Enbrel

Dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Enbrel is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids

Enbrel - Pharmacology:

There are two distinct receptors for TNF (TNFRs), a 55 kilodalton protein (p55) and a 75 kilodalton protein (p75). The biological activity of TNF is dependent upon binding to either cell surface receptor (p75 or p55). Enbrel is a dimeric soluble form of the p75 TNF receptor that can bind to two TNF molecules, thereby effectively removing them from circulation.

Enbrel mini report

Enbrel BLA
BLA - A product marketed under an approved Biologic License Application
Enbrel SUBCUTANEOUS
SUBCUTANEOUS
Enbrel KIT
KIT
Enbrel SOLUTION
SOLUTION
Enbrel HUMAN PRESCRIPTION DRUG
HUMAN PRESCRIPTION DRUG
Start - Stop data
START DATA:
2003-Jan-02
Start - Stop data
STOP DATA
not occurred

Enbrel for patients

Single-use Prefilled Syringe
PATIENT INFORMATION

ENBREL® (pronounced en-brel)

Read these instructions carefully before you start taking ENBREL®. You should read this leaflet each time you get your prescription refilled, in case something has changed. The information in this leaflet does not take the place of talking with your doctor before you start taking this medication and at check-ups. Talk to your doctor if you have any questions about your treatment with ENBREL®.


What is ENBREL®?

ENBREL® is a medicine for adults and children with moderate to severe forms of rheumatoid arthritis (RA) and a type of disease called psoriatic (sore-ee-ah-tick) arthritis. ENBREL® is also for adults with a type of arthritis called ankylosing spondylitis (ank-e-low-sing spond-e-lie-tis) (AS). ENBREL® is also for adults with moderate to severe psoriasis (sore-I-ah-sis). RA, psoriatic arthritis, and AS are inflammatory diseases that affect the joints in your body. Psoriasis is an inflammatory disease that affects the skin and can cause raised, thick, red and scaly patches ("psoriatic skin lesions") that can appear anywhere on the body. Psoriatic arthritis is usually seen in patients with psoriasis and affects both the joints and the skin.


How does ENBREL® work?

ENBREL® is a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance your body makes called TNF-alpha. Tumor necrosis factor-alpha is made by your bodys immune system. People with immune diseases like RA, psoriasis, and psoriatic arthritis, as well as patients with AS, have too much TNF-alpha in their bodies, which can cause inflammation and lead to painful, swollen joints and raised, thick, red, scaly patches ("psoriatic skin lesions") that can appear anywhere on the body. ENBREL® can reduce the amount of TNF in the body to normal levels, helping to treat joint damage and skin lesions.

While taking ENBREL® can block the damage that too much TNF-alpha can cause, it can also lower the ability of your immune system to fight infections. So, taking ENBREL® can make you more prone to getting infections or make any infection that you may have worse.


What important information do I need to know about taking ENBREL®?

All medicines have side effects. Medicines, like ENBREL®, that affect your immune system can cause serious side effects. The possible serious side effects include:

  • Serious infections. There have been rare cases where patients taking ENBREL® or other TNF-blocking agents have developed serious infections, including tuberculosis (TB) and infections caused by bacteria or fungi that have spread throughout their body (sepsis). Some patients have died from these infections. If you tend to get infections easily or if you develop an infection while taking ENBREL®, you should tell your doctor right away. Taking ENBREL® with Kineret. (anakinra) is not recommended because this may increase your risk of getting a serious infection.
  • Nervous system diseases. There have been rare cases of disorders that affect the nervous system of people taking ENBREL® or other TNF blockers. Signs that you could be experiencing a problem affecting your nervous system include: numbness or tingling throughout your body, problems with your vision, weakness in your arms and/or legs, and dizziness.
  • Blood problems. In some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you to stop bleeding. If you develop a fever that doesnt go away, bruise or bleed very easily or look very pale, call your doctor right away. Your doctor may decide to stop your treatment. Some people have also had symptoms that resemble lupus (rash on your face and arms that gets worse in the sun) that may go away when you stop taking ENBREL®.
  • Heart problems. You should also tell your doctor if you have ever been treated for heart failure. If you have, your doctor may choose not to start you on ENBREL®, or may want to monitor you more closely.
  • Allergic reactions. Some patients have had allergic reactions to ENBREL®. If you develop a severe rash, swollen face or difficulty breathing while taking ENBREL®, call your doctor right away.
  • Malignancies. RA patients, particularly those with highly active RA, may be at higher risk for lymphoma (a type of cancer). There have been rare reports of lymphoma in patients taking ENBREL® or other TNF blockers, occurring more often than expected for people in general. The role of ENBREL® in the development of cancer is not known.

