Daiichi Sankyo, Inc.

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Daiichi Sankyo, Inc. Drugs

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2.1 Nonvalvular Atrial Fibrillation

The recommended dose of SAVAYSA is 60 mg taken orally once daily [see Warnings and Precautions (5.1), Clinical Studies (14.1)]. Assess creatinine clearance, as calculated using the Cockcroft-Gault equation*, before initiating therapy with SAVAYSA. Do not use SAVAYSA in patients with CrCL > 95 mL/min.

Reduce SAVAYSA dose to 30 mg once daily in patients with CrCL 15 to 50 mL/min [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

*Cockcroft-Gault CrCL = (140-age) x (weight in kg) x (0.85 if female) / (72 x creatinine in mg/dL).

2.2 Treatment of Deep Vein Thrombosis and Pulmonary Embolism

The recommended dose of SAVAYSA is 60 mg taken orally once daily following 5 to 10 days of initial therapy with a parenteral anticoagulant [see Clinical Studies (14.2)].

The recommended dose of SAVAYSA is 30 mg once daily in patients with CrCL 15 to 50 mL/min, patients who weigh less than or equal to 60 kg, or patients who are taking certain concomitant P-gp inhibitor medications based on clinical study data in this indication [see Clinical Studies (14.2)].

2.3 Administration Information

If a dose of SAVAYSA is missed, the dose should be taken as soon as possible on the same day. Dosing should resume the next day according to the normal dosing schedule. The dose should not be doubled to make up for a missed dose.

SAVAYSA can be taken without regard to food [see Clinical Pharmacology (12.3)].

2.4 Transition to or from SAVAYSA
Transition to SAVAYSA From To Recommendation Warfarin or other Vitamin K Antagonists SAVAYSA Discontinue warfarin and start SAVAYSA when the INR is ≤ 2.5 Oral anticoagulants other than warfarin or other Vitamin K Antagonists SAVAYSA Discontinue current oral anticoagulant and start SAVAYSA at the time of the next scheduled dose of the other oral anticoagulant Low Molecular Weight Heparin (LMWH) SAVAYSA Discontinue LMWH and start SAVAYSA at the time of the next scheduled administration of LMWH Unfractionated heparin SAVAYSA Discontinue the infusion and start SAVAYSA 4 hours later Transition from SAVAYSA Abbreviations: INR=International Normalized Ratio From To Recommendation SAVAYSA Warfarin Oral option: For patients taking 60 mg of SAVAYSA, reduce the dose to 30 mg and begin warfarin concomitantly. For patients receiving 30 mg of SAVAYSA, reduce the dose to 15 mg and begin warfarin concomitantly. INR must be measured at least weekly and just prior to the daily dose of SAVAYSA to minimize the influence of SAVAYSA on INR measurements. Once a stable INR ≥ 2.0 is achieved, SAVAYSA should be discontinued and the warfarin continued SAVAYSA Warfarin Parenteral option: Discontinue SAVAYSA and administer a parenteral anticoagulant and warfarin at the time of the next scheduled SAVAYSA dose. Once a stable INR ≥ 2.0 is achieved the parenteral anticoagulant should be discontinued and the warfarin continued SAVAYSA Non-Vitamin-K Dependent Oral anticoagulants Discontinue SAVAYSA and start the other oral anticoagulant at the time of the next dose of SAVAYSA SAVAYSA Parenteral anticoagulants Discontinue SAVAYSA and start the parenteral anticoagulant at the time of the next dose of SAVAYSA
2.5 Discontinuation for Surgery and Other Interventions

Discontinue SAVAYSA at least 24 hours before invasive or surgical procedures because of the risk of bleeding [see Warnings and Precautions (5.3)].

If surgery cannot be delayed, there is an increased risk of bleeding. This risk of bleeding should be weighed against the urgency of intervention [see Warnings and Precautions (5.3)].

SAVAYSA can be restarted after the surgical or other procedure as soon as adequate hemostasis has been established noting that the time to onset of pharmacodynamic effect is 1-2 hours [see Warnings and Precautions (5.2)]. Administer a parenteral anticoagulant and then switch to oral SAVAYSA, if oral medication cannot be taken during or after surgical intervention.
Welchol

Welchol

2.1 Primary Hyperlipidemia

The recommended dose of WELCHOL Tablets in adults, whether used as monotherapy or in combination with a statin, is 6 tablets once daily or 3 tablets twice daily. WELCHOL Tablets should be taken with a meal and liquid.

