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Document: leaflet MAH GENERIC_PL 14510-0061 change

• leaflet MAH GENERIC_PL 00289-0310
• leaflet MAH GENERIC_PL 04416-1314
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• leaflet MAH GENERIC_PL 14510-0061
• leaflet MAH GENERIC_PL 18727-0012
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• leaflet MAH GENERIC_PL 40378-0015
• leaflet SANDOZ_PL 14510-0061

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Package leaflet: Information for the patient

Oxaliplatin 5 mg/ml concentrate for solution for infusion

Oxaliplatin

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have further questions, please ask your doctor.

•    If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Oxaliplatin is and what it is used for

2.    What you need to know before you are given Oxaliplatin

3.    How Oxaliplatin is used

4.    Possible side effects

5 How to store Oxaliplatin

6. Contents of the pack and other information

1.    What Oxaliplatin is and what it is used for

Oxaliplatin is an anticancer medicine and contains the active substance oxaliplatin.

Oxaliplatin is used for treating bowel cancer after it has been removed by surgery or when it has already spread.

Oxaliplatin is used in combination with other anticancer medicines called 5-fluorouracil (5-FU) and folinic acid (FA).

2.    What you need to know before you are given Oxaliplatin You should not be given Oxaliplatin:

1.if you are allergic to oxaliplatin 2. if you are breast-feeding

3.if you already have a reduced number of blood cells

4. if you already have tingling and numbness in the fingers and/or toes, and have difficulty performing delicate tasks, such as buttoning clothes 5.if you have severe kidney problems Warnings and precautions:

Talk to your doctor before you are given Oxaliplatin

•    if you have ever suffered an allergic reaction to platinum-containing medicines such as carboplatin, cisplatin. Allergic reactions can occur during any oxaliplatin infusion.

•    if you have mild or moderate kidney problems

•    if you have any liver problems

Inform your doctor immediately if you experience numbness or tingling in your fingers or toes or difficulty in swallowing. These symptoms

•    can persist after the end of the treatment up to 3 years and may not be reversible. Your doctor will perform a neurological examination regularly, especially if other drugs are coadministered which affect the nerves.

•    if you experience persistent or severe diarrhoea, nausea or vomiting.

•    if you experience sore lips or mouth ulcers.

•    if you have abnormal bruising, bleeding, or signs of infection such as a sore throat and high temperature. As oxaliplatin can cause a reduction of the number of blood cells, your doctor will check your blood frequently.

•    if you experience unexplained respiratory symptoms such as a non-productive cough, difficulty in breathing or crackles.

Tell your doctor or your nurse immediately, if you notice a sensation of discomfort close to or at the injection site during the infusion (possible leakage into the surrounding tissue)

If you are pregnant or planning a pregnancy it is very important that you discuss this with your doctor before you receive any treatment. 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. Male patients should take appropriate contraceptive measures during and after cessation of therapy continuing for 6 months.

Children

There is no relevant indication for use of oxaliplatin in children. The safety and efficacy of Oxaliplatin in children has not been established.

Other medicines and Oxaliplatin

Tell your doctor if you are using, have recently used or might use any other medicines. Pregnancy, breast-feeding and fertility

You must not be treated with oxaliplatin during pregnancy unless clearly indicated by your doctor. It is therefore important to tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.

You must not become pregnant during treatment with oxaliplatin and must use an effective method of contraception. If pregnancy occurs 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.

You must not breast-feed while you are treated with oxaliplatin.

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.

Driving and using machines

Oxaliplatin treatment may result in an increase risk of dizziness, nausea and vomiting, and other neurological symptoms that affect gait and balance. These can influence your ability to drive and use machines, so do not do either until you are sure of how Oxaliplatin affects you. If you have vision problems while taking Oxaliplatin, do not drive, operate heavy machines, or engage in dangerous activities.

3.    How Oxaliplatin is used

This medicine will be administered by medical personnel; do not take it yourself.

Oxaliplatin is intended in adults only.

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.

•    Oxaliplatin is given by slow injection into one of your veins (an intravenous infusion) over a 2 to 6 hour period. If feelings of discomfort or pain arise at the injection site inform the healthcare professionals immediately.

