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Zetia
Overview
What is Zetia?
ZETIA (ezetimibe) is in a class of lipid-lowering compounds that
selectively inhibits the intestinal absorption of cholesterol and related
phytosterols. The chemical name of ezetimibe is
1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone.
The empirical formula is CHFNO. Its
molecular weight is 409.4 and its structural formula is:
Ezetimibe is a white, crystalline powder that is freely to very soluble in
ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe has
a melting point of about 163°C and is stable at ambient temperature. ZETIA is
available as a tablet for oral administration containing 10 mg of ezetimibe and
the following inactive ingredients: croscarmellose sodium NF, lactose
monohydrate NF, magnesium stearate NF, microcrystalline cellulose NF, povidone
USP, and sodium lauryl sulfate NF.
What does Zetia look like?
What are the available doses of Zetia?
10-mg tablets are white to off-white, capsule-shaped tablets debossed with "414"
on one side.
What should I talk to my health care provider before I take Zetia?
8.1 Pregnancy
Pregnancy Category C:
There are no adequate and well-controlled studies of ezetimibe in pregnant
women. Ezetimibe should be used during pregnancy only if the potential benefit
justifies the risk to the fetus.
In oral (gavage) embryo-fetal development studies of ezetimibe conducted in
rats and rabbits during organogenesis, there was no evidence of embryolethal
effects at the doses tested (250, 500, 1000 mg/kg/day). In rats, increased
incidences of common fetal skeletal findings (extra pair of thoracic ribs,
unossified cervical vertebral centra, shortened ribs) were observed at 1000
mg/kg/day (~10 × the human exposure at 10 mg daily based on AUC for total ezetimibe). In rabbits treated with ezetimibe,
an increased incidence of extra thoracic ribs was observed at 1000 mg/kg/day
(150 × the human exposure at 10 mg daily based on AUC for total ezetimibe). Ezetimibe crossed the placenta
when pregnant rats and rabbits were given multiple oral doses.
Multiple-dose studies of ezetimibe given in combination with statins in rats
and rabbits during organogenesis result in higher ezetimibe and statin
exposures. Reproductive findings occur at lower doses in combination therapy
compared to monotherapy.
All statins are contraindicated in pregnant and nursing
women. When ZETIA is administered with a statin in a woman of childbearing
potential, refer to the pregnancy category and product labeling for the statin.
It is not known whether ezetimibe is excreted into human breast
milk. In rat studies, exposure to total ezetimibe in nursing pups was up to half
of that observed in maternal plasma. Because many drugs are excreted in human
milk, caution should be exercised when ZETIA is administered to a nursing woman.
ZETIA should not be used in nursing mothers unless the potential benefit
justifies the potential risk to the infant.
The effects of ZETIA co-administered with simvastatin (n=126)
compared to simvastatin monotherapy (n=122) have been evaluated in adolescent
boys and girls with heterozygous familial hypercholesterolemia (HeFH). In a
multicenter, double-blind, controlled study followed by an open-label phase, 142
boys and 106 postmenarchal girls, 10 to 17 years of age (mean age 14.2 years,
43% females, 82% Caucasians, 4% Asian, 2% Blacks, 13% multi-racial) with HeFH
were randomized to receive either ZETIA co-administered with simvastatin or
simvastatin monotherapy. Inclusion in the study required 1) a baseline LDL-C
level between 160 and 400 mg/dL and 2) a medical history and clinical
presentation consistent with HeFH. The mean baseline LDL-C value was 225 mg/dL
(range: 161–351 mg/dL) in the ZETIA co-administered with simvastatin group
compared to 219 mg/dL (range: 149–336 mg/dL) in the simvastatin monotherapy
group. The patients received co-administered ZETIA and simvastatin (10 mg, 20
mg, or 40 mg) or simvastatin monotherapy (10 mg, 20 mg, or 40 mg) for 6 weeks,
co-administered ZETIA and 40 mg simvastatin or 40 mg simvastatin monotherapy for
the next 27 weeks, and open-label co-administered ZETIA and simvastatin (10 mg,
20 mg, or 40 mg) for 20 weeks thereafter.
The results of the study at Week 6 are summarized in . Results at Week 33 were consistent with those at Week 6.
From the start of the trial to the end of Week 33, discontinuations due to an
adverse reaction occurred in 7 (6%) patients in the ZETIA co-administered with
simvastatin group and in 2 (2%) patients in the simvastatin monotherapy
group.
