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Drug: KYNAMRO (mipomersen sodium) Injection
Solution for Subcutaneous Injection
PDF] Dosing: Click (+) next to Dosage and Administration section
(drug info link) Initial U.S. Approval: 2013
WARNINGS:RISK OF HEPATOTOXICITY
See full prescribing information for complete boxed warning.
KYNAMRO can cause elevations in transaminases.
Measure alanine aminotransferase (ALT), aspartate aminotransferase
(AST), alkaline phosphatase, and total bilirubin before initiating
treatment and then ALT and AST regularly as recommended.
During treatment, withhold the dose of KYNAMRO if the ALT or AST is = 3
times the upper limit of normal (ULN).
Discontinue KYNAMRO for clinically significant liver toxicity.
KYNAMRO increases hepatic fat (hepatic steatosis) with or without
concomitant increases in transaminases.
Hepatic steatosis associated with KYNAMRO may be a risk factor for
progressive liver disease, including steatohepatitis and cirrhosis.
Because of the risk of hepatotoxicity, KYNAMRO is available only through
a restricted program called the KYNAMRO REMS .
INDICATIONS AND USAGE
KYNAMRO™ is an oligonucleotide inhibitor of apolipoprotein B-100
synthesis indicated as an adjunct to lipid-lowering medications and diet
to reduce low density lipoprotein-cholesterol (LDL-C), apolipoprotein B
(apo B), total cholesterol (TC), and non-high density
lipoprotein-cholesterol (non HDL-C) in patients with homozygous familial
Limitations of Use:
The safety and effectiveness of KYNAMRO have not been established in
patients with hypercholesterolemia who do not have HoFH.
The effect of KYNAMRO on cardiovascular morbidity and mortality has not
The use of KYNAMRO as an adjunct to LDL apheresis is not recommended.
DOSAGE AND ADMINISTRATION
200 mg once weekly as a subcutaneous injection.
Before treatment, measure ALT, AST, alkaline phosphatase, and total
DOSAGE FORMS AND STRENGTHS
Single-use vial containing 1 mL of a 200 mg/mL solution
Single-use pre-filled syringe containing 1 mL of a 200 mg/mL solution
Moderate or severe hepatic impairment, or active liver disease,
including unexplained persistent elevations of serum transaminases.
Known sensitivity to product components.
WARNINGS AND PRECAUTIONS
Injection site reactions occur in 84% of patients and typically consist
of one or more of the following: erythema, pain, tenderness, pruritus
and local swelling.
Flu-like symptoms, which typically occur within 2 days after an
injection, occur in 30% of patients and include one or more of the
following: influenza-like illness, pyrexia, chills, myalgia, arthralgia,
malaise or fatigue.