DOCSLIB.ORG

Compare and Contrast: IBS/IBD Irritable Bowel Syndrome: Diagnosis

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Compare and Contrast: IBS/IBD Irritable Bowel Syndrome: Diagnosis Irritable Bowel Syndrome: Treatment Disclosure Overview Focusing on Newly Approved Medications • I, or an immediate family member, including spouse or partner, have no financial relationship(s) relevant to the contents of this Southwest Florida Society of Health System Pharmacists continuing education activity Jose Barboza, Pharm.D., C.D.E. Faculty Pharmacotherapeutics & Clinical Research University of South Florida College of Pharmacy Objectives Irritable Bowel Syndrome: Definition • Gastrointestinal (GI) syndrome 1. Describe the pathophysiology of Irritable – Altered bowel function – Abdominal pain or discomfort Bowel Syndrome • Diarrhea predominant – Altered bowel habits (IBS‐D) 2. Review the treatments for Irritable Bowel – Absence of organic cause • Constipation Syndrome • Recurring symptoms predominant (IBS‐C) – Incomplete evacuation • Constipation/ diarrhea 3. Discuss the use of rifaximin and – Urgency (IBS‐M) eluxadoline in treating diarrhea – Bloating • Undefined (IBS‐U) predominant irritable bowel syndrome Compare and Contrast: IBS/IBD Irritable Bowel Syndrome: Diagnosis Irritable Bowel Inflammatory Bowel Rome III Criteria for Irritable Bowel Syndrome Syndrome (IBS) Disease (IBD) Recurrent abdominal pain or discomfort Three episodes per month Pain/ Discomfort Last 3 months associated Chronic inflammation Change in Bowel habits Two or more of… of the intestines Absence of organic cause 1 Improvement with defecation 2 Onset associated with change in frequency of stool Diarrhea (IBS‐D) Crohn’s disease (CD) Constipation (IBS‐C) Ulcerative colitis (UC) 3 Onset associated with a change in form of stool Alternating/Mixed (IBS‐M) Am J Gastroenterol, 2009. 104 Suppl 1: p. S1‐35. 1 Irritable Bowel Syndrome: IBS Epidemiology Pathophysiology • Prevalence in US: 10‐15% • Disturbed GI motility – More common • Visceral hypersensitivity • Females (~2:1) • Psychological stress • Young adulthood • Intestinal microflora and – 15% of those affected seek inflammation medical attention • Altered levels of 5HT • Most commonly diagnosed GI • 5HT3 and 5HT4 are extensively condition found in the gut, responsible for – 25‐50% of gastroenterologist secretion, sensitization, and referrals motility Clin Epidemiol. 2014; 6: 71–80. Physiological distribution of 5‐HT • Prucalopride CNS – 5% • 5HT4 agonist • IBS-C • Alosetron • 5HT3 antagonist • IBS-D GI tract – 95% • Causes altered GI Pathophysiology: • Motility • Sensitivity Drugs. 2014 Oct;74(16):1849-70. • Secretions Gershon, Aliment Pharmacol Ther.,1999 IBS –Positive Diagnosis and Outcome IBS: Dietary Modifications • Identify concerns • Avoid caffeine, alcohol, and artificial • Basis for patient’s symptoms sweeteners • Reassurance – Can irritate the gut > laxative effect • Cost effective evaluation • Evaluate lactose intolerance • Involve patient in decision making • Rule out Celiac sprue (1%) • Provide continuity • Rule out gluten intolerance (6%) • Set realistic limits • Low FODMAP diet • No association between negative colonoscopy and – Fermentable Oligosaccharides, Disaccharides, improved health related quality of life Monosaccharides and Polyols – Poorly absorbed by some Gastrointest Endosc 2005; 62:892-9. 2 IBS: Fiber IBS‐C: Non‐Pharmacologic MOA/ Role in Therapy • Secondary constipation: Correct the cause • MOA: Contain hydrophilic polysaccharide • Dietary modification: Basis of therapy derivatives – Gradually increase fiber – 20‐25 grams/day – Absorb water to: Increase bulk, soften the stool, and facilitate peristalsis and elimination • Other lifestyle – Exercise – Effects seen in 2‐3 days – Adjust bowel habits • Role in therapy: – Increase fluid intake – Safest – Acceptable in pregnancy IBS: Fiber IBS: Fiber Agents and Availability Adverse Effects/Drug Interactions • Agents (Not FDA approved for IBS) • Adverse effects – Methylcellulose (Citrucel) – Abdominal distention, cramping, and flatulence – Calcium Polycarbophil (FiberCon) • Minimized by gradual increase, resolved with continued use – Psyllium (Metamucil) • Drug Interactions – Barley malt extract (Maltsupex) – Possible binding to digoxin and warfarin • Powders, flakes, granules, tablets, and liquids – May bind with tetracyclines • Doses vary, typically administered in divided doses – Separate other medications by 1‐2 hours IBS: Fiber IBS: Fiber Precautions Evidence • Severely fluid restrictions • Psyllium/ispaghula husk showed • May cause hypersentitivity improvement over placebo • Diabetes – NNT=6 (IBS type not differentiated) • Other agents are similar to placebo • Fecal impaction or intestinal obstruction • Psyllium/ispaghula husk (20‐30 g/day) – Avoid: intestinal ulcerations, stenosis, and disabling improves constipation adhesions Drugs. 2014 Oct;74(16):1849-70. 3 IBS: Antispasmodics/Anticholinergics IBS: Antidepressants • MOA: Relax smooth muscles in the colon and • MOA: Improve dysregulation of neuroenteric pathway small bowel • Symptomatic treatment: Abdominal pain • – Reserved for patients with severe or refractory pain Symptomatic relief –Pain • Visceral analgesia, changes in motility, smooth muscle • Agents: Peppermint oil, hyoscine, cimetropium, relaxation pinaverium, mebeverine, and otilonium • Agents: – Paroxetine, fluoxetine, citalopram, amitriptyline, and • Side effects: Anticholinergic, generally safe imipramine • Adverse effects (antibiotic dependent): – insomnia, restlessness, sexual dysfunction, nausea, constipation, diarrhea Drugs. 2014 Oct;74(16):1849-70. Drugs. 2014 Oct;74(16):1849-70. IBS: Probiotics • MOA: restore normal flora – Alterations may cause Diarrhea‐Predominant IBS (IBS‐D) • Increased fermentation of food • Changes in intestinal motor and sensory function, • Mucosal immune activation • Malabsorption • Agents: – Lactobacillus, bifidobacterium, streptococcus, others – Limitations in clinical trials • Generally safe IBS‐D: Alosetron IBS‐D: Loperamide MOA/Agent • Evaluated in randomized controlled trials for • MOA: Potent and selective 5‐HT3 antagonist IBS‐D – Results in modulation of the enteric nervous system – Effective for treatment of diarrhea • Alosetron (Lotronex) – Not FDA approved for IBS – Approved in chronic, severe IBS‐D for patients who • No impact on abdominal bloating or global IBS failed to responded to conventional treatments – Starting dose: 0.5mg BID symptoms – Reassess at 4 weeks • Acute diarrhea: Oral: Initial: 4 mg, followed by • No adequate control of symptoms: Increase to 1mg BID 2 mg after each loose stool, up to 16 mg/day – Re‐assess at 4 weeks • No adequate control of symptoms: Discontinue medication ACG Task Force on IBS. Am J Gastro. 2009 4 IBS‐D: Alosetron IBS‐D: Alosetron Restricted Use/Precautions Contraindications • Adverse effects (dose related) • Constipation – Constipation • intestinal obstruction, stricture, toxic megacolon, gastrointestinal perforation, and/or adhesions – GI discomfort/pain • Ischemic colitis, impaired intestinal circulation, • Restricted FDA use thrombophlebitis, or hypercoagulable state – Females only • Crohn's disease or ulcerative colitis – Enroll in Prometheus prescribing program • Diverticulitis • Ischemic colitis (FDA warning) • Severe hepatic impairment – 1.1 cases/1,000 patient‐years • Concomitant fluvoxamine use • Precautions: Constipation, ischemic colitis Chang L et al. Am J Gastro 2010 IBS‐D: Rifaximin • Broad spectrum antibiotic with low bioavailability – <0.4% absorbed • FDA approved • Dose: 550mg TID for 2 weeks – May be repeated up to 2 times – Improvement shown in up to 10 weeks • Showed to improve global IBS symptoms: TARGET 1 & 2 • Adverse effects: Flatulence, abdominal pain, tenesmus, fecal incontinence, nausea, and headaches • High Cost, Xifaxan 550mg (#60)~ $2000 IBS‐D: Eluxadoline (Viberzi) IBS‐D: Eluxadoline • MOA: kappa and mixed mu and opioid receptor agonist, delta opioid receptor antagonist • Adverse effects – Decrease pain and intestine contractility – Constipation (~8% vs. 2.4%), nausea (~7.5% vs. 4.8), – Shown to improve stool consistency and pain vomiting • Global symptoms, QOL, and adequate relief • Contraindications: • FDA Approved: IBS3001 and 3002 – Severe hepatic impairment, biliary duct obstruction, • Dose: 100mg BID diseases of the pancreas, alcoholism • Unable to tolerate, no gallbladder, mild hepatic impairment: 75mg BID 5 IBS‐C: Osmotic Laxatives MOA/ Role in Therapy Constipation‐Predominant IBS (IBS‐C) • MOA: Osmotic agent, causes water retention in the stool and increases stool frequency – Not absorbed systemically – Onset 1‐4 days Role in therapy Low doses for constipation Bowel cleansing before diagnostic or colorectal procedures Safe use chronically, studied in up to 6 months Agent: Polyethylene Glycol 3350 (Miralax): Rx or OTC IBS‐C: Osmotic Laxatives: IBS‐C: Chloride Channel Activator Dose/ Side Effects/ Contraindications Lubiprostone‐ MOA/ Agent Available with and without electrolytes • MOA: Chloride channel activator – Open chloride channels locally on the GI luminal PEG: Constipation epithelium 10–30 g or 17–34 g per 120–240 mL QD or BID – Stimulates chloride‐rich fluid secretion into the lumen Not FDA Approved for IBS – Results in softening of the stool and increased motility Side effects – Onset: 24‐48 hours Bloating, abdominal discomfort, cramping, Agent: Lubiprostone (Amitiza) flatulence FDA Approved to treat chronic constipation in adults (Rx) Contraindications IBS‐C: 8 mcg BID with food GI Obstruction Constipation: 24mcg BID with food IBS‐C: Lubiprostone IBS‐C: Guanylate Cyclase‐C agonist Lubiprostone‐ Role in Therapy/ Adverse Effects Linaclotide‐ MOA/ Agents • MOA:
Load more

Recommended publications
  • Crofelemer Oral Delayed Release Tablet
    Contains Nonbinding Recommendations Draft – Not for Implementation Draft Guidance on Crofelemer This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the Office of Generic Drugs. Active Ingredient: Crofelemer Dosage Form; Route: Tablet, delayed release; oral Strength: 125 mg Recommendations for the Assessment of Identity and Quality of Botanical Raw Material (BRM): Crofelemer is a botanical drug derived from BRM, the crude red latex of Croton lechleri Müll. Arg. [Fam. Euphorbiacae], which is also called dragon’s blood (sangre de drago). Generic drug applicants should use the same plant species and perform BRM assessment: 1. Crofelemer BRM should be collected from the crude red latex of Croton lechleri. The plant species should be correctly identified and authenticated based on techniques such as macroscopic/microscopic and/or analysis of genetic material. 2. Crude red latex as BRM should be collected from the mature tree with defined eco- geographic regions (EGRs). Implementing and enforcing established good agricultural and collection practice (GACP) procedures will minimize variations in BRM and ensure batch- to-batch consistency of crofelemer. 3. BRMs should be analyzed for their crofelemer content, total phenolics and taspine content, as well as heavy metals and pesticides. Recommendations for Demonstrating API Sameness: API sameness can be established by showing equivalence between Test API and API from the reference listed drug (RLD) product with the three criteria described in detail below.
