VECTIBIX 20 mg. / Ml. 5 ml.

What is Vectibix and what it is used
Vectibix is used to treat metastatic colorectal cancer (colon cancer) in adult patients with a particular type of tumor called "wild-type RAS tumor". Vectibix is used alone or in combination with other anticancer drugs.
Vectibix contains the active substance panitumumab, which belongs to a group of medicines called monoclonal antibodies. Monoclonal antibodies are proteins that specifically recognize and attach (connect) to other unique proteins in the body.
Panitumumab recognizes and binds specifically to a protein called epidermal growth factor (EGFR), which is located on the surface of some tumor cells. When growth factors (other body proteins) attach to the EGFR, the cancer cell is stimulated to grow and divide. Panitumumab binds to EGFR and prevents the cancer cells to receive this signal necessary 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 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 the chemotherapy on the basis of oxaliplatin if your RAS test indicates that have mutated RAS tumor, or if your RAS tumor status is not known. Please ask your doctor if you are unsure of your RAS tumor status.
Warnings and Precautions
You may get skin reactions or severe swelling and tissue damage. If they worsen or become intolerable please tell your doctor or nurse. If you get 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 stop your treatment with Vectibix.
It is recommended to limit sun exposure whilst receiving Vectibix and if you are experiencing skin reactions as sunlight can worsen. Wear sunscreen and wear a hat if you are going to be exposed to sunlight. Your doctor may ask you to use a moisturizer, sun protection (SPF> 15), topical steroid and / or oral antibiotics which may help curb skin reactions associated with the use of Vectibix.
Your doctor will check your blood levels of several substances such as magnesium, calcium and potassium, before you start treatment with Vectibix. Your doctor will also check the levels of magnesium and calcium in the blood periodically during treatment and up to 8 weeks after you have finished your treatment. If these levels are too low, your doctor may prescribe you appropriate supplements.
Please tell your doctor or nurse if you develop severe diarrhea as your body can lose a lot of fluid (dehydration) and this can damage your kidneys.
Tell your doctor if you wear contact lenses and / or have had 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 lacrimation, blurred vision and / or sensitivity to light, please tell your doctor or nurse, as you may need urgent treatment (see "Possible side effects" below).
Based on your age (over 65 years) or general health, your doctor will discuss with you your ability to tolerate adoption of Vectibix simultaneously 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 for colon cancer), or combination chemotherapy, known as "IFL".

Pregnancy and lactation
Vectibix has not been studied in pregnant women. It is important to tell your doctor if you are pregnant, think you may be pregnant or planning to become pregnant. Vectibix could affect your unborn child or the ability to stay pregnant.
If you are a woman may become pregnant should use effective contraception during treatment with Vectibix and for 2 months after the last dose.
If you become pregnant during treatment with Vectibix, you will be directed to programs for monitoring of the pregnancy. Contact details of local representatives are referred to in section 6 of this leaflet.
It is not recommended to breast-feed during treatment with Vectibix and for 2 months after the last dose. It is important to tell your doctor if you plan to breastfeed. If you breast-feed during treatment with Vectibix, you will be directed to programs to monitor breastfeeding. Contact details of local representatives are referred to in section 6 of this leaflet.
Ask your doctor or pharmacist before taking any medicine.

Driving and using machines
Ask your doctor before driving or using machines, as some side effects may impair your ability to do so safely.

Vectibix contains sodium
This product contains 0,150 mmol sodium (which is 3,45 mg sodium) per ml of concentrate. Should be considered in patients on a diet with a controlled intake of sodium.

3. How to use Vectibix
Vectibix will be administered in a healthcare facility under the supervision of a physician experienced in the use of anticancer drugs.
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) administered once every two weeks. Treatment will generally be administered for a period of about 60 minutes.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious and main side effects of Vectibix are listed below:
Effects associated with the infusion
During or after treatment may experience reactions, infusion-related. They can be mild or moderate (likely to occur in approximately 4 out of 100 people who take Vectibix), or severe (likely to occur in less than 1 in 100 people who take Vectibix). Symptoms may include headache, rashes, itching or hives, flushing, swelling (face, lips, mouth, eye and throat area), rapid and irregular heartbeat, rapid heartbeat, sweating, nausea, vomiting, dizziness, difficulty breathing or swallowing, or lowering blood pressure may be serious or life threatening and, rarely, can lead to death. If you get any of these symptoms, you should inform your doctor immediately. Your doctor may decide to reduce the rate of infusion or discontinue your treatment with Vectibix.

allergic reactions
Very rarely serious allergic reactions (hypersensitivity) reactions involving symptoms similar reaction associated with infusion (see "related reactions Infusion") 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 not only difficulty breathing, chest tightness, feeling of choking, dizziness or fainting.

