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Lofibra
Overview
What is Lofibra?
LOFIBRA [Fenofibrate capsules (micronized)] is a lipid regulating agent available as capsules for oral administration. The chemical name for fenofibrate is 2-[4-(4- chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula:
The empirical formula is CHOCl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions.
Each 67 mg LOFIBRAcontains the following inactive ingredients: croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, sodium lauryl sulfate, talc, D&C Red #28, FD&C Blue #1, FD&C Red #40, titanium dioxide and gelatin.
Each 134 mg LOFIBRA contains the following inactive ingredients: croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, sodium lauryl sulfate, talc, D&C Red #28, FD&C Blue #1, titanium dioxide and gelatin.
Each 200 mg LOFIBRA contains the following inactive ingredients: croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, sodium lauryl sulfate, talc, FD&C Red #40, D&C Red #28, FDA/E172 yellow iron oxide, titanium dioxide and gelatin.
What does Lofibra look like?
What are the available doses of Lofibra?
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What should I talk to my health care provider before I take Lofibra?
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How should I use Lofibra?
Fenofibrate capsules (micronized) are indicated as adjunctive therapy to diet for the reduction of LDL-C, total-C, Triglycerides and apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb. Lipid altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below).
Patients should be placed on an appropriate lipid-lowering diet before receiving LOFIBRA [Fenofibrate capsules (micronized)], and should continue this diet during treatment with LOFIBRA. LOFIBRA should be given with meals, thereby optimizing the bioavailability of the medication.
For the treatment of adult patients with primary hypercholesterolemia or mixed hyperlipidemia, the initial dose of LOFIBRA is 200 mg per day.
For adult patients with hypertriglyceridemia, the initial dose is 67 to 200 mg per day.
Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 200 mg per day.
Treatment with LOFIBRA should be initiated at a dose of 67 mg/day in patients having impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose. In the elderly, the initial dose should likewise be limited to 67 mg/day.
Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of LOFIBRAif lipid levels fall significantly below the targeted range.
What interacts with Lofibra?
LOFIBRA is contraindicated in patients who exhibit hypersensitivity to fenofibrate.
LOFIBRA is contraindicated in patients with hepatic or severe renal dysfunction, including primary biliary cirrhosis, and patients with unexplained persistent liver function abnormality.
LOFIBRA is contraindicated in patients with preexisting gallbladder disease (see ).
What are the warnings of Lofibra?
Liver Function
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Cholelithiasis
Fenofibrate, like clofibrate and gemfibrozil, may increase cholesterol excretion into the bile, leading to cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated. Fenofibrate therapy should be discontinued if gallstones are found.
Concomitant Oral Anticoagulants
Caution should be exercised when anticoagulants are given in conjunction with fenofibrate because of the potentiation of coumarin-type anticoagulants in prolonging the prothrombin time/INR. The dosage of the anticoagulant should be reduced to maintain the prothrombin time/lNR at the desired level to prevent bleeding complications. Frequent prothrombin time/INR determinations are advisable until it has been definitely determined that the prothrombin time/INR has stabilized.
Concomitant HMG-CoA Reductase Inhibitors
T
C
T
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Mortality
The effect of fenofibrate on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established.
Other Considerations
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B
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What are the precautions of Lofibra?
Initial Therapy
Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting fenofibrate therapy. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (beta-blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy.
Continued Therapy
Periodic determination of serum lipids should be obtained during initial therapy in order to establish the lowest effective dose of LOFIBRA[Fenofibrate capsules (micronized)]. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 200 mg per day.
Pancreatitis
Pancreatitis has been reported in patients taking fenofibrate, gemfibrozil, and clofibrate. This occurrence may represent a failure of efficacy in patients with severe hypertriglyceridemia, a direct drug effect, or a secondary phenomenon mediated through biliary tract stone or sludge formation with obstruction of the common bile duct.
