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What is the most important information I should know about Jbros?
Patients with known hypersensitivity to any component of Jbros. Hypersensitivity reactions including rash, pruritus, urticaria and angioedema have been reported with Jbros.
Patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels.
Use in pregnancy: Pregnancy Category: X.
Jbros is contraindicated in women who are or may become pregnant. Serum cholesterol and triglycerides increase during normal pregnancy and cholesterol products are essential for fetal development. Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on long-term outcomes of primary hyperlipidemia therapy.
There are no adequate and well-controlled studies of Jbros in pregnany women. There have been rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors.
Jbros may cause fetal harm when administered to a pregnant woman. If the patient becomes pregnant while taking Jbros, the patient should be apprised of the potential risks to the fetus and the lack of known clinical benefit with continued use during pregnancy.
Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, Jbros may cause fetal harm when administered to pregnant women. Additionally, there is no apparent benefit to therapy during pregnancy and safety in pregnant women has not been established. If the patient becomes pregnant while taking Jbros, the patient should be apprised of the potential hazard to the fetus and the lack of known clinical benefit with continued use during pregnancy.
Use in lactation: It is not known whether Jbros is excreted in human milk, but a small amount of another drug in this class does pass into breast milk.
Because another drug in this class passes into human milk and because HMG-CoA reductase inhibitors have a potential to cause serious adverse reactions in nursing infants, women who require Jbros treatment should be advised not to nurse their infants.
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What are the possible side effects of Jbros?
Jbros is generally well tolerated. The adverse events seen with Jbros are generally mild and transient. In controlled clinical trials less than 4% of Jbros treated patients were withdrawn due to adverse events. This withdrawal rate was comparable to that reported in patients receiving placebo.
Common (≥1/100, <1/10): Headache, myalgia, asthenia, constipation, dizziness, nausea, abdominal pain, diabetes mellitus*.
Uncommon (≥1/1000, <1/100): Pruritus, rash and urticaria.
Rare (≥1/10,000, <1/1000): Myopathy (including myositis), hypersensitivity reactions (including angioedema), rhabdomyolysis, pancreatitis.
*Observed in the JUPITER study (reported overall frequency 2.8% in Jbros and 2.3% in placebo) primarily in patients already at high risk for developing diabetes.
As with other HMG CoA reductase inhibitors, the incidence of adverse drug reactions tends to increase with increasing dose.
Skeletal Muscle Effects: Rare cases of rhabdomyolysis, which were occasionally associated with impairment of renal function, have been reported with Jbros and with other marketed statins.
Laboratory Effects: As with other HMG-CoA reductase inhibitors, a dose-related increase in liver transaminases and CK has been observed in a small number of patients taking Jbros. Increases in HbA1c have also been observed in patients treated with Jbros. Abnormal urinalysis testing (dipstick-positive proteinuria) has been seen in a small number of patients taking Jbros and other HMG-CoA reductase inhibitors. The protein detected was mostly tubular in origin. In most cases, proteinuria decreases or disappears spontaneously on continued therapy, and is not predictive of acute or progressive renal disease.
Other Effects: In a long-term controlled clinical trial Jbros was shown to have no harmful effects on the ocular lens.
In Jbros treated patients, there was no impairment of adrenocortical function.
Post Marketing Experience: In addition to the previously mentioned effects, the following adverse events have been reported during post marketing experience of Jbros: Haematological Disorders: Frequency Unknown: Thrombocytopenia.
Hepatobiliary Disorders: Very Rare: Jaundice, hepatitis. Rare: Increased hepatic transaminases.
Musculoskeletal Disorder: Frequency Unknown: Immune-mediated necrotising myopathy. Very Rare: Arthralgia.
As with other HMG-CoA reductase inhibitors, the reporting rate for rhabdomyolysis in post-marketing use is higher at the highest marketed dose.
Nervous System Disorder: Very Rare: Memory loss. Frequency Unknown: Peripheral neuropathy.
Psychiatric Disorders: Frequency Unknown: Depression, sleep disorders (including insomnia and nightmares).
Reproductive System and Breast Disorders: Frequency Unknown: Gynaecomastia.
