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
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
NEW WARNING FOR ARTHRITIS DRUG, ENBREL
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
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.
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.
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.
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
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.
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.