Hypersensitivity Reactions
Acute hypersensitivity reactions including severe skin rashes requiring patient hospitalization and treatment with steroids have occurred very rarely during treatment with fenofibrate, including rare spontaneous reports of Stevens-Johnson syndrome, and toxic epidermal necrolysis. Urticaria was seen in 1.1 vs. 0%, and rash in 1.4 vs. 0.8% of fenofibrate and placebo patients respectively in controlled trials.
Hematologic Changes
Mild to moderate hemoglobin, hematocrit, and white blood cell decreases have been observed in patients following initiation of fenofibrate therapy. However, these levels stabilize during long-term administration. Extremely rare spontaneous reports of thrombocytopenia and agranulocytosis have been received during postmarketing surveillance outside of the U.S. Periodic blood counts are recommended during the first 12 months of fenofibrate administration.
Skeletal Muscle
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P
Venothromboembolic Disease
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Serum Creatinine
Elevations in serum creatinine have been reported in patients on fenofibrate. These elevations tend to return to baseline following discontinuation of fenofibrate. The clinical significance of these observations is unknown.
Drug Interactions
Oral Anticoagulants
HMG-CoA Reductase Inhibitors
The combined use of fenofibrate and HMG-CoA reductase inhibitors should be avoided unless the benefit of further alterations in lipid levels is likely to outweigh the increased risk of this drug combination (see ).
Resins
Since bile acid sequestrants may bind other drugs given concurrently, patients should take LOFIBRAat least 1 hour before or 4 to 6 hours after a bile acid binding resin to avoid impeding its absorption.
Cyclosporine
Because cyclosporine can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of fibrate drugs including fenofibrate, there is a risk that an interaction will lead to deterioration. The benefits and risks of using fenofibrate with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dose employed.
Carcinogenesis, Mutagenesis, Impairment of Fertility
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E
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Pregnancy
Pregnancy category C
Safety in pregnant women has not been established. There are no adequate and well controlled studies of fenofibrate in pregnant women. Fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
In female rats given oral dietary doses of 15, 75, and 300 mg/kg/day of fenofibrate from 15 days prior to mating through weaning, maternal toxicity was observed at 0.3 times the MRHD, based on body surface area comparisons; mg/m.
In pregnant rats given oral dietary doses of 14, 127, and 361 mg/kg/day from gestation day 6 to 15 during the period of organogenesis, adverse developmental findings were not observed at 14 mg/kg/day (less than 1 times the MRHD, based on body surface area comparisons; mg/m). At higher multiples of human doses evidence of maternal toxicity was observed.
In pregnant rabbits given oral gavage doses of 15, 150, and 300 mg/kg/day from gestation day 6 to 18 during the period of organogenesis and allowed to deliver, aborted litters were observed at 150 mg/kg/day (10 times the MRHD, based on body surface area comparisons: mg/m). No developmental findings were observed at 15 mg/kg/day (at less than 1 times the MRHD, based on body surface area comparisons: mg/m).
In pregnant rats given oral dietary doses if 15, 75, and 300 mg/kg/day from gestation day 15 through lactaction day 21 (weaning), maternal toxicity was observed at less than 1 times the MRHD, based on body surface area comparisons: mg/m.
Nursing Mothers
It is not known whether fenofibrate is excreted into milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from fenofibrate, a decision should be made whether to discontinue nursing or administration of fenofibrate taking into account the importance of the drug to the lactating woman.
Pediatric Use
Safety and efficacy in pediatric patients have not been established.
Geriatric Use
Fenofibric acid is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Fenofibric acid exposure is not influenced by age. However, elderly patients have a higher incidence of renal impairment, such that dose selection for the elderly should be made on the basis of renal function (see CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency). Elderly patients with normal renal function should require no dose modifications.
What are the side effects of Lofibra?
CLINICAL
Adverse events reported by 2% or more of patients treated with fenofibrate during the double-blind, placebo-controlled trials, regardless of causality, are listed in the table below. Adverse events led to discontinuation of treatment in 5.0% of patients treated with fenofibrate and in 3.0% treated with placebo. Increases in liver function tests were the most frequent events, causing discontinuation of fenofibrate treatment in 1.6% of patients in double-blind trials.