During the trial, hepatic transaminase elevations (two consecutive
measurements for ALT and/or AST greater than or equal to 3 × ULN) occurred in four (3%) individuals in
the ZETIA co-administered with simvastatin group and in two (2%) individuals in
the simvastatin monotherapy group. Elevations of CPK (greater than or equal to 10 × ULN) occurred in two
(2%) individuals in the ZETIA co-administered with simvastatin group and in zero
individuals in the simvastatin monotherapy group.
In this limited controlled study, there was no significant effect on growth
or sexual maturation in the adolescent boys or girls, or on menstrual cycle
length in girls.
Co-administration of ZETIA with simvastatin at doses greater than 40 mg/day
has not been studied in adolescents. Also, ZETIA has not been studied in
patients younger than 10 years of age or in pre-menarchal girls.
Based on total ezetimibe (ezetimibe + ezetimibe-glucuronide), there are no
pharmacokinetic differences between adolescents and adults. Pharmacokinetic data
in the pediatric population less than 10 years of age are not available.
Monotherapy Studies
Of the 2396 patients who received ZETIA in clinical studies, 669 (28%) were
65 and older, and 111 (5%) were 75 and older.
Statin Co-Administration Studies
Of the 11,308 patients who received ZETIA + statin in clinical studies, 3587
(32%) were 65 and older, and 924 (8%) were 75 and older.
No overall differences in safety and effectiveness were observed between
these patients and younger patients, and other reported clinical experience has
not identified differences in responses between the elderly and younger
patients, but greater sensitivity of some older individuals cannot be ruled out
.
ZETIA is not recommended in patients with moderate to severe
hepatic impairment and .
ZETIA given concomitantly with a statin is contraindicated in patients with
active liver disease or unexplained persistent elevations of hepatic
transaminase levels; .
How should I use Zetia?
Therapy with lipid-altering agents should be only one component
of multiple risk factor intervention in individuals at significantly increased
risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug
therapy is indicated as an adjunct to diet when the response to a diet
restricted in saturated fat and cholesterol and other nonpharmacologic measures
alone has been inadequate.
Monotherapy
ZETIA,
administered alone, is indicated as adjunctive therapy to diet for the reduction
of elevated total cholesterol (total-C), low-density lipoprotein cholesterol
(LDL-C), and apolipoprotein B (Apo B) in patients with primary (heterozygous
familial and non-familial) hyperlipidemia.
Combination Therapy with HMG-CoA Reductase
Inhibitors (Statins)
ZETIA, administered in combination with a 3-hydroxy-3-methylglutaryl-coenzyme
A (HMG-CoA) reductase inhibitor (statin), is indicated as adjunctive therapy to
diet for the reduction of elevated total-C, LDL-C, and Apo B in patients with
primary (heterozygous familial and non-familial) hyperlipidemia.
Combination Therapy with Fenofibrate
ZETIA, administered in combination with fenofibrate, is indicated as
adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B,
and non-high-density lipoprotein cholesterol (non-HDL-C) in adult patients with
mixed hyperlipidemia.
The combination of ZETIA and atorvastatin or simvastatin is
indicated for the reduction of elevated total-C and LDL-C levels in patients
with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL
apheresis) or if such treatments are unavailable.
ZETIA is indicated as adjunctive therapy to diet for the
reduction of elevated sitosterol and campesterol levels in patients with
homozygous familial sitosterolemia.
The effect of ZETIA on cardiovascular morbidity and mortality has
not been determined.
ZETIA has not been studied in Fredrickson Type I, III, IV, and V
dyslipidemias.
The recommended dose of ZETIA is 10 mg once daily.
ZETIA can be administered with or without food.
ZETIA may be administered with a statin (in patients with primary
hyperlipidemia) or with fenofibrate (in patients with mixed hyperlipidemia) for
incremental effect. For convenience, the daily dose of ZETIA may be taken at the
same time as the statin or fenofibrate, according to the dosing recommendations
for the respective medications.
Dosing of ZETIA should occur either ≥2 hours before or ≥4 hours
after administration of a bile acid sequestrant .
No dosage adjustment is necessary in patients with mild hepatic
impairment .
No dosage adjustment is necessary in patients with renal
impairment
No dosage adjustment is necessary in geriatric patients .
What interacts with Zetia?
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What are the warnings of Zetia?
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What are the precautions of Zetia?
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What are the side effects of Zetia?
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What should I look out for while using Zetia?
ZETIA is contraindicated in the following conditions:
Drug Interactions:
Array
WARNINGS
What might happen if I take too much Zetia?
In clinical studies, administration of ezetimibe, 50 mg/day to 15
healthy subjects for up to 14 days, or 40 mg/day to 18 patients with primary
hyperlipidemia for up to 56 days, was generally well tolerated.
