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For patients with T2D on metformin with HbA1c > 7% #1
#
The general target is ≤7% 2
PBS Information: Nesina — Authority required for dual therapy. STREAMLINED: 4349.
Nesina Met — Authority required STREAMLINED: 4423/4427.
Refer to PBS schedule for full information.
Life-threatening lactic acidosis can occur due to accumulation of metformin. Risk factors include renal impairment,
old age and the use of high doses of metformin above 2000 mg per day.
Please review Product Information before prescribing. To access a copy of the Product Information please go to www.servier.com.au/PI
or telephone [phone].
Minimum Product Information — Nesina 25MG, 12.5MG, 6.25MG (alogliptin benzoate) / Nesina Met 12.5MG/500MG, 12.5MG/850MG, 12.5MG/1000MG (alogliptin benzoate/metformin hydrochloride) Pharmacology: Nesina: Alogliptin is a
competitive inhibitor of dipeptidyl peptidase 4 (DPP-4), an enzyme that rapidly degrades incretin hormones. Nesina Met: 2 oral antihyperglycaemic drugs used in the management of T2D. Alogliptin, is a DPP-4 inhibitor, and metformin hydrochloride, is
a member of the biguanide class. Indications: Nesina: To improve glycaemic control in patients ≥18 years old with T2D when diet and exercise do not provide adequate glycaemic control, as add on to metformin, a sulphonylurea, a thiazolidinedione
(TZD), insulin (with or without metformin), or in combination with metformin and a TZD when dual therapy does not provide adequate glycaemic control. Nesina Met: To improve glycaemic control in patients ≥18 years old with T2D when diet and
exercise do not provide adequate glycaemic control and treatment with both alogliptin and metformin is appropriate: when treatment with metformin alone does not provide adequate control; or in combination with a TZD or with insulin, when dual
therapy does not provide adequate control. Can be used to replace separate tablets of alogliptin and metformin in patients already being treated with this combination. Contraindications: Nesina: Hypersensitivity to any components of Nesina.
Nesina Met: Renal disease or dysfunction (serum creatinine levels ≥135 μmol/L for men, ≥110 μmol/L for women or creatinine clearance <60mL/min); acute or chronic metabolic acidosis, including diabetic ketoacidosis, diabetic coma or pre-coma;
hypersensitivity to any components of Nesina Met; temporarily discontinue in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials. Precautions: Nesina & Nesina Met: Should not be used in
type 1 diabetes; hypoglycaemia in combination with metformin and TZD, insulin or insulin secretagogues; hepatic effects; acute pancreatitis (discontinue Nesina/Nesina Met); serious hypersensitivity reactions incl Stevens-Johnson syndrome and
angioedema (discontinue Nesina/Nesina Met); effect on fertility has not been studied; lactation not studied in humans. Nesina: Should not be used for the treatment of diabetic ketoacidosis; renal impairment (assess renal function prior to initiation and
periodically thereafter); severe hepatic impairment; cardiac failure NYHA class IV; pregnancy (Cat B3). Nesina Met: lactic acidosis; monitor renal function; medications that may affect renal function or metformin disposition; iodinated contrast agents
— see contraindications; hypoxic states; impaired hepatic function; alcohol; surgery; vitamin B12 levels; safety/efficacy not established when used as dual therapy with sulphonylureas; change in clinical status of patients previously controlled; pregnancy
(Cat C). Interactions: Nesina & Nesina Met: No clinically significant interactions were observed with CYP-substrates or inhibitors, or with renally excreted drugs. Nesina Met: nifedipine, glimepiride, cationic drugs, drugs that induce hyperglycaemia.
Adverse Reactions: Nesina & Nesina Met: upper respiratory tract infection, nasopharyngitis, headache, abdominal pain, gastroesophageal reflux disease, pruritis, rash. Nesina Met: metallic taste, diarrhoea, loss of appetite, nausea, vomiting. Dosage
and Administration: Nesina: 25mg taken orally once daily with or without food. Swallow tablets whole with water. When combined, maintain dose of metformin or TZD. Consider lower dose of insulin to reduce risk of hypoglycaemia. The safety and
efficacy of Nesina when used as triple therapy with metformin and a sulphonylurea have not been fully established. No dose adjustment in mild renal impairment or mild to moderate hepatic impairment. Nesina 12.5mg for patients with moderate renal
impairment. Nesina 6.25mg for patients with severe renal impairment. No dose adjustment based on age. Nesina Met: Taken orally twice daily with food with gradual dose escalation to reduce metformin GI side effects. Swallow tablets whole with water.
Individualise starting dose based on the patient’s current regimen. Maximum daily dose of 25mg alogliptin and 2000mg metformin. Consider lower dose of insulin to reduce the risk of hypoglycaemia. No dose adjustment in mild renal impairment. Should
not be used in hepatic impairment or moderate to severe renal impairment. No dose adjustment based on age. Not indicated for initial combination therapy. Overdosage: consult Approved PI Date of most recent amendment to Nesina/ Nesina
Met Approved Product Information: 6 April 2017 Sponsor: Takeda Pharmaceuticals Aust Pty Ltd. Level 5, 2 Chifley Square, Sydney NSW 2000 Distributor: Servier Laboratories (Aust.) Pty Ltd. 8 Cato Street,
Hawthorn VIC 3122. SER2403. Material prepared: December 2017.
References: 1. Nesina Met ® Product Information. 2. RACGP/Diabetes Australia. General practice management of T2D 2016-18.
For more information or to report an adverse event contact Medical Information on 1800 153 590.