TWYNSTA

What it is

TWYNSTA is a fixed-dose combination tablet containing telmisartan (40 mg or 80 mg) and amlodipine as besilate (5 mg or 10 mg) for oral administration. The medicine combines an angiotensin II receptor blocker (telmisartan) and a dihydropyridine calcium channel blocker (amlodipine), which have complementary mechanisms to control blood pressure. The combination of these substances has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.

Approved indications

— Treatment of hypertension.

Dosing overview

TWYNSTA should be taken once daily. Patients receiving telmisartan and amlodipine from separate tablets can instead receive TWYNSTA containing the same component doses in one tablet once daily to enhance convenience or compliance. TWYNSTA may be administered in patients whose blood pressure is not adequately controlled with amlodipine or telmisartan alone, and individual dose titration with the components is recommended before changing to the fixed-dose combination. No dosage adjustment is required for patients with renal impairment, including those on haemodialysis. In patients with mild to moderate hepatic impairment, TWYNSTA should be administered with caution, and for telmisartan the dosage should not exceed 40 mg once daily. No dose adjustment is necessary for elderly patients.

Key safety warnings

There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system. Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting, and such conditions should be corrected before administration of TWYNSTA. As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function (including acute renal failure) have been reported in susceptible individuals; dual blockade of the renin-angiotensin-aldosterone system is not recommended and should be limited to individually defined cases with close monitoring of renal function. Patients receiving the combination of telmisartan and ramipril did not obtain any additional benefit compared to monotherapy but experienced an increased incidence of hyperkalaemia, renal failure, hypotension and syncope, and concomitant use of TWYNSTA and ramipril is therefore not recommended in patients with already controlled blood pressure. Exploratory analyses of telmisartan trials suggested an increased risk of fatal myocardial infarction and unexpected cardiovascular death in patients with diabetes mellitus without documented coronary heart disease, as coronary heart disease may be asymptomatic and blood pressure reduction may further reduce coronary perfusion; patients with diabetes mellitus should undergo specific diagnostics and be treated accordingly before initiating therapy with TWYNSTA. During treatment with medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur, especially in the presence of renal impairment and/or heart failure, and monitoring of serum potassium in patients at risk is recommended.

Contraindications

TWYNSTA is contraindicated in patients with hypersensitivity to the active ingredients or excipients, hypersensitivity to dihydropyridine derivatives, pregnancy, lactation, biliary obstructive disorders, severe hepatic impairment, severe hypotension, shock (including cardiogenic shock), obstruction of the outflow tract of the left ventricle (such as high grade aortic stenosis), haemodynamically unstable heart failure after acute myocardial infarction, and the concomitant use of TWYNSTA with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73 m²).

PBS listing

No source document contains information about PBS listing, including strength, item count, restriction type, or ex-manufacturer price.

Regulatory history

TWYNSTA was first listed on the ARTG on 2011-02-18 in four strengths: 40/5 mg, 40/10 mg, 80/5 mg, and 80/10 mg. The TGA approved TWYNSTA on 2011-02-14 for the treatment of hypertension, concluding that the benefits outweigh the risks based on comprehensive quality, nonclinical, and clinical evaluations.