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OXALIPLATIN 5MG/ML POWDER FOR SOLUTION FOR INFUSION

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Oxaliplatin 5mg/ml Powder for Solution for Infusion
Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. In this leaflet: 1 What Oxaliplatin powder is and what it is used for 2 Before you use 3 How to use 4 Possible side effects 5 How to store 6 Further information
1 What Oxaliplatin powder is and what
Breast-feeding should be discontinued before starting treatment with Oxaliplatin powder. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

It is unknown whether treatment with Oxaliplatin powder affects the ability to drive and use machines. If you feel sleepy and/or dizzy or have nausea or vomiting following oxaliplatin infusion do not drive, operate potentially dangerous machinery, or engage in other activities that may be hazardous because of decreased alertness. Oxaliplatin treatment may transiently affect vision. If you have problems with vision, do not drive, operate potentially dangerous machinery, or engage in other activities that may be hazardous.

3 How to use

it is used for

Oxaliplatin powder is used to treat metastatic (advanced) cancer of the colon (large bowel) or rectum (back passage), or as additional treatment following surgery to remove a tumour (growth) in the colon. It is used in combination with other anticancer agents, 5-fluorouracil (5-FU) and folinic acid (FS).

2 Before you use Do not use Oxaliplatin powder if you:

are allergic (hypersensitive) to oxaliplatin or the other ingredient of Oxaliplatin powder, lactose monohydrate. are breast-feeding already have a reduced number of blood cells (white blood cells and/or platelets). already have tingling and numbness in the fingers and/or toes, and have difficulty performing delicate tasks, such as buttoning clothes have severe kidney problems Even if you are male, please ensure that you read the section of this leaflet that concerns pregnancy and breast-feeding.

For adults only. Oxaliplatin powder will be prescribed for you by a specialist in cancer treatment. Oxaliplatin powder is given by injection into a vein (an intravenous infusion) over a 2 to 6 hour period. The dose of Oxaliplatin powder is based on your body surface area (calculated from your height and weight). The dose will also depend on results of blood tests and whether you have previously experienced side effects with Oxaliplatin powder. The usual dose for adults including the elderly is 85 mg/m2 of body surface area once every 2 weeks at the same time as folinic acid and before the infusion of 5-fluorouracil. The duration of the treatment will be determined by your doctor. Your treatment will last a maximum of 6 months when used after complete resection of your tumour. The needle must remain in the vein while the drug is being given. If the needle comes out or becomes loose, or the solution is going into the tissue outside the vein (you may feel discomfort or pain) - tell the doctor or nurse immediately.

If you use more Oxaliplatin powder than you should
As this medicine is given in a hospital, it is unlikely that you will be given too little or too much. However tell your doctor if you have any concerns.

If you forget to use Oxaliplatin powder

Oxaliplatin powder needs to be given on a fixed schedule. Be sure to keep all appointments. If you miss a dose, you should discuss this with your doctor. Your doctor will decide when you should be given your next dose of Oxaliplatin powder.

if you have ever suffered an allergic reaction to platinum-containing medicines such as carboplatin or cisplatin if you have moderate kidney problems if you have any liver problems if you are pregnant or planning a pregnancy. It is very important that you discuss this with your doctor before you receive any treatment. if your blood cell counts are too low after previous oxaliplatin treatment. Your doctor will perform tests to check that you have sufficient blood cells before treatment. if you have symptoms of nerve damage such as weakness, numbness, disturbances of feeling or taste after previous oxaliplatin treatment. These effects are often triggered by exposure to cold. If you notice such symptoms tell your doctor, especially if they are troublesome and/or last longer than 7 days. Your doctor will carry out neurological examinations, before and regularly during treatment, especially if you are given other drugs which may cause nerve damage. Symptoms of nerve damage can persist after the end of the treatment. if you also receive 5-fluorouracil, because the risk of diarrhoea, vomiting, sore mouth and blood abnormalities is increased. if you experience symptoms such as headache, altered mental functioning, seizures and abnormal vision from blurriness to vision loss (symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disorder).