    [Show full text]
  • Supplementary Information
    Supplementary Information Network-based Drug Repurposing for Novel Coronavirus 2019-nCoV Yadi Zhou1,#, Yuan Hou1,#, Jiayu Shen1, Yin Huang1, William Martin1, Feixiong Cheng1-3,* 1Genomic Medicine Institute, Lerner Research Institute, Cleveland Clinic, Cleveland, OH 44195, USA 2Department of Molecular Medicine, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, OH 44195, USA 3Case Comprehensive Cancer Center, Case Western Reserve University School of Medicine, Cleveland, OH 44106, USA #Equal contribution *Correspondence to: Feixiong Cheng, PhD Lerner Research Institute Cleveland Clinic Tel: +1-216-444-7654; Fax: +1-216-636-0009 Email: [email protected] Supplementary Table S1. Genome information of 15 coronaviruses used for phylogenetic analyses. Supplementary Table S2. Protein sequence identities across 5 protein regions in 15 coronaviruses. Supplementary Table S3. HCoV-associated host proteins with references. Supplementary Table S4. Repurposable drugs predicted by network-based approaches. Supplementary Table S5. Network proximity results for 2,938 drugs against pan-human coronavirus (CoV) and individual CoVs. Supplementary Table S6. Network-predicted drug combinations for all the drug pairs from the top 16 high-confidence repurposable drugs. 1 Supplementary Table S1. Genome information of 15 coronaviruses used for phylogenetic analyses. GenBank ID Coronavirus Identity % Host Location discovered MN908947 2019-nCoV[Wuhan-Hu-1] 100 Human China MN938384 2019-nCoV[HKU-SZ-002a] 99.99 Human China MN975262
    [Show full text]
  • Biotechnology INITIATION REPORT Member FINRA/SIPC
    INSTITUTIONAL RESEARCH Biotechnology INITIATION REPORT Member FINRA/SIPC Toll-Free: 561-391-5555 ⬧ www.DawsonJames.com ⬧ 1 North Federal Highway - Suite 500 ⬧ Boca Raton, FL 33432 Jaguar (NASDAQ/JAGX) January 3, 2019 BUY It’s Time for a Natural Solution Jason H. Kolbert Head of Healthcare Research 646-465-6891 It's time for a natural solution. Crofelemer, brand name Mytesi, is a natural product derived from an abundant source, the Corton lechleri tree. It treats diarrhea at its [email protected] source by normalizing secretion of water into the gut. Mytesi is the only FDA approved antisecretory diarrhea treatment on the market today. Investment Highlights Current Price $0.28 Mytesi revenues are starting to build, reflecting Jaguar's focused product launch Price Target $1.00 efforts. Chronic diarrhea is a common side-effect of HIV therapy and annually Estimates F2017A F2018E F2019E impacts greater than 250,000 people in the U.S. Jaguar is looking to address this Revenues ($000s) $ 4,361 $ 4,620 $ 16,054 population with a new salesforce that is now actively promoting the drug. Sales growth 1Q March $ 822 $ 804 $ 2,482 since promotion efforts began in 2017 looks favorable. We estimate Mytesi could 2Q June $ 897 $ 884 $ 3,085 3Q September $ 1,100 $ 1,132 $ 4,542 reach $4.4M in revenues this year, $15.7M in 2019, and $28.7M in 2020, driving the 4Q December $ 1,542 $ 1,800 $ 5,946 company to break-even. We estimate that by 2028 Mytesi in HIV alone can reach F2017A F2018E F2019E $76M in revenues, which would represent less than 10% of the total HIV market.
    [Show full text]
  • Federal Register/Vol. 85, No. 224/Thursday, November 19, 2020/Notices PRODUCTS—Continued
    73726 Federal Register / Vol. 85, No. 224 / Thursday, November 19, 2020 / Notices information on the cover sheet and not guidances are posted on FDA’s website TABLE 2—REVISED DRAFT PRODUCT- in the body of your comments and you and announced periodically in the SPECIFIC GUIDANCES FOR DRUG must identify this information as Federal Register. The public is PRODUCTS—Continued ‘‘confidential.’’ Any information marked encouraged to submit comments on as ‘‘confidential’’ will not be disclosed those recommendations within 60 days Active ingredient(s) except in accordance with 21 CFR 10.20 of their announcement in the Federal and other applicable disclosure law. For Register. FDA considers any comments Fluphenazine hydrochloride more information about FDA’s posting received and either publishes final Hydrocortisone acetate of comments to public dockets, see 80 guidances or publishes revised draft Isotretinoin (multiple referenced listed drugs) Levorphanol tartrate FR 56469, September 18, 2015, or access guidances for comment. Guidances were Lomitapide mesylate the information at: https:// last announced in the Federal Register Methylphenidate hydrochloride www.govinfo.gov/content/pkg/FR-2015- on August 26, 2020. This notice Pimavanserin tartrate 09-18/pdf/2015-23389.pdf. announces draft product-specific Propranolol hydrochloride (multiple ref- Docket: For access to the docket to guidances, either new or revised, that erenced listed drugs) read background documents or the are posted on FDA’s website. Tofacitinib citrate electronic and written/paper comments II. Drug Products For Which New Draft received, go to https:// For a complete history of previously Product-Specific Guidances Are www.regulations.gov and insert the published Federal Register notices Available docket number, found in brackets in the related to product-specific guidances, go heading of this document, into the FDA is announcing the availability of to https://www.regulations.gov and ‘‘Search’’ box and follow the prompts new draft product-specific guidances for enter Docket No.
