PL CE LIVE December 2011 Long Guide

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1 This handout accompanies the related articles published in December 2011 ~ Volume 27 ~ Number 12 following PL CE LIVE December 2011 Long Guide CARDIOLOGY You ll start hearing lots more about the comparisons between warfarin, dabigatran (Pradaxa), and rivaroxaban (Xarelto). Now that Xarelto is approved for atrial fib, people are asking if they should switch to it or Pradaxa as an alternative to warfarin. Efficacy is where Pradaxa may have a slight edge. Pradaxa 150 mg BID prevents about 5 more strokes per 1000 patients/year than warfarin. Xarelto 20 mg once a day doesn t seem to work better than warfarin. Side effects such as overall bleeding are similar between Pradaxa and Xarelto compared to warfarin. Both seem to cause FEWER intracranial bleeds...and MORE GI bleeds than warfarin. But dyspepsia is a problem with Pradaxa. Cost is less with warfarin...totaling about $80/month with INR monitoring once/month. Pradaxa and Xarelto both cost about $260/month. Continue to suggest warfarin for many atrial fib patients. Suggest another oral anticoag if INR control is poor...warfarin interactions are a concern...or monitoring isn t feasible. If a newer anticoagulant is needed, suggest Pradaxa first...it s more effective than warfarin in some patients. Tell patients that Pradaxa is now good for 4 MONTHS after opening...instead of just 60 days. For now, suggest Xarelto for patients who can t tolerate Pradaxa due to dyspepsia...or have trouble with its BID dosing. Advise taking Xarelto with dinner to improve absorption. Recommend monitoring renal function with the new anticoagulants...and lowering the dose if needed. Discourage using aspirin for atrial fib. New evidence suggests that it s not much better than placebo...and it still increases bleeding. Suggest saving aspirin for younger patients without additional stroke risk factors...or those who won t take an anticoagulant. If you want to be the smartest person in your area about the new anticoags for atrial fib, go to our PL Detail-Document...and listen to our experts talking on PL Voices. Also see our PL Chart, Comparison of Oral Antithrombotics, for their indications, dosing, interactions, etc. Go to the Warfarin vs Pradaxa or Xarelto for Atrial Fib Detail-Document. DISCUSSION POINTS Appropriate use of Xarelto and Pradaxa in atrial fibrillation patients LEARN MORE ABOUT THIS POINT... (Just click on the link for access!) August 2011 Article new ORAL anticoagulant called Xarelto (zuh-rel-toe) Detail-Doc Warfarin vs Pradaxa or Xarelto for Atrial Fib

2 This handout accompanies the related articles published in December 2011 ~ Volume 27 ~ Number 12 following Pharmacist's Letter; August 2011; Vol: 27 PL CE LIVE November 2011 Long Guide Anticoagulants You'll see a new ORAL anticoagulant called Xarelto (zuh-rel-toe). It's initially approved to prevent thrombosis after hip or knee replacement surgery. It'll also likely be approved to prevent stroke in patients with atrial fibrillation. Xarelto (rivaroxaban) is the first ORAL factor Xa inhibitor. It has a fast onset and doesn't need coagulation monitoring. Xarelto is more effective than enoxaparin 40 mg/day after knee replacement. One more major blood clot is prevented for every 62 patients treated with Xarelto...with a similar bleeding risk. Xarelto also costs about $8 a day...compared to $25 to $50 a day for generic enoxaparin. Patients will take Xarelto 10 mg once daily for 35 days after a hip replacement...or for 12 days after knee replacement surgery. Watch for drug interactions when patients are on Xarelto. Don't combine it with drugs that significantly DECREASE CYP3A4 and p-glycoprotein elimination, such as ketoconazole or ritonavir. Also try not to combine Xarelto with drugs that INCREASE its elimination, such as phenytoin, carbamazepine, and rifampin. If the combo is unavoidable, recommend increasing to Xarelto 20 mg/day. Watch that Xarelto isn't given to patients with severe renal impairment...or moderate to severe hepatic impairment.

