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Paclitaxel - Package Insert - Ireland+UK (Bordon) Circulation No. 1

(Travesh Sharma) D:\Europe\Paclitaxel (Bordan)\Ireland-UK\18 April 2013\Paclitaxel - Package Insert - Ireland+UK (Bordon).indd Size: 339 x 280 mm

Package leaflet: information for the user

Paclitaxel 6 mg/ml

concentrate for solution for infusion

Paclitaxel

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

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

- If you have any further questions, ask your doctor or nurse.

- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1. What Paclitaxel is and what it is used for

2. What you need to know before you use Paclitaxel

3. How to use Paclitaxel

4. Possible side effects

5. How to store Paclitaxel

6. Contents of the pack and other information

1. What Paclitaxel is and what it is used for

The name of your medicine is ‘Paclitaxel 6 mg/ml concentrate for solution for infusion’ but in the rest of the leaflet it will be called “Paclitaxel”.

This medicine belongs to a group of anti-cancer medicines called taxanes. These agents inhibit the growth of cancer cells.

Paclitaxel is used to treat:

Ovarian cancer:

• as first therapy (after initial surgery in combination with the platinum-containing medicine cisplatin).

• after standard platinum-containing medicines have been tried but did not work.

Breast cancer:

• as first therapy for advanced disease or disease which has spread to other parts of the body (metastatic disease). Paclitaxel is either combined with an anthracycline (e.g. doxorubicin) or with a medicine called trastuzumab (for patients for whom anthracycline is not suitable and whose cancer cells have a protein on their surface called HER 2, see package leaflet of trastuzumab).

• after initial surgery following treatment with anthracycline and cyclophosphamide (AC) as an additional treatment.

• as a second-line treatment for patients who have not responded to standard treatments using anthracyclines, or for whom such treatment should not be used.

Advanced non-small-cell lung cancer:

• in combination with cisplatin, when surgery and/or radiation therapy aren’t suitable. AIDS-related Kaposi’s sarcoma:

• where another treatment (i.e. liposomal anthracyclines) has been tried but did not work.

2. What you need to know before you use Paclitaxel Do not use Paclitaxel:

- if you are allergic to paclitaxel or any of the other ingredients of this medicine (listed in section 6), especially macrogolglycerol ricinoleate);.

- if you are breast-feeding;

- if you have too few white blood cells count (baseline neutrophil counts <1.5 x 10⁹/l - your doctor will advise you on this) in your blood. Your doctor will take blood samples to check this.

- If you have a serious, uncontrolled infection and paclitaxel is to be given for the treatment of Kaposi’s sarcoma

To minimize allergic reactions, you will be given other medicines before you receive Paclitaxel.

Paclitaxel is not recommended for use in children (under 18 years).

Warnings and precautions

Talk to your doctor or nurse before using Paclitaxel

Tell your doctor immediately if any of these apply to you.

- If you experience allergic reactions.

- If you have signs of bone marrow suppression.

- If you have numbness, tingling, pricking sensations, sensitivity to touch, or weakness of the arms and legs.

- if you have severe liver problems

- If you have heart problems.

- If you develop severe or persistent diarrhoea.

- If you had previous radiation to your chest.

- If you have a sore or red mouth and are treated for Kaposi’s Sarcoma.

Paclitaxel should always be administered into veins. Administration of Paclitaxel in the arteries can cause inflammation of the arteries, and you can suffer from pain, swelling, redness and heat.

Other medicines and Paclitaxel

Tell your doctor if you are using or have recently used any other medicines.

Interaction means that different medicines may influence each other. Interaction may occur and your doctor needs to know when using Paclitaxel together with:

• cisplatin (to treat cancer): Paclitaxel must be given before cisplatin. Your renal function may need to be checked more frequently.

• doxorubicin (to treat cancer): Paclitaxel must be administered 24 hours after doxorubicin, to avoid high level of doxorubicine in your body.

• trastuzumab (to treat cancer): Paclitaxel can be started immediately after trastuzumab infusion if it was tolerated. If otherwise, infusion of Paclitaxel maybe delayed.

• efavirenz, nevirapine, ritonavir, nelfinavir, or other protease-inhibitors, which are HIV treatments. A dose adjustment of Paclitaxel may be necessary.