    [Show full text]
  • Patent Application Publication ( 10 ) Pub . No . : US 2019 / 0192440 A1
    US 20190192440A1 (19 ) United States (12 ) Patent Application Publication ( 10) Pub . No. : US 2019 /0192440 A1 LI (43 ) Pub . Date : Jun . 27 , 2019 ( 54 ) ORAL DRUG DOSAGE FORM COMPRISING Publication Classification DRUG IN THE FORM OF NANOPARTICLES (51 ) Int . CI. A61K 9 / 20 (2006 .01 ) ( 71 ) Applicant: Triastek , Inc. , Nanjing ( CN ) A61K 9 /00 ( 2006 . 01) A61K 31/ 192 ( 2006 .01 ) (72 ) Inventor : Xiaoling LI , Dublin , CA (US ) A61K 9 / 24 ( 2006 .01 ) ( 52 ) U . S . CI. ( 21 ) Appl. No. : 16 /289 ,499 CPC . .. .. A61K 9 /2031 (2013 . 01 ) ; A61K 9 /0065 ( 22 ) Filed : Feb . 28 , 2019 (2013 .01 ) ; A61K 9 / 209 ( 2013 .01 ) ; A61K 9 /2027 ( 2013 .01 ) ; A61K 31/ 192 ( 2013. 01 ) ; Related U . S . Application Data A61K 9 /2072 ( 2013 .01 ) (63 ) Continuation of application No. 16 /028 ,305 , filed on Jul. 5 , 2018 , now Pat . No . 10 , 258 ,575 , which is a (57 ) ABSTRACT continuation of application No . 15 / 173 ,596 , filed on The present disclosure provides a stable solid pharmaceuti Jun . 3 , 2016 . cal dosage form for oral administration . The dosage form (60 ) Provisional application No . 62 /313 ,092 , filed on Mar. includes a substrate that forms at least one compartment and 24 , 2016 , provisional application No . 62 / 296 , 087 , a drug content loaded into the compartment. The dosage filed on Feb . 17 , 2016 , provisional application No . form is so designed that the active pharmaceutical ingredient 62 / 170, 645 , filed on Jun . 3 , 2015 . of the drug content is released in a controlled manner. Patent Application Publication Jun . 27 , 2019 Sheet 1 of 20 US 2019 /0192440 A1 FIG .
    [Show full text]
  • Mississippi Division of Medicaid Universal Preferred Drug List
    MISSISSIPPI DIVISION OF MEDICAID EFFECTIVE 01/01/2021 UNIVERSAL PREFERRED DRUG LIST Version 2021.13a Updated: 8-30-2021 (For All Medicaid, MSCAN and CHIP Beneficiaries) Conduent’s SmartPA Pharmacy Application (SmartPA) is a proprietary electronic prior authorization system used for Medicaid fee for service claims. MSCAN plans may/may not -have electronic PA functionality. However, they must adhere to Medicaid’s PA criteria. THERAPEUTIC PREFERRED AGENTS NON-PREFERRED AGENTS PA CRITERIA DRUG CLASS ACNE AGENTS ANTI-INFECTIVE clindamycin gel (generic Cleocin-T) ACZONE (dapsone) Maximum Age Limit clindamycin lotion AKNE-MYCIN (erythromycin) • 21 years – all agents except clindamycin solution azelaic acid isotretinoins AMZEEQ FOAM (minocycline) AZELEX (azelaic acid) CLEOCIN-T (clindamycin) CLINDAMYCIN PAC (clindamycin) CLINDAGEL (clindamycin) clindamycin foam clindamycin gel daily (generic Clindagel) dapsone ERY (erythromycin) ERYGEL (erythromycin) erythromycin gel, swabs, solution EVOCLIN (clindamycin) KLARON (sulfacetamide) sulfacetamide RETINOIDS RETIN-A (tretinoin) adapalene tretinoin cream AKLIEF (trifarotene) ALTRENO (tretinoin) ARAZLO (tazarotene) ATRALIN (tretinoin) AVITA (tretinoin) DIFFERIN (adapalene) FABIOR (tazarotene) PLIXDA (adapalene) 1 Drug coverage subject to the rules and regulations set forth in Sec. 1927 of Social Security Act.This is not an all-inclusive list of available covered drugs and includes only managed categories. Unless otherwise stated, the listing of a particular brand or generic name includes all dosage forms of that drug. NR indicates a new drug that has not yet been reviewed by the P&T Committee. PREFERRED BRANDS will not count toward the two brand monthly Rx limit. Drugs highlighted in yellow denote a change in PDL status. An * denotes existing users will be grandfathered; grandfathering is defined as approving a Non-Preferred agent for an existing user; all other changes will not qualify for grandfathering.
    [Show full text]
  • Quantity Limit Drugs and Diabetic Supplies
    Quantity Limit Drugs and Diabetic Supplies Effective 2/1/2015 Class and Name Effective Date ALLERGEN EXTRACTS, GRASS POLLEN 34 Per Month Quantity Limit Grastek 7/1/2014 Oralair 9/26/2014 ALLERGEN EXTRACTS, RAGWEED 34 Per Month Quantity Limit Ragwitek 7/1/2014 ALZHEIMER'S AGENTS 34 Per Month Quantity Limit memantine 7 mg er 6/1/2013 memantine 14 mg er 6/1/2013 memantine 21 mg er 6/1/2013 memantine 28 mg er 6/1/2013 memantine er starter pack 6/1/2013 68 Per Month Quantity Limit memantine 5 mg 6/1/2013 memantine 10 mg 6/1/2013 memantine starter pack 6/1/2013 ANALGESICS/ANESTHETICS, TOPICAL 90 Patches Per Month Quantity Limit lidocaine topical 5% patch 10/1/2010 ANALGESICS, OPIOIDS, LONG-ACTING 4 Per Month Quantity Limit buprenorphine transderm 5 mcg/hr patch 2/1/2011 buprenorphine transderm 7.5 mcg/hr patch 10/1/2014 buprenorphine transderm 10 mcg/hr patch 2/1/2011 buprenorphine transderm 15 mcg/hr patch 10/1/2013 buprenorphine transderm 20 mcg/hr patch 2/1/2011 34 Per Month Quantity Limit Hydrocodone Products hydrocodone 20 mg er tab 1/1/2015 hydrocodone 30 mg er tab 1/1/2015 hydrocodone 40 mg er tab 1/1/2015 hydrocodone 60 mg er tab 1/1/2015 hydrocodone 80 mg er tab 1/1/2015 hydrocodone 100 mg er tab 1/1/2015 hydrocodone 120 mg er tab 1/1/2015 Tramadol Products tramadol 200 mg er 10/1/2011 tramadol 200 mg sr 9/1/2010 Page 1 of 16 Class and Name Effective Date ANALGESICS, OPIOIDS, LONG-ACTING (Continued) 34 Per Month Quantity Limit (Continued) Tramadol Products (Continued) tramadol 300 mg er 10/1/2011 tramadol 300 mg sr 9/1/2010 68 Per
    [Show full text]
  • 4Aug201701045346
    4AUG201701045346 June 25, 2020 DEAR FELLOW MEMBERS OF JAGUAR AND NAPO’S GLOBAL FAMILY: I was recently reading the adult noir fiction novel Bottle Grove by David Handler. As anyone who has children is likely aware, Daniel Handler is also known as Lemony Snicket, author of the great young adult A Series of Unfortunate Events stories. The series of thirteen novels comprising A Series of Unfortunate Events tell the story of three siblings who become orphans when an unfortunate event happens to their parents. Lemony Snicket’s stories struck me. In a very real sense, Mytesiா, our precious drug product, has been orphaned. A product granted approval for noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy (ART)—our goal when we put Mytesi in clinical trials more than 15 years ago for the hundreds of thousands of people living with HIV (PLWH) and associated unrelenting diarrhea—is now orphaned. What does that mean? Yes, Mytesi is the only oral plant- based, non-opioid, fair trade-sourced medicine approved by the FDA under botanical guidance. Yes, our team fought and prevailed in a six-year legal battle to regain control of this first-in-class drug we developed which was allegedly being neglected by a commercial partner that had other potentially competitive plans in place. And now, here we are in 2020, recognizing that less than 5,000 PLWH are currently being prescribed Mytesi. Mytesi has been orphaned. Is that an unfortunate event? Is that not a success? What is success for an emerging drug discovery pharmaceutical company? I personally know several PLWH who are on Mytesi.
