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  • Gail Samples
    Winnie- Following are several articles regarding Enbrel. It does not really sound very safe for heppers to take until more is learned about the long-term
    Message 1 of 1 , Aug 31, 2000
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      Following are several articles regarding Enbrel. It does not really sound
      very safe for heppers to take until more is learned about the long-term
      safety/sides of this drug. It sounds like it might possibly counteract the
      interferon that your husband is taking!!!


      What does etanercept do?
      ETANERCEPT (Enbrel®) is used for the treatment of rheumatoid arthritis in
      adults and children. Generic etanercept injections are not yet available.

      What should my health care professional know before I take etanercept?
      They need to know if you have any of these conditions:
      *currently receiving vaccinations
      *exposed to chickenpox
      *low white blood cell count
      *other immune disorders
      *an unusual or allergic reaction to etanercept, latex, other medicines,
      foods, dyes, or preservatives

      How should I use this medicine?
      Etanercept is given by a small injection under the skin twice weekly, at
      least 3-4 days apart. Follow the directions on the prescription label. You
      may give etanercept injections to yourself or receive your injections in a
      clinic or doctor's office. Your prescriber or health care professional will
      assist you in preparing and injecting your first dose (or first few doses).
      Make sure you or your caregiver understands how to prepare the product.
      Several educational materials are available from your health care
      professional to assist you. You may also call the Enbrel® Patient Support
      Line at 1-888-4ENBREL (1-888-436-2735) with any questions you may have about
      etanercept. Rotate sites where you inject etanercept. Usual sites of
      injection include the thigh, stomach, and upper arms. Do not attempt to
      prepare or give the medicine by yourself if you do not understand how to mix
      and inject a dose.

      Contact your pediatrician or health care professional regarding the use of
      this medicine in children. Special care may be needed.

      What if I miss a dose?
      If you miss a dose, take it as soon as you can. If it is almost time for
      your next dose, consult your prescriber or health care professional. Do not
      take double or extra doses without advice.

      What other medicines can interact with etanercept?

      Tell your prescriber or other health care professional about all other
      medicines you are taking including non-prescription medicines, nutritional
      supplements, or herbal products. Also, tell your prescriber or health care
      professional if you are a frequent user of drinks with caffeine or alcohol,
      if you smoke or if you use illegal drugs. These may affect the way your
      medicine works. Check before stopping or starting any of your medications.

      What side effects may I notice from receiving etanercept?
      Side effects that you should report to your prescriber or health care
      professional as soon as possible:
      *fever, chills or any other sign of infection
      *stomach pain

      Side effects that usually do not require medical attention (report to your
      prescriber or health care professional if they continue or are bothersome):
      *reddness, itching or swelling at the injection site

      What do I need to watch for while I receive etanercept?
      If you get a cold or other infection while receiving etanercept, call your
      prescriber or health care professional. Etanercept may decrease your body's
      ability to fight infections.

      If you have never had chickenpox and are exposed to chickenpox, call your
      prescriber or health care professional right away. You may develop a more
      serious infection while receiving etanercept.

      When giving etanercept to yourself, make sure to rotate the sites where you
      inject the medicine. Make sure the new site is at least one inch from a
      previous injection site. Do not give in an area where the skin is tender,
      red, bruised or hard.

      Make sure you receive a puncture-resistant container to dispose of the
      needles and syringes once you have finished with them. Do not reuse these
      items. Return the container to your prescriber or health care professional
      for proper disposal.

      Where can I keep my medicine?
      Keep out of reach of children. Keep unopened vials in the refrigerator
      between 36û-46ûF (2û-8ûC). Do not freeze or use after the date stamped on
      the carton or vial. Once you have dissolved the powder, use it as soon as
      possible. The dissolved powder may be kept in the refrigerator for up to 6
      hours after mixing then must be thrown away.