• erythromycin, an antibiotic, fluoxetine, an antidepressant or gemfibrozil, used for lowering cholesterol. A dose reduction of Paclitaxel may be necessary.

• rifampicin, an antibiotic used for tuberculosis. A dose increase of Paclitaxel may be necessary.

• carbamazepine, phenytoin or phenobarbital, used for epilepsy.

Paclitaxel with food, drink and alcohol

Paclitaxel is unaffected by food and drink (For alcohol refer below to sections Driving and using machines and Excipients.).

Pregnancy, breast-feeding and fertility

Tell your doctor if you are pregnant or think you may be pregnant before receiving treatment with Paclitaxel. If there is a chance that you could become pregnant, use an effective and safe method of contraception during treatment. Paclitaxel should not be used during pregnancy unless clearly necessary. Female and male patients of fertile age, and/or their partners should use contraceptions for at least 6 months after treatment with paclitaxel. Male patients should seek advice regarding cryoconservation of sperm prior to treatment with paclitaxel because of the possibility of irreversible infertility.

If you are breast-feeding, tell your doctor. It is not known if paclitaxel passes into breast milk. Because of the possibility of harm to the infant stop breast-feeding if you are taking Paclitaxel. Do not restart breast-feeding unless your doctor has allowed you to.

Driving and using machines

Paclitaxel has not been reported to interfere with this ability. However as it contains alcohol, your ability to drive and use machines may be decreased.

Paclitaxel contains castor oil (macrogolglycerol ricinolate) and alcohol

Paclitaxel contains castor oil that may cause severe allergic reactions. If you are allergic to castor oil, talk to your doctor before you receive Paclitaxel.

This medicinal product contains 49.7 vol % ethanol (alcohol), i.e. up to 23 g per dose, equivalent to approximately 600 ml beer, approximately 250 ml wine per dose.

Harmful for those suffering from alcoholism.

To be taken into account in pregnant or breast-feeding women, children and high risk groups such as patients with liver disease or epilepsy.

3. How to use Paclitaxel

• To minimise allergic reactions, you will be given other medicines such as corticosteroids (dexamethasone), antihistamines (diphenhydramine) and ^-blocker (cimetidine) before starting Paclitaxel. These medicines can be given as either tablets or infusion into a vein or both.

• You will receive paclitaxel as a drip into one of your veins (by intravenous infusion), through an in-line filter. Paclitaxel will be administered to you by a healthcare professional. He or she will prepare the solution for infusion before it is given to you. The dose you receive will also depend on results of your blood tests. Depending on the type and severity of the cancer you will receive Paclitaxel either alone or in combination with another anticancer agent.

• Paclitaxel should always be administered into one of your veins over a period of 3 or 24 hours. It is usually given every 2 or 3 weeks, unless your doctor decides otherwise. Your doctor will inform you about the number of courses of Paclitaxel you need to receive.

If you have any further questions on the use of this product, ask your doctor.

If you use more Paclitaxel than you should

There is no known antidote for Paclitaxel overdose. You will receive treatment of your

symptoms.

If you forget to use Paclitaxel If you think a dose has been missed let your doctor or nurse

know.

A double of the dose should not be given if a dose has been forgotten.

If you stop using Paclitaxel

Your doctor will decide when to stop treatment with paclitaxel.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if you notice any signs of allergic reactions. These may

include one or more of the following:

• flushing,

• skin reactions,

• itching,

• chest tightness,

• shortness or difficulty in breathing,

• swelling.

These can all be signs of serious side effects.

Tell your doctor immediately if you experience;

• fever, severe chills, sore throat or mouth ulcers (signs of bone marrow suppression).

• numbness or weakness of the arms and legs (signs of peripheral neuropathy).

• severe or persistent diarrhoea, with fever and stomach pain.

