Vectibix

Package leaflet: Information for the user

Vectibix 20 mg/mL concentrate for solution for infusion

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

Contents of this leaflet

1. What Vectibix is and what it is used for
2. What you need to know before using Vectibix
3. How to use Vectibix
4. Possible side effects
5. How to store Vectibix
6. Contents of the pack and other information

1. What Vectibix is and what it is used for

Vectibix is used to treat metastatic colorectal cancer (cancer of the bowel) in adult patients with a certain type of tumour known as "RAS wild-type tumour". Vectibix is used alone or in combination with other anti-cancer medicines.
Vectibix contains the active substance panitumumab, which belongs to a group of medicines called monoclonal antibodies. Monoclonal antibodies are proteins that recognise and specifically bind to particular proteins in the body.
Panitumumab specifically recognises and binds to a protein called epidermal growth factor receptor (EGFR), which is found on the surface of some tumour cells. When growth factors (other proteins in the body) bind to EGFR, the tumour cell is stimulated to grow and multiply. Panitumumab binds to EGFR and prevents the tumour cell from receiving signals it needs to grow and multiply.

2. What you need to know before using Vectibix

Do not use Vectibix

• if you are allergic to panitumumab or to any of the other ingredients of this medicine (listed in section 6).
• if you are currently experiencing or have previously experienced signs of interstitial pneumonia (lung inflammation causing cough and breathing difficulties) or pulmonary fibrosis (scarring and thickening in the lungs leading to shortness of breath).
• in combination with oxaliplatin-based chemotherapy, if the RAS test shows that you have a RAS mutated tumour or if the RAS status of your tumour is unknown. Please consult your doctor if you are unsure about your tumour’s RAS status.

Warnings and precautions
Skin reactions or severe swelling and tissue damage may occur; if these worsen or become intolerable, you must inform your doctor or nurse immediately. If you develop a severe skin reaction, your doctor may recommend adjusting the dose of Vectibix. If you develop a serious infection or fever as a result of skin reactions, your doctor may discontinue treatment with Vectibix.
You are advised to limit sun exposure during treatment with Vectibix and especially if skin reactions occur, as sunlight may worsen them. Use sunscreen and wear a hat when exposed to sunlight. Your doctor may recommend a moisturizing cream, a sunscreen (sun protection factor > 15), a topical steroid cream, and/or oral antibiotics, which may help manage skin toxicities associated with the use of Vectibix.
Your doctor will check blood levels of certain substances, including magnesium, calcium, and potassium, before starting treatment with Vectibix. Your doctor will also monitor blood levels of magnesium and calcium periodically during treatment and for up to 8 weeks after you have completed treatment. If these levels are too low, your doctor may prescribe appropriate supplements.
If you develop severe diarrhoea, inform your doctor or nurse immediately, as you may lose a significant amount of fluid from your body (become dehydrated), which could damage your kidneys.
Inform your doctor if you wear contact lenses and/or have a history of eye problems such as severe dry eyes, inflammation of the front part of the eye (cornea), or corneal ulcers.
If you develop acute or worsening eye redness and pain, increased tearing, blurred vision, and/or sensitivity to light, inform your doctor or nurse immediately, as urgent treatment may be required (see “Possible side effects” below).
Depending on your age (over 65 years) or general health status, your doctor will discuss with you your ability to tolerate Vectibix in combination with chemotherapy.

Other medicines and Vectibix
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Vectibix must not be used in combination with bevacizumab (another monoclonal antibody used for bowel cancer) or with the combination of chemotherapeutic agents irinotecan, 5-fluorouracil, and leucovorin, known as “IFL”.

Pregnancy and breastfeeding
Vectibix has not been studied in pregnant women. It is important that you inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. Vectibix may harm the unborn baby or impair your ability to carry a pregnancy to term.
If you are a woman of childbearing potential, you must use effective contraception during treatment with Vectibix and for 2 months after receiving the last dose.
Breastfeeding is not recommended during treatment with Vectibix and for 2 months after the last dose. It is important to inform your doctor if you are considering breastfeeding.

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

Driving and using machines
Consult your doctor before driving or operating machinery, as certain side effects may impair your ability to perform these activities safely.

Vectibix contains sodium
This medicine contains 3.45 mg of sodium (a key component of table salt) per mL. This corresponds to 0.17% of the maximum daily recommended dietary intake for an adult.

3. How to use Vectibix

Vectibix is administered in a healthcare setting under the supervision of a physician experienced in the use of anticancer medicinal products.
Vectibix is given intravenously (into a vein) using an infusion pump (a device that delivers the injection slowly).
The recommended dose of Vectibix is 6 mg/kg (milligrams per kilogram of body weight) every two weeks. The treatment is usually administered over approximately 60 minutes.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious and main side effects of Vectibix are listed below:

Infusion reactions
During or after treatment, an infusion reaction may occur. This may be mild or moderate and may affect up to 1 in 100 people, or may be severe and affect 1 in 1,000 people. Symptoms may include headache, skin rash, itching or hives, redness, swelling (face, lips, mouth, around the eyes and throat area), rapid and irregular heartbeat, fast pulse, sweating, nausea, vomiting, dizziness, difficulty breathing or swallowing, or a drop in blood pressure which may be severe or life-threatening, and very rarely may lead to death. If you experience any of these symptoms, you must inform your doctor immediately. Your doctor may decide to reduce the infusion dose or stop treatment with Vectibix.