Take special care with Oxaliplatin powder

If you stop treatment with Oxaliplatin powder

Stopping your treatment with Oxaliplatin powder may stop the effect on tumour growth. Do not stop treatment with Oxaliplatin powder unless you have discussed this with your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4 Possible side effects

Like all medicines, Oxaliplatin powder can cause side effects, although not everybody gets them. If you experience any side effect it is important that you inform your doctor before your next treatment. Immediately inform your doctor 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. Sore lips or mouth ulcers (stomatitis/mucositis). Unexplained symptoms from the respiratory system such as non-productive cough, breathing difficulties or voice alterations. Symptoms of an allergic reaction such as swelling of hands, feet, ankles, face, lips, mouth or throat (which may cause difficulties in swallowing or breathing). A group of symptoms such as headache, altered mental functioning, seizures and abnormal vision from blurriness to vision loss (symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disorder). Very common side effects (seen in more than 1 of every 10 patients): Effects on the nerves (peripheral sensory neuropathy). You may feel a tingling and/ or numbness in the fingers, toes, around the mouth or in the throat which may sometimes occur in association with cramps. This side effect is often triggered by exposure to cold e.g. opening a refrigerator or holding a cold drink. You may also have difficulty in performing delicate tasks, such as buttoning clothes. Although in the majority of cases these symptoms disappear completely there is a possibility of continued symptoms of peripheral sensory neuropathy (weakness or numbness because of nerve damage) after the end of the treatment.

Using other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Oxaliplatin powder should not be used during pregnancy. It is therefore important to tell your doctor if you are pregnant. If you become pregnant during your treatment, you must inform your doctor immediately. Effective birth control to prevent pregnancy is advised during treatment and after the end of treatment for the following 4 months for women and for 6 months for men. Oxaliplatin may have an anti-fertility effect which could be irreversible. Men treated with oxaliplatin 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.
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Pregnancy and breast-feeding

continued over page

!
The following information is intended for medical or healthcare professionals only:

Oxaliplatin 5mg/ml Powder for Solution for Infusion
Instructions for use ANTINEOPLASTIC AGENT This medicinal product should not be mixed with other medicinal products except for those mentioned below in section Reconstitution of the solution. Oxaliplatin can be co-administered with folinic acid (FA) via a Y-line. Do not mix with alkaline medicinal products or solutions, in particular 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 (see below section Reconstitution of the solution). Do not reconstitute or dilute for infusion with saline or other solutions containing chloride ions (including calcium, potassium or sodium chloride). Do not use injection equipment containing aluminium. Unopened vials: This medicinal product does not require any special storage conditions. Reconstituted solution in the original vial: From a microbiological point of view, the reconstituted solution should be diluted immediately. Infusion preparation: Chemical and physical in-use stability has been demonstrated for 24 hours at 2C to 8C. 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 to 8C, unless dilution has taken place in controlled and validated aseptic conditions. The handling of this cytotoxic agent by healthcare 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 medicinal 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 to avoid handling 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 chapter Disposal. If Oxaliplatin powder, reconstituted solution or solution for infusion, should come into contact with skin, wash immediately and thoroughly with water. If Oxaliplatin powder, reconstituted solution or solution for infusion, should come into contact with mucous membranes, wash immediately and thoroughly with water.

Instructions for Handling

Incompatibilities

Storage conditions

Instruction for handling, use and disposal

Special precautions for administration

As with other potentially toxic compounds, caution should be exercised when handling and preparing oxaliplatin solutions.

DO NOT use injection equipment containing aluminium. DO NOT administer oxaliplatin undiluted. Only glucose 5% (50mg/ml) infusion solution is to be used as a diluent. DO NOT reconstitute or dilute for infusion with sodium chloride or chloride containing solutions.

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Oxaliplatin powder - 5 mg/ml United Kingdom
item no: AAAD5872 print proof no: 03 origination date: 29/03/12 originated by: C.Paull approved for print/date dimensions: 130x600 pharmacode: min pt size:

colours/plates: 1. Black 2. 3. 4. 5. 6. Non Printing Colours 1. 2. 3.

