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Actos (pioglitazone)

BOXED WARNING

Thiazolidinediones cause or exacerbate congestive heart failure (CHF) in some patients. After initiation and dose increases, monitor carefully for signs and symptoms of heart failure (HF) and manage accordingly; consider discontinuation or dose reduction. Not recommended in patients with symptomatic HF. Contraindicated with established NYHA Class III or IV HF.

THERAPEUTIC CLASS

Thiazolidinedione (glitazone)

DEA CLASS

RX

INDICATIONS

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (DM).

ADULT DOSAGE

Type 2 Diabetes Mellitus

W/O CHF:
Initial: 15mg or 30mg qd
Titrate: In increments of 15mg
Max: 45mg qd

W/ CHF (NYHA Class I or II):
Initial: 15mg qd
Titrate: In increments of 15mg
Max: 45mg qd

DOSING CONSIDERATIONS

Concomitant Medications
Insulin Secretagogue:
Reduce dose of insulin secretagogue if hypoglycemia occurs

Insulin:

Decrease insulin dose by 10-25% if hypoglycemia occurs

Gemfibrozil/Other Strong CYP2C8 Inhibitors:
Max: 15mg qd

ADMINISTRATION

Oral route

Take w/o regard to meals

HOW SUPPLIED

Tab: 15mg, 30mg, 45mg

CONTRAINDICATIONS

Established NYHA Class III or IV HF.

WARNINGS/PRECAUTIONS

Not for use in treatment of type 1 DM or diabetic ketoacidosis. Fatal and nonfatal hepatic failure reported. May use with caution in patients with lesser ALT elevations or bilirubin and with an alternate probable cause. Obtain LFTs prior to initiation; caution with liver disease/abnormal LFTs. D/C if ALT >3X ULN; do not restart if cause of abnormal LFTs not established or if ALT remains >3X ULN with total bilirubin >2X ULN without alternative etiologies. Not for use in patients with active bladder cancer; consider benefits versus risks in patients with a prior history of bladder cancer. New onset or worsening of edema reported; caution in patients with edema and in patients at risk for CHF. Increased incidence of bone fractures reported in females. Macular edema reported; refer to an ophthalmologist if visual symptoms develop. Ovulation in premenopausal anovulatory patients may occur; use adequate contraception.

ADVERSE REACTIONS

CHF, URTI, hypoglycemia, edema, headache, cardiac failure, pain in extremity, sinusitis, back pain, myalgia, pharyngitis, chest pain.

DRUG INTERACTIONS

Increased exposure and T1/2 with CYP2C8 inhibitors (eg, gemfibrozil). Decreased exposure with CYP2C8 inducers (eg, rifampin). Risk of fluid retention and hypoglycemia with insulin and other antidiabetic medications (eg, insulin secretagogues such as sulfonylureas).

PREGNANCY AND LACTATION

Category C, not for use in nursing.

MECHANISM OF ACTION

Thiazolidinedione; decreases insulin resistance in the periphery and liver, resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output.

PHARMACOKINETICS

Absorption: Tmax=Within 2 hrs, 3-4 hrs (with food). Distribution: Vd=0.63L/kg; plasma protein binding (>99%). Metabolism: Hydroxylation and oxidation (extensive), CYP2C8, CYP3A4; M-III [keto derivative] and M-IV [hydroxyl derivative] (active metabolites). Elimination: Urine (15-30%), bile and feces; T1/2=3-7 hrs (pioglitazone), 16-24 hrs (metabolites).

ASSESSMENT

Assess for previous hypersensitivity, HF, edema, risk factors for developing HF, liver disease, bone health, active/history of bladder cancer, pregnancy/nursing status, and possible drug interactions. Obtain baseline LFTs.

MONITORING

Monitor for signs and symptoms of HF, edema, weight gain, hematological changes (eg, decreases in Hgb, Hct), liver injury, macular edema, bone fractures, ovulation in premenopausal anovulatory women, and other adverse reactions. Perform periodic measurements of FPG and HbA1c. Periodically monitor LFTs in patients with liver disease. Perform periodic eye exams.

PATIENT COUNSELING

Advise to adhere to dietary instructions and have blood glucose and glycosylated Hgb levels tested regularly. Instruct to seek medical advice promptly during periods of stress and report rapid increase in weight or edema, SOB, or other symptoms of HF to physician. Instruct to d/c and consult physician if unexplained N/V, abdominal pain, anorexia, fatigue, or dark urine occurs. Advise to report any signs of macroscopic hematuria or other symptoms such as dysuria or urinary urgency. Advise to take qd with or without meals. If dose is missed, advise to not double the dose the following day. Inform about the risk of hypoglycemia when using with insulin or other antidiabetic medications. Inform that therapy may result in ovulation in some premenopausal anovulatory women; recommend adequate contraception for all premenopausal women.

STORAGE

25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from light, moisture, and humidity.

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