Before you start taking ENBREL® you should tell your doctor if you have or have had any of the following:

  • Any kind of infection including an infection that is in only one place in your body (such as an open sore), or an infection that is in your whole body (such as the flu). Having an infection could put you at risk for serious side effects from ENBREL®.
  • A history of infections that keep coming back or other conditions, like diabetes, that might increase your risk of infections.
  • Tuberculosis (TB), or if you have been in close contact with someone who has had tuberculosis. If you develop any of the symptoms of tuberculosis (a dry cough that doesnt go away, weight loss, fever, night sweats) call your doctor. You will need to be examined for TB and have a skin test.
  • Any numbness or tingling or a disease that affects your nervous system like multiple sclerosis.
  • Been newly diagnosed or are being treated for congestive heart failure.
  • Been scheduled to have major surgery.
  • Been scheduled to be vaccinated for anything.

If you are not sure or have any questions about any of this information, ask your doctor.


What are the other more common side effects with ENBREL®?

  • Reactions where the injection was given. These reactions are usually mild and include redness, rash, swelling, itching, or bruising. These usually go away within 3 to 5 days. If you have pain, redness or swelling around the injection site that doesnt go away or gets worse, call your doctor.
  • Upper respiratory infections (sinus infections)
  • Headaches


What are other possible side effects with ENBREL®?

You should not take ENBREL® if you have ever had an allergic reaction to ENBREL®.


Can I take ENBREL® if I am pregnant or breast-feeding?

ENBREL® has not been studied in pregnant women or nursing mothers, so we dont know what the effects are on pregnant women or nursing babies. You should tell your doctor if you are pregnant, become pregnant, or are thinking about becoming pregnant.

Pregnancy Registry: Amgen has developed a registry for pregnant women exposed to ENBREL®. The purpose of this registry is to check the health of the pregnant mother and her child. Patients are encouraged to contact the registry themselves or ask their doctors to contact the registry for them by calling 1-877-311-8972.


Can I take ENBREL® if I am taking other medicines for my Rheumatoid Arthritis, Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis or other conditions?

Yes, you can take other medicines if your doctor has prescribed them or has told you it is OK to take them while you are taking ENBREL®. It is important that you tell your doctor about any other medicines (for example, high blood pressure medicine) you are taking for other conditions before you start taking ENBREL®. Taking ENBREL® with Kineret. (anakinra) is not recommended because this may increase your risk of getting a serious infection. Taking ENBREL® with cyclophosphamide (used to treat cancer or other immune diseases) is not recommended.

You should also tell your doctor about any over-the-counter drugs, herbal medicines and vitamin and mineral supplements you are taking.

How do I take ENBREL®?

ENBREL® is given by injection under the skin.

Make sure you have been shown how to inject ENBREL® before you do it yourself. You can call your doctor or the ENBREL® toll-free information line at 1-888-4ENBREL (1-888-436-2735) if you have any questions about ENBREL® or about giving yourself an injection. Someone you know can also help you with your injection. Remember to take this medicine just as your doctor has told you and do not miss any doses.

Adults

If you have RA, psoriatic arthritis, or AS, the recommended dose of ENBREL® for adults is 50 mg per week given as one injection using a single-use prefilled syringe.

If you have psoriasis, the recommended starting dose of ENBREL® for adult patients is a 50 mg dose twice a week (3 or 4 days apart) given for three months. After 3 months, your doctor will tell you to reduce your dose to 50 mg once per week. The 50 mg dose of ENBREL® can be given as one injection using a single-use prefilled syringe.

Children

The recommended dose of ENBREL® for children with juvenile rheumatoid arthritis is based upon the childs body weight. Your childs doctor will tell you the correct amount of ENBREL® your child should take. The 50 mg/mL single-use prefilled syringe of ENBREL® is only recommended for children weighing 138 pounds or more.


What should I do if I miss a dose of ENBREL®?

If you forget to take ENBREL® when you are supposed to, contact your doctor to find out when to take your next dose of ENBREL®.


What do I need to do to prepare and give an injection of ENBREL®?

STEP 1: Setting Up for an Injection

  1. Select a clean, well-lit, flat work surface, such as a table.
  2. Take the ENBREL® carton containing the prefilled syringes out of the refrigerator and place it on your flat work surface. Remove one prefilled syringe and place it on your work surface. Do not shake the prefilled syringe of ENBREL®. Place the carton containing any remaining prefilled syringes back into the refrigerator (2° to 8°C (36° to 46°F)). If you have any questions about storage, contact your doctor, nurse, or pharmacist for further instructions.
  3. Check the expiration date on the prefilled syringe. If the expiration date has passed, do not use the prefilled syringe and contact your pharmacist or call 1-888-4ENBREL (1-888-436-2735) for assistance.
  4. Wait 15 to 30 minutes to allow the ENBREL® in the prefilled syringe to reach room temperature. DO NOT remove the needle cover while allowing it to reach room temperature.

