Mipomersen (Subcutaneous)
Medically reviewed by Drugs.com. Last updated on May 20, 2022.
Mipomersen sodium can cause elevations in transaminases and also increases hepatic fat (with or without concomitant increases in transaminases). Hepatic steatosis is a risk factor for advanced liver disease, including steatohepatitis and cirrhosis. Measure ALT, AST, alkaline phosphatase, and total bilirubin prior to initiation. Measure ALT and AST regularly. If ALT or AST are 3 times the ULN or greater, interrupt therapy. If clinically significant liver toxicity occurs, discontinue therapy. Mipomersen sodium is available only through a restricted program called the Kynamro(R) REMS. Prescribe mipomersen sodium only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia .
Commonly used brand name(s)
In the U.S.
- Kynamro
Pharmacologic Class: Mipomersen
Uses for mipomersen
Mipomersen injection is used together with a proper diet and other medicines to treat high cholesterol levels in patients with homozygous familial hypercholesterolemia (HoFH).
Mipomersen is only available through a restricted access program. Only doctors who are enrolled in the restricted program can write a prescription for mipomersen.
Before using mipomersen
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For mipomersen, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to mipomersen or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of mipomersen injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
In clinical studies, elderly patients receiving mipomersen had higher rates of high blood pressure and swelling compared with other elderly patients not receiving this medication and younger patients receiving the medication. Elderly patients receiving mipomersen were also more likely to develop fatty liver than younger patients.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Interactions with food/tobacco/alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. ..
