alogliptin/pioglitazone (Rx)

Brand and Other Names:Oseni
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

alogliptin/pioglitazone

tablet

  • 12.5mg/15mg
  • 12.5mg/30mg
  • 12.5mg/45mg
  • 25mg/15mg
  • 25mg/30mg
  • 25mg/45mg
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Diabetes Mellitus Type 2

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Starting dose based on patient’s current regimen

Dosage Modifications

Limit initial dose of pioglitazone to 15 mg/day with NYHA Class 1 or II heart failure

Coadministration with strong CYP2C8 inhibitors (eg, gemfibrozil): Do not exceed 15 mg/day pioglitazone

Renal impairment

  • Moderate (CrCl >30 to <60 mL/min): Not to exceed 12.5 mg/day alogliptin
  • Severe (CrCl <30 mL/min or ESRD): Not recommended; coadministration of pioglitazone and alogliptin 6.25 mg qDay may be considered

Dosing Considerations

Assess renal function before initiating alogliptin and periodically thereafter

Safety and efficacy not established

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Interactions

Interaction Checker

and alogliptin/pioglitazone

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    Contraindicated

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            Adverse Effects

            >10% (pioglitazone)

            Worsening CHF (9.9-13.4%)

            Edema when used in combination with sulfonylurea or insulin

            1-10%

            Hypoglycemia (0.8-4.5%)

            Nasopharyngitis (4%)

            Back pain (4.2%)

            Upper respiratory tract infection (4.1%)

            <1% (alogliptin)

            Hypersensitivity (0.6%)

            Pancreatitis (0.2%)

            Postmarketing reports (alogliptin)

            Severe and disabling arthralgia

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            Warnings

            Black Box Warnings

            Thiazolidinediones (eg, pioglitazone) can cause or exacerbate congestive heart failure in some patients

            After initiation and dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain; dyspnea; and/or edema)

            If these signs or symptoms develop, the heart failure should be managed according to the current standards of care

            Discontinuation or dose reduction of thiazolidinedione must be considered

            Thiazolidinediones not recommended with symptomatic heart failure; initiation in patients with established NYHA class III or IV heart failure is contraindicated

            Contraindications

            Hypersensitivity to alogliptin or pioglitazone, including anaphylaxis, angioedema, or severe cutaneous adverse reactions including Stevens-Johnson syndrome

            Do not initiate pioglitazone in patients with NYHA Class III or IV heart failure (see Black Box Warnings)

            Cautions

            Pioglitazone can cause dose-related fluid retention that may lead to or exacerbate CHF (see Black Box Warnings)

            Edema; thiazolidinediones, which are peroxisome proliferator-activated receptor (PPAR) gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin

            Pancreatitis reported

            Caution with sensitivity to another DPP-4 inhibitor; discontinue if serious hypersensitivity reaction suspected (see Contraindications)

            Fatal and nonfatal hepatic failure reported; type 2 DM is also known to cause fatty liver disease and liver enzyme elevation; monitor carefully and interrupt alogliptin/pioglitazone treatment if LFTs elevated, do not restart alogliptin/pioglitazone without another explanation for the liver test abnormalities

            Insulin secretagogues (eg, sulfonylureas) are known to cause hypoglycemia; therefore, a lower dose may be needed to minimize hypoglycemia risk

            Increased fracture risk in females

            Macular edema reported with thiazolidinediones (eg, pioglitazone)

            Pioglitazone may result in ovulation in premenopausal anovulatory women

            Severe and disabling arthralgia reported in patients taking DPP-4 inhibitors; consider as a possible cause for severe joint pain and discontinue drug if appropriate

            Congestive heart failure (CHF) risk

            • Also see Black Box Warnings regarding CHF risk of pioglitazone
            • The EXAMINE (Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care) trial enrolled 5,380 patients with type 2 diabetes and recent acute coronary syndrome
            • Hospitalization for CHF was observed in 106 (3.9%) patients treated with alogliptin and 89 (3.3%) patients treated with placebo; although the difference was not statistically significant (hazard ratio, 1.19), heart failure was not an end point of the study
            • Health care professionals should consider discontinuing medications containing alogliptin in patients who develop heart failure and monitor their diabetes control
            • Lancet. 2015 May 23;385(9982):2067-76

            Cancer risk

            • Bladder cancer
              • Pioglitazone may be linked to an increased risk of bladder cancer
              • Do not prescribe for patients with active bladder cancer
              • Consider benefit:risk ratio before prescribing in patients with a history of bladder cancer
              • Instruct patients to contact their physician if signs of bladder cancer observed after initiating therapy (eg, blood or red colored urine, new or worsening urinary urgency, pain on urination)
            • Prostate cancer
              • 7/22/2015: Compared with nonuse, pioglitazone use was associated with increased risk for prostate cancer (453.3 vs. 449.3 per 100,000 person-years) [JAMA 2015 July 21;314(3):265-277]
            • Pancreatic cancer
              • 7/22/2015: Compared with nonuse, pioglitazone use was associated with increased risk for pancreatic cancer (81.1 vs. 48.4 per 100,000 person-years) [JAMA 2015 July 21;314(3):265-277]
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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Unknown whether distributed in breast milk

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Alogliptin: Selective dipeptidyl peptidase-4 (DPP-4) inhibitor; slows inactivation of incretin hormones (eg, GLP-1, GIP), thereby reducing fasting and postprandial glucose concentrations in a glucose-dependent manner

            Pioglitazone: Thiazolidinedione; improves target cell response to insulin; decreases hepatic gluconeogenesis

            Absorption

            Bioavailability: ~100% (alogliptin)

            Duration: 24 hr (pioglitazone)

            Peak plasma time: 1-2 hr (alogliptin); 2-4 hr (pioglitazone)

            Distribution

            Protein bound: 20% (alogliptin); >99% (pioglitazone)

            Vd: 417 L (alogliptin); 0.63 L/kg (pioglitazone)

            Metabolism

            alogliptin

            • Does not undergo extensive metabolism and 60-71% of the dose is excreted unchanged in the urine
            • Active metabolite: N-demethylated (<1% of parent compound)
            • Inactive metabolite: N-acetylated alogliptin (<6% of parent compound)
            • Minor substrate of CYP3A4 and CYP2D6

            pioglitazone

            • Metabolized to active metabolites by hepatic CYP2C8 and CYP3A4
            • Metabolites: metabolite II (hydroxy derivative), metabolite III (keto derivative), metabolite IV (active hydroxy derivative) (active)

            Elimination

            alogliptin

            • Half-life: 21 hr
            • Renal clearance: 9.6 L/hr
            • Total body clearance: 14 L/hr
            • Excretion: 76% urine; 13% feces

            pioglitazone

            • Half-Life: 3-7 hr
            • Excretion: 15-30% urine
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            Administration

            Instructions

            May take with or without food

            Swallow whole, do not chew, split, or crush

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
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            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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