What are the possible side effects of Colesvir?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
In rare cases, Colesvir can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.
Also call your doctor at once if you have:
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signs of a kidney problem--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath; or
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liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common side effects may include:
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constipation, stomach pain;
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muscle cramps; or
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headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Colesvir in details
Colesvir™ (Colesvir extended-release tablets)
Colesvir™ (Colesvir extended-release tablets) Clinical Studies
In clinical studies with Colesvir™ (Colesvir extended-release tablets), adverse reactions have generally been mild and transient. In controlled studies with 467 patients who received Colesvir™ (Colesvir extended-release tablets), < 3% of patients were discontinued due to adverse experiences attributable to Colesvir (Colesvir extended-release tablets) ™. This was similar to the discontinuation rate in the placebo and Colesvir immediate-release treatment groups. Pooled results from clinical studies with Colesvir™ (Colesvir extended-release tablets) show that the most frequently reported adverse reactions in the Colesvir™ (Colesvir extended-release tablets) group were infection, headache and accidental injury. Similar incidences of these adverse reactions were seen in the Colesvir and placebo groups. The most frequent adverse events thought to be related to Colesvir™ (Colesvir extended-release tablets) were nausea, abdominal pain, insomnia, dyspepsia, headache, asthenia, and myalgia. In controlled trials (e.g., vs. placebo and vs. Colesvir immediate-release), clinical adverse experiences reported as ≥ 5% in any treatment group are shown in Table VII below.
Table VII: Pooled Controlled Studies TESS by Body System and COSTART Term, Most Common ( ≥ 5% in Any Group)
| Randomized Patients | Treatment | |||
| n = | Placebo 34 | Colesvir™ 467 | MEVACOR™ 329 | |
| Body System | COSTART Term | |||
| Body as a Whole | Infection | 3 (9) | 52 (11) | 52 (16) |
| Accidental Injury | 3 (9) | 26 (6) | 12 (4) | |
| Asthenia | 2 (6) | 12 (3) | 6 (2) | |
| Headache | 2 (6) | 34 (7) | 26 (8) | |
| Back Pain | 1 (3) | 23 (5) | 18 (5) | |
| Flu Syndrome | 1 (3) | 24 (5) | 18 (5) | |
| Pain | 0 | 14 (3) | 17 (5) | |
| Digestive | Diarrhea | 2 (6) | 15 (3) | 8 (2) |
| Musculoskeletal | Arthralgia | 2 (6) | 24 (5) | 20 (6) |
| Myalgia | 5 (15) | 14 (3) | 11 (3) | |
| Nervous | Dizziness | 2 (6) | 10 (2) | 5 (2) |
| Respiratory | Sinusitis | 1 (3) | 17 (4) | 20 (6) |
| Urogenital | Urinary Tract Infection | 2 (6) | 8 (2) | 9 (3) |
Colesvir Immediate-Release
Colesvir Immediate-Release Phase III Clinical Studies
In Phase III controlled clinical studies involving 613 patients treated with Colesvir immediate-release, the adverse experience profile was similar to that shown below for the 8,245-patient EXCEL study. Persistent increases of serum transaminases have been noted. About 11% of patients had elevations of CK levels of at least twice the normal value on one or more occasions. The corresponding values for the control agent cholestyramine was 9 %. This was attributable to the noncardiac fraction of CK. Large increases in CK have sometimes been reported.
Expanded Clinical Evaluation of Colesvir (EXCEL) Study
Colesvir immediate-release was compared to placebo in 8,245 patients with hypercholesterolemia [Total-C 240-300 mg/dL (6.2-7.8 mmol/L)] in the randomized, double-blind, parallel, 48-week EXCEL study. Clinical adverse experiences reported as possibly, probably or definitely drug-related in ≥ 1% in any treatment group are shown in the table below. For no event was the incidence on drug and placebo statistically different.
