Vectibix

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  • Heiti vöru:
  • Vectibix
  • Lyf við lungum:
  • Mannfólk
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  • Allópatísk lyf

Skjöl

Staðsetning

  • Fáanlegt í:
  • Vectibix
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Antineoplastic agents,
  • Lækningarsvæði:
  • Colorectal Neoplasms
  • Ábendingar:
  • Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC):in first-line in combination with Folfox or Folfiri.in second-line in combination with Folfiri for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan). as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
  • Vörulýsing:
  • Revision: 30

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/000741
  • Leyfisdagur:
  • 02-12-2007
  • EMEA númer:
  • EMEA/H/C/000741
  • Síðasta uppfærsla:
  • 28-03-2019

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United Kingdom

An agency of the European Union

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+44 (0)20 3660 6000

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+44 (0)20 3660 5555

Send a question via our website

www.ema.europa.eu/contact

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

EMA/165646/2017

EMEA/H/C/000741

EPAR summary for the public

Vectibix

panitumumab

This is a summary of the European Public Assessment Report (EPAR) for Vectibix. It explains how the

Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is

not intended to provide practical advice on how to use Vectibix.

For practical information about using Vectibix, patients should read the package leaflet or contact their

doctor or pharmacist.

What is Vectibix and what is it used for?

Vectibix is a medicine for treating colorectal (bowel) cancer that has spread to other parts of the body.

Vectibix is used alone or with other cancer medicines in patients with a type of tumour that has normal

(‘wild-type’) copies of a gene known as RAS.

It contains the active substance panitumumab.

How is Vectibix used?

Vectibix can only be obtained with a prescription. Treatment with Vectibix should be supervised by a

doctor who has experience in the use of cancer therapy. It should only be started after the presence of

wild-type RAS has been confirmed by an experienced laboratory using a validated test method.

Vectibix is available as a concentrate that is made up into a solution for infusion (drip) into a vein. The

recommended dose of Vectibix is 6 mg per kilogram body weight given once every two weeks. The

recommended infusion time is approximately 60 minutes, but larger doses may need 90 minutes. The

dose may need to be modified if severe skin reactions occur.

How does Vectibix work?

The active substance in Vectibix, panitumumab, is a monoclonal antibody, a type of protein that has

been designed to attach to and block a target called EGFR on the surface of certain cells, including in

Vectibix

EMA/165646/2017

Page 2/3

some tumours. As a result, these tumour cells can no longer receive the messages transmitted via

EGFR that they need to grow and spread to other parts of the body.

Panitumumab does not seem to work against tumour cells that contain mutated (abnormal) RAS

genes. This is because growth of these types of cells does not depend on EGFR and they can continue

to grow uncontrollably even when EGFR is blocked.

What benefits of Vectibix have been shown in studies?

Several bowel cancer studies have shown that Vectibix is effective at prolonging life or slowing disease

progression in patients with ‘wild-type’ RAS tumours that have spread. The studies show Vectibix can

be effective when used alone and together with the standard chemotherapy regimens FOLFOX (a

combination of 5-fluorouracil with folinic acid and the cancer medicine oxaliplatin) or FOLFIRI (5-

fluorouracil with folinic acid and a different cancer medicine, irinotecan).

Here are some of the main results from these studies:

Patients receiving Vectibix in combination with FOLFOX lived for an average of 10.1 months

without the disease getting worse in a study of 1,183 previously untreated patients compared with

7.9 months for those receiving FOLFOX alone.

Around 59% of patients who received Vectibix plus FOLFIRI in a study of 154 previously untreated

had some reduction in signs of cancer. Patients in this study (there was no comparator

treatment)lived for an average of 11.2 months without their disease getting worse.

Around 73% of patients given Vectibix plus FOLFIRI and 78% of those given Vectibix with FOLFOX

had some reduction in signs of cancer in a study of 80 previously untreated patients. Patients given

these combinations lived for an average of 14.8 months and 12.8 months respectively without their

disease getting worse.