3 PL Detail-Document # This PL Detail-Document gives subscribers additional insight related to the Recommendations published in October 2011 Comparison of Oral Antithrombotics (Last modified November 2011) The recent proliferation of oral anticoagulants and antiplatelet agents has health care professionals questioning how to choose among them. The newest anticoagulants are dabigatran (Pradaxa, Pradax [Canada]) and rivaroxaban (Xarelto). Also look for the direct factor Xa inhibitor apixaban possibly in 2012, and edoxaban and betrixaban in the next few years. The following chart compares the indications, clinical benefit, antidotes, washout, and other therapeutic considerations for these agents. Abbreviations: ACS = acute coronary syndrome; ADP = adenosine diphosphate; A fib = atrial fibrillation; AV = arteriovenous; AWP = average wholesale price; BID = twice daily; CAD = coronary artery disease; DVT = deep vein thrombosis; LMWH = low molecular weight heparin; LVD = left ventricular dysfunction; MI = myocardial infarction; PE= pulmonary embolism; STEMI = ST segment elevation myocardial infarction; TIA = transient ischemic attack; VTE = venous thromboembolism Drug: Mechanism Cost of 30-day supply a Approved Indications (Usual Maintenance Dose) b Clinical Benefit In c ANTICOAGULANTS (see information about the investigational drug apixaban at the end of the chart) Dabigatran (Pradaxa; Pradax [Canada]): direct thrombin inhibitor 5,6 U.S.: 5 Thromboembolism (e.g., stroke) prevention in A fib (150 mg BID) 5 A fib: prevents about five more strokes per 1000 patients per year than warfarin. Lower rate of hemorrhagic stroke, higher rate of major GI bleed 7 (150 mg BID) U.S.: $ (AWP) Canada: $ Continued Canada: 6 Thromboembolism (e.g., stroke) prevention in A fib (150 mg BID, 110 mg BID for patients over 80 yrs). VTE prevention post-hip or knee replacement (220 mg once daily x 10 days [knee] or 28 to 35 days [hip]. If started 1-4 hrs post-op, initial dose is 110 mg) Post-hip/knee replacement (off-label [U.S.]): comparable to enoxaparin for prevention of VTE & mortality (combined endpoint); comparable major bleeding 8-10 VTE treatment (off-label): comparable to warfarin for prevention of recurrent VTE or VTE death (combined endpoint); comparable Antidote/ pre-op, preprocedure washout (if indicated) No specific antidote See our PL Detail- Document, Reversing Dabigatran and Rivaroxaban P.O. Box 8190, Stockton, CA ~ Phone: ~ Fax: ~ Therapeutic Considerations Requires BID dosing for A fib. 5,6 Dispense/store in original container. Once opened, discard after four months (U.S.) or 30 days (Canada). 5,6 To switch from warfarin, stop warfarin, then start dabigatran when INR <2. 5,6 See product labeling for instructions for switching to warfarin, or to/from injectable anticoagulants. Check renal function at baseline, and yearly in

4 DIABETES Reps will promote using Byetta WITH Lantus for type 2 diabetes. Adding Byetta (exenatide) to Lantus lowers A1C by 1.7%...compared to 1% for Lantus alone. Think of it as an alternative to adding a short-acting insulin (Humalog, etc) before meals. Byetta doesn t increase hypoglycemia risk...and it can help reduce the weight gain associated with insulin. In fact, patients on the combo for 30 weeks LOSE about 4 pounds...compared to GAINING 2 pounds with just Lantus. But about one in 12 patients will stop Byetta due to nausea, vomiting, diarrhea, or other side effects. And Byetta costs about $340/month...compared to up to $190/month for prandial insulin plus extra for glucose monitoring. Suggest adding either Byetta or a prandial insulin when basal insulin and oral meds aren t enough for type 2 diabetes. Lean towards Byetta to reduce weight gain or hypoglycemia. When starting Byetta, suggest lowering the basal insulin dose by 20% if the patient s A1C is 8 or less. Point out that Byetta isn t appropriate for use with prandial insulin. For help with insulin, see our algorithm, Initiation and Adjustment of Insulin Regimens for Type 2 Diabetes. Go to the Using Exenatide (Byetta) with Insulin Glargine (Lantus) Detail-Document. DISCUSSION POINTS Use of Byetta (exenatide) for diabetes Insulin dosing in type 2 diabetes LEARN MORE ABOUT THIS POINT... (Just click on the link for access!) March 2010 Article Victoza (VIC-tow-za) will compete with Byetta for type 2 diabetes November 2008 Article More type 2s are using insulin

