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Juvisync

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Juvisync

Indications
Dosage
How Supplied

INDICATIONS

JUVISYNC™ (sitagliptin and simvastatin) is indicated in patients for whom treatment with both sitagliptin and simvastatin is appropriate.

Sitagliptin

Sitagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. [See Clinical Studies]

Simvastatin

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin can be started simultaneously with diet.

Reductions in Risk of CHD Mortality and Cardiovascular Events

In patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, simvastatin is indicated to:

  • Reduce the risk of total mortality by reducing CHD deaths.
  • Reduce the risk of non-fatal myocardial infarction and stroke.
  • Reduce the need for coronary and non-coronary revascularization procedures.
Hyperlipidemia

Simvastatin is indicated to:

  • Reduce elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia (Fredrickson type IIa, heterozygous familial and nonfamilial) or mixed dyslipidemia (Fredrickson type IIb).
  • Reduce elevated TG in patients with hypertriglyceridemia (Fredrickson type lV hyperlipidemia).
  • Reduce elevated TG and VLDL-C in patients with primary dysbetalipoproteinemia (Fredrickson type lll hyperlipidemia).
  • Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

Important Limitations Of Use

JUVISYNC should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

JUVISYNC has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JUVISYNC. [See WARNINGS AND PRECAUTIONS]

JUVISYNC has not been studied in conditions where the major abnormality is elevation of chylomicrons (i.e., hyperlipidemia Fredrickson types I and V).

Because doses of JUVISYNC appropriate for patients with severe renal impairment (CrCl < 30 mL/min, approximately corresponding to serum creatinine levels of > 3.0 mg/dL in men and > 2.5 mg/dL in women) or end-stage renal disease (ESRD) are not available in this combination product, JUVISYNC is not recommended in patients with severe renal impairment or ESRD.

DOSAGE AND ADMINISTRATION

Recommended Dosing

The dosages for therapy with JUVISYNC are 100 mg/10 mg, 100 mg/20 mg, 100 mg/40 mg, 50 mg/10 mg, 50 mg/20 mg, and 50 mg/40 mg (sitagliptin/simvastatin) once daily. JUVISYNC should be taken as a single daily dose in the evening. JUVISYNC must not be split or divided before swallowing.

The recommended starting dose is 100 mg/40 mg per day. For patients already taking simvastatin (10, 20, or 40 mg daily) with or without sitagliptin 100 mg daily, JUVISYNC may be initiated at the dose of 100 mg sitagliptin and the dose of simvastatin already being taken.

After initiation or titration of JUVISYNC, lipid levels may be analyzed after 4 or more weeks and dosage adjusted, if needed.

Patients With Renal Impairment

JUVISYNC is not recommended in patients with severe renal impairment or ESRD. JUVISYNC can be used in patients with normal renal function or mild renal impairment (creatinine clearance [CrCl] greater than or equal to 50 mL/min, approximately corresponding to serum creatinine levels of less than or equal to 1.7 mg/dL in men and less than or equal to 1.5 mg/dL in women), without adjustment of the sitagliptin dose. Because simvastatin does not undergo significant renal excretion, modification of the dose of the simvastatin component should not be necessary in patients with mild renal impairment.

For patients with moderate renal impairment (CrCl greater than or equal to 30 to less than 50 mL/min, approximately corresponding to serum creatinine levels of greater than 1.7 to less than or equal to 3.0 mg/dL in men and greater than 1.5 to less than or equal to 2.5 mg/dL in women), the recommended starting dose of JUVISYNC is 50 mg/40 mg once daily. For patients with moderate renal impairment who are already taking simvastatin (10, 20, or 40 mg daily) with or without sitagliptin 50 mg daily, JUVISYNC may be initiated at the dose of 50 mg sitagliptin and the dose of simvastatin already being taken.

Assessment of renal function is recommended prior to initiation of JUVISYNC and periodically thereafter. Creatinine clearance can be estimated from serum creatinine using the Cockcroft-Gault formula. [See WARNINGS AND PRECAUTIONS; CLINICAL PHARMACOLOGY] There have been postmarketing reports of worsening renal function in patients with renal impairment treated with sitagliptin, some of whom were prescribed inappropriate doses of sitagliptin.

Concomitant Use With An Insulin Secretagogue (e.g., Sulfonylurea) Or With Insulin

When JUVISYNC is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia. [See WARNINGS AND PRECAUTIONS]

Coadministration With Other Drugs

Patients taking Verapamil, Diltiazem, or Dronedarone
Patients taking Amiodarone, Amlodipine or Ranolazine

Patients With Homozygous Familial Hypercholesterolemia

The recommended dosage is 100 mg/40 mg (for patients with normal or mildly impaired renal function) or 50 mg/40 mg (for patients with moderately impaired renal function) per day in the evening. JUVISYNC should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

Simvastatin exposure is approximately doubled with concomitant use of lomitapide; therefore, the dose of simvastatin should be reduced by 50% if initiating lomitapide. For patients with normal or mildly impaired renal function, JUVISYNC dosage should not exceed 100 mg/20 mg daily (or 100 mg/40 mg daily for patients who have previously taken simvastatin 80 mg daily chronically, e.g., for 12 months or more, without evidence of muscle toxicity) while taking lomitapide. For patients with moderately impaired renal function, JUVISYNC dosage should not exceed 50 mg/20 mg daily (or 50 mg/40 mg daily for patients who have previously taken simvastatin 80 mg daily chronically, e.g., for 12 months or more, without evidence of muscle toxicity) while taking lomitapide.