skin reactions
Effects associated with the skin is likely to occur in approximately 90 out of 100 people who take Vectibix and are generally mild to moderate. The skin rash usually resemble acne, and often affects the face, upper chest and back, but can affect any area of the body. Some rashes are 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 can be fatal. Prolonged exposure to the sun can worsen the rash. Have also been reported dry skin, fissures (cracks in the skin) on the fingers or toes, infection (paronychia) or inflammation of the nail bed of the fingers or toes. Skin reactions generally resolve on discontinuation of therapy. 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:
reduced number of red blood cells (anemia), low potassium in your blood (hypokalemia); low magnesium levels in the blood (hypomagnesemia);
inflammation of the eye (conjunctivitis);
localized or generalized rash, which may be uneven (with or without spots), itchy, red or scaly;
hair loss (alopecia); ulcers and cold sores (stomatitis); mouth inflammation (mucositis);
diarrhea; nausea; vomiting; abdominal pain; constipation; anorexia (persistent loss of appetite); weight loss;
extreme tiredness (fatigue); fever or high temperature (pyrexia); loss or lack of strength (asthenia); accumulation of fluid in the extremities (peripheral edema);
back pain;
insomnia (insomnia);
cough; dyspnea (difficulty breathing).
Common: may affect up to 1 in 10 people:
decreased number of white blood cells (leukopenia); low blood calcium (hypocalcemia); low levels of phosphate in the blood (hypophosphatemia); high blood sugar (hyperglycemia);
eyelash growth; increased tearing (lacrimation increased); redness of the eye (ocular hyperemia); dry eye; itchy eyes (ocular pruritus); eye irritation; inflammation of the eyelids (blepharitis);
skin ulcers; scabs; excessive hair growth (hypertrichosis); redness and swelling of the hands or feet (hand-foot syndrome);
spreading infection under the skin (cellulitis); inflammation of hair follicles (folliculitis); localized infection; skin rash with blisters filled with pus (pustular rash);
nail disorder; Brittle nails (onychoclasis);
dehydration;
dry mouth; indigestion (dyspepsia); rectal bleeding (rectal haemorrhage); inflammation of the lips (cheilitis); heartburn (gastroesophageal reflux);
chest pain; pain; chills; pain in extremity; immune response (hypersensitivity); rapid heart rate (tachycardia);
blood clot in the lung (pulmonary embolism); nosebleeds (epistaxis); blood clot in the deep veins (deep vein thrombosis); high blood pressure (hypertension); flushing;
headache; dizziness; concern.
Uncommon: may affect up to 1 in 100 people:
bluish skin or mucous membranes (cyanosis);
keratitis (inflammation of the front of the eye (cornea));
eyelid irritation; chapped lips; eye infection; eyelid infection; dry nose; loosening of the nails (onycholysis); ingrown nails; excessive hair growth (hirsutism);
Rare: may affect up to 1 in 1000 people:
ulcerative keratitis (a serious condition of ulceration of the front part of the eye (cornea) requiring urgent treatment);
death of skin cells (skin necrosis).
Not known: from the available data can not be estimated:
lung inflammation (interstitial lung disease).
Adverse event reporting
If you get any side effects, tell your doctor or nurse. This includes any possible effects not listed in this leaflet. You can also report adverse events directly through the national reporting system. As reported adverse reactions, you can do your bit to get 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 out of the reach and sight of children.
Store in a refrigerator (2 ° C - 8 ° C).
Do not freeze.
Store in the original package in order to protect from light.
Do not use this medicine after the expiry date stated on the label and carton respectively after "EXP" or after "EXP". The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to 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 100 mg panitumumab in 5 ml, 200 mg panitumumab in 10 ml, or 400 mg panitumumab in 20 ml.
The other ingredients are sodium chloride, sodium acetate trihydrate, glacial acetic acid and water for injections.

What Vectibix looks like and contents of the pack
Vectibix is a colorless liquid that may contain visible particles and is supplied in vials. Each pack contains one vial of concentrate.

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 a healthcare professional using aseptic technique. Do not shake vigorously agitate the vial. Do not use Vectibix, if there is a change in color. Withdraw the necessary amount of Vectibix for a dose of 6 mg / kg. Dilute in a total volume of 100 ml. Doses higher than 1000 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.
The infusion line should be washed with sodium chloride solution before and after Vectibix administration to avoid mixing with other medicinal products or intravenous solutions.
Vectibix should not be administered as an intravenous infusion via an infusion pump, using the 0.2 or 0.22 micrometer filter with low protein binding, through a peripheral line or indwelling catheter. The recommended infusion time is approximately 60 minutes. Doses higher than 1000 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 polyvinylchloride or polyolefin.