Additional adverse events reported during postmarketing surveillance or by three or more patients in placebo-controlled trials or reported in other controlled or open trials, regardless of causality are listed below.
BODY AS A WHOLE:
CARDIOVASCULAR SYSTEM:
DIGESTIVE SYSTEM:
ENDOCRINE SYSTEM:
HEMIC AND LYMPHATIC SYSTEM:
LABORATORY INVESTIGATIONS:
METABOLIC AND NUTRITIONAL DISORDERS:
MUSCULOSKELETAL SYSTEM:
NERVOUS SYSTEM:
RESPIRATORY SYSTEM:
SKIN AND APPENDAGES:
SPECIAL SENSES:
UROGENITAL SYSTEM:
| Abdominal Pain | 4.6% | 4.4% |
| Back pain | 3.4% | 2.5% |
| Headache | 3.2% | 2.7% |
| Asthenia | 2.1% | 3.0% |
| Flu Syndrome | 2.1% | 2.7% |
| Liver Function Tests Abnormal | 7.5% | 1.4% |
| Diarrhea | 2.3% | 4.1% |
| Nausea | 2.3% | 1.9% |
| Constipation | 2.1% | 1.4% |
| SPGT Increased | 3.0% | 1.6% |
| Creatine Phosphokinase Increased | 3.0% | 1.4% |
| SGOT Increased | 3.4% | 0.5% |
| Respiratory Disorder | 6.2% | 5.5% |
| Rhinitis | 2.3% | 1.1% |
What should I look out for while using Lofibra?
LOFIBRA is contraindicated in patients who exhibit hypersensitivity to fenofibrate.
LOFIBRA is contraindicated in patients with hepatic or severe renal dysfunction, including primary biliary cirrhosis, and patients with unexplained persistent liver function abnormality.
LOFIBRA is contraindicated in patients with preexisting gallbladder disease (see ).
What might happen if I take too much Lofibra?
There is no specific treatment for overdose with fenofibrate. General supportive care of the patient is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage; usual precautions should be observed to maintain the airway. Because fenofibrate is highly bound to plasma proteins, hemodialysis should not be considered.
How should I store and handle Lofibra?
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]PHARMACIST:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]PHARMACIST:LOFIBRA, 67 mg are opaque pink cap and body, hard gelatin capsules, printed in black ink Lofibra over 67 mg and Gate over 322 on opposing cap and body portions of the capsule. They are supplied as follows:NDC 57844-322-01 Bottles of 100 capsulesLOFIBRA, 134 mg are opaque light blue cap and body, hard gelatin capsules, printed in black ink Lofibra over 134 mg and Gate over 323 on opposing cap and body portions of the capsule. They are supplied as follows:NDC 57844-323-01 Bottles of 100 capsulesLOFIBRA, 200 mg are opaque orange cap and body, hard gelatin capsules, printed in black ink Lofibra over 200 mg and Gate over 324 on opposing cap and body portions of the capsule. They are supplied as follows:NDC 57844-324-01 Bottles of 100 capsulesLOFIBRA, 67 mg are opaque pink cap and body, hard gelatin capsules, printed in black ink Lofibra over 67 mg and Gate over 322 on opposing cap and body portions of the capsule. They are supplied as follows:NDC 57844-322-01 Bottles of 100 capsulesLOFIBRA, 134 mg are opaque light blue cap and body, hard gelatin capsules, printed in black ink Lofibra over 134 mg and Gate over 323 on opposing cap and body portions of the capsule. They are supplied as follows:NDC 57844-323-01 Bottles of 100 capsulesLOFIBRA, 200 mg are opaque orange cap and body, hard gelatin capsules, printed in black ink Lofibra over 200 mg and Gate over 324 on opposing cap and body portions of the capsule. They are supplied as follows:NDC 57844-324-01 Bottles of 100 capsulesLOFIBRA, 67 mg are opaque pink cap and body, hard gelatin capsules, printed in black ink Lofibra over 67 mg and Gate over 322 on opposing cap and body portions of the capsule. They are supplied as follows:NDC 57844-322-01 Bottles of 100 capsulesLOFIBRA, 134 mg are opaque light blue cap and body, hard gelatin capsules, printed in black ink Lofibra over 134 mg and Gate over 323 on opposing cap and