5 mg / ml powder for solution for infusion , dispersion
paclitaxel
What Pazenir is and what it is used for
What Pazenir is
The active substance in Pazenir is paclitaxel. Paclitaxel is bound to the human protein et albumin in the form of very small particles called nanoparticles. Paclitaxel belongs to a group of medicines called “taxanes” and is used to treat cancer.
- Paclitaxel is the part of medicine that affects cancer. It works by preventing cancer cells from dividing, which means they die.
- Albumin is the part of the drug that helps paclitaxel to dissolve in the blood, pass through the walls of blood vessels, and penetrate the tumor. This means that other chemical substances that can cause side effects that can be life-threatening are not needed. Such side effects occur to a much lesser extent with Pazenir.
What Pazenir is used for
Pazenir is used to treat the following types of cancer:
Breast cancer
- Breast cancer has spread to other parts of the body (this is called “metastatic” breast cancer).
- Pazenir is used in metastatic breast cancer when at least one other treatment has been tried but has not worked, and when treatments with a group of medicines called ‘anthracyclines’ are not appropriate.
- People with metastatic breast cancer who received paclitaxel bound to the human protein et albumin when another treatment did not work had a greater reduction in tumor size and lived longer than people who received another treatment.
Pancreatic cancer
- Pazenir is used with a medicine called gemcitabine if you have metastatic pancreatic cancer (pancreatic cancer has spread to other parts of the body). People with metastatic pancreatic cancer who received Pazenir with gemcitabine in a clinical trial lived longer than those who received gemcitabine alone.
Lung cancer
- Pazenir is also used with a medicine called carboplatin if you have the most common type of lung cancer, called ‘non-small cell lung cancer’.
- Pazenir is used in non-small cell lung cancer when surgery or radiation therapy is not appropriate to treat the disease.
What you need to know before using Pazenir
Do not use Pazenir
- if you are allergic (hypersensitive) to paclitaxel or any of the other ingredients of Pazenir (listed in section 6).
- if you are breastfeeding.
- if you have a low white blood cell count (neutrophil count <1.5 x 10 9 / l before treatment – your doctor will tell you).
Warnings and cautions
Talk to your doctor or nurse before using Pazenir
- if you have poor kidney function.
- if you have severe liver problems.
- if you have heart problems.
Talk to your doctor or nurse if you experience any of these symptoms during treatment with Pazenir, as treatment may need to be stopped or a dose reduced:
- if you get abnormal bruising, bleeding, or signs of infection such as a sore throat or fever
- if you experience numbness, tingling or tingling, are sensitive to touch, or have muscle weakness
- if you experience breathing problems, e.g. shortness of breath or dry cough.
Children and young people
This medicine is for adults only and should not be taken by children and adolescents under 18 years of age.
Other medicines and Pazenir
Tell your doctor if you are taking or have recently taken any other medicines. This also applies to over-the-counter ones, including herbal preparations. This is because Pazenir may affect the effectiveness of other medicines. In addition, other medicines may affect the effect of Pazenir.
Be careful and talk to your doctor while taking Pazenir while taking any of the following:
- medicines to treat your infections (ie antibiotics such as erythromycin and rifampicin; ask your doctor, nurse, or pharmacist if you are not sure if the medicine you are taking is an antibiotic ) and medicines to treat fungal infections (eg ketoconazole )
- drugs used to help stabilize your mood, also called antidepressants (eg fluoxetine )
- medicines used to treat seizures ( epilepsy ) (eg carbamazepine and phenytoin )
- medicines used to lower blood lipid levels (eg gemfibrozil)
- medicines used to treat heartburn or stomach ulcers (eg cimetidine)
- medicines used to treat HIV and AIDS (eg ritonavir, saquinavir, indinavir, nelfinavir, efavirenz and nevirapine)
- a drug called clopidogrel used to prevent blood clots.
Pregnancy, breastfeeding, and fertility
Paclitaxel can cause serious birth defects and should therefore not be used if you are pregnant. Your doctor will make sure that you have to leave a pregnancy test before starting treatment with Pazenir.
If you are a woman of childbearing potential, you should use effective contraception during and up to one month after being treated with Pazenir.
You should not breastfeed while taking Pazenir as it is unknown if the active substance paclitaxel passes into breast milk.
If you are a man, you should not try to have children during and up to six months after treatment. Male patients may also consult sperm preservation before treatment, as treatment with Pazenir may lead to irreversible infertility.
Talk to your doctor before taking this medicine.
Driving and using machines
Some people may feel tired or dizzy after receiving Pazenir. If this happens to you, do not drive, use any tools or machines.
If you are taking any other medicines as part of your treatment, you should consult your doctor about driving and using machines.
Pazenir contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per vial, ie essentially ‘sodium-free’.
