WARNING

Mipomersen Injection is a medication used to treat a rare genetic condition called homozygous familial hypercholesterolemia (HoFH), which causes extremely high levels of low-density lipoprotein cholesterol (LDL-C) in the blood. While it can be effective in managing this condition, it also comes with certain risks and potential side effects. Here are some of the key risks associated with Mipomersen Injection:

• Liver Problems: Mipomersen can cause liver problems, including elevations in liver enzymes and, in some cases, liver damage. Regular monitoring of liver function is necessary while taking this medication.
• Injection Site Reactions: Like many injectable medications, Mipomersen can cause pain, redness, or swelling at the injection site.
• Flu-Like Symptoms: Some people may experience flu-like symptoms such as fever, fatigue, and muscle aches.
• Increased Risk of Bleeding: Mipomersen may increase the risk of bleeding, so caution is advised if you are also taking medications that affect blood clotting.
• Allergic Reactions: In rare cases, individuals may experience allergic reactions to Mipomersen, which can include symptoms like rash, itching, and difficulty breathing.
• Decreased Platelet Count: Mipomersen may reduce the number of platelets in your blood, which can increase the risk of bleeding.
• Potential Interactions: Mipomersen can interact with other medications you may be taking, so it’s essential to inform your healthcare provider about all the drugs and supplements you are using.
• Limited Data: Mipomersen’s long-term safety and effectiveness are not well-established due to its relatively recent introduction to the market.

It’s crucial to discuss the potential risks and benefits of Mipomersen Injection with your healthcare provider. They can help determine if this medication is suitable for your specific medical condition and monitor your health while you are taking it to minimize potential risks. As with any medication, you should follow your healthcare provider’s instructions carefully and report any unusual or severe side effects promptly.

Why is this medication prescribed?

Mipomersen Injection is prescribed for the treatment of a rare genetic condition called homozygous familial hypercholesterolemia (HoFH). HoFH is a severe form of inherited high cholesterol that leads to extremely elevated levels of low-density lipoprotein cholesterol (LDL-C) in the blood. This condition increases the risk of early cardiovascular disease, including heart attacks and strokes. Mipomersen is used as an adjunct to diet and other lipid-lowering treatments to help lower LDL-C levels in individuals with HoFH who have not achieved adequate control of their cholesterol levels through other means.

How should this medicine be used?

Here are some general guidelines on how Mipomersen Injection should be used:

• Administration: Mipomersen is administered as a subcutaneous (under the skin) injection. It is typically given once a week by a healthcare professional or as directed by your healthcare provider.
• Dosage: The dosage of Mipomersen will be determined by your healthcare provider based on your specific medical condition and needs.
• Diet and Lifestyle: You should continue to follow a cholesterol-lowering diet and exercise program as recommended by your healthcare provider while taking Mipomersen.
• Monitoring: Your healthcare provider will regularly monitor your cholesterol levels and liver function while you are on Mipomersen to assess its effectiveness and check for any potential side effects.
• Follow Instructions: It’s essential to follow your healthcare provider’s instructions precisely, including the dosing schedule and any other recommendations they provide.
• Interactions: Inform your healthcare provider about all other medications, supplements, or treatments you are currently using to ensure there are no interactions with Mipomersen.
• Storage: Store Mipomersen according to the manufacturer’s instructions, typically in the refrigerator. Do not freeze the medication.

Mipomersen is a specialized medication prescribed for a specific, severe genetic condition, and its use should be closely monitored by healthcare professionals. If you have been prescribed Mipomersen Injection, it’s essential to work closely with your healthcare provider to ensure proper administration and monitoring while managing your cholesterol levels and the associated risks of HoFH.

Other uses for this medicine

Mipomersen Injection is primarily indicated for the treatment of homozygous familial hypercholesterolemia (HoFH), and its use for other medical conditions is limited. It is essential to use this medication only under the guidance of a healthcare provider who has experience in treating HoFH and who can assess the potential risks and benefits for your specific situation.

What special precautions should I follow?

As for special precautions when using Mipomersen Injection, here are some important considerations:

• Liver Function Monitoring: Regular monitoring of liver function is crucial while taking Mipomersen. Elevated liver enzymes and liver damage have been reported with its use. Your healthcare provider will order blood tests to assess your liver function before and during treatment.
• Risk of Bleeding: Mipomersen may increase the risk of bleeding. If you are taking medications that affect blood clotting, such as anticoagulants or antiplatelet drugs, inform your healthcare provider. They will need to carefully manage your treatment plan to minimize the risk of bleeding complications.
• Allergic Reactions: Although rare, allergic reactions can occur with Mipomersen. If you experience symptoms like rash, itching, swelling, severe dizziness, or difficulty breathing after receiving an injection, seek immediate medical attention.
• Pregnancy and Breastfeeding: The safety of Mipomersen during pregnancy and breastfeeding has not been well studied. If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential risks and benefits with your healthcare provider.
• Interactions: Inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking. Mipomersen may interact with other medications, and dose adjustments or modifications may be necessary.
• Diet and Lifestyle: Continue to follow a cholesterol-lowering diet and exercise plan as recommended by your healthcare provider while taking Mipomersen.
• Storage: Store Mipomersen as directed by the manufacturer, typically in the refrigerator. Do not freeze the medication.
• Regular Follow-Up: Keep all scheduled appointments with your healthcare provider to monitor your progress, assess the effectiveness of Mipomersen, and address any concerns or side effects.

