"The U.S. Food and Drug Administration today approved Farxiga (dapaglifozin) tablets to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
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KOMBIGLYZE XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate. [See Clinical Studies.]
Limitations of Use
KOMBIGLYZE XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using KOMBIGLYZE XR. [See WARNINGS AND PRECAUTIONS.]
DOSAGE AND ADMINISTRATION
The dosage of KOMBIGLYZE XR should be individualized on the basis of the patient's current regimen, effectiveness, and tolerability. KOMBIGLYZE XR should generally be administered once daily with the evening meal, with gradual dose titration to reduce the gastrointestinal side effects associated with metformin. The following dosage forms are available:
- KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) tablets 5 mg/500 mg
- KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) tablets 5 mg/1000 mg
- KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) tablets 2.5 mg/1000 mg
The recommended starting dose of KOMBIGLYZE XR in patients who need 5 mg of saxagliptin and who are not currently treated with metformin is 5 mg saxagliptin/500 mg metformin extended-release once daily with gradual dose escalation to reduce the gastrointestinal side effects due to metformin.
In patients treated with metformin, the dosage of KOMBIGLYZE XR should provide metformin at the dose already being taken, or the nearest therapeutically appropriate dose. Following a switch from metformin immediate-release to metformin extended-release, glycemic control should be closely monitored and dosage adjustments made accordingly.
Patients who need 2.5 mg saxagliptin in combination with metformin extended-release may be treated with KOMBIGLYZE XR 2.5 mg/1000 mg. Patients who need 2.5 mg saxagliptin who are either metformin naive or who require a dose of metformin higher than 1000 mg should use the individual components.
The maximum daily recommended dosage is 5 mg for saxagliptin and 2000 mg for metformin extended-release.
No studies have been performed specifically examining the safety and efficacy of KOMBIGLYZE XR in patients previously treated with other antihyperglycemic medications and switched to KOMBIGLYZE XR. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.
Inform patients that KOMBIGLYZE XR tablets must be swallowed whole and never crushed, cut, or chewed. Occasionally, the inactive ingredients of KOMBIGLYZE XR will be eliminated in the feces as a soft, hydrated mass that may resemble the original tablet.
Dosage Adjustments with Concomitant Use of Strong CYP3A4/5 Inhibitors
The maximum recommended dosage of saxagliptin is 2.5 mg once daily when coadministered with strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitors (e.g., ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin). For these patients, limit the KOMBIGLYZE XR dosage to 2.5 mg/1000 mg once daily. [See DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY.]
Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin
When KOMBIGLYZE XR is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dosage of the insulin secretagogue or insulin may be required to minimize the risk of hypoglycemia. [See WARNINGS AND PRECAUTIONS.]
Dosage Forms And Strengths
- KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) 5 mg/500 mg tablets are light brown to brown, biconvex, capsule-shaped, film-coated tablets with “5/500” printed on one side and “4221” printed on the reverse side, in blue ink.
- KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) 5 mg/1000 mg tablets are pink, biconvex, capsule-shaped, film-coated tablets with “5/1000” printed on one side and “4223” printed on the reverse side, in blue ink.
- KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) 2.5 mg/1000 mg tablets are pale yellow to light yellow, biconvex, capsule-shaped, film-coated tablets with “2.5/1000” printed on one side and “4222” printed on the reverse side, in blue ink.
KOMBIGLYZE™ XR (saxagliptin and metformin HCl extended-release) tablets have markings on both sides and are available in the strengths and packages listed in Table 12.
Table 12: KOMBIGLYZE XR
|Tablet Strength (saxagliptin and metformin HCl extended-release)||Film-Coated Tablet Color/Shape||Tablet Markings||Package Size||NDC Code|
|5 mg/500 mg||light brown to brown, biconvex, capsule-shaped||“5/500” on one side and “4221” on the reverse, in blue ink||Bottles of 30||0003-4221-11|
|5 mg/1000 mg||pink, biconvex, capsule-shaped||“5/1000” on one side and “4223” on the reverse, in blue ink||Bottles of 30||0003-4223-11|
|Bottles of 90||0003-4223-21|
|Bottles of 500||0003-4223-31|
|2.5 mg/1000 mg||pale yellow to light yellow, biconvex, capsule-shaped||“2.5/1000” on one side and “4222” on the reverse, in blue ink||Bottles of 60||0003-4222-16|
|Bottles of 500||0003-4222-31|
Storage and Handling
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
Manufactured by: Bristol-Myers Squibb Company Princeton, NJ 08543 USA. Marketed by: Bristol-Myers Squibb Company Princeton, NJ 08543 and AstraZeneca Pharmaceuticals LP Wilmington, DE 19850. Rev May 2013
Last reviewed on RxList: 6/17/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Kombiglyze XR Information
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