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Kynamro Side Effects

Generic name: mipomersen

Medically reviewed by Drugs.com. Last updated on Sep 10, 2020.

Note: This document contains side effect information about mipomersen. Some of the dosage forms listed on this page may not apply to the brand name Kynamro.

In 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. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to mipomersen: parenteral injection

Warning

    Hepatotoxicity
  • Increases in serum aminotransferase (ALT and/or AST) concentrations and/or hepatic steatosis reported; hepatic steatosis is a risk factor for progressive liver disease, including steatohepatitis and cirrhosis.1 (See Hepatotoxicity under Cautions.)

  • Monitor liver-related laboratory tests prior to initiation of therapy and at recommended intervals during therapy.1 If hepatotoxicity occurs, interrupt or discontinue therapy depending on severity and persistence of toxicity.1 (See Hepatotoxicity under Dosage and Administration.)

    Restricted Distribution Program
  • Available only through the Kynamro® REMS program.1 3 9 (See REMS and also see Restricted Distribution Program under Dosage and Administration.)

REMS:

FDA approved a REMS for mipomersen to ensure that the benefits outweigh the risks. The REMS may apply to one or more preparations of mipomersen and consists of the following: elements to assure safe use and implementation system. See the FDA REMS page ([Web]). Also see Restricted Distribution Program under Dosage and Administration.

Side effects include:

Injection site reactions, fatigue, nausea, influenza-like illness, headache, increased serum aminotransferase (ALT, AST) concentrations, pyrexia, hepatic steatosis, extremity pain, hypertension, chills, peripheral edema, abnormal liver function test, angina pectoris, vomiting, musculoskeletal pain, palpitations, abdominal pain, increased hepatic enzyme, insomnia.

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]

References

1. "Product Information. Kynamro (mipomersen)." Genzyme Corporation, Cambridge, MA.

Further information

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.