Allergic reactions
Very rarely, severe allergic reactions (hypersensitivity) with symptoms similar to an infusion reaction (see "Infusion reactions") have occurred more than 24 hours after treatment and have led to death. Seek immediate medical help if you experience symptoms of an allergic reaction to Vectibix, including, but not limited to, difficulty breathing, tightness in the chest, feeling of suffocation, dizziness or fainting.

Skin reactions
Skin reactions may occur in about 94 out of 100 people taking Vectibix and are usually mild to moderate. The skin rash commonly resembles acne and often affects the face, upper chest and back, but may involve any area of the body. Some rashes are associated with redness, itching and skin peeling which may become severe. In some cases, this may lead to infected wounds requiring medical and/or surgical treatment, or cause serious skin infections which, in rare cases, may be fatal. Rarely, blistering of the skin, mouth, eyes and genitals may occur, which may indicate a serious skin reaction called "Stevens-Johnson syndrome", or blistering of the skin which may indicate a serious skin reaction called "toxic epidermal necrolysis". If you notice the appearance of blisters, you must inform your doctor immediately. Prolonged sun exposure may worsen the rash.
In addition, dry skin, fissures (cracks in the skin) of the fingers or toes, infection (paronychia) or inflammation of the nail beds of the hands or feet have been reported. Once treatment is suspended or discontinued, skin reactions generally resolve. Your doctor may decide to treat the rash, adjust the dose or suspend treatment with Vectibix.

Other side effects include:

Very common: may affect more than 1 in 10 people

• low red blood cell count (anaemia); low potassium levels in the blood (hypokalaemia); low magnesium levels in the blood (hypomagnesaemia);
• conjunctivitis;
• localized or widespread skin rash which may be accompanied by bumps (with or without spots), itchy, red or scaly;
• hair loss (alopecia); mouth ulcers and cold sores (herpes labialis) (stomatitis); inflammation of the mouth (mucosal inflammation);
• diarrhoea; nausea; vomiting; abdominal pain; constipation; decreased appetite; weight loss;
• extreme tiredness; fever or high temperature; lack or loss of strength (asthenia); fluid accumulation in a limb (peripheral oedema);
• back pain;
• difficulty falling asleep (insomnia);
• cough; breathing difficulties (dyspnoea).

Common: may affect up to 1 in 10 people

• low white blood cell count (leucopenia); low calcium levels in the blood (hypocalcaemia); low phosphate levels in the blood (hypophosphataemia); high blood glucose levels (hyperglycaemia);
• excessive growth of eyelashes; persistent tearing; eye redness; dry eyes; eye itching; eye irritation; inflammation of the eyelids (blepharitis);
• skin ulcer; crusts; excessive hair growth; redness and swelling of the palms of the hands or soles of the feet (hand-foot syndrome); excessive sweating; dermatitis;
• widespread skin infection beneath the skin (cellulitis); inflammation of the hair follicle (folliculitis); localized infection; skin rash with pus-filled blisters (pustular skin rash); urinary tract infection;
• nail disorders; nail breakage;
• dehydration;
• dry mouth; indigestion (dyspepsia); bleeding from the rectum (rectal haemorrhage); inflammation of the lips (cheilitis); heartburn (gastro-oesophageal reflux);
• chest pain; pain; chills; limb pain; immune reaction (hypersensitivity); rapid heartbeat (tachycardia);
• blood clot in the lung (pulmonary embolism), symptoms of which may include sudden shortness of breath or chest pain; nosebleed (epistaxis); blood clot in a deep vein (deep vein thrombosis); high blood pressure (hypertension); redness;
• headache; dizziness; anxiety.

Uncommon: may affect up to 1 in 100 people

• bluish discolouration of the skin and mucous membranes (cyanosis);
• death of skin cells (cutaneous necrosis);
• severe skin reaction with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome);
• severe skin reaction with blistering (toxic epidermal necrolysis);
• a serious condition involving ulceration of the front part of the eye (cornea) requiring urgent treatment (ulcerative keratitis);
• inflammation of the cornea, i.e. the front part of the eye (keratitis);
• eyelid irritation; chapped and/or dry lips; eye infection; eyelid infection; nasal dryness; nail loss; ingrown nail; excessive hair growth (hirsutism);
• inflammation of the lungs (interstitial lung disease).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vectibix

Vectibix will be stored at the healthcare facility where it will be administered.
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Keep in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Vectibix contains

• Each mL of concentrate contains 20 mg of panitumumab. Each vial may contain 100 mg of panitumumab in 5 mL, or 400 mg of panitumumab in 20 mL.
• The other components are sodium chloride, sodium acetate trihydrate, glacial acetic acid, and water for injections. See section 2 "Vectibix contains sodium".

