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Valturna (Aliskiren Hemifumarate / Valsartan) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Valturnais indicated for the treatment of hypertension.

Add- o n Therapy

A patient whose blood pressure is not adequately controlled with aliskiren alone or valsartan (or another angiotensin receptor blocker) alone may be switched to combination therapy with Valturna.

Replacement Therapy

Valturna may be substituted for the titrated components.

I nitial Therapy

Valturna may be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

The choice of Valturna as initial therapy should be based on an assessment of potential benefits and risks.

Patients with Stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient's risk.

Data from the high-dose multifactorial study [see Clinical Studies] provide estimates of the probability of reaching a target blood pressure with Valturna compared to aliskiren or valsartan monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Valturna 300/320mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable because of a small number of subjects with high baseline blood pressures.

Figure 1: Probability of Achieving Systolic Blood Pressure (SBP) <140 mmHg in Patients at Endpoint

Figure 1: Probability of Achieving Systolic Blood Pressure (SBP) <140 mmHg in Patients at Endpoint

Figure 2: Probability of Achieving Diastolic Blood Pressure (DBP) <90 mmHg in Patients at Endpoint

Figure 2: Probability of Achieving Diastolic Blood Pressure (DBP) <90 mmHg in Patients at Endpoint

Figure 3: Probability of Achieving Systolic Blood Pressure (SBP) <130 mmHg in Patients at Endpoint

Figure 3: Probability of Achieving Systolic Blood Pressure (SBP) <130 mmHg in Patients at Endpoint

Figure 4: Probability of Achieving Diastolic Blood Pressure (DBP) <80 mmHg in Patients at Endpoint

Figure 4: Probability of Achieving Diastolic Blood Pressure (DBP) <80 mmHg in Patients at Endpoint

At all levels of baseline blood pressure, the probability of achieving any given diastolic or systolic goal is greater with the combination than for either monotherapy.For example, the mean baseline SBP/DBP for patients participating in this multifactorial study was 154/100 mmHg.A patient with a baseline blood pressure of 154/100 mmHg has about a 51% likelihood of achieving a goal of <140 mmHg (systolic) and 46% likelihood of achieving <90 mmHg (diastolic) on aliskiren alone, and the likelihood of achieving these goals on valsartan alone is about 47% (systolic) and 47% (diastolic). The likelihood of achieving these goals on Valturna rises to about 62% (systolic) and60% (diastolic). The likelihood of achieving these goals on placebo is about 28% (systolic) and 25% (diastolic) [see Dosage and Administration and Clinical Studies].

DOSAGE AND ADMINISTRATION

Dose Selection

The recommended once-dailydose of Valturnais 150/160mgor 300/320mg. The recommended initial once-daily dose of Valturna is 150/160 mg. Titrate as needed to a maximum of 300/320 mg.

Patients switched from monotherapy to Valturnaon average experience greater blood pressure reductions with use of the combination product.

Dose Titration

The antihypertensive effect of Valturna is largely attained within 2 weeks.If blood pressure remains uncontrolled after 2 to 4 weeks of therapy, the dose may be titrated up to a maximum of 300/320mg.

Add-o n Therapy

A patient whose blood pressure is not adequately controlled with aliskiren alone or valsartan (or another angiotensin receptor blocker) alone may be switched to combination therapy with Valturna. The usual recommended starting dose is 150/160mg once daily as needed to control blood pressure.

Replacement Therapy

For convenience, patients receiving aliskiren and valsartan from separate tablets may instead wish to receive a single tablet of Valturna containing the same component doses.

Initial Therapy

The usual recommended starting dose of Valturna is 150/160mg once daily as needed to control blood pressure. The dose may be titrated up to a maximum of 300/320mg once daily.

Valturna is not recommended for use as initial therapy in patients with intravascular volume depletion [s ee Warnings and Precautions].

Use with Other Antihypertensive Drugs

Valturna may be administered with other antihypertensive agents. There are no data available with use of Valturna with angiotensin-converting enzyme inhibitors or other renin-angiotensin-aldosterone blockers.

Relationship to Meals

Patients should establish a routine pattern for taking Valturnawith regard to meals. High-fat meals decrease absorption substantially [s ee Clinical Pharmacology (12.3)].

Dosing in Specific Populations

Renal Impairment

Adjustment of the starting dose is not required in patients with mild-to-moderate renal impairment. Clinical experience withdosing Valturna in patients with moderate renal impairmentis limited. No data are available in patients with severe renal impairment [see Warnings and Precautions].

Hepatic Impairment

Adjustment of the starting dose is not necessary with mild or moderate hepatic impairment.Clinical experience with dosing Valturna in patients with severe hepatic impairment is limited [see Warnings and Precautions].

Elderly Patients

Adjustment of the starting dose is not required for elderly patients.

DOSAGE FORMS AND STRENGTHS

  • 150/160mg aliskiren/valsartan tablets: light red, standard convex ovaloid, film-coated tablets with beveled edgesdebossed with NVR/HDU
  • 300/320mg aliskiren/valsartan tablets: light brown, shallow convex ovaloid,film-coated tablets with beveled edges debossed with NVR/SNB

HOW SUPPLIED/STORAGE AND HANDLING

Valturna is supplied asconvex, beveled edged, ovaloid film-coated tablets.

All strengths are packaged in bottles and unit-dose blister packages (10 strips of 10 tablets) as described below.

Table 2: Valturna Tablets Supply
Tablet Color Debossed Debossed NDC 0078- XXXX-XX
Aliskiren/valsartan Side 1 Side 2 Bottle of 30 Bottle of 90 Blister Packages of 100
150mg/160mg Light Red NVR HDU 0572-15 0572-34 0572-35
300mg/320mg Light Brown NVR SNB 0574-15 0574-34 0574-35

Storage

Store at 25C (77F); excursions permitted to 15-30C (59-86F) in original container.[See USP Controlled Room Temperature.]

Protect from moisture.

Dispense in tight container (USP).

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