CONTENTS
<br/>
<br/>Disclaimer
<br/>Introduction to Enbrel
<br/>Why Enbrel is Used With Reproductive Immunology Patients
<br/>Indicators of NK Cells in the Uterine Lining
<br/>How is Enbrel Administered?
<br/>What are the Side Effects of Enbrel?
<br/>Is Enbrel Safe?
<br/>Insurance Coverage / Cost of Enbrel
<br/>Enbrel Vaginal Gel
<br/>Resources
<br/>
<br/>
<br/>DISCLAIMER
<br/>Informed reproductive immunology patients prepared this document. The
<br/>data was gathered from doctors, nurses, medical papers, shared
<br/>knowledge among patients using Enbrel, and from personal experience.
<br/>You are encouraged to research and ask questions of your physician
<br/>until you are personally satisfied that the benefits of this
<br/>treatment exceed the possible risks. The information provided is not
<br/>intended to substitute for the advice of a doctor.
<br/>
<br/>
<br/>
<br/>II. INTRODUCTION TO ENBREL
<br/>
<br/>Enbrel (etanercept) was developed for patients who have severe
<br/>rheumatoid arthritis. It was approved by the Federal Drug
<br/>Administration for use in these patients in November of 1998.
<br/>Enbrel's function is to bind with tumor necrosis factor alpha (TNFa),
<br/>which is secreted by activated Natural Killer (NK) cells. Patients
<br/>with rheumatoid arthritis have been found to have elevated levels of
<br/>TNFa in their joints. Enbrel binds to the TNFa, rendering it
<br/>biologically inactive, resulting in significant reduction of
<br/>inflammatory activity.
<br/>
<br/>
<br/>
<br/>III. WHY ENBREL IS USED WITH REPRODUCTIVE IMMUNOLOGY PATIENTS
<br/>
<br/>Enbrel is used with reproductive immunology patients who have been
<br/>found to have evidence of active NK cells residing in their uterine
<br/>lining (NKUs). Women who have active NK cells in their uterine lining
<br/>that are secreting TNFa are prone to a disordered lining development,
<br/>failed implantation, poor embryo development and/or pregnancy
<br/>failure . At the time of ovulation these women often have thin
<br/>endometriums, often only 7-8mm thick. A full week before menstruation
<br/>there is often evidence of stromal hemorrhages in the uterine lining
<br/>as well.
<br/>
<br/>TNFa produced by the Natural Killer cells in the uterus damages the
<br/>embryo and it often fails to grow, divide, and implant. TNFa also
<br/>damages the blood vessels in zone three of the endometrium. This
<br/>often creates stromal hemorrhages and robs blood and nutrients from
<br/>the embryo. This also results in thinner than normal endometrium.
<br/>
<br/>
<br/>A cycle day-26 endometrial biopsy, or an analysis of the products of
<br/>conception following miscarriage, can confirm the presence of NK
<br/>cells in the uterus (NKUs). If confirmed, Enbrel is prescribed to
<br/>neutralize TNFa. Enbrel is used for a minimum of 30 days before
<br/>trying a cycle of conception. See: http://repro-
<br/>med.net/tests/endomet.php
<br/>
<br/>
<br/>
<br/>IV. INDICATORS OF NK CELLS IN THE UTERINE LINING
<br/>
<br/>The following factors may indicate the presence of NK cells in the
<br/>uterus (NKUs):
<br/>
<br/>(1) Highest incidence is in women with one live-born child and then a
<br/>history of infertility or recurrent miscarriage.
<br/>
<br/>History of endometriosis.
<br/>History of mononucleosis.
<br/>History of HPV or Herpes.
<br/>Those who experience flu-like symptoms with implantation or IVF
<br/>transfer.
<br/>Those who have IgA anticardiolopin antibodies.
<br/>Those who have a positive skin test allergic reaction to HCG within
<br/>30 minutes.
<br/>History of IVF failures (2 or more).
<br/>Those who have a known autoimmune disorder (such as fibromyaglia,
<br/>lupus, rheumatoid arthritis, Crohn's disease, thyroiditis, chronic
<br/>fatigue syndrome, Raynaud's disease).
<br/>Those who have a history of dysplasia of the cervix.
<br/>Those who have recurrent spontaneous abortions, who lose their
<br/>pregnancies earlier, have implantation failures, or who have
<br/>secondary infertility.
<br/>Those who have luteal phase defects.
<br/>Those who experience premenstrual spotting.
<br/>Those who have odd/irregular menstrual cycles.
<br/>Those who have poor egg quality.
<br/>Those who experience failure to carry to term with all other
<br/>traditional immune treatments (i.e. IVIg and LIT).
<br/>
<br/>
<br/>HOW IS ENBREL ADMINISTERED?
