Prospect: information for the user

Vectibix 20 mg/ml concentrate for infusion solution

panitumumab

Read this prospect carefully before starting to use this medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor.
• If you experience any adverse effects, consult your doctor, even if they are not listed in this prospect. See section 4.

Vectibix is used in the treatment of metastatic colorectal cancer (colon cancer) in adult patients with a type of tumors known as “tumors with non-mutated RAS”. Vectibix is used as monotherapy or in combination with other anticancer treatments.

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

Panitumumab specifically recognizes and binds 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 EGFR, they stimulate the growth and division of cancer cells. Panitumumab binds to EGFR and prevents the cancer cell from receiving the signals it needs for growth and division.

Do not use Vectibix

• if you are allergic to panitumumab or any of the other components of this medication (listed in section 6).
• if you have experienced or are experiencing symptoms of interstitial pneumonitis (inflammation of the lungs that causes cough 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 tumor with a RAS mutated tumor, or if the RAS status is unknown. Inform your doctor if you are unsure of your tumor's RAS status.

Warnings and precautions

You may experience severe skin reactions or swelling and tissue damage. If these worsen or you cannot tolerate them, inform 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.

It is recommended that you limit your exposure to the sun while receiving Vectibix and especially if you experience skin reactions, as sunlight may exacerbate them. Use sunscreens and a hat if you will be exposed to the sun. Your doctor may ask you to use a moisturizing cream, sunscreen (FPS > 15), topical steroid, and/or oral antibiotics that may help manage the cutaneous toxicity associated with Vectibix treatment.

Your doctor will monitor your blood levels of various substances, such as magnesium, calcium, and potassium before starting treatment with Vectibix. Your doctor will also monitor your blood levels of magnesium and calcium on a periodic basis during treatment and up to 8 weeks after its completion. If these levels are very low, your doctor may prescribe suitable supplements.

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

Inform your doctor if you wear 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 on the front part of the eye.

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

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

Use of Vectibix with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including over-the-counter medications and herbal medications.

Vectibix should not be used in combination with bevacizumab (another monoclonal antibody used in colon cancer) or with a combination of chemotherapy known as "IFL".

Pregnancy and breastfeeding

Vectibix has not been studied in pregnant women. It is essential that you inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Vectibix may affect the fetus or your ability to become pregnant.

If you are a fertile woman, you should use effective contraceptive methods during Vectibix treatment and for 2 months after the last dose.

It is not recommended to breastfeed during Vectibix treatment and for 2 months after the last dose. It is essential to inform your doctor if you are considering breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Consult your doctor before driving or operating machinery, as some of the side effects produced by Vectibix may impair your ability to perform these activities safely.

Vectibix contains sodium

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

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

Vectibix is administered intravenously (into a vein) using a pump (a device that slowly administers the medication).

The recommended dose of Vectibix is 6 mg/kg (milligrams per kilogram of body weight) administered once every two weeks. Treatment is generally administered over a period of approximately 60 minutes.

Like all medicines, Vectibix can cause side effects, although not everyone will experience them.

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

Infusion reactions

You may experience an infusion reaction during or after treatment. These reactions can be mild or moderate (probability of occurring in 5 out of 100 people using Vectibix), or severe (probability of occurring in 1 out of 100 people using Vectibix). Symptoms may include headache, rashes, itching or urticaria, flushing, swelling (face, lips, mouth, around the eyes, and throat area), rapid and irregular heartbeat, rapid pulse, sweating, nausea, vomiting, dizziness, difficulty breathing or swallowing, or a decrease 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 should inform 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 infusion reactions (see "Infusion reactions"), with 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 should seek medical attention immediately.

