JUXTAPID- lomitapide mesylate capsule

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

LOMITAPIDE MESYLATE (UNII: X4S83CP54E) (LOMITAPIDE - UNII:82KUB0583F)

Disponibil de la:

Amryt Pharmaceuticals DAC

INN (nume internaţional):

LOMITAPIDE MESYLATE

Compoziție:

LOMITAPIDE 5 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

JUXTAPID is indicated as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH). Limitations of Use - The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH, including those with heterozygous familial hypercholesterolemia (HeFH). - The effect of JUXTAPID on cardiovascular morbidity and mortality has not been determined. JUXTAPID is contraindicated in the following conditions: - Pregnancy [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1)] . - Concomitant administration of JUXTAPID with moderate or strong CYP3A4 inhibitors, as this can increase JUXTAPID exposure [see Warnings and Precautions (5.6), Drug Interactions (7.1), and Clinical Pharmac

Rezumat produs:

5 mg capsules: Orange/orange hard gelatin capsule printed with black ink "A733" and "5 mg" 10 mg capsules: Orange/white hard gelatin capsule printed with black ink "A733" and "10 mg" 20 mg capsules: White/white hard gelatin capsule printed with black ink "A733" and "20 mg" 30 mg capsules: Orange/yellow hard gelatin capsule printed with black ink "A733" and "30 mg" Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. Keep container tightly closed and protect from moisture.

Statutul autorizaţiei:

New Drug Application

Prospect

Amryt Pharmaceuticals DAC
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Medication Guide
JUXTAPID® (JUKS-tuh-pid)
(lomitapide)
capsules
What is the most important information I should know about JUXTAPID?
•
JUXTAPID is available only through certified pharmacies that are
enrolled in the JUXTAPID REMS
Program. Your doctor must be enrolled in the program in order for you
to be prescribed JUXTAPID.
•
There is a registry that collects information about the effects of
taking JUXTAPID over time. Ask
your doctor for more information about this registry or visit
www.JUXTAPID.com or call 1-877-
902-4099.
JUXTAPID may cause serious side effects including:
1. Liver problems. JUXTAPID can cause liver problems such as increased
liver enzymes or increased fat in
the liver.
•
Your doctor should do blood tests to check your liver before you start
JUXTAPID, if your dose is
increased, and while you take JUXTAPID. If your tests show some liver
problems, your doctor may
adjust your dose of JUXTAPID or stop it altogether.
•
Tell your doctor if you have had liver problems, including liver
problems while taking other
medicines.
•
JUXTAPID may cause nausea, vomiting and stomach pain, especially if
you do not eat a low-fat diet.
These side effects can also be symptoms of liver problems.
•
Tell your doctor right away if you have any of these symptoms of liver
problems while taking
JUXTAPID:
•
Nausea, vomiting, or stomach pain that gets worse, does not go away,
or changes
•
fever
•
flu-like symptoms
•
yellowing of your eyes or skin
•
you are more tired than usual
•
Drinking alcohol may increase your chance of having liver problems or
make your liver problems
worse. You should not have more than 1 alcoholic drink each day while
taking JUXTAPID.
2. Harm to your unborn baby. JUXTAPID may cause harm to your unborn
baby.
•
If you are pregnant, think you may be pregnant, or are planning to
become pregnant, do not take
JUXTAPID.
•
If you are a female who can get pregnant, you should have a pregnancy
test before you start taking
JUXTAPID. Your pregnancy

Caracteristicilor produsului

JUXTAPID- LOMITAPIDE MESYLATE CAPSULE
AMRYT PHARMACEUTICALS DAC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
JUXTAPID SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR JUXTAPID.
JUXTAPID (LOMITAPIDE) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2012
WARNING: RISK OF HEPATOTOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
JUXTAPID CAN CAUSE ELEVATIONS IN TRANSAMINASES (5.1).
MEASURE ALANINE AND ASPARTATE AMINOTRANSFERASES (ALT, AST), ALKALINE
PHOSPHATASE,
AND TOTAL BILIRUBIN BEFORE INITIATING TREATMENT AND THEN ALT AND AST
REGULARLY AS
RECOMMENDED (2.4, 5.1).
DURING TREATMENT, ADJUST THE DOSE OF JUXTAPID IF THE ALT OR AST IS
≥3 TIMES THE
UPPER LIMIT OF NORMAL (ULN) (2.4, 5.1).
DISCONTINUE JUXTAPID FOR CLINICALLY SIGNIFICANT LIVER TOXICITY (2.4,
5.1).
JUXTAPID INCREASES HEPATIC FAT (HEPATIC STEATOSIS) WITH OR WITHOUT
CONCOMITANT
INCREASES IN TRANSAMINASES (5.1).
HEPATIC STEATOSIS ASSOCIATED WITH JUXTAPID MAY BE A RISK FACTOR FOR
PROGRESSIVE
LIVER DISEASE, INCLUDING STEATOHEPATITIS AND CIRRHOSIS (5.1).
BECAUSE OF THE RISK OF HEPATOTOXICITY, JUXTAPID IS AVAILABLE ONLY
THROUGH A RESTRICTED
PROGRAM CALLED THE JUXTAPID REMS PROGRAM (5.2). PRESCRIBE JUXTAPID
ONLY TO PATIENTS
WITH A CLINICAL OR LABORATORY DIAGNOSIS CONSISTENT WITH HOFH. THE
SAFETY AND
EFFECTIVENESS OF JUXTAPID HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH
HYPERCHOLESTEROLEMIA WHO DO NOT HAVE HOFH (1).
INDICATIONS AND USAGE
JUXTAPID is a microsomal triglyceride transfer protein inhibitor
indicated as an adjunct to a low-fat diet and
other lipid-lowering treatments, including LDL apheresis where
available, to reduce low-density lipoprotein
cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B),
and non-high-density lipoprotein
cholesterol (non-HDL-C) in patients with homozygous familial
hypercholesterolemia (HoFH) (1).
Limitations of Use
The safety and effectiveness of JUXTAPID have not been established in
patients with
hypercholesterolemia