VECTIBIX 20 mg /Ml Концентрат Для Раствора Для Инфузий

Содержание инструкции

1. Vectibix 20 mg/mL concentrate for solution for infusion
   1. What is Vectibix and what is it 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. Package contents and other information

Vectibix 20 mg/mL concentrate for solution for infusion

panitumumab

Read this leaflet carefully before you use 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 any side effects occur, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

• 1. What Vectibix is and what it is used for
• 2. What you need to know before you use 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 is Vectibix and what is it used for

Vectibix is used in the treatment of metastatic colorectal cancer (bowel cancer) for adult patients with a certain type of cancer known as “RASwild-type” cancer. Vectibix is used alone or in combination with other anticancer medicines.
Vectibix contains the active substance panitumumab, which belongs to a group of drugs called
monoclonal antibodies. Monoclonal antibodies are proteins that recognize and bind
specifically to other particular proteins in the body.
Panitumumab recognizes and binds specifically to a protein called the epidermal growth factor receptor (EGFR), which is found on the surface of some cancer cells. When growth factors (other proteins in the body) bind to the EGFR, the cancer cell is stimulated to
grow and multiply. Panitumumab binds to the EGFR and prevents the cancer cell from receiving the
messages 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 any of the other ingredients of this medicine (listed in section 6).
• if you have or have had in the past signs of interstitial pneumonia (swelling of the lungs that causes cough and difficulty breathing) or pulmonary fibrosis (scarring and thickening in the lungs that causes shortness of breath).
• in combination with oxaliplatin-based chemotherapy, if the RAStest shows that you have a mutated RAStumor or if the RASstatus of the tumor is unknown. Consult your doctor if you are unsure of your tumor's RASstatus.

Warnings and precautions
Skin reactions or severe swelling and tissue damage may occur. If these
worsen or become intolerable, you should immediately inform your doctor or nurse. If you
experience a severe skin reaction, your doctor may recommend an adjustment to the dose
of Vectibix. If, following skin reactions, you should develop a serious infection or fever, your
doctor may discontinue treatment with Vectibix.
It is recommended to limit exposure to the sun during treatment with Vectibix and if
skin reactions occur, as sunlight can worsen them. Use sunscreen and
a hat when exposed to sunlight. Your doctor may recommend a moisturizer,
a sunscreen (sun protection factor > 15), a topical steroid cream, and/or
oral antibiotics that may help you manage skin toxicities that may be
associated with the use of Vectibix.
Your doctor will check the levels in your blood of certain substances including magnesium, calcium and potassium
before starting treatment with Vectibix. Your doctor will also check the levels in your blood of
magnesium and calcium periodically during treatment, and up to 8 weeks after you have
finished treatment. If these levels are too low, your doctor may prescribe you
appropriate supplements.
If you experience severe diarrhea, immediately inform your doctor or nurse as
you may lose a lot of water from your body (becoming 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 eyes, inflammation of the front of the eye (cornea) or ulcers that
involve the front of the eye.
If you develop acute or worsening redness and pain in the eye, increased
tearing, blurred vision and/or sensitivity to light, immediately inform your doctor or
nurse as urgent treatment may be necessary (see “Possible side effects” below).
Based on your age (over 65 years) or general health status, your doctor will discuss with you
your ability to tolerate Vectibix with chemotherapy treatment.

Other medicines and Vectibix
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription and herbal medicines.
Vectibix must not be used in combination with bevacizumab (another monoclonal antibody
used for bowel cancer) or with the combination of chemotherapy drugs irinotecan,
5-fluorouracil and leucovorin, known as “IFL”.

Pregnancy and breastfeeding
Vectibix has not been studied in pregnant women. It is important that you tell your doctor if you are
pregnant, suspect you may be pregnant or are planning a pregnancy. Vectibix may harm
the fetus or impair the ability to carry a pregnancy to term.
If you are a woman of childbearing potential, you must use effective contraceptive methods during treatment with
Vectibix and for 2 months after the last dose is administered.
Breastfeeding is not recommended during treatment with Vectibix and for 2 months
after the last dose is administered. It is important to tell your doctor if you think you
are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.

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

Vectibix contains sodium
This medicine contains 3.45 mg of sodium (the main component of table salt) per mL.
This is equivalent to 0.17% of the recommended daily intake of salt 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 drugs.
Vectibix is administered 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. Usually treatment is administered over a period of approximately 60 minutes.

4. Possible side effects

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

Infusion reactions
A reaction to the infusion may occur during or after treatment. This can be mild or
moderate (may occur in approximately 5 out of 100 people taking Vectibix) or be severe (may
occur in 1 out of 100 people taking Vectibix). Symptoms may include headache,
skin rashes, itching or hives, redness, swelling (face, lips, mouth, around the eyes, and the throat area), fast and irregular heartbeat, rapid 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, can lead to death. If you experience any of these
symptoms, you should immediately inform your doctor. The doctor may decide to reduce the dose
of the infusion 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 caused death. Seek immediate medical attention if you experience symptoms of an allergic
reaction to Vectibix, including, but not limited to difficulty breathing, a feeling of tightness in the chest,
a feeling of suffocation, dizziness or fainting.

Skin reactions
Skin reactions can occur in approximately 94 out of 100 people taking Vectibix and are usually
mild to moderate. The 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 scaling of the skin that can become severe. In some cases,
it can cause infected wounds requiring medical and/or surgical treatment, or cause serious skin infections that, in rare cases, can be fatal. In rare cases, blisters may appear on the
skin, mouth, eyes and genitals, which may indicate a severe skin reaction called
“Stevens-Johnson syndrome” or blisters on the skin, which may indicate a severe skin
reaction called “toxic epidermal necrolysis”. If you notice the appearance of blisters, you should
immediately inform your doctor. Prolonged exposure to sunlight can worsen the rash.
In addition, dry skin, cracking (fissures) of the fingers or toes, infection (paronychia) or inflammation of the nail bed of the hands or feet has been reported. Once
treatment is stopped or discontinued, skin reactions generally resolve. The doctor may
decide to treat the rash, change the dose or stop treatment with Vectibix. Other side effects include:

Very common:may affect more than 1 in 10 people

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

Common:may affect up to 1 in 10 people

• low white blood cell count (leukopenia); low calcium levels in the blood (hypocalcaemia); low phosphate levels in the blood (hypophosphataemia); high glucose levels in the blood (hyperglycaemia);
• excessive growth of eyelashes; persistent tearing; red eye; dry eyes; itchy eye; eye irritation; inflammation of the eyelids (blepharitis);
• skin ulcer; crusts; excessive hair growth; redness and swelling of the palm of the hands or sole of the feet (hand-foot syndrome); excessive sweating; dermatitis;
• widespread infection under the skin (cellulitis); inflammation of the hair follicle (folliculitis); localized infection; skin rash with pus-filled blisters (pustular 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; pain in a limb; immune reaction (hypersensitivity); fast heartbeat (tachycardia);
• blood clot in the lung (pulmonary embolism) whose symptoms may be sudden shortness of breath or chest pain; nosebleed (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

• bluish discoloration of the skin and mucous membranes (cyanosis);
• death of skin cells (skin necrosis);
• severe skin reaction with blisters, mouth, eyes and genitals (Stevens Johnson syndrome);
• severe skin reaction with blisters (toxic epidermal necrolysis);
• a serious condition of ulceration of the front of the eye (cornea) requiring urgent treatment (ulcerative keratitis);
• inflammation of the cornea, i.e. the front of the eye (keratitis);
• eye irritation; cracked 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 get any side effects, even those not listed in this leaflet, tell your
doctor or nurse. You can also report side effects directly through the national reporting system detailed 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 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.
Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date which is stated on the label and the carton after
EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. 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 ingredients are sodium chloride, sodium acetate trihydrate, glacial acetic acid and water for injections. See section 2 "Vectibix contains sodium".

Description of Vectibix and package contents
Vectibix is a colorless solution that may contain visible particles and is supplied in a glass vial. Each pack contains one vial.

Marketing authorization holder and manufacturer
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
Netherlands

Marketing authorization holder
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
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 medicine, contact the local representative of the marketing authorization 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 S.r.l.
Italy
Tel: +39 02 6241121

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 4220606

Hrvatska
Amgen d.o.o.
Tel: +385 (0)1 562 57 20

România
Amgen România SRL
Tel: +4021 527 3000

Ireland
Amgen Ireland Limited
Tel: +353 1 8527400

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 (Northern Ireland)
Amgen Limited
Tel: +44 (0)1223 420305
More detailed information on this medicine is available on the European Medicines Agency website: http://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 sodium chloride 9 mg/mL (0.9%) injection solution by healthcare personnel using aseptic techniques. Do not shake or vigorously agitate the vial. Vectibix must be visually inspected before administration. The solution should be colorless and may contain visible particles, amorphous, from translucent to white, of a protein nature (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 needleless devices (i.e., vial adapters) to withdraw the contents of the vial. Dilute in a total volume of 100 mL. Doses higher than 1,000 mg must be diluted in 150 mL of sodium chloride 9 mg/mL (0.9%) injection solution. The final concentration should not exceed 10 mg/mL. The diluted solution must be mixed by gently inverting the vial, but without shaking it.
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 timing and conditions of storage before administration, which should not exceed 24 hours at a temperature of 2°C - 8°C. The diluted solution must not be frozen.
Dispose of the vial and any remaining liquid in the vial after single use.
Before and after the administration of Vectibix, the infusion line must be flushed with sodium chloride solution to prevent mixing with other medicines or intravenous solutions.
Vectibix must be administered intravenously using an infusion pump and with a peripheral line or a central venous catheter, equipped with a 0.2 or 0.22 micrometer low protein binding in-line filter. The recommended infusion time is approximately 60 minutes. Doses greater than 1,000 mg must be infused over approximately 90 minutes.
No incompatibilities have been observed between Vectibix and sodium chloride 9 mg/mL (0.9%) injection solution in polyvinyl chloride or polyolefin bags.