Oxaliplatin 5mg/Ml Concentrate For Solution For Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
Oxaliplatin Hikma, 5mg/ml Concentrate for solution for infusion
Oxaliplatin
Read all of this leaflet carefully before you start taking this medicine.
1. Keep this leaflet. You may need to read it again.
2. If you have any further questions, ask your doctor or pharmacist.
3. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Oxaliplatin Hikma, 5mg/ml Concentrate for solution for infusion, is and what it is used for
2. Before you are given Oxaliplatin Hikma, 5mg/ml Concentrate for solution, for infusion
3. How you are given Oxaliplatin Hikma, 5mg/ml Concentrate for solution, for infusion
4. Possible side effects
5. How to store Oxaliplatin Hikma, 5mg/ml Concentrate for solution for infusion
6. Further information
1. WHAT OXALIPLATIN HIKMA, 5MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION, IS AND WHAT IT IS USED FOR
The active ingredient of Oxaliplatin Hikma, 5mg/ml Concentrate for solution for infusion, is oxaliplatin.
It is used to treat cancer of the large bowel (metastatic cancer of colon and rectum). Oxaliplatin is used in combination with other anticancer medicines called 5-fluorouracil and folinic acid.
Oxaliplatin Hikma, 5mg/ml Concentrate for solution for infusion, has to be diluted before it can be injected into a vein.
Oxaliplatin is an antineoplastic or anticancer drug and contains platinum.
2. BEFORE YOU ARE GIVEN OXALIPLATIN HIKMA, 5MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Do not use Oxaliplatin Hikma, 5mg/ml Concentrate for solution for infusion
- if you are allergic (hypersensitive) to oxaliplatin or any of the other ingredients of the product
- if you are breast-feeding
- if you already have a reduced number of blood cells
- if you already have tingling and numbness in the fingers and/or toes, and have difficulty performing delicate tasks, such as buttoning clothes or lacing up shoes
- if you have severe kidney problems (creatinine clearance below 30 ml/min)
- If any of these apply to you and you have not already discussed this with your doctor or nurse, you should do so as soon as possible and before the first administration of the preparation.
Take special care with Oxaliplatin Hikma, 5mg/ml Concentrate for solution for infusion if you
- are pregnant or planning to become pregnant
- have ever suffered an allergic reaction to platinum-containing medicines such as carboplatin or cisplatin
- have moderate kidney problems
- have any liver problems
- experience numbness or tingling in your fingers or toes or difficulty in swallowing.
If any of these apply to you and you have not already discussed this with your doctor or nurse, you should do so as soon as possible and before the first administration of the product.
Your doctor or nurse will administer this medicine and will carefully and frequently monitor you during and after the treatment, including taking blood tests before each administration of the product. Before and after treatment you will be given a neurological examination. This monitoring is necessary to see how your body is responding to the medicine and to prevent possible unwanted side effects that can occur. On the basis of the test results, your doctor may decide to discontinue your medication or to change your treatment accordingly.
If you experience swelling or pain around the area where your infusion has been given, inform your doctor or nurse immediately.
If you experience breathing problems or a cough inform your doctor or nurse immediately.
If you experience sore lips or mouth ulcers inform your doctor or nurse immediately.
Oxaliplatin should not come into contact with the eyes or skin. If there is any accidental spillage, tell the doctor or nurse immediately.
During oxaliplatin treatment, feeling or being sick can occur. Therefore, your doctor can administer sickness reducing preparations, to stop this happening or to treat it.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Currently, no information is available on the safety of this medicine during its administration in the course of pregnancy. In animal studies, a negative effect was seen on the foetus. You must not use oxaliplatin during pregnancy unless clearly indicated by your doctor.
You must not become pregnant during treatment with oxaliplatin and must use an effective method of contraception. If you get pregnant during your treatment, you must immediately inform your doctor. You should take appropriate contraceptive measures during and after cessation of therapy continuing for 4 months for women and 6 months for men.
Oxaliplatin may have an anti-fertility effect, which could be irreversible. Male patients are therefore advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment.
You must not breast-feed while you are treated with oxaliplatin.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Oxaliplatin may result in an increased risk of dizziness, feeling or being sick and other neurological symptoms that affect your gait and balance. Do not drive or use machines if you are suffering from these side-effects.
3. HOW YOU ARE GIVEN OXALIPLATIN HIKMA, 5MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Oxaliplatin Hikma, 5mg/ml Concentrate for solution for infusion, is intended only for adults.
Dosage:
The dose of oxaliplatin is based on your body surface area. This is calculated from your height and weight.
The usual dose for adults including the elderly is 85 mg/m2 of body surface area. The dose you receive will also depend on results of blood tests and whether you have previously experienced side effects with oxaliplatin.