body portions of the capsule. They are supplied as follows:NDC 57844-323-01 Bottles of 100 capsulesLOFIBRA, 200 mg are opaque orange cap and body, hard gelatin capsules, printed in black ink Lofibra over 200 mg and Gate over 324 on opposing cap and body portions of the capsule. They are supplied as follows:NDC 57844-324-01 Bottles of 100 capsulesLOFIBRA, 67 mg are opaque pink cap and body, hard gelatin capsules, printed in black ink Lofibra over 67 mg and Gate over 322 on opposing cap and body portions of the capsule. They are supplied as follows:NDC 57844-322-01 Bottles of 100 capsulesLOFIBRA, 134 mg are opaque light blue cap and body, hard gelatin capsules, printed in black ink Lofibra over 134 mg and Gate over 323 on opposing cap and body portions of the capsule. They are supplied as follows:NDC 57844-323-01 Bottles of 100 capsulesLOFIBRA, 200 mg are opaque orange cap and body, hard gelatin capsules, printed in black ink Lofibra over 200 mg and Gate over 324 on opposing cap and body portions of the capsule. They are supplied as follows:NDC 57844-324-01 Bottles of 100 capsulesLOFIBRA, 67 mg are opaque pink cap and body, hard gelatin capsules, printed in black ink Lofibra over 67 mg and Gate over 322 on opposing cap and body portions of the capsule. They are supplied as follows:NDC 57844-322-01 Bottles of 100 capsulesLOFIBRA, 134 mg are opaque light blue cap and body, hard gelatin capsules, printed in black ink Lofibra over 134 mg and Gate over 323 on opposing cap and body portions of the capsule. They are supplied as follows:NDC 57844-323-01 Bottles of 100 capsulesLOFIBRA, 200 mg are opaque orange cap and body, hard gelatin capsules, printed in black ink Lofibra over 200 mg and Gate over 324 on opposing cap and body portions of the capsule. They are supplied as follows:NDC 57844-324-01 Bottles of 100 capsulesLOFIBRA, 67 mg are opaque pink cap and body, hard gelatin capsules, printed in black ink Lofibra over 67 mg and Gate over 322 on opposing cap and body portions of the capsule. They are supplied as follows:NDC 57844-322-01 Bottles of 100 capsulesLOFIBRA, 134 mg are opaque light blue cap and body, hard gelatin capsules, printed in black ink Lofibra over 134 mg and Gate over 323 on opposing cap and body portions of the capsule. They are supplied as follows:NDC 57844-323-01 Bottles of 100 capsulesLOFIBRA, 200 mg are opaque orange cap and body, hard gelatin capsules, printed in black ink Lofibra over 200 mg and Gate over 324 on opposing cap and body portions of the capsule. They are supplied as follows:NDC 57844-324-01 Bottles of 100 capsules
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Clinical experience has been obtained with two different formulations of fenofibrate: a “micronized” and “non-micronized” formulation, which have been demonstrated to be bioequivalent. Comparisons of blood levels following oral administration of both formulations in healthy volunteers demonstrate that a single capsule containing 67 mg of the “micronized” formulation is bioequivalent to 100 mg of the “non-micronized” formulation. Three capsules containing 67 mg LOFIBRA are bioequivalent to a single 200 mg LOFIBRA capsule.
Non-Clinical Toxicology
LOFIBRA is contraindicated in patients who exhibit hypersensitivity to fenofibrate.LOFIBRA is contraindicated in patients with hepatic or severe renal dysfunction, including primary biliary cirrhosis, and patients with unexplained persistent liver function abnormality.
LOFIBRA is contraindicated in patients with preexisting gallbladder disease (see ).
Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting fenofibrate therapy. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (beta-blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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