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Stelara - Ustekinumab

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About Stelara (Ustekinumab)

Stelara, also known as Ustekinumab is a Biologic Treatment that is currently in Phase III clinical trials for Crohn's Disease after excellent results in Phase II. It can be prescribed for off-label use by physicians as it is approved for the treatment of Psoriasis but many health insurance companies will not cover the off-label use.

Stelara Dosage

Stelara is given as an injection under the skin ever four weeks for the first two doses and then every twelve weeks. Dosage is determined by weight of the patient. A Tuberculosis test will be performed before your first dosage and patients with active infections will sometimes not be given Stelara.

Possible Side Effects

Dizziness
Tiredness
Back pain
Headache
Irritation at the point of injection
Seizures
Confusion
Difficulty breathing
Vision changes
Feeling faint
Swelling of the face, eyelids, throat, or tongue
Tightness in the chest or throat
Rash
Reversible Posterior Leukoencephalopathy Syndrome (RPLS)

Stelara may also increase your chance of certain kinds of cancer and lower your ability to fight infections. Anyone on Stelara should not be given a live Vaccine.

The Science

Stelara (Ustekinumab) is a biological therapy type of Immunosuppressant that targets Cytokine subunit p40 of Interleukin-12 (IL12) and interleukin-23(IL23). Manufactured by Janssen Biotech Inc., Stelara is a human monoclonal Antibody (IgG1-kappa). The active ingredient is ustekinumab
The inactive ingredients are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, and sucrose.

Phase II Results

Stelara showed strong results in its Phase II clinical trials. 39.7% of patients responded (by definition of a 100 point reduction in the CDAI (Crohn's Disease Activity Index) to Stelara versus 23.5% for the placebo and the Stelara remission rate was 41.7% at week 22. The side effects were similar to that of the placebo group.
To see these kind of outcomes, where you have high response rates in the short term and then good remission rates out toward five or six months of therapy, it shows unequivocally that the drug is effective for treating Crohn's disease," said Dr. William Sandborn, the study's lead investigator, who presented the data at the Digestive Disease Week meeting in Chicago on Sunday.

"It's effective in the patient population that has the greatest unmet need at this point in time," Sandborn said of patients who do not respond to anti-TNF drugs.

Financial Help for Stelara (Ustekinumab) Prescriptions

Johnson & Johnson Patient Assistance Foundation - Financial Help for Stelara (Ustekinumab)
The Johnson & Johnson Patient Assistance Foundation, Inc. has generously provided prescription medications to those who are in need of certain medications taken at home or administered by a medical professional. Johnson & Johnson Patient Assistance Foundation offers financial assistance for Stelara (Ustekinumab) prescriptions.

93% of Applicants are accepted into the Johnson & Johnson Patient Assistance Foundation Program.

Eligibility Guidelines (from Johnson & Johnson Patient Assistance Foundation, Inc. 2012)[4]:

1. Do not have public or private prescription drug coverage

2. Have a yearly gross income of:
-For Self-Administered Products
$21,660 or less for a single person
$29,140 or less for a family size of two*

-For Physician-Administered Products
$43,320 or less for a single person
$58,280 or less for a family size of two*
*Larger family sizes are adjusted accordingly

3.Reside in the United States or a United States territory

4.Are being treated by a U.S.-licensed healthcare provider

5.Are being treated as an outpatient

For more information regarding the Johnson & Johnson Patient Assistance Foundation to help with your prescription medications, please visit the Johnson & Johnson Patient Assistance Foundation website, Call 1 -800-652 - 6227 or click HERE.
Stelara Instant Savings Program
http://www.stelarainfo.com/pdf/instant-savings.pdf[5] -- Unfortunately, this is not able to be used if you are prescribed Stelara for off-label use.

References


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06-12-2013, 11:50 PM   #1
vtfamily
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Nicely done! Thanks for all of your work!!
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