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Pharmacy Update – April 2011
Issues are also available at
In this issue: -Summary of the February P&T meeting (pgs 1 - 3) Summary of February P&T Meeting
Updated review of azelastine (Astelin & Astepro
limited health plan coverage of Astepro are also issues Nasal Sprays): The Committee considered an updated
to consider (see table below) before using nasal summary review of azelastine (Astelin & Astepro antihistamines prior to trying a non-sedating OTC oral Nasal Sprays by Meda). Azelastine nasal sprays are H antihistamine or prescription nasal corticosteroid receptor antagonists indicated for the relief of the symptoms of seasonal allergic rhinitis. The safety and
Cost & Health Plan Coverage of Nasal Antihistamine
effectiveness of Astepro has not been established in Sprays:
patients younger than 12 years of age. Astelin is approved for children 5-11 years old and for adults. Health Plan
The recommended dose of both products is 1 or 2 Coverage
Azelastine (generic)
sprays per nostril twice daily. Astepro Nasal Spray requires priming before initial use by releasing 6 sprays or until a fine mist appears. When Astepro Azelastine (Astelin)
Nasal Spray has not been used for 3 or more days, it must be re-primed with 2 sprays or until a fine mist appears. Patients allergic to Splenda® or products Azelastine (Astepro)
containing Splenda® should not use Astepro. Astepro Nasal Spray claims to be an improvement over the marketed Astelin Nasal Spray, due to being Olopatadine (Patanase)
better tolerated by patients (i.e.: less bitter taste and nasal discomfort). Astepro is comprised of unique vehicle formulated with sorbitol and sucralose, a taste The Committee voted unanimously to maintain masking agent while older Astelin has a saline based Astepro as non-formulary but they also voted vehicle. The active ingredient, azelastine, remains the unanimously to add the newly available generic same and both products have the same strength, azelastine nasal spray to the formulary. 137mcg. An advantage of intranasal antihistamines is that they have a quick onset, at around 30 minutes. Review of methylnaltrexone (Relistor): The
This is quicker than intranasal corticosteroids or oral Committee was provided an executive summary antihistamines. As such, intranasal antihistamines are review of subcutaneous methylnaltrexone (Relistor – Wyeth/Progenics), a selective mu-opioid receptor Intranasal antihistamines might reduce nasal antagonist, which is indicated for the treatment of congestion more than oral antihistamines, but not as opioid-induced constipation in patients with advanced well as intranasal steroids. Like some oral illness who are receiving palliative care when response antihistamines, intranasal antihistamines can cause also to laxative therapy has not been sufficient. sedation. Despite the fact that Astepro is relatively Methylnaltrexone (Relistor) injected subcutaneously new, there is a new drug application (NDA) for another every other day is effective for relief of constipation newly formulated higher strength azelastine nasal associated with opioid treatment in about 50% of spray which has now been accepted by the FDA as patients with advanced illness receiving palliative care, complete for substantive review after initial evaluation. without interfering with analgesia or precipitating signs This newest product has the potential to become the of central-nervous-system withdrawal. It appears to be first once-a-day nasal antihistamine in the U.S. an important advance in the treatment of such patients Currently, Astelin and Astepro are non-formulary items. The committee felt that although intranasal South Shore Physician-Hospital Organization Pharmacy antihistamines may be appropriate for PRN use and Newsletter is published exclusively for members of South Shore might reduce nasal congestion more than oral Physician-Hospital Organization. Comments on its contents are antihistamines, they don’t work as well as intranasal encouraged. Please call Steven Golden, MD, South Shore PHO Medical Director at (781) 340-4068 or Geraldine McNamara, RN, steroids. Like some oral antihistamines, intranasal at (781) 340-8160. Information published in this newsletter is antihistamines can also cause sedation. This appears to confidential and intended for the addressee named. Any disclosure be especially true for azelastine. The high cost and…. or unauthorized copying is strictly prohibited. The mechanism for the delays in gastric emptying, needle, and 2 alcohol swabs. Vials should be stored at oral-cecal, and colonic transit time, and inhibition of room temperature and protected from light. The defecation associated with opiate-induced bowel average wholesale price (AWP) for methylnaltrexone dysfunction is the stimulation of the mu receptor. is about $50 per single-use vial or $350 for a 7-tray kit. Methylnaltrexone is a peripherally acting selective mu- The annual cost of treatment with Relistor can range opioid receptor