Vectibix 20 mg/ml concentrate for solution for infusion

Vectibix is used in the treatment of metastatic colorectal carcinoma (cancer of the bowel) after failure of chemotherapy (medicines used to treat cancer) treatment.

Vectibix is for use in adults 18 years and over.

Vectibix contains the active substance panitumumab, which belongs to a group of medicines called monoclonal antibodies. Monoclonal antibodies are proteins, which specifically recognise and attach (bind) to other unique proteins in the body.

Panitumumab recognises and binds specifically to a protein known as epidermal growth factor receptor (EGFR), which is found on the surface of some cancer cells. When growth factors (other body proteins) attach to the EGFR, the cancer cell is stimulated to grow and divide. Panitumumab binds onto the EGFR and prevents the cancer cell from receiving the messages it needs for growth and division.

Do not use Vectibix

• if you have ever had a severe or life-threatening allergic (hypersensitivity) reaction to panitumumab or any of the other ingredients of Vectibix.
• if you have previously had or have evidence of interstitial pneumonitis (swelling of the lungs causing coughing and difficulty breathing) or pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath).

Take special care with Vectibix

Your doctor will check your blood levels of several substances such as magnesium, and other electrolyte levels such as calcium and potassium in your blood before you start Vectibix treatment. If these levels are too low, your doctor may prescribe you appropriate supplements.

During treatment with Vectibix

You may experience dermatologic toxicities (skin reactions), if these worsen or become intolerable please tell your doctor or nurse immediately.

It is recommended that you limit sun exposure whilst receiving Vectibix and if you are experiencing skin reactions as sunlight can worsen these. Wear sunscreen and a hat if you are going to be exposed to sunlight.

Your doctor will ask you to come in for tests to monitor hypomagnesaemia (low magnesium levels in the blood) and hypocalcaemia (low calcium levels in the blood) periodically during your treatment, and for up to 8 weeks after you have finished your treatment.

Using other medicines

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

Pregnancy and breast-feeding

Vectibix has not been tested in pregnant women. It is important to tell your doctor if you are pregnant; think you may be pregnant; or plan to get pregnant. Vectibix could affect your ability to stay pregnant.

If you are a woman of child bearing potential, you should use suitable methods of contraception during treatment with Vectibix and for 6 months after the last dose.

Do not breast-feed your baby during treatment with Vectibix and for 3 months after the last dose.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. You should speak with your doctor before driving or using machines, as some side effects may impair your ability to do so safely.

Vectibix will be administered in a healthcare facility under the supervision of a doctor experienced in the use of anti-cancer medicines.

Vectibix is administered intravenously (into a vein) with an infusion pump (a device that gives a slow injection).

The recommended dose of Vectibix is 6 mg/kg (milligrams per kilogram of body weight) given once every two weeks. The treatment will usually be given over a period of approximately 60 minutes.

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

Very common side effects (seen in more than 1 in 10 people who take Vectibix) were:

• acne-like rash; acne; pruritus (itching); erythema (redness of skin); rash; skin exfoliation (flaking skin); dry skin; skin fissures (cracks in the skin); exfoliating rash (flaking rash);
• diarrhoea; nausea; vomiting; abdominal pain; constipation;
• stomatitis (chapped lips, mouth ulcers and cold sores);
• fatigue (extreme tiredness);
• pyrexia (fever or high temperature);
• paronychia (nail infection);
• cough; dyspnoea (breathing difficulties).

Common side effects (seen in more than 1, but less than 10 in 100 people taking Vectibix) were:

• infusion type reactions which may include signs and symptoms such as abdominal pain, back pain, breathing difficulties, chest pain, flushing, rapid heart rate,; hypotension (low blood pressure); hypertension (high blood pressure);, vomiting; chills; new onset of facial swelling and/or swelling of the mouth; and/or pyrexia (fever or high temperature);
• hand-foot syndrome (redness and swelling of palms of hands or soles of feet);
• onycholysis (loosening of the nails); nail disorder;
• rash pustular (skin rash with pus-filled blisters);
• eye infection; eyelid infection;
• cellulitis (spreading infection below the skin);
• hypomagnesaemia (low magnesium levels in the blood);
• hypocalcaemia (low calcium levels in the blood);
• hypokalaemia (low potassium levels in the blood);
• dehydration;
• nasal dryness; epistaxis (nose bleed);
• headache; dizziness;
• rash papular (bumpy rash); rash pruritic (itchy rash); rash erythematous (red skin rash); rash macular (spotty rash); rash maculo-papular (rash with bumps and spots); skin ulcer; scab;
• conjunctivitis (eye inflammation); growth of eyelashes and lacrimation increased (flow of tears); ocular hyperaemia (redness of the eye); dry eye; eye pruritus (itchy eyes); eyelid irritation; eye irritation;
• pulmonary embolism (blood clot in the lung);
• mucosal inflammation (inflammation of the mouth); dry mouth;
• onychoclasis (breaking of the nails);
• hypertrichosis (excess hair growth); alopecia (hair loss).