5 This handout accompanies the related articles published in December 2011 ~ Volume 27 ~ Number 12 following Pharmacist's Letter; March 2010; Vol: 26 PL CE LIVE November 2011 Long Guide Diabetes Victoza (VIC-tow-za) will compete with Byetta for type 2 diabetes. These injectable meds are called GLP-1 receptor agonists. GLP-1 (glucagon-like peptide-1) is an incretin hormone that's secreted by the gut...mainly after meals. GLP-1 stimulates the pancreas to INCREASE insulin and DECREASE glucagon secretion. Reps will say that Victoza (liraglutide) is more effective and better tolerated than Byetta (exenatide). But keep this in perspective. A1C lowering is more with Victoza than Byetta...but not much. Expect Victoza to drop A1C about 1.1% when added to metformin and/or a sulfonylurea...compared to 0.8% with Byetta. Weight loss is similar with Victoza and Byetta. Tell patients to expect about a 6 pound drop with either drug. Side effects such as nausea and vomiting are common with both...but nausea can be more persistent with Byetta. Both drugs are associated with pancreatitis...but this is rare. And there are reports of renal impairment with Byetta, so be careful using either drug in patients with kidney disease. Victoza has a black box warning about a possible risk of thyroid tumors. But explain this has only been seen in rodents. Convenience is Victoza's biggest advantage. It's injected just ONCE daily compared to TWICE daily for Byetta. Cost of Victoza is about $360/month for the highest dose...about 50% more than Byetta. Recommend sticking with metformin, sulfonylureas, or insulin for most type 2s. Suggest Byetta or Victoza instead of a sulfonylurea or insulin to reduce hypoglycemia risk...or for possible weight loss. Suggest Victoza for patients who want fewer injections...if they can afford it. But explain that instead of starting on a new drug, they may want to wait for once-weekly Byetta...possibly later this year. Keep in mind to give patients the Victoza or Byetta MedGuide. You can get them anytime from our MedGuide tab. See our updated chart, Comparison of Insulins and Injectable Diabetes Meds, for administration, stability, cost, etc.

6 PL Detail-Document # This PL Detail-Document gives subscribers additional insight related to the Recommendations published in December 2011 Using Exenatide (Byetta) with Insulin Glargine (Lantus) Introduction Diabetes is common. In the U.S., 25.8 million children and adults or 8.3% of the population have diabetes. 1 In Canada, it is estimated that 2.7 million people or 7.6% of the population have diabetes. 2 Given the substantial morbidity and mortality associated with diabetes, effective treatment regimens are vital. There are a variety of oral and subcutaneous agents available for use. More and more, combinations of these agents are being used. Recently, the labeling for exenatide (Byetta) was expanded in the U.S. to include use of exenatide with insulin glargine (Lantus) in patients with type 2 diabetes. 3 Exenatide is an incretin mimetic. Incretins are secreted by the GI tract after meals and stimulate insulin secretion and slow stomach emptying. This document discusses the evidence to support the use of exenatide with insulin glargine. Clinical Trials There have been a number of clinical trials evaluating the combination of exenatide and insulin therapy. 4 In one of the earlier trials, Viswanathan and colleagues retrospectively evaluated 52 obese patients with type 2 diabetes whose diabetes was uncontrolled and who continued to gain weight on their current diabetes regimens with a combination of oral agents and insulin. At baseline, their A1C was 7.9%, weight was /- 2.9 kg, and body mass index was 41.3 kg/m 2. Patients with an A1C greater than 7% were offered exenatide 5 mg subcutaneously before breakfast and dinner. Patients who chose to start exenatide and who continued on exenatide without problems were compared with those who chose not to take exenatide by choice or because of insurance issues. Doses of rapid-acting insulin and mixed insulins were empirically reduced by 10%. If preprandial or bedtime glucose concentrations were greater than 130 mg/dl, insulin doses were increased, and if these glucose concentrations were less than 110 mg/dl, insulin doses were decreased. After 26 weeks of therapy, A1C levels decreased from 7.7 +/- 0.2% to 7.1 +/- 0.2% (p=0.007) in patients who received exenatide but remained unchanged (8.4% +/- 0.5%) in those who did not receive exenatide. Obese patients who received exenatide had significant reductions in body weight (from /- 3.5 kg at baseline to /- 3.2 kg at completion of the study) while those who received placebo had an increase in body weight ( /- 5.7 kg at baseline compared with /- 6.1 kg at completion). In addition there was a 28% reduction in daily doses of short-acting/rapidacting insulins and a 60% reduction in combination insulins (e.g., 70/30 NPH/regular or 75/25 lispro/insulin aspart), but no significant reduction in doses of basal insulin, NPH insulin or insulin glargine in patients who received exenatide. 5 The authors concluded that exenatide, when added to insulin, can improve glucose concentrations, body weight and allow for a reduction in dose of rapid-acting/short-acting and premix insulins. 5 However, it is important to note that in this study exenatide was added to patients receiving prandial and short- or rapid-acting insulins. The new U.S. Byetta product labeling only addresses the use of exenatide as add-on therapy to basal insulin (i.e., insulin glargine). Most recently, Buse and colleagues conducted a 30-week parallel, randomized, placebocontrolled trial. Patients were stratified by baseline A1C (>8% vs <8%) and received placebo or exenatide 5 mcg subcutaneously twice daily for four weeks and then 10 mcg subcutaneously twice daily thereafter. A total of 261 patients with type 2 diabetes were included. All patients were receiving a minimum of 20 units a day of insulin glargine, without any other insulin, for at least three months. Some patients were also receiving a stable dose of metformin or pioglitazone or P.O. Box 8190, Stockton, CA ~ Phone: ~ Fax: ~