antagonist. It is a quaternary derivative of naltrexone, unlike naloxone. The addition of the Methylnaltrexone appears effective in the therapy of methyl group at the amine in the naltrexone ring results opioid-induced constipation and will likely be useful in a compound with greater polarity and lower lipid for patients failing to respond to traditional laxative solubility, thus preventing it from crossing the blood- regimens. Activity has not been as clearly brain barrier. This allows the drug to block peripheral demonstrated in postoperative bowel dysfunction. receptor opioid effects without affecting the central Since Relistor is a prescription product and has a very narrow indication, it is likely to be used only by Approval of Relistor was based on two randomized, palliative care patients with advanced illness. double-blind trials in terminally ill patients with Although impressed by the clinical data and constipation caused by opioid therapy. In the first trial, acknowledging the appropriate use of the drug in a bowel movement occurred within 4 hours after a hospitals and extended care environments, the single subcutaneous dose of methylnaltrexone 0.15 Committee voted unanimously to classify Relistor as mg/kg, methylnaltrexone 0.3 mg/kg or placebo in 62%, non-formulary on the SSPHO outpatient formulary. 58% and 14% of patients, respectively. In the second trial 133 patients were randomized to receive Review of combination dutasteride 0.5 mg and
methylnaltrexone 0.15 mg/kg or placebo every other tamsulosin hydrochloride 0.4 mg (Jalyn): The
day for 2 weeks. About 50% of patients who received Committee was provided an executive summary methylnaltrexone had a bowel movement within 4 review of the combination product dutasteride 0.5 mg hours compared to 15% of those who received placebo. and tamsulosin hydrochloride 0.4 mg (Jalyn A bowel movement occurred within 24 hours after manufactured by GSK). In combination as a 5α- each of the 7 doses in the trial in 55-66% of patients reductase inhibitor and alpha adrenergic antagonist, injected with methylnaltrexone and in 29-39% of those Jalyn is indicated for the treatment of symptomatic injected with placebo. These rates of response persisted benign prostatic hyperplasia (BPH) in men with an throughout the study and during a 3-month open-label Each of the two drugs utilizes a different In clinical trials, adverse effects associated with mechanism of action to improve lower urinary tract methylnaltrexone included abdominal pain, flatulence, symptoms (LUTS) in patients with BPH. Tamsulosin diarrhea, nausea and dizziness. One patient died with works by antagonizing alpha-1 adrenoreceptors in the severe diarrhea and dehydration. Treatment with human prostate. The smooth muscle relaxation methylnaltrexone did not appear to diminish the improves urinary flow rate and BPH symptoms. analgesic effect of opioids or precipitate non- Dutasteride is a 5α-reductase inhibitor which exerts its gastrointestinal signs of opioid withdrawal. The usual effects by blocking the conversion of testosterone to dosage of methylnaltrexone is 8 mg injected dihydrotestosterone. Dihydrotestosterone is the agent subcutaneously in the abdomen, thigh or upper arm responsible for the enlargement of the prostate gland. every other day as needed (maximum is one dose per 5α-reductase is present in two forms in the body, type 24 hours) for patients 38 to <62 kg, or 12 mg for 1 and type 2. Type 1 is primarily found in the patients 62-114 kg. For all other patients, the reproductive tissues and type 2 is present in the skin recommended dosage is 0.15 mg/kg. According to the and liver. Dutasteride is a competitive and specific manufacturer, patients with creatinine clearance inhibitor of both types 1 and 2. The individual <30mL/min should reduce their dosage by half. The pharmacokinetic properties of dutasteride and subcutaneous formulation for use in opioid-induced tamsulosin are maintained whether given separately or constipation received FDA approval in April 2008. Submission of an IV form for postoperative ileus and The CombAT study (funded by GSK) was primarily an oral form for use in opioid-induced constipation in used in the evaluation of Jalyn. The study was an patients with chronic pain is anticipated in the near international, double-blind, randomized, and parallel group controlled trial in men with moderate to severe Relistor is covered by BCBSMA and Tufts at tier-2, symptoms and an increased risk of disease progression. and by HPHC at tier-3. It is available as individual The trial compared combination therapy of dutasteride single-use vials containing 12 mg/0.6 mL, or as a 7- 0.5 mg/day with tamsulosin 0.4 mg/day to the same tray kit. Each tray within the kit contains a 12 mg/0.6 doses of each agent individually. The primary mL single-use vial, a 1 mL syringe with retractable endpoint was time to first event of acute urinary retention (AUR) or BPH related prostatic surgery. The hydrochloride 500 mg and as repaglinide 2 mg / secondary endpoints included time to first BPH clinical metformin hydrochloride 500 mg. It is indicated as an progression, change in IPSS score and BPH related adjunct to diet and exercise to improve glycemic health status (IPSS Q8), IPSS score improvement of control in adults with type-2 diabetes mellitus who are 25% and >3 point improvement, urinary flow rate as already treated with a meglitinide and metformin, or measured by Qmax, and change in prostate volume. who have inadequate glycemic control on a meglitinide The investigators found that combination therapy was significantly superior to tamsulosin monotherapy but The results of a bioequivalence study in healthy not dutasteride monotherapy at reducing the relative subjects demonstrated that repaglinide 1 mg/metformin risk of AUR or BPH related surgery. Combination 500 mg and repaglinide 2 mg/metformin 500 mg therapy was also significantly superior at reducing combination tablets are bioequivalent to BPH clinical progression and provided greater coadministration of corresponding doses of repaglinide Safety and tolerability were relatively consistent In clinical studies, repaglinide add-on to metformin between all treatment groups. At 24 months adverse resulted in statistically significant improvements in effects were more common in the combination group hemoglobin A1c and fasting plasma glucose levels but most were not serious enough to result in compared with the monotherapy arms. However, the discontinuation. The discontinuation rate of all groups repaglinide add-on to metformin group had a higher was under 5%. The most common adverse effects incidence of hypoglycemia than the repaglinide shown were impotence, decreased libido, breast disorders, ejaculation disorders, and dizziness. Ejaculation disorders occurred more frequently during Cost Comparison & Health Plan Coverage: The normal dosage of Jalyn is one capsule (0.5 mg dutasteride / 0.4 mg tamsulosin) taken once daily 30 minutes after the same meal each day. The capsule metformin Tier 1
should be swallowed whole and not chewed, crushed, Prandimet N/C
or opened. No dosage adjustment is needed in renal impairment. Dosing in end stage renal disease has not been studied. No recommendation can be made in At this time, there is no generic PrandiMet available hepatic impairment due to absence of data. No dosage in the US, as the patent on PrandiMet does not expire adjustment is necessary in elderly patients. until 2018. Although the patent for Prandin expired in March 2009, there are also no generic versions of Cost Comparison & Local Health Plan Coverage: Prandin available in the US. It will likely be decided in the courts whether generic versions of PrandiMet Cost/month
will be allowed before 2018. Currently both Prandin and metformin are SSPHO formulary drugs, so Prandimet represents a potential addition to formulary. The cost of Prandimet is actually less than the cost of the two individual drugs; however, local health plan coverage is quite poor at present and thus the Committee voted unanimously to classify Prandimet as After considering the current data available and given the poor health plan coverage of Jalyn, despite its somewhat favorable present cost, the Committee Review of combination pioglitazone & metformin
voted unanimously to classify Jalyn as non-formulary. extended-release tablets (Actoplus Met XR): The
The cost of generic tamsulosin is expected to continue Committee was provided an executive summary review of the combination product pioglitazone & metformin extended-release tablet (Actoplus Met XR ). Review of combination repaglinide & metformin
Approved in May of 2009, Actoplus Met XR is the (Prandimet): The Committee was provided an
first oral antidiabetic fixed-dose combination executive summary review of the combination product medication approved with the extended-release form of repaglinide & metformin (Prandimet). Prandimet is a metformin. Actoplus Met XR is available as: fixed-dose combination of the fast-acting secretagogue pioglitazone/metformin extended-release tablets 15 repaglinide (Prandin) and insulin sensitizer, metformin, mg/1000 mg strength tablets and 30 mg/1000 mg. for the treatment of type-2 diabetes. Prandimet is Actoplus Met XR is indicated as an adjunct to diet and available as: repaglinide 1 mg / metformin exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with the market however, the cost of the combo agents will pioglitazone and metformin or who have inadequate be significantly higher. The Committee voted glycemic control on pioglitazone alone or metformin unanimously to classify Actoplus Met XR as non- Pioglitazone is a thiazolidinedione that acts primarily by decreasing insulin resistance and is used Pharmacy News Clips
in the management of type II diabetes. Pharmacologic studies indicate that it improves sensitivity to insulin in Poison Control Warning: Using Bath Salts to Get
muscle and adipose tissue and inhibits hepatic High {extracted from Prescribers Letter; March 2011; Vol.
