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The Route Less Traveled Committee Met April 16, 2013

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The Route Less Traveled Committee Met April 16, 2013 Volume 27, Number 5 May 2013 PRESCRIBING FORMULARY UPDATE The Pharmacy and Therapeutics The route less traveled Committee met April 16, 2013. No drugs were added in the Formu- he rectal route of administration is when the rectal route is an alterna- tive to an injection, if patients are not lary, 2 drugs were deleted, and 5 T underused. The “per rectum” (PR) hospitalized. Diazepam is available in a drugs were designated nonformulary route offers a convenient and cost effec- tive option. There are few true contra- gel formulation that is instilled rectally and not available. 2 interchanges were indications. A drug’s route of admin- using a prefilled syringe. approved and 4 drugs had criteria for istration is limited by the formulations Terminally ill patients commonly lose use changes. available. Formulations are dependent their ability to take drugs orally. This on the innate physical and chemical can be due to absorptive impairment, properties of drugs. mental status changes, or an obstruc- ◆ ADDED By mouth or “per os” (PO) is the most tion. Utilizing the rectal route can None common route of drug administration. ensure adequate pain control, minimize Most currently approved drugs are adverse effects, and maximize comfort. ◆ DELETED administered PO, either as a solid oral One of the concerns from health care dosage form (eg, capsule or tablet), professionals is the perception that rec- Amyl Nitrite Ampule/Inhalant orally disintegrating tablet, buccal or tal absorption is erratic. Drug absorption (Generic)* sublingual route, or as an oral liquid. may be delayed or prolonged as the rate *Nonformulary and not available These drugs are convenient, can be of rectal absorption is affected by sev- self-administered, and are often less ® eral factors. The formulation determines Sildenafil 25-mg Tablets (Viagra )* expensive compared to parenteral (ie, the time to liquification of the sup- *Nonformulary and not available; “nonenteral”) routes. pository. The rate is also affected by the interchanged to 20-mg However, some oral drugs are sus- volume, retention, and the concentra- ceptible to first-pass effect, which can ◆ NONFORMULARY AND tion of the suppository. Data are lacking reduce bioavailability. The properties of that show the variability in absorption NOT AVAILABLE the active ingredients may not withstand impacts therapeutic outcomes. Carfilzomib (Kyprolis®)* stomach acid. In emergent situations, the Is the rectal route less effective or is onset of action may be too slow or not the effect delayed? A study by Karbasi *May be used in the BMT Outpatient Clinic & Infusion Center practical in an unconscious patient. and colleagues compared the effective- Alternative routes of drug administra- ness of oral and rectal acetaminophen Clozapine Suspension (Versacloz®) tion include transdermal, parenteral, as an antipyretic in 60 febrile children. nasal, and rectal. The transdermal route Children aged 6 months to 6 years who Crofelemer (Fulyzaq®)* can increase compliance but can cause presented to an emergency department *Patients may use their own supply dermatitis. Adverse events can occur were randomly assigned to receive 15 when patches are not removed before mg/kg acetaminophen rectally or the Hydrocodone-Chlorpheniramine placing a new patch. Parenteral agents same dose orally. Temperature was (Vituz®) are convenient and have a quick onset of recorded at baseline and 1 and 3 hours action. Obtaining intravenous access can Ospemifene (Osphena®)* after administration. In the rectal group, be a challenge, and can lead to infection. mean decrease in temperature, 1 and 3 *CANNOT USE IN INPATIENT SETTING The rectal route of administration is hours after administration of acetamino- underused and underappreciated. Few phen, was 1.1˚C and 1.7˚C, respectively, ◆ INTERCHANGES drugs can be administered rectally and and in the oral group it was 2.0˚C and are overlooked as therapeutic options. Oral Phosphate for IV Phosphate 1.7˚C, respectively. Based on this study These drugs are capable of providing lo- and other similar studies that have been Sildenafil 20-mg (Generic) for cal effects or achieving systemic concen- conducted, rectal and oral acetamino- trations, usually within 5 to 30 minutes. Sildenafil 25-mg(Viagra ®) phen preparations have similar anti- The rectal route is ideal when other pyretic effectiveness. routes are impractical or not feasible. ◆ CRITERIA-FOR-USE CHANGES IV promethazine is associated with It is preferred in patients who have significant adverse effects. The Institute ® nausea, vomiting, or esophageal ob- Acetaminophen IV (Ofirmev )‡ (continued on page 6) struction. This also applies to patients ‡Neutropenic fever when the oral