•    Oxaliplatin will be given to you at the same time as folinic acid and before the infusion of 5 fluorouracil.

Frequency of administration

You should usually receive your infusion once every 2 weeks.

Duration of treatment

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.

If you received more Oxaliplatin than you should

As this medicine is administered by a healthcare professional it is highly unlikely that you will be given too much or too little.

In case of overdose you may experience increased side effects. Your doctor may give you appropriate treatment for these side effects.

If administration of Oxaliplatin is forgotten

Your doctor will decide on what time you will receive this medicine. If you think you missed a dose, please contact your doctor as soon as possible.

If you have any questions about your treatment ask your doctor or pharmacist.

4.    Possible side effects

Like all medicines, this medicine 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.

Tell your doctor immediately, if you notice any of the following:

•    Persistent or severe diarrhoea or vomiting

•    Presence of blood or dark brown coffee-coloured particles in your vomit

•    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).

•    Stomatitis/mucositis (sore lips or mouth ulcers)

•    Swelling of the face, lips, mouth or throat

•    Unexplained respiratory symptoms such as non-productive cough, difficulty in breathing or crackles

•    Difficulty in swallowing

•    Numbness or tingling in your fingers or toes

•    Extreme tiredness

•    Abnormal bruising or bleeding

•    Signs of infection, such as sore throat and high temperature

•    Sensation of discomfort close to or at the injection site during the infusion.

Known side effects of Oxaliplatin:

Very common (may affect more than 1 in 10 people):

•    A disorder of the nerves which can cause weakness, tingling or numbness in the fingers, toes, around the mouth or in the throat that may sometimes occur in association with cramps. This 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 resolve completely there is a possibility of persistent symptoms after the end of the treatment

•    A tingling shock-like sensation passing down the arms or chest when the neck is flexed (Lhermitte's sign)

•    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 usually subsides without the need for any treatment

•    Jaw spasm, abnormal tongue sensation, possibly affecting speech, and a feeling of chest pressure. Your doctor may decide to alter your treatment as a result

•    Taste alteration

•    Headache

•    Sore throat and high temperature (signs of infection)

•    Reduction in the number of white blood cells, which make infections more likely

•    Reduction in red blood cells, which can make the skin pale and cause weakness or breathlessness

•    Reduction in blood platelets, which increases risk of bleeding or bruising

•    Your doctor will take blood to check that you have sufficient blood cells before you start treatment and before each subsequent course.

•    Nosebleeds

•    Allergic reactions - skin rash including red itchy skin, inflammation of the conjunctiva, swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing) and you may feel you are going to faint

•    Shortness of breath, coughing

•    Loss or lack of appetite

•    Nausea (feeling sick), vomiting (being sick) - medication to prevent sickness is usually given to you by your doctor 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 mouth or lips, mouth ulcers

•    Stomach pain, constipation

•    Skin disorder

•    Hair loss

•    Back pain

•    Tiredness, loss of strength/weakness, body pain

•    Pain or redness close to or at the injection site during the infusion

•    Fever

•    Weight gain

•    High levels of glucose (sugar) in your blood, which may cause a great thirst, dry mouth or a need to urinate more often

•    Rigors (tremors)

•    Low blood levels of potassium, which can cause abnormal heart rhythm and can be recognised by muscle cramps, muscle weakness or fatigue.

•    High levels of blood sodium which can cause confusion, muscle twitching or abnormal heart rhythm.

•    Abnormal blood tests which show changes of liver function (increase of alkaline phosphatase, bilirubin, LDH and hepatic enzymes)

Common (may affect up to 1 in 10 people):

•    Reduction in the number of a special form of white blood cells accompanied by fever and/ or generalized infection / infections of the respiratory tract

•    Dehydration

•    Depression

•    Difficulty sleeping

•    Dizziness

•    Inflammation of nerves leading to muscle spasms, cramps, loss of certain reflexes