Method and route of administration:
Oxaliplatin will be prescribed for you by a specialist in cancer treatment.
You will be treated by a healthcare professional, who will have made up the required dose of oxaliplatin. It is administered by slow injection into a vein (as an intravenous infusion) over a 2 to 6 hour period.
The injection is made by diluting the solution in 5% glucose solution.
Oxaliplatin Hikma, 5mg/ml Concentrate for solution for infusion, will be given to you at the same time as folinic acid and before the infusion of 5-fluorouracil.
Frequency of administration:
Oxaliplatin Hikma, 5mg/ml Concentrate for solution for infusion, will be administered once every 2 weeks. Duration of treatment:
The duration of the treatment will be determined by your doctor.
If you receive more Oxaliplatin Hikma, 5mg/ml Concentrate for solution for infusion, than you should
As this medicine is administered by a healthcare professional it is highly unlikely that you will receive too much oxaliplatin. Your doctor will ensure that the correct dose for your condition is given. In case of overdose, you may experience increased side effects. Your doctor may give you appropriate treatment for these side effects. If
you are worried that too much has been administered or you have any questions about the dose being given, ask
your nurse or doctor administering your medicine.
If you miss a dose of Oxaliplatin Hikma, 5mg/ml Concentrate for solution for infusion
If you think you have missed a dose please talk to your nurse or doctor in charge.
If you have any further questions on the use of this product ask your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Oxaliplatin Hikma, 5mg/ml Concentrate for solution for infusion, can cause side effects,
although not everybody gets them.
Tell your doctor or go to the nearest hospital immediately if you notice any of the following
- Abnormal bruising, bleeding, or signs of infection such as a sore throat and high temperature
- Persistent or severe diarrhoea or vomiting.
- Stomatitis/ mucositis (sore lips or mouth ulcers).
- Unexplained respiratory symptoms such as dry cough, difficulties in breathing or crackles.
- Swelling of hands, feet, ankles, face, lips, mouth or throat (which may cause difficulties in swallowing or breathing and are symptoms of angioedema).
- Sensation of discomfort close to or at the injection site during infusion.
Very common side effects (affecting a least 1 in 10 people treated)
- Allergic reactions such as skin rash (particularly raised lumps), inflammation of the conjunctiva, swelling of hands, feet, ankles, face, mouth, lips or throat which may cause difficulties in swallowing or breathing, sudden wheeziness or tightness of chest, which can make you feel like fainting.
- Reduction of red blood cells (anaemia), which makes the skin pale and causes weakness or breathlessness
- Reduction in blood platelets, which increases the risk of abnormal bleeding or bruising
- Reduction in white blood cells, which increases the risk of infections
- Fever, tremors, tiredness, lack or loss of strength or energy.
- Low potassium in blood (this can be recognized by muscle cramps, muscle weakness or fatigue).
- Abnormal sodium blood level (this can be recognized by tiredness and confusion).
- Changes in blood glucose level (this can be recognized by great thirst, dry mouth or a need to urinate more often).
- Alteration in blood tests including those relating to abnormalities in liver function.
- Increase in liver enzymes, increase in alkaline phosphatase in the blood, increase in bilirubin in the blood, increase in lactate dehydrogenase in the blood.
- Skin disorder.
- Oxaliplatin may affect the nerves (peripheral sensory neuropathy). You may experience tingling and/or numbness in the fingers, toes, around the mouth or in the throat, which may sometimes occur in association with cramps. These side effects are often triggered by the cold, e.g. at opening the refrigerator or holding a cold drink. Additionally, you can have difficulties performing delicate tasks like buttoning clothes. Although in most cases, these symptoms resolve themselves completely there is a possibility of persistent symptoms of peripheral sensory neuropathy after the end of the treatment.
- Some people have experienced a tingling, shock-like sensation passing down the arms or trunk when the neck is flexed (Lhermitte’s sign).
- Oxaliplatin can sometimes cause an unpleasant sensation in the throat, in particular when swallowing, and give the sensation of shortness of breath. This sensation, if it happens, usually occurs during or within hours of the infusion and may be triggered by exposure to the cold. Although unpleasant, it will not last long and goes away without the need for any treatment. Your doctor may decide to alter your treatment as a result.
- Headache.
- Diarrhoea.
- Nausea and vomiting (feeling or being sick). Medication to prevent the sickness is usually given to you by your doctor before treatment and may be continued after treatment.
- Ulcers in mouth, sore lips or gums.
- Abdominal pain, constipation, lack or loss of appetite.
- Weight gain.
- Back pain.
- Bleeding from nose.
- Coughing, difficulty breathing.
- Loss of hair (alopecia).
- Taste alteration.
Common side effects (affecting at least 1 in 100 people treated)
- Flushing.