Patients given Vectibix in combination with FOLFIRI lived for 16.2 months in a study of 1,186

previously treated patients compared with 13.9 months in patients receiving FOLFIRI alone.

Patients receiving Vectibix also had a longer period of time without their disease getting worse: 6.4

months versus 4.6 months.

Patients with wild-type tumours who received Vectibix alone had no disease progression for an

average of 16 weeks in a study of 463 patients, compared with 8 weeks in those who did not

receive Vectibix and only had supportive care. This study involved patients with either wild-type or

mutant RAS whose disease had got worse despite treatments that included a fluoropyrimidine,

oxaliplatin and irinotecan. It was later confirmed that benefit is limited only to patients with wild-

type RAS tumours.

What are the risks associated with Vectibix?

In studies, 93% of the patients receiving Vectibix had side effects affecting the skin, although most of

these were mild or moderate. The most common side effects with Vectibix (seen in more than 2

patients in 10) were diarrhoea, nausea (feeling sick), vomiting, constipation, abdominal pain (stomach

ache), fatigue (tiredness), pyrexia (fever), lack of appetite, paronychia (nail bed infection), rash,

acneiform dermatitis (skin inflammation resembling acne), pruritus (itching), erythema (reddening of

the skin) and dry skin. For the full list of all side effects reported with Vectibix, see the package leaflet.

Vectibix must not be used in patients who have had a severe or life-threatening hypersensitivity

(allergic) reaction to panitumumab or any of the other ingredients in the past. It must not be used in

Vectibix

EMA/165646/2017

Page 3/3

patients with interstitial pneumonitis or pulmonary fibrosis (lung diseases). Vectibix must not be used

with oxaliplatin-containing chemotherapy in patients whose tumour contains the mutated RAS gene or

for whom the RAS status is not known.

Why is Vectibix approved?

The CHMP concluded that Vectibix’s benefits are greater than its risks and recommended that it be

given marketing authorisation.

Vectibix was originally given ‘conditional approval’ because there was more evidence to come about

the medicine. As the company has supplied the additional information necessary, the authorisation has

been switched from conditional to full approval.

What measures are being taken to ensure the safe and effective use of

Vectibix?

The company that markets Vectibix will ensure that all doctors who are expected to prescribe Vectibix

are provided with educational material informing them of the importance of carrying out a RAS test

before treatment with Vectibix and only using Vectibix in patients whose tumour is confirmed to

contain the wild-type RAS gene.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Vectibix have also been included in the summary of product characteristics and the

package leaflet.

Other information about Vectibix

The European Commission granted a conditional marketing authorisation valid throughout the

European Union for Vectibix on 3 December 2007. This was switched to a full marketing authorisation

on 15 January 2015.

The full EPAR for Vectibix can be found on the Agency’s website ema.europa.eu/Find medicine/Human

medicines/European Public Assessment Reports. For more information about treatment with Vectibix,

read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 04-2017.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

Package Leaflet: Information for the user

Vectibix 20 mg/mL concentrate for solution for infusion

panitumumab

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.

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

What Vectibix is and what it is used for

What you need to know before you use Vectibix

How to use Vectibix

Possible side effects

How to store Vectibix

Contents of the pack and other information

1.

What Vectibix is and what it is used for

Vectibix is used in the treatment of metastatic colorectal cancer (cancer of the bowel) for adult patients

with a certain type of tumour known as a “Wild-type

RAS

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, 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.

2.

What you need to know before you use Vectibix

Do not use Vectibix:

if you are allergic to panitumumab or any of the other ingredients of this medicine (listed in

section 6).

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).

in combination with oxaliplatin-based chemotherapy, if your

RAS

test shows that you have

mutant

RAS

tumour, or if your

RAS

tumour status is unknown. Please consult your doctor if you

are unsure of your

RAS

tumour status.

Warnings and precautions

You may experience skin reactions or severe swelling and tissue damage, if these worsen or become

intolerable please tell your doctor or nurse immediately. If you experience a severe skin reaction, your

doctor may recommend an adjustment of the dose of Vectibix. If you develop a severe infection or

fever as a result of skin reactions, your doctor may stop your treatment with Vectibix.

