5 mg / ml concentrate for solution for infusion
Oxaliplatin
WHAT OXALIPLATIN ACCORD IS AND WHAT IT IS USED FOR
This medicine is called Oxaliplatin Accord 5 mg/ml concentrate for solution for infusion, but in the rest of the package leaflet, it is called Oxaliplatin Accord.
The active substance in Oxaliplatin Accord is oxaliplatin.
Oxaliplatin Accord is used to treat cancer of the colon (treatment of stage III colon cancer after the entire original tumor has been removed and treatment of metastatic cancer of the colon and rectum). Oxaliplatin Accord is used in combination with other anticancer medicines, called 5-fluorouracil (5-FU) and folic acid (FA).
Oxaliplatin Accord must be diluted before being injected into a blood vessel (a vein). Oxaliplatin Accord is an antineoplastic drug, ie a cancer drug, which contains platinum.
Oxaliplatin contained in Oxaliplatin Accord may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before using Oxaliplatin Accord
You should not use Oxaliplatin Accord:
- if you are allergic to oxaliplatin or any of the other ingredients of this medicine (listed in section 6)
- if you are breast-feeding
- if you already have a reduced number of red blood cells ,
- if you already have tingling and numbness in your fingers and / or toes and have difficulty performing movements that require precision, such as to press buttons
- if you have severe kidney problems.
Warnings and cautions
Talk to your doctor or pharmacist before using Oxaliplatin Accord
- if you have ever had an allergic reaction to medicines containing platinum, e.g. carboplatin or cisplatin; allergic reactions may occur with infusion of oxaliplatin
- if you have moderate or mild kidney problems
- if you have any form of liver problems or abnormal results on liver function tests during treatment
- if you have or have had heart problems, such as abnormal electrical signals called prolonged QT interval, irregular heartbeat, or family heart problems.
Children
Oxaliplatin should not be used in children and adolescents under 18 years of age.
Other medicines and Oxaliplatin Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
- 5-fluorouracil (an anti-cancer drug)
- Erythromycin (an antibiotic )
- Salicylates (an analgesic)
- Granisetron (an anti-nausea medicine)
- Paclitaxel (an anticancer medicine)
- Sodium valproate (a medicine used to treat epilepsy )
Pregnancy, breastfeeding, and fertility
Pregnancy
- You should not become pregnant during treatment with oxaliplatin and must use an effective contraceptive. Female patients should use appropriate contraception during treatment and for 4 months after stopping treatment.
- If you are pregnant or planning to have a baby, it is important to consult a doctor before taking this medicine.
- If you become pregnant during treatment, you must contact a doctor immediately.
Breast-feeding
- You should not breast-feed during treatment with oxaliplatin.
Fertility
- Oxaliplatin may impair fertility and this effect may be permanent. Male patients should be informed about the possibilities of preserving semen before treatment.
- Male patients are advised not to have children during treatment and up to 6 months after stopping treatment and to use appropriate contraception during this time.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Treatment with oxaliplatin can cause dizziness, nausea, and vomiting as well as other neurological symptoms that can affect gait and balance. Do not drive or use machines if this happens to you. You should also not drive, use heavy machinery or engage in dangerous activities if you experience vision problems during treatment with Oxaliplatin Accord.
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
How to use Oxaliplatin Accord
Oxaliplatin Accord should only be used by adults.
For single use only.
Dose
Dosage one of Oxaliplatin Accord depends on your body surface area and is calculated based on your height and weight.
The usual dose for adults (even the elderly) is 85 mg / m 2 body surface area. The dose you receive also depends on blood test results and whether you have had any side effects from previous oxaliplatin treatment.
Methods of administration and routes of administration
- Oxaliplatin Accord is prescribed by a cancer treatment specialist.
- You will be treated by healthcare professionals who have prepared the necessary dose of Oxaliplatin Accord.
- Oxaliplatin Accord is given as a slow drip into a vein ( intravenous infusion ) for 2-6 hours.
- Oxaliplatin Accord is given concomitantly with folic acid and before infusion of 5-fluorouracil.
How often you are given the medicine
You will usually be given an infusion every two weeks.
How long does the treatment last
Your doctor will decide how long the treatment should last.
If your original tumor has been removed, the treatment will last for a maximum of 6 months.
If you take more Oxaliplatin Accord than you should
The medicine is given by healthcare professionals and it is very unlikely that you will receive too much or too little medicine.
If overdose nevertheless occurs, you may experience more and more severe side effects. Your doctor may give you appropriate treatment for the side effects.
If you have any further questions on the use of this product, ask your doctor, healthcare professional, or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effects, you must tell your doctor before the next treatment.
