WARNING

Juxtapid is a medication used to treat a rare genetic condition called homozygous familial hypercholesterolemia (HoFH). While it can be effective in reducing cholesterol levels, it also carries certain risks that need to be considered. Here are some of the potential risks associated with taking Juxtapid:

• Liver problems: Juxtapid can cause liver damage or abnormalities. Regular monitoring of liver function is essential while taking this medication.
• Gastrointestinal issues: Common side effects of Juxtapid include diarrhea, nausea, abdominal pain, and vomiting. These symptoms can sometimes be severe.
• Fat-soluble vitamin deficiency: Juxtapid can interfere with the absorption of fat-soluble vitamins such as vitamins A, D, E, and K. This can lead to deficiencies and may require supplementation.
• Pregnancy risks: Juxtapid is known to cause harm to the fetus, so it should not be used during pregnancy. Effective contraception is necessary for women of childbearing potential who are taking Juxtapid.
• Drug interactions: Juxtapid can interact with other medications, including those that affect liver enzymes. This can potentially lead to adverse effects or reduced efficacy of either medication.

It is important to note that the risks associated with Juxtapid should be weighed against the potential benefits it offers in treating HoFH. If you have been prescribed Juxtapid, it is crucial to closely follow your healthcare provider’s instructions, attend regular check-ups, and report any concerning symptoms or side effects promptly.

Why is this medication prescribed?

Juxtapid (lomitapide) is prescribed for the treatment of a specific medical condition called homozygous familial hypercholesterolemia (HoFH). HoFH is a rare genetic disorder that leads to extremely high levels of low-density lipoprotein cholesterol (LDL-C) in the blood. LDL-C, often referred to as “bad” cholesterol, is a type of cholesterol that can build up in the arteries and increase the risk of cardiovascular problems such as heart disease and stroke. In individuals with HoFH, the body is unable to effectively remove LDL-C from the blood, resulting in significantly elevated levels. Juxtapid works by inhibiting the production of certain lipoproteins in the liver that contribute to high cholesterol levels. By reducing the production of these lipoproteins, Juxtapid helps to lower LDL-C, total cholesterol, apolipoprotein B, and non-high-density lipoprotein cholesterol levels in patients with HoFH.

It’s important to note that Juxtapid is specifically indicated for the treatment of HoFH and should not be used for other forms of high cholesterol or in patients who have not responded adequately to other lipid-lowering treatments. Juxtapid is typically prescribed as an adjunct therapy, meaning it is used in combination with a low-fat diet and other lipid-lowering treatments, such as statins, to further manage cholesterol levels in patients with HoFH.

How should this medicine be used?

When prescribing Juxtapid, healthcare professionals typically follow specific guidelines for its use. Here is a general overview of how Juxtapid should be used:

• Prescribing and Monitoring: Juxtapid should only be prescribed by physicians experienced in the management of lipid disorders. Before starting Juxtapid, a baseline lipid profile should be obtained, and liver function tests should be performed. Regular monitoring of lipid levels and liver function is necessary during treatment.
• Dosing: The initial recommended dose of Juxtapid is 5 mg once daily. The dose can be increased to a maximum of 60 mg once daily based on individual patient response and tolerability. The medication should be taken at least two hours after the evening meal to improve absorption.
• Dietary Restrictions: Juxtapid requires adherence to a low-fat diet and other lipid-lowering treatments. A low-fat diet should be maintained throughout the treatment period to minimize gastrointestinal side effects and optimize the medication’s effectiveness.
• Drug Interactions: Juxtapid has significant interactions with other medications, particularly those metabolized by the liver enzymes CYP3A4 and CYP2C8. Healthcare providers should review all the medications a patient is taking to identify potential interactions and adjust doses accordingly.

It’s important to note that Juxtapid is a potent medication with potentially serious side effects. It is generally reserved for individuals with HoFH who have not adequately responded to other lipid-lowering treatments. The decision to use Juxtapid should be made after careful consideration of the risks and benefits, and under the guidance of a healthcare professional.

Other uses for this medicine

Regarding other uses for Juxtapid, it is primarily indicated for the treatment of HoFH and has not been approved for any other conditions. Its safety and efficacy have not been established for use in the general population with high cholesterol or other lipid disorders. Therefore, it is crucial to use Juxtapid only as directed by a healthcare professional and for its approved indication.

What special precautions should I follow?

Juxtapid (lomitapide) is a prescription medication used to treat a rare genetic condition called homozygous familial hypercholesterolemia (HoFH). It is important to follow specific precautions while taking Juxtapid to ensure its safe and effective use. Here are some general precautions to keep in mind:

• Prescription and supervision: Juxtapid is available only with a prescription and should be taken under the supervision of a healthcare professional who has experience in managing HoFH.
• Strict adherence to the prescribed dose: Follow your healthcare provider’s instructions regarding the dosage and schedule of Juxtapid. Do not take more or less than the prescribed amount, and take it at the same time every day.
• Dietary restrictions: Juxtapid is associated with potentially severe liver toxicity. To minimize this risk, it is crucial to follow a low-fat diet and adhere to any dietary guidelines provided by your healthcare professional. Avoid consuming foods high in fat and cholesterol, as they can increase the risk of liver problems.
• Liver function monitoring: Regular monitoring of liver function is necessary while taking Juxtapid. Your healthcare provider will order liver function tests before starting treatment and periodically thereafter to assess the health of your liver.
• Contraindications and interactions: Inform your healthcare provider about all the medications, supplements, and herbal products you are taking before starting Juxtapid. Certain medications and substances can interact with Juxtapid, leading to potentially harmful effects. Also, if you have a history of liver problems or certain other medical conditions, your healthcare provider may determine that Juxtapid is not suitable for you.
• Pregnancy and breastfeeding: Juxtapid should not be used during pregnancy or while breastfeeding, as it may harm the developing fetus or infant. If you are planning to become pregnant or are already pregnant, discuss alternative treatment options with your healthcare provider.
• Additional precautions: Be cautious about the potential side effects of Juxtapid, which may include gastrointestinal symptoms like diarrhea, nausea, vomiting, and abdominal pain. If you experience any severe or persistent side effects, inform your healthcare provider promptly.