MOCK UP ONLY

revision date: 05/04/12 revised by: C.Paull supplier: Sindan

Technical Approval date sent: 29/03/12 technically app. date: 03/04/12

Some people have experienced a tingling shock-like sensation passing down the arms or trunk when the neck is flexed. 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. Signs of infection such as a sore throat and high temperature. Decreased number of white blood cells, which increase the risk of infection. Decreased number of blood platelets, which increase the risk of bleedings and bruising. Decreased number of red blood cells, which may make the skin pale, and cause weakness or breathlessness. Your doctor will take blood to check that you have sufficient blood cells before you start treatment and before each subsequent course. Allergic reaction skin rash including red itchy skin, swelling of hands, feet, ankles, face, lips, mouth or throat (which may cause difficulties in swallowing or breathing) and can make you feel like fainting. Loss or lack of appetite. High levels of glucose (blood sugar) in your blood, which may cause thirst, dry mouth and frequent urination. Low levels of potassium in your blood, which may cause abnormal heart beat. Low levels of sodium in your blood, which may cause fatigue and confusion, muscular jerking, cramps or coma. High levels of sodium in your blood, which may cause weakness or swelling caused by fluid retention. Taste alterations. Headache. Nose bleeds. Breathlessness. Cough. Nausea (feeling sick) and vomiting (being sick) - medication to prevent the sickness is usually given before treatment and may be continued after treatment. Diarrhoea, if you suffer from persistent or severe diarrhoea or vomiting contact your doctor immediately for advice. Sore lips or mouth ulcers. Abdominal pain, constipation. Skin disorder. Hair loss. Back pain. Fatigue, weakness and pain. Reaction close to or at the injection site during the infusion (local pain, redness, swelling of skin, hardening of skin, death of skin tissue). Fever. Alteration in blood tests including those relating to abnormalities in liver function. Weight increase. Rigors (tremors). Common side effects (seen in more than 1 of every 100 but in less than 1 of every 10 patients): Runny nose (rhinitis). Upper respiratory tract infection. Dehydration. Depression, sleeplessness. Dizziness. Swelling of the nerves to the muscles. Rigidity, intolerance of bright light and headache (meningism). Inflammation of the conjunctiva, abnormal vision. Abnormal bleeding, blood in the urine/stools. Blood clots, usually in the leg, which can cause pain, swelling or redness. Blood clots in the lungs, which can cause chest pain and breathing difficulties. Flushing. Hiccups, chest pain. Indigestion and heart burn. Flaking skin, skin rash, increased sweating and nail disorders. Joint pain and bone pain. Pain on passing urine and changes in the frequency of urination. Alteration in blood test which measures the kidney function. Weight decrease. Tightness of the chest caused by cramp of the respiratory tract muscles (bronchospasm). Decrease in blood pressure. Shock (strong blood pressure drop, paleness, restlessness, rapid heart rate, moist skin, decreased consciousness) caused by a sudden vascular dilatation as a result of a severe hypersensitivity reaction to certain substances (anaphylactic shock). Swelling of hands, feet, ankles, face, lips, mouth or throat which may cause difficulties in swallowing or breathing (angioedema). Blood abnormality (deficiency of certain white blood cells) accompanied by increased susceptibility to infections (febrile neutropenia/ neutropenic sepsis). Uncommon side effects (seen in more than 1 of every 1,000 but in less than 1 of every 100 patients): Hearing problems. Blockage or swelling of the bowel. Nervousness. Blood test which indicates increased acidity in the blood. Jaw spasms, muscle spasms, involuntary muscle contractions, muscle twitching. Difficulties with co-ordination, balance, and walking. Throat or chest tightness.
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Eye disorders such as drooping of the upper eye lid, and double vision. Loss or impairment of the voice, roughness of the voice (hoarseness). Abnormal tongue sensation, difficulty speaking. Facial pain and/or eye pain. Rare side effects (seen in more than 1 of every 10,000 but in less than 1 of every 1,000 patients): Slurred speech. Deafness. Unexplained symptoms from the respiratory system such as non-productive cough, breathing difficulties or crackles (interstitial lung disease, pulmonary fibrosis). Inflammation of the large bowel which may cause abdominal pain or diarrhoea (colitis). Blood abnormality (lack of platelets) caused by an allergic reaction associated with bruises and abnormal bleeding (immunoallergic thrombocytopenia). Lack of red blood cells caused by too much degradation of blood (haemolytic anaemia). Transient reduction in visual acuity, disturbance of the visual field, inflammation of the optic nerve (optic neuritis). Very rare side effects (seen in less than 1 of every 10,000 patients): Liver disease Kidney inflammation and kidney failure If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5 How to store

Keep out of the reach and sight of children. This medicinal product does not require any special storage conditions when the vial is unbroken. Do not use Oxaliplatin powder after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month. The reconstituted solution should immediately be diluted with 5% glucose solution to give a concentration between 0.2mg/ml and 0.7mg/ ml. Once diluted the infusion solution should be used immediately. Chemical and physical in-use stability has been demonstrated for 24 hours at 2C to 8C. Oxaliplatin should not come into contact with the eyes or skin. If there is any accidental spillage, tell the doctor or nurse immediately. When the infusion has finished, any remaining Oxaliplatin powder will be disposed of carefully by the doctor or nurse. 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 What Oxaliplatin powder contains
The active substance is oxaliplatin. The other ingredient is lactose monohydrate. One ml of the reconstituted concentrate solution contains 5mg oxaliplatin. 50mg vial: Each vial contains 50mg oxaliplatin for reconstitution in 10ml of solvent. 100mg vial: Each vial contains 100mg oxaliplatin for reconstitution in 20ml of solvent.

