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Remicade

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What is Remicade?

Remicade (Infliximab), from Janssen Biotech, Inc. is biological therapy initially approved by the U.S. FDA in 1998. Remicade is used to treat multiple autoimmune or immune deficiency- related conditions and diseases such as: Crohn's disease, Ulcerative colitis, Rheumatoid Arthritis, Plaque Psoriasis, Ankylosing Spondylitis, and Psoriatic Arthritis. [5]

Remicade acts to block TNF (Tumor Necrosis Factor), subtype TNF-α, and is given by intraveinous infusion (IV) over 2 hours or more per infusion.
Remicade for Crohn's Disease (CD)
Remicade is used for adults and children with Crohn's Disease that do not effectively respond to traditional modes of treatment or initially if the doctor decides a "top-down" treatment is called for. Remicade is prescribed for maintaining remission in Crohn's disease that is characterized as moderate to severe, to reduce symptoms, and/or treatment of Fistulas.[5]
Remicade for Ulcerative Colitis (UC)
Remicade is used in moderate to severe cases of Ulcerative Colitis that do not effectively respond to traditional treatment, or to reduce steroids in treatment. Remicade is used to reduce symptoms, maintain remission, and promote mucosal healing in Ulcerative Colitis patients.[5]

Remicade and Mucosal Healing

Intestinal mucosa healing is now thought to be an important variable in long term remission. A study of Remicade showed mucosal healing (defined as disappearance of ulcerations) after 4 weeks in 74% of patients with disease in the ileum and 96% in the rectum.[13]

"Scheduled therapy" of Remicade is shown to have better mucosal healing rates than periodic treatments with complete mucosal healing in 31% of the scheduled therapy patients and 0% of the periodic patients at the 10 week mark and 50%/7% at week 54.[14]

In another trial where Remicade was given 3 times then Azathioprine was used as a maintenance medication, mucosal healing was evident in 73% of patients after two years versus 30% who used conventional step up treatment. At year four, no mucosal lesions correlated with higher remission rates and those patients were four times more likely to be in remission or to need steroids.[15]

Remicade Dosing Schedule

Remicade treatment for IBD is typically given at 5mg/kg in a loading dose (doses more frequently given at the beginning of treatment) at 0 Weeks, 2 Weeks and 6 Weeks. Treatment is then given as a maintainence dose (at regular intervals) every 8 Weeks. Patients that do not respond to Remicade treatment by 14 Weeks do not typically respond with additional treatments. Remicade will be stopped as a treatment in these patients. CD patients that respond to Remicade initially and then do not respond in later treatments may be given a higher dose (10mg/kg).[5]

Remicade trough level concentrations have been shown to predict clinical outcome and dosage duration can be adjusted based upon these levels.[12]

Potential Side Effects

During Remicade infusion side effects may include: flu-like symptoms, low blood pressure, fever, GI upset, skin rashes, or Anaphylaxis (Anaphylaxis may occur during or following Remicade treatment). Approximately 20% of patients get infusion reactions during Remicade treatment.

Premedications may be administered before Remicade infusions to reduce Remicade-related side effects and may include antihistamines, Steroids, or Tylenol.[5]
  • Weak extremeties
  • Painful urination
  • Rash
  • Stuffy nose
  • Sinus pain
  • Seizure
  • Stomach pain

Warnings and Precautions

Risk of Serious Infection
Patients receiving Remicade therapy are at increased risk of infection which may be uncommon, such as an opportunistic pathogen. These infections may be increased in severity during Remicade therapy (i.e. systemic vs. localized infection). [5]

Patients receiving Remicade that have visited- or reside in certain areas (Ohio, Mississippi River Valleys, or Southwest United States) may be at increased risk for invasive fungal pathogens, including Histoplasmosis (Histoplasma capsulatum)[6], Coccidioidomycosis (Valley Fever)[8], and Blastomycosis[9]. In some cases, patients and physicians were unaware of this increased risk and antifungal treatment was delayed, resulting in patient fatalaties. [7]
- Histoplasmosis in Ohio and Mississippi River Valley - up to 80% prevalence[7]

- Coccidioidomycosis has a prevalence rate in the Southwestern US and San Joaquin Valley (California) - up to 50%[7]
Risk of Cancer
Remicade treatment increases cancer risk. These cancers may be very aggressive and/or fatal.

In particular, increased rates of lymphoma have been seen in children and young adults. A very aggressive and rare type of lymphoma has been shown in young males called Hepatosplenic T-Cell Lymphoma (HSTCL). All patients were being treated with Remicade for Crohn's Disease or Ulcerative Colitis and were being treated with Azathioprine (Aza) or 6-MercaptoPurine (6-MP) during- or immediately preceding Remicade treatment. All cases were fatal. [5]

Over time Remicade may cause strictures (narrowing of the intestines) to form in the intestines as it promotes scarring as it helps the gut heal.[1] Patients treated with Remicade should be monitored closely for the development of intestinal obstruction.[2]

Cost

Each dosage (including the costs of administering the drug) costs at least a few thousand dollars. Therefore, it is important to determine if your insurance will cover this treatment or discuss payment options with your doctor before using Remicade as a treatment option.

Remicade Should Not be Used If:

- Patients with moderate to severe heart failure should not be given Remicade because it has been shown to worsen heart failure symptoms.

- Patients that have experienced an Anaphylactic or Severe Hypersensitivity reaction to Remicade should not receive further Remicade treatment.

- Patients with an active infection or who have recently been exposed to persons with a contagious infection should not receive Remicade until the infection has been cleared. Remicade can decrease a persons ability to fight infection and may contribute to infection severity. Patients receiving Remicade treatment are more likely to have certain "opportunistic pathogens" or have localized infections become systemic (throughout the entire body). Infections resulting in death have been reported.
- Patients who have visited certain areas that are known to have or characteristically have certain infectious agents (or opportunistic microbes) should be cleared of the infectious organism before receiving Remicade treatment.
- For example people exploring caves may have increased exposure to Histoplasmosis (inhalation of spores found in bat droppings). [6][7]

Johnson & Johnson Patient Assistance Foundation - Financial Help for Remicade

The Johnson & Johnson Patient Assistance Foundation, Inc. has generously provided medications to those who are in need of prescription medications taken at home or administered by a medical professional. Johnson & Johnson Patient Assistance Foundation offers financial assistance with Remicade (Infliximab) prescriptions.

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

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

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.

Clinical Trials for Remicade (Infliximab)

References

[pos]1a[/pos][1] http://www.medicinenet.com/inflammat...lems/page4.htm
[pos]2a[/pos][2] http://www.medscape.com/viewarticle/729747
[3]. Remicade Monograph
4. National Cancer Institute (NCI), National Institutes of Health (NIH): Biological Therapy. http://www.cancer.gov/dictionary/print?cdrid=45617
5. FDA Highlights of Prescribing information for Remicade. http://www.accessdata.fda.gov/drugsa...72s5281lbl.pdf
6. Histoplasmosis. Centers for Disease Control and Prevention. National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) Division of Foodbourne, Waterbourne, and Environmental Diseases (DFWED). http://www.cdc.gov/fungal/histoplasmosis
7. Risk Evaluation Strategy for Remicade. Federal Drug Administration (FDA).
http://www.fda.gov/downloads/Drugs/D.../UCM193310.pdf
8. Coccidioidomycosis (Valley Fever). Centers for Disease Control and Prevention. National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) Division of Foodbourne, Waterbourne, and Environmental Diseases (DFWED). http://www.cdc.gov/fungal/coccidioidomycosis
9. Blastomycosis. Centers for Disease Control and Prevention. National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) Division of Foodbourne, Waterbourne, and Environmental Diseases (DFWED). http://www.cdc.gov/fungal/blastomycosis
10. Johnson & Johnson Patient Assistance Foundation, Inc. For Prescription Medication Assistance. http://www.jjpaf.org/eligibility/index.html
11. Cottone M and Criscuoli V. Infliximab to treat Crohn's disease: an update. Clinical and Experimental Gastroenterology. 2011;4: 277-238.http://www.ncbi.nlm.nih.gov/pmc/arti.../ceg-4-227.pdf
[pos]12a[/pos][12] http://www.ncbi.nlm.nih.gov/pubmed/16931170
[pos]13a[/pos][13] http://www.ncbi.nlm.nih.gov/pubmed/10220494
[pos]14a[/pos][14] http://www.ncbi.nlm.nih.gov/pubmed/16500392
[pos]15a[/pos][15] http://www.ncbi.nlm.nih.gov/pubmed/18295023
[pos]16a[/pos][16] http://www.ncbi.nlm.nih.gov/pmc/arti...JG-18-5058.pdf

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