•    Neck stiffness, intolerance/dislike of bright light and headache

•    Conjunctivitis, visual problems

•    Abnormal bleeding, blood in the urine and stools

•    Presence of blood or dark brown coffee-coloured particles in your vomit

•    Blood clot, usually in a leg, which causes pain, swelling or redness

•    Blood clot in the lungs which causes chest pain and breathlessness

•    Runny nose

•    Upper respiratory tract infection

5940-Reg

•    Flushing

•    Chest [pain, hiccups

•    Indigestion and hpartburn

•    Loss of weight

•    Peeling skin, skin rash, increased sweating and nail disorder

•    .Joint pain and hone pain

•    Pain on passingurinp or a change in frequency when passing urine

•    Ahnormpl blood tests which show changes of kidney function (e.g. increase of creatinine)

•    High blood pressnre

Uncommon (may dftect up to 1 in100 people):

•    Nervousness

•    Hearing problems (ototoxicity)

• Imaairgd or blocseo bowel passage

•    Disturbdnce in the body's acid-base balance Rare (may/ dffect up to 1 in'! ,000 phopleh

• Reduc tion i n ptoo d dt atelets due to an allergic reaction associated with bruises and ahnotmal bleeding (immunoalleroic t/rom bocytopenia/

• Reduction in red oio od cells ceused by cneM destruction

•    Slurred speech

•    Temeorary fall in visual acuityi eisual field d isturbances, reversible short-term vision loss

•    Deafness

• Unexplained respiratary symptoms, difficultie;^ in breafoioe_i s^c<nrriho of the lung which causes shortness of oreath, sometimes fatal

• Bowel inflammation causing abdominal pain or diarrhoea , induding severe haoterial infectio n (Clostrid ium difficile)

• inflamm<^tion of tlie optic mg/e

•    Paupreetitis

Very/ ram (may affect u p to 1 in 10,000 people):

•    Liver disease that your doctor will moniton you for

•    Chandes in kidney punction

F requency mor ncr^4^vtfn (cannot be estimated from the available data):

•    Convulsion.

Reporting of sidr effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (www.mhra. gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Oxaliplatin

Koep th is medicine out of the sight and reach of children.

Oxaliplatin should not come into contact with tine eyes or sdin. If there is any accidental spiNage, tell the doctor* oe nurne immediately.

Priar to mixing this medicinal product must bw kept in the ooter carton in order to be protected from tg ht xnd must not Ice frozen.

Do nog etore <^Imo\/«^ 25tC.

Do nog use tdt m medicinb after she expiry date which is stated on the carton and the label. The expiry date refers to the last day of that month.

Do not throw away dny medicines viawastewateror household waste_: Ask your pharmahist how So throw away medidnes you no longer uso. These measures will help protect the environment.

6.    Contents of the pack and other information

What Oxa liplatin contains

•    The scpive subsnancr is Oxaliplatin.

•    The othvn ingredient is Water for injections

What Oxaliplatin looks like and contents ofthe pack

CI eat, colourlass solution . lit i s frec Ifrom visiOle part:cles .

1 ml of uolution (^fpnt^in;^ 5 mg oxcliplatin as active ingredient.

This medicinol product is a cgncenfrate for holution for infosion.

10 ml of concenrrate for solution for lnfusion conUains 50 mg ofoxaliplatin.

2° mlof conuenrrate for solyUan    for    inSusion    conUainu 10(0    mo    of oxaliplatin.

30 ml of concentrate forsolution    for    infusion    contains 150    mg    oo oxaliplann.

40 ml of concentrate for solution    for    infusion    contains 200    mg    of oxaliplatin.

150 ml of concentrate for solution    for    infusion    contains 250    mg    of oxaliplatin.

⁵ack siz0s:

50 mg/^,10 ml: 1 viaf 5 vials, 10 vials 100 mg/20 ml: 1 vial 100 mg/30 ml: 1 vial 200 mg/40 ml: 1 vial 200 mg/50 ml: t v ial

With or witkout a prote ctive plastic overwrnu (Onuo-Safe).

Not all [pack sizes may bn marketed.

Marketing Authorisation Holder and Manufacturer:

Nos²eting Authorisation Holder:

4BEWE Pharma G2s.m.b.H. Nfg. KG Mondueestrasse 11,

A866 lUnteraeh NBstria

Manufacture!:

ABEWE Phacma Ges.m.b.H. Nfg. KG

A866 Unterawh

Austria

This leaflet was lostrevised in 01/2^5.