What Oxaliplatin powder looks like and contents of the pack

Powder for solution for infusion: A white or almost white powder, which is provided in a colourless glass vial that has a rubber closure and has a metallic cap containing a plastic disk. Vial will be packed with or without a protective plastic overwrap. Pack sizes: 1 x 50mg vial 1 x 100mg vial Not all pack sizes may be marketed.

Marketing Authorisation Holder
Actavis Group hf. Reykjavkurvegi 76-78 IS-220 Hafnarfjrur Iceland

Manufacturer

Actavis Nordic A/S rnegrdsvej 16 DK-2820 Gentofte Denmark or S.C. Sindan S.R.L. 11 Ion Mihalache Blvd 011171 Bucharest Romania This leaflet was last revised in April 2012



If you would like a leaflet with larger text, please contact 01271 311257.

Actavis, Barnstaple, EX32 8NS, UK

!
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, in particular 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. Withdraw the required amount of reconstituted solution from the vial(s) and then dilute with 250ml to 500 ml of a 5% glucose solution to give an oxaliplatin concentration between not less than 0.2mg/ml and 0.7 mg/ml. The concentration range over which the physico-chemical stability of oxaliplatin has been demonstrated is 0.2mg/ml to 0.7mg/ml. Administer by intravenous infusion. Chemical and physical in-use stability has been demonstrated for 24 hours at 2C to 8C. 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. 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 solution or chloride containing solutions for either reconstitution or dilution. The compatibility of Oxaliplatin solution for infusion has been tested with representative, PVC-based, administrative sets.

Instruction for use with folinic acid (FA) (as calcium folinate or disodium folinate)

Oxaliplatin 85mg/m intravenous infusion in 250 to 500ml of glucose 5% (50mg/ml) solution is given at the same time as folinic acid (FA) intravenous infusion in glucose 5% 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 (FA) must not contain trometamol as an excipient and must only be diluted using isotonic glucose 5% solution, never in alkaline solutions or sodium chloride or chloride containing solutions.

Instruction for use with 5 fluorouracil (5 FU)

Oxaliplatin should always be administered before fluoropyrimidines i.e. 5 fluorouracil (5 FU). After oxaliplatin administration, flush the line and then administer 5 fluorouracil (5 FU). For additional information on medicinal products combined with oxaliplatin, see the corresponding manufacturers summary of product characteristics. Water for injections or 5% glucose solution should be used to reconstitute the solution: For a vial of 50mg: add 10ml of solvent to obtain a concentration of 5mg oxaliplatin/ml. For a vial of 100mg: add 20ml of solvent to obtain a concentration of 5mg oxaliplatin/ml. Reconstituted solutions should be diluted immediately with 5% glucose solution. Inspect visually prior to use. Only clear solutions without particles should be used. Any reconstituted solution that shows evidence of precipitation should not be used and should be destroyed with due regard to legal requirements for disposal of hazardous waste. The medicinal product is for single use only. Any unused infusion solution should be discarded.

Infusion

Reconstitution of the solution

The administration of oxaliplatin does not require prehydration. Oxaliplatin reconstituted and diluted in 250 to 500ml 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. Remnants of the medicinal product as well as all materials that have been used for reconstitution, for dilution and administration must be destroyed according to standard procedures applicable to cytotoxic agents in accordance with local requirements related to the disposal of hazardous waste.

Disposal

Dilution for intravenous infusion

Only to be used with recommended diluents.

continued on top of next column AAAD5872

Actavis, Barnstaple, EX32 8NS, UK

Oxaliplatin powder - 5 mg/ml United Kingdom
item no: AAAD5872 print proof no: 03 origination date: 29/03/12 originated by: C.Paull approved for print/date dimensions: 130x600 pharmacode: min pt size:

colours/plates: 1. Black 2. 3. 4. 5. 6. Non Printing Colours 1. 2. 3.