It’s essential to have open and regular communication with your healthcare provider while taking Mipomersen Injection. They can provide personalized guidance, monitor your health, and make any necessary adjustments to your treatment plan to ensure its safety and effectiveness in managing HoFH. Additionally, only use Mipomersen for the specific condition it is prescribed for, as it is not intended for other uses.

What special dietary instructions should I follow?

Special Dietary Instructions:

• Low-Fat Diet: A low-fat diet is typically recommended while taking Mipomersen. Follow your healthcare provider’s dietary guidelines closely. Reducing your intake of saturated and trans fats can help improve the effectiveness of the medication.
• Alcohol Consumption: Limit or avoid alcohol consumption, as it can have a negative impact on liver function, which may be exacerbated by Mipomersen.
• Grapefruit and Grapefruit Juice: Avoid consuming grapefruit and grapefruit juice while taking Mipomersen, as they can interact with the medication and increase the risk of side effects.

What should I do if I forget a dose?

If you forget a dose of Mipomersen Injection, contact your healthcare provider or follow their instructions for missed doses. Do not take a double dose to make up for a missed one. Consistency in dosing is essential for the effectiveness of the medication, so it’s best to stick to your prescribed schedule. If you have any questions or concerns about your medication regimen, always consult with your healthcare provider for guidance.

What side effects can this medication cause?

Mipomersen Injection can cause a range of side effects, some of which can be serious. It’s important to be aware of these potential side effects and to promptly report any unusual or severe symptoms to your healthcare provider. Common side effects of Mipomersen Injection may include:

• Injection Site Reactions: Pain, redness, swelling, or itching at the injection site are common and usually mild.
• Flu-Like Symptoms: Some people may experience flu-like symptoms, such as fever, fatigue, muscle aches, and chills.
• Nausea: Nausea can occur in some individuals taking Mipomersen.
• Headache: Headaches may occur as a side effect.
• Elevated Liver Enzymes: Mipomersen can lead to elevations in liver enzymes. Your healthcare provider will monitor your liver function regularly.
• Decreased Platelet Count: Some individuals may experience a reduction in platelet count, which can increase the risk of bleeding.
• Allergic Reactions: While rare, allergic reactions to Mipomersen can occur. Allergic symptoms may include rash, itching, swelling, severe dizziness, and difficulty breathing. Seek immediate medical attention if you experience any signs of an allergic reaction.
• Liver Problems: In some cases, Mipomersen has been associated with liver problems, including liver damage. Regular monitoring of liver function is essential while taking this medication.
• Risk of Bleeding: Mipomersen may increase the risk of bleeding, particularly in individuals taking medications that affect blood clotting.
• Other Side Effects: Other less common side effects may also occur. If you experience any unusual symptoms or side effects, be sure to inform your healthcare provider.

It’s crucial to work closely with your healthcare provider while taking Mipomersen to monitor for side effects and assess its effectiveness in managing your condition. The benefits of this medication in treating homozygous familial hypercholesterolemia (HoFH) should be weighed against the potential risks. Your healthcare provider will tailor your treatment plan, monitor your health, and provide guidance on managing any side effects or complications that may arise.

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

Storage:

• Refrigeration: Mipomersen Injection should be stored in the refrigerator, typically at temperatures between 2°C to 8°C (36°F to 46°F).
• Do Not Freeze: Do not freeze Mipomersen. Freezing can damage the medication.
• Protect from Light: Keep the medication in its original carton to protect it from light.
• Keep Out of Reach: Store Mipomersen out of the reach of children and pets.

Disposal:

• Unused Medication: Do not use Mipomersen that has passed its expiration date.
• Proper Disposal: Dispose of used syringes, needles, and empty medication vials according to your local regulations or guidelines for the safe disposal of medical waste.

In case of emergency/overdose

In case of an overdose or emergency related to Mipomersen Injection, seek immediate medical attention or contact your local poison control center at 1-800-222-1222 (if available in your region).

What other information should I know

• Follow Instructions: Always follow the dosing and administration instructions provided by your healthcare provider. Do not change the dose or frequency of Mipomersen without consulting your healthcare provider.
• Regular Monitoring: Your healthcare provider will monitor your cholesterol levels and liver function regularly while you are on Mipomersen to assess its effectiveness and check for any potential side effects.
• Medication Interactions: Inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking, as Mipomersen may interact with other medications.
• Lifestyle Changes: Continue to follow a low-cholesterol diet and exercise program as prescribed by your healthcare provider while taking Mipomersen.
• Pregnancy and Breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential risks and benefits of Mipomersen with your healthcare provider.
• Allergies: Inform your healthcare provider of any allergies you have, especially if you have a history of allergic reactions to medications.
• Regular Check-Ups: Keep all scheduled appointments with your healthcare provider for follow-up assessments and discussions regarding your treatment.

Mipomersen Injection is a specialized medication prescribed for a specific condition, and its use should be closely monitored by healthcare professionals. If you have any questions or concerns about your treatment with Mipomersen, do not hesitate to discuss them with your healthcare provider for personalized guidance and support.