    [Show full text]
  • Mytesi™ (Crofelemer)
    Pharmacy Medical Necessity Guidelines: Mytesi™ (crofelemer) Effective: November 10, 2020 Prior Authorization Required √ Type of Review – Care Management Not Covered Type of Review – Clinical Review √ Pharmacy (RX) or Medical (MED) Benefit Rx Department to Review RXUM These pharmacy medical necessity guidelines apply to the following: Fax Numbers: Commercial Products RXUM: 617.673.0988 Tufts Health Plan Commercial products – large group plans Tufts Health Plan Commercial products – small group and individual plans Tufts Health Freedom Plan products – large group plans Tufts Health Freedom Plan products – small group plans • CareLinkSM – Refer to CareLink Procedures, Services and Items Requiring Prior Authorization Tufts Health Public Plans Products Tufts Health Direct – A Massachusetts Qualified Health Plan (QHP) (a commercial product) Tufts Health Together – MassHealth MCO Plan and Accountable Care Partnership Plans Tufts Health RITogether – A Rhode Island Medicaid Plan Note: This guideline does not apply to Medicare Members (includes dual eligible Members). OVERVIEW FOOD AND DRUG ADMINISTRATION-APPROVED INDICATIONS Mytesi (crofelemer) is indicated for symptomatic relief of non-infectious diarrhea in adult patients with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) on anti-retroviral therapy. Mytesi (crofelemer) is an anti-diarrheal and is the first drug indicated for the treatment of diarrhea in patients with HIV/AIDS. It is also the second approved botanical product. Mytesi (crofelemer) is extracted from the sap of the Croton lechleri plant. Several studies have found that patients with HIV experience diarrhea at a higher rate than other populations. The management of idiopathic, noninfectious diarrhea, associated with HIV or protease inhibitor use has generally been nonspecific. Commonly used therapies include anti-motility agents (e.g., loperamide, diphenoxylate/atropine, opioids), adsorbents (e.g., bismuth subsalicylate), bulk- forming fiber supplements, calcium supplements, and at times, pancrelipase or octreotide.
    [Show full text]
  • 202292Orig1s000
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 202292Orig1s000 CROSS DISCIPLINE TEAM LEADER REVIEW CDTL Memo ● NDA 202-292 ● Fulyzaq (crofelemer) ● Diarrhea - HIV/AIDS on Anti-Retrovirals ● Salix Pharmaceuticals 1 Introduction This submission, received December 5, 2011, is the initial New Drug Application (NDA) for Fulyzaq® (crofelemer), a polymeric proanthocyanidin extracted from the red latex sap of the plant species Croton lechleri from the Amazon regions of South America. The Applicant’s proposed indication for crofelemer is: “…for the control and symptomatic relief of diarrhea in patients with HIV/AIDS on anti- retroviral therapy.” Based on in vitro and in vivo studies, crofelemer is believed to be an inhibitor of both the cAMP stimulated cystic fibrosis transmembrane conductance regulator (CFTR) chloride channel and the calcium-activated chloride channels (CaCC); the inhibition is believed to block chloride secretion and high volume water loss that occurs with diarrhea. The proposed product is a delayed-release tablet. The proposed dose is 125 mg BID. All the review disciplines recommend in favor of approval, but several Phase 4 commitments were recommended. 2 Background 2.1 Diarrhea in HIV/AIDS Patients In the era of highly active antiretroviral therapies (HAART), diarrhea from opportunistic infections is uncommon.1 No pathogen can be identified in 15-46% of HIV-infected patients with diarrhea.2 HIV-associated diarrhea often has non-infectious causes including adverse effects of HAART (especially protease inhibitors), HIV enteropathy, HIV-associated malignancies, and pancreatitis.3 Mechanisms of HAART-associated diarrhea include increased calcium-dependent chloride conductance and cellular apoptosis, necrosis and decreased proliferation of intestinal epithelial cells.4 Diarrhea is reported in up to 60% of patients with HIV infection.5,6 However, precise prevalence estimates are difficult due to variations in defining HIV-associated diarrhea such 7 as duration (acute versus chronic), definition of diarrhea, and assessment tools.
