Note: This document contains side effect information about mipomersen. Some dosage forms listed on this page may not apply to the brand name Kynamro.
Summary
Common side effects of Kynamro 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. Continue reading for a comprehensive list of adverse effects.
Applies to mipomersen: subcutaneous solution.
Warning
Mipomersen is available only from a certified pharmacy.
You should not use mipomersen if you have active liver disease or abnormal liver function tests. Tell your doctor right away if you have liver symptoms, such as vomiting, fever, stomach pain, itching, tiredness, dark urine, or jaundice (yellowing of the skin or eyes).
Mipomersen can cause your liver enzymes to get too high. Your blood will need to be tested often. Your treatments may be stopped based on the results of these tests.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using mipomersen (the active ingredient contained in Kynamro) and call your doctor at once if you have:
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flu symptoms within 2 days after an injection--fever, chills, body aches, tired feeling, joint or muscle pain;
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pain, swelling, redness, itching, bruising, or tenderness where an injection was given; or
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nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common side effects may include:
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nausea;
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headache; or
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flu symptoms.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to mipomersen: subcutaneous solution.
Cardiovascular
Common (1% to 10%): Hypertension (7%), angina pectoris (4%), palpitations (3%)[Ref]
Dermatologic
Very common (10% or more): [All injection site reactions (84%)], erythema (59%), pain (56%), hematoma (32%), pruritus (29%), swelling (18%), discoloration (17%)[Ref]
Gastrointestinal
Very common (10% or more): Nausea (14%)
Common (1% to 10%): Vomiting (4%), abdominal pain (3%)[Ref]
Hepatic
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]
Immunologic
Rare (less than 0.1%): One case of hypersensitivity with angioedema was reported[Ref]
Metabolic
Common (1% to 10%): Proteinuria (9%), peripheral edema (5%)[Ref]
Musculoskeletal
Common (1% to 10%): Pain in extremity (7%), musculoskeletal pain (4%)[Ref]
Nervous system
Very common (10% or more): Fatigue (15%), headache (12%)
Common (1% to 10%): Pyrexia (8%), chills (6%)[Ref]
Oncologic
Common (1% to 10%): Neoplasms [benign and malignant] (4%)[Ref]
Psychiatric
Common (1% to 10%): Insomnia (3%)[Ref]
Renal
Rare (less than 0.1%): One case of glomerular nephritis was reported[Ref]