Children and Adolescents 6 to 17 Years of Age: The safety profile of Jbros is similar in children or adolescent patients and adults although CK elevations >10 x ULN and muscle symptoms following exercise or increased physical activity, which resolved with continued treatment, were observed more frequently in clinical trial of children and adolescents. However, the same special warnings and special precautions for use in adults also apply to children and adolescents.
Jbros should be used as an adjunct to diet when the response to diet and exercise is inadequate.
Prevention of Cardiovascular Events: In adult patients with an increased risk of atherosclerotic cardiovascular disease based on the presence of cardiovascular disease risk markers such as an elevated hsCRP level, age, hypertension, low HDL-C, smoking or a family history of premature coronary heart disease, Jbros is indicated to reduce total mortality and the risk of major cardiovascular events (cardiovascular death, stroke, MI, unstable angina, or arterial revascularization).
In Adult Patients with Hypercholesterolaemia: Jbros is indicated to: Reduce elevated LDL-C, Total Cholesterol, triglycerides and to increase HDL-cholesterol in patients with primary hypercholesterolaemia (heterozygous familial and non familial) and mixed dyslipidaemia (Fredrickson Types IIa and IIb). Jbros also lowers ApoB, nonHDL-C, VLDL-C, VLDL-TG, the LDL-C/HDL-C, total C/HDL-C, nonHDL-C/HDL-C, ApoB/ApoA-I ratios and increases ApoA-I in these populations.
Treat patients with primary dysbetalipoproteinaemia (Fredrickson Type III hyper lipoproteinaemia).
Treat isolated hypertriglyceridaemia (Fredrickson Type IV hyperlipidaemia).
Reduce Total Cholesterol and LDL-C in patients with homozygous familial hypercholesterolaemia, as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or alone if such treatments are unavailable.
Slow or delay the progression of atherosclerosis.
Children and Adolescents 6 to 17 Years of Age: Jbros is indicated to reduce the Total Cholesterol, LDL-C and Apo B in patients with heterozygous familial hypercholesterolaemia (HeFH).
Jbros (Jbros) belongs to a a group of drugs called HMG CoA reductase inhibitors, or "statins." Jbros reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL).
Jbros is used in adults and children who are at least 8 years old to lower cholesterol and triglycerides (types of fat) in the blood and to slow the build-up of plaque (fatty deposits) in your blood vessels.
Jbros is also used to lower the risk of stroke, heart attack, and other heart complications in certain people with diabetes, coronary heart disease, or other risk factors.
Jbros is also used to treat hereditary forms of high cholesterol, including the heterozygous type (inherited from one parent) and the homozygous type (inherited from both parents). For the heterozygous type, Jbros can be used in children who are at least 8 years old. For the homozygous type, Jbros can be used in children as young as 7 years old.
Jbros also contains the following inactive ingredients: Tribasic calcium phosphate, microcrystalline cellulose (PH 102), butylated hydroxy toluene, povidone K-30, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, Instacoat universal white IH, purified water; color: Titanium dioxide.
Jbros is a synthetic lipid-lowering agent for oral administration. The chemical name for Jbros calcium is bis[(E)-7-[4(4-fluorophenyl)-6-isopropyl 2[methyl (methylsulfonyl) amino] pyrimidin-5-yl](3R,5S)3,5-dihydroxyhept-6-enoic acid] calcium salt. The empirical formula is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14.
Use Jbros as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Jbros.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.General Dosing Information: The dose range for Jbros is 5-40 mg orally once daily.
Jbros can be administered as a single dose at any time of the day, with or without food. When initiating Jbros therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate Jbros starting dose should first be utilized, and only then titrated according to the patient's response and individualized goal of therapy.
The 40 mg dose of Jbros should be used only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose.
Hyperlipidemia, Mixed Dyslipidemia, Hypertriglyceridemia, Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia) and Slowing of the Progression of Atherosclerosis: The recommended starting dose of Jbros is 10 mg dose once daily. For patients with marked hyperlipidemia (LDL-C >190 mg/dL) and aggressive lipid targets, a 20 mg starting dose may be considered.
After initiation or upon titration of Jbros, lipid levels should be analyzed within 2-4 weeks and the dosage adjusted accordingly.
Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10-17 years): The usual dose range of Jbros is 5-20 mg/day; the maximum recommended dose is 20 mg/day (doses >20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy. Adjustments should be made at intervals of ≥4 weeks.
