You can take Vectibix without chemotherapy

Patient Info Service - information for patients

1. What is Vectibix and what is it used for?

Vectibix is ​​used in the treatment of metastatic colorectal cancer (colon cancer) in adult patients with a type of tumor called "RAS-Wild-type tumor "is known. Vectibix is ​​used alone or in combination with other cancer medicines.

Vectibix contains the active substance panitumumab, which belongs to a group of medicines called monoclonal antibodies. Monoclonal antibodies are proteins that specifically recognize certain other proteins in the body and bind to them.

Panitumumab specifically recognizes and binds to a protein called "epidermal growth factor receptor (EGFR = Epidermal Growth Factor Receptor)", which is found on the surface of some cancer cells. When growth factors (other body proteins) bind to EGFR, the cancer cell is stimulated to grow and divide. Panitumumab binds to the EGFR, preventing the cancer cell from receiving the signals it needs to grow and divide.

2. What should you 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 ever had signs of interstitial pneumonitis (inflammation of the lungs with water retention causing coughing and difficulty breathing) or pulmonary fibrosis (scarring and thickening of the lungs with shortness of breath).

  • in combination with oxaliplatin-containing chemotherapy, if your RASTest shows you have a mutated tumor RAS have or if your RAS-Tumor status is unknown. Please ask your doctor if you have any questions regarding your RAS-Tumor status are uncertain.

Warnings and Precautions

You may experience skin reactions or severe swelling and tissue damage. If these worsen or are no longer tolerable, please inform your doctor or nurse immediately. If you develop a severe skin reaction, your doctor may consider adjusting the dose of Vectibix. If you develop a severe infection or fever as a result of skin reactions, your doctor may stop treatment with Vectibix.

It is recommended that you have limited exposure to sunlight while using Vectibix and having skin reactions, as sunlight can worsen skin reactions. Wear sun protection and a hat when you are exposed to sunlight. Your doctor may ask you to use a moisturizer, sunscreen (SPF> 15), topical steroid, and / or oral antibiotics. These can help treat any skin toxicities that may be related to the use of Vectibix.

Before you start Vectibix treatment, your doctor will test your blood for various substances, such as: B. Magnesium, Calcium and Potassium. Your doctor will also check your blood magnesium and calcium levels regularly during and up to 8 weeks after your treatment has ended. If these levels are too low, your doctor may prescribe an appropriate supplement for you.

Please tell your doctor or nurse if you develop severe diarrhea as you can lose a lot of water from your body (dehydrate) and this can damage your kidneys.

Tell your doctor if you use contact lenses and / or have ever had eye problems such as severe dry eye, inflammation of the front part of the eye (cornea), or ulcers that affect the front part of the eye.

Please tell your doctor or nurse immediately if you experience acute or worsening redness and pain in the eye, increased tearing in the eye, blurred vision and / or sensitivity to light as you may need immediate treatment (see below "Which Side effects are possible? ").

Your doctor will discuss with you, taking into account your age (over 65 years of age) or your general health, whether you can tolerate treatment with Vectibix at the same time as your chemotherapy treatment.

Other medicines and Vectibix

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription and herbal medicines.

Vectibix must not be used in combination with bevacizumab (another monoclonal antibody used in colorectal cancer) or with a combination of chemotherapy called 'IFL'.

pregnancy and breast feeding period

Vectibix has not been studied in pregnant women. It is important that you tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Vectibix could affect your unborn baby or the maintenance of your pregnancy.

If you are a woman of childbearing potential, you should use effective contraception during treatment with Vectibix and for 2 months after the last dose.

It is recommended that you do not 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 breastfeed.

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

Driving and using machines

Talk to your doctor before driving or using machines. Some of the side effects of Vectibix may affect your ability to do so safely.

Vectibix contains sodium

This medicinal product contains 3.45 mg sodium (main component of table salt) per ml. This corresponds to 0.017% of the maximum recommended daily intake of sodium with food for an adult.

3. How to use Vectibix

Vectibix will be used in a medical setting under the supervision of a doctor who is experienced in the use of cancer therapies.

Vectibix is ​​given intravenously (into a vein) using an infusion pump (a device that allows you to give a slow injection).

The recommended dose of Vectibix is ​​6 mg / kg (milligrams per kilogram of body weight) given once every 2 weeks. The dose is usually given over a period of about 60 minutes.