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 may ask you to use a moisturiser, sun screen (SPF > 15), topical steroid,

and/or oral antibiotics which may help in the management of skin toxicities that can be associated with

the use of Vectibix.

Your doctor will check your blood levels of several substances such as magnesium, calcium and

potassium in your blood before you start Vectibix treatment. Your doctor will also check your blood

levels of magnesium and calcium periodically during your treatment, and for up to 8 weeks after you

have finished your treatment. If these levels are too low, your doctor may prescribe you appropriate

supplements.

If you experience severe diarrhoea please tell your doctor or nurse since you may lose a lot of water

from your body (become dehydrated) and this could damage your kidneys.

Tell your doctor if you use contact lenses and/or have a history of eye problems such as severe dry

eye, inflammation of the front part of the eye (cornea) or ulcers involving the front part of the eye.

If you develop acute or worsening redness and pain in the eye, increased eye watering, blurred vision

and/or sensitivity to light, please tell your doctor or nurse immediately as you may need urgent

treatment (see “Possible side effects” below).

Based on your age (older than 65 years) or general health, your doctor will discuss with you your

ability to tolerate taking Vectibix with your chemotherapy treatment.

Other medicines and Vectibix

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,

including medicines obtained without a prescription and herbal medicines.

Vectibix should not be used in combination with bevacizumab (another monoclonal antibody used in

cancer of the bowel) or with a chemotherapy combination known as “IFL”.

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 unborn baby or ability

to stay pregnant.

If you are a woman of child bearing potential, you should use effective methods of contraception

during treatment with Vectibix and for 2 months after the last dose.

It is not recommended to breast-feed your baby during treatment with Vectibix and for 2 months after

the last dose. It is important to tell your doctor if you plan to breast-feed.

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

Driving and using machines

You should speak with your doctor before driving or using machines, as some side effects may impair

your ability to do so safely.

Vectibix contains sodium

This medicine 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.

3.

How to use Vectibix

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.

4.

Possible side effects

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

The most serious side effects and main side effects for Vectibix are listed below:

Infusion reactions

During or following treatment you may experience an infusion reaction. These can be mild or

moderate (likely to occur in approximately 5 out of 100 people who take Vectibix), or severe (likely to

occur in 1 out of 100 people who take Vectibix). Symptoms may include headache, rashes, itching or

hives, flushing, 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

decrease in blood pressure that may be severe or life-threatening and, very rarely, may lead to death. If

you experience any of these symptoms, you should notify your doctor immediately. Your doctor may

decide to reduce the rate of your infusion or discontinue your treatment with Vectibix.

Allergic reactions

Very rarely, serious allergic (hypersensitivity) reactions involving symptoms similar to an infusion

reaction (see “Infusion reactions”) have occurred more than 24 hours after treatment and resulted in a

fatal outcome. Seek medical attention immediately if you experience symptoms of an allergic reaction

to Vectibix, including but not limited to difficulty breathing, chest tightness, a sensation of choking,

dizziness, or fainting.

Skin reactions

Skin-related reactions are likely to occur in approximately 94 out of 100 people who take Vectibix and

are usually mild to moderate. The skin rash commonly resembles acne and often involves the face,

upper chest and back, but can affect any area of the body. Some rashes have been associated with

redness, itching and flaking of the skin which can become severe. In some cases, it may cause infected

sores requiring medical and/or surgical treatment, or cause severe skin infections that in rare cases

could be fatal. In rare cases patients may experience blistering of the skin, mouth, eyes and genitals,

which may indicate a severe skin reaction called “Stevens-Johnson syndrome” or blistering of the

skin, which may indicate a severe skin reaction called “toxic epidermal necrolysis”. If you experience

blistering, you should notify your doctor immediately. Prolonged exposure to the sun can make the

rash worse. Also, dry skin, fissures (cracks in the skin) on the fingers or toes, fingernail bed or toenail

bed infection (paronychia) or inflammation has been reported. Once treatment is withheld or

discontinued, the skin reactions will generally resolve. Your doctor may decide to treat the rash, adjust

the dose or discontinue your treatment with Vectibix.