Chinese Patients Taking Lipid-Modifying Doses (greater than or equal to 1 g/day Niacin) Of Niacin-Containing Products

Because of an increased risk for myopathy in Chinese patients taking simvastatin 40 mg coadministered with lipid-modifying doses (greater than or equal to 1 g/day niacin) of niacin-containing products, caution should be used when treating Chinese patients with JUVISYNC 100 mg/40 mg or 50 mg/40 mg per day coadministered with lipid-modifying doses of niacin-containing products. The cause of the increased risk of myopathy is not known. It is also unknown if the risk for myopathy with coadministration of JUVISYNC with lipid-modifying doses of niacin-containing products observed in Chinese patients applies to other Asian patients. [See WARNINGS AND PRECAUTIONS]

HOW SUPPLIED

Dosage Forms And Strengths

  • JUVISYNC 100 mg/10 mg tablets are pink-beige, bi-convex round, film-coated tablets, coded with the Merck logo and “753” on one side and plain on the other.
  • JUVISYNC 100 mg/20 mg tablets are pink-beige, bi-convex modified capsule-shaped, film-coated tablets, coded with the Merck logo and “757” on one side and plain on the other.
  • JUVISYNC 100 mg/40 mg tablets are orange-beige, bi-convex modified capsule-shaped, film-coated tablets, coded with the Merck logo and “773” on one side and plain on the other.
  • JUVISYNC 50 mg/10 mg tablets are red, bi-convex modified capsule-shaped, film-coated tablets, coded with the Merck logo and “533” on one side and plain on the other.
  • JUVISYNC 50 mg/20 mg tablets are orange-beige, bi-convex modified capsule-shaped, film-coated tablets, coded with the Merck logo and “535” on one side and plain on the other.
  • JUVISYNC 50 mg/40 mg tablets are red, bi-convex modified capsule-shaped, film-coated tablets, coded with the Merck logo and “537” on one side and plain on the other.

Storage And Handling

JUVISYNC 100 mg/10 mg tablets are pink-beige, bi-convex round, film-coated tablets, coded with the Merck logo and “753” on one side and plain on the other. They are supplied as follows:

NDC 0006-0753-31 unit of use bottles of 30
NDC 0006-0753-54 unit of use bottles of 90
NDC 0006-0753-82 bottles of 1000.

JUVISYNC 100 mg/20 mg tablets are pink-beige, bi-convex modified capsule-shaped, film-coated tablets, coded with the Merck logo and “757” on one side and plain on the other. They are supplied as follows:

NDC 0006-0757-31 unit of use bottles of 30
NDC 0006-0757-54 unit of use bottles of 90
NDC 0006-0757-82 bottles of 1000.

JUVISYNC 100 mg/40 mg tablets are orange-beige, bi-convex modified capsule-shaped, film-coated tablets, coded with the Merck logo and “773” on one side and plain on the other. They are supplied as follows:

NDC 0006-0773-31 unit of use bottles of 30
NDC
0006-0773-54 unit of use bottles of 90
NDC 0006-0773-82 bottles of 1000.

JUVISYNC 50 mg/10 mg tablets are red, bi-convex modified capsule-shaped, film-coated tablets, coded with the Merck logo and “533” on one side and plain on the other. They are supplied as follows:

NDC 0006-0533-31 unit of use bottles of 30
NDC 0006-0533-54 unit of use bottles of 90

JUVISYNC 50 mg/20 mg tablets are orange-beige, bi-convex modified capsule-shaped, film-coated tablets, coded with the Merck logo and “535” on one side and plain on the other. They are supplied as follows:

NDC 0006-0535-31 unit of use bottles of 30
NDC 0006-0535-54 unit of use bottles of 90

JUVISYNC 50 mg/40 mg tablets are red, bi-convex modified capsule-shaped, film-coated tablets, coded with the Merck logo and “537” on one side and plain on the other. They are supplied as follows:

NDC 0006-0537-31 unit of use bottles of 30
NDC 0006-0537-54 unit of use bottles of 90

Storage

Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Store in a dry place with cap tightly closed.

Storage of 1000 count bottles

Dispense into a USP tightly closed, moisture-resistant container.

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manufactured by: MSD International GmbH Clonmel, Co. Tipperary, Ireland. Revised: Feb 2014

Last reviewed on RxList: 3/11/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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