Table VIII: Clinical Adverse Events Reported as Possibly, Probably or Definitely Drug-Related in ≥ 1% in Any Treatment Group in the EXCEL Study
| Placebo (N=1663) % | Colesvir IR 20 mg q.p.m. (N=1642) % | Colesvir IR 40 mg q.p.m. (N=1645) % | Colesvir IR 20 mg b.i.d. (N=1646) % | Colesvir IR 40 mg b.i.d. (N=1649) % | |
| Body As a Whole | |||||
| Asthenia | 1.4 | 1.7 | 1.4 | 1.5 | 1.2 |
| Gastrointestinal | |||||
| Abdominal pain | 1.6 | 2.0 | 2.0 | 2.2 | 2.5 |
| Constipation | 1.9 | 2.0 | 3.2 | 3.2 | 3.5 |
| Diarrhea | 2.3 | 2.6 | 2.4 | 2.2 | 2.6 |
| Dyspepsia | 1.9 | 1.3 | 1.3 | 1.0 | 1.6 |
| Flatulence | 4.2 | 3.7 | 4.3 | 3.9 | 4.5 |
| Nausea | 2.5 | 1.9 | 2.5 | 2.2 | 2.2 |
| Musculoskeletal | |||||
| Muscle cramps | 0.5 | 0.6 | 0.8 | 1.1 | 1.0 |
| Myalgia | 1.7 | 2.6 | 1.8 | 2.2 | 3.0 |
| Nervous System/Psychiatric | |||||
| Dizziness | 0.7 | 0.7 | 1.2 | 0.5 | 0.5 |
| Headache | 2.7 | 2.6 | 2.8 | 2.1 | 3.2 |
| Skin Rash | 0.7 | 0.8 | 1.0 | 1.2 | 1.3 |
| Special Senses | |||||
| Blurred vision | 0.8 | 1.1 | 0.9 | 0.9 | 1.2 |
Other clinical adverse experiences reported as possibly, probably or definitely drug-related in 0.5% to 1.0% of patients in any drug-treated group are listed below. In all these cases the incidence on drug and placebo was not statistically different. Body as a Whole: chest pain; Gastrointestinal: acid regurgitation, dry mouth, vomiting; Musculoskeletal: leg pain, shoulder pain, arthralgia; Nervous System/Psychiatric: insomnia, paresthesia; Skin: alopecia, pruritus; Special Senses: eye irritation.
In the EXCEL study, 4.6% of the patients treated up to 48 weeks were discontinued due to clinical or laboratory adverse experiences which were rated by the investigator as possibly, probably or definitely related to therapy with Colesvir immediate-release. The value for the placebo group was 2.5%.
Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS)
In AFCAPS/TexCAPS involving 6,605 participants treated with 20-40 mg/day of Colesvir immediate-release (n=3,304) or placebo (n=3,301), the safety and tolerability profile of the group treated with Colesvir immediate-release was comparable to that of the group treated with placebo during a median of 5.1 years of follow-up. The adverse experiences reported in
AFCAPS/TexCAPS were similar to those reported in EXCEL.
Concomitant Therapy
In controlled clinical studies in which Colesvir immediate-release was administered concomitantly with cholestyramine, no adverse reactions peculiar to this concomitant treatment were observed. The adverse reactions that occurred were limited to those reported previously with Colesvir or cholestyramine. Other lipid-lowering agents were not administered concomitantly with Colesvir during controlled clinical studies. Preliminary data suggests that the addition of gemfibrozil to therapy with Colesvir is not associated with greater reduction in LDL-C than that achieved with Colesvir alone. In uncontrolled clinical studies, most of the patients who have developed myopathy were receiving concomitant therapy with cyclosporine, gemfibrozil or niacin (nicotinic acid)
The following effects have been reported with drugs in this class. Not all the effects listed below have necessarily been associated with Colesvir therapy.
Skeletal: muscle cramps, myalgia, myopathy, rhabdomyolysis, arthralgias.
