Dexilant FPI review

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Dexilant FPI review
2010-06-24 14:07:00

FPI of Dexilant
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  1. Q: where can you find the approved indications for Dexilant?
    A: Dexilant is indicated for: 1) healing of Erosive Esophogitis 2) Maintenance of Healed Erosive Esophagitis 3) Symptomatic Non-Erosive Gastroesophageal Reflux Disease. section 1.1, 1.2, 1.3 indications and usage.
  2. Q: do I need to adjust the dosage for elderly patient? Where on the PFI?
    A: No dosage adjustment is needed in geriatric patients. The T1/2 of dexilant significant increased in older patients compare to younger patients 2.23 hours vs. 1.5 hours. This difference is not clinically relevant. AUC is 34.5% higher in older patients. 2.2 special populations; 8.5 geriatric use; 12.5 special population: Geriatric use.
  3. Q: Do patients need to take Dexilant before the first meal of the day? Where on the PFI?
    A: Dexilant can be taken with or without food. Dexilant should be swallowed whole. Alternatively, Dexilant capsules can be opened and administered as follows: · Open capsule · Sprinkle intact granules on one tablespponof applesauce · Swallow immediately 2.3 important administration information and 12.4 effect of food on pharmacokinetics and pharmacodynamics.
  4. Q: what is the effect of food on pharmacokinetics and pharmacodynamics?
    A: compared to fasting, Dexilant increase Cmax range from 12%-55%, and increases AUC range from 9%-37%, and Tmax varied ranging from .7-3 hours. No mean difference in intragistric pH. Intragistric pH exceeded 4 over 24-hour dosing interval decrease slightly when Dexilant was administered after a meal 57% relative to fasting 64% primary due to a decrease response in intragastric pH during the first 4 hours after dosing. So, DEXilant can be takend without regard to food.
  5. Q: What is the drug-drug effect on atazanavir, a drug with pH-dependent absorption pharmacokinetic? Where on the PFI?
    A: 7.1 –because Dexilant causes inhibition of gastric acid secretion, it is likely to decrese the systemic concentratons of the HIV protease inhibitor atazanavir, which depends on the presences of gastric acid for absorption and may result in loss of therapeutic effect of atazanavir and the development of HIV resistance.
  6. Q: It is theoretically possible, Dexilant may interfere with the absorption of what other drugs, where gastric pH is an important determinant of oral bioavaility?
    A: 7.1 ampicillin esters, digoxin, iron salts, ketoconzazole.
  7. Q: is there any drug-drug effect on warfarin with Dexilant?
    A: 7.2 there is no effect of the pharmacokinetics of warfarin or INR when Dexilant 90mg and Warfarin 25mg are co-administered. However there have been reports of increased INR and prothrombin time. Increase in INR and prothrombin time may lead to abnormal bleeding and even death. If use together, patients needed to be monitor for increases in INR and prothrombin time.
  8. Q: there any drug-drug effect on tacrolimus with Dexilant?
    A: 7.3 coadminstration may increase whole blood levels of tacrolimus, esp. in transplant patients intermediate or poor metabolizers of CYP2C19.
  9. Q: what are the clinical results for the healing of EE? Where in the FPI?
    • A: 14.1 Healing of EE. 4092 patients, 2 studies, Dexilant, 60mg, 90mg and lansoprazole 30mg.
    • Study 1: Dexilant 60mg: 70% healed at week 4 and 87% at wk 8 Lansoprazole 30mg: 65% at week 4 and 85% at wk 8 Study 2: Dexilant 60mg: 66% healed at week 4 and 85% at wk 8 Lansoprazole 30mg: 65% at week 4 and 79% at wk 8
  10. Q: where in the FPI for safety? what are the adverse events?
    A: section 6 adverse reactions. 6.1 has the table. The most common AE equal or greater than 2% are Diarrhea 4.7-5.1% Abdominal Pain 3.5-4.0% Nausea 2.8-3.3% Upper respiratory tract infection 1.7-2.9% Others: vomiting and flatulence
  11. Q: what is treatment-emergent adverse reactions?
    A: they are adverse events that occurred (emerged) sometime after the first dose of the study medication; these adverse reactions may or may not be related to study medication, but they occurred after dosing began.
  12. Q: what is treatment-related adverse reactions?
    A: they are subset of treatment emergent adverse reactions that the investigator consider may be related to study medication.
  13. Q: does Dexilant have a pediatric indication? Where in the FPI?
    A: no studies in pediatric. 8.4 pediatric use & 12.5 special populations.
  14. Q: how does this dual delayed release formulation work? Where in the FPI?
    A: MOA: Dexilant is a PPi that suppresses gastric acid secretion by inhibition of the (H+,K+)-ATPase in the gastric parietal cell. By acting specifically on the proton pump, dexlansoprazole blocks the final step of acid production. section 11 in description and 12.1 Mechamism of Action.
  15. Q: What is the mean plasma Dexilant concentration-time profile following oral administration of 30mg 0r 60 mg of Dexilant?
    A: Once daily for 5 days: first peak at 1-2 hour after administration and then 4-5 hours. T1/2 is 1-2 hour. Section 12.2 pharmacodynamics.
  16. Q: any dosage adjustment for severe hepatic impairment? Where in the FPI?
    A: No dosage adjustment for mild. Maximum dose of 30mg for moderate. No studies for severe hepatic impairment? 12.5 special population, 2.2 special populations, 8.7 hepatic impairment.
  17. Q: what are the important information on the pregnancy with dexilant? Where in the FPI?
    A: it is under pregnancy category B. it is not known if dexilant is excreted in milk. section 8.
  18. Q: what is the dosage for symptomatic GERD? Where in the FPI?
    A: 30mg once daily for 4 weeks. section 2.1 recommended dose.
  19. Q: what effect does Dexilant have on mean intragastic pH? Where in the FPI?
    A: For once daily for 5 days on 24-hour intragistric pH, 4.44 mean intragastic pH for Dexilant 60mg and 4.13 mean intragastic pH for lansoprazole 30mg. section 12.2 pharmacodynamics.
  20. Q: what are the clinical studies for the maintenance of healed EE? Where in the FPI?
  21. A: 445 patients, 6 months, Dexilant 30mg and 60mg. 66.4% of patients treated with Dexilant 30mg healted over 6months as confirmed by endoscopy. 60mg did not provide additional clinical benefit over 30mg. Dexilant 30mg demonstrated a higher median percent of 24-hour heartburn-free compared to placebo over the 6-month treatment period. section 14.2. Maintenance of healed erosive esophagitis.