Formulary Coverage

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Pentasa Formulary Coverage

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Plan Name1 Status1 Co-Pay/Co-Ins1
Product1 Status1 Co-Pay/Co-Ins1
Plan Name1 PENTASA1 Asacol® HD1 Delzicol™1

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Formulary Coverage Key1

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  • Tier 1: These drugs are available at the lowest co-pay. Most commonly, these are generic drugs.
  • Tier 2: These drugs are available at a middle-level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
  • Tier 3P: These drugs are available at a preferred co-pay. Most commonly used when Tiers 1 and 2 apply to preferred generic and non-preferred generic drugs, respectively.
  • Tier 3: These drugs are available at a higher-level co-pay. Most commonly, these are "non-preferred" brand drugs.
  • Tier 4: These drugs are available at a higher-level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
  • Tier >4: These drugs are available at a higher-level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
  • N/A: Not Available. Formulary data for this drug/health plan are not available.
  • NC: Not Covered. Drugs that are not covered by the plan.
  • PA: Prior Authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
  • QL: Quantity Limits. Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of drug that will be covered.
  • ST: Step Therapy. This restriction typically requires that certain criteria be met prior to approval for the prescription.
  • OR: Other Restrictions. Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.

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INDICATION

PENTASA is indicated for the induction of remission and for the treatment of patients with mildly to moderately active ulcerative colitis.

IMPORTANT SAFETY INFORMATION

  • PENTASA is contraindicated in patients with a hypersensitivity to mesalamine, any other components in this medication, or salicylates.

IMPORTANT SAFETY INFORMATION (CONTINUED)

  • Caution should be exercised if PENTASA is administered to patients with impaired hepatic function.
  • Mesalamine has been associated with an acute intolerance syndrome (3% of patients in clinical trials with mesalamine or sulfasalazine) that may be difficult to distinguish from a flare of inflammatory bowel disease. Symptoms include cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache, and rash. If acute intolerance syndrome is suspected, prompt withdrawal is required.
  • Caution should be exercised if PENTASA is administered to patients with impaired renal function. Single reports of nephrotic syndrome and interstitial nephritis associated with mesalamine therapy have been described in the foreign literature. There have been rare reports of interstitial nephritis in patients receiving PENTASA. Patients with preexisting renal disease, increased BUN or serum creatinine, or proteinuria should be carefully monitored, especially during the initial phase of treatment. Mesalamine-induced nephrotoxicity should be suspected in patients developing renal dysfunction during treatment.
  • Use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection, because of the similarity in the chromatograms of normetanephrine and mesalamine’s main metabolite, N-acetylaminosalicylic acid (N-Ac-5-ASA). An alternative, selective assay for normetanephrine should be considered.
  • The most common adverse events in US clinical trials (N=451) were diarrhea (3.5%), headache (2.2%), nausea (3.1%), abdominal pain (1.1%), rash (1.3%), anorexia (1.1%), and nausea and vomiting (1.1%). In combined domestic and foreign trials (N>2100), the most common adverse events were diarrhea (3.4%), headache (2.0%), nausea (1.8%), abdominal pain (1.7%), dyspepsia (1.6%), vomiting (1.5%), and rash (1.0%).
  • Safety and efficacy of PENTASA in pediatric patients have not been established.

Please click here for Full Prescribing Information for PENTASA (mesalamine).


References

  1. Fingertip Formulary Analytics®, DR/Decision Resources, LLC. As of April 24, 2017.

Fingertip Formulary® is a registered trademark of DR/Decision Resources, LLC.

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