Juxtapid 30mg Capsules

Lomitapide is a microsomal triglyceride transfer protein (MTP) inhibitor. MTP is located in the lumen of the endoplasmic reticulum and is essential for the assembly of apolipoprotein B (apoB)-containing lipoproteins (VLDL and chylomicrons) in the liver and intestine, respectively. By inhibiting MTP, lomitapide reduces the production of VLDL and chylomicrons, leading to decreased plasma levels of LDL-C, total cholesterol, and triglycerides.

Serious Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Chest pain
Abnormal heartbeat
Flu-like symptoms
Severe diarrhea that requires hospitalization
Signs of dehydration, such as:
+ Severe dizziness or fainting
+ Inability to urinate or changes in urine output
+ Extreme fatigue

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects, contact your doctor or seek medical help if they bother you or persist:

Stomach cramps
Bloating
Dizziness, tiredness, or weakness
Gas
Constipation
Heartburn
Weight loss
Back pain
Nose or throat irritation
Headache
Diarrhea
Upset stomach
Vomiting
* Stomach pain

A low-fat diet may help reduce the likelihood of experiencing these side effects. If any of these side effects are severe, bothersome, or persistent, contact your doctor.

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you have liver disease or elevated liver enzymes, as this may affect the medication's safety and efficacy.
If you have been diagnosed with problems digesting certain sugars, including lactose, glucose, or galactose, as this medication may contain these sugars.
If you have difficulty swallowing the medication whole, as it must not be crushed, chewed, or split.
If you are taking any other medications, including prescription and over-the-counter (OTC) drugs, natural products, or vitamins, that may interact with this medication. Certain medications, such as those used to treat HIV, infections, or depression, should not be taken with this drug. Your doctor or pharmacist can provide guidance on potential interactions.
If you are pregnant or think you may be pregnant. Do not take this medication if you are pregnant, as it may harm the fetus.
* If you are breast-feeding. Do not breast-feed while taking this medication, as it may pass into breast milk and harm the baby.

This list is not exhaustive, and it is crucial to discuss all your medications, health problems, and concerns with your doctor and pharmacist to ensure safe treatment. Do not start, stop, or change the dose of any medication without consulting your doctor first.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to follow the diet and exercise plan recommended by your doctor.

To minimize potential interactions, avoid consuming grapefruit and grapefruit juice while taking this medication. If you plan to drink alcohol, discuss this with your doctor first, and limit your intake to no more than one alcoholic drink per day.

When taking this medication, do not take colesevelam, colestipol, or cholestyramine within 4 hours before or after taking your dose. If you experience diarrhea or vomiting, oral medications may not be absorbed properly. This is particularly important if you are taking birth control pills, as their effectiveness may be reduced. In such cases, use an additional form of birth control, such as a condom, for 7 days after the diarrhea or vomiting has stopped. If you have any questions or concerns, consult your doctor.

Your doctor may recommend taking certain supplements, such as vitamin E and fatty acids, while you are on this medication. It is crucial to follow your doctor's instructions regarding these supplements.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

This medication can cause harm to an unborn baby. Therefore, a pregnancy test will be conducted before you start taking this medication to confirm that you are not pregnant. If you may become pregnant, you must use birth control while taking this medication and for a specified period after the last dose. Your doctor will advise you on the duration of birth control use. If you become pregnant while taking this medication, notify your doctor immediately.

• Moderate or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin, telithromycin, erythromycin, nefazodone, cobicistat, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, telaprevir, boceprevir, diltiazem, verapamil, grapefruit juice)

• Warfarin (increased INR, risk of bleeding)
• Simvastatin (increased simvastatin exposure, risk of myopathy/rhabdomyolysis)
• Atorvastatin (increased atorvastatin exposure, risk of myopathy/rhabdomyolysis)
• P-glycoprotein (P-gp) substrates (e.g., digoxin, dabigatran - increased substrate exposure)
• Other lipid-lowering agents (additive effects, potential for increased adverse events)

• Weak CYP3A4 inhibitors (e.g., amiodarone, fluconazole, fluvoxamine, cimetidine)
• CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital, St. John's Wort - decreased lomitapide efficacy)

• Not available

• Symptoms of liver injury (e.g., unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, dark urine, jaundice, scleral icterus)
• Symptoms of gastrointestinal adverse events (e.g., diarrhea, nausea, vomiting, dyspepsia, abdominal pain, flatulence)
• Symptoms of bleeding (if on warfarin)

Contraindicated in pregnancy. Lomitapide can cause fetal harm when administered to a pregnant woman. It is classified as Pregnancy Category X.

Contraindicated during breastfeeding. It is not known whether lomitapide is excreted in human milk, but due to the potential for serious adverse reactions in a breastfed infant, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and efficacy have not been established in pediatric patients (under 18 years of age). Use is not recommended.

No specific dose adjustment is required based on age. However, elderly patients may be more susceptible to adverse effects, and monitoring for liver function and gastrointestinal symptoms should be diligent.

• Lomitapide is part of a REMS (Risk Evaluation and Mitigation Strategy) program due to the risk of hepatotoxicity. Prescribers and pharmacies must be certified, and patients must be enrolled.
• Strict adherence to a low-fat diet (less than 20% of total calories from fat) is critical to minimize gastrointestinal side effects (e.g., diarrhea, nausea, vomiting) and optimize efficacy.
• Patients must take daily supplements of fat-soluble vitamins (A, D, E, K) and essential fatty acids due to potential malabsorption caused by MTP inhibition.
• Significant drug-drug interactions, especially with CYP3A4 inhibitors, necessitate careful medication review and dose adjustments or contraindication.
• Lomitapide is indicated only for homozygous familial hypercholesterolemia (HoFH), a rare genetic disorder, and is not for general hyperlipidemia.

• Mipomersen (Kynamro) - another HoFH-specific drug, antisense oligonucleotide
• PCSK9 inhibitors (e.g., alirocumab, evolocumab) - often used in HoFH in combination with other therapies
• Apheresis (LDL apheresis) - a non-pharmacological treatment for severe HoFH
• Statins (high-intensity) - often used in combination, but limited efficacy alone in HoFH
• Ezetimibe - often used in combination

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.