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What Erbitux is and what it is used for
What is Erbitux?
Erbitux contains cetuximab-monoclonal antibody. Monoclonal antibodies are proteins that specifically recognize and bind to other unique proteins called antigens. Cetuximab binds to the epidermal growth factor receptor (PEP), which is an antigen on the surface of some cancer cells. PEP activates proteins called PAC. RAC proteins play an important role in the biochemical pathway of a RERF-complex signaling cascade that is involved in the development and progression of cancer. As a result of this connection, the cancer cell is unable to receive the signals necessary for its growth, progression and metastasis.
What Erbitux is used for
Erbitux is used to treat two different types of cancers:
Metastatic carcinoma of the colon. In these patients, Erbitux is used alone or in combination with other anticancer medicines;
A certain type of head and neck cancer (squamous cell cancer). In these patients, Erbitux is used in combination with radiation therapy or other anticancer medicines.
2. What you need to know before using Erbitux
Do not use Erbitux:
Do not use Erbitux if you have ever had a severe hypersensitivity reaction (an allergic reaction) to cetuximab.
Before starting treatment for metastatic carcinoma of the colon, your doctor will check whether the cancer cells in your case contain the normal (wild type) or mutant form of PAC. You should not take Erbitux in combination with other oxaliplatin-containing anticancer medicines if the cancer cells in your case contain the mutant form of PAC.
Warnings and precautions
Talk to your doctor before using Erbitux if any of the following information is unclear.
Erbitux may cause infusion-related side effects. These reactions may be allergic in nature. Please read "Infusion-related reactions" in section 4 for more information as they may have serious consequences for you, including life-threatening conditions. These side effects usually occur during the infusion, within one hour afterwards or sometimes later. To recognize the early signs of these reactions, your condition should be monitored regularly during each infusion of Erbitux and at least 1 hour after it.
The likelihood of getting severe allergic reactions is greater if you are allergic to red meat, a tick bite, or have positive results for certain antibodies (from a test). Your doctor will discuss with you the appropriate measures.
Erbitux can cause side effects that affect the skin. Your doctor will discuss with you whether you need any prophylactic or early treatment. Please also read "Side effects related to the skin" in section 4 for more details, as skin reactions may have serious consequences for you, including life-threatening conditions.
If you have heart problems, your doctor will discuss with you whether you can take Erbitux in combination with other anticancer medicines, especially if you are 65 years of age or older.
Erbitux may cause undesirable effects affecting the eyes. Please tell your doctor if you have severe or worsening eye problems such as blurred vision, eye pain, red eyes and / or severe dry eyes, if you have experienced similar problems in the past or if you are using contact lenses. Your doctor will discuss with you whether you should consult a specialist.
If you receive Erbitux in combination with anticancer medicines, including platinum, the number of your white blood cells is likely to decrease. Therefore, your doctor will monitor your blood counts and your general condition for signs of infection (see also "Adverse reactions when combined with other anticancer treatments" in section 4).
If you are taking Erbitux in combination with other anticancer medicines, including fluoropyrimidines, you may be more likely to have heart problems that may be life-threatening. Your doctor will discuss with you whether you need special monitoring (see also "Adverse Reactions Combined with Other Anticancer Treatments" in section 4).
Children and adolescents
There is no corresponding use of Erbitux in children and adolescents.
Other medicines and Erbitux
Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Tell your doctor if you are pregnant or if you do not use reliable contraceptives (ask your doctor if you are not sure). Your doctor will discuss with you the risk and benefits of using Erbitux in these situations.
You should not breast-feed while you are being treated with Erbitux and for two months after the last dose.
Driving and using machines
Do not drive or use any tools or machines if treatment-related symptoms occur that affect your ability to concentrate and react.
3. How to use Erbitux
Your treatment with Erbitux will be managed by an experienced doctor, an oncologist. During each infusion and at least 1 hour afterwards, your condition will be regularly monitored for early signs of possible infusion-related reactions.
Preparation for treatment
Before the first dose, you will receive an anti-allergic drug to reduce the risk of an allergic reaction. Your doctor will decide if such preparation is necessary at the next doses.
Dosage and route of administration
Erbitux is usually infused intravenously (as a drip) once a week. Your doctor will calculate the correct dose of Erbitux for you as it depends on your body surface. The first dose (400 mg / m2 body surface area) is infused for about 2 hours at an infusion rate of not more than 5 mg / min. Each subsequent dose (250 mg / m 2 body surface area) is infused for about 1 hour at a rate of infusion not higher than 10 mg / min.
