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INVOKANA PI
MASTERY
FIXED DOSE COMBINATION
METFORMIN BACKGROUNDER
MET & INVOKANA TRIVIA
FUN POTPOURRI
100
The four studies that contribute to the pooled AE data represented in Table #1 of the Invokana PI
What are Studies 3002, 3005, 3006, and 3012?
100
Fixed-dose combination (FDC) products that have a boxed warning in their PI for causing or exacerbating CHF
What are Actoplus Met, Actoplus Met XR, and Avandamet
100
______,the oral solution of Metformin is indicated for use with_______.
What is Riomet; indicated for use in "children 10 to 16 years of age with T2DM"
100
Invokana is mainly metabolized by_____and _____; coadministration of drugs that induce these enzymes affect the body's exposure to Invokana, these inducers include:
What are UGT1A9 and UGT2B4; Rifampin, Phenytoin, Phenobarbital, and Ritonavir
100
INVOKANA has been studied in combination with these classes of drugs.
What are Metformin, Sulfonylureas, TZDs, DPP4s, and Insulin?
200
The indicated use of INVOKANA
What is in Type 2 Diabetes mellitus as an adjunct to diet and exercise to improve glycemic control in adults?
200
AACE Guidelines recommend caution when choosing these oral diabetes therapies.
What are TZD's, Sulfonylureas, and Meglitinides?
200
The incidence of lactic acidosis with Metformin
What is approximately 3 cases per 100,000 patient years and fatal in approximately 50% of cases?
200
In the pool of four placebo-controlled clinical trials, female genital mycotic infections occurred in ____%,____%, and ___% of females treated with placebo, Invokana 100mg, and Invokana 300mg, respectively.
What is 3.2%, 10.4%, and 11.4% of females
200
Which FDC needs to be taken 15-30 minutes before a meal?
What is Prandimet?
300
In Study ____, 714 older patients (ages 55-80yrs) with T2DM that were inadequately controlled on current therapy and achieved A1c reductions of _____and _____with INVOKANA 100mg and 300mg respectively relative to placebo.
What is study 3010 and A1c Reductions of -0.57 and -.70 with INVOKANA 100mg and 300mg respectively were achieved relative to placebo?
300
FDC products with more than 1MM scripts and +2% overall diabetes market share.
What is Glucovance (MET+SU) and Janumet (MET+DPP4)?
300
The usual starting dose of Glucophage in adults and increase regimen...
What is 500mg BID or 850mg QD, with meals. Dosage increases should be made in increments of 500mg weekly or 850mg every 2 weeks, up to 2,000mg/day, given in divided doses. Patients can also be titrated from 500mg twice daily to 850mg twice daily after 2 weeks Max dose= 2,550mg per day
300
Metformin is indicated as an adjunct to diet and exercise to improve glycemic control in__________________________________________________?
What are adults with T2DM. Glucophage and Riomet are also indicated for children aged 10 to 16 years with T2DM.
300
INVOKANA is taken in the morning before the first meal of the day for this reason
What is its potential to reduce postprandial plasma glucose excursions due to delayed intestinal glucose absorption.
400
The most common adverse reactions associated with INVOKANA use (5% or greater incidence) are...
What are Female genital mycotic infections, urinary tract infections, and increased urination
400
These FDC products carry a special safety warning for increased risk of cardiovascular mortality, a class warning for all drugs that contain ______. ______are associated with a risk of hypoglycemia and weight gain.
What is Glucovance, Metaglip, and Sulfonylureas; Sulfonylureas
400
Describe the MOA of Metformin
What is not exactly known. However, it is thought to act primarily by reducing insulin resistance in the liver thereby gluconeogenesis is reduced. Metformin also improves insulin sensitivity by increasing uptake and utilization of glucose in peripheral tissues (muscle and fat cells). Additionally, metformin decreases intestinal absorption of glucose. Collectively, these activities help lower basal and postprandial glucose.
400
Metformin is contraindicated in patients with __________ or ___________,which is suggested by serum creatinine levels of greater than or equal to 1.5 mg/dL in males and greater than or equal to 1.4 mg/dL in females, or by abnormal creatinine clearance. Metformin is also contraindicated in patients with __________, and ______________, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated w/ insulin.
What is renal disease or renal dysfunction, Known sensitivity to metformin hydrochloride, and patients with acute or chronic metabolic acidosis?
400
Top 2 AEs with Metformin (Glucophage & Glucophage XR) are ______ and _____. The side effect resulting in the highest discontinuation with Glucophage is _______.
What are Diarrhea and Nausea/Vomitting. Diarrhea
500
The signs and symptoms related to reduced intravascular volume/volume depletion with INVOKANA
What are Hypotension, Syncope, Orthostatic hypotension, postural dizziness, and dehydration?
500
This class of drugs is associated with low hypoglycemia, moderate A1c reductions, hypersensitivity reactions including urticaria and angioedema, as well as some acute pancreatitis cases, some fatal. Name the drug class, treatments included, and FDC products containing this drug class.
What are DPP4 Inhibitors Januvia (sitagliptin), Onglyza (saxagliptin), Nesina (alogliptin), and Tradjenta (linagliptin) FDC: Janumet, Janumet XR, Jentadueto, Kazano, and Kombiglyze XR
500
Lactic acidosis typically occurs in patients with _____, including both intrinsic renal disease and renal hyperperfusion, often in the setting of multiple medical conditions and/or concomitant medications. Patients with ____, who require medication are also at increased risk.
What are significant renal insufficiency and CHF?
500
Metformin is characterized as an _______ ________. The dose should be individualized to maximize efficacy and tolerance, and started at a low dose and up-titrated to _____________.
What is insulin sensitizer, and to minimize gastrointestinal adverse events and identify the minimum dose required for glycemic control.
500
Reasons that a patient may need to discontinue metformin use.
What are radiologic contrast acutely altering renal function, surgical procedure (48 hrs. prior), and/ or conditions characterized by hypoxemia, such as acute CHF and myocardial infarction, stress such as a fever,infection or other trauma resulting in temporary loss of glycemic control.