Skin reactions

Skin-related reactions can occur in approximately 94 out of 100 people using Vectibix and are usually mild to moderate. The skin rash often resembles acne and frequently 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 be severe. In some cases, they can cause infected sores requiring medical and/or surgical treatment, or cause severe skin infections that rarely can be fatal. In rare cases, patients may experience the formation of blisters on the skin, mouth, eyes, and genitals, which may indicate a severe skin reaction called "Stevens-Johnson syndrome" or the formation of blisters on the skin, which may indicate a severe skin reaction called "toxic epidermal necrolysis". You should inform your doctor immediately if you experience the formation of blisters. Prolonged exposure to the sun can worsen the rash. Dry skin, cracks (dry skin) on the fingers of the hands and feet, paronychia (infection in the nail bed of the hands and feet), or inflammation have also been reported. Skin reactions usually resolve after suspension or interruption of treatment. 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 1 in 10 people

• low red blood cell count (anemia); low potassium levels in the blood (hypokalemia);low magnesium levels in the blood (hypomagnesemia);
• eye inflammation (conjunctivitis);
• local or generalized rash that can be irregular (with or without spots), with itching, redness, or scaling;
• hair loss (alopecia); mouth ulcers and herpes on the lip (stomatitis); inflammation of the mouth (mucosal inflammation);

• diarrhea; nausea; vomiting; abdominal pain; constipation; decreased appetite; weight loss;

• extreme fatigue (fatigue); fever or high temperature (pyrexia); lack or loss of strength (asthenia); fluid accumulation in the extremities (peripheral edema);

• back pain;
• insomnia;
• toxins; respiratory difficulty.

Common::may affect up to 1 in 10 people

• low white blood cell count (leucopenia); low calcium levels in the blood (hypocalcemia); low phosphate levels in the blood (hypophosphatemia); high blood glucose levels (hyperglycemia);

• eyelash growth; increased tear production (excessive lacrimation); eye redness (hyperemia); dry eyes; eye itching (pruritus); eye irritation; eyelid inflammation (blepharitis);
• skin ulcers; crust; excessive hair growth (hypertrichosis); redness and swelling in the palms of the hands or soles of the feet (hand-foot syndrome); excessive sweating (hyperhidrosis); skin reaction (dermatitis);

• cellulitis (infection below the skin); folliculitis (inflammation of the hair follicles); localized infection; pustular rash (eruptive pustulosis); urinary tract infection;
• changes in the nails; nail breakage (onychoclasis);
• dehydration;
• dry mouth; indigestion (dyspepsia); rectal bleeding (hemorrhoids); lip inflammation (cheilitis); acid reflux (gastroesophageal reflux);
• chest pain; pain; chills; limb pain; immune reaction (hypersensitivity); rapid heart rate (tachycardia);
• pulmonary embolism (blood clot in the lung) whose symptoms may be sudden difficulty breathing or chest pain; nasal bleeding (epistaxis); deep vein thrombosis (blood clot in a deep vein); high blood pressure (hypertension); flushing;
• headache; dizziness; anxiety.

Uncommon:may affect up to 1 in 100 people

• blue discoloration of the skin and mucous membranes (cyanosis);
• skin cell death (cutaneous necrosis);
• severe skin reaction with blister formation on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome);

• severe skin reaction with blister formation on the skin (toxic epidermal necrolysis).
• severe eye disease with ulceration affecting the front part of the eye (cornea) that requires urgent treatment (ulcerative keratitis);
• inflammation affecting the front part of the eye (cornea) (keratitis);
• eyelid irritation; cracked and/or dry lips; eye infection; eyelid infection; dry nose; nail loss (onycholysis); ingrown nails; excessive hair growth (hirsutism).
• interstitial lung disease (inflammation of the lungs).

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaRAM.es . By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

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

Do not freeze.

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the label and on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medications that you no longer need. In this way, you will help protect the environment.

Composition of Vectibix

• Each milliliter 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 injection. See section 2 “Vectibix contains sodium”.

Appearance of the product and contents of the pack

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

Marketing authorization holder and responsible 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:

Last review date of this leaflet

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

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This information is intended solely for healthcare professionals:

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

Vectibix does not contain any antimicrobial preservative or bacteriostatic agent. The medicine must be used immediately after dilution. If not used immediately, the times and conditions of storage in use before its use are the responsibility of the user and must not exceed 24hours between 2°Cand8°C. The diluted solution must not be frozen.

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

The route through which the infusion is administered must be cleaned with sodium chloride solution before and after the administration of Vectibix to avoid mixing with other medicines or intravenous solutions.

Vectibix must be administered by intravenous infusion through a peripheral vein or a permanent catheter and using a low protein-binding filter of 0.2 or 0.22 micrometers placed in line. The recommended infusion time is approximately

60 minutes. Doses above 1,000 mg must be infused for approximately 90 minutes.

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