How to use Pazenir
If you stop using Pazenir
Pazenir is given to you by a doctor or nurse with an intravenous drip into a vein. The dose you receive is based on your body surface area and your blood test results. The usual dose for breast cancer is 260 mg / m 2 body surface area given for 30 minutes. The usual dose for advanced pancreatic cancer is 125 mg / m 2 body surface area given for 30 minutes. The usual dose for non-small cell lung cancer is 100 mg / m 2 body surface area given over 30 minutes.
How often will you receive Pazenir?
For the treatment of metastatic breast cancer, Pazenir is usually given once every three weeks (on day 1 of a 21-day cycle).
For the treatment of advanced pancreatic cancer, Pazenir is given on days 1, 8, and 15 of each 28-day cycle and gemcitabine is given immediately after Pazenir.
In the treatment of non-small cell lung cancer, Pazenir is given once a week (ie days 1, 8, and 15 in a 21-day cycle), and carboplatin is given once every three weeks (ie only day 1 in each 21-day cycle) immediately after Pazenir‑ dose one has been given.
If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 user in 10):
- Hair loss (most cases occurred within one month of starting paclitaxel treatment. When it does occur, hair loss is pronounced [over 50%] in most patients)
- Rash
- An abnormal decrease in the number of different types of white blood cells ( neutrophils, lymphocytes, or leukocytes ) in the blood
- Lack of red blood cells
- Reduction in the number of platelets in the blood
- Effects on peripheral nerves (pain, numbness, tingling, or loss of sensation)
- Pain in a joint or joints
- Muscle pain
- Nausea, diarrhea, constipation, soreness in the mouth, loss of appetite
- Vomiting
- Weakness and fatigue, fever
- Dehydration, taste changes, weight loss
- Low levels of potassium in the blood
- Depression, sleep problems
- Headache
- Overindulge
- Hard to breathe
- Dizziness
- Swollen mucous membranes and soft parts
- Elevated liver function tests
- Pain in arms and legs
- Cough
- Stomach pain
- Nosebleed
Common (may affect up to 1 in 10 people):
- Itching, dry skin, nail problems
- Infection, fever with decreased number of white blood cell types ( neutrophils ) in the blood, redness, cold sores, severe infection in the blood that can be caused by the decreased number of white blood cells
- Reduced number of all blood cells
- Chest or neck pain
- Indigestion, feeling of discomfort in the abdomen
- Nasal congestion
- Back pain, skeletal pain
- Decreased muscle coordination and difficulty reading, increased or decreased tear formation, eyelash waste
- Changes in heart rate or heart rate, heart failure
- Lowered or increased blood pressure
- Redness or swelling at the place where the needle was inserted into the body
- Anxiety
- Infection of the lungs
- Urinary tract infection
- Intestinal obstruction, inflammation of the colon, inflammation of the bile ducts
- Acute renal failure
- Increased level of bilirubin in the blood
- Coughing up of blood
- Dry mouth, difficulty swallowing
- Muscle weakness
- Dimsyn
Uncommon ( may affect up to 1 in 100 people):
- Increased weight, increased level of lactate dehydrogenase in the blood, decreased kidney function, increased blood sugar, increased level of phosphorus in the blood
- Impaired reflexes or lack of reflexes, involuntary movements, pain along a nerve, fainting, dizziness when getting up, tremors, facial paralysis
- Irritated eyes, aching eyes, red eyes, itchy eyes, double vision, impaired vision or seeing flashing light, blurred vision due to swelling of the retina (cystoid macular edema)
- Ear pain, ringing in the ears
- Cough with mucus, shortness of breath when walking or walking upstairs, runny nose or dry nose, decreased breathing noise, water in the lungs, loss of voice, blood clot in the lung, dryness in the throat
- Gases, stomach cramps, painful or sore gums, rectal bleeding
- Pain when urinating, frequent urination, blood in the urine, inability to hold urine
- Fingernail pain, fingernail discomfort, loss of fingernails, hives, skin pain, red skin if exposed to sunlight, skin discoloration, increased sweating, night sweats, white areas on the skin, sores, swollen face
- Decreased level of phosphorus in the blood, accumulation of fluid in the body, low albumin value in the blood, increased thirst, decreased level of calcium in the blood, decreased blood sugar, decreased level of sodium in the blood
- Pain and swelling in the nose, skin infections, infection due to catheter tubing
- Bruises
- Tumor pain, tumor necrosis (tumor tissue dies)
- Reduced blood pressure when standing up, cold hands and feet
- Difficulty walking, swelling
- Allergic reaction
- Decreased liver function, increased size of the liver
- Chest pain
- Restlessness
- Minor bleeding in the skin due to blood clotting
- A condition that involves the breakdown of red blood cells and acute renal failure
Rare (may affect up to 1 in 1,000 people):
- Skin reaction to another agent or pneumonia after irradiation
- Blood clotting
- Very low heart rate, heart attack
- Leakage of drugs outside the vein
- Irregular conduction of electrical impulses in the heart (atrioventricular block)
Very rare ( may affect up to 1 in 10,000 people):
- Severe inflammation/shedding of skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis )
No known frequency (can not be calculated from the available data):
- Hardening/thickening of the skin ( scleroderma )
How to store Pazenir
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 after EXP. day. or EXP. The expiration date is the last day of the specified month.
