Mipomersen Side Effects
Medically reviewed by Drugs.com. Last updated on Sep 10, 2020.
Commonly reported side effects of mipomersen include: bleeding at injection site, fatigue, flu-like symptoms, hematoma at injection site, increased serum alanine aminotransferase, lipomatosis, rash at injection site, arthralgia, fever, increased serum aspartate aminotransferase, injection site reaction, myalgia, nausea, chills, induration at injection site, inflammation at injection site, injection-site pigmentation changes, swelling at injection site, erythema at injection site, malaise, pain at injection site, and tenderness at injection site. Other side effects include: abnormal hepatic function tests, and vomiting. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to mipomersen: subcutaneous solution
Subcutaneous route (Solution)
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® REMS. Prescribe mipomersen sodium only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia.
Side effects requiring immediate medical attention
Along with its needed effects, mipomersen may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking mipomersen:
- dark urine
- general feeling of discomfort or illness
- joint pain
- light-colored stools
- loss of appetite
- muscle aches and pains
- nausea and vomiting
- runny nose
- sore throat
- trouble sleeping
- unusual tiredness or weakness
- upper right abdominal or stomach pain
- yellow eyes and skin
- Arm, back, or jaw pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- chest pain or discomfort
- chest tightness or heaviness
- fast or irregular heartbeat
- irregular, pounding, or racing heartbeat or pulse
- rapid weight gain
- shortness of breath
- tingling of the hands or feet
- unusual weight gain or loss
Side effects not requiring immediate medical attention
Some side effects of mipomersen may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- pain in the arms or legs
- Abdominal or stomach pain
For Healthcare Professionals
Applies to mipomersen: subcutaneous solution
Very common (10% or more): Nausea (14%)
Very common (10% or more): Alanine aminotransferase (ALT) increased (10%)
Common (1% to 10%): Hepatic steatosis (7%), aspartate aminotransferase (AST) increased (6%), liver function test abnormal (5%), hepatic enzyme increased (3%)[Ref]
Common (1% to 10%): Pain in extremity (7%), musculoskeletal pain (4%)[Ref]
Very common (10% or more): Fatigue (15%), headache (12%)
Common (1% to 10%): Pyrexia (8%), chills (6%)[Ref]
Common (1% to 10%): Neoplasms [benign and malignant] (4%)[Ref]
Rare (less than 0.1%): One case of glomerular nephritis was reported[Ref]
1. "Product Information. Kynamro (mipomersen)." Genzyme Corporation, Cambridge, MA.
More about mipomersen
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- En Español
- 1 Review
- Drug class: miscellaneous antihyperlipidemic agents
- Other brands
Related treatment guides
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.