MICARDIS and MICARDIS HCT for Hypertension

Indications

Micardis^® (telmisartan) tablets is an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension.

MICARDIS 80 mg is also indicated for risk reduction of myocardial infarction, stroke, or death from cardiovascular (CV) causes in patients ≥55 years of age at high risk of developing major CV events who are unable to take ACE inhibitors.

• High risk for cardiovascular events can be evidenced by a history of coronary artery disease, peripheral arterial disease, stroke, transient ischemic attack, or high-risk diabetes (insulin dependent or non-insulin dependent) with evidence of end-organ damage. MICARDIS can be used in addition to other needed treatment (such as antihypertensive, antiplatelet, or lipid-lowering therapy).
• Studies of telmisartan in this setting do not exclude that it may not preserve a meaningful fraction of the effect of the ACE inhibitor to which it was compared. Consider using the ACE inhibitor first, and, if it is stopped for cough only, consider retrying the ACE inhibitor after the cough resolves. Use of telmisartan with an ACE inhibitor is not recommended.
  
  

Micardis^® HCT (telmisartan/hydrochlorothiazide) tablets is indicated for the treatment of hypertension. MICARDIS HCT is not indicated for initial therapy or for cardiovascular risk reduction.

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 hypertension 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

MICARDIS is contraindicated in patients with known hypersensitivity (eg, anaphylaxis or angioedema) to telmisartan, or any other component of this product.

MICARDIS HCT is contraindicated in patients with known hypersensitivity (eg, anaphylaxis or angioedema) to telmisartan, hydrochlorothiazide, or any other component of this product and in patients with anuria.

TWYNSTA is contraindicated in patients with known hypersensitivity (eg, anaphylaxis or angioedema) to telmisartan, amlodipine, or any other component 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 therapy with MICARDIS, MICARDIS HCT, or TWYNSTA or start treatment under close supervision with a reduced dose. Monitor carefully in patients with impaired renal function.

Patients taking MICARDIS, MICARDIS HCT, or 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. Monitor carefully in patients with impaired renal function.

In patients with impaired hepatic function, initiate treatment of MICARDIS and MICARDIS HCT at low doses and titrate slowly. MICARDIS HCT is not recommended for patients with severe renal or hepatic impairment.

TWYNSTA must be titrated slowly in patients with hepatic or severe renal impairment and closely monitored. 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 ARBs such as MICARDIS, MICARDIS HCT, or 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 MICARDIS, MICARDIS HCT, or TWYNSTA with ramipril is not recommended.

The most common adverse events occurring with MICARDIS tablets at a rate of ≥1% than placebo were upper respiratory tract infection (URTI), back pain, sinusitis, diarrhea, and pharyngitis.

The most common adverse events occurring with MICARDIS HCT tablets at a rate of ≥2% than placebo were dizziness, diarrhea, fatigue, nausea, influenza-like symptoms, sinusitis, and URTI.

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

Hydrochlorothiazide

Thiazide drugs such as hydrochlorothiazide can cause a reaction that can result in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated angle-closure glaucoma can lead to permanent vision loss. Discontinue MICARDIS HCT as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

Thiazides can exacerbate or activate systemic lupus erythematosus.

Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma.

Lithium generally should not be given with thiazides as this could put patients at high risk for lithium toxicity.

Amlodipine

Uncommonly, patients starting or increasing their dose of CCB have developed increased frequency, duration, or severity of angina or acute myocardial infarction. Monitor patients with heart failure for worsening of their condition.

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

This information is intended for the U.S. only.

* Only Micardis^® (telmisartan) 80-mg tablets are indicated for cardiovascular risk reduction. All other MICARDIS and Micardis^® HCT (telmisartan and hydrochlorothiazide) tablets dosages are indicated for the treatment of hypertension only. MICARDIS 80 mg is indicated for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events who are unable to take ACE inhibitors. High risk for cardiovascular events can be evidenced by a history of coronary artery disease, peripheral arterial disease, stroke, transient ischemic attack, or high-risk diabetes (insulin-dependent or non-insulin-dependent) with evidence of end-organ damage. MICARDIS can be used in addition to other needed treatment (such as antihypertensive, antiplatelet, or lipid-lowering therapy). Studies of telmisartan in this setting do not exclude that it may not preserve a meaningful fraction of the effect of the ACE inhibitor to which it was compared. Consider using the ACE inhibitor first, and, if it is stopped for cough only, consider re-trying the ACE inhibitor after the cough resolves. Use of telmisartan with an ACE inhibitor is not recommended.¹

† Dosage must be individualized. In the treatment of hypertension, the usual starting dose of MICARDIS tablets is 40 mg once a day. Blood pressure response is dose-related over the range of 20-80 mg. For patients who need even greater efficacy, MICARDIS HCT is available in 40/12.5-mg, 80/12.5-mg, and 80/25-mg tablets. Available as a unit dose. In the treatment of cardiovascular risk reduction, the recommended dose of MICARDIS is 80 mg once a day. It is not known whether doses lower than 80 mg of telmisartan are effective in reducing the risk of cardiovascular morbidity and mortality. When initiating MICARDIS therapy for cardiovascular risk reduction, monitoring of blood pressure is recommended and, if appropriate, adjustment of medications that lower blood pressure may be necessary.¹

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