4. What side effects are possible?

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

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

Infusion reactions

You may experience an infusion reaction during or after treatment. This can be mild or moderate (affects about 5 in 100 people treated with Vectibix) or severe (affects 1 in 100 people treated with Vectibix). Symptoms may include headache, rashes, itching or hives, reddening of the skin, swelling (face, lips, mouth, eyes and throat), fast and irregular heartbeat, increased pulse, sweating, nausea, vomiting, dizziness, difficulty breathing or swallowing, or a drop in blood pressure Blood pressure, which can be severe or life-threatening and, in very rare cases, can result in death. Please tell your doctor immediately if you develop any of these symptoms. Your doctor may decide to reduce the infusion rate or to stop your Vectibix treatment.

Allergic reaction

Very rarely, serious allergic (hypersensitivity) reactions occurred more than 24 hours after treatment and were fatal. The symptoms were similar to an infusion reaction (see “Infusion reactions”). See a doctor straight away if you develop symptoms of an allergic reaction (including difficulty breathing, chest tightness, choking, dizziness, or fainting) to Vectibix.

Skin reactions

Skin reactions occur in approximately 94 out of 100 people who receive Vectibix and are usually mild to moderate. The rash is generally similar to acne, and often affects the face and the upper chest and back. However, it can affect any other part of the body as well. Some rashes are associated with redness, itching, and flaking of the skin, which can develop into a severe appearance. In some cases, this can lead to inflamed wounds that require medical and / or surgical treatment, or it can lead to serious skin infections that, in rare cases, can be fatal. In rare cases, people may have blisters on their skin, mouth, eyes, and genitals, which may indicate a severe skin reaction called "Stevens-Johnson Syndrome," or blisters may form on the skin, which may indicate a severe skin reaction called May indicate “toxic epidermal necrolysis”. If you develop blisters, you should tell your doctor immediately. The rash may worsen after extended exposure to the sun. Dry skin, fissures (cracks in the skin) of the fingers or toes, nail bed infection or nail bed inflammation of the fingernails or toenails (paronychia) have also been reported. Once treatment is suspended or stopped, skin reactions will usually resolve. Your doctor may decide to treat the rash, adjust the dose, or stop treatment with Vectibix.

Other side effects include:

Very often: may affect more than 1 in 10 people

  • low red blood cell count (anemia); low levels of potassium in the blood (hypokalaemia); low levels of magnesium in the blood (hypomagnesaemia);

  • Inflammation of the eyes (conjunctivitis);

  • local or widespread skin rash that may be pebbled (with or without spots), itchy, red, or scaly;

  • Hair loss (alopecia); Mouth ulcers and cold sores (stomatitis); Inflammation of the mouth (inflammation of the mucous membrane);

  • Diarrhea; Nausea; Vomit; Stomach pain; Constipation; decreased appetite; Weight loss;

  • extreme tiredness (fatigue); Fever or high temperature (pyrexia); Lack or loss of strength (asthenia); Fluid build-up in the limbs (peripheral edema);

  • Back pain;

  • Sleeplessness (insomnia);

  • To cough; Dyspnoea (difficulty breathing).

Often: may affect up to 1 in 10 people

  • low white blood cell count (leukopenia); low levels of calcium in the blood (hypocalcaemia); low levels of phosphate in the blood (hypophosphataemia); high levels of glucose in the blood (hyperglycaemia);

  • Growth of eyelashes; Lacrimation (increased secretion of tears); Redness of the eyes (ocular hyperemia); dry eye; itchy eyes (eye pruritus); Irritation to the eyes; Inflammation of the eyelids (blepharitis);

  • Skin ulcers; Scab; excessive hair growth (hypertrichosis); Redness and swelling of the balls of your hands or soles of your feet (hand-foot syndrome); excessive sweating (hyperhidrosis); Skin reactions (dermatitis);

  • inflammation spreading under the skin (bacterial inflammation of the subcutaneous tissue, cellulitis); Inflammation of the hair follicles (folliculitis); localized inflammation; Rash with pus-filled blisters (purulent rash); Urinary tract infections;

  • Nail disease; brittle nails (onychoclasia);

  • Dehydration;

  • dry mouth; Upset stomach (dyspepsia); rectal bleeding (rectal hemorrhage); Inflammation of the lips (cheilitis); Heartburn (gastroesophageal reflux disease);

  • Chest pain; Pain; Chills; Pain in the limbs; Immune reaction (hypersensitivity); high heart rate (tachycardia);

  • Blood clots in the lungs (pulmonary embolism) which symptoms may include sudden shortness of breath or chest pain; Nosebleeds (epistaxis); Blood clots in a deep vein (deep vein thrombosis); high blood pressure (hypertension); Reddening of the skin;

  • A headache; Dizziness; Feeling anxious.