7 NEUROLOGY / PSYCHIATRY The new generic olanzapine (Zyprexa) means you ll see even more off-label use of atypical antipsychotics. About 60% of Rxs for atypicals are for off-label uses. Some of these are appropriate...but some aren t. And don t assume that any atypical will work for a given indication... evidence DOESN T support a class effect. Insomnia. Low doses of quetiapine (Seroquel, etc) and others are often used for sleep. But there s no evidence they work and they have serious side effects. Recommend trying zolpidem, trazodone, and others first. Generalized anxiety disorder. Suggest trying quetiapine if patients don t respond to an SSRI (sertraline, etc) or SNRI (venlafaxine, etc). There s no evidence that any of the others are effective for anxiety. Depression. Olanzapine, Abilify (aripiprazole), and Seroquel XR are approved to use with an antidepressant for depression...and there s good evidence for risperidone. But they have a modest benefit and serious side effects. Recommend an adequate trial of antidepressants first. Dementia. Antipsychotics increase strokes and mortality in elderly dementia patients. Recommend saving them for patients who are a risk to themselves and others due to aggression, hallucinations, or delusions. Suggest using one-quarter to one-half the usual starting dose of risperidone, olanzapine, or Abilify...they have the most evidence. But suggest quetiapine for patients with Lewy body dementia or Parkinson s. Recommend monitoring blood glucose and lipids at baseline, 12 weeks, and then periodically for patients on an atypical. Also suggest checking weight every month for 3 months, then every 3 months. Get our PL Chart, Comparison of Atypical Antipsychotics, for help choosing an atypical based on adverse effects, interactions, etc. Go to the Off-Label Use of Atypical Antipsychotics in Adults Detail-Document. Off-label use of antipsychotics DISCUSSION POINTS LEARN MORE ABOUT THIS POINT... (Just click on the link for access!) May 2009 Article Atypical antipsychotics will be used more for treating depression Detail-Doc Off-Label Use of Atypical Antipsychotics in Adults

8 This handout accompanies the related articles published in December 2011 ~ Volume 27 ~ Number 12 following Pharmacist's Letter; May 2009; Vol: 25 PL CE LIVE November 2011 Long Guide Neurology / Psychiatry Atypical antipsychotics will be used more for treating depression. Both Abilify (aripiprazole) and Symbyax (olanzapine/fluoxetine) are already approved for resistant depression...and Seroquel (quetiapine) will likely get a similar indication. More than half of patients with depression still have symptoms despite an adequate trial of an antidepressant. But DON'T be too quick to recommend an atypical antipsychotic. First suggest counseling and changing antidepressant regimens. For example, suggest switching from one SSRI to another...or adding an antidepressant from a different class such as bupropion. If this isn't enough, suggest augmenting antidepressants with other drugs...lithium, thyroid, buspirone, antipsychotics, etc. Atypical antipsychotics are especially useful for patients who also have bipolar or psychotic symptoms...but they can also be used for patients without psychotic symptoms. Keep in mind that atypical antipsychotics can cause more adverse metabolic side effects...obesity, dyslipidemia, and diabetes. There are also concerns about tardive dyskinesia and sudden cardiac death. Recommend checking weight, blood pressure, plasma glucose, and lipids at baseline, 12 weeks, and then at least annually. If metabolic changes are a concern, suggest Abilify instead of Seroquel or olanzapine (Symbyax, Zyprexa). On the other hand, suggest olanzapine or Seroquel if a more sedating drug is needed. Abilify can cause restlessness and insomnia.

