| Simponi |
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DOCTOR IMMEDIATELY. ALL RIGHTS RESERVED 2008. DO NOT COPY NOR TRANSFER ARTICLES TO OTHER WEBSITES NOR OTHER
FORMS OF PUBLICATIONS. Privacy Policy. ARTICLE INDEX
PHYTONUTRIENTS AND DRUG PRODUCTS. THIS WEBSITE ALSO TALKS ABOUT SOME POPULAR HEALTH ISSUES AND DISEASES.
ARTICLES IN THIS WEB SITE IS FOR YOUR REFERENCE ONLY. IF YOU HAVE ANY QUESTION, YOU SHOULD CONSULT WITH YOUR
DOCTOR IMMEDIATELY. ALL RIGHTS RESERVED 2008. DO NOT COPY NOR TRANSFER ARTICLES TO OTHER WEBSITES NOR OTHER
FORMS OF PUBLICATIONS. Privacy Policy. ARTICLE INDEX
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Simponi
The U.S. Food and Drug Administration approved Simponi (golimumab) on
April 24, 2009, a monthly treatment for adults with moderate-to-severe
rheumatoid arthritis, active psoriatic arthritis, and active ankylosing
spondylitis. Simponi is injected under the skin. It is intended for use in
combination with the immunosuppressant drug methotrexate in patients
with rheumatoid arthritis. It also may be used with or without methotrexate
for psoriatic arthritis and alone in patients with ankylosing spondylitis, a
chronic inflammatory arthritis of the spine. All three conditions are chronic
disorders in which the immune system attacks multiple joints, causing
stiffness, pain, and restricted motion.
In clinical trials, patients who received Simponi for one of the three
conditions showed improvements in the signs and symptoms common to
their form of arthritis. Simponi is in a class of drugs that target and
neutralize tumor necrosis factor-alpha (TNF-α), a protein that, when
overproduced in the body due to chronic inflammatory diseases, can cause
inflammation and damage to bones, cartilage and tissue.
What are the side effects or warnings of Simponi?
Like other TNF- α blockers, Simponi labeling includes a boxed warning
alerting patients and health care professionals to the risk of tuberculosis
and invasive fungal infections with use of the drug. The FDA also required
a risk evaluation mitigation strategy (REMS) for Simponi, as it required for
other TNF-α blockers. The REMS for Simponi includes a Medication Guide
for patients and a communication plan to help prescriber's understand the
drug's risks. The most common adverse reactions to Simponi include upper
respiratory tract infection, sore throat and nasal congestion.
Simponi is marketed by Centocor Ortho Biotech Inc., Malvern, Pa.
SOURCE FDA Approves Monthly Injectable Drug for Treating Three Types
of Immune-Related Arthritis FDA NEWS RELEASE April 24, 2009
The U.S. Food and Drug Administration approved Simponi (golimumab) on
April 24, 2009, a monthly treatment for adults with moderate-to-severe
rheumatoid arthritis, active psoriatic arthritis, and active ankylosing
spondylitis. Simponi is injected under the skin. It is intended for use in
combination with the immunosuppressant drug methotrexate in patients
with rheumatoid arthritis. It also may be used with or without methotrexate
for psoriatic arthritis and alone in patients with ankylosing spondylitis, a
chronic inflammatory arthritis of the spine. All three conditions are chronic
disorders in which the immune system attacks multiple joints, causing
stiffness, pain, and restricted motion.
In clinical trials, patients who received Simponi for one of the three
conditions showed improvements in the signs and symptoms common to
their form of arthritis. Simponi is in a class of drugs that target and
neutralize tumor necrosis factor-alpha (TNF-α), a protein that, when
overproduced in the body due to chronic inflammatory diseases, can cause
inflammation and damage to bones, cartilage and tissue.
What are the side effects or warnings of Simponi?
Like other TNF- α blockers, Simponi labeling includes a boxed warning
alerting patients and health care professionals to the risk of tuberculosis
and invasive fungal infections with use of the drug. The FDA also required
a risk evaluation mitigation strategy (REMS) for Simponi, as it required for
other TNF-α blockers. The REMS for Simponi includes a Medication Guide
for patients and a communication plan to help prescriber's understand the
drug's risks. The most common adverse reactions to Simponi include upper
respiratory tract infection, sore throat and nasal congestion.
Simponi is marketed by Centocor Ortho Biotech Inc., Malvern, Pa.
SOURCE FDA Approves Monthly Injectable Drug for Treating Three Types
of Immune-Related Arthritis FDA NEWS RELEASE April 24, 2009