gluconeogenesis. It decreases insulin resistance in the 27 (3)} "Bath salts" abuse is making headlines. In the periphery and in the liver resulting in increased insulin- U.S., poison control centers are receiving record high dependent glucose disposal and decreased hepatic phone calls related to "bath salts" abuse and lawmakers glucose output. In addition, pioglitazone may have are in the process of, or have already, banned "bath effects at the peroxisome-proliferator-activated The "bath salts" being abused are not really bath Metformin is an antihyperglycemic agent that salts. These are designer stimulants being packaged as improves glucose tolerance in patients with type 2 "bath salts" and are sold in smoke shops, convenience diabetes by lowering both the basal and postprandial stores, gas stations, truck stops, etc., and online. The plasma glucose. Metformin decreases hepatic glucose salts come in small packets or jars with brands such as production, decreases intestinal absorption of glucose, Cloud 9, Ivory Wave, Vanilla Sky, Purple Wave, and improves insulin sensitivity by increasing Blizzard, Blue Silk, etc. There are over 40 name peripheral glucose uptake and utilization. brands noted so far. Some street names include In bioequivalence studies of Actoplus met XR 15 "meow-meow," "drone," "bubbles," and "MCAT." mg/1000 mg and 30 mg/1000 mg, the area under the The substances are available as white, tan, or brown curve (AUC) and maximum concentration (Cmax) of powders and are selling for about $20 to $50 per 50 mg both the pioglitazone and the extended-release packet. In addition to "bath salts," these products are metformin components following a single dose of the marketed as bath crystals, plant food, insect repellant, combination tablet were bioequivalent to pioglitazone and herbal incense. Some plant foods are packaged as (Actos 15 mg and 30 mg) concomitantly administered capsules and are intended to be opened for use. with extended-release metformin (Fortamet) 1000 mg Bath salts or plant foods are not subject to tablets under fed conditions in healthy subjects. regulation. These products masquerading as bath salts Patients should be informed that Actoplus met XR mainly contain powerful stimulants such as 3,4- must be swallowed whole and not chewed, cut, or crushed, and that the inactive ingredients may methylmethcathinone (mephedrone) and are being occasionally be eliminated in the feces as a soft mass snorted, smoked, injected, and even mixed with water as beverages. At this time, these products do not show Cost Comparison & Local Health Plan Coverage: These stimulants produce effects that are similar to methamphetamine, ecstasy, and cocaine and can induce rapid heart rate, visual hallucinations, paranoia, and psychosis, as well as suicidal or homicidal metformin
thoughts. The psychosis can cause extreme violent and combative behavior. Self-injurious behavior is also common. There are reports of self mutilation, suicides, Actoplus
and homicides linked to "bath salts" highs. There are no specific treatment recommendations Actoplus
since health care providers cannot be sure of the substances contained in the "bath salts." In general, supportive care such as fluids and benzodiazepines for chemical sedation or physical restraints for severe Presently, there is no generic Actos, Actoplus Met, or combativeness, agitation, and hallucinations are Actoplus Met XR available in the US (despite the fact that the patent for Actos was due to expire in January A ban of "bath salt" products containing MDPV 2011). The costs of the Actos’ combination products went into effect in the U.K. in April, 2010. In the U.S., are presently about equal to that of the individual some states, such as Florida and Louisiana, have drugs; and, local health plans cover the combo’s at the same level as Actos. Once generic pioglitazone hits


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