Other side effects include:

Very common:

may affect more than 1 in 10 people

low red blood cell numbers (anaemia); low potassium levels in the blood (hypokalaemia); low

magnesium levels in the blood (hypomagnesaemia);

eye inflammation (conjunctivitis);

local or widespread rash which may be bumpy (with or without spots), itchy, red or flaky;

hair loss (alopecia); mouth ulcers and cold sores (stomatitis); inflammation of the mouth

(mucosal inflammation);

diarrhoea; nausea; vomiting; abdominal pain; constipation; decreased appetite; decreased

weight;

extreme tiredness (fatigue); fever or high temperature (pyrexia); lack or loss of strength

(asthenia); accumulation of fluid in the extremities (oedema peripheral);

back pain;

inability to sleep (insomnia);

cough; dyspnoea (breathing difficulties).

Common:

may affect up to 1 in 10 people

low white blood numbers (leucopenia); low calcium levels in the blood (hypocalcaemia); low

phosphates in the blood (hypophosphataemia); high glucose in the blood (hyperglycaemia);

growth of eyelashes; flow of tears (lacrimation increased); redness of the eye (ocular

hyperaemia); dry eye; itchy eyes (eye pruritus); eye irritation; eyelid inflammation (blepharitis);

skin ulcer; scab; excess hair growth (hypertrichosis); redness and swelling of palms of hands or

soles of feet (hand-foot syndrome); excess sweating (hyperhidrosis); skin reaction (dermatitis);

spreading infection below the skin (cellulitis); hair follicle inflammation (folliculitis); localised

infection; skin rash with pus-filled blisters (rash pustular); urinary tract infection;

nail disorder; breaking of the nails (onychoclasis);

dehydration;

dry mouth; indigestion (dyspepsia); rectal bleeding (rectal haemorrhage); lip inflammation

(cheilitis); heartburn (gastroesophageal reflux);

chest pain; pain; chills; pain in the extremity; immune reaction (hypersensitivity); rapid heart

rate (tachycardia);

blood clot in the lung (pulmonary embolism) the symptoms of which may be sudden onset of

shortness of breath or chest pain; nose bleed (epistaxis); blood clot in a deep vein (deep vein

thrombosis); high blood pressure (hypertension); flushing;

headache; dizziness; anxiety.

Uncommon:

may affect up to 1 in 100 people

blue colouration of the skin and mucous membranes (cyanosis);

ulcerative keratitis (a serious condition of ulceration of the front part of the eye (cornea)

requiring urgent treatment);

keratitis (inflammation of the front part of the eye (cornea));

skin cell death (skin necrosis);

severe skin reaction with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson

syndrome);

severe skin reaction with blistering of the skin (toxic epidermal necrolysis);

eyelid irritation; chapped lips and/or dry lips; eye infection; eyelid infection; nasal dryness;

loosening of the nails (onycholysis); ingrowing nail; excessive hair growth (hirsutism);

inflammation of the lungs (interstitial lung disease).

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not

listed in this leaflet. You can also report side effects directly via the national reporting system listed in

Appendix 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 in the healthcare facility where it is used.

Keep this medicine out of the sight and reach 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 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 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 Vectibix contains

Each mL of concentrate contains 20 mg panitumumab. Each vial contains either 100 mg of

panitumumab in 5 mL, or 400 mg of panitumumab in 20 mL.

The other ingredients 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 concentrate.

Not all pack sizes may be marketed.

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

Co Dublin

Ireland

Manufacturer

Amgen NV

Telecomlaan 5-7

1831 Diegem

Belgium

For any information about this medicinal product, please contact the local representative of the

Marketing Authorisation Holder:

België/Belgique/Belgien

s.a. Amgen n.v.

