Generic Name: mipomersen (MI-poe-MER-sen)
Brand Name: Kynamro
Mipomersen may increase the risk of liver problems. The risk may be greater if you already have liver problems. Lab tests will be performed while you use mipomersen to check for liver problems. Contact your doctor right away if you experience dark urine; fever; flu-like symptoms; nausea, vomiting, or stomach pain that gets worse, does not go away, or changes; pale stools; unusual tiredness; or yellowing of the skin or eyes.
Mipomersen is used for:
Lowering high cholesterol in certain patients. It is used along with an appropriate diet and other cholesterol treatments.
Mipomersen is a lipid-lowering agent. It works by reducing a protein that carries cholesterol in the blood.
Do NOT use mipomersen if:
- you are allergic to any ingredient in mipomersen
- you have severe kidney problems or are receiving dialysis
- you are receiving apheresis treatments for high cholesterol
- you have moderate or severe liver problems, active liver disease, or unexplained abnormal liver function tests
Contact your doctor or health care provider right away if any of these apply to you.
Before using mipomersen:
Some medical conditions may interact with mipomersen. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are able to become pregnant
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of kidney problems or liver problems (eg, liver problems while taking other medicines)
- if you drink alcohol
- if you are taking other cholesterol-lowering medicines
Some MEDICINES MAY INTERACT with mipomersen. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Medicines that may harm the liver (eg, acetaminophen; amiodarone; isotretinoin; methotrexate; tamoxifen; tetracycline antibiotics, such as doxycycline) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver
This may not be a complete list of all interactions that may occur. Ask your health care provider if mipomersen may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use mipomersen:
Use mipomersen as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Mipomersen comes with an extra patient information sheet called a Medication Guide. It also comes with detailed instructions for use. Read them carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about mipomersen.
- Mipomersen is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using mipomersen at home, a health care provider will teach you how to use it. Be sure you understand how to use mipomersen. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not use mipomersen if it contains particles, is cloudy or discolored, or if the vial or syringe is cracked or damaged.
- Allow mipomersen to reach room temperature for at least 30 minutes before using it.
- Use the proper technique taught to you by your doctor. Inject mipomersen deep under the skin, NOT into muscle or a vein. Inject into the stomach, thigh, or outer area of the upper arm. Rotate injection sites with each dose of mipomersen.
- Do not inject mipomersen into an area with skin disease or into skin that is inflamed, infected, scarred, sunburned, or tattooed. Do not inject into active areas of psoriasis.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- Take mipomersen on the same day of the week at the same time of the day. Do not miss any doses.
- If you miss a dose of mipomersen, use it as soon as you remember. If it is less than 3 days until your next weekly dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use mipomersen.
Important safety information:
- Drinking alcohol while taking mipomersen may increase the risk of liver problems. Do not drink more than 1 drink with alcohol in it each day while you are taking mipomersen. Discuss any questions or concerns with your doctor.
- Do NOT change your dose or stop taking mipomersen without checking with your doctor.
- Tell your doctor or dentist that you take mipomersen before you receive any medical or dental care, emergency care, or surgery.
- If you may become pregnant, you must use an effective form of birth control while you take mipomersen. Talk with your doctor to find the best method of birth control for you.
- Lab tests, including liver function, may be performed while you use mipomersen. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use mipomersen with caution in the ELDERLY; they may be more sensitive to its effects.
- PREGNANCY and BREAST-FEEDING: Mipomersen may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if mipomersen is found in breast milk. Do not breast-feed while taking mipomersen.
Possible side effects of mipomersen:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Headache; mild itching, pain, redness, tenderness, or swelling at the injection site; nausea; tiredness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; flu-like symptoms (eg, fever, chills, or persistent sore throat; muscle or joint pain); irregular heartbeat; severe or persistent headache or dizziness; severe or persistent nausea or vomiting; swelling of the hands, legs, or feet; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, yellowing of the skin or eyes); unusual tiredness or weakness.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of mipomersen:
Store mipomersen in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. If you are not able to store mipomersen in the refrigerator, it may be stored at or below 86 degrees F (30 degrees C) for up to 14 days. Store away from heat, moisture, and light in the original carton. Do not store in the bathroom. Keep mipomersen out of the reach of children and away from pets.
- If you have any questions about mipomersen, please talk with your doctor, pharmacist, or other health care provider.
- Mipomersen is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take mipomersen or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about mipomersen. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to mipomersen. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using mipomersen.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.