New Drug Update 2009-2010 - LAFP

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Gardasil should be administered IM in the deltoid region of the upper arm or in the higher anterolateral area of the thigh. (Subcutaneous and interdermal administration have not been studied and are not recommended). No reconstitution or dilution is necessary. Keep refrigerated between 2-8 degrees C or 36-46 degrees F. Shake well before use to maintain suspension of the vaccine. Available in both a single dose vial and a single dose pre-filled syringe. Cost is about $120.00 per dose of $360.00 for the 3 dose series. Summary: This is the first FDA approved vaccine that has the potential to significantly reduce the risk of the second leading cancer in women (cervical cancer) and the leading cause of sexually transmitted disease. While it is not a means to reduce recommended monitoring or screening for cervical cancer and it is not a reason to neglect the need for safe sexual practices it is a major therapeutic breakthrough that should be of significant public health benefit worldwide. The Advisory Committee on Immunization Practices (ACIP) (Minimum age: 9 years) • Administer the first dose of the HPV vaccine series to females at age 11–12 years. • Administer the second dose 2 months after the first dose and the third dose 6 months after the first dose. • Administer the HPV vaccine series to females at age 13–18 years if not previously vaccinated. HPV vaccination is recommended for all females aged
SAXAGLIPTIN - Onglyza (Bristol-Myers Squibb / Astra Zeneca) 1S INDICATIONS: Saxagliptin is indicated for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It has been evaluated for use as monotherapy or in combination with other antidiabetic agents, including metformin, sulfonylureas, and thiazolidinediones. It has not been assessed in combination with insulin. Saxagliptin and sitagliptin share the same Food and <strong>Drug</strong> Administration (FDA)-approved indication. CLINICAL PHARMACOLOGY: Saxagliptin is a reversible, competitive dipeptidyl peptidase-4 (DPP-4) inhibitor. DPP-4 inhibitors lower blood glucose by preventing the breakdown of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), thus prolonging the activity of these peptides. Saxagliptin is 10-fold more potent than sitagliptin and vildagliptin at inhibiting DPP-4. The saxagliptin active metabolite is 2-fold less potent than saxagliptin. Both saxagliptin and its active metabolite are more selective for inhibition of DPP-4 than DPP-8 (400- and 950-fold) and DPP-9 (75- and 160-fold). Saxagliptin and its active metabolite have exhibited slow dissociation from DPP-4, with a halflife of dissociation of 50 and 23 minutes, respectively. Plasma DPP-4 inhibition 24 hours after saxagliptin 2.5 and 400 mg doses was 50% and 79% of predose, respectively. Maximal inhibition was observed at a 150 mg dose. After an oral glucose load or meal, saxagliptin DPP-4 inhibition results in a 2- to 3-fold increase in circulating levels of active GLP-1 and GIP, decreased glucagon concentration, and increased insulin secretion from pancreatic beta-cells. PHARMACOKINETICS: Saxagliptin has high oral bioavailability (75% in animal models). Systemic exposure is dose-proportional over doses from 2.5 to 400 mg. Peak concentrations (C max ) of saxagliptin are reached within 2 hours of oral administration; C max of the active metabolite are reached within 4 hours. Administration with a high-fat meal slightly delayed absorption (approximately 20 minutes), but was associated with a 27% increase in overall exposure. Saxagliptin is metabolized via CYP 3A4/5. Mean saxagliptin half-life is 2.2 to 3.8 hours; the half-life of the active metabolite is 3 to 7.4 hours. 6 Approximately 70% of the dose is recovered in the urine as saxagliptin or the active metabolite; 12% to 29% was recovered as the parent drug. Saxagliptin pharmacokinetics did not differ by gender, although levels of the active metabolite were increased approximately 25% in females. Saxagliptin C max were increased 1.2-fold and area under the curve (AUC) values were increased 1.6-fold in elderly subjects compared with younger subjects. Elderly subjects had a greater volume of distribution and reduced metabolic and renal clearance of saxagliptin. Age-related decline in renal function accounted for 50% of the difference in pharmacokinetics. Dosage adjustments on the basis of age are not necessary. In patients with hepatic function impairment (Child-Pugh class A, B, or C), a trend toward increased saxagliptin levels (AUC increased 10% to 77%) and reduced levels of the active metabolite (AUC reduced by 7% to 33%) were observed; however, routine dosage adjustments do not appear necessary. In patients with mild renal impairment, the AUC of saxagliptin and its active metabolite were 20% and 70%, higher, respectively, than those in patients with healthy renal function. In patients with moderate to severe renal impairment, AUC levels of saxagliptin and its active metabolite were up to 2.1- and 4.5-fold higher than in patients with healthy renal function. Dose restrictions are advised for patients with moderate and severe renal impairment and patients with end-stage renal disease requiring hemodialysis. 23
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Page 13 and 14: trivalent influenza vaccine (Fluzon
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Page 17 and 18: June 13, 2010 Modest lung-cancer si
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Percentage rating study drug “goo
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Acute intoxication Warnings and Pre
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DOSING: Tapentadol may be taken ora
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In elderly patients with psychosis
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Investigations Weight increased
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Table 2. Pharmacokinetics of the Be
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haloperidol (P = 0.006). No differe
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Priapism X X X X Cognitive and moto
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Flatulence 1.9% 1.3% 1.6% 5.1% 2.3%
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adjustment in hepatic impairment re
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dosing, inhibition of platelet aggr
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thrombocytopenic purpura has been r
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“Despite the thumbs-up, the panel
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dronedarone and its N-debutyl metab
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ANDROMEDA Study (Increased Mortalit
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In clinical trials, patients treate
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Dronedarone was developed to lack a
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BENZYL ALCOHOL 5% LOTION - Ulesfia
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Table 2. Contraindications, Warning
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pediculocides, to improve outcomes.
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adolescents (ages 13-17), respectiv
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with TS+ADHD, aged 8 to 16 years. T
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HOW SUPPLIED/COST/STORAGE AND HANDL
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Pitavastatin - Livalo by Kowa and L
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Sipuleucel - T - Provenge by Dendre
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Women who are not pregnant and use
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Ketorolac tromethamine Nasal Spray-
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DENOSUMAB - Prolia by Amgen INDICAT
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71% for the pooled denosumab groups
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The most frequently observed advers
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New Drug Update 2009-2010 - LAFP

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