route is unavailable that are unconscious or uncooperative. ◆ Children are frequently administered INSIDE THIS ISSUE drugs rectally, especially when the oral liquid formulation tastes unpleasant. ◆ Restricted Distribution Systems (continued on next page) Seizures are an emergent situation Formulary update, from page 1 Carfilzomib is a potent, selective, and Crofelemer is an antidiarrheal with a irreversible proteasome inhibitor with labeled indication for the symptomatic Ado-trastuzumab (Kadcyla®)† antiproliferative and proapoptotic relief of non-infectious diarrhea in †Added in the Chemotherapy Policy activity in multiple myeloma. The drug adults with HIV/AIDS on anti-retrovi- received its indication in relapsed or ral therapy. The proposed mechanism Methadone (Generic)§ refractory myeloma based on a phase II of action is local in the gut by decreas- §Restrictions modified single agent trial of 266 patients with ing gastrointestinal fluid accumula- progressive myeloma. All patients were tion. By inhibiting the secretion of Phosphate IV (Generic)§ responsive to at least 1 prior regimen chloride ions via the cystic fibrosis §Restricted and refractory to their most recent transmembrane regulator chloride therapy; all patients must have also Amyl nitrite is a rapidly acting channels and the calcium activated received greater than or equal to 2 prior vasodilator administered by inhala- chloride channels of the luminal regimens for relapsed disease. Overall tion. A nonspecific smooth muscle membrane of intestinal cells fluid response rate was 23.7% with a median relaxant, it is used for its prominent secretion is decreased. response duration of 7.8 months. Median effect on vascular smooth muscle. Diarrhea is experienced by many overall survival was 15.6 months. The primary user of amyl nitrite has HIV/AIDS patients and is a common Carfilzomib is administered intrave- been the Echocardiography Lab, reason why patients discontinue or nously over 2 to 10 minutes on 2 which has been notified that this switch their antiretroviral therapies. consecutive days each week for 3 weeks product is no longer available. Amyl Patients take crofelemer 2 times a day (days 1, 2, 8, 9, 15, 16). This is followed nitrite has been used in echocardiog- to manage watery diarrhea due to the by a 12-day rest period (days 17-28); raphy to measure provocable left secretion of electrolytes and water in each 28-day period is 1 treatment cycle. ventricular outflow obstruction. the gastrointestinal tract. During cycle 1, carfilzomib is adminis- The safety of crofelemer was Amyl nitrate is very flammable, tered at a dose of 20 mg/m2. If tolerated, which requires special storage. established in placebo-controlled trials the dose is escalated to 27 mg/m2 in involving 696 patients. There were 374 Diversion is also an issue because cycle 2 and continued at 27 mg/m2 in amyl nitrite can be used to cause HIV-positive patients on stable subsequent cycles. Carfilzomib treatment antiretroviral therapy with a history of euphoria (ie, “poppers”). Amyl nitrite may be continued until disease progres- has been used with drugs of abuse. diarrhea lasting 1 month or longer sion or until unacceptable toxicity. enrolled in the ADVENT efficacy trial. It has also been used as an antidote There are no contraindications or for cyanide poisoning. It was a The baseline median number of boxed warnings for carfilzomib. The watery bowel movements was 2.5 per component of the Cyanide Antidote most common adverse reactions noted Kit, which was deleted from the day. Patients who had diarrhea caused in clinical trials were fatigue, anemia, by an infection or a gastrointestinal Formulary in 2007. It induces nausea, thrombocytopenia, dyspnea, methemoglobinemia, which can disease were excluded from participat- diarrhea, and pyrexia. There are ing in the trials. The trial was de- sequester cyanide. Hydroxocobalamin warnings for cardiac arrest, congestive (Cyanokit®) is listed in the Formulary signed to measure clinical response, heart failure, myocardial ischemia, defined as the number of patients who for cyanide poisonings. pulmonary complications, infusion The only supplier of amyl nitrite had 2 or fewer watery bowel move- reactions, tumor lysis syndrome, ments weekly. Results showed that ampules for inhalation has discontin- thrombocytopenia, and hepatic toxicity ued making this product, so it was 17.6% of patients taking crofelemer and failure. experienced clinical response com- deleted from the Formulary and is not Carfilzomib costs approximately available for nonformulary use. pared with 8% taking placebo. In some $10,000 for the first cycle. patients, a persistent antidiarrheal Sildenafil is a phosphodiesterase Carfilzomib was designated nonformu- inhibitor that was first approved in effect was seen for 20 weeks. No dose lary and not available for inpatient
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