      NOTE: This information is not intended to cover all possible uses,
      precautions, interactions, or adverse effects for this drug. If you have
      questions about the drug(s) you are taking, check with your health care

      FDA is advising physicians about new safety concerns regarding the use of
      etanercept (Enbrel), a product recently approved to treat moderate to severe
      rheumatoid arthritis (RA). New postmarketing reports indicate that certain
      patients receiving Enbrel have developed serious infections, including
      sepsis, and that several of these patients have died from their infections.
      The Immunex Corporation, Seattle, Wash., the co-sponsor of Enbrel, (along
      with Wyeth-Ayerst Laboratories, Philadelphia, Pa.) is sending a "Dear
      Doctor" letter alerting physicians to the new safety concerns, reminding
      them of the current label warning and informing them that the labeling for
      Enbrel has been revised to incorporate the new information.
      Enbrel was approved last November with labeling that says that it should not
      be given to patients with sepsis and should be discontinued if a patient
      develops a serious infection.
      Because of new information obtained from adverse reaction reports to FDA and
      Immunex, the warning related to sepsis has been expanded to include patients
      with any active infection, including chronic or localized infections.
      In addition, it is now recommended that patients who develop a new infection
      while being treated with Enbrel be monitored closely.
      It is further recommended that physicians be cautious when considering
      prescribing Enbrel to patients with a history of recurring infections or
      with underlying conditions such as advanced or poorly controlled diabetes
      that may predispose them to infections.
      Since the drug's approval, 30 of the estimated 25,000 patients treated with
      Enbrel are reported to have developed serious infections, including sepsis.
      Six of these patients died within two to sixteen weeks after starting
      treatment. A number of these RA patients had a history of chronic or
      recurrent infections, pre-existing infections, diabetes, or other conditions
      that predisposed them to infections.
      Even though many RA patients are predisposed to infections, significant
      concerns remain that Enbrel may contribute to the occurrence of serious
      infections. Many of the infections occurred shortly after initiation of
      Enbrel therapy. In addition, a controlled study of Enbrel to treat sepsis
      showed a higher incidence of death in patients treated with Enbrel.
      Moreover, Enbrel inhibits the action of tumor necrosis factor, a component
      of the body's natural defenses against serious infection.
      To date, controlled clinical studies have not shown an increase in serious
      infections in patients receiving Enbrel. FDA has requested that Immunex
      perform additional studies to assess the risk of serious infection related
      to Enbrel therapy.
      At this time, without further controlled clinical studies, it is unclear
      whether Enbrel truly is the cause of the serious infections in patients with
      RA. However, as a precautionary measure, physicians should consider these
      new reports when assessing the risks and benefits of Enbrel.
      Enbrel, a genetically engineered protein, was approved to treat patients
      with symptoms of moderate to severe, active RA who have not responded well
      to other treatments. It can significantly reduce pain and swollen joints in
      people disabled with RA, an autoimmune disease that affects more than two
      million Americans.
      FDA requests that all cases of serious infection or sepsis occurring in
      patients taking Enbrel be reported to the agency through MEDWATCH. Reports
      to Medwatch should be made by phone to 1-800-FDA-1088, by fax to
      1-800-FDA-0178, by mail to MEDWATCH, HF-2, FDA, 5600 Fishers Lane,
      Rockville, MD 20857. Reports can also be made through the internet at
      www.fda.gov/medwatch/ </medwatch/>. Health professionals may also contact
      Wyeth-Ayerst Product Information at 1-800-934-5556 or Immunex Professional
      Services at 1-800-IMMUNEX (1-800-466-8639).

      Enbrel Approved for the Management of Severe Rheumatoid Arthritis

      Moreland LW et al. Treatment of rheumatoid arthritis with a
      recombinant human tumor necrosis factor receptor (p75)-Fc fusion protein. N
      Engl J Med 1997;337(3):141.
      Feldman M et al. The role of cytokines in rheumatoid arthritis. Ann
      Rev Immunol. 1996;14:397.
      Enbrel Package Insert, Nov 1998, Wyeth-Ayerst Laboratories/Immunex
      HHS News. Press Release. First Biotechnology Product for Arthritis
      Approved. Nov. 2, 1998.