    [Show full text]
  • (THMP) Medication Formulary and Maximum Quantities
    Texas HIV Medication Program (THMP) Medication Formulary and Maximum Quantities MAX Drug Name Priority Class Strength/Form Per Unit Qty/30- Notes day script If the THMP provides Aptivus, then the Norvir used as a Aptivus (tipranivir) ** 1 PI 250 mg capsules 120/btl 120 capsules boosting agent must be obtained thru the Abbott PAP. Atripla (Sustiva / Truvada) Sustiva 600 mg / Emtriva 200 mg / Atripla counts as 3 medications towards a 4 antiretroviral drug 1 STR 30/btl 30 tablets (Sustiva / Emtriva / Viread) Viread 300 mg tablets combination limit. Biktarvy Bictegravir 50 mg / emtricitabine Biktarvy counts as 3 medications towards a 4 antiretroviral drug (bictegravir/emtricitabine/tenofovir 200 mg / tenofovir alafenamide 25 1 STR 30/btl 30 tablets combination limit. alafenamide) mg Combivir counts as 2 medications towards a 4 antiretroviral drug Combivir (AZT / 3TC) 1 RTI AZT 300 mg / 3TC 150 mg tablets 60/btl 60 tablets combination limit. Emtriva 200 mg / Edurant 25 mg / Complera counts as 3 medications towards a 4 antiretroviral drug Complera (Emtriva/Edurant/Viread) 1 STR 30/btl 30 tablets Viread 300 mg tablets combination limit. Doravirine 100 mg /lamivudine 300 Delstrigo 1 STR mg/tenofovir disoproxil fumarate 30/btl 30 tablets 300 mg emtricitabine 200mg / tenofovir TAF Descovy 1 RTI 30/btl 30 tablets 25mg Dolutegravir sodium 50mg/ Dovato (dolutegravir/lamivudine) 1 STR 30/btl 30 tablets lamivudine 300mg Emtriva (emtricitabine) 1 RTI 200 mg capsules 30/btl 30 capsules Emtriva OS (emtricitabine) 1 RTI 10 mg/ml suspension 170 ml/btl 4 bottles Epivir (lamivudine, 3TC) 1 RTI 100 mg tablets 60/btl 60 tablets Epivir (lamivudine, 3TC) 1 RTI 150 mg tablets 60/btl 60 tablets Epivir (lamivudine, 3TC) 1 RTI 300 mg tablets 30/btl 30 tablets Epivir OS (lamivudine, 3TC) 1 RTI 10 mg/ml suspension 240 ml/btl (8 oz) 4 bottles Epzicom counts as 2 medications towards a 4 antiretroviral drug Epzicom (Epivir / Ziagen) 1 RTI Epivir 300 mg / Ziagen 600 mg 30/btl 30 capsules combination limit.
    [Show full text]
  • Anti-Infective Drug Poster
    Anti-Infective Drugs Created by the Njardarson Group (The University of Arizona): Edon Vitaku, Elizabeth A. Ilardi, Daniel J. Mack, Monica A. Fallon, Erik B. Gerlach, Miyant’e Y. Newton, Angela N. Yazzie, Jón T. Njarðarson Streptozol Spectam Novocain Sulfadiazine M&B Streptomycin Chloromycetin Terramycin Tetracyn Seromycin Tubizid Illosone Furadantin Ethina Vancocin Polymyxin E Viderabin Declomycin Sulfamethizole Blephamide S.O.P. ( Sulfanilamide ) ( Spectinomycin ) ( Procaine ) ( Sulfadiazine ) ( Sulfapyridine ) ( Streptomycin ) ( Chloramphenicol ) ( Oxytetracycline ) ( Tetracycline ) ( Cycloserine ) ( Isoniazid ) ( Erythromycin ) ( Nitrofurantoin ) ( Ethionamide ) ( Vancomycin ) ( Colistin ) ( Vidarabine ) ( Demeclocycline ) ( Sulfamethizole ) ( Prednisolone Acetate & Sulfacetamide ) ANTIBACTERIAL ANTIBACTERIAL ANTIBACTERIAL ANTIBACTERIAL ANTIBACTERIAL ANTIBACTERIAL ANTIBACTERIAL ANTIBACTERIAL ANTIBACTERIAL ANTIMYCOBACTERIAL ANTIMYCOBACTERIAL ANTIBACTERIAL ANTIBACTERIAL ANTIMYCOBACTERIAL ANTIBACTERIAL ANTIBACTERIAL ANTIVIRAL ANTIBACTERIAL ANTIBACTERIAL ANTIBACTERIAL Approved 1937 Approved 1937 Approved 1939 Approved 1941 Approved 1942 Approved 1946 Approved 1949 Approved 1950 Approved 1950s Approved 1950s Approved 1952 Approved 1953 Approved 1953 Approved 1956 Approved 1958 Approved 1959 Approved 1960 Approved 1960 Approved 1960s Approved 1961 Coly-Mycin S Caprocin Poly-Pred Aureocarmyl Stoxil Flagyl NegGram Neomycin Flumadine Omnipen Neosporin G.U. Clomocycline Versapen-K Fungizone Vibramycin Myambutol Pathocil Cleocin Gentak Floxapen
    [Show full text]