cells per microliter (for patients with Kaposi’s sarcoma ). This is measured by healthcare.
- if you have a severe and uncontrolled infection and Pacligen is used to treat Kaposi’s sarcoma
- if you suffer from severe liver disease
If any of these apply to you, talk to your doctor before starting Pacligen.
Warnings and cautions
To reduce the risk of allergic reactions, you will be pre-treated with other medicines before receiving Pacligen.
- If you experience severe allergic reactions (eg difficulty breathing, shortness of breath, chest tightness, drop in blood pressure, dizziness, skin reactions such as rash or swelling).
- If you have a fever, severe chills, sore throat, or sore mouth (signs of bone marrow suppression).
- If you have conduction disturbance in the heart.
- If you have severe liver disease.
- If you have previously had problems with your arms and legs such as loss of sensation, weakness, stinging, or burning sensation (signs of peripheral neuropathy ). A dose reduction may need to be made.
- If your chest has previously been irradiated (as this may increase the risk of pneumonia ).
- If you develop severe or persistent diarrhea with fever and stomach pain during or shortly after treatment with Pacligen. Your bowel may then be inflamed (pseudomembranous colitis ).
- If your mouth is sore and red (signs of mucositis) and you are being treated for Kaposi’s sarcoma. You may need a lower dose.
Tell your doctor immediately if any of these apply to you.
Pacligen should always be given intravenously. If Pacligen is given in the arteries, it can cause inflammation in them, which can cause pain, swelling, redness, and a feeling of warmth.
Before using Pacligen remember that this medicine contains alcohol (see section “Pacligen contains alcohol and macrogol glycerol ricinoleate”).
Children and young people
Pacligen is not recommended for use in children (under 18 years).
Other drugs and Pacligen
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 )
- 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.
Pacligen must be given
- before cisplatin (for the treatment of cancer) in combination therapy. Your kidney function may need to be checked more often.
- 24 hours after doxorubicin (for the treatment of cancer) to avoid high levels of doxorubicin in the body.
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
Tell your doctor if you are pregnant or think you may be pregnant before receiving Pacligen treatment. If there is a risk that you may become pregnant, use an effective and safe method of contraception during treatment. Pacligen should not be used during pregnancy unless necessary.
Women and men of childbearing potential and their partners should use effective contraception for at least 6 months after stopping paclitaxel treatment.
Men should seek advice on freezing semen before treatment with paclitaxel as there is a risk of sterility.
Breast-feeding
Do not use Pacligen if you are breastfeeding. Tell your doctor if you abreastfeedinging. If you are using Pacligen, stop breastfeeding. Do not resume breastfeeding until your doctor has permitted you to do so.
Driving and using machines
This medicine contains alcohol. Therefore, you should not drive immediately after a course of treatment.
The amount of alcohol in this medicine may also affect your ability to use tools and machines. Refrain from driving or using tools or machines if you feel dizzy or unsure if you can.
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.
Pacligen contains alcohol and macrogol glycerol ricinoleate
Pacligen contains 50% ethanol (volume) ie. up to 20 g per dose corresponding to 520 ml beer or 210 ml wine per dose. This can be harmful to people suffering from alcoholism. Should be observed by pregnant and lactating women, child,ren and high-risk groups such as patients with liver disease or epilesy .
The amount of alcohol in this medicine may also affect teffectivenessect of other medicines.
Pacligen also contains macrogol glycerol ricinoleate which may cause severe allergic reactions. If you are allergic to macrogol glycerol ricinoleate, tell your doctor before using Pacligen.
How Pacligen is given
Pacligen should only be administered under the supervision of a qualified oncologist at clinics specializing in the administration of cytotoxic agents.
To reduce the risk of allergic reactions, you will be pre-treated with other medicines before receiving Pacligen. These drugs can be given as tablets or as an infusion into a vein, or both.
The infusion solution has been prepared by mixing the product with glucose solution or sodium chloride solution, see information for healthcare professionals only in this leaflet.
Pacligen will be given as a drip into one of your veins ( intravenous infusion ) via a filter.
Your doctor will decide which dose and how many doses of Pacligen you need. The amount ( dose one) that you should have is based on your body surface area in square meters (m 2 ) and the results from the blood tests. Depending on the type and severity of your cancer, you will be treated with Pacligen alone or in combination with other cancer drugs.
