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LIPOFEN (FENOFIBRATE)
- High density lipoprotein deficiency
- Hypercholesterolemia
- Hypertriglyceridemia
- Heterozygous familial hypercholesterolemia
- Hyperlipidemia
- Mixed hyperlipidemia
150 mg capsule
- 1 capsule (150 mg) by oral route once daily with food
50 mg capsule
- 1 capsule (50 mg) by oral route once daily with a meal
150 mg capsule
- 1 capsule (150 mg) by oral route once daily with food
50 mg capsule
- 1 capsule (50 mg) by oral route once daily with a meal
Heterozygous familial hypercholesterolemia
- 1 capsule (50 mg) by oral route once daily with a meal
- 2 capsules (100 mg) by oral route once daily with a meal
- 1 capsule (150 mg) by oral route once daily with food
Hypercholesterolemia
- 1 capsule (150 mg) by oral route once daily with food
Hyperlipidemia
- 1 capsule (50 mg) by oral route once daily with a meal
- 2 capsules (100 mg) by oral route once daily with a meal
- 1 capsule (150 mg) by oral route once daily with food
Hypertriglyceridemia
- 1 capsule (50 mg) by oral route once daily with a meal
- 1 capsule (150 mg) by oral route once daily with food
Mixed hyperlipidemia
- 1 capsule (150 mg) by oral route once daily with food
- None
Contraindicated
- Actoplus Met
- Actoplus Met Xr
- Actos
- alogliptin-pioglitazone
- Coumadin
- Duetact
- Jantoven
- Oseni
- pioglitazone
- pioglitazone-glimepiride
- pioglitazone-metformin
- warfarin
Severe
Moderate
- cholestyramine (with sugar)
- Cholestyramine Light
- cholestyramine-aspartame
- colchicine
- colchicine-probenecid
- Colcrys
- colesevelam
- Colestid
- Colestid Flavored
- colestipol
- ezetimibe
- ezetimibe-atorvastatin
- ezetimibe-simvastatin
- Liptruzet
- Prevalite
- Questran
- Questran Light
- Vytorin 10-10
- Vytorin 10-20
- Vytorin 10-40
- Vytorin 10-80
- Welchol
- Zetia
- Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
- Chronic kidney disease stage 5 (failure) GFr<15 ml/min
- Lactating mother
Contraindicated
- Abnormal hepatic function tests
- Acute pancreatitis
- Agranulocytosis
- Anemia
- Chronic kidney disease stage 2 (mild) GFR 60-89 ml/min
- Chronic kidney disease stage 3A (moderate) GFR 45-59
- Chronic kidney disease stage 3B (moderate) GFR 30-44
- Disease of liver
- Gallbladder disease
- Leukopenia
- Myopathy
- Myositis
- Primary biliary cirrhosis
- Rhabdomyolysis
- Thrombocytopenic disorder
- Thromboembolic disorder
Severe
Moderate
- None
LIPOFEN (FENOFIBRATE)
- High density lipoprotein deficiency
- Hypercholesterolemia
- Hypertriglyceridemia
- Heterozygous familial hypercholesterolemia
- Hyperlipidemia
- Mixed hyperlipidemia
- Abnormal hepatic function tests
- Rhinitis
More Frequent
Severe
Less Severe
- Infection
- Myalgias
- Pruritus of skin
- Skin rash
- Thrombophlebitis
- Urticaria
- Acute abdominal pain
- Back pain
- Constipation
- Dizziness
- Eructation
- Flatulence
- Flu-like symptoms
- General weakness
- Headache disorder
- Libido changes
- Myopathy
- Nausea
- Ocular irritation
- Pharyngitis
- Skin photosensitivity
- Upper respiratory infection
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Acute pancreatitis
- Acute renal failure
- Agranulocytosis
- Anaphylaxis
- Angioedema
- Biliary calculus
- Cholecystitis
- DRESS syndrome
- Eczema
- Hepatic cirrhosis
- Hepatitis
- Hypersensitivity pneumonitis
- Interstitial lung disease
- Muscle weakness
- Myositis
- Neutropenic disorder
- Pulmonary thromboembolism
- Respiration changes
- Rhabdomyolysis
- Stevens-johnson syndrome
- Thrombocytopenic disorder
- Toxic epidermal necrolysis
- Venous thrombosis
Less Severe
- Anemia
- Arthralgias
- Cough
- Diarrhea
- Dyspepsia
- High density lipoprotein deficiency
- Insomnia
- Muscle spasm
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Fibric Acid Derivatives
Safety and efficacy not established in pediatrics.
- 1 Day – 18 Years
- Safety and efficacy not established in pediatrics.
Fenofibric Acid Derivatives
- Severity Level:
2
- Additional Notes: Insufficient human data
Contraindicated
Fenofibrate
Avoid breastfeeding during treatment and for 5 days after last dose
| General | Excretion Potential | Effect on Infant | Notes |
| Drug should not be given to breast feeding mothers | Unknown | Not known; no or inclusive data | Avoid breastfeeding during treatment and for 5 days after last dose |
Precaution Exists
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
Fenofibrate Derivatives
General-Elderly patients and patients with diabetes, hypothyroidism, or renal insufficiency are at increased risk for serious muscle toxicity. Renal-Avoid use in patients with mild to moderate renal impairment. Contraindicated in those with severe renal impairment. Consider monitoring renal function.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | Y | N | N | N | N | N |
BEERS: N HEDIS: N STOPP: N
No Known Risk
None
- None
| Heterozygous familial hypercholesterolemia | |
| E78.01 | Familial hypercholesterolemia |
| High density lipoprotein deficiency | |
| E78.6 | Lipoprotein deficiency |
| Hypercholesterolemia | |
| E78.0 | Pure hypercholesterolemia |
| E78.00 | Pure hypercholesterolemia, unspecified |
| E78.01 | Familial hypercholesterolemia |
| Hyperlipidemia | |
| E78.2 | Mixed hyperlipidemia |
| E78.4 | Other hyperlipidemia |
| E78.49 | Other hyperlipidemia |
| E78.5 | Hyperlipidemia, unspecified |
| Hypertriglyceridemia | |
| E78.1 | Pure hyperglyceridemia |
| E78.2 | Mixed hyperlipidemia |
| Mixed hyperlipidemia | |
| E78.2 | Mixed hyperlipidemia |
| 0-9 | A-Z |
|---|---|
| E78.0 | Pure hypercholesterolemia |
| E78.00 | Pure hypercholesterolemia, unspecified |
| E78.01 | Familial hypercholesterolemia |
| E78.01 | Familial hypercholesterolemia |
| E78.1 | Pure hyperglyceridemia |
| E78.2 | Mixed hyperlipidemia |
| E78.2 | Mixed hyperlipidemia |
| E78.2 | Mixed hyperlipidemia |
| E78.4 | Other hyperlipidemia |
| E78.49 | Other hyperlipidemia |
| E78.5 | Hyperlipidemia, unspecified |
| E78.6 | Lipoprotein deficiency |
Formulary Reference Tool