9 PL Detail-Document # This PL Detail-Document gives subscribers additional insight related to the Recommendations published in December 2011 Off-Label Use of Atypical Antipsychotics in Adults Sixty percent of atypical prescriptions are for an off-label use. But don t assume that just any atypical will work for a given indication; evidence does not support a class effect. 7 Weight gain and metabolic effects are of concern with atypicals, especially olanzapine, 17 and very few of these off-label uses are backed by large, high-quality, randomized controlled trials. Consider options with more data and less side effects first. If an atypical is used, check weight, glucose, and lipids at baseline. Check weight every four weeks for 12 weeks, then every three months. Recheck glucose and lipids at 12 weeks. Then check glucose again at four months and annually, and lipids every two to five years. 17 The following chart lists common off-label uses for atypicals with at least level B evidence, and therapeutic considerations. See our PL Charts, Comparison of Atypical Antipsychotics (U.S. subscribers; Canadian subscribers), for approved indications and side effects. a. Inclusion means medication has at least level B evidence. But inclusion does not mean agent is effective for studied indication. See Therapeutic Considerations column for details. Use Off-Label Medication a Therapeutic Considerations Depression, treatmentresistant, adjunct Risperidone (Risperdal, generics) Ziprasidone (Geodon, Zeldox [Canada]) Abilify (aripiprazole), Seroquel XR (quetiapine), and Zyprexa (olanzapine, with fluoxetine [Symbyax]) are FDA-approved for adjunctive treatment of treatment-resistant major depressive disorder. 1-3 Risperidone s strength of evidence of efficacy is similar to aripiprazole or quetiapine. 5 In Canada, Seroquel XR is also approved as monotherapy for treatment-resistant depression. 4 Dementia behaviors Aripiprazole (Abilify) Olanzapine (Zyprexa, generics ) Risperidone (Risperdal, generics) Quetiapine (Seroquel) Small benefits on agitation or behavioral disturbances in dementia. 5 Use about one-quarter to one-half the usual adult starting dose. 6 Aripiprazole, olanzapine, and risperidone have the best evidence of efficacy. 5 Risperidone has the best evidence for psychosis. 5 Risperidone and olanzapine have the best evidence for agitation. 5 Increased risk of metabolic syndrome. Increased risk of stroke and mortality in elderly dementia patients. One additional death for every 52 nursing home dementia patients treated for ten weeks. Discuss risks/benefits with patient/family. 6 Reserve for agitation or distress with psychosis (delusions, hallucinations, paranoia), or for treatment-refractory agitation or aggression, in patients who are a danger to themselves or others. 6,7 Use caution in patients with cerebrovascular disease or hypovolemia. 6 Patients with Parkinson s dementia and Lewy body dementia are extra-sensitive to antipsychotic extrapyramidal effects. Low-dose quetiapine is the antipsychotic of choice. 8 P.O. Box 8190, Stockton, CA ~ Phone: ~ Fax: ~