Occasionally: may affect up to 1 in 100 people

  • blue coloring of the skin and mucous membranes (cyanosis);

  • ulcerative keratitis (a severe form of ulceration that affects the front of the eye [cornea] and requires immediate 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);

  • Irritation of the eyelids; chapped lips and / or dry lips; Inflammation of the eyes; Inflammation of the eyelids; dry nose; Loosening of the nails (onycholysis); ingrown nails; excessive hair growth (hirsutism);

  • Pneumonia (interstitial lung disease).

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This also applies to side effects not listed in this leaflet. You can also report side effects directly (see below for details). By reporting side effects you can help provide more information on the safety of this medicine.

Germany

Federal Institute for Vaccines and Biomedical Medicines

Paul Ehrlich Institute

Paul-Ehrlich-Str. 51-59

63225 Langen

Tel: +49 6103 77 0

Fax: +49 6103 77 1234

Website: www.pei.de

Austria

Federal Office for Safety in Health Care

Traisengasse 5

1200 VIENNA

AUSTRIA

Fax: + 43 (0) 50 555 36207

Website: http://www.basg.gv.at/

Italia

Agenzia Italiana del Farmaco

Sito web: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

5. How to store Vectibix

Vectibix is ​​kept in the medical facility where it is used.

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

Store in the refrigerator (2 ° C - 8 ° C).

Do not freeze.

Store in the original box in order to protect from light.

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

Do not dispose drugs in the wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. You help to protect our environment.

6. Contents of the pack and other information

What Vectibix contains

  • Each ml of the concentrate contains 20 mg panitumumab. Each vial contains either 100 mg panitumumab in 5 ml or 400 mg panitumumab in 20 ml.

  • The other ingredients are sodium chloride, sodium acetate trihydrate, acetic acid (glacial acetic acid) and water for injections. See section 2 “Vectibix contains sodium”.

What Vectibix looks like and contents of the pack

Vectibix is ​​a colorless solution that may contain visible particles and is presented in a glass vial. Each pack contains one vial.

Marketing Authorization Holder and Manufacturer

Amgen Europe B.V.

Minervum 7061

4817 Breda Central Committee

Netherlands

For more information about the medicine, please contact the local representative of the Marketing Authorization Holder.

Germany

AMGEN GmbH

Tel .: +49 89 1490960

Austria

Amgen GmbH

Tel: +43 (0) 1 50 217

Italia

Amgen S.r.l.

Tel: +39 02 6241121

This leaflet was last revised in September 2019.

Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu/ available.

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The following information is intended for healthcare professionals only:

Vectibix is ​​intended for single use only. Vectibix should be diluted with 9 mg / ml sodium chloride solution (0.9%) for injection by a healthcare professional under aseptic conditions. Do not shake or vigorously agitate the vial. Vectibix should be visually inspected prior to use. The solution should be colorless and may contain visible, translucent to white, amorphous, proteinaceous particles that will be removed by in-line filtration. Vectibix must not be used if it does not look as described above. To withdraw the required amount of Vectibix for a dose of 6 mg / kg, only a hypodermic needle of 21 gauge or smaller diameter should be used. No needleless medical devices (e.g. adapter for the vial) may be used to remove the contents of the vial.Dilute to a total volume of 100 ml. A dose greater than 1,000 mg should be diluted in 150 ml of a 9 mg / ml sodium chloride solution (0.9%) for injections. The final concentration must not exceed 10 mg / ml. The diluted solution should be mixed by gently swirling. Don't shake.

The vial and any remaining liquid in the vial after single use should be discarded.

The infusion lines should be flushed with sodium chloride solution before and after using Vectibix to avoid mixing with other medicinal products or intravenous solutions.

Vectibix is ​​administered as an intravenous infusion through a peripheral venous or indwelling catheter using an infusion pump and an in-line filter with a pore size of 0.2 or 0.22 micrometers and a low protein binding capacity. The recommended infusion time is approximately 60 minutes. For doses over 1,000 mg, the infusion time must be approximately 90 minutes.

No incompatibilities have been observed between Vectibix and sodium chloride 9 mg / ml (0.9%) solution for injections in polyvinyl chloride bags or polyolefin bags.