Juvisync
Loading...Juvisync Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
JUVISYNC™ (sitagliptin and simvastatin) is indicated in patients for whom treatment with both sitagliptin and simvastatin is appropriate.
Sitagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. [See Clinical Studies (14.1).]
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.
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 (5.1).]
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.
History
There is currently no drug history available for this drug.
Other Information
JUVISYNC Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme, and simvastatin, a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus.
Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate.
The empirical formula is C16H15F6N5O•H3PO4•H2O and the molecular weight is 523.32. The structural formula is:
Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate.
After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol.
Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:
Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol.
Each bilayer tablet of JUVISYNC contains 128.5 mg or 64.25 mg of sitagliptin phosphate monohydrate, which is equivalent to 100 mg or 50 mg of free base, respectively, either 10 mg, 20 mg, or 40 mg of simvastatin, and the following inactive ingredients: anhydrous dibasic calcium phosphate, microcrystalline cellulose, croscarmellose sodium, sodium stearyl fumarate, magnesium stearate, ascorbic acid, citric acid monohydrate, lactose monohydrate, and pre-gelatinized corn starch. In addition, the film coating contains the following inactive ingredients for all tablet strengths: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and red iron oxide. The film coating for the 100 mg/10 mg, 100 mg/20 mg, 100 mg/40 mg, and 50 mg/20 mg tablet strengths also contains yellow iron oxide and black iron oxide. Butylated hydroxyanisole is added as a preservative.
Sources
Juvisync Manufacturers
-
Merck Sharp & Dohme Corp.
![Juvisync (Sitagliptin And Simvastatin) Tablet, Film Coated Juvisync (Sitagliptin And Simvastatin) Tablet, Film Coated [Merck Sharp & Dohme Corp.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Juvisync | Merck Sharp & Dohme Corp.
2.1 Recommended DosingThe 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.
2.2 Patients with Renal ImpairmentJUVISYNC 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 (5.4); Clinical Pharmacology (12.3).] 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.
2.3 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with InsulinWhen 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 (5.5).]
2.4 Coadministration with Other DrugsPatients taking Verapamil, Diltiazem, or Dronedarone
The dose of simvastatin should not exceed 10 mg per day (100 mg/10 mg or 50 mg/10 mg per day of JUVISYNC) [see Warnings and Precautions (5.2); Drug Interactions (7.3); Clinical Pharmacology (12.3)].Patients taking Amiodarone, Amlodipine or Ranolazine
The dose of simvastatin should not exceed 20 mg per day (100 mg/20 mg or 50 mg/20 mg per day of JUVISYNC) [see Warnings and Precautions (5.2); Drug Interactions (7.3); Clinical Pharmacology (12.3)]. 2.5 Patients with Homozygous Familial HypercholesterolemiaThe 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.
2.6 Chinese Patients Taking Lipid-Modifying Doses (greater than or equal to 1 g/day Niacin) of Niacin-Containing ProductsBecause 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 (5.2).]
Login To Your Free Account