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Formulary Additions JUNE 2016 FORMULARY ADDITIONS MELOXICAM (MOBIC®) Rationale for Addition: Meloxicam is a once daily NSAID used for the treatment of rheumatoid arthritis and osteoarthritis. Meloxicam will provide another oral NSAID option to Celecoxib for patients who are being discharged home and whose insurance does not cover celecoxib. Adverse Effects: abdominal pain, diarrhea, dyspepsia, flatulence, nausea, edema, influenza-like symptoms, dizziness, headache, rash Contraindications: peri-operative pain in setting of coronary artery bypass graft surgery Drug Interactions: other NSAIDS, antiplatelet agents, calcium polysterene sulfonate, cyclosporine, digoxin, lithium, methotrexate, vancomycin, vitamin K antagonist, corticosteroids Dosage & Administration: meloxicam 7.5 mg PO daily, some patients my experience some benefit by increasing to 15 mg PO daily Renal Impairment: not recommended in patients with renal function ≤ 20 mL/min Dosage Form & Cost: meloxicam 7.5 mg tablet $0.02/day meloxicam 15 mg $0.03/day IVABRADINE (CORLANOR®) *Restrictions*: restricted to cardiology only for initiation of therapy Rationale for Addition: Ivabradine blocks the funny current leading to a reduction in heart rate at the sinoatrial node. Ivabradine is indicated to reduce the risk of hospitalization for worsening heart failure in patients with stable symptomatic chronic heart failure with LVEF ≤ 35% who are in sinus rhythm with resting heart rate (HR) ≥ 70 beats per minute and either on maximally tolerated doses of β-blockers or have a contraindication to β-blockers. Ivabradine has shown to reduce the risk of hospitalization, but not mortality in this specific subset of heart failure patients. Adverse Effects: bradycardia (10%), heart block (sinoatrial arrest), hypertension (9%), atrial fibrillation (8%), phosphenes (visual brightness) (3%) Contraindications: acute decompensated heart failure, blood pressure < 90/50 mmHg, resting HR < 60 bpm prior to initiation, sick sinus syndrome, sinoatrial block, or third-degree AV block (unless a functioning demand pacemaker is present), severe hepatic impairment, pacemaker dependence, concomitant use with strong CYP3A4 inhibitors Drug Interactions: increase risk of bradycardia with negative chronotropes (i.e. digoxin, amiodarone, β-blockers), increase exposure of ivabradine with 3A4 inhibitors thus concomitant use with strong/moderate 3A4 inhibitors (azole antifungals, macrolide antibiotics, protease inhibitors, nefazodone, diltiazem, verapamil, grapefruit juice) and strong inducers (St. John’s Wort, rifampicin, barbituates, phenytoin) is contraindicated Dosage & Administration: Starting dose is 5 mg PO twice daily Starting dose of 2.5 mg PO twice daily in patients with bradycardia that could lead to hemodynamic compromise After 2 weeks adjust dose as needed based on resting heart rate and tolerability as follows: Heart Rate Dose Adjustment Increase dose by 2.5 mg (given twice daily) up to a maximum dose > 60 bpm of 7.5 mg twice daily 50-60 bpm Maintain dose < 50 bpm or signs and Decrease dose by 2.5 mg (given twice daily). If concurrent dose is symptoms of bradycardia 2.5 mg twice daily, discontinue therapy Dosage Form & Cost: ivabradine 5 mg and ivabradine 7.5 mg $5.75/tablet DEXTROMETHORPHAN/QUINIDINE (NUEDEXTA®) Rationale for Addition: Dextromethorphan may relieve agitation in Alzheimer Dementia by binding to sigma-1 receptors in the brain which may be involved with behavior. Quinidine is used to block the rapid metabolism of dextromethorphan, thereby increasing serum concentrations. Current pharmacologic therapies for agitation in patients with dementia involves off-label use of atypical antipsychotics. Adverse Effects (≥ 5% incidence): diarrhea, dizziness, vomiting, neuromuscular and skeletal weakness, cough Contraindications: concomitant medications containing quinidine, quinine, or mefloquine; history of thrombocytopenia, hepatitis, bone marrow depression, or lupus-like syndrome due to quinidine, quinine, or mefloquine; administration of MAO inhibitor within 2 weeks; patient with prolonged QT interval; heart failure, complete AV block without pacemaker Drug Interactions: Dextromethorphan/quinidine may increase levels of: analgesics, antipsychotics, anticholinergics, aripiprazole, calcium channel blockers, cardiac glycosides, QTc prolonging agents Increase levels of dextromethorphan/quinidine: antacids, antiemetics, antifungal agents, calcium channel blockers, CYP2D6 inhibitors, diltiazem, erythromycin, haloperidol, SSRIs, TCA, verapamil Dosage & Administration: dextromethorphan/quinidine 20/10 mg PO daily in the morning for one week. Then increase to twice daily for weeks 2 and 3. Then increase to dextromethorphan/quinidine 30/10 mg PO twice daily for weeks 4 and 5 Dosage Form & Cost: dextromethorphan/quinidine 20/10 mg $10.82/tablet NIVOLUMAB (OPDIVO®) *Restrictions*: restricted to hematology/oncology Rationale for Addition: Nivolumab is a fully human immunoglobulin G4 monoclonal antibody that selectively inhibits programmed cell death-1 (PD-1) activity by binding to the PD-1 receptor to block the ligands PD-L1 and PD- L2 from binding. Nivolumab is indicated for BRAF V600 wild-type unresectable or metastatic melanoma, as a single agent; BRAF V600 mutation-positive unresectable or metastatic melanoma, as a single agent; unresectable or metastatic melanoma, in combination with ipilimumab; metastatic non-small cell lung cancer (NSCLC) and progression on or after platinum-based chemotherapy; and advanced renal cell carcinoma who have received prior anti-angiogenic therapy. Adverse Effects: (differ based on indication) fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, pyrexia, vomiting, dyspnea, decreased appetite, constipation, arthralgia, constipation Dosage & Administration: Indication Dosing of Nivolumab Nivolumab 3 mg/kg every 2 weeks Melanoma, unresectable or metastatic Nivolumab with ipilimumab: nivolumab 1 mg/kg, followed by ipilimumab on the same day every 3 weeks for 4 doses; then nivolumab 3 mg/kg every 2 weeks Metastatic NSCLC Nivolumab 3 mg/kg every 2 weeks Advanced Renal Cell Carcinoma Nivolumab 3 mg/kg every 2 weeks Dosage Form & Cost: 40 mg/4 mL in single-dose vial ($973.59/vial) and 100 mg /10mL in single-dose vial ($2,433.97/vial) DABIGATRAN (PRADAXA®) Rationale for Line Extension: Dabigatran is a competitive, direct thrombin inhibitor. Dabigatran 110 mg is a new strength approved by the FDA and added to formulary. Dabigatran 110 mg is indicated for the use in prophylaxis of deep vein thromboembolism and pulmonary embolism in patients who have undergone hip replacement surgery. Adverse Effects: bleeding (>10%), gastrointestinal symptoms (>10%) Drug Interactions: P-gp inducers Dosage & Administration: dabigatran 110 mg PO first day; then dabigatran 220 mg PO daily for 28 to 35 days Dosage Form & Cost: dabigatran 110 mg tablet $9.58/day RIFAXIMIN (XIFAXAN®) Rationale for Addition: Rifaximin was added to formulary to prevent overt hepatic encephalopathy (HE) recurrence. The literature shows that rifaximin in combination with lactulose decreases mortality compared to lactulose alone in patients with hepatic encephalopathy. Adverse Effects (≥ 5% incidence): nausea, dizziness, fatigue, ascites, peripheral edema, headache, anemia, arthralgia/muscle spasm, pruritus/skin rash, depression, nasopharyngitis/dyspnea/epistaxis Drug Interactions: may increase serum concentration of rifaximin (P-gp/ABCB1 inhibitors) – cyclosporine, ketoconazole, erythromycin/clarithromycin, verapamil, amiodarone Dosage & Administration: rifaximin 550 mg PO twice daily Dosage Form & Cost: rifaximin 550 mg tablets ($36.65/tablet) POLICIES & PROTOCOLS Hospice (in-patient) Admission Order Form (updated) – Standardize across Meridian hospitals and included new titration for morphine and hydromorphone continuous infusions IV Medication Guidelines (updated) – Guidelines expand the utilization of atropine, haloperidol, lorazepam, methadone, and midazolam in non-monitored units for mechanically ventilated and non-ventilated patients admitted to hospice Sotalol Guidelines (new) – Guidelines will serve as a resource to direct appropriate telemetry monitoring of sotalol to prevent QT prolongation that may lead to life threatening arrhythmia (Torsade de Pointes) Automatic Substitution: Advair HFA® to Advair Diskus® (new) – Automatic substitution from Advair HFA MDI® to Advair Diskus® at all sites except Riverview Medical Center. Pediatrics patients will continue to use Advair HFA®. Severe Sepsis/Septic Shock Order Set (updated) – Updated to include a lactate level every four hours after the first level and fluid administration of normal saline 3 liters IV over 1 hour Automatic Substitution: Novolog® to Humalog® (new) – Automatic therapeutic substitution from Novolog® to Humalog® given that both products are therapeutically equal and interchangeable Lantus® Preferred Over Levemir® (new) – Insulin glargine (Lantus®) is the preferred long acting insulin at with insulin detemir (Levemir®) being available when needed Sleep Center Medication Management: Self-Administration Policy (updated) – Policy ensures that patients have a written order from a licensed independent practitioner prior to self-administering their own medications at Meridian Sleep Centers and standardizes that a written order be obtained upon referral prior to arriving at the sleep center Warfarin Use Policy (updated) – Pharmacists may now order an INR when clinically indicated (i.e. baseline INR prior to dispensing warfarin or for patients with an active order
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