Detailed instructions for your doctor or nurse for the preparation of the Erbitux infusion solution are included at the end of this leaflet (see "Instructions for use").
Duration of treatment
Erbitux is usually injected once a week. The duration of treatment may vary depending on the disease and is individual in individual patients, so your doctor will discuss with you how long you will receive Erbitux.
Combination with other anticancer treatment
If you take Erbitux in combination with other anticancer medicines they should be given at least 1 hour after the end of the Erbitux infusion.
If you take Erbitux in combination with radiation therapy, treatment with Erbitux is usually started 1 week before radiation therapy.
If you have any further questions on the use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The main side effects of Erbitux are infusion-related reactions and reactions affecting the skin:
Infusion-related reactions were seen in more than 10 in 100 patients; In more than 1 in 100 patients these side effects may be severe. Such reactions may be allergic in nature. These usually occur during the infusion, within an hour or more, or sometimes later.
Adverse reactions when combined with other anticancer treatments
If you take Erbitux in combination with other anticancer medicines, some of the possible side effects may also be associated with the combination or with other medicines. So please read the leaflets of other medicines.
If you receive Erbitux in combination with anticancer medicines, including platinum, the number of your white blood cells is likely to decrease. This can lead to infectious complications, including life-threatening conditions, especially if you have skin reactions, inflammation of the lining of the intestine and the oral cavity or diarrhea. Therefore, if general signs of infection such as fever and fatigue occur, please contact your doctor immediately.
If you take Erbitux in combination with an anti-cancer drug containing fluoropyrimidines, you are more likely to have the following side effects of this medicine:
Redness and swelling of the palms or soles, which may lead to skin peeling (hand-foot syndrome).
If you take Erbitux in combination with radiation therapy, some of the possible side effects may also be associated with this combination such as:
Inflammation of the lining of the intestine and the oral cavity;
Radiation-specific skin reactions;
Decreased number of white blood cells.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system. As you report side effects, you can contribute to getting more information on the safety of this medicine.
5. How to store Erbitux
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 ° C - 8 ° C).
Erbitux should be used immediately after opening the pack.
6. Package Contents and Additional Information
What Erbitux contains
The active substance is cetuximab.
Each milliliter of the infusion solution contains 5 mg cetuximab.
Each 20 ml vial contains 100 mg cetuximab.
Each 100 ml vial contains 500 mg of cetuximab.
The other ingredients are: sodium chloride, glycine, polysorbate 80, citric acid monohydrate, sodium hydroxide and water for injections.
What Erbitux looks like and contents of the pack
Erbitux 5 mg / ml solution for infusion is supplied in 20 ml or 100 ml vials.
Each pack contains one vial.
Not all vials can be marketed.
The following information is intended for medical professionals only:
Instruction for use
Erbitux can be given by a drop method, via an infusion pump or an injection pump. Because Erbitux is only compatible with sterile sodium chloride 9 mg / ml (0.9%) solution for injection, it should not be mixed with other intravenous medicinal products. A separate infusion line should be used, which at the end of the infusion must be flushed with sterile injectable 9 mg / ml sodium chloride solution (0.9%).
Erbitux 5 mg / ml is compatible with:
Polyethylene (PE), ethyl vinyl acetate (EVA) or polyvinyl chloride (PVC) bags;
Polyethylene (PE), polyurethane (PUR), ethyl vinyl acetate (EVA), polyolefin thermoplastic (TP) or polyvinyl chloride (PVC) infusion sets;
Polypropylene (PP) syringes for an injection pump.
Erbitux 5 mg / ml is chemically and physically stable for 48 hours at 25 ° C if the solution is prepared as described below. However, since it does not contain any antimicrobial preservative or bacteriostatic agent, it is intended for immediate use.
Care should be taken to ensure aseptic conditions for the preparation of the infusion. Erbitux 5 mg / ml should be prepared as follows:
For infusion or drip infusion (diluted with sterile sodium chloride 9 mg / ml (0.9%)): Take a sterile sodium chloride 9 mg / ml (0.9%) solution with appropriate Volume. The required volume of Erbitux is calculated. Remove the appropriate amount of sodium chloride solution from the bag using a suitable sterile syringe with a corresponding needle. Take a suitable sterile syringe and attach a corresponding needle. The required volume of Erbitux is withdrawn from the vial. Erbitux is transferred to the prepared infusion bag. This procedure is repeated until the calculated volume for infusion is reached. The infusion line is connected and flushed with the diluted Erbitux before the infusion starts. When infused, a drip method or an infusion pump is used. The first dose (400 mg / m2 body surface) is infused for about 2 hours
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