The recommended dose of WELCHOL for Oral Suspension, in adults and children 10 to 17 years of age, is one 3.75 gram packet once daily or one 1.875 gram packet twice daily. To prepare, empty the entire contents of one packet into a glass or cup. Add ½ to 1 cup (4 to 8 ounces) of water, fruit juice, or diet soft drinks. Stir well and drink. WELCHOL for Oral Suspension should be taken with meals. To avoid esophageal distress, WELCHOL for Oral Suspension should not be taken in its dry form. Due to tablet size, it is recommended that any patient who has difficulty swallowing tablets use WELCHOL for Oral Suspension.

WELCHOL can be dosed at the same time as a statin or the two drugs can be dosed apart [See Clinical Studies (14.1)].

After initiation of WELCHOL, lipid levels should be analyzed within 4 to 6 weeks.

2.2 Type 2 Diabetes Mellitus

The recommended dose of WELCHOL Tablets is 6 tablets once daily or 3 tablets twice daily. WELCHOL should be taken with a meal and liquid.

The recommended dose of WELCHOL for Oral Suspension is one 3.75 gram packet once daily or one 1.875 gram packet twice daily. To prepare, empty the entire contents of one packet into a glass or cup. Add ½ to 1 cup (4 to 8 ounces) of water, fruit juice, or diet soft drinks. Stir well and drink. WELCHOL for Oral Suspension should be taken with meals. To avoid esophageal distress, WELCHOL for Oral Suspension should not be taken in its dry form.
Benicar Hct

Benicar Hct

The usual recommended starting dose of BENICAR® (olmesartan medoxomil) is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose may be increased to 40 mg. Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily. No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40mL/min) or with moderate to marked hepatic dysfunction (see CLINICAL PHARMACOLOGY, Special Populations). For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), BENICAR® should be initiated under close medical supervision and consideration should be given to use of a lower starting dose (see WARNINGS, Hypotension in Volume- or Salt-Depleted Patients).

Hydrochlorothiazide is effective in doses between 12.5 mg and 50 mg once daily.

The side effects (see WARNINGS) of BENICAR® are generally rare and independent of dose; those of hydrochlorothiazide are most typically dose-dependent (primarily hypokalemia). Some dose-independent phenomena (e.g., pancreatitis) do occur with hydrochlorothiazide. Therapy with any combination of olmesartan medoxomil and hydrochlorothiazide will be associated with both sets of dose-independent side effects.

To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.

Replacement Therapy

BENICAR HCT® (olmesartan medoxomil-hydrochlorothiazide) may be substituted for its titrated components.

Dose Titration by Clinical Effect

BENICAR HCT® is available in strengths of 20 mg/12.5 mg, 40 mg/12.5 mg and 40 mg/25 mg. A patient whose blood pressure is inadequately controlled by BENICAR® or hydrochlorothiazide alone may be switched to once daily BENICAR HCT® (olmesartan medoxomil-hydrochlorothiazide).

Dosing should be individualized. Depending on the blood pressure response, the dose may be titrated at intervals of 2-4 weeks.

If blood pressure is not controlled by BENICAR® alone, hydrochlorothiazide may be added starting with a dose of 12.5 mg and later titrated to 25 mg once daily.

If a patient is taking hydrochlorothiazide, BENICAR® may be added starting with a dose of 20 mg once daily and titrated to 40 mg, for inadequate blood pressure control. If large doses of hydrochlorothiazide have been used as monotherapy and volume depletion or hyponatremia is present, caution should be used when adding BENICAR® or switching to BENICAR HCT® as marked decreases in blood pressure may occur (see WARNINGS, Hypotension in Volume- or Salt-Depleted Patients). Consideration should be given to reducing the dose of hydrochlorothiazide to 12.5 mg before adding BENICAR®. The antihypertensive effect of BENICAR HCT® is related to the dose of both components over the range of 10 mg/12.5 mg to 40 mg/25 mg (see CLINICAL PHARMACOLOGY, Clinical Trials). The dose of BENICAR HCT® is one tablet once daily. More than one tablet daily is not recommended.

BENICAR HCT® may be administered with other antihypertensive agents.

Patients with Renal Impairment

The usual regimens of therapy with BENICAR HCT® may be followed provided the patient’s creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so BENICAR HCT® is not recommended.

Patients with Hepatic Impairment

No dosage adjustment is necessary with hepatic impairment (see CLINICAL PHARMACOLOGY, Special Populations).
Tribenzor

Tribenzor

General Considerations Dose once daily.

Dosage may be increased after 2 weeks. The full blood pressure lowering effects are attained within 2 weeks after a change in dose. The maximum recommended dose of Tribenzor is 40/10/25 mg. Tribenzor may be taken with or without food.

