Home' Australian Pharmacist : Australian Pharmacist March 2014 Contents 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 two 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 m
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, an
crushed, cut, or chewed.PRESENTATION:KOMBIGLYZEXR 5 mg/500 mg(light brown), 5 mg/1000mg(pink)are available in blister packs of 7 and 28 tablets, KOMBIGLYZ
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. KOMBIGLY ZE® XR Approved Product Information. 2. Hutchins V et al. Current Medical Research & Opinion 2011; 27( 6 ):1157--116 8.
DPP4i = Dipeptidyl peptidase-4 inhibitor.
KOMBIGLY ZE ® XR is a registered trademark of Bristol-Myers Squibb. Bristol-Myers Squibb Australia Pty Ltd. ABN 33 004 333 322. 4 Nexus Court,
Mulgrave, VIC 3170. Medical Information: 1800 805 342. AstraZeneca Pty Ltd. ABN 54 009 682 311. 5 Alma Road, North Ryde, NSW 2113.
AU-KXR000006a. Date of preparation: March 2014. 11657-AP.
n therapy start with
Before prescribing please review full Product Information available on request from AstraZeneca at www.astrazeneca.com.au/PI
PBS Information: Authority Required (STREAMLINED).
Type 2 diabetes.
Refer to PBS Schedule for full Authority Required Information.
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.
Convenience & simplicity of a once-daily treatment
regimen for patients with type 2 diabetes1
Fewer tablets for patients (vs DPP4i and metformin XR
separately) may offer potential to improve compliance
and reduce cost to patients1,2
NEW PBS LISTING: Kombiglyze XR will be reimbursed for
patients with HbA1c >7% currently treated with metformin.
There is no requirement of contraindication or intolerance
to metformin and sulfonylurea.
NEW PBS LISTING -- unlocking the convenience
of the first once-daily, fixed-dose combination
of DPP4i (saxagliptin) and metformin XR1
PBS Listed - Streamlined Authority Code 4423
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