TWYNSTA® FOR HEALTHCARE PROFESSIONALS — Twynsta (telmisartan/amlodipine) tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents. They may be used in patients whose blood pressure is not adequately controlled on antihypertensive monotherapy. TWYNSTA tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. Read full indication statement Twynsta Home Important Safety Information Prescribing Information Side Effects & Safety Information — Twynsta® (telmisartan/amlodipine) tablets — Safety

TWYNSTA Safety

Review safety data for TWYNSTA—A fixed-dose ARB/CCB combining telmisartan and amlodipine for the treatment of hypertension

Team Up with TWYNSTA & Achieve Better Tolerability*
Fewer patients taking TWYNSTA reported peripheral edema than those taking amlodipine 10 mg1


*Defined as lower occurrence of peripheral edema.

An 8-week, randomized, multicenter, double-blind, placebo-controlled study in patients with mild to moderate hypertension (defined as mean seated cuff diastolic blood pressure [DBP] ≥95 and ≤119 mmHg) compared TWYNSTA with respective monotherapies.1

CLINICAL SAFETY INFORMATION

The concomitant use of telmisartan and amlodipine has been evaluated for safety in more than 3700 patients with hypertension; approximately 1900 of these patients were exposed for at least 6 months and over 160 of these patients were exposed for at least 1 year. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy.

In the placebo-controlled factorial-design study, the population treated with a telmisartan and amlodipine combination had a mean age of 53 years and included approximately 50% males; 79% were Caucasian, 17% Black, and 4% Asian. Patients received doses ranging from 20/2.5 mg to 80/10 mg orally, once daily.

The frequency of adverse reactions was not related to gender, age, or race.

PERIPHERAL EDEMA

Peripheral edema is a known, dose-dependent adverse reaction of amlodipine, but not of telmisartan. In the factorial-design study, the incidence of peripheral edema during the 8-week, randomized, double-blind treatment period was highest with amlodipine 10 mg monotherapy. The incidence was notably lower when telmisartan was used in combination with amlodipine 10 mg.

The incidence of peripheral edema during the 8-week treatment period is presented in the following table.


ADVERSE REACTIONS

The adverse reactions that occurred in the placebo-controlled factorial-design trial in ≥2% of patients treated with TWYNSTA and at a higher incidence in TWYNSTA-treated patients (n=789) than placebo-treated patients (n=46) are presented in the following table.


In addition, other adverse reactions that occurred in more than 1% of the patients treated with TWYNSTA tablets (n=789) were dizziness (2.0% vs 2.2% on placebo) and headache (1.4% vs 4.3% on placebo).

In the placebo-controlled factorial-design trial, discontinuation due to adverse events occurred in 2.2% of all treatment cells of patients in the telmisartan/amlodipine-treated patients and in 4.3% in the placebo-treated group. The most common reasons for discontinuation of therapy with TWYNSTA tablets were peripheral edema, dizziness, and hypotension (each ≤0.5%).

NOTE: Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

References

1. Data on file, Study 1235.1, Boehringer Ingelheim Pharmaceuticals, Inc.
2. Twynsta PI. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; 2009.

TWYNSTA is available in 4 dosage strengths, so therapy can be individualized to your patients' needs.2

Review dosing information

Visit the MICARDIS for Healthcare Professionals Web site to access tools and resources designed to help you create individualized treatment plans for your hypertensive patients.

Go to www.MicardisPro.com

INDICATION

Twynsta® (telmisartan/amlodipine) tablets is an angiotensin II receptor blocker (ARB) and a dihydropyridine calcium channel blocker (DHP-CCB) combination product indicated for the treatment of hypertension, alone or with other antihypertensive agents. It may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

Base the choice of TWYNSTA tablets as initial therapy for hypertension on an assessment of potential benefits and risks including whether the patient is likely to tolerate the starting dose of TWYNSTA tablets. Consider the patient's baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy when deciding whether to use TWYNSTA tablets as initial therapy.

IMPORTANT SAFETY INFORMATION

WARNING: AVOID USE IN PREGNANCY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue TWYNSTA as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.

TWYNSTA is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan or amlodipine or any other components of this product.

Symptomatic hypotension may occur in patients with an activated renin-angiotensin system. Correct volume and/or salt depletion in patients before initiating TWYNSTA or start treatment under close supervision with a reduced dose.

Patients taking TWYNSTA should be told not to use potassium supplements or salt substitutes that contain potassium without consulting their physician. Consider periodic determinations of serum electrolytes to detect possible electrolyte imbalances.

Titrate slowly in patients with hepatic or severe renal impairment and closely monitor. Initial therapy with TWYNSTA is not recommended in hepatically impaired patients.

In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system such as patients with severe congestive heart failure or renal dysfunction, treatment with ACE inhibitors and an ARB such as TWYNSTA has been associated with oliguria and/or progressive azotemia and, rarely, with acute renal failure and/or death. In patients with renal artery stenosis, increases in serum creatinine or blood urea nitrogen may occur. When adding an ACE inhibitor to an ARB, monitor renal function closely. Use of TWYNSTA with ramipril is not recommended.

Uncommonly, patients starting or increasing their dose of a CCB have developed increased frequency, duration, or severity of angina or acute myocardial infarction.

Monitor patients with heart failure for worsening of their condition.

In clinical trials, the most common reasons for discontinuation of therapy with TWYNSTA were peripheral edema, dizziness, and hypotension. Adverse events that occurred at a ≥2% higher incidence with TWYNSTA than with placebo were peripheral edema, dizziness, and back pain.

Please see full Prescribing Information, including boxed WARNING, for TWYNSTA.



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