Tel/Tél: +32 (0)2 7752711

Lietuva

Amgen Switzerland AG Vilniaus filialas

Tel: +370 5 219 7474

България

Амджен България ЕООД

Тел.: +359 (0)2 424 7440

Luxembourg/Luxemburg

s.a. Amgen

Belgique/Belgien

Tel/Tél: +32 (0)2 7752711

Česká republika

Amgen s.r.o.

Tel: +420 221 773 500

Magyarország

Amgen Kft.

Tel.: +36 1 35 44 700

Danmark

Amgen, filial af Amgen AB, Sverige

Tlf: +45 39617500

Malta

Amgen B.V.

The Netherlands

Tel: +31 (0)76 5732500

Deutschland

AMGEN GmbH

Tel.: +49 89 1490960

Nederland

Amgen B.V.

Tel: +31 (0)76 5732500

Eesti

Amgen Switzerland AG Vilniaus filialas

Tel: +372 586 09553

Norge

Amgen AB

Tel: +47 23308000

Ελλάδα

Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.

Τηλ.: +30 210 3447000

Österreich

Amgen GmbH

Tel: +43 (0)1 50 217

España

Amgen S.A.

Tel: +34 93 600 18 60

Polska

Amgen Biotechnologia Sp. z o.o.

Tel.: +48 22 581 3000

France

Amgen S.A.S.

Tél: +33 (0)9 69 363 363

Portugal

Amgen Biofarmacêutica, Lda.

Tel: +351 21 4220550

Hrvatska

Amgen d.o.o.

Tel: +385 (0)1 562 57 20

România

Amgen România SRL

Tel: +4021 527 3000

Ireland

Amgen Limited

United Kingdom

Tel: +44 (0)1223 420305

Slovenija

AMGEN zdravila d.o.o.

Tel: +386 (0)1 585 1767

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

Amgen Slovakia s.r.o.

Tel: +421 2 321 114 49

Italia

Amgen S.r.l.

Tel: +39 02 6241121

Suomi/Finland

Amgen AB, sivuliike Suomessa/Amgen AB, filial

i Finland

Puh/Tel: +358 (0)9 54900500

Kύπρος

C.A. Papaellinas Ltd

Τηλ.: +357 22741 741

Sverige

Amgen AB

Tel: +46 (0)8 6951100

Latvija

Amgen Switzerland AG Rīgas filiāle

Tel: +371 257 25888

United Kingdom

Amgen Limited

Tel: +44 (0)1223 420305

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu/

---------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

Vectibix is intended for single use only. Vectibix should be diluted in sodium chloride 9 mg/mL

(0.9%) solution for injection by healthcare professional using aseptic technique. Do not shake or

vigorously agitate the vial. Vectibix should be inspected visually prior to administration. The solution

should be colourless and may contain visible translucent-to-white, amorphous, proteinaceous

particulates (which will be removed by in-line filtration). Do not administer Vectibix if its appearance

is not as described above. Using only a 21-gauge or smaller diameter hypodermic needle, withdraw

the necessary amount of Vectibix for a dose of 6 mg/kg. Do not use needle-free devices (e.g. vial

adapters) to withdraw vial contents. Dilute in a total volume of 100 mL. Doses higher than 1,000 mg

should be diluted in 150 mL sodium chloride 9 mg/mL (0.9%) solution for injection. The final

concentration should not exceed 10 mg/mL. The diluted solution should be mixed by gentle inversion,

do not shake.

Discard the vial and any liquid remaining in the vial after the single-use.

The infusion line should be flushed with sodium chloride solution before and after Vectibix

administration to avoid mixing with other medicinal products or intravenous solutions.

Vectibix must be administered as an intravenous infusion via an infusion pump, using a low protein

binding 0.2 or 0.22 micrometre in-line filter, through a peripheral line or indwelling catheter. The

recommended infusion time is approximately 60 minutes. Doses higher than 1,000 mg should be

infused over approximately 90 minutes.

No incompatibilities have been observed between Vectibix and sodium chloride 9 mg/mL (0.9%)

solution for injection in polyvinyl chloride bags or polyolefin bags.