- Chest pain.
- Dizziness, stiff neck, inflammation of the nerves associated with muscle weakness, difficulty with specific movements and sometimes muscle cramps (motor neuritis).
- Digestion disorders and heartburn, hiccups.
- Skin rash including red, itching, and peeling skin.
- Dehydration (lack of body liquids).
- Joint and bone pain.
- Blood in urine/faeces, vein swelling, clots in lungs.
- Depression, inability to sleep.
- Blocked or stuffy nose.
- Increased sweating, nail disorders.
- Pain when passing urine, changes in frequency of passing urine.
- Changes in kidney function (increase in blood creatinine).
- Conjunctivitis, visual disturbances.
- Weight loss.
- Infection of the respiratory tract.
- Serious condition (with fever or blood poisoning) caused by a decrease of white blood cells associated with an increased susceptibility for infections (febrile neutropenia, neutropenic sepsis).
Uncommon side effects (affecting at least 1 in 1000 people treated)
- Blockage or swelling of the bowel (usually demonstrated by abdominal pain and failure to pass wind). If you suspect a blockage or swelling of the bowel, inform the doctor immediately.
- Nervousness.
- Hearing problems (ototoxicity).
- Blood tests which show an increase in acidity (metabolic acidosis).
Rare side effects (affecting at least 1 in 10,000 people treated)
- Serious lung condition associated with shortness of breath, difficulties in breathing and/or scarring of the lungs (interstitial lung disease, pulmonary fibrosis).
- Deafness.
- Transient decrease of visual definition, abnormal visual field, decrease in eyesight caused by inflammation of the optical nerve (optical neuritis).
- Blood abnormality (short of platelets) caused by an allergic reaction associated with bruises and abnormal bleeding (immunoallergic thrombocytopenia).
- Reduction of red blood cells (anaemia) caused by too much degradation of blood (haemolytic anaemia).
- Difficulty speaking.
Very rare side effects (affecting less than 1 in 10,000 people treated)
- Liver disease that your doctor will monitor for you.
- Changes in kidney function leading to kidney failure.
Your doctor will take blood to check that you have a sufficient blood cell count before you start treatment and before each subsequent course.
If you experience any side effects, it is important to inform your doctor before the next treatment.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet please tell your doctor or nurse.
5. HOW TO STORE OXALIPLATIN HIKMA, 5MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Keep out of the reach and sight of children.
Keep the vial in the outer carton in order to protect from light.
Do not freeze.
Do not use Oxaliplatin Hikma, 5mg/ml Concentrate for solution for infusion, after the expiry date which is stated on the carton and vial after: EXP. The expiry date refers to the last day of that month.
After dilution in 5% glucose the product should be used immediately or can be stored for 48 hours at 2°C to 8°C or for 24 hours at 25°C.
Do not use Oxaliplatin Hikma, 5mg/ml Concentrate for solution for infusion, if you notice any changes in colour or unusual particles.
Medicines should not be disposed of via wastewater or household waste. Your doctor, nurse, or pharmacist will dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Oxaliplatin Hikma, 5mg/ml Concentrate for solution for infusion, contains
- The active substance is oxaliplatin. 1ml of concentrate contains 5mg of oxaliplatin.
50mg vial: Each vial contains 50mg of oxaliplatin in 10ml.
100mg vial: Each vial contains 100mg of oxaliplatin in 20ml.
200mg vial: Each vial contains 200mg of oxaliplatin in 40ml.
- The other ingredients are water for injections and gluconolactone.
What Oxaliplatin Hikma, 5mg/ml Concentrate for solution for infusion, looks like and contents of the pack
Concentrate for solution for infusion
Oxaliplatin Hikma, 5mg/ml Concentrate for solution for infusion, is a clear, colourless liquid.
Pack sizes: 1 vial containing 50mg, 100mg or 200mg of oxaliplatin in 10ml, 20ml or 40ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Hikma Farmaceutica (Portugal), S.A.
Estrada do Rio da Mo nos 8, 8A e 8B -Fervenga
2705-906 Terrugem SNT Portugal
Tel.: 21-960 84 10
Fax: 21-961 51 02
e-mail: geral@hikma.pt
Manufacturer:
PLIVA - Lachema a.s., Brno, Czech Republic
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria: Oxaliplatin Hikma, 5 mg/ml Konzentrat zur Herstellung einer Infusionslosung
Germany: Riboxatin-L, 5 mg/ml Konzentrat zur Herstellung einer Infusionslosung
Portugal: Oxaliplatina Hikma, 5mg/ml Concentrado para solugao para perfusao
Slovakia: Oxaliplatin Hikma, 5mg/ml Infuzny Koncentrat
The Netherlands: Oxaliplatine Hikma, 5 mg/ml Concentraat voor oplossing voor infusie United Kingdom: Oxaliplatin Hikma, 5mg/ml Concentrate for solution for infusion
This leaflet was last approved in 01/2010
The following information is intended for medical or healthcare professionals only:
GUIDELINES FOR THE PREPARATION AND USE OF OXALIPLATIN HIKMA, 5MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
It is important to read all of the contents of these guidelines before the preparation and use of the medicinal product Oxaliplatin Hikma, 5mg/ml Concentrate for solution for infusion.