Homozygous Familial Hypercholesterolemia: The recommended starting dose of Jbros is 20 mg once daily. Response to therapy should be estimated from pre-aphereses LDL-C levels.
Dosage in Asian Patients: Initiation of Jbros therapy with 5 mg once daily should be considered for Asian patients.
Use with Cyclosporine or Lopinavir/Ritonavir: In patients taking cyclosporine, the dose of Jbros should be limited to 5 mg once daily. In patients taking a combination of lopinavir and ritonavir, the dose of Jbros should be limited to 10 mg once daily.
Concomitant Lipid-Lowering Therapy: The risk of skeletal muscle effects may be enhanced when Jbros is used in combination with niacin or fenofibrate; a reduction in Jbros is used in combination with gemfibrozil, the dose of Jbros should be limited to 10 mg daily.
Dosage in Patients with Severe Renal Impairment: For patients with severe renal impairment (CrCl <30 mL/min/1.73 m2) not on hemodialysis, dosing of Jbros should be started at 5 mg once daily and should not exceed 10 mg once daily.
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What other drugs will affect Jbros?
Effect of Co-Administered Medicinal Products on Jbros: In vitro and in vivo data indicate that Jbros has no clinically significant cytochrome P450 interactions (as a substrate, inhibitor or inducer). Jbros is a substrate for certain transporter proteins including the hepatic uptake transporter OATP1B1 and efflux transporter BCRP. Concomitant administration of Jbros with medicinal products that are inhibitors of these transporter proteins may result in increased Jbros plasma concentrations and an increased risk of myopathy.
Interactions Requiring Jbros Dose Adjustments : When it is necessary to co-administer Jbros with other medicinal products known to increase exposure to Jbros, doses of Jbros should be adjusted. It is recommended that prescribers consult the relevant product information when considering administration of such products together with Jbros. Start with a 5 mg once daily dose of Jbros if the expected increase in exposure (AUC) is approximately 2-fold or higher. The maximum daily dose of Jbros should be adjusted so that the expected Jbros exposure would not likely exceed that of a 40 mg daily dose of Jbros taken without interacting medicinal products, for example a 5 mg dose of Jbros with ciclosporin (7.1-fold increase in exposure), a 10 mg dose of Jbros with ritonavir/atazanavir combination (3.1-fold increase) and a 20 mg dose of Jbros with gemfibrozil (1.9-fold increase).
Other Interacting Medicinal Products: Antacid: The simultaneous dosing of Jbros with an antacid suspension containing aluminum and magnesium hydroxide resulted in a decrease in Jbros plasma concentration of approximately 50%. This effect was mitigated when the antacid was dosed 2 hours after Jbros. The clinical relevance of this interaction has not been studied.
Fusidic Acid: Interaction studies with Jbros and fusidic acid have not been conducted. As with other statins, muscle related events, including rhabdomyolysis, have been reported in post-marketing experience with Jbros and fusidic acid given concurrently. Patients should be closely monitored and temporary suspension of Jbros treatment may be appropriate.
Effect of Jbros on Co-Administered Medicinal Products: Warfarin: The pharmacokinetics of warfarin are not significantly affected following co-administration with Jbros. However, as with other HMG-CoA reductase inhibitors, co-administration of Jbros and warfarin may result in a rise in INR compared to warfarin alone. In patients taking vitamin K antagonists monitoring of INR is recommended both at initiation or cessation of therapy with Jbros or following dose adjustment.
Fenofibrates/Fibric Acid Derivatives: Although no pharmacokinetic interaction between Jbros and fenofibrate was observed; a pharmacodynamic interaction may occur. Gemfibrozil, fenofibrate and other fibric acids, including nicotinic acid, may increase the risk of myopathy when given concomitantly with HMG-CoA reductase inhibitors.
Cyclosporin: Co-administration of Jbros with cyclosporin resulted in no significant changes in cyclosporin plasma concentration.
Other Medications: There were no clinically significant interactions with an oral contraceptive, digoxin, ezetimibe, or fenofibrate.
In clinical studies Jbros was co-administered with antihypertensive agents, antidiabetic agents and hormone replacement therapy. These studies did not produce any evidence of clinically significant adverse interactions.