A few cases of overdosage with ZETIA have been reported; most have not been
associated with adverse experiences. Reported adverse experiences have not been
serious. In the event of an overdose, symptomatic and supportive measures should
be employed.
How should I store and handle Zetia?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].No. 3861 — Tablets ZETIA, 10 mg, are white to off-white, capsule-shaped tablets debossed with "414" on one side. They are supplied as follows: NDCNDC.StorageStore at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.] Protect from moisture. No. 3861 — Tablets ZETIA, 10 mg, are white to off-white, capsule-shaped tablets debossed with "414" on one side. They are supplied as follows: NDCNDC.StorageStore at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.] Protect from moisture. No. 3861 — Tablets ZETIA, 10 mg, are white to off-white, capsule-shaped tablets debossed with "414" on one side. They are supplied as follows: NDCNDC.StorageStore at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.] Protect from moisture. No. 3861 — Tablets ZETIA, 10 mg, are white to off-white, capsule-shaped tablets debossed with "414" on one side. They are supplied as follows: NDCNDC.StorageStore at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.] Protect from moisture. No. 3861 — Tablets ZETIA, 10 mg, are white to off-white, capsule-shaped tablets debossed with "414" on one side. They are supplied as follows: NDCNDC.StorageStore at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.] Protect from moisture. No. 3861 — Tablets ZETIA, 10 mg, are white to off-white, capsule-shaped tablets debossed with "414" on one side. They are supplied as follows: NDCNDC.StorageStore at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.] Protect from moisture.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Ezetimibe reduces blood cholesterol by inhibiting the absorption
of cholesterol by the small intestine. In a 2-week clinical study in 18
hypercholesterolemic patients, ZETIA inhibited intestinal cholesterol absorption
by 54%, compared with placebo. ZETIA had no clinically meaningful effect on the
plasma concentrations of the fat-soluble vitamins A, D, and E (in a study of 113
patients), and did not impair adrenocortical steroid hormone production (in a
study of 118 patients).
The cholesterol content of the liver is derived predominantly from three
sources. The liver can synthesize cholesterol, take up cholesterol from the
blood from circulating lipoproteins, or take up cholesterol absorbed by the
small intestine. Intestinal cholesterol is derived primarily from cholesterol
secreted in the bile and from dietary cholesterol.
Ezetimibe has a mechanism of action that differs from those of other classes
of cholesterol-reducing compounds (statins, bile acid sequestrants [resins],
fibric acid derivatives, and plant stanols). The molecular target of ezetimibe
has been shown to be the sterol transporter, Niemann-Pick C1-Like 1 (NPC1L1),
which is involved in the intestinal uptake of cholesterol and phytosterols.
Ezetimibe does not inhibit cholesterol synthesis in the liver, or increase
bile acid excretion. Instead, ezetimibe localizes at the brush border of the
small intestine and inhibits the absorption of cholesterol, leading to a
decrease in the delivery of intestinal cholesterol to the liver. This causes a
reduction of hepatic cholesterol stores and an increase in clearance of
cholesterol from the blood; this distinct mechanism is complementary to that of
statins and of fenofibrate .
Clinical studies have demonstrated that elevated levels of
total-C, LDL-C and Apo B, the major protein constituent of LDL, promote human
atherosclerosis. In addition, decreased levels of HDL-C are associated with the
development of atherosclerosis. Epidemiologic studies have established that
cardiovascular morbidity and mortality vary directly with the level of total-C
and LDL-C and inversely with the level of HDL-C. Like LDL, cholesterol-enriched
triglyceride-rich lipoproteins, including very-low-density lipoproteins (VLDL),
intermediate-density lipoproteins (IDL), and remnants, can also promote
atherosclerosis. The independent effect of raising HDL-C or lowering TG on the
risk of coronary and cardiovascular morbidity and mortality has not been
determined.
ZETIA reduces total-C, LDL-C, Apo B, and TG, and increases HDL-C in patients
with hyperlipidemia. Administration of ZETIA with a statin is effective in
improving serum total-C, LDL-C, Apo B, TG, and HDL-C beyond either treatment
alone. Administration of ZETIA with fenofibrate is effective in improving serum
total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia as
compared to either treatment alone. The effects of ezetimibe given either alone
or in addition to a statin or fenofibrate on cardiovascular morbidity and
mortality have not been established.
Absorption
After oral administration, ezetimibe is absorbed and extensively conjugated
to a pharmacologically active phenolic glucuronide (ezetimibe-glucuronide).