Tlie following information ip intended for* healthnare professionals only:

^Apenial precautions foc dispocol and other ^fandli nig

As with other pHtentially toxic compounds, caution should be exercised when handling and [preparing oxaliplatin soluUons_l Instructions for Handling

Tina liandling pf thiscyto toxic ;^i^«nnt liy liealthcare personnel requires every precaution td guacanlt^pe the proltection of ■tlno handler and his sutroundings.

T’lie preparatiou of injecta^Ole solutions of cytotoxic ogents must be carrisd out Ittyc tl^ainect seaciyⁱist persenueⁱ with knowlddye of tine medicinel producrs used, in conc^|itiyns that ^pu<^c<^nt:«^«^ tine intesri^rrr of tlie .uroduct, foe proltectfon of the environment and in particular the ^drotecti on cplf ^Io^ personnel handling °he medteinal ^productS^: in accordance wifo ^he hospi tal Policyi It r^^cqui0(0;=^ a preparation trap reserved for this puraose. It in forbidden to smoke, ewt or dninlo in this area.

F^:,ersonnel must Ipe provided with appropriate loandling materials, notabl^o lontij s^: eeved gowns, pwErxocrkree:caarie:oann,::dmc:oavnsokmasiin,::cemrasup:as,n:bpder:co:hoeallcentcdivlieod:ng::wobgiaghl:sec:safo,r:ers:.werailse:es.ingle-use:gloves,:protective:covers:for:the: work area, containers .and collection Mu<3(:)s for waste.

Axcreta and vomlt must be handled with carei

bregnant women must be warned to avoid wandling cprotoxic agents.

Any broken cont«^iner must lie troa^red with the same precantions and considered as contamincted waste. Contominated waste should be incinerated it iiuitably labelled rigid <^on'telir^<^i'S3^ So<^ below section “Disaosor.

if oxaliiplatin concentrate or solution for infusion shoul^e come into uon^ract with skin, wosh immediately and thoroughly with water.

If oxaffplatin cone pnrrard or solution for infusion chonⁱd come into contact with mucous membranes, wash immediateiy and thorougHy with water.

Special precautions for administration

• IDO NO^u use ^: nji:^(^'tion materia¹ (^ont<^inius a^: umini um ^:

•    IDO NOT edmin^|uter undilu^rred^,

• Only glucose °% infusuion    lut^|on is to Mpe used as a diluent. DO NOT diluto for infnsion with sod^|um cClohde solution or c^lt'ilc^l'icle conrainins selutions

• Dm INOT mitt with enyr ofoer medicinal products in the same infusuion bag or e^ominister sfimu^|tenedusly Mu;u foe same in^rusion l^|neⁱ

• IDO NO^y mix with 011011x0 mgdteinal products or soⁱu^risnSⁱ in ^yarticular 5-fluorouracil, polinic add [procructs cont<^ining trometamol as sun excipient and tromeramol salts nf othof products. Alkalme medicinal products/ or snolution will adversely aftect the stability of oxaiiplatin

instructions for use with foiinic act^d (as calcium fo^insate or disodium folin <at<^)

Oxaliplatin 85 mg/m^{2 |X} infusion in 250 to ^p00 ml of 5% giucose solution is given atthe name time as folln:n acid IV infosi on in 5% g lucose so lu tion, over 2 to ^{u s}ou rS¹ nsin g a Y0 i ne p Iuso/ immediately before foe site of infusion. Tuese two medicinal products should not be combined ^|n the same infosion ba^pi ^linfo aci^o must not cctntain trvmetamol as an excipient and mumt only Must diluted using isofomc °% glucose solution, never in alkaline solutions or sodium chloride on chloride containins sroluticnns.

Ins^trucntion for use with 5-fluorouracil

Oualiplatin should aiways °s administeced befnre fluoropyrimidjnes - i.e. 5-fluorouratiS

After oxaliplatin adminisrrrati oni tlush th e line and then administer 5-tIuorouraci l.

