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Inotersen

Published: July 26, 2026Updated: August 20, 2026

Inotersen is an antisense oligonucleotide medication used to treat hereditary transthyretin amyloidosis (hATTR) with polyneuropathy in adults. It works by reducing the production of transthyretin protein in the liver, thereby slowing the progression of nerve damage caused by the accumulation of abnormal amyloid deposits.

Quick summary

Inotersen is an antisense therapy that treats hereditary transthyretin amyloidosis by reducing TTR protein production to slow nerve damage progression.

Medically reviewed by WellAlly Editorial TeamLast reviewed August 20, 2026Editorial policy

Key facts at a glance

ATC
N07XX15
RxNorm
2099289
Generic
Inotersen
Class
atc-n07
Brands
Tegsedi
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

adult (standard)tablet
Usual dose
500mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
250mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
400mg daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Approximately 10 times the recommended weekly dose of 284 mg may cause significant toxicity
Chronic overdose: Cumulative dosing above recommended weekly dose over extended periods may lead to liver toxicity and thrombocytopenia
Immediate actions
Discontinue drug, monitor vital signs, check liver function tests and platelet count, supportive care
Antidote
No specific antidote exists(Supportive care is the primary treatment; early intervention improves outcomes)
Poison Control: 1-800-222-1222

Special Populations

10 groups
⚠

pregnancy

first trimester
caution
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

use only if potential benefits outweigh potential risks to the fetus

Monitor

regular fetal monitoring and ultrasound assessments

Use with caution and monitor for adverse effects.

⚠

pregnancy

second trimester
caution
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

continue only if benefits outweigh risks, consider discontinuation if pregnancy confirmed

Monitor

regular fetal monitoring

Use with caution and monitor for adverse effects.

⚠

pregnancy

third trimester
caution
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

use only if benefits outweigh risks, close monitoring required

Monitor

fetal monitoring and assessment of maternal condition

Use with caution and monitor for adverse effects.

?

lactation

breastfeeding
unknown
FDA Category
N
Dose Adjustment

not recommended

Key Recommendations

discontinue breastfeeding or discontinue drug, considering importance of drug to mother

Monitor

monitor infant for adverse effects

⚠

geriatric

elderly 65 plus
caution
FDA Category
N
Dose Adjustment

no specific dose adjustment required

Key Recommendations

use with caution due to increased risk of thrombocytopenia and glomerulonephritis in elderly

Monitor

more frequent monitoring of platelet counts and renal function

Use with caution and monitor for adverse effects.

?

pediatric_age

children under 18
unknown
FDA Category
N
Dose Adjustment

not established

Key Recommendations

not recommended for use in pediatric patients due to lack of safety and efficacy data

Monitor

not applicable

⚠

renal_impairment

mild renal impairment
caution
FDA Category
N
Dose Adjustment

no dose adjustment recommended

Key Recommendations

monitor renal function closely, increased risk of glomerulonephritis

Monitor

regular monitoring of serum creatinine and urinalysis

Use with caution and monitor for adverse effects.

⚠

renal_impairment

moderate severe renal impairment
caution
FDA Category
N
Dose Adjustment

use with caution

Key Recommendations

use only if benefits outweigh risks, close monitoring required

Monitor

frequent monitoring of renal function and platelet counts

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

mild hepatic impairment
caution
FDA Category
N
Dose Adjustment

no dose adjustment recommended

Key Recommendations

use with caution, monitor hepatic function

Monitor

regular monitoring of liver function tests

Use with caution and monitor for adverse effects.

?

hepatic_impairment

moderate severe hepatic impairment
unknown
FDA Category
N
Dose Adjustment

not studied

Key Recommendations

use not recommended due to lack of data

Monitor

monitor hepatic function if used

Statistics and clinical data

drug_classFDA
2023

Drug class

Value:Antisense oligonucleotide (ASO)

Inotersen is a transthyretin-directed antisense oligonucleotide

indicationFDA
2023

Primary indication

Value:Treatment of polyneuropathy in hereditary transthyretin amyloidosis (hATTR)

Approved for adult patients with hATTR with polyneuropathy

prescribingFDA
2023

FDA approval year

Value:2018

FDA approved Inotersen in October 2018

mechanismFDA
2023

Mechanism of action

Value:Reduces production of transthyretin (TTR) protein

Binds to TTR mRNA and inhibits TTR protein production

Inotersen is indicated for the treatment of hereditary transthyretin amyloidosis (hATTR amyloidosis) in adults with Stage 1 or Stage 2 polyneuropathy. This is a rare genetic condition where abnormal transthyretin proteins form amyloid deposits that damage nerves and other organs.

Inotersen is an antisense oligonucleotide that binds to messenger RNA (mRNA) encoding transthyretin (TTR), preventing the translation of TTR protein. By reducing hepatic production of TTR, it decreases the amount of abnormal protein available to form amyloid deposits in peripheral nerves and other tissues.

Inotersen is administered as a weekly subcutaneous injection. Regular monitoring for thrombocytopenia and kidney function is required due to risk of serious side effects including glomerulonephritis. Monitoring of platelet counts and renal function should occur before and during treatment. Patients should be educated on signs of bleeding or kidney problems. Anticoagulant medications may increase bleeding risk.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

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.

Medical Disclaimer

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