VECTIBIX 20 mg/ml concentrate for solution for infusion

Introduction

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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Vectibix and what is it used for
2. What you need to know before you use Vectibix
3. How to use Vectibix
4. Possible side effects
5. Storing Vectibix
6. Package contents and further information

1. What is Vectibix and what is it used for

Vectibix is used to treat metastatic colorectal cancer (cancer of the intestine) in adult patients with a type of tumour known as "tumours with non-mutated RAS". Vectibix is used alone or in combination with other anti-cancer treatments.

Vectibix contains the active substance panitumumab, which belongs to a group of medicines called monoclonal antibodies. Monoclonal antibodies are proteins that recognise and bind to specific proteins in the body.

Panitumumab recognises 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 body proteins) bind to EGFR, they stimulate the growth and division of cancer cells. Panitumumab binds to EGFR and prevents the cancer cell from receiving the messages it needs to grow and divide.

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 had or are experiencing symptoms of interstitial pneumonitis (inflammation of the lungs that causes coughing and difficulty breathing) or pulmonary fibrosis (scarring and thickening of the lungs that also causes difficulty breathing).
• in combination with oxaliplatin-based chemotherapy, if the RAS test confirms that you have a tumour with mutated RAS, or if the RAS status is unknown. Tell your doctor if you are not sure of the RAS status of your tumour.

Warnings and precautions

You may experience skin reactions or severe swelling and tissue damage. If these worsen or you cannot tolerate them, tell your doctor or nurse immediately. If you experience a severe skin reaction, your doctor may recommend a dose adjustment of Vectibix. If you develop a severe infection or fever as a result of skin reactions, your doctor may interrupt your treatment with Vectibix.

You are advised to limit your exposure to the sun while you are being treated with Vectibix and especially if you experience skin reactions, as sunlight can worsen them. Use sunscreens and a hat if you are going to be exposed to the sun. Your doctor may ask you to use a moisturising cream, sunscreen (SPF > 15), topical steroid, and/or oral antibiotics that can help manage the skin toxicity that may be associated with treatment with Vectibix.

Your doctor will monitor your blood levels of various substances, such as magnesium, calcium, and potassium, before you start treatment with Vectibix. Your doctor will also monitor your blood levels of magnesium and calcium periodically during treatment and up to 8 weeks after treatment is completed. If these levels are too low, your doctor may prescribe you appropriate supplements.

If you experience severe diarrhoea, tell your doctor or nurse as you may lose a lot of water from your body (become dehydrated) and this could damage your kidneys.

Tell your doctor if you wear contact lenses and/or have a history of eye problems such as severe dryness of the eye, inflammation of the front part of the eye (cornea), or ulcers on the front part of the eye.

If you experience acute or worsening redness and pain in the eye, increased tearing of the eye, blurred vision and/or sensitivity to light, tell your doctor or nurse immediately as you may need urgent treatment (see "Possible side effects" below).

Based on your age (over 65 years) or your general health, your doctor will discuss your ability to tolerate the administration of Vectibix with your chemotherapy treatment.

Using Vectibix with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Vectibix must not be used in combination with bevacizumab (another monoclonal antibody used in intestinal cancer) or with a combination of chemotherapy 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, think you may be pregnant or are planning to become pregnant. Vectibix may affect the unborn baby or your ability to become pregnant.

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.

Breastfeeding is not recommended during treatment with Vectibix and for 2 months after the last dose. It is important to tell your doctor if you are considering breastfeeding.

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

Driving and using machines

Ask your doctor before driving or using machines, as some of the side effects of Vectibix may impair your ability to perform these activities safely.

Vectibix contains sodium

This medicine contains 3.45 mg of sodium (main component of cooking/table salt) in each ml. This is equivalent to 0.17% of the maximum recommended daily intake of sodium for an adult.

3. How to use Vectibix

Vectibix will be administered to you in a healthcare facility and under the supervision of an experienced doctor in the use of cancer medicines.

Vectibix is given by infusion into a vein using an infusion pump (a device that slowly gives you the medicine).