After a single 10-mg dose of ZETIA to fasted adults, mean ezetimibe peak plasma
concentrations (C) of 3.4 to 5.5 ng/mL were attained
within 4 to 12 hours (T). Ezetimibe-glucuronide mean
C values of 45 to 71 ng/mL were achieved between 1 and
2 hours (T). There was no substantial deviation from
dose proportionality between 5 and 20 mg. The absolute bioavailability of
ezetimibe cannot be determined, as the compound is virtually insoluble in
aqueous media suitable for injection.
Effect of Food on Oral Absorption
Concomitant food administration (high-fat or non-fat meals) had no effect on
the extent of absorption of ezetimibe when administered as ZETIA 10-mg tablets.
The C value of ezetimibe was increased by 38% with
consumption of high-fat meals. ZETIA can be administered with or without
food.
Distribution
Ezetimibe and ezetimibe-glucuronide are highly bound (greater than 90%) to human
plasma proteins.
Metabolism and Excretion
Ezetimibe is primarily metabolized in the small intestine and liver via
glucuronide conjugation (a phase II reaction) with subsequent biliary and renal
excretion. Minimal oxidative metabolism (a phase I reaction) has been observed
in all species evaluated.
In humans, ezetimibe is rapidly metabolized to ezetimibe-glucuronide.
Ezetimibe and ezetimibe-glucuronide are the major drug-derived compounds
detected in plasma, constituting approximately 10 to 20% and 80 to 90% of the
total drug in plasma, respectively. Both ezetimibe and ezetimibe-glucuronide are
eliminated from plasma with a half-life of approximately 22 hours for both
ezetimibe and ezetimibe-glucuronide. Plasma concentration-time profiles exhibit
multiple peaks, suggesting enterohepatic recycling.
Following oral administration of C-ezetimibe (20 mg)
to human subjects, total ezetimibe (ezetimibe + ezetimibe-glucuronide) accounted
for approximately 93% of the total radioactivity in plasma. After 48 hours,
there were no detectable levels of radioactivity in the plasma.
Approximately 78% and 11% of the administered radioactivity were recovered in
the feces and urine, respectively, over a 10-day collection period. Ezetimibe
was the major component in feces and accounted for 69% of the administered dose,
while ezetimibe-glucuronide was the major component in urine and accounted for
9% of the administered dose.
Specific Populations
Geriatric Patients:
Pediatric Patients:
[See .]
Gender:
Race:
Hepatic Impairment:
[see
]
Renal Impairment:
Drug Interactions [See also ]
ZETIA had no significant effect on a series of probe drugs (caffeine,
dextromethorphan, tolbutamide, and IV midazolam) known to be metabolized by
cytochrome P450 (1A2, 2D6, 2C8/9 and 3A4) in a "cocktail" study of twelve
healthy adult males. This indicates that ezetimibe is neither an inhibitor nor
an inducer of these cytochrome P450 isozymes, and it is unlikely that ezetimibe
will affect the metabolism of drugs that are metabolized by these enzymes.
Non-Clinical Toxicology
ZETIA is contraindicated in the following conditions:Array
Concurrent administration of ZETIA with a specific statin or fenofibrate should be in accordance with the product labeling for that medication.
In controlled clinical monotherapy studies, the incidence of consecutive elevations (≥3 × the upper limit of normal [ULN]) in hepatic transaminase levels was similar between ZETIA (0.5%) and placebo (0.3%).
In controlled clinical combination studies of ZETIA initiated concurrently with a statin, the incidence of consecutive elevations (≥3 × ULN) in hepatic transaminase levels was 1.3% for patients treated with ZETIA administered with statins and 0.4% for patients treated with statins alone. These elevations in transaminases were generally asymptomatic, not associated with cholestasis, and returned to baseline after discontinuation of therapy or with continued treatment. When ZETIA is co-administered with a statin, liver tests should be performed at initiation of therapy and according to the recommendations of the statin. Should an increase in ALT or AST ≥3 × ULN persist, consider withdrawal of ZETIA and/or the statin.
In clinical trials, there was no excess of myopathy or rhabdomyolysis associated with ZETIA compared with the relevant control arm (placebo or statin alone). However, myopathy and rhabdomyolysis are known adverse reactions to statins and other lipid-lowering drugs. In clinical trials, the incidence of creatine phosphokinase (CPK) >10 × ULN was 0.2% for ZETIA vs 0.1% for placebo, and 0.1% for ZETIA co-administered with a statin vs 0.4% for statins alone. Risk for skeletal muscle toxicity increases with higher doses of statin, advanced age (>65), hypothyroidism, renal impairment, and depending on the statin used, concomitant use of other drugs.
