After consultation with a healthcare professional who has considered and advised the patient of the risks and benefits of AVANDIA®, this drug is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who either are:

• already taking AVANDIA, or
• not already taking AVANDIA and are unable to achieve adequate glycemic control on other diabetes medications and, in consultation with their healthcare provider, have decided not to take pioglitazone (ACTOS®) for medical reasons.

Other Important Limitations of Use

• Due to its mechanism of action, AVANDIA is active only in the presence of endogenous insulin. Therefore, AVANDIA should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
• The coadministration of AVANDIA and insulin is not recommended [see WARNINGS AND PRECAUTIONS.].

Prior to prescribing AVANDIA, refer to INDICATIONS for appropriate patient selection. Only prescribers enrolled in the AVANDIA-Rosiglitazone Medicines Access Program can prescribe AVANDIA [see WARNINGS AND PRECAUTIONS.].

AVANDIA may be administered at a starting dose of 4 mg either as a single daily dose or in 2 divided doses. For patients who respond inadequately following 8 to 12 weeks of treatment, as determined by reduction in fasting plasma glucose (FPG), the dose may be increased to 8 mg daily. Increases in the dose of AVANDIA should be accompanied by careful monitoring for adverse events related to fluid retention [see BOXED WARNING and WARNINGS AND PRECAUTIONS.]. AVANDIA may be taken with or without food.

The total daily dose of AVANDIA should not exceed 8 mg.

Patients receiving AVANDIA in combination with other hypoglycemic agents may be at risk for hypoglycemia, and a reduction in the dose of the concomitant agent may be necessary.

Specific Patient Populations

Renal Impairment: No dosage adjustment is necessary when AVANDIA is used as monotherapy in patients with renal impairment. Since metformin is contraindicated in such patients, concomitant administration of metformin and AVANDIA is also contraindicated in patients with renal impairment.

Hepatic Impairment: Liver enzymes should be measured prior to initiating treatment with AVANDIA. Therapy with AVANDIA should not be initiated if the patient exhibits clinical evidence of active liver disease or increased serum transaminase levels (ALT > 2.5X upper limit of normal at start of therapy). After initiation of AVANDIA, liver enzymes should be monitored periodically per the clinical judgment of the healthcare professional. [See WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY.]

Pediatric: Data are insufficient to recommend pediatric use of AVANDIA [see Use In Specific Populations].

Dosage Forms and Strengths

Pentagonal film-coated TILTAB® tablet contains rosiglitazone as the maleate as follows:

• 2 mg - pink, debossed with SB on one side and 2 on the other
• 4 mg - orange, debossed with SB on one side and 4 on the other
• 8 mg - red-brown, debossed with SB on one side and 8 on the other

Each pentagonal film-coated TILTAB tablet contains rosiglitazone as the maleate as follows: 2 mg-pink, debossed with SB on one side and 2 on the other; 4 mg-orange, debossed with SB on one side and 4 on the other; 8 mg-red-brown, debossed with SB on one side and 8 on the other.

2 mg bottles of 60: NDC 0173-0834-18
4 mg bottles of 30: NDC 0173-0835-13
8 mg bottles of 30: NDC 0173-0836-13

Store at 25°C (77°F); excursions 15° to 30°C (59° to 86°F). Dispense in a tight, light-resistant container.

Glaxo SmithKline, Research Triangle Park, NC 27709

Last reviewed on RxList: 11/30/2011
This monograph has been modified to include the generic and brand name in many instances.