10 Detail-Document # This Detail-Document accompanies the related article published in October 2009 ~ Volume 25 ~ Number Comparison of Atypical Antipsychotics (Full update January 2011) Second-generation or atypical antipsychotics have a lower propensity than the first generation agents to cause extrapyramidal side effects. Clozapine may be the most effective atypical for schizophrenia, but its use is limited due to the risk of agranulocytosis. 1,21 All carry black box warnings regarding mortality risk in dementia-related psychosis, and suicidality if indicated for depression. Atypicals pose varying risks of QT prolongation, drug interactions, and metabolic adverse effects. The newest agents are asenapine (Saphris), paliperidone (Invega, Invega Sustenna), iloperidone (Fanapt), and lurasidone (Latuda). Thus, their side effect profiles are not as well-characterized as the older agents. Extrapyramidal side effects seem lowest with iloperidone and quetiapine (Seroquel), and higher with risperidone and paliperidone Hyperprolactinemia, associated with sexual dysfunction, gynecomastia, and irregular periods, seems most common with risperidone and paliperidone. 28 Side effects, cost, and dosing frequency, are all considerations in choice of agent. The chart below compares atypicals in regard to indications, dosing, metabolic side effects, sedation, QT prolongation, CYP3A4 metabolism, and cost. FDA-approved pediatric indications/doses are available in our document, Atypical Antipsychotics in Kids. NOTE: *Usual or target daily adult dosage range may not include initial and maximum doses. Use lowest effective dose. Maximum doses of oral aripiprazole, lurasidone, olanzapine, paliperidone, quetiapine XR, and risperidone are approved for once-daily administration. Divide asenapine, iloperidone, and ziprasidone twice daily. Generic (Brand)/ Cost b Aripiprazole (Abilify) c,l,m 10 mg $ FDA-Approved Indications for Adults and Usual or Target Adult Daily Dosage Range (mg/day)*,a Schizophrenia: mg Bipolar disorder (acute manic or mixed episodes; maintenance): 15 mg Depression (adjunct): 5-10 mg Metabolic Adverse Effects a,1,14-17,21,24 Weight Diabetes Dyslipidemia Gain Risk Low to None None Yes o none QT Prolongation a,18 (see footnote concerning incidence) CYP3A4 Sedation a,19 Metabolism a Yes Low Asenapine (Saphris) n 20 mg $ Schizophrenia: 10 mg (acute), 20 mg (maintenance) Bipolar disorder (acute manic or mixed episodes): mg For sublingual use. Avoid food or drink for 10 min. after administration. Low to none Low to none Low to none Yes d Yes (minor) Low to Moderate Copyright 2009 by Therapeutic Research Center

11 COLCHICINE Dosing and drug interactions with colchicine (Colcrys) for acute gout are still causing confusion. We re all used to the old way of dosing colchicine for acute gout...two tabs initially then one tab every hour until either diarrhea starts or the pain stops. But this causes too much toxicity...and even some deaths. When FDA approved Colcrys, they also approved safer dosing. The new dosing for a gout flare is to give two 0.6 mg tablets followed by just ONE tab one hour later. Recommend even lower and less frequent dosing if colchicine is used with other drugs that inhibit its metabolism. Recommend just one tab per attack with cyclosporine...one tab followed by a half tab with strong 3A4 inhibitors (clarithromycin, etc)...and two tabs with moderate 3A4 inhibitors (verapamil, etc). Tell patients not to repeat these colchicine doses for at least 3 days. For severe renal or hepatic impairment, recommend a 3-tablet course...but wait at least 2 weeks before repeating the course. Avoid colchicine plus cyclosporine or a strong 3A4 inhibitor if patients have renal or hepatic impairment. This can be fatal. Continue to recommend NSAIDs or corticosteroids first-line for acute gout. They re usually better tolerated and cost less...at least until generic colchicine is available again. If needed, get our PL Chart, Colchicine Dosing and Interactions, for both treatment and prophylaxis of gout. Go to the Colchicine Dosing and Drug Interactions Detail-Document. Use and dosing of colchicine DISCUSSION POINTS LEARN MORE ABOUT THIS POINT... (Just click on the link for access!) September 2009 Article changes in how colchicine is dosed for acute gout Detail-Doc Colchicine Dosing and Drug Interactions

12 This handout accompanies the related articles published in December 2011 ~ Volume 27 ~ Number 12 following Pharmacist's Letter; September 2009; Vol: 25 PL CE LIVE November 2011 Long Guide Gout You'll see changes in how colchicine is dosed for acute gout. Most acute gout patients get NSAIDs or corticosteroids...but colchicine is still a good second-line choice. The problem is that generic colchicine tabs are old drugs that were never approved by the FDA. This means their labeling and dosing info were never reviewed by FDA. And inappropriate colchicine dosing is leading to problems. An FDA analysis shows 117 deaths from colchicine toxicity at usual doses...about half in patients taking clarithromycin. This is coming to a head now...because now for the first time there is an FDA-approved colchicine...called Colcrys (KOL-kris). When FDA reviewed and approved Colcrys, they also approved new, safer dosing info based on recent studies. Eventually any unapproved products will be taken off the market. The old regimen was two 0.6 mg colchicine tablets...followed by one tab every hour until pain subsides or GI toxicity occurs. The new regimen is TWO tablets followed by just ONE tab one hour later for a gout flare. Taking more than 3 tablets is NOT more effective...and it causes more adverse effects. About 25% of patients on the lower dose get GI effects...compared to almost everyone on the higher doses. Recommend even lower and less frequent dosing if colchicine is combined with drugs that inhibit its metabolism. For moderate CYP3A4 inhibitors (verapamil, etc), have patients take just TWO colchicine tabs...and NOT repeat for at least 3 DAYS. For strong CYP3A4 inhibitors (clarithromycin, etc), have patients take ONE colchicine tab, then HALF a tab an hour later if needed...and not redose for at least 3 days. Don't use colchicine with strong inhibitors if patients have renal or hepatic impairment. And limit colchicine courses to every 2 weeks for severe impairment. Counsel patients to avoid grapefruit when taking colchicine. Colcrys will come with a MedGuide. Give one with each Colcrys Rx...and consider giving a copy with generic colchicine Rxs. You can get this or any MedGuide from our list of MedGuides.

