Home' Australian Pharmacist : Australian Pharmacist June 2014 Contents Before prescribing please review full Product Information available on request
from AstraZeneca at www.astrazeneca.com.au/PI
WARNING: Life-threatening lactic acidosis can occur due to accumulation of metformin. The main risk factor is renal impairment,
other risk factors include old age associated with reduced renal function and high doses of metformin above 2 g per day.
PBS Information: Authority Required (STREAMLINED). Type 2 diabetes. Refer to PBS Schedule for full Authority Required Information.
PBS Listed - Streamlined Authority Code 4423. No need to show intolerance/contraindication for metformin + sulfonylurea.
KOMBIGLYZE® XR (saxagliptin/metformin hydrochloride extended release). INDICATIONS: As an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when
treatment with both saxagliptin and metformin is appropriate. CONTRAINDICATIONS: A history of a serious hypersensitivity reaction to any DPP-4 inhibitor. Hypersensitivity to the active substances or to any of
the excipients of Kombiglyze XR; diabetic ketoacidosis, diabetic pre-coma; moderate or severe renal impairment (creatinine clearance < 60 ml/min); acute conditions with the potential to alter renal function; acute
or chronic disease which may cause tissue hypoxia; during or immediately following surgery where insulin is essential, elective major surgery; hepatic impairment; acute alcohol intoxication, alcoholism; lactation.
PRECAUTIONS: Not for Type 1 Diabetes or diabetic ketoacidosis. Has not been studied in combination with GLP-1 agonists. Lactic acidosis; serious hypersensitivity reactions; acute pancreatitis (discontinue
treatment with Kombiglyze XR); renal impairment - assessment of renal function is recommended prior to initiation and periodically thereafter (discontinue treatment if evidence of renal impairment is present);
change in clinical status in previously well controlled patient; impaired hepatic function; administration of iodinated contrast agent; hypoxic states; surgery; vitamin B12 levels; alcohol intake; pregnancy (category C);
lactation; use in elderly; not for use in children (see full PI). INTERACTIONS: Saxagliptin: No clinically significant interactions observed with metformin, glibenclamide, pioglitazone, digoxin, simvastatin, diltiazem,
ketoconazole, rifampicin, omeprazole, aluminium hydroxide + magnesium hydroxide + simethicone, famotidine, or an estrogen/progestin oral contraceptive (see full PI). Metformin: Careful patient monitoring and
dose adjustment of metformin and/or the interfering drug is recommended in patients who are taking cationic medications (eg. amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, cimetidine,
triamterene, trimethoprim, or vancomycin) that are excreted via the proximal renal tubular secretory system (see full PI). ADVERSE REACTIONS: Common (≥5%): Upper respiratory tract infection, urinary tract
infection, nasopharyngitis, diarrhea, headache; hypoglycemia; mild gastrointestinal symptoms; others see full PI. Post marketing experience: Acute pancreatitis and hypersensitivity reactions with saxagliptin.
DOSAGE AND ADMINISTRATION: One tablet (5 mg/500 mg or 5 mg/1000 mg) or t wo tablets 2.5 mg/1000 mg once daily with the evening meal with gradual dose titration to reduce gastrointestinal side
effects associated with metformin. For initial combination therapy start with one tablet 5 mg/500 mg once daily. Patients with inadequate glycemic control on this starting dose should
further have their metformin dose increased to one tablet 5 mg/1000 mg or two tablets 2.5 mg/1000 mg once daily. The maximum dose is 5 mg/2000 mg taken as two
2.5 mg/1000 mg tablets once daily. Tablet must be swallowed whole, and never crushed, cut, or chewed. PRESENTATION: KOMBIGLYZE XR 5 mg/500 mg (light brown),
5 mg/1000 mg (pink) are available in blister packs of 7 and 28 tablets, KOMBIGLYZE XR 2.5 mg/1000 mg (light yellow) are available in blister packs of 14 and 56 tablets.
DATE OF APPROVAL: 10 October 2013.
References: 1. KOMBIGLYZE® XR Approved Product Information. 2 . DeFronzo RA et al. Diabetes Care 2009;32:1649–1655. 3. DeFronzo RA et al.
Diabetes Care 2009;58:A147, Abstract 547-P. 4. Fujioka K et al. Clinical Therapeutics 2003; 25(2):515–529.
KOMBIGLYZE® XR is a registered trademark of Bristol-Myers Squibb. Bristol-Myers Squibb Australia Pty Ltd. ABN 33 004 333 322. 4 Nexu s Cour t,
Mulgrave, VIC 3170. AstraZeneca Pty Ltd. ABN 54 009 682 311. 5 Alma Road, North Ryde, NSW 2113. Medical Information: 1800 805 342.
AU-KXR000028c. Date of preparation: May 2014. 11854-AP.
The simplicity of a once-daily treatment regimen1
Sustained HbA1c lowering over 2 years
in type 2 diabetes patients not adequately
controlled on metformin alone1–3 *
*Saxagliptin 5mg and metformin IR administered as
separate components. †Comparable glycaemic control
has been demonstrated between metformin IR and
Bioequivalence of Kombiglyze
coadministered saxagliptin and metformin XR tablets
has been demonstrated.
in treating type 2 diabetes
11854- AP - 1 2014- 05- 19T12: 11: 50+10: 00
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