Tribenzor may be administered with other antihypertensive agents.

Renal Impairment The usual regimens of therapy with Tribenzor may be followed if the patient’s creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so avoid use of Tribenzor [see Warnings and Precautions (5.4)].

Elderly Patients ≥ 75 years of age should start amlodipine at 2.5 mg, which is not available with Tribenzor.

Hepatic Impairment Patients with severe hepatic impairment should start amlodipine at 2.5 mg, which is not available with Tribenzor [see Warnings and Precautions (5.5)].

Replacement Therapy Tribenzor may be substituted for its individually titrated components.

Add-on/Switch Therapy Tribenzor may be used to provide additional blood pressure lowering for patients not adequately controlled on maximally tolerated, labeled, or usual doses of any two of the following antihypertensive classes: angiotensin receptor blockers (ARB), calcium channel blockers (CCB), and diuretics.

A patient who experiences dose-limiting adverse reactions to an individual component while on any dual combination of the components of Tribenzor may be switched to Tribenzor containing a lower dose of that component to achieve similar blood pressure reductions.
Benicar

Benicar

2.1 Adult Hypertension

Dosage must be individualized. The usual recommended starting dose of Benicar is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Benicar may be increased to 40 mg. Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.

No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 mL/min) or with moderate to marked hepatic dysfunction [see Warnings and Precautions (5.4), Use in Specific Populations (8.5, 8.6, 8.7) and Clinical Pharmacology (12.3)]. For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), initiate Benicar under close medical supervision and give consideration to use of a lower starting dose [see Warnings and Precautions (5.3)].

Benicar may be administered with or without food.

If blood pressure is not controlled by Benicar alone, a diuretic may be added. Benicar may be administered with other antihypertensive agents.

2.2 Pediatric Hypertension (6 to 16 years of age)

Dosage must be individualized. For children who can swallow tablets, the usual recommended starting dose of Benicar is 10 mg once daily for patients who weigh 20 to <35 kg (44 to 77 lb), or 20 mg once daily for patients who weigh ≥35 kg. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Benicar may be increased to a maximum of 20 mg once daily for patients who weigh <35 kg or 40 mg once daily for patients who weigh ≥35 kg.

Children <1 year of age must not receive Benicar for hypertension.

For children who cannot swallow tablets, the same dose can be given using an extemporaneous suspension as described below [see Clinical Pharmacology (12.3)]. Follow the suspension preparation instructions below to administer Benicar as a suspension.

Preparation of Suspension (for 200 mL of a 2 mg/mL suspension)

Add 50 mL of Purified Water to an amber polyethylene terephthalate (PET) bottle containing twenty Benicar 20 mg tablets and allow to stand for a minimum of 5 minutes. Shake the container for at least 1 minute and allow the suspension to stand for at least 1 minute. Repeat 1-minute shaking and 1-minute standing for four additional times. Add 100 mL of Ora-Sweet®* and 50 mL of Ora-Plus®* to the suspension and shake well for at least 1 minute. The suspension should be refrigerated at 2-8°C (36-46°F) and can be stored for up to 4 weeks. Shake the suspension well before each use and return promptly to the refrigerator. * Ora-Sweet® and Ora-Plus® are registered trademarks of Paddock Laboratories, Inc.
Azor

Azor

General Considerations

The side effects of olmesartan medoxomil are generally rare and apparently independent of dose. Those of amlodipine are generally dose-dependent (mostly edema).

Maximum antihypertensive effects are attained within 2 weeks after a change in dose.

Azor may be taken with or without food.

Azor may be administered with other antihypertensive agents.

Dosage may be increased after 2 weeks. The maximum recommended dose of Azor is 10/40 mg.

Replacement Therapy

Azor may be substituted for its individually titrated components.

When substituting for individual components, the dose of one or both of the components can be increased if blood pressure control has not been satisfactory.

Add-on Therapy

Azor may be used to provide additional blood pressure lowering for patients not adequately controlled with amlodipine (or another dihydropyridine calcium channel blocker) alone or with olmesartan medoxomil (or another angiotensin receptor blocker) alone.

Initial Therapy

The usual starting dose of Azor is 5/20 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum dose of one 10/40 mg tablet once daily as needed to control blood pressure [See Clinical Studies (14.1)].

Initial therapy with Azor is not recommended in patients ≥75 years old or with hepatic impairment [See Warnings and Precautions (5.7) and Use in Specific Populations (8.5, 8.6)].

Daiichi Sankyo, Inc.

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Daiichi Sankyo, Inc. Drugs