      Summary: A new approach to treating moderate to severe, active
      rheumatoid arthritis is now available in the US with the market approval of
      Enbrel (etanercept). The drug is co- marketed by the Immunex Corporation and
      Wyeth-Ayerst Laboratories and represents the first genetically engineered
      protein to be designed to help in the management of this crippling disease
      in patients who have not responded well to other therapies. It is estimated
      that RA affects more than two million Americans and that as many as one
      third to a half of these have moderate to severe disease. This drug is not
      indicated for the management of osteoarthritis, a disease associated with
      the aging process.
      How it Works
      Etanercept is a fusion protein consisting of the extracellular
      ligand-binding portion of the human tumor necrosis factor (TNF) receptor
      linked to the Fc portion of human IgG1. It is produced by recombinant DNA
      technology and is supplied as a lyophilized powder for parenteral
      administration. Enbrel binds to TNF, a naturally occurring protein that is a
      dominant cytokine in the cascade of reactions that cause the inflammatory
      process of RA. TNF is also involved in numerous immune responses. By
      preventing TNF from binding to TNF receptor sites, Enbrel renders the
      cytokine inactive, resulting in a reduction in inflammatory activity. In
      addition, Enbrel affects other responses modulated by TNF including the
      expression of adhesion molecules responsible for leukocyte migration, serum
      cytokines, and matrix metalloproteinases.
      Clinical Tips
      Two clinical trials formed the basis for the approval of Enbrel. In
      these studies, about 59% of patients treated with the drug experienced a
      significant reduction in symptoms including swollen and painful joints after
      six months of treatment, this compared to 11 percent of untreated patients.
      Among treated patients, the clinical responses generally appeared within 1
      to 2 weeks of starting therapy and nearly always occurred by the third month
      of treatment. Similarly, when a health assessment questionnaire was
      administered to patients to determine their quality of life, all components
      of the evaluation were improved in patients treated with Enbrel compared to
      controls at 3 and 6 months. In treated patients who discontinued therapy,
      symptoms of RA generally returned within a month. But reintroduction of
      treatment even following discontinuation for up to 18 months resulted in the
      same magnitude of response as patients who had received uninterrupted
      Enbrel can be used in combination with methotrexate in patients who
      do not respond well to methotrexate alone. It can also be administered
      concomitantly with glucocorticoids, salicylates, NSAIDs, or analgesics.
      The drug has been studied in children aged 4 to 17 years old. In
      children with moderate to severe juvenile rheumatoid arthritis, the results
      have been generally similar to those observed in adults.
      Enbrel has a serum half-life of 115 hours following a single
      subcutaneous dose. Patients may undergo a 2- to 5-fold increase in serum
      levels following repeated drug dosing. Although no formal pharmacokinetic
      studies have been conducted for Enbrel to determine the effects of renal or
      hepatic function or interactions with methotrexate, it is known that
      pharmacokinetic parameters do not vary with gender or age.
      About 37% of Enbrel-treated patients develop injection site
      reactions (such as pain, itching or swelling) that lasts a few days. Other
      common side effects include headache, runny nose and dizziness. Allergic
      reactions occurred in fewer than 1% of those receiving the drug. Although it
      is theoretically possible that Enbrel may weaken the body's defenses against
      infections and malignancies, clinical studies to date have not shown an
      increase in serious infections or malignancies in patients using the drug;
      however, studies are underway to evaluate the product's long-term safety
      profile. The manufactures indicates that the drug should not be administered
      to patients with sepsis or in those who develop a serious infection during
      The usual dose of Enbrel for an adult is 25 mg given twice a week as
      a subcutaneous injection.
      What the Patient Should Know
      Patients may be asked to self-administer Enbrel during continued
      therapy. Specific instructions must be followed to reconstitute and inject
      the drug appropriately. The patient should not self-administer the drug
      until trained to do so by their doctor. They should consult frequently with
      their physician and pharmacist about proper injection techniques and their
      response to therapy.
      When possible, children should be up to date with vaccine
      immunizations before starting therapy with Enbrel because it is not known
      whether treatment will affect the response to immunization.