MOCK UP ONLY

revision date: 05/04/12 revised by: C.Paull supplier: Sindan

Technical Approval date sent: 29/03/12 technically app. date: 03/04/12

1

2
10 mm

3

4

5

6

7

8

9

10

11

10 mm

Oxaliplatin 5mg/ml Powder for Solution for Infusion
Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. In this leaflet: 1 What Oxaliplatin powder is and what it is used for 2 Before you use 3 How to use 4 Possible side effects 5 How to store 6 Further information
219 mm

Breast-feeding should be discontinued before starting treatment with Oxaliplatin powder. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

It is unknown whether treatment with Oxaliplatin powder affects the ability to drive and use machines. If you feel sleepy and/or dizzy or have nausea or vomiting, following oxaliplatin infusion do not drive, operate potentially dangerous machinery, or engage in other activities that may be hazardous because of decreased alertness. Oxaliplatin treatment may transiently affect vision. If you have problems with vision, do not drive, operate potentially dangerous machinery, or engage in other activities that may be hazardous.

3 How to use

1 What Oxaliplatin powder is and

what it is used for

Oxaliplatin powder is used to treat metastatic (advanced) cancer of the colon (large bowel) or rectum (back passage), or as additional treatment following surgery to remove a tumour (growth) in the colon. It is used in combination with other anticancer agents, 5-fluorouracil (5-FU) and folinic acid (FS).

2 Before you use Do not use Oxaliplatin powder if you:

For adults only. Oxaliplatin powder will be prescribed for you by a specialist in cancer treatment. Oxaliplatin powder is given by injection into a vein (an intravenous infusion) over a 2 to 6 hour period. The dose of Oxaliplatin powder is based on your body surface area (calculated from your height and weight). The dose will also depend on results of blood tests and whether you have previously experienced side effects with Oxaliplatin powder. The usual dose for adults including the elderly is 85 mg/m2 of body surface area once every 2 weeks at the same time as folinic acid and before the infusion of 5-fluorouracil. The duration of the treatment will be determined by your doctor. Your treatment will last a maximum of 6 months when used after complete resection of your tumour. The needle must remain in the vein while the drug is being given. If the needle comes out or becomes loose, or the solution is going into the tissue outside the vein (you may feel discomfort or pain) - tell the doctor or nurse immediately.

are allergic (hypersensitive) to oxaliplatin or the other ingredient of Oxaliplatin powder, lactose monohydrate. are breast-feeding already have a reduced number of blood cells (white blood cells and/or platelets). already have tingling and numbness in the fingers and/or toes, and have difficulty performing delicate tasks, such as buttoning clothes have severe kidney problems

If you use more Oxaliplatin powder than you should

As this medicine is given in a hospital, it is unlikely that you will be given too little or too much.
continued below

continued below
14 mm

20 mm -1 mm ITF high 8 mm +1 mm

14 mm

20 mm

Even if you are male, please ensure that you read the section of this leaflet that concerns pregnancy and breast-feeding.

However tell your doctor if you have any concerns.

Take special care with Oxaliplatin powder

If you forget to use Oxaliplatin powder
Oxaliplatin powder needs to be given on a fixed schedule. Be sure to keep all appointments. If you miss a dose, you should discuss this with your doctor. Your doctor will decide when you should be given your next dose of Oxaliplatin powder.

if you have ever suffered an allergic reaction to platinum-containing medicines such as carboplatin or cisplatin if you have moderate kidney problems if you have any liver problems if you are pregnant or planning a pregnancy. It is very important that you discuss this with your doctor before you receive any treatment. if your blood cell counts are too low after previous oxaliplatin treatment. Your doctor will perform tests to check that you have sufficient blood cells before treatment. if you have symptoms of nerve damage such as weakness, numbness, disturbances of feeling or taste after previous oxaliplatin treatment. These effects are often triggered by exposure to cold. If you notice such symptoms tell your doctor, especially if they are troublesome and/or last longer than 7 days. Your doctor will carry out neurological examinations, before and regularly during treatment, especially if you are given other drugs which may cause nerve damage. Symptoms of nerve damage can persist after the end of the treatment. if you also receive 5-fluorouracil, because the risk of diarrhoea, vomiting, sore mouth and blood abnormalities is increased. if you experience symptoms such as headache, altered mental functioning, seizures and abnormal vision from blurriness to vision loss (symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disorder).

If you stop treatment with Oxaliplatin powder

Stopping your treatment with Oxaliplatin powder may stop the effect on tumour growth. Do not stop treatment with Oxaliplatin powder unless you have discussed this with your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4 Possible side effects

Like all medicines, Oxaliplatin powder can cause side effects, although not everybody gets them. If you experience any side effect it is important that you inform your doctor before your next treatment. Immediately inform your doctor 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. Sore lips or mouth ulcers (stomatitis/ mucositis). Unexplained symptoms from the respiratory system such as non-productive cough, breathing difficulties or voice alterations. Symptoms of an allergic reaction such as swelling of hands, feet, ankles, face, lips, mouth or throat (which may cause difficulties in swallowing or breathing). A group of symptoms such as headache, altered mental functioning, seizures and abnormal vision from blurriness to vision loss (symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disorder).

Using other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Oxaliplatin powder should not be used during pregnancy. It is therefore important to tell your doctor if you are pregnant. If you become pregnant during your treatment, you must inform your doctor immediately. Effective birth control to prevent pregnancy is advised during treatment and after the end of treatment for the following 4 months for women and for 6 months for men. Oxaliplatin may have an anti-fertility effect which could be irreversible. Men treated with oxaliplatin 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.

453 mm

continued on top of next column AAAE4443

continued over page

10 mm

!

The following information is intended for medical or healthcare professionals only:

Oxaliplatin 5mg/ml Powder for Solution for Infusion
Instructions for use ANTINEOPLASTIC AGENT This medicinal product should not be mixed with other medicinal products except for those mentioned below in section Reconstitution of the solution. Oxaliplatin can be co-administered with folinic acid (FA) via a Y-line. Do not mix with alkaline medicinal products or solutions, in particular 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 (see below section Reconstitution of the solution). Do not reconstitute or dilute for infusion with saline or other solutions containing chloride ions (including calcium, potassium or sodium chloride). Do not use injection equipment containing aluminium. Unopened vials: This medicinal product does not require any special storage conditions. Reconstituted solution in the original vial: From a microbiological point of view, the reconstituted solution should be diluted immediately. Infusion preparation: Chemical and physical in-use stability has been demonstrated for 24 hours at 2C to 8C. 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 to 8C, unless dilution has taken place in controlled and validated aseptic conditions.

Instructions for Handling

Incompatibilities

Storage conditions

The handling of this cytotoxic agent by healthcare 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 medicinal 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 to avoid handling 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 chapter Disposal. If Oxaliplatin powder, reconstituted solution or solution for infusion, should come into contact with skin, wash immediately and thoroughly with water. If Oxaliplatin powder, reconstituted solution or solution for infusion, should come into contact with mucous membranes, wash immediately and thoroughly with water.

Instruction for handling, use and disposal
As with other potentially toxic compounds, caution should be exercised when handling and preparing oxaliplatin solutions.

continued on top of next column AAAE4443 Supplier coding area
5 mm 10 mm

continued over page

Oxaliplatin Powder 5 mg/ml PIL - United Kingdom
item no: AAAE4443 print proof no: 01 origination date: 17-10-2012 originated by: NM approved for print/date dimensions: 124 x 700 pharmacode: min pt size:

colours/plates: 1. Black 2. 3. 4. 5. 6. Non Printing Colours 1. 2. 3.