<br/>Enbrel is administered by subcutaneous injection in the thigh,
<br/>stomach, or back of the upper arm. It is given every 84 hours, or
<br/>twice a week. An example of a typical weekly schedule might be to
<br/>administer the first injection Saturday at 6 p.m. and a second
<br/>injection on Wednesday at 6 a.m. Enbrel is packaged with four doses
<br/>in each box, which provides a two-week supply. Each of the four doses
<br/>comes in an individually wrapped tray, which includes the syringe,
<br/>one 25mg vial of Enbrel, one plunger and two alcohol swabs. The drug
<br/>should be refrigerated. Enbrel's manufacturer, Amgen, provides an
<br/>information service at 1-888-436-2735 to answer any questions
<br/>consumers might have. Website: http://www.embrel.com/home.jsp?fvar=1 .
<br/>
<br/>
<br/>It is important to note that Enbrel users should dispose of the used
<br/>syringes appropriately. A Sharps container for correct disposal of
<br/>used syringes may be requested of your providing pharmacy or your
<br/>physician.
<br/>
<br/>
<br/>
<br/>WHAT ARE THE SIDE EFFECTS OF ENBREL?
<br/>As with any drug, it is advisable to notify any physician (including
<br/>dentists) that you are on this medication. Live vaccines should not
<br/>be given concurrently with Enbrel. Also, it is important that you
<br/>check with your doctor if you develop a cold or any other infection
<br/>while on Enbrel. The current label for Enbrel states that the drug
<br/>should not be used with patients who develop a serious infection or
<br/>have sepsis. It should also be noted that the needle cover of the
<br/>syringe contains dry natural rubber (latex) which should not be
<br/>handled by people who are sensitive to this substance.
<br/>
<br/>Possible side effects that have been noted are included below. If you
<br/>experience any other side effects not listed below, or any side
<br/>effects that cause you concern, please contact your physician.
<br/>
<br/>pain, redness, itching, swelling, or bruising at the injection site
<br/>(rash is often delayed, often starting after the 4th injection )
<br/>joint pain and/or flu-like symptoms and fatigue for the first 30
<br/>days, decreased body aches after 30 days
<br/>increased energy
<br/>positive menstrual cycle changes including ovulation closer to day 14
<br/>(for those who experienced later ovulation), heavier menstrual flow
<br/>(in those who formerly had light periods), LH surge more defined and
<br/>recognizable with the use of an LH kit, increase in the quantity of
<br/>cervical mucus, cervical mucus more closely synchronized with
<br/>ovulation, and decreased pre-menstrual syndrome
<br/>negative menstrual cycle changes including possible harsher menstrual
<br/>cramping, increased breast tenderness, anovulatory cycles, late
<br/>ovulation, poor lining and follicle development, and little cervical
<br/>mucus in some cycles (most cycles become more normal after longer use
<br/>of Enbrel)
<br/>dizzinesss, queasiness
<br/>increased nightsweats (which usually decrease with longer use of
<br/>Enbrel)
<br/>heart palpitations, pounding, high blood pressure (notify physician
<br/>immediately if these occur)
<br/>vivid dreams
<br/>sleeplessness
<br/>increased risk of complications as a consequence of respiratory
<br/>infections (colds) and sinus infections
<br/>anxiety/nervousness
<br/>shakiness and/or panic attack (less common)
<br/>
<br/>
<br/>IS ENBREL SAFE?
<br/>The FDA classifies drugs into 5 categories with respect to pregnancy:
<br/>Category A, B, C, D, and X, with A being deemed the safest. Enbrel
<br/>has been classified as category B; there have been studies in animals
<br/>at doses 60 to 100 times higher than human doses that have revealed
<br/>no evidence of harm to the fetus. At this time, there are no formal
<br/>studies with pregnant women.
<br/>
<br/>Enbrel is usually taken until the patient is pregnant and a heartbeat
<br/>is confirmed on ultrasound and until the NK assay at 50:1 is 15% or
<br/>less and the NK cell numbers are 12% or below. Current data suggests
<br/>that Enbrel does not pass the placenta to the fetus. Dr Beer's
<br/>patient support group reported 162 successful deliveries after Enbrel
<br/>use as of July 2003.
<br/>
<br/>Additionally, women are concerned that Enbrel might have a
<br/>detrimental effect on their bodies' natural cancer fighting ability.
<br/>Current data suggests that use of Enbrel does not reduce the body's
<br/>ability to fight cancer.
<br/>
<br/>Also, Enbrel does not increase a woman's susceptibility to catch
<br/>colds or viruses. However, if a woman does catch a cold or virus
<br/>while on Enbrel, it is important to notify the physician.
<br/>
<br/>
<br/>
<br/>VIII. INSURANCE COVERAGE / COST OF ENBREL
<br/>
<br/>The use of Enbrel for reproductive immunology is a newly emerging
<br/>treatment. As such, some insurance companies will not cover Enbrel if
<br/>they are aware that it is not for treatment of rheumatoid arthritis.
<br/>The out-of-pocket cost for the drug can vary significantly. It may
<br/>range from $400 to $750 for a two-week supply. Some users consider it
<br/>advisable to submit an Enbrel prescription on a separate occasion
<br/>from other fertility drugs.
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