      Etanercept (Enbrel)
      Enbrel is a medication that interferes with the action of TNF (tumor
      necrosis factor). TNF is a naturally occurring protein involved in normal
      human inflammatory and immune activities. However, TNF is present in
      excessive amounts in the joints of persons with rheumatoid arthritis.
      Excessive levels of TNF contribute to the pain, swelling, stiffness and
      damage of rheumatoid arthritis. Another naturally occurring molecule (TNF
      soluble receptor) acts to decrease the activity of TNF. Unfortunately, the
      quantity of TNF soluble receptor is insufficient to counteract the excessive
      Enbrel is a genetically engineered medication that combines two of the TNF
      soluble receptors into one molecule (combining two soluble receptors helps
      them stay in the bloodstream longer). Enbrel binds much of the excessive
      TNF, thus reducing the ability of TNF to worsen arthritis.
      Enbrel is not a cure for arthritis. However, scientific studies show Enbrel
      to be rapidly effective in many patients (sometimes causing improvement
      within 1-2 weeks). If Enbrel does not help arthritis within twelve weeks, it
      is unlikely to do so. Enbrel is helpful only as long as it is taken. If it
      is stopped, benefit usually is lost within 4 weeks. If it is stopped and
      then restarted, it is expected to work as well the second time as it did
      when first used. Enbrel is a "second line" drug in the treatment of
      rheumatoid arthritis and as such, is reserved for persons with severe
      arthritis who have not responded to other medications. Enbrel can be used in
      combination with methotrexate, prednisone, aspirin, other nonsteroidal
      anti-inflammatory drugs and common pain medications.
      Dosage and Administration:
      Enbrel must be taken as an injection. It is injected under the skin similar
      to an insulin shot twice weekly (Monday & Thursday or Tuesday & Friday or
      Wednesday & Saturday). The patient, family member or friend is taught how to
      give the injection. Enbrel must be kept refrigerated and not exposed to
      temperature extremes. Do not freeze Enbrel.
      Drug Interactions:
      There are no known drug interactions with Enbrel.
      Precautions and Side-effects:
      Persons with serious infections should not take Enbrel. Also, a person
      taking Enbrel should stop it immediately and notify his/her physician if a
      serious infection develops.
      Allergic reactions due to Enbrel have been rare (occurring in less than
      one-half of one percent of patients). It should not be taken by anyone known
      to be allergic to Enbrel.
      Treatments like Enbrel may affect the body's ability to fight infection and
      cancer. Studies done so far have not shown an increased risk of cancer due
      to Enbrel.
      Persons taking Enbrel should not receive live virus vaccinations such as
      live polio vaccine. Vaccinations using "dead" viruses such as flu shots and
      hepatitis B shots are allowed. It is unknown whether Enbrel makes
      vaccinations less effective.
      The safety of taking Enbrel during pregnancy and breast feeding is unknown,
      and unless a physician specifically recommends otherwise, it should be
      avoided during pregnancy and breast feeding. Whether Enbrel influences
      fertility is unknown.
      * Injection site reactions:
      Slightly over one-third of patients treated with Enbrel
      develop mild to moderate irritation (redness, itching, swelling or
      discomfort) at the injection site. Irritated injection sites usually improve
      within 3 to 5 days and rarely require discontinuation of the medication.
      Injection site reactions most often occur during the first month and
      gradually subside with time.
      * Infections
      Mild upper respiratory infections or "cold" symptoms may
      occur while taking Enbrel. These usually do not require interruption of
      Bacterial and serious viral infections may be more likely,
      more serious and more difficult to treat in patients taking Enbrel.
      Infections can be life threatening. Therefore, any person who develops fever
      or other sign of infection should call his/her physician and refrain from
      taking Enbrel until advised by a physician to restart it.
      * Other side effects reported in at least 3% of patients taking Enbrel
      include headache, dizziness, weakness, rash and stomach upset.
      As more patients receive Enbrel, other (unanticipated) side
      effects may be discovered. These could be serious, even life threatening. If
      you feel that you are developing a significant side effect, call your
      physician immediately. It is recommended that you ask your pharmacist for an
      Enbrel package insert when picking up your prescription. Read the insert.
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