MOCK UP ONLY

revision date: revised by: supplier: Nerviano

Technical Approval date sent: 17-10-2012 technically app. date: 17-10-2012

10 mm

10 mm

Very common side effects (seen in more than 1 of every 10 patients): Effects on the nerves (peripheral sensory neuropathy). You may feel a tingling and/ or numbness in the fingers, toes, around the mouth or in the throat which may sometimes occur in association with cramps. This side effect is often triggered by exposure to cold e.g. opening a refrigerator or holding a cold drink. You may also have difficulty in performing delicate tasks, such as buttoning clothes. Although in the majority of cases these symptoms disappear completely there is a possibility of continued symptoms of peripheral sensory neuropathy (weakness or numbness because of nerve damage) 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. 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. Signs of infection such as a sore throat and high temperature. Decreased number of white blood cells, which increase the risk of infection. Decreased number of blood platelets, which increase the risk of bleedings and bruising. Decreased number of red blood cells, which may make the skin pale, and cause weakness or breathlessness. Your doctor will take blood to check that you have sufficient blood cells before you start treatment and before each subsequent course. Allergic reaction skin rash including red itchy skin, swelling of hands, feet, ankles, face, lips, mouth or throat (which may cause difficulties in swallowing or breathing) and can make you feel like fainting. Loss or lack of appetite. High levels of glucose (blood sugar) in your blood, which may cause thirst, dry mouth and frequent urination. Low levels of potassium in your blood, which may cause abnormal heart beat. Low levels of sodium in your blood, which may cause fatigue and confusion, muscular jerking, cramps or coma. High levels of sodium in your blood, which may cause weakness or swelling caused by fluid retention. Taste alterations. Headache. Nose bleeds. Breathlessness. Cough. Nausea (feeling sick) and vomiting (being sick) - medication to prevent the sickness is usually given before treatment and may be continued after treatment. Diarrhoea, if you suffer from persistent or severe diarrhoea or vomiting contact your doctor immediately for advice. Sore lips or mouth ulcers. Abdominal pain, constipation. Skin disorder. Hair loss. Back pain. Fatigue, weakness and pain. Reaction close to or at the injection site during the infusion (local pain, redness, swelling of skin, hardening of skin, death of skin tissue). Fever. Alteration in blood tests including those relating to abnormalities in liver function. Weight increase. Rigors (tremors). Common side effects (seen in more than 1 of every 100 but in less than 1 of every 10 patients): Runny nose (rhinitis). Upper respiratory tract infection. Dehydration. Depression, sleeplessness. Dizziness. Swelling of the nerves to the muscles. Rigidity, intolerance of bright light and headache (meningism). Inflammation of the conjunctiva, abnormal vision. Abnormal bleeding, blood in the urine/ stools. Blood clots, usually in the leg, which can cause pain, swelling or redness. Blood clots in the lungs, which can cause chest pain and breathing difficulties. Flushing. Hiccups, chest pain. Indigestion and heart burn. Flaking skin, skin rash, increased sweating and nail disorders. Joint pain and bone pain. Pain on passing urine and changes in the frequency of urination. Alteration in blood test which measures the kidney function. Weight decrease. Tightness of the chest caused by cramp of the respiratory tract muscles (bronchospasm). Decrease in blood pressure. Shock (strong blood pressure drop, paleness, restlessness, rapid heart rate, moist skin, decreased consciousness) caused by a sudden vascular dilatation as a result of a severe hypersensitivity reaction to certain substances (anaphylactic shock). Swelling of hands, feet, ankles, face, lips, mouth or throat which may cause difficulties in swallowing or breathing (angioedema). Blood abnormality (deficiency of certain white blood cells) accompanied by increased susceptibility to infections (febrile neutropenia/neutropenic sepsis).

Uncommon side effects (seen in more than 1 of every 1,000 but in less than 1 of every 100 patients): Hearing problems. Blockage or swelling of the bowel. Nervousness. Blood test which indicates increased acidity in the blood. Jaw spasms, muscle spasms, involuntary muscle contractions, muscle twitching. Difficulties with co-ordination, balance, and walking. Throat or chest tightness. Eye disorders such as drooping of the upper eye lid, and double vision. Loss or impairment of the voice, roughness of the voice (hoarseness). Abnormal tongue sensation, difficulty speaking. Facial pain and/or eye pain. Rare side effects (seen in more than 1 of every 10,000 but in less than 1 of every 1,000 patients): Slurred speech. Deafness. Unexplained symptoms from the respiratory system such as non-productive cough, breathing difficulties or crackles (interstitial lung disease, pulmonary fibrosis). Inflammation of the large bowel which may cause abdominal pain or diarrhoea (colitis). Blood abnormality (lack of platelets) caused by an allergic reaction associated with bruises and abnormal bleeding (immunoallergic thrombocytopenia). Lack of red blood cells caused by too much degradation of blood (haemolytic anaemia). Transient reduction in visual acuity, disturbance of the visual field, inflammation of the optic nerve (optic neuritis). Very rare side effects (seen in less than 1 of every 10,000 patients): Liver disease Kidney inflammation and kidney failure If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5 How to store

Keep out of the reach and sight of children. This medicinal product does not require any special storage conditions when the vial is unbroken. Do not use Oxaliplatin powder after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month. The reconstituted solution should immediately be diluted with 5% glucose solution to give a concentration between 0.2mg/ml and 0.7mg/ ml. Once diluted the infusion solution should be used immediately. Chemical and physical in-use stability has been demonstrated for 24 hours at 2C to 8C. Oxaliplatin should not come into contact with the eyes or skin. If there is any accidental spillage, tell the doctor or nurse immediately. When the infusion has finished, any remaining Oxaliplatin powder will be disposed of carefully by the doctor or nurse. 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

What Oxaliplatin powder contains The active substance is oxaliplatin. The other ingredient is lactose monohydrate. One ml of the reconstituted concentrate solution contains 5mg oxaliplatin. 50mg vial: Each vial contains 50mg oxaliplatin for reconstitution in 10ml of solvent. 100mg vial: Each vial contains 100mg oxaliplatin for reconstitution in 20ml of solvent.