13 PL Detail-Document # This PL Detail-Document gives subscribers additional insight related to the Recommendations published in December 2011 Colchicine Dosing and Drug Interactions Colchicine is a very old drug that has a history of serious safety issues. It has a narrow therapeutic index, is metabolized by the liver, and excreted by the kidneys. 1,2 Acute ingestion of less than ten times the daily dose has resulted in death. 2 About nine out of ten patients who take colchicine for gout flares will have gastrointestinal symptoms such as diarrhea and nausea before they have pain relief. 2 Signs and symptoms of colchicine toxicity include gastrointestinal symptoms as well as organ failure (e.g., arrhythmias, myopathy, seizures, etc). 2 With the approval process for Colcrys, the first FDA-approved single-ingredient colchicine product available in the U.S., more information on safe doses and drug interactions of colchicine has become available. However, dosing for Colcrys can be tricky, since there are differences depending on the indication, concomitant drug therapy, and liver and kidney function. The following chart lists doses and dose adjustments from the Colcrys product labeling. A listing of some drugs that interact with colchicine is also included. NOTE: Information in Canadian colchicine labeling may differ. The following chart reflects the most current safety information for colchicine. Dosing and Dose Adjustments for Colchicine (Colcrys) 1 Prophylaxis of gout flare (>16 years old) Treatment of gout flare (>16 years old) Familial Mediterranean fever (>12 years old) Normal Dose 0.6 mg once daily or BID Max is 1.2 mg per day 1.2 mg x1 dose then 0.6 mg one hour later 1.2 to 2.4 mg per day given once daily or BID Max is 1.8 mg in a one-hour period Wait 12 hours to resume prophylactic dose Wait at least three days to repeat Increase in increments of 0.3 mg per day to max of 2.4 mg per day Decrease in increments of 0.3 mg per day if side effects are intolerable Strong CYP3A4 Inhibitors (see end of document for list of drugs) 0.3 mg once daily if original dose was 0.6 mg BID 0.3 mg once every other day if original dose was 0.6 mg once a day Avoid colchicine in patients with kidney or liver impairment 0.6 mg x1 dose then 0.3 mg one hour later Wait at least three days to repeat Avoid colchicine for treatment if patient also taking colchicine for gout prophylaxis Avoid colchicine in patients with kidney or liver impairment 0.6 mg once daily or 0.3 mg BID Max is 0.6 mg per day Avoid colchicine in patients with kidney or liver impairment P.O. Box 8190, Stockton, CA ~ Phone: ~ Fax: ~

14 TESTOSTERONE You ll face questions about the new strengths of AndroGel and Androderm (testosterone). AndroGel now comes in a higher concentration so patients can use less gel. Two pumps of the new AndroGel 1.62% are similar to using 4 pumps of AndroGel 1%. The new strength will be priced a little lower to entice patients to switch. But they both still cost over $300 a month...and a generic is 2 years or more away. Advise men to apply AndroGel 1.62% to their upper arms and shoulders...and NOT to their abdomen like AndroGel 1%. Explain that absorption is better on the upper arms and shoulders. Androderm now comes in smaller, lower-strength patches...the original patches will be discontinued at the end of this year. Recommending using the new 2 mg patch instead of the older 2.5 mg patch...and the new 4 mg patch instead of the 5 mg patch. To save money, consider whether compounded testosterone is appropriate. But keep in mind, it can t be identical to a commercially available product. Get our latest PL Chart, Comparison of Testosterone Products, with all dosage forms including injectable, buccal, and others.

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