Mipomersen Injection

Uses

Mipomersen injection is used to decrease levels of cholesterol and other fatty substances in the blood in people who have homozygous familial hypercholesterolemia (HoFH; a rare inherited condition that causes very high levels of cholesterol in the blood, increasing the risk of serious heart disease). Some people with HoFH may be treated with LDL apheresis (a procedure that removes LDL from the blood), but mipomersen injection should not be used along with this treatment. Mipomersen injection should not be used to decrease cholesterol levels in people who do not have HoFH. Mipomersen injection is in a class of medications called antisense oligonucleotide (ASO) inhibitors. It works by preventing certain fatty substances from forming in the body.

Side Effects Of Mipomersen Injection

Mipomersen injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • redness, pain, tenderness, swelling, discoloration, itching, or bruising of the skin where you injected mipomersen
  • flu-like symptoms such as fever, chills, muscle pain, joint pain, weakness, and tiredness that are most likely to occur during the first 2 days after you inject mipomersen
  • headache
  • difficulty falling asleep or staying asleep
  • pain in the arms or legs

Some side effects can be serious. If you experience any of these symptoms or those listed in the WARNING section, call your doctor immediately or get emergency medical treatment:

  • chest pain
  • pounding heartbeat
  • swelling of the arms, hands, feet, ankles, or lower legs
  • rash
  • hives
  • swelling of the face, throat, tongue, lips, or eyes
  • hoarseness
  • difficulty swallowing or breathing

Mipomersen injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

Warnings & Precautions

Before injecting mipomersen injection:

  • tell your doctor and pharmacist if you are allergic to mipomersen, any other medications, or any of the ingredients in mipomersen injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • do not inject any other medications at the same time that you inject mipomersen. Ask your doctor or pharmacist when to inject your medications.
  • tell your doctor if you have or have ever had kidney disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should use birth control to prevent pregnancy during your treatment. Talk to your doctor about methods of birth control that will work for you. If you become pregnant during your treatment, stop using mipomersen injection and call your doctor immediately.

Dosage Of Mipomersen Injection

  • Mipomersen injection comes as a solution to inject under the skin. It is usually injected once a week. Inject mipomersen injection on the same day of the week and at around the same time of day every time you inject it. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use mipomersen injection exactly as directed. Do not inject more or less of it or inject it more often than prescribed by your doctor.
  • Mipomersen injection may help control your cholesterol but will not cure your condition. It may take 6 months or longer for your cholesterol level to decrease significantly. Continue to use mipomersen injection even if you feel well. Do not stop using mipomersen injection without talking to your doctor.
  • You can inject mipomersen yourself or have a friend or relative inject the medication for you. Your doctor will show you or the person who will be injecting the medication how to give the injection. You and the person who will be injecting the medication should read the manufacturer’s instructions for use that come with the medication. Ask your doctor if you have any questions or do not understand how to inject mipomersen.
  • Mipomersen injection comes in pre-filled syringes and in vials. If you are using vials of mipomersen injection, your doctor will tell you what type of syringe you should use and how you should draw the medication into the syringe. Do not mix any other medications in the syringe with mipomersen injection.
  • Take mipomersen injection out of the refrigerator at least 30 minutes before you plan to inject it to allow the medication to come to room temperature. Keep the syringe in its packaging to protect it from light during this time. Do not try to warm the syringe by heating it in any way.
  • Always look at mipomersen injection before injecting it. Be sure that the packaging is sealed, undamaged, and labeled with the correct name of the medication and an expiration date that has not passed. Check that the solution in the vial or syringe is clear and colorless or slightly yellow. Do not use a vial or syringe if it is damaged, expired, discolored, or cloudy, or if it contains particles.
  • You can inject mipomersen anywhere on the outer part of your upper arms, your thighs, or your stomach, except your navel (belly button) and the area 2 inches around it. Choose a different spot each time you inject the medication. Do not inject into skin that is red, swollen, infected, scarred, tattooed, sunburned, or that is affected by a rash or a skin disease such as psoriasis.
  • Each pre-filled syringe or vial only contains enough mipomersen injection for one dose. Do not try to use vials or syringes more than once. Dispose of used syringes in a puncture-resistant container. Ask your doctor or pharmacist how to dispose of the puncture-resistant container.

Other

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Source

All information has been provided courtesy of MedLinePlus from the National Library of Medicine and from the FDA.