Fenoglide (Page 2 of 4)

5.7 Pancreatitis

Pancreatitis has been reported in patients taking fenofibrate. 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.

5.8 Venothromboembolic Disease

In the FIELD trial, pulmonary embolus (PE) and deep vein thrombosis (DVT) were observed at higher rates in the fenofibrate- than the placebo-treated group. Of 9,795 patients enrolled in FIELD, there were 4,900 in the placebo group and 4,895 in the fenofibrate group. For DVT, there were 48 events (1%) in the placebo group and 67 (1%) in the fenofibrate group (p = 0.074); and for PE, there were 32 (0.7%) events in the placebo group and 53 (1%) in the fenofibrate group (p = 0.022).

In the Coronary Drug Project, a higher proportion of the clofibrate group experienced definite or suspected fatal or nonfatal pulmonary embolism or thrombophlebitis than the placebo group (5.2% vs. 3.3% at five years; p less than 0.01).

5.9 Hypersensitivity Reactions

Acute hypersensitivity reactions including severe skin rashes requiring patient hospitalization and treatment with steroids have occurred rarely during treatment with fenofibrate, including rare spontaneous reports of Stevens-Johnson syndrome, and toxic epidermal necrolysis.

5.10 Hematologic Changes

Mild to moderate hemoglobin, hematocrit, and white blood cell decreases have been observed in patients following initiation of fenofibrate therapy.

5.11 Concomitant HMG-CoA Reductase Inhibitors

The combined use of fenofibric acid derivatives, particularly gemfibrozil, and HMG-CoA reductase inhibitors results in an increased risk of rhabdomyolysis and myoglobinuria leading in a high proportion of cases to acute renal failure.

The combined use of Fenoglide 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 Drug Interactions (7.3).]

6 ADVERSE REACTIONS

To report SUSPECTED ADVERSE REACTIONS, contact Sciele Drug Safety Department at 1-800-849-9707 ext. 1454 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1 Clinical Studies Experience

Table 1. Adverse Reactions Reported by 2% or More of Patients Treated with Fenofibrate and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials
BODY SYSTEMAdverse Reaction Fenofibrate * (N=439) Placebo(N=365)
BODY AS A WHOLE
Abdominal Pain 4.6% 4.4%
Back Pain 3.4 % 2.5%
Headache 3.2% 2.7%
DIGESTIVE
Nausea 2.3% 1.9%
Constipation 2.1% 1.4%
INVESTIGATIONS
Abnormal Liver Tests 7.5% 1.4%
Increased AST 3.4% 0.5%
Increased ALT 3.0% 1.6%
Increased Creatine Phosphokinase 3.0% 1.4%
RESPIRATORY
Respiratory Disorder 6.2% 5.5%
Rhinitis 2.3% 1.1%

* Dosage equivalent to 130 mg fenofibrate

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of fenofibrate: myalgia, rhabdomyolysis, increased creatinine phosphokinase, pancreatitis, increased alanine aminotransaminase, increased aspartate aminotransaminase, renal failure, muscle spasms, acute renal failure, hepatitis, cirrhosis, nausea, abdominal pain, anemia, headache, arthralgia, and asthenia. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a casual relationship to drug exposure.

7 DRUG INTERACTIONS

7.1 Coumarin Anticoagulants

Caution should be exercised when coumarin anticoagulants are given in conjunction with Fenoglide. The dosage of the anticoagulants should be reduced to maintain the prothrombin time/INR 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. [see Concomitant Coumarin Anticoagulants (5.3). ]

7.2 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 Fenoglide, there is a risk that an interaction will lead to deterioration of renal function. The benefits and risks of using Fenoglide with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dose employed.

7.3 HMG-CoA Reductase Inhibitors

The combined use of fenofibric acid derivatives, particularly gemfibrozil, and HMG-CoA reductase inhibitors results in an increased risk of rhabdomyolysis and myoglobinuria leading in a high proportion of cases to acute renal failure. [See Concomitant HMG-CoA Reductase Inhibitors (5.11) ]

The combined use of Fenoglide 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.

In a single-dose drug interaction study in 23 healthy adults the concomitant administration of fenofibrate and pravastatin resulted in no clinically important difference in the pharmacokinetics of fenofibric acid, pravastatin, or its active metabolite 3α-hydroxy iso-pravastatin when compared to either drug given alone.

7.4 Bile-Acid Resins

Since bile acid sequestrants may bind other drugs given concurrently, patients should take Fenoglide at least 1 hour before or 4-6 hours after a bile acid binding resin to avoid impeding its absorption.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Fenofibrate is classified as pregnancy category C. Fenofibrate has been shown to be embryocidal and teratogenic in rats when given in doses 7 to 10 times the maximum recommended human dose and embryocidal in rabbits when given at 9 times the maximum recommended human dose (on the basis of mg/meter2 surface area). There are no adequate and well-controlled studies in pregnant women. Fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. [see Nonclinical Toxicology [13]).

8.3 Nursing Mothers

Fenofibrate should not be used in nursing mothers. Because of the potential for tumorigenicity seen in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug.

8.4 Pediatric Use

Safety and efficacy in pediatric patients have not been established.

8.5 Geriatric Use

Fenofibric acid exposure is not influenced by age. However, elderly patients have a higher incidence of renal impairment. Dose selection for the elderly should be made on the basis of renal function.

8.6 Renal Impairment

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. Fenofibrate should be avoided in patients with severe renal impairment and dose reduction is required in patients with mild to moderate renal impairment.

10 OVERDOSAGE

There is no specific treatment for overdose with Fenoglide. 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.

11 DESCRIPTION

Fenoglide (fenofibrate) Tablets, is a lipid regulating agent available as tablets for oral administration. Each tablet contains 40 mg or 120 mg fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula:

image of chemical structure

The empirical formula is C20 H21 O4 Cl 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.

Inactive Ingredients: Each tablet contains lactose monohydrate, NF; Polyethylene Glycol 6000, NF; Poloxamer 188, NF; and magnesium stearate, NF.

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