In post-marketing experience with ZETIA, cases of myopathy and rhabdomyolysis have been reported. Most patients who developed rhabdomyolysis were taking a statin prior to initiating ZETIA. However, rhabdomyolysis has been reported with ZETIA monotherapy and with the addition of ZETIA to agents known to be associated with increased risk of rhabdomyolysis, such as fibrates. ZETIA and any statin or fibrate that the patient is taking concomitantly should be immediately discontinued if myopathy is diagnosed or suspected. The presence of muscle symptoms and a CPK level >10 × the ULN indicates myopathy.
Due to the unknown effects of the increased exposure to ezetimibe in patients with moderate to severe hepatic impairment, ZETIA is not recommended in these patients.
The following serious adverse reactions are discussed in greater detail in other sections of the label:
Monotherapy Studies:
The most commonly reported adverse reactions (incidence ≥2% and greater than placebo) in the ZETIA monotherapy controlled clinical trial database of 2396 patients were: upper respiratory tract infection (4.3%), diarrhea (4.1%), arthralgia (3.0%), sinusitis (2.8%), and pain in extremity (2.7%).
Statin Co-Administration Studies:
The most commonly reported adverse reactions (incidence ≥2% and greater than statin alone) in the ZETIA + statin controlled clinical trial database of 11,308 patients were: nasopharyngitis (3.7%), myalgia (3.2%), upper respiratory tract infection (2.9%), arthralgia (2.6%) and diarrhea (2.5%).
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.
Monotherapy
In 10 double-blind, placebo-controlled clinical trials, 2396 patients with primary hyperlipidemia (age range 9–86 years, 50% women, 90% Caucasians, 5% Blacks, 3% Hispanics, 2% Asians) and elevated LDL-C were treated with ZETIA 10 mg/day for a median treatment duration of 12 weeks (range 0 to 39 weeks).
Adverse reactions reported in ≥2% of patients treated with ZETIA and at an incidence greater than placebo in placebo-contr
The frequency of less common adverse reactions was comparable between ZETIA and placebo.
Combination with a Statin
In 28 double-blind, controlled (placebo- or active-controlled) clinical trials, 11,308 patients with primary hyperlipidemia (age range 10–93 years, 48% women, 85% Caucasians, 7% Blacks, 4% Hispanics, 3% Asians) and elevated LDL-C were treated with ZETIA 10 mg/day concurrently with or added to on-going statin therapy for a median treatment duration of 8 weeks (range 0 to 112 weeks).
The incidence of consecutive increased transaminases (≥3 × ULN) was higher in patients receiving ZETIA administered with statins (1.3%) than in patients treated with statins alone (0.4%).
Clinical adverse reactions reported in ≥2% of patients treated with ZETIA + statin and at an incidence greater than statin, regardless of causality assessment, are shown in .
TABLE 2: Clinical Adverse Reactions Occurring in ≥2% of Patients Treated with ZETIA Co-Administered with a Statin and at an Incidence Greater than Statin, Regardless of Causality
Combination with Fenofibrate
This clinical study involving 625 patients with mixed dyslipidemia (age range 20–76 years, 44% women, 79% Caucasians, 0.1% Blacks, 11% Hispanics, 5% Asians) treated for up to 12 weeks and 576 patients treated for up to an additional 48 weeks evaluated co-administration of ZETIA and fenofibrate. This study was not designed to compare treatment groups for infrequent events. Incidence rates (95% CI) for clinically important elevations (≥3 × ULN, consecutive) in hepatic transaminase levels were 4.5% (1.9, 8.8) and 2.7% (1.2, 5.4) for fenofibrate monotherapy (n=188) and ZETIA co-administered with fenofibrate (n=183), respectively, adjusted for treatment exposure. Corresponding incidence rates for cholecystectomy were 0.6% (95% CI: 0.0%, 3.1%) and 1.7% (95% CI: 0.6%, 4.0%) for fenofibrate monotherapy and ZETIA co-administered with fenofibrate, respectively . The numbers of patients exposed to co-administration therapy as well as fenofibrate and ezetimibe monotherapy were inadequate to assess gallbladder disease risk. There were no CPK elevations >10 × ULN in any of the treatment groups.
Because the reactions below are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following additional adverse reactions have been identified during post-approval use of ZETIA:
Hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria; erythema multiforme; arthralgia; myalgia; elevated creatine phosphokinase; myopathy/rhabdomyolysis ; elevations in liver transaminases; hepatitis; abdominal pain; thrombocytopenia; pancreatitis; nausea; dizziness; paresthesia; depression; headache; cholelithiasis; cholecystitis.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Interactions
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