Description of the appearance of Vectibix and contents of the pack
Vectibix is a colourless solution which may contain visible particles and is supplied in a glass vial. Each pack contains one vial.
Marketing Authorisation Holder and Manufacturer
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands
Marketing Authorisation Holder
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands
Manufacturer
Amgen Technology (Ireland) Unlimited Company
Pottery Road
Dun Laoghaire
Dublin
Ireland
Manufacturer
Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
s.a. Amgen n.v. Amgen Switzerland AG Vilniaus filialas
Tél/Tel: +32 (0)2 7752711 Tel. +370 5 219 7474
България Luxembourg/Luxemburg
Амджен България ЕООД s.a. Amgen
Тел.: +359 (0)2 424 7440 Belgique/Belgien
Tél/Tel: +32 (0)2 7752711
Česká republika Magyarország
Amgen s.r.o. Amgen Kft.
Tel: +420 221 773 500 Tel.: +36 1 35 44 700
Danmark Malta
Amgen, filial af Amgen AB, Sverige Amgen S.r.l.
Tlf.: +45 39617500 Italy
Tel: +39 02 6241121
Deutschland Nederland
Amgen GmbH Amgen B.V.
Tel.: +49 89 1490960 Tel: +31 (0)76 5732500
Eesti Norge
Amgen Switzerland AG Vilniaus filialas Amgen AB
Tel: +372 586 09553 Tlf: +47 23308000
Ελλάδα Österreich
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε. Amgen GmbH
Τηλ: +30 210 3447000 Tel: +43 (0)1 50 217
España Polska
Amgen S.A. Amgen Biotechnologia Sp. z o.o.
Tel: +34 93 600 18 60 Tel.: +48 22 581 3000
France Portugal
Amgen S.A.S. Amgen Biofarmacêutica, Lda.
Tél: +33 (0)9 69 363 363 Tel: +351 21 4220606
Hrvatska România
Amgen d.o.o. Amgen România SRL
Tel: +385 (0)1 562 57 20 Tel: +4021 527 3000
Ireland Slovenija
Amgen Ireland Limited AMGEN zdravila d.o.o.
Tel: +353 1 8527400 Tel: +386 (0)1 585 1767
Ísland Slovenská republika
Vistor hf. Amgen Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 321 114 49
Italia Suomi/Finland
Amgen S.r.l. Amgen AB, sivuliike Suomessa/Amgen AB, filial
Tel: +39 02 6241121 i Finland
Puh/Tel: +358 (0)9 54900500
Kύπρος Sverige
C.A. Papaellinas Ltd Amgen AB
Τηλ: +357 22741 741 Tel: +46 (0)8 6951100
Latvija
Amgen Switzerland AG Rīgas filiāle
Tel: +371 257 25888
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu .

The following information is intended for healthcare professionals only:

Vectibix is intended for single-use only. Vectibix must be diluted in 9 mg/mL (0.9%) sodium chloride injection solution by healthcare personnel using aseptic techniques. Do not shake or vigorously agitate the vial. Vectibix must be inspected visually prior to administration. The solution should be colourless and may contain visible, amorphous, translucent to white, proteinaceous particles (which will be removed by in-line filtration). Do not administer Vectibix if it does not appear as described above. Using only a 21-gauge or smaller diameter hypodermic needle, withdraw the required amount of Vectibix for a dose of 6 mg/kg. Do not use needle-free devices (i.e., vial adapters) to withdraw the contents of the vial. Dilute to a total volume of 100 mL. Doses exceeding 1,000 mg must be diluted in 150 mL of 9 mg/mL (0.9%) sodium chloride injection solution. The final concentration must not exceed 10 mg/mL. The diluted solution must be mixed by gently inverting the vial, but must not be shaken.
Vectibix does not contain antimicrobial preservatives or bacteriostatic agents. The product must be used immediately after dilution. If not used immediately, the user is responsible for the storage times and conditions prior to administration, which must not exceed 24 hours at a temperature of 2°C–8°C. The diluted solution must not be frozen.
Discard the vial and any residual liquid remaining in the vial after single use.
The infusion line must be flushed before and after administration of Vectibix with a sodium chloride solution to avoid mixing with other medicinal products or intravenous solutions.
Vectibix must be administered intravenously via an infusion pump and through a peripheral line or indwelling catheter equipped with a low-protein-binding in-line filter of 0.2 or 0.22 micrometres. The recommended infusion time is approximately 60 minutes. Doses exceeding 1,000 mg must be infused over approximately 90 minutes.
No incompatibilities have been observed between Vectibix and 9 mg/mL (0.9%) sodium chloride injection solution in polyvinylchloride or polyolefin bags.