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KYNAMRO™ (mipomersen sodium) injection, solution

Disclaimer - Please see package insert for additional information and possible updates. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.   Read the disclaimer
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Drug
: KYNAMRO (mipomersen sodium) Injection
Solution for Subcutaneous Injection
[Drug information  /  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 hypercholesterolemia (HoFH)

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 been determined.
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 bilirubin.

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

CONTRAINDICATIONS
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.

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REFERENCE

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