    Do not warm ENBREL® in any other way (for example, do not warm it in a microwave or in hot water).
  5. Assemble the additional supplies you will need for your injection. These include an alcohol swab, a cotton ball or gauze, and a puncture-resistant disposal container.
  6. Wash your hands with soap and warm water.
  7. Make sure the solution in the prefilled syringe is clear and colorless. Do not inject the solution if it is discolored, contains lumps, flakes, or particles. If the solution in the prefilled syringe is not clear and colorless, or contains particles; contact your pharmacist or call 1-888- 4ENBREL (1-888-436-2735) for assistance.

STEP 2: Choosing and Preparing an Injection Site

  1. Three recommended injection sites for ENBREL® using a prefilled syringe include: (1) the front of the middle thighs; (2) the abdomen, except for the two-inch area right around the navel; and, (3) the outer area of the upper arms.
  2. Rotate the site for each injection. Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid areas with scars or stretch marks.
  3. If you have psoriasis, you should try not to inject directly into any raised, thick, red, or scaly skin patches ("psoriasis skin lesions").
  4. To prepare the area of skin where ENBREL® is to be injected, wipe the injection site with an alcohol swab. Do not touch this area again before giving the injection.

STEP 3: Injecting ENBREL® Using a Prefilled Syringe

  1. Pick up the prefilled syringe from your flat work surface. Hold the barrel of the prefilled syringe with one hand and pull the needle cover straight off.

    When you remove the needle cover, there may be a drop of liquid at the end of the needle; this is normal. Do not touch the needle or allow it to touch any surface. Do not touch or bump the plunger. Doing so could cause the liquid to leak out.
  2. Holding the syringe with the needle pointing up, check the syringe for air bubbles. If there are bubbles, gently tap the syringe with your finger until the air bubbles rise to the top of the syringe. Slowly push the plunger up to force the air bubbles out of the syringe.
  3. Holding the syringe in one hand like a pencil, use the other hand to gently pinch a fold of skin at the cleaned injection site and hold it firmly.
  4. Insert the needle at a slight angle (45 degrees) to the skin. With a quick, "dart-like" motion, insert the needle into the skin.
  5. After the needle is inserted, let go of the skin. Pull the plunger back slightly. If blood comes into the syringe, do not inject ENBREL® because the needle has entered a blood vessel. Withdraw the needle and discard it in a puncture-resistant container. Repeat the steps to prepare for an injection using a new prefilled syringe of ENBREL®. Do not use the same prefilled syringe.
  6. If no blood appears in the syringe, slowly push the plunger all the way down to inject ENBREL®.
  7. When the syringe is empty, pull the needle out of the skin, being careful to keep it at the same angle as inserted. There may be a little bleeding at the injection site. You can press a cotton ball or gauze over the injection site for 10 seconds. Do not rub the injection site. If needed, you may cover the injection site with a bandage.

STEP 4: Disposing of Supplies

  • The syringe should NEVER be reused. NEVER recap a needle.
  • Dispose of the used syringe in a puncture-resistant container. Use a hard plastic container with a screw top or hard plastic lid. A SHARPS container made specifically for disposing of used syringes and needles may be used. Puncture-resistant containers may also be purchased at your local pharmacy. Do not recycle the container.
  • Keep the container out of reach of children. When the container is about two-thirds full, dispose of it as instructed by your healthcare provider. Follow any special state or local laws regarding the proper disposal of needles and syringes.
  • Used alcohol swabs should be placed in the trash.

A healthcare provider familiar with ENBREL® should answer all questions. A toll-free information service is also available: 1-888-4ENBREL (1-888-436-2735).



Manufactured by:
Immunex Corporation,
Thousand Oaks, CA 91320-1799
Marketed by Amgen and Wyeth Pharmaceuticals

©2005 Immunex Corporation. All rights reserved.

Issue Date: 07/28/2005
Printed in the U.S.A.

Enbrel Interactions

Specific drug interaction studies have not been conducted with ENBREL®. However, it was observed that the pharmacokinetics of ENBREL® was unaltered by concomitant methotrexate in rheumatoid arthritis patients.

In a study in which patients with active RA were treated for up to 24 weeks with concurrent ENBREL® and anakinra therapy, a 7% rate of serious infections was observed, which was higher than that observed with ENBREL® alone (0%). Two percent of patients treated concurrently with ENBREL® and anakinra developed neutropenia (ANC < 1 x 109/L).

Patients in a clinical study who were on established therapy with sulfasalazine, to which ENBREL was added, were noted to develop a mild decrease in mean neutrophil counts in comparison to groups treated with either ENBREL CI or sulfasalazine alone. The clinical significance of this observation is unknown.

Enbrel Contraindications

ENBREL® should not be administered to patients with sepsis or with known hypersensitivity to ENBREL® or any of its components.

Generic name, Overdose, Half Life Enbrel, Food Interactions, Chemical, etc..

Enbrel see also