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

4. Possible side effects

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

The following are the most serious and the most common side effects:

Infusion reactions

You may experience an infusion reaction during or after treatment. These reactions can be mild or moderate and can affect up to 1 in 100 people, or be severe and affect 1 in 1,000 people. Symptoms can include headache, rash, itching or hives, flushing, swelling (face, lips, mouth, around the eyes and throat), rapid or irregular heartbeat, rapid pulse, sweating, nausea, vomiting, dizziness, difficulty breathing or swallowing, or a drop in blood pressure that can be severe or life-threatening and, very rarely, can lead to death. If you experience any of these symptoms, you must tell your doctor immediately. Your doctor may decide to reduce the infusion rate or interrupt your treatment with Vectibix.

Allergic reactions

Very rarely, severe allergic reactions (hypersensitivity) have occurred, including symptoms similar to an infusion reaction (see "Infusion reactions"), with a fatal outcome more than 24 hours after treatment. If you experience symptoms of an allergic reaction to Vectibix, including, but not limited to, difficulty breathing, chest tightness, feeling of choking, dizziness, or fainting, you must seek medical attention immediately.

Skin reactions

Skin-related reactions can occur in approximately 94 out of 100 people who use Vectibix and are usually mild to moderate. The skin rash often looks like acne and often appears on the face, upper chest, and back, but can affect any part of the body. Some rashes have been associated with redness, itching, and skin peeling that can become severe. In some cases, they can cause infected ulcers that require medical and/or surgical treatment, or cause severe skin infections that can rarely be fatal. In rare cases, patients may experience blistering of the skin, mouth, eyes, and genitals, which can indicate a severe skin reaction called "Stevens-Johnson syndrome" or blistering of the skin, which can indicate a severe skin reaction called "toxic epidermal necrolysis". You must tell your doctor immediately if you experience blistering. Prolonged exposure to the sun can worsen the rash. Dry skin, fissures (cracked skin) on the fingers of the hands and feet, infection of the nail bed of the hands and feet (paronychia), or inflammation have also been reported. Skin reactions usually resolve after treatment is stopped or interrupted. Your doctor may decide to treat the rash, adjust the dose, or interrupt your treatment with Vectibix.

Other side effects include:

Very common:may affect up to 1 in 10 people

• low levels of red blood cells (anaemia); low levels of potassium in the blood (hypokalaemia); low levels of magnesium in the blood (hypomagnesaemia);
• eye inflammation (conjunctivitis);
• localised or generalised rash that can be irregular (with or without spots), with itching, redness, or peeling;
• hair loss (alopecia); mouth ulcers and cold sores (stomatitis); mouth inflammation (mucosal inflammation);
• diarrhoea; nausea; vomiting; abdominal pain; constipation; decreased appetite; weight loss;
• extreme tiredness (fatigue); fever or high temperature (pyrexia); lack or loss of strength (asthenia); fluid accumulation in the limbs (peripheral oedema);
• back pain;
• difficulty sleeping (insomnia);
• cough; shortness of breath (dyspnoea).

Common:may affect up to 1 in 10 people

• low levels of white blood cells (leucopenia); low levels of calcium in the blood (hypocalcaemia); low levels of phosphate in the blood (hypophosphataemia); high levels of glucose in the blood (hyperglycaemia);
• eyelash growth; increased tearing (lacrimation); eye redness (ocular hyperaemia); dry eyes; eye itching (ocular pruritus); eye irritation; eyelid inflammation (blepharitis);
• skin ulcers; scabbing; excessive hair growth (hypertrichosis); redness and swelling on the palms of the hands or soles of the feet (hand-foot syndrome); excessive sweating (hyperhidrosis); skin reaction (dermatitis);
• spread of infection under the skin (cellulitis); hair follicle inflammation (folliculitis); localised infection; blistering skin rash (pustular rash); urinary tract infection;
• nail disorders; nail breaking (onychoclasis);
• dehydration;
• dry mouth; indigestion (dyspepsia); rectal bleeding (rectal haemorrhage); lip inflammation (cheilitis); acid reflux (gastro-oesophageal reflux);
• chest pain; pain; chills; limb pain; allergic reaction (hypersensitivity); rapid heart rate (tachycardia);
• blood clots in the lungs (pulmonary embolism) whose symptoms can be difficulty breathing or chest pain of sudden onset; nosebleeds (epistaxis); blood clots 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 colour of the skin and mucous membranes (cyanosis);
• death of skin cells (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).
• a severe disease with the appearance of ulcers that affect the front part of the eye (cornea) that requires urgent treatment (ulcerative keratitis);
• inflammation that affects the front part of the eye (cornea) (keratitis);
• eyelid irritation; cracked and/or dry lips; eye infection; eyelid infection; dry nose; loss of nails (onycholysis); ingrown nails; excessive hair growth (hirsutism).
• inflammation of the lungs (interstitial lung disease).