You may experience any of the side effects listed below.
The most serious side effects
Contact a doctor immediately if you get any of the following symptoms:
Very common (may affect more than 1 user in 10):
- Allergies / allergic reactions, occur mainly during infusion one, sometimes with fatal outcome.
- Sore lips or sores in the mouth ( stomatitis or mucositis ).
- Low platelet count , abnormal bruising (thromocytopenia). Your doctor will take blood samples to check that you have a sufficient amount of blood cells before starting treatment and before each treatment cycle.
- Unexplained respiratory problems such as dry cough, difficulty breathing or wheezing.
Common (may affect up to 1 in 10 people):
- Serious infection in the blood in combination with a decrease in the number of white blood cells ( neutropenic sepsis ) which can be fatal.
- Decreased white blood cell count accompanied by fever above 38.3 ° C or prolonged fever above 38 ° C for more than one hour (febrile neutropenia ).
- Symptoms of an allergic or anaphylactic reaction with sudden signs such as rash, itching or hives on the skin, difficulty swallowing, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty breathing, extreme fatigue (it may feel like that you will faint). In most cases, these symptoms occur during infusion one or immediately after, but delayed allergic reactions have also been observed hours or even days after infusion one.
- Pain in the chest or upper back, difficulty breathing and coughing up blood (signs of blood clot in the lung).
Uncommon (may affect up to 1 in 100 people):
- Serious infection in the blood ( sepsis ), which can be fatal.
- Stopping or swelling in the intestine
- Difficulty hearing, dizziness, ringing in the ears.
Rare (may affect up to 1 in 1,000 people):
- Unexpected bleeding or bruising due to extensive blood clots in the body’s small blood vessels (disseminated intravascular coagulation ), which can be fatal.
- Abnormal bruising, bleeding or signs of infection such as sore throat and fever.
- Persistent or severe diarrhea or vomiting.
- Transient temporary loss of vision
- A group of symptoms such as headache, altered mental functions, seizures and visual disturbances from blurring to loss of vision (symptoms of reversible posterior leukoencephalopathy syndrome, an unusual neurological disease).
- Extreme fatigue with decreased red blood cell count and shortness of breath ( haemolytic anemia ), alone or together with low platelet counts , abnormal bruising ( thrombocytopenia ) and kidney disease that means you urinate little or not at all (symptoms of haemolytic uremic syndrome ).
- Scarring and thickening of the lungs with difficulty breathing, sometimes with fatal outcome (interstitial lung disease).
- Upper abdominal pain and back pain along with nausea and vomiting.
Very rare (may affect up to 1 in 10,000 people):
- Kidney disease which means that you urinate a little or not at all (symptoms of acute kidney failure ).
- Disease of the blood vessels of the liver (symptoms that include abdominal pain and swelling, weight gain and swelling of the feet, ankles or other parts of the body).
Has been reported (occurs in an unknown number of users):
- Severe infection in the blood and low blood pressure ( septic shock ), which can be fatal.
- Abnormal heart rhythm ( QT prolongation) that can be seen on electrocardiograms ( ECG ), which can be fatal.
- Muscle pain and swelling, in combination with weakness, fever or red ‑ brown urine (symptoms of muscle damage called rhabdomyolysis ), which can be fatal.
- Abdominal pain, nausea, bloody vomiting or vomiting that looks like “coffee grounds” or dark, tar-like stools (symptoms of ulcers in the gastrointestinal tract, with the risk of bleeding or perforation ), which can be fatal.
- Decreased blood flow to the intestines (intestinal ischemia), which can be fatal.
- Spasm of the throat leading to difficulty breathing.
- Autoimmune reaction leading to decreased number of all types of blood cells ( autoimmune pancytopenia) (with symptoms such as easy bleeding, bruising, shortness of breath, extreme fatigue and weakness and increased risk of infection due to impaired immune status).
- Symptoms of stroke (including severe headache, confusion, visual difficulties in one or both eyes, numbness or weakness of face, arm or leg, usually unilateral, drooping face, difficulty walking, dizziness, loss of balance and difficulty speaking).
- Pneumonia (severe pneumonia ) which can be fatal
Other known side effects of Oxaliplatin Accord are:
Very common (may affect more than 1 user in 10):
- Oxaliplatin Accord may affect the nervous system ( peripheral neuropathy ) and you may experience tingling and / or numbness in the fingers, toes, around the mouth or in the throat. These symptoms can sometimes occur along with seizures.These side effects are often triggered by cold such as. when opening the refrigerator or holding a cold beverage. You may also find it difficult to perform fine motor tasks such as pushing buttons. In most cases, the symptoms subside completely by themselves, but there is a risk of persistent symptoms of this nerve disorder after the end of treatment. Some people experience a stinging, shock-like sensation that moves down the arms or torso when bending the neck.