Very common: may affect more than 1 in 10 people

• Minor allergic reactions such as flushing, rash, itching

• Infections: mainly upper respiratory infection, urinary tract infection

• Shortness of breath

• Sore throat or mouth ulcers, sore and red mouth, diarrhoea, feeling or being sick (nausea, vomiting)

• Hair loss

• Pain in the muscles, cramps, pain in the joints

• Fever, severe chills, headache, dizziness, tiredness, looking pale, bleeding, bruising more easily than normal

• Numbness, tingling or weakness in arms and legs (all symptoms of peripheral neuropathy) o

• Tests may show: reduction of blood platelet count, white or red blood cells count, low blood pressure

Common: may affect up to 1 in 10 people |

• Temporary mild nail change and skin changes, reactions at injection sites (localised swelling, pain, and redness of the skin)

• Tests may show: slower heart rate, severe elevation in liver enzymes (alkaline phosphatase

and AST - SGOT) |

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Uncommon: may affect up to 1 in 100 people

• Shock due to infections (known as ‘septic shock’)

• Palpitations, cardiac dysfunction (AV block), rapid beating of the heart, heart attack, respiratory distress

• Fatigue, sweating, fainting (syncope), significant allergic reactions, phlebitis (inflammation of a vein), swelling of the face, lips, mouth, tongue or throat

• Back pain, chest pain, pain around hands and feet, chills, abdominal (tummy) pain

• Tests may show: severe elevation of bilirubin (jaundice), high blood pressure, and blood clot.

Rare: may affect up to 1 in 1,000 people

• Shortage of white blood cells with fever and increased risk of infection (febrile neutropenia)

• Affection of nerves with feeling of weakness in muscles of arms and legs (motor neuropathy)

• Heart failure (Cardiac failure)

• Shortness of breath, pulmonary embolism, lung fibrosis, interstitial pneumonia, dyspnoea, pleural effusion

• Bowel obstruction, bowel perforation, inflammation of colon (ischaemic colitis), inflammation of the pancreas (pancreatitis)

• Pruritus, rash, skin redness (erythema)

• Blood poisoning (sepsis), peritonitis

• Pyrexia, dehydration, asthenia, oedema, malaise

• Serious and potentially fatal hypersensitivity reactions (anaphylactic reactions)

• Tests may show: increase in blood creatinine indicating renal function impairment Very rare: may affect up to 1 in 10,000 people

• Irregular rapid heart rhythm (atrial fibrillation, supraventricular tachycardia)

• Sudden disorder in blood forming cells (acute myeloid leukaemia, myelodysplastic syndrome)

• Optic nerve and/or visual disturbances (scintillating scotomata)

• Hearing loss or reduction (ototoxicity), ringing in the ears (tinnitus), vertigo

• Cough

• Blood clot in a blood vessel of abdomen and bowel (mesenteric thrombosis), inflammation of colon sometimes with persistent severe diarrhoea (pseudomembranous colitis, neutropenic colitis), dropsy (ascites), oesophagitis, constipation.

• Serious hypersensitivity reactions including fever, skin redness, pain in joints and/or inflammation of the eye (Stevens-Johnson syndrome), local peeling of the skin (epidermal necrolysis), redness with irregular red (exudative) spots (erythema multiforme), inflammation of the skin with blisters and peeling (exfoliative dermatitis), urticaria, loose nails (patients on therapy should wear sun protection on hands and feet).

• Loss of appetite (anorexia).

• Serious and potentially fatal hypersensitivity reactions with shock (anaphylactic shock).

• Disturbed liver function (hepatic necrosis, hepatic encephalopathy (both with reported cases of fatal outcome))

• Confusional state.

Not known: frequency cannot be estimated from the available data

• Tumor lysis syndrome

• Macular edema, photospia, vitreous floaters

• Phlebitis

• Scleroderma

• Systemic lupus erythematous Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

For UK - You can also report side effects directly via the Yellow Card Scheme at: www.mhra. gov.uk/yellowcard

For Ireland - Reports may be made by following the links to the online reporting option accessible from the IMB homepage, or by completing the downloadable report form also

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accessible from the IMB website, which may be completed manually and submitted to the IMB via freepost, to the following address:

FREEPOST

Pharmacovigilance Section Irish Medicines Board Kevin O’Malley House Earlsfort Centre Earlsfort Terrace Dublin 2

Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.imb.ie(http://www.imb.ie) e-mail: imbpharmacovigilance@imb.ie

5. How to store Paclitaxel

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Keep the vial in the outer carton in order to protect from light.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Do not use this medicine if you notice cloudy solution or an insoluble precipitate.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Paclitaxel contains

- The active substance is paclitaxel . Each ml of concentrate for solution for infusion contains 6 mg of paclitaxel.

A vial contains 5 ml of paclitaxel (corresponding to 30 mg paclitaxel).

A vial contains 16.7 ml of paclitaxel (corresponding to 100 mg paclitaxel).

A vial contains 25 ml of paclitaxel (corresponding to 150 mg paclitaxel).

A vial contains 50 ml of paclitaxel (corresponding to 300 mg paclitaxel).

A vial contains 100 ml of paclitaxel (corresponding to 600 mg paclitaxel).

- The other ingredients are ethanol anhydrous, macrogolglycerol ricinoleate and citric acid anhydrous (for pH adjustment)

What Paclitaxel looks like and contents of the pack

Concentrate for solution for infusion.

Paclitaxel is a clear, slightly yellowish solution.

Paclitaxel is available in glass vials. The glass vials are sealed with Teflon® coated rubber stoppers.

Pack sizes: Packs containing 1 or 5 glass vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder Fresenius Kabi Limited Cestrian Court, Eastgate Way,

Manor Park, Runcorn,

Cheshire, WA7 1NT UK

Manufacturer

Fresenius Kabi Oncology Plc.

Lion Court, Farnham Road, Bordon,

Hampshire, GU35 0NF, United Kingdom

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria	Paclitaxel Kabi 6 mg/ml Konzentrat zur Herstellung einer Infusionslosung
Belgium	Paclitaxel Fresenius Kabi
Bulgaria	Paclitaxel Kabi 6 mg/ml KoH^mpaT 3a HH$y3HOHeH pa3TB0p
Cyprus	Paclitaxel Kabi 6 mg/ml nuKvo Sialupa yia napaaKsu^ Sialnpaxoq npoq syxuan
Czech Republic	Paclitaxel Kabi 6 mg/ml koncentrat pro pnpravuinfuzmho roztoku
Denmark	Paclitaxel Fresenius Kabi 6 mg/ koncentrat til infusionsvaeske, opl0sning
Estonia	Paclitaxel Kabi 6 mg/ml infusioonilahuse kontsentraat
Germany	Paclitaxel Kabi 6 mg/ml Konzentrat zur Herstellung einer Infusionslosung
Greece	Paclitaxel Kabi 6 mg/ml nuKvo Sialupa yia napaaKsu^ Sialnpaxoq npoq syxuan
Finland	Paclitaxel Fresenius Kabi 6 mg/ml infuusiokonsentraatti, liuosta varten
France	Paclitaxel Kabi 6 mg/ml solution a diluer pour perfusion
Hungary	Paclitaxel Kabi 6 mg/ml koncentratum oldatos infuziohoz
Ireland	Paclitaxel 6 mg/ml concentrate for solution for infusion
Italy	Paclitaxel Kabi 6 mg/ml concentrato per soluzione per infusione
Latvia	Paclitaxel Kabi 6 mg/ml koncentrats infuziju sklduma pagatavosanai
Lithuania	Paclitaxel Kabi 6 mg/ml koncentratas infuziniam tirpalui
Luxemburg	Paclitaxel Kabi 6 mg/ml Konzentrat zur Herstellung einer Infusionslosung
Netherlands	Paclitaxel Fresenius Kabi
Norway	Paclitaxel Fresenius Kabi 6 mg/ml konsentrat til infusjonsv^ske
Poland	Paclitaxel Kabi
Portugal	Paclitaxel Kabi 6 mg/ml concentrado para solu9ao para perfusao
Romania	Paclitaxel Kabi 6 mg/ml concentrat pentru solutie perfuza
Slovakia	Paclitaxel Kabi 6 mg/ml
Slovenia	Paklitaksel Kabi 6 mg/ml koncentrat za raztopino za infundiranje
Spain	Paclitaxel Fresenius Kabi 6 mg/ml concentrado para solucion para perfusion
Sweden	Paclitaxel Fresenius Kabi 6 mg/ml koncentrat till infusionsvatska, losning
United Kingdom	Paclitaxel 6 mg/ml concentrate for solution for infusion

This leaflet was last revised in 08/2013.

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