Pacligen should always be given in one of your veins for 3-24 hours. Pacligen is usually given every two or three weeks unless your doctor decides otherwise. Your doctor will inform you about how many courses of Pacligen you need.
You may feel discomfort or pain if the needle comes loose or is disturbed or if the solution reaches the surrounding tissue. Contact a doctor or nurse immediately if this happens.
If you take more Pacligen than you should
There is no known antidote for paclitaxel overdose. You will receive treatment for your symptoms.
If you forget to use Pacligen
Paclitaxel needs to be given regularly. Be sure to keep all appointments and inform doctors if you have missed a dse .
If you stop using Pacligen
Stopping using paclitaxel may cause the effect on tumor growth to cease. Do not stop treatment with Pacligen unless you have discussed it with your doctor.
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.
Tell your doctor immediately if you notice any signs of allergic reactions. Which may include one or more of the following symptoms:
- Hot flashes
- Rash
- Itching
- Pressure over the chest
- Shortness of breath or difficulty breathing
- Swelling
These symptoms may be signs of serious side effects.
Tell your doctor immediately if you:
- have a fever, severe chills, sore throat, or sore mouth (signs of bone marrow suppression)
- have a loss of sensation or experience weakness in arms and legs (signs of peripheral neuropathy ) *
- gets severe or persistent diarrhea with fever and stomach pain
* May persist for more than six months after stopping paclitaxel use.
Very common (may affect more than 1 user in 10):
- Infection (mainly upper respiratory tract and urinary tract infection) If you have a fever or other signs of infection, tell your doctor immediately
- Respiratory distress
- Studies can show a decrease in platelets, white and red blood cells
- Fever, severe chills, headache, dizziness, tiredness, pallor, bleeding, if you get bruises more easily than normal
- Mild hypersensitivity reactions such as hot flashes, rash, and itching.
- Damage to peripheral nerves characterized by ant crawling, loss of sensation, and/or pain in arms and/or legs (symptoms of peripheral neuropathy ) *
- Low blood pressure
- Nausea, vomiting, diarrhea
- Sore throat or sore mouth, sore and red mouth
- 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 or joint pain, cramps
* 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.
- Injection site reactions (local swelling, pain, redness, hardening of tissue, sometimes cellulite, thickening of the skin (skin fibrosis), tissue death ( necrosis ))
- Investigations may show: Slow heart rate ( pulse ), severely elevated levels of liver enzymes (alkaline phosphatases and AST ) indicating impaired liver function.
Uncommon (may affect up to 1 in 100 people):
- Shock condition due to blood poisoning (known as septic shock ).
- Severe hypersensitivity reactions such as
- drop in blood pressure, swelling of the face, lips, mouth, tongue, or throat and shortness of breath, and hives; these reactions require medical treatment
- overindulge
- back pain
- chest pain
- palpitation
- abdominal pain
- pain in hands and feet
- Sweating
- Fatigue
- High blood pressure
- Inflammation in a friend
- Blood clot
- Respiratory distress
- Fast heartbeat
- Ventricular fibrillation or cessation of impulse conduction between the atria of the heart and ventricles
- Fainting
- Myocardial infarction
- Tests may show elevated levels of bilirubin (a yellow bile degradation product) in the blood (jaundice)
Rare (may affect up to 1 in 1,000 people):
- Blood poisoning ( sepsis )
- Peritonitis
- Decreased number of white blood cell types with fever increased risk of infection (febrile neutropenia)
- Life-threatening allergic reaction ( anaphylactic reaction )
- Effects on nerves that control the muscles, with muscle weakness in the arms and legs as a result (motor neuropathy )
- Shortness of breath, blood clots in the lungs, pulmonary fibrosis, interstitial pneumonia, shortness of breath, pleural effusion
- Armored
- Holes in the intestine
- Inflammation of the colon (ischemic colitis )
- Inflammation of the pancreas ( pancreatitis )
- Itching, rash, redness ( erythema )
- The elevated level of creatinine in the blood, may indicate impaired renal function
- Impact on the nerves with the feeling of muscle weakness in arms and legs
- Fever, dehydration, weakness, fluid swelling, malaise
- Heart problems that can cause shortness of breath or swollen ankles
Very rare (may affect up to 1 in 10,000 people) :
- Sudden disturbance in the blood-forming cells ( acute leukemia, myelodysplastic syndrome ).