Unopened vials: Keep the vial in the outer carton until ready to use. Sensitive to light.
After the first preparation, the dispersion should be used immediately. If the dispersion is not used immediately, it can be stored in a refrigerator (2 ° C-8 ° C) for up to 24 hours in a vial, provided that the vial is in the outer carton to protect it from light.
Prepared dispersion in an infusion bag can be stored for up to 24 hours at 2 ° C – 8 ° C, protected from light, followed by 4 hours at 15 ° C – 25 ° C.
Physicians or pharmacists are responsible for disposing of unused Pazenir properly.
Contents of the pack and other information
Content declaration
The active substance is paclitaxel.
Each vial contains 100 mg of paclitaxel in the form of albumin-bound nanoparticles.
After reconstitution, each ml of dispersion contains 5 mg of paclitaxel in the form of albumin-bound nanoparticles.
The other ingredients are human albumin (containing sodium, sodium caprylate, and N-acetyl-DL-tryptophanate, see section 2 “Pazenir contains sodium”).
What the medicine looks like and the contents of the pack
Pazenir is a white-yellow powder for infusion and dispersion. Pazenir is supplied in glass vials containing 100 mg paclitaxel in the form of albumin-bound nanoparticles.
Each pack contains 1 vial.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm
Germany
Manufacturer
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany
Pharmachemie BV
Swensweg 5
Haarlem
2031 GA
Netherlands
Teva Pharma BV
Swensweg 5
2031 GA Haarlem
Netherlands
Teva Nederland BV
Swensweg 5
2031 GA Haarlem
Netherlands
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienTeva Pharma Belgium NV / SA / AGTel / Tel: +32 3 820 73 73 | LithuaniaUAB “Sicor Biotech”Tel: +370 5 266 02 03 |
| BulgariaActavis EADTel: +359 2 489 95 85 | Luxembourg / LuxemburgTeva Pharma Belgium NV / SA / AG,Tel: +32 3 820 73 73 |
| Czech RepublicTeva Pharmaceuticals CR, sroTel: +420 251 007 111 | HungaryTeva Gyógyszergyár Zrt.Tel .: +36 1 288 6400 |
| DenmarkTeva Denmark A / STel: +45 44 98 55 11 | MaltaTeva Pharmaceuticals Ireland, L-Ireland:El: +353 (0) 1912 7700 |
| Germanyratiopharm GmbHTel: +49 731 402 02 | The NetherlandsTeva Nederland BVTel: +31 (0) 800 0228400 |
| EestiUAB Sicor Biotech Eesti subsidiaryTel: +372 661 0801 | NorwayTeva Norway ASTel: +47 66 77 55 90 |
| GreeceSpecify ΑΒΕΕ:Ηλ: +30 211 880 5000 | Austriaratiopharm Arzneimittel Vertriebs-GmbHTel: +43 1 970070 |
| SpainTeva Pharma, SLUTel: +34 91 387 32 80 | PolandTeva Pharmaceuticals Polska Sp. z ooTel .: +48 22 345 93 00 |
| FranceTeva HealthTel: +33 1 55 91 78 00 | PortugalTeva Pharma – Pharmaceutical Products LdaTel: +351 214 767 550 |
| CroatiaPliva Hrvatska dooTel: + 385 1 37 20 000 | RomaniaTeva Pharmaceuticals SRLTel: +40 21 230 65 24 |
| IrelandTeva Pharmaceuticals IrelandTel: +353 (0) 1912 7700 | SloveniaPliva Ljubljana dooTel: +386 1 58 90 390 |
| IcelandActavis Pharmaceutical Iceland ehf.Phone: + 354 550 3300 | Slovak RepublicTeva Pharmaceuticals Slovakia sroTel: +421 2 5726 7911 |
| ItalyTeva Italia SrlTel: +39 0289 17981 | Finland / Finlandratiopharm OyPuh / Tel: +358 20 180 5900 |
| .ΠροςSpecify ΑΒΕΕ, Greece:Ηλ: +30 211 880 5000 | SwedenTeva Sweden ABTel: +46 42 12 11 00 |
| LatviaUAB Sicor Biotech subsidiary LatvijāTel: +371 67 323 666 | United KingdomTeva UK LimitedTel: +44 1977 628 500 |