Mipomersen
Mipomersen is an injectable antisense oligonucleotide medication used as adjunct therapy for patients with homozygous familial hypercholesterolemia (HoFH), a rare genetic condition causing severely elevated LDL cholesterol that is difficult to control with statins and other lipid-lowering therapies alone. It works by inhibiting the synthesis of apolipoprotein B-100, a key component of LDL particles.
Mipomersen is an injectable medication for homozygous familial hypercholesterolemia that lowers LDL cholesterol by blocking apolipoprotein B-100 synthesis.
Key facts at a glance
- ATC
- C10AX11
- RxNorm
- 1367839
- Generic
- Mipomersen
- Class
- atc-c10
- Brands
- Kynamro
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- prefilled syringe
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
7 groupspregnancy
all trimestersavoid
do not use during pregnancy. discontinue therapy prior to conception
not applicable - avoid use
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingavoid
do not breastfeed during treatment - excretion in milk unknown
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
children adolescentsnot established
not recommended - safety and efficacy not established in patients under 18 years
not applicable
geriatric
elderly 65 yearsno specific adjustment
use with caution - monitor for adverse effects including injection site reactions and liver function
regular liver function monitoring recommended
Use with caution and monitor for adverse effects.
renal_impairment
mild moderateno specific adjustment
use with caution - limited pharmacokinetic data available
monitor renal function periodically
Use with caution and monitor for adverse effects.
hepatic_impairment
mildno specific adjustment
use with caution - mipomersen may increase hepatic fat content
regular liver function tests and hepatic imaging recommended
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate severeavoid
not recommended in moderate to severe hepatic impairment including fatty liver disease
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
Statistics and clinical data
FDA approval year
FDA approval date for Mipomersen (Kynamro)
Drug class
Pharmacological classification
Indication
Primary therapeutic indication
Route of administration
Method of drug delivery
Adjunct therapy for homozygous familial hypercholesterolemia (HoFH) in patients who have not responded adequately to other lipid-lowering treatments such as statins and LDL apheresis.
Mipomersen is an antisense oligonucleotide that binds to messenger RNA (mRNA) encoding apolipoprotein B-100, preventing its translation into protein and thereby reducing the production of LDL cholesterol and lipoprotein(a) in the liver.
Administered by subcutaneous injection once weekly. Common side effects include injection site reactions, flu-like symptoms, and liver toxicity with increased hepatic fat content. Requires regular liver function monitoring. Reserved for patients with limited treatment options due to its safety profile.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed August 20, 2026. · Read our editorial policy