- Oxaliplatin Accord can sometimes give rise to an unpleasant sensation in the throat, especially when swallowing and give a feeling of shortness of breath. If this feeling occurs, it usually occurs during or within a few hours after infusion one and can be triggered by cold. Although the feeling is unpleasant, it does not last long and disappears without treatment. The doctor may decide to change the treatment as a result.
- Oxaliplatin Accord may cause diarrhea, mild nausea and vomiting. However, you are usually given medicines that prevent nausea before the treatment and possibly also after the treatment.
- Oxaliplatin Accord causes a temporary decrease in the amount of blood cells . The decrease in the amount of red blood cells can cause anemia ( anemia ), abnormal bleeding or bruising (due to a reduced amount of platelets ). Reducing the amount of white blood cells can make you more susceptible to infection . Before starting treatment, and at each subsequent treatment, blood samples are taken to check that you have a sufficient number of blood cells .
- A feeling of discomfort near or at the injection site during infusion .
- Fever, tremors, mild or severe fatigue, body aches.
- Weight changes, loss of appetite, taste changes, constipation.
- Headache, back pain.
- Abnormal sensation in the tongue that can give rise to speech changes.
- Abdominal pain.
- Abnormal bleeding such as nosebleeds.
- Allergic reactions, skin rash that may be red and itchy, mild hair loss ( alopecia ).
- Altered blood counts, including abnormal liver function values.
Common (may affect up to 1 in 10 people):
- Indigestion and heartburn, hiccups, hot flashes, dizziness.
- Increased sweating and nail problems, scaly skin.
- Chest pain.
- Pulmonary problems and runny nose.
- Pain in joints and skeleton.
- Pain when urinating and altered liver function, changes in urination frequency, dehydration.
- Blood in urine or feces, swollen blood vessels, blood clots in the lung.
- High blood pressure .
- Depression and difficulty sleeping.
- Inflammation of the conjunctiva of the eye ( conjunctivitis ) and visual problems.
- Decreased calcium levels in the blood.
- Swelling of the nerves to your muscles, neck stiffness
- Fall accident.
Uncommon (may affect up to 1 in 100 people):
- Nervousness.
Rare (may affect up to 1 in 1,000 people):
- Impaired hearing.
Has been reported (occurs in an unknown number of users):
- Allergic vasculitis ( inflammation of blood vessels).
- Cramps (uncontrolled shaking of the body).
- Myocardial infarction, angina pectoris (pain or discomfort in the chest).
- Esophagitis ( inflammation (angina) in the esophagus – the tube that connects your mouth to the stomach – which leads to pain and difficulty swallowing).
- Risk of new cancer. Leukemia , a form of blood cancer, has been reported in patients following the use of Oxaliplatin Accord in combination with certain other medicines. Talk to your doctor about the increased risk of this type of cancer when using Oxaliplatin Accord and some other medicines.
How to store Oxaliplatin Accord
Keep out of sight and reach of children.
Keep the vial in the outer carton. Sensitive to light. Do not freeze.
Do not use this medicine after the expiry date which is stated on the outer carton and vial label after EXP. The expiration date is the last day of a specified month.
Chemical and physical in-use stability has been demonstrated for 48 hours at +2 to + 8 ° C and for 24 hours at + 25 ° C. From a microbiological perspective, the infusion preparation should be used immediately. If the reconstituted product is not used immediately, the user is responsible for the storage time and storage conditions before use. Normally the product should not be stored for longer than 24 hours at +2 to + 8 ° C, unless diluted under controlled and validated aseptic conditions.
Only clear solutions without particles should be used.
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.
Avoid contact with eyes and skin. In case of splashes or spills, contact a doctor or healthcare professional immediately.
After completion of the infusion, doctors or healthcare professionals will discard the medicine by taking appropriate precautions.
Contents of the package and other information
Content declaration
The active substance is oxaliplatin.
Other ingredients are water for injections.
What the medicine looks like and contents of the pack
1 ml concentrate for solution for infusion contains 5 mg oxaliplatin.
Oxaliplatin Accord is a clear, colorless liquid, with no visible particles.
Each carton contains one vial.
10 ml concentrate for solution for infusion contains 50 mg oxaliplatin.
20 ml concentrate for solution for infusion contains 100 mg oxaliplatin.
40 ml concentrate for solution for infusion contains 200 mg oxaliplatin.
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 HA1 4HF, United Kingdom
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland
Accord Healthcare BV
Winthontlaan 200
3526 kV Utrecht
Netherlands