Neurological: dysfunction of certain cranial nerves (including alteration of taste, impairment of extra-ocular movement, facial paresis), tremor, dizziness, vertigo, memory loss, paresthesia, peripheral neuropathy, peripheral nerve palsy, psychic disturbances, anxiety, insomnia, depression.
Hypersensitivity Reactions: An apparent hypersensitivity syndrome has been reported rarely which has included one or more of the following features: anaphylaxis, angioedema, lupus erythematous-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, ESR increase, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, erythema multiforme, including Stevens-Johnson syndrome.
Gastrointestinal: pancreatitis, hepatitis, including chronic active hepatitis, cholestatic jaundice, fatty change in liver; and rarely, cirrhosis, fulminant hepatic necrosis, and hepatoma; anorexia, vomiting.
Skin: alopecia, pruritus. A variety of skin changes (e.g., nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails) have been reported.
Reproductive: gynecomastia, loss of libido, erectile dysfunction.
Eye: progression of cataracts (lens opacities), ophthalmoplegia.
Laboratory Abnormalities: elevated transaminases, alkaline phosphatase, y-glutamyl transpeptidase, and bilirubin; thyroid function abnormalities.
What is the most important information I should know about Colesvir?
- Colesvir extended-release tablets may cause dizziness or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Colesvir extended-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Colesvir extended-release tablets may cause liver problems. Rarely, severe and sometimes fatal liver problems have been reported in patients taking "statin" medicines, including Colesvir extended-release tablets. Your risk of developing liver problems may be greater if you drink alcohol daily or in large amounts with Colesvir extended-release tablets or if you have a history of liver problems. Check with your doctor before drinking alcohol while you are taking Colesvir extended-release tablets. Tell your doctor right away if you experience symptoms of liver problems (eg, dark urine; pale stools; severe or persistent nausea, loss of appetite, or stomach pain; unusual tiredness; yellowing of the skin or eyes).
- Follow the diet and exercise program given to you by your health care provider.
- Tell your doctor or dentist that you take Colesvir extended-release tablets before you receive any medical or dental care, emergency care, or surgery.
- Women who may become pregnant should use effective birth control while taking Colesvir extended-release tablets. Check with your doctor if you have questions about using birth control.
- Do NOT take more than the recommended dose without checking with your doctor.
- Muscle problems (myopathy) may occur with Colesvir extended-release tablets. Report any unexplained muscle pain, tenderness, or weakness to your doctor right away, especially if you also have a fever or general body discomfort. Tell your doctor if you have muscle problems that persist even after your doctor has told you to stop taking Colesvir extended-release tablets.
- Diabetes patients - Colesvir extended-release tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Lab tests, including blood cholesterol levels, liver function, and creatine phosphokinase (CPK) blood levels, may be performed while you use Colesvir extended-release tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Colesvir extended-release tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially serious muscle problems.
- Colesvir extended-release tablets should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use Colesvir extended-release tablets if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Colesvir extended-release tablets is found in breast milk. Do not breast-feed while you are taking Colesvir extended-release tablets.
Colesvir contraindications
Hypersensitivity to any component of this medication. Active liver disease or unexplained persistent elevations of serum transaminases.
Pregnancy and Lactation
Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. Moreover, cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes. Because of the ability of inhibitors of HMG-CoA reductase such as Colesvir™ (Colesvir extended-release tablets) to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway, Colesvir™ (Colesvir extended-release tablets) is contraindicated during pregnancy and in nursing mothers. Colesvir™ (Colesvir extended-release tablets) should be administered to women of childbearing age only when such patients are highly unlikely to conceive. If the patient becomes pregnant while taking this drug, Colesvir™ (Colesvir extended-release tablets) should be discontinued immediately and the patient should be apprised of the potential hazard to the fetus.
References
- DailyMed. "LOVASTATIN: 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).
- DTP/NCI. "lovastatin: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "(1S,3R,7S,8S,8aR)-8-{2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl}-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl (2S)-2-methylbutanoate: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Colesvir are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Colesvir. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
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Information checked by Dr. Sachin Kumar, MD Pharmacology