Uncommon side effects (seen in less than 1 in 100, but more than 1 in 1000 people taking Vectibix)

were:

• bronchospasm (constriction of the airways);
• anaphylactic reactions (severe allergic reaction);
• flushing; hypotension (low blood pressure); hypertension (high blood pressure);
• cyanosis (blue coloration of the skin and mucous membranes).

Rare side effects (seen in less than 1 in 1000, but more than 1 in 10,000 people taking Vectibix) were:

• angioedema (swelling of the mouth, face and throat causing difficulty in breathing).

Infusion-type reactions, which may include signs and symptoms such as chills, new onset of facial swelling, breathing difficulties, vomiting and/or fever or pyrexia (high temperature) may appear several hours or days after an infusion. If any of these side effects gets serious , please tell your doctor.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Important information about some of the ingredients of Vectibix

This medicinal product contains 0.150 mmol sodium (which is 3.45 mg sodium) per ml of concentrate. To be taken into consideration by patients on a controlled sodium diet.

Vectibix will be stored in the healthcare facility where it is used.

Keep out of the reach and sight of children.

Store in a refrigerator (2°C ? 8°C).
Do not freeze.
Store in the original carton in order to protect from light.

Do not use Vectibix 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.

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.

What Vectibix contains

The active substance is panitumumab 20 mg/ml.
The other ingredients of Vectibix are sodium chloride, sodium acetate trihydrate, acetic acid (glacial) and water for injections.

What Vectibix looks like and contents of the pack

Vectibix is a colourless liquid that may contain visible particles and is supplied in a vial. Each pack contains one vial of either 5 ml, 10 ml or 20 ml of concentrate.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgiqueBelgien s.a. Amgen n.v. TelTél 32 02 7752711 LuxembourgLuxemburg s.a. Amgen BelgiqueBelgien TelTél 32 02 7752711

. 359 02 805 7020 Magyarország Amgen Kft. Tel. 36 1 35 44 700

eská republika Amgen s.r.o Tel 420 2 21 773 500 Malta Amgen B.V. The Netherlands Tel 31 076 5732500

Danmark Amgen filial af Amgen AB, Sverige Tlf 45 39617500 Nederland Amgen B.V. Tel 31 076 5732500

Deutschland AMGEN GmbH Tel 49 089 1490960 Norge Amgen AB Tlf 47 23308000

Eesti Amgen Switzerland AG Eesti filiaal Tel 372 5125 501 Österreich Amgen GmbH Tel 43 01 50 217

Amgen . . 30 210 3447000 Polska Amgen Sp. z o.o. Tel. 48 22 581 3000

España Amgen S.A. Tel 34 93 600 19 00 Portugal AMGEN Biofarmacêutica, Lda. Tel 351 21 4220550

France Amgen S.A.S Tél 33 01 40 88 27 00 România Amgen România SRL Tel 4021 527 3000

Slovenská republika Amgen Switzerland AG Slovakia Tel 421 33 321 13 22 Ireland Amgen Limited United Kingdom Tel 44 01223 420305

Ísland Vistor hf. Sími 354 535 7000 Slovenija AMGEN zdravila d.o.o. Tel 386 1 585 1767

Italia Amgen Dompé S.p.A. Tel 39 02 6241121 SuomiFinland Amgen AB, sivuliike SuomessaAmgen AB, filial i Finland PuhTel 358 09 54900500

K Papaellinas Co Ltd 357 22741 741 Sverige Amgen AB Tel 46 08 6951100

Latvija Amgen Switzerland AG Rgas filile Tel 371 29284 807 United Kingdom Amgen Limited Tel 44 01223 420305

Lietuva

Amgen Switzerland AG Vilniaus filialas
Tel: +370 6983 6600

This leaflet was last approved in

This medicine has been given ?conditional approval?.
This means that there is more evidence to come about this medicine.
The European Medicines Agency (EMA) will review new information on the medicine every year and this leaflet will be updated as necessary.
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The following information is intended for medical or healthcare professionals only:

Vectibix should be diluted in 0.9% sodium chloride injection by healthcare professional using aseptic technique. Do not shake or vigorously agitate the vial. Do not administer Vectibix if discolouration is observed. Withdraw the necessary amount of Vectibix for a dose of 6 mg/kg. Dilute in a total volume of 100 ml. Doses higher than 1000 mg should be diluted in 150 ml 0.9% sodium chloride injection. The final concentration should not exceed 10 mg/ml. The diluted solution should be mixed by gentle inversion, do not shake.

The infusion line should be flushed with sodium chloride solution before and after Vectibix administration to avoid mixing with other medicinal products or IV solutions.

Vectibix must be administered as an intravenous infusion via an infusion pump, using a low protein binding 0.2 or 0.22 micrometer in-line filter, through a peripheral line or indwelling catheter. The recommended infusion time is approximately 60 minutes. Doses higher than 1000 mg should be infused over approximately 90 minutes.

No incompatibilities have been observed between Vectibix and 0.9% sodium chloride injection in polyvinyl chloride bags or polyolefin bags.