As with other potentially toxic compounds, caution should be exercised when handling and preparing oxaliplatin solutions.
Instructions for handling
The handling of this cytotoxic agent by nursing or medical personnel requires every precaution to guarantee the protection of the handler and his surroundings.
The preparation of injectable solutions of cytotoxic agents must be carried out by trained specialist personnel with knowledge of the medicines used, in conditions that guarantee the integrity of the product, the protection of the environment and in particular the protection of the personnel handling the medicines, in accordance with the hospital policy. It requires a preparation area reserved for this purpose. It is forbidden to smoke, eat or drink in
this area.
Personnel must be provided with appropriate handling materials, notably long sleeved gowns, protection masks, caps, protective goggles, sterile single-use gloves, protective covers for the work area, containers and collection bags for waste.
Excreta and vomit must be handled with care.
Pregnant women must be warned not to handle cytotoxic agents.
Any broken container must be treated with the same precautions and considered as contaminated waste. Contaminated waste should be incinerated in suitably labelled rigid containers. See below section “Disposal”.
If oxaliplatin concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with water.
If oxaliplatin concentrate or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Special precautions for administration
- DO NOT use injection equipment containing aluminium.
- DO NOT administer undiluted.
- ONLY 5% glucose infusion solution is to be used as a diluent. DO NOT dilute for infusion with sodium chloride or chloride containing solutions.
- DO NOT mix with any other medicinal products in the same infusion bag or administer simultaneously by the same infusion line.
- DO NOT mix with alkaline medicinal products or solutions, especially 5-fluorouracil, folinic acid preparations containing trometamol as an excipient, and trometamol salts of other active substances. Alkaline medicinal products or solutions will adversely affect the stability of oxaliplatin.
Instruction for use with folinic acid (as calcium folinate or sodium folinate)
Oxaliplatin 85 mg/m2 IV infusion in 250 to 500ml of 5% glucose solution is given at the same time as folinic acid IV infusion in 5% glucose solution, over 2 to 6 hours, using a Y line placed immediately before the site of infusion.
These two medicinal products should not be combined in the same infusion bag. Folinic acid must not contain trometamol as an excipient and can only be diluted using isotonic 5% glucose solution, never in alkaline solutions or sodium chloride or chloride containing solutions.
Instruction for use with 5-fluorouracil
Oxaliplatin should always be administered before fluoropyrimidines - i.e. 5-fluorouracil.
After oxaliplatin administration, flush the line and then administer 5- fluorouracil.
For additional information on medicinal products combined with oxaliplatin, see the corresponding manufacturer’s summary of product characteristics.
Concentrate for solution for infusion
Inspect visually prior to use. Only clear solutions without particles should be used.
This medicinal product is for single use only. Any unused concentrate should be discarded.
Dilution before infusion
Withdraw the required amount of concentrate from the vial(s) and dilute with 250 to 500ml of a 5% glucose solution to give an oxaliplatin concentration between 0.2mg/ml and 0.7mg/ml.
Administer by IV infusion.
Inspect visually prior to use. Only clear solutions without particles should be used.
The medicinal product is for single use only. Any unused infusion solution should be discarded.
NEVER use sodium chloride or chloride containing solutions for dilution.
Infusion
The administration of oxaliplatin does not require prehydration.
Oxaliplatin diluted in 250 to 500 ml of a 5% glucose solution to give a concentration not less than 0.2 mg/ml must be infused either by peripheral vein or central venous line over 2 to 6 hours. When oxaliplatin is administered with 5-fluorouracil, the oxaliplatin infusion must precede the administration of 5-fluorouracil.
Disposal
Remnants of the medicinal product as well as all materials that have been used for dilution and administration must be destroyed according to hospital standard procedures applicable to cytotoxic agents and with due regard to current laws related to the disposal of hazardous waste.
Storage
Unopened vial:
Keep the vial in the outer carton in order to protect from light.
Do not freeze.
Diluted product:
After dilution in 5% glucose, chemical and physical in-use stability has been demonstrated for 48 hours at +2°C to +8°C and for 24 hours at +25°C.
From a microbiological point of view, this infusion preparation should be used immediately.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C unless dilution has taken place in controlled and validated aseptic conditions.