Inotersen

What is Inotersen?

• Inotersen (TEGSEDI) is a transthyretin-directed antisense oligonucleotide used to treat the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis.

What are the uses of this medicine?

This medicine is used to treat the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.

How does this medicine work?

• Inotersen is an antisense oligonucleotide that causes degradation of mutant and wild-type TTR mRNA through binding to the TTR mRNA, which results in a reduction of serum TTR protein and TTR protein deposits in tissues.

Who Should Not Use this medicine ?

This medcine cannot be used in patients with:

• a platelet count that is low.
• had kidney inflammation (glomerulonephritis) caused by TEGSEDI.
• had an allergic reaction to inotersen or any of the ingredients in TEGSEDI.

What drug interactions can this medicine cause?

• Because of the risk of thrombocytopenia, caution should be used when using antiplatelet drugs (e.g., adenosine, clopidogrel, prasugrel, ticagrelor, or ticlopidine), including non-prescription products that affect platelets (e.g., aspirin, nonsteroidal anti-inflammatory drugs), or anticoagulants (e.g., heparin, warfarin), concomitantly with TEGSEDI.
• Because of the risk of glomerulonephritis and renal toxicity, caution should be used when using nephrotoxic drugs and other drugs that may impair renal function concomitantly with TEGSEDI.

Is this medicine FDA approved?

• It was approved for use in the United States in 2018.

How should this medicine be used?

• Laboratory tests must be measured prior to treatment, continue to be monitored after treatment initiation, and for 8 weeks following discontinuation of treatment, as directed.

Recommended Dosage

• The recommended dosage of LIBTAYO is 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.

Administration

• Read the detailed Instructions for Use that come with your TEGSEDI.
• Your healthcare provider will show you or your caregiver how to inject TEGSEDI the first time.
• If you or your caregiver have any questions, ask your healthcare provider.
• TEGSEDI is injected under your skin (subcutaneously) in your stomach area (abdomen), or the front of your upper legs (thighs) by you or a caregiver. A caregiver may also give you an injection of TEGSEDI in the outer area of your upper arm.
• Do not inject into the same site each time.
• Do not inject into the 2-inch area around the belly-button (naval).
• Do not inject where the skin is bruised, tender, red, or hard.
• Do not inject into areas with scars or tattoos.
• Do not inject through clothing.
• Follow your healthcare provider’s instructions on when to inject TEGSEDI.
• TEGSEDI should be injected 1 time each week on the same day.
• If you miss a dose, take the missed dose as soon as possible, unless your next scheduled dose is within 2 days. If your next scheduled dose is within 2 days, skip the missed dose and take your next scheduled dose on the scheduled day.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 284 mg/ 1.5 mL in a single-dose prefilled syringe

This medicine is available in fallowing brand namesː

• TEGSEDI

What side effects can this medication cause?

The most common side effects of this medicine include:

• injection site reactions (such as redness or pain at the injection site)
• nausea
• headache
• tiredness
• low platelet counts (thrombocytopenia)
• fever

TEGSEDI may cause serious side effects, including:

• stroke
• inflammatory and immune system problems
• liver effects
• allergic reactions
• eye problems (low vitamin A levels)

What special precautions should I follow?

• TEGSEDI may cause stroke and cervicocephalic arterial dissection. These adverse events occurred within 2 days of first dose and with symptoms of cytokine release. Educate patients on symptoms of stroke and central nervous system arterial dissection.
• Inflammatory and immune changes are an effect of some antisense oligonucleotide drugs, including TEGSEDI.
• TEGSEDI may cause liver injury. Monitor alanine amino-transferase, aspartate aminotransferase, and total bilirubin every 4 months during treatment and in case of symptoms of hepatic dysfunction.
• TEGSEDI can cause hypersensitivity reactions. If these occur, discontinue and initiate appropriate therapy.
• TEGSEDI causes reductions in platelet count that may result in sudden and unpredictable thrombocytopenia that can be life-threatening. Repeat test if this is suspected.
• TEGSEDI treatment leads to a decrease in serum vitamin A levels. Supplement with the recommended daily allowance of vitamin A. Refer to an ophthalmologist if ocular symptoms suggestive of vitamin A deficiency occur.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no data on the developmental risk associated with the use of TEGSEDI in pregnant women.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to TEGSEDI during pregnancy. Health care providers are encouraged to register patients and pregnant women are encouraged to register themselves by calling: 1-877-465-7510.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredients: inotersen
• Inactive ingredients: purified water (water for injection), hydrochloric acid and or sodium hydroxide for pH adjustment

Who manufactures and distributes this medicine?

• Distributed by Akcea Therapeutics, Inc, Boston, MA
• TEGSEDI is registered in the US Patent and Trademark Office.

What should I know about storage and disposal of this medication?

• Store TEGSEDI in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original container.
• Do not freeze.
• TEGSEDI prefilled syringes can also be kept at room temperature that is no higher than 86°F (30°C) in the original container for up to 6 weeks.
• Do not let TEGSEDI reach temperatures above 86°F (30°C).
• If you do not use TEGSEDI kept at room temperature within 6 weeks, throw it away.
• Protect from light.
• Keep TEGSEDI and all medicines out of the reach of children.

• Dailymed label info on Inotersen
• FDA Inotersen

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