Powder for solution for infusion: A white or almost white powder, which is provided in a colourless glass vial that has a rubber closure and has a metallic cap containing a plastic disk. Vial will be packed with or without a protective plastic overwrap. Pack sizes: 1 x 50mg vial 1 x 100mg vial Not all pack sizes may be marketed. Marketing Authorisation Holder
Actavis Group hf. Reykjavkurvegi 76-78 IS-220 Hafnarfjrur Iceland

What Oxaliplatin powder looks like and contents of the pack

Manufacturer

Actavis Nordic A/S rnegrdsvej 16 DK-2820 Gentofte Denmark or Actavis Italy S.p.A. Via Pasteur 10, 20014 Nerviano (MI), Italy

This leaflet was last revised in October 2012



If you would like a leaflet with larger text, please contact 01271 311257.

continued on top of next column AAAE4443

Actavis, Barnstaple, EX32 8NS, UK

!
DO NOT use injection equipment containing aluminium. DO NOT administer oxaliplatin undiluted. Only glucose 5% (50mg/ml) infusion solution is to be used as a diluent. DO NOT reconstitute or 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, in particular 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.

Special precautions for administration

Dilution for intravenous infusion

Only to be used with recommended diluents. Withdraw the required amount of reconstituted solution from the vial(s) and then dilute with 250ml to 500 ml of a 5% glucose solution to give an oxaliplatin concentration between not less than 0.2mg/ml and 0.7 mg/ml. The concentration range over which the physico-chemical stability of oxaliplatin has been demonstrated is 0.2mg/ml to 0.7mg/ml. Administer by intravenous infusion. Chemical and physical in-use stability has been demonstrated for 24 hours at 2C to 8C. 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. 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 solution or chloride containing solutions for either reconstitution or dilution. The compatibility of Oxaliplatin solution for infusion has been tested with representative, PVCbased, administrative sets.

Instruction for use with folinic acid (FA) (as calcium folinate or disodium folinate)

Oxaliplatin 85mg/m intravenous infusion in 250 to 500ml of glucose 5% (50mg/ml) solution is given at the same time as folinic acid (FA) intravenous infusion in glucose 5% 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 (FA) must not contain trometamol as an excipient and must only be diluted using isotonic glucose 5% solution, never in alkaline solutions or sodium chloride or chloride containing solutions.

Infusion

Instruction for use with 5 fluorouracil (5 FU)
Oxaliplatin should always be administered before fluoropyrimidines i.e. 5 fluorouracil (5 FU). After oxaliplatin administration, flush the line and then administer 5 fluorouracil (5 FU). For additional information on medicinal products combined with oxaliplatin, see the corresponding manufacturers summary of product characteristics.

The administration of oxaliplatin does not require prehydration. Oxaliplatin reconstituted and diluted in 250 to 500ml 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. Remnants of the medicinal product as well as all materials that have been used for reconstitution, for dilution and administration must be destroyed according to standard procedures applicable to cytotoxic agents in accordance with local requirements related to the disposal of hazardous waste.

Water for injections or 5% glucose solution should be used to reconstitute the solution: For a vial of 50mg: add 10ml of solvent to obtain a concentration of 5mg oxaliplatin/ml. For a vial of 100mg: add 20ml of solvent to obtain a concentration of 5mg oxaliplatin/ml. Reconstituted solutions should be diluted immediately with 5% glucose solution. Inspect visually prior to use. Only clear solutions without particles should be used. Any reconstituted solution that shows evidence of precipitation should not be used and should be destroyed with due regard to legal requirements for disposal of hazardous waste. The medicinal product is for single use only. Any unused infusion solution should be discarded.

Reconstitution of the solution

Disposal

continued on top of next column AAAE4443 Supplier coding area Actavis, Barnstaple, EX32 8NS, UK

Oxaliplatin Powder 5 mg/ml PIL - United Kingdom
item no: AAAE4443 print proof no: 01 origination date: 17-10-2012 originated by: NM approved for print/date dimensions: 124 x 700 pharmacode: min pt size:

colours/plates: 1. Black 2. 3. 4. 5. 6. Non Printing Colours 1. 2. 3.

MOCK UP ONLY

revision date: revised by: supplier: Nerviano

Technical Approval date sent: 17-10-2012 technically app. date: 17-10-2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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