- Life-threatening allergic reaction with shock (anaphylactic shock )
- Loss of appetite ( anorexia )
- Confusion state
- Visual disturbance and/or visual disturbances (fibrillation scotoma)
- Hearing loss or hearing loss (ototoxicity), tinnitus, dizziness
- Irregular, rapid heartbeat ( atrial fibrillation, supraventricular tachycardia )
- Blood clots (thrombosis) in the blood vessels of the abdominal cavity and intestines
- Inflammation of the colon, sometimes with persistent, severe diarrhea (pseudomembranous colitis, neutropenic colitis ), accumulation of fluid in the abdomen ( ascites ), inflammation of the esophagus, constipation.
- Failure of liver function (tissue death in the liver, effects on the brain due to impaired liver function) Fatal cases were reported for both conditions
- Severe allergic reactions include fever, skin redness, joint pain and/or inflammation of the eyes ( Stevens-Johnson syndrome ), localized skin redness ( epidermal necrolysis ), redness with irregular red (fluid-filled) spots (erythema multiforme), skin inflammation with blisters and flaking skin (exfoliative dermatitis ), hives, nail solution (hands and feet should be protected from sunlight during treatment)
Has been reported (may occur in an unknown number of users) :
- Tumor light syndrome that caused:
- High levels of potassium in the blood, can cause abnormal heart rhythm (hyperkalemia),
- Skeletal muscle spasm ( tetany ), seizures, developmental disorders, movement disorders, emotional instability/anxiety/worry, pain or weakness in muscles (hypocalcemia)
- Fatigue, loss of appetite, headache, accumulation of fluid in arms, legs, and lungs ( kidney failure )
- Swelling in the back of the eye (macular edema) that has distorted the central visual field
- Photopsia that caused perceived flashes in the field of view.
- Vitreous clouding appears as spots, threads, or fragments of cobwebs that slowly flow past the observer’s eyes.
- Inflammation in a friend ( phlebitis )
- Symmetrical thickening of the skin ( scleroderma )
- Systemic lupus erythematosus has caused fever, malaise, joint pain, muscle aches, fatigue, and temporary loss of cognitive ability.
- 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 skin flaking.
How to store Pacligen
Keep this medicine out of the sight and reach of children.
Keep the vial (s) in the outer carton. Sensitive to light. No special temperature instructions.
Do not use this medicine after the expiry date which is stated on the carton and vial 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.
6. Contents of the pack and other information
Content declaration
- The active substance is paclitaxel. One milliliter of concentrate contains 6 mg of paclitaxel.One 5 ml vial contains 30 mg paclitaxelOne 16.7 ml vial contains 100 mg paclitaxelOne 25 ml vial contains 150 mg paclitaxelOne 50 ml vial contains 300 mg paclitaxelOne 100 ml vial contains 600 mg paclitaxel
- The other ingredients are anhydrous ethanol (alcohol) and polyoxyethylated castor oil (macrogol glycerol castinoleate).
What the medicine looks like and the contents of the pack
Pacligen is a clear, colorless to pale yellow, viscous solution in colorless vials (type I glass) with fluoropolymer-coated halo butyl rubber stopper and corrugated aluminum capsule.
Each vial contains 30 mg, 100 mg, 150 mg, 300 mg or 600 mg of paclitaxel.
Pacligen is available in packs of 1, 5, 10, 20 vials. Pack sizes of 1 vial, 5 vials, and 10 vials are supplied with or without plastic protection (Onco-Safe or protective foil) in a carton. Once-Safe and protective foil are not in contact with the medicine and provide increased safety during transport, which increases the safety of pharmacy and healthcare staff.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen, Denmark
Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
or
Lek Pharmaceuticals dd, Verovskova 57, 1526 Ljubljana, Slovenia
or
Ebewe Pharma Ges.mbH Nfg. KG, Mondseestrasse 11, 4866 Unterach, Austria
or
Fareva Unterach GmbH, Mondseestrasse 11, 4866 Unterach, Austria