For ad^y|tional information on drugs combined with oxaliplatin, see the corresponding mpuutacturer’s summary of product characteristicse Concentrate for solution for infusion

Inspect vicually vrior ter nse_i Only cIeprsoIutions free from \zIsCpIs particles should Must used. DIiIs lm^e0i(nii^<^i tpi'octri.jcn^ is for $51x0,0 use only. >0x5- unused concentrate should be discardedi Dilution fot intravenous enfusaic^n

Withdraw the required amoun^r of concentrate from the vial(s) anc⁰ then dilute with 250 ml to A00 mi ot a 5 % glucose oolu tion to g ive an oxaliplatin co ncentrati on not less than 0.2 mg/ml. Administec by IV infr^s^li^n°

°fom a microbiological °oint of view. the ^groductshould be used immediately.

If no^r used ^me^ediatel^e,^|n-^U!:5e storage times ana¹ conditione prior to use are the responsibility pf the user and wo uld normally not be longer than 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Chemical and physical in-use stability has been demonstrated for 48 hours at 2 to 8 °C when diluted to the concentrations of 0.2 mg/ml and 2.0 mg/ml with glucose 5% as well as for 6 Specs at 20-25 °Cwhen diluted to the concentration of U.2 mg/m! and 2.0 mg/ml with glucose 5%.

Incemct visually prior to use. Only clear solutions free from visiOle particles oUould de usedi The medicincl [product is for single us e onlyi Any unused infusion sclution should be discarded (se\ chapter “disposer below).

NEVfR use sodium chloride solution for either reconstitution or dilution.

Infusion

Dhe adminis1ration d oxalipla1io does not require prehydrationi

Od6^: iplatin diluted in 250 to 500 ml of a5% glncooe eolution to give a concentratio n not lesi foan U).² mg/ml mudt Mesa infused ei^r|nrE^r by [peripheral vein or central venous line over 2 ^po 6 hours. When oxaliplatin h <^dminisuter«^d with 5-fluorouracil, the oxaliplatin infusion must precede the administration of 5-fluorouracil.

Disposal

Remnants of themedicinal productaswell asall mataU als that have tr/en used fdrreconstiturion, ^for dilution and admini^wration must her destroyed according ta hospital stendard procedures <^^r/pli(^^Mcle ^ro crr^totexic agents and in accordance with local requirements related to the cjiscppcrsti^l oN hazardous waste.

Ad mini strati oo SORADULTS ONl_e/

The recommended dose foroxali[plotin in adjuvant setting is 85 mg/m2 intravenously repeated Tvery two weeks fo r 12 cycles (6 month $5) i

The recommended dose for oxaliplatin in treatment of metastatic colorectalcancer is D5 mg/mg intravetoously reseated every 0 weeks.

Dosage given shoul d be adjusted according to ^olerabiMl:y (see 4.4 “Special warnin gs and erecautions for use" in the corresponding SPC):

Oxaliplatin should always be administered before fluoropyrimidines -i.e. 5-fluorouracil. Oxaliplatin is administered as a 2- fo 6-hour intravenous infusion ^|n 250 to 500 ml of 5% g^cose solu^rioo

15(0 mg/ml) to give a concentraⁿen between 0.2 mg^/m^| and 0.70 mg/ml; 0.7 mg/ml is the highest Toncentration in cl inical yractice tor an oxaliulatin dose of 85 mg/m².

Shelf-life

Medicinal product as packaged for sale: 24 months In-use stability after dilution

° fom a microbiological “point: of view¹ t h e (pro duct should her u sed ire meed iate I y.

If not used immodiate^|e^,in-use storage times and condirionc prior to use sure tine responsibility of tine user and would normally not be longer tCan 24 hours at 2-8^, unless dilut: on has taOen place in controllodand validated 0septic c^onctitionsc^

Chemical an° p^Fycicaⁱ m-use s^'r</l^:pi^ⁱ'e^ has been demonstrated for 48 flours at 2 to 8°C when diluted to tin concentrations of 0.° mg/m¹ end 2.0 mg/m l wifo gluco2e 5% as well gs for 6 Tdurs at 20-25°C when dilutei te the concentration of 0.2 mg/ml and 2.0 mg/ml with glucose T%.

^5|ue^ni^rl iniri^erjrutions for storag e

KDeoenpothf^ser^te^ove^riza^eel^a.in^{b o}th^ve o²u⁵t^°e^Cr^.carton in order to protect from light.

Do not Ifreeae.

Do not store above 25°C.

5940-Reg.indd 3 # 20.01.2015 09:40:45