Reporting of side effects

If you experience 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. Storing Vectibix

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

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

Store in a refrigerator (between 2 °C and 8 °C).

Do not freeze.

Store in the original package 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 is the last day of the month shown.

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 protect the environment.

6. Container contents and additional information

Composition of Vectibix

• Each ml of concentrate contains 20 mg of panitumumab. Each vial contains 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 injectable preparations. See section 2 "Vectibix contains sodium".

Appearance of the product and container contents

Vectibix is a colorless liquid that may contain visible particles and is supplied in a glass vial. Each container 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

Co Dublin

Ireland

Manufacturer

Amgen NV

Telecomlaan 5-7

1831 Diegem

Belgium

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of last revision of this prospectus

Other sources of information

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

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This information is intended only for healthcare professionals:

Vectibix is designed for single use. Vectibix must be diluted in a 9 mg/ml (0.9%) sodium chloride injectable solution by healthcare professionals using an aseptic technique. Do not shake the vial vigorously. Vectibix should be visually inspected before administration. The solution must be colorless and may contain translucent to white, amorphous, visible protein particles (which will be eliminated by in-line filtration). Do not administer Vectibix if its appearance is not as described above. Use only a 21 G or smaller hypodermic needle, withdraw the required amount of Vectibix for a dose of 6 mg/kg. Do not use needleless devices (e.g., vial adapters) to withdraw the contents of the vial. Dilute in a total volume of 100 ml. Doses greater than 1,000 mg should be diluted in a 150 ml injectable solution of 9 mg/ml (0.9%) sodium chloride. The final concentration should not exceed 10 mg/ml. The diluted solution should be mixed by gentle inversion, without shaking.

Vectibix does not contain any antimicrobial preservative or bacteriostatic agent. The medicine should be used immediately after dilution. If not used immediately, the in-use storage times and conditions are the responsibility of the user and should not exceed 24 hours between 2°C and 8°C. The diluted solution should not be frozen.

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

The infusion line should be flushed with sodium chloride solution before and after administration of Vectibix to avoid mixing with other medicines or intravenous solutions.

Vectibix should be administered by intravenous infusion using a infusion pump through a peripheral or permanent catheter and using a low protein-binding filter of 0.2 or 0.22 micrometers in line. The recommended infusion time is approximately 60 minutes. Doses greater than 1,000 mg should be infused over approximately 90 minutes.

No incompatibility has been observed between Vectibix and the 9 mg/ml (0.9%) sodium chloride injectable solution in polyvinyl chloride or polyolefin bags.

• Country of registration
  Spain
• Active substance
  panitumumab
• Prescription required
  Yes
• Manufacturer
  Amgen Europe B.V.
• Composition
  CLORURO DE SODIO (0 - mg), ACETATO DE SODIO TRIHIDRATO (0 - mg)
• This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
• Alternatives to VECTIBIX 20 mg/ml concentrate for solution for infusion
  VECTIBIX 20 mg/mL concentrate for infusion solution

  Dosage form: INJECTABLE INFUSION, 20 mg

  Active substance: panitumumab

  Manufacturer: Amgen Europe B.V.

  Prescription required

  ERBITUX 5 mg/ml SOLUTION FOR INFUSION

  Dosage form: INJECTABLE PERFUSION, 5 mg

  Active substance: cetuximab

  Manufacturer: Merck Europe B.V.

  Prescription required

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