Rosufen Uses

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• Rosufen indications
• Uses of Rosufen in details
• Rosufen description
• Rosufen dosage
• Rosufen interactions
• Rosufen side effects
• Rosufen contraindications

What is Rosufen?

Rosufen (Rosufen) belongs to a a group of drugs called HMG CoA reductase inhibitors, or "statins." Rosufen 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).

Rosufen 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.

Rosufen 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.

Rosufen 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, Rosufen can be used in children who are at least 8 years old. For the homozygous type, Rosufen can be used in children as young as 7 years old.

Rosufen indications

Rosufen 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, Rosufen 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: Rosufen 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). Rosufen 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: Rosufen is indicated to reduce the Total Cholesterol, LDL-C and Apo B in patients with heterozygous familial hypercholesterolaemia (HeFH).

How should I use Rosufen?

Use Rosufen as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Rosufen. Talk to your pharmacist if you have questions about this information.
• Take Rosufen by mouth with or without food.
• Swallow the tablets whole.
• If you also take an antacid that has aluminum or magnesium in it, take it at least 2 hours after taking Rosufen. Check with your doctor if you have any questions.
• Taking Rosufen at the same time each day will help you remember to take it.
• Continue to take Rosufen even if you feel well. Do not miss any doses.
• If you miss a dose of Rosufen, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once or within 12 hours of each other.

Ask your health care provider any questions you may have about how to use Rosufen.

Uses of Rosufen in details

• Rosufen is used for the treatment of high cholesterol, high LDL, high triglycerides and low HDL in addition to diet, when response to non-medicine options (diet, exercise and weight loss) is not adequate.
• It is also used to lower the risk of stroke, heart attack, or other heart complications in people who are at high risk of heart diseases, as an adjuvant to correction of the risk factors.

Rosufen description

Rosufen 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.

Rosufen is a synthetic lipid-lowering agent for oral administration. The chemical name for Rosufen 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.

Rosufen dosage

General Dosing Information: The dose range for Rosufen is 5-40 mg orally once daily.

Rosufen can be administered as a single dose at any time of the day, with or without food. When initiating Rosufen therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate Rosufen 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 Rosufen 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 Rosufen 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 Rosufen, 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 Rosufen 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 Rosufen is 20 mg once daily. Response to therapy should be estimated from pre-aphereses LDL-C levels.

Dosage in Asian Patients: Initiation of Rosufen 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 Rosufen should be limited to 5 mg once daily. In patients taking a combination of lopinavir and ritonavir, the dose of Rosufen should be limited to 10 mg once daily.

Concomitant Lipid-Lowering Therapy: The risk of skeletal muscle effects may be enhanced when Rosufen is used in combination with niacin or fenofibrate; a reduction in Rosufen is used in combination with gemfibrozil, the dose of Rosufen 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 Rosufen should be started at 5 mg once daily and should not exceed 10 mg once daily.

Rosufen interactions

See also:
What other drugs will affect Rosufen?

Effect of Co-Administered Medicinal Products on Rosufen: In vitro and in vivo data indicate that Rosufen has no clinically significant cytochrome P450 interactions (as a substrate, inhibitor or inducer). Rosufen is a substrate for certain transporter proteins including the hepatic uptake transporter OATP1B1 and efflux transporter BCRP. Concomitant administration of Rosufen with medicinal products that are inhibitors of these transporter proteins may result in increased Rosufen plasma concentrations and an increased risk of myopathy.

Interactions Requiring Rosufen Dose Adjustments : When it is necessary to co-administer Rosufen with other medicinal products known to increase exposure to Rosufen, doses of Rosufen should be adjusted. It is recommended that prescribers consult the relevant product information when considering administration of such products together with Rosufen. Start with a 5 mg once daily dose of Rosufen if the expected increase in exposure (AUC) is approximately 2-fold or higher. The maximum daily dose of Rosufen should be adjusted so that the expected Rosufen exposure would not likely exceed that of a 40 mg daily dose of Rosufen taken without interacting medicinal products, for example a 5 mg dose of Rosufen with ciclosporin (7.1-fold increase in exposure), a 10 mg dose of Rosufen with ritonavir/atazanavir combination (3.1-fold increase) and a 20 mg dose of Rosufen with gemfibrozil (1.9-fold increase).

Other Interacting Medicinal Products: Antacid: The simultaneous dosing of Rosufen with an antacid suspension containing aluminum and magnesium hydroxide resulted in a decrease in Rosufen plasma concentration of approximately 50%. This effect was mitigated when the antacid was dosed 2 hours after Rosufen. The clinical relevance of this interaction has not been studied.

Fusidic Acid: Interaction studies with Rosufen and fusidic acid have not been conducted. As with other statins, muscle related events, including rhabdomyolysis, have been reported in post-marketing experience with Rosufen and fusidic acid given concurrently. Patients should be closely monitored and temporary suspension of Rosufen treatment may be appropriate.

Effect of Rosufen on Co-Administered Medicinal Products: Warfarin: The pharmacokinetics of warfarin are not significantly affected following co-administration with Rosufen. However, as with other HMG-CoA reductase inhibitors, co-administration of Rosufen 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 Rosufen or following dose adjustment.

Fenofibrates/Fibric Acid Derivatives: Although no pharmacokinetic interaction between Rosufen 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 Rosufen 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 Rosufen was co-administered with antihypertensive agents, antidiabetic agents and hormone replacement therapy. These studies did not produce any evidence of clinically significant adverse interactions.

Rosufen side effects

See also:
What are the possible side effects of Rosufen?

Rosufen is generally well tolerated. The adverse events seen with Rosufen are generally mild and transient. In controlled clinical trials less than 4% of Rosufen 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 Rosufen 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 Rosufen 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 Rosufen. Increases in HbA1c have also been observed in patients treated with Rosufen. Abnormal urinalysis testing (dipstick-positive proteinuria) has been seen in a small number of patients taking Rosufen 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 Rosufen was shown to have no harmful effects on the ocular lens.

In Rosufen 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 Rosufen: 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 Rosufen 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.

Rosufen contraindications

See also:
What is the most important information I should know about Rosufen?

Hypersensitivity to Rosufen or to any of the excipients of Rosufen Sandoz.

Hepatic impairment; severe renal impairment; repeated or unexplained muscle aches or pain (myopathy); ciclosporin (eg, used after organ transplants).

In addition, the 40 mg dose of Rosufen Sandoz is contraindicated in: Repeated or unexplained muscle aches or pains (myopathy), a personal or family history of muscle problems or a previous history of muscle problems when taking other cholesterol-lowering drugs; moderate renal impairment; thyroid gland disorders; regular consumption of large amounts of alcohol; if taking fibrates to lower cholesterol; Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).

Use in pregnancy & lactation: Rosufen Sandoz should not be taken by pregnant and breastfeeding women. If the patient become pregnant while taking Rosufen Sandoz, stop taking it immediately and inform the physician. Women should avoid becoming pregnant while taking Rosufen Sandoz by using suitable contraception.

Active ingredient matches for Rosufen:

Rosuvastatin in Argentina.

Fenofibrate/rosuvastatin Ca in Philippines.

References

1. DailyMed. "ROSUVASTATIN CALCIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. DailyMed. "FENOFIBRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
3. PubChem. "Rosuvastatin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology