Generic Name and Formulations:
Mipomersen sodium 200mg/mL; soln for SC inj; preservative-free.
Sanofi Genzyme Company
Indications for KYNAMRO:
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:
Not established in patients with hypercholesterolemia who do not have HoFH, including those with heterozygous familial hypercholesterolemia (HeFH). Effect on cardiovascular morbidity, mortality has not been determined. Not recommended as an adjunct to LDL apheresis.
Give on the same day every week. Administer 1st inj under supervision of qualified health care provider. 200mg SC inj once weekly into the abdomen, thigh region, or outer area of the upper arm. Monitor lipids at least every 3 months for the first year; assess LDL-C after 6 months to determine if reduction achieved warrants potential hepatotoxicity. Adjustments and monitoring in elevated transaminases: see full labeling.
Moderate or severe hepatic impairment (Child-Pugh B or C). Active liver disease (including unexplained persistent elevations of serum transaminases).
Risk of hepatotoxicity. Measure ALT, AST, alkaline phosphatase, and total bilirubin before initiating therapy, then ALT and AST monthly for 1st year, subsequently, at least every 3 months. Withhold if ALT or AST are ≥3XULN; discontinue if persistent or clinically significant elevations, liver injury, bilirubin ≥2XULN, or active liver disease occurs. Severe renal impairment, significant proteinuria, or on dialysis: not recommended. Do not inject into areas of active skin disease, injury (eg, sunburns, rashes, inflammation, skin infections, active psoriasis areas), tattooed skin, or scarring. Females of reproductive potential should use effective contraception during therapy. Pregnancy (Cat.B). Nursing mothers: not recommended.
Caution with concomitant isotretinoin, amiodarone, acetaminophen (>4g/day for ≥3 days/week), methotrexate, tetracyclines, tamoxifen: increased risk for hepatotoxicity. Concomitant other LDL-lowering agents that can increase steatosis: not recommended. Limit one alcoholic drink per day.
Oligonucleotide inhibitor of Apo B-100 synthesis.
Inj site reactions, flu-like symptoms, nausea, headache, elevated serum transaminases (specifically ALT); hepatic steatosis.
Available only through the Kynamro REMS program. Further information is available at www.KynamroREMS.com or call (877) KYNAMRO.
Single-use prefilled syringe—1, 4