Remember, these are general precautions, and it is essential to follow the specific instructions provided by your healthcare professional. They will provide you with personalized guidance based on your medical history and individual circumstances.

What special dietary instructions should I follow?

Juxtapid (generic name lomitapide) is a medication prescribed for the treatment of homozygous familial hypercholesterolemia (HoFH). It is important to follow certain dietary instructions while taking Juxtapid to ensure its effectiveness and minimize potential side effects. Here are the special dietary instructions for Juxtapid:

• Low-fat diet: You should follow a low-fat diet while taking Juxtapid. Your healthcare provider or a registered dietitian can provide specific guidance on the appropriate amount of fat you should consume daily.
• Cholesterol-lowering diet: In addition to a low-fat diet, it’s essential to follow a cholesterol-lowering diet. This diet typically includes consuming foods low in cholesterol and saturated fats while emphasizing fruits, vegetables, whole grains, and lean proteins.
• Avoid excess alcohol: It is recommended to limit or avoid alcohol consumption while taking Juxtapid. Alcohol can increase the risk of liver problems associated with the medication.
• Regular monitoring: Regular blood tests will be necessary to monitor your liver function and lipid levels. Your healthcare provider will determine the appropriate frequency of these tests.

What should I do if I forget a dose?

If you forget to take a dose of Juxtapid, follow these steps:

• Take the missed dose as soon as you remember, unless it is close to the time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule.
• Do not double the dose to make up for the missed one.
• If you have any concerns or questions about missed doses, consult your healthcare provider or pharmacist for guidance.

What side effects can this medication cause?

Juxtapid (lomitapide) may cause various side effects. It is important to note that not all individuals will experience these side effects, and their severity can vary. If you have concerns about potential side effects, it is recommended to discuss them with your healthcare provider. Here are some common side effects associated with Juxtapid:

1. Gastrointestinal Effects:

• Diarrhea
• Nausea
• Vomiting
• Abdominal pain or discomfort
• Indigestion
• Gas (flatulence)
• Constipation

2. Liver Abnormalities:

• Increased levels of liver enzymes (aspartate transaminase, alanine transaminase)
• Liver fat accumulation (hepatic steatosis)
• Liver enzyme abnormalities (hepatic abnormalities)

3. Vitamin Deficiency:

• Deficiency of fat-soluble vitamins (such as vitamins A, D, E, and K) due to decreased absorption in the intestines

4. Fat Accumulation:

• Fat accumulation under the skin (subcutaneous fat) or in other organs (visceral fat)

5. Cardiovascular Effects:

• High blood pressure (hypertension)
• Irregular heart rhythms (arrhythmias)

6. Respiratory Effects:

• Difficulty breathing (dyspnea)

7. Central Nervous System Effects:

• Headache
• Dizziness

8. Other:

• Fatigue
• Flu-like symptoms
• Muscle and joint pain
• Increased blood sugar levels (hyperglycemia)

It’s important to report any unusual or severe side effects to your healthcare provider promptly. They can monitor your condition and make any necessary adjustments to your treatment plan. Additionally, keep in mind that Juxtapid carries a boxed warning regarding the risk of liver toxicity. Regular monitoring of liver function is necessary while taking this medication.

This list does not include all possible side effects. If you experience any new or bothersome symptoms while taking Juxtapid, it is essential to consult your healthcare provider for further evaluation and guidance.

What should I know about storage and disposal of this medication?

Storage:

• Keep Juxtapid in its original container and store it at room temperature, away from moisture, heat, and direct light.
• Do not freeze the medication.
• Keep it out of the reach of children and pets.

Disposal:

• Dispose of unused or expired Juxtapid safely. Follow any specific disposal instructions provided by your healthcare provider or local guidelines.
• Do not dispose of medications in wastewater or household waste unless instructed to do so.
• Contact your pharmacist or local waste disposal facility to inquire about proper disposal methods.

In case of emergency/overdose

• In case of an emergency or suspected overdose, call your local emergency services immediately or go to the nearest emergency room.
• If possible, bring the Juxtapid container or packaging with you to provide information about the medication.

What other information should I know?

• Attend all scheduled appointments with your healthcare provider for monitoring and follow-up.
• Inform your healthcare provider about all the medications, including prescription, over-the-counter, and herbal supplements, that you are taking concurrently with Juxtapid. Some medications may interact with Juxtapid, affecting its effectiveness or increasing the risk of side effects.
• Inform your healthcare provider if you have a history of liver problems, as Juxtapid may cause liver abnormalities.
• Avoid consuming grapefruit or grapefruit juice while taking Juxtapid, as it can increase the levels of the medication in your blood and potentially increase the risk of side effects.
• It is important to use effective contraception while taking Juxtapid, as it can cause harm to an unborn baby. Discuss with your healthcare provider the appropriate contraception methods to use.
• If you are planning to undergo surgery, inform your healthcare provider about your Juxtapid use well in advance.

Remember, always follow the instructions and advice provided by your healthcare provider regarding the safe and appropriate use of Juxtapid. If you have any specific concerns or questions, consult with your healthcare provider or pharmacist for further guidance.