Tegsedi Syringe

GENERIC NAME(S): Inotersen

OTHER NAME(S): Tegsedi Syringe

WARNINGS:

This medication decreases the number of platelets in your blood, which may cause serious (even fatal) bleeding problems. Tell your doctor right away if you notice symptoms such as easy bruising, a rash of tiny reddish-purple spots (especially on your lower legs), bleeding gums, nosebleeds, blood in urine/stools, vomiting or coughing up blood, neck stiffness, unusual severe headache, or unusual/heavy menstrual periods (women).

This medication can cause serious kidney damage that may result in the need for dialysis. Tell your doctor right away if you have swelling in your face/feet/hands, shortness of breath, cough, blood in urine, brown/foamy urine, or change in amount of urine.

Careful monitoring and treatment by your doctor may decrease your risk for serious side effects. Lab and/or medical tests (such as kidney/liver function, complete blood count, urine tests) should be done before you start using this medication, while you are using it, and for 8 weeks after stopping treatment. Keep all medical and lab appointments.

For patients to receive this medication, all doctors, pharmacists, and patients must agree to, understand, and carefully follow the requirements of the Tegsedi REMS Program. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

Who should not take Tegsedi Syringe?

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Uses

Uses

This medication is used to treat nerve problems due to a certain inherited condition (transthyretin-mediated amyloidosis). This condition causes a protein that your body normally makes (transthyretin-TTR), to change shape and build up in different parts of your body, which can affect the nerves, heart, eyes, and gut. This medication works by decreasing the buildup of TTR in your body.

How to use Tegsedi Syringe

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using inotersen and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Before use, take inotersen out of the refrigerator. Let it warm up to room temperature for at least 30 minutes. Do not heat this medication any other way, such as by heating in the microwave or placing in hot water. Do not shake this medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Inject this medication under the skin of the thigh, abdomen, or upper arm as directed by your doctor, usually once weekly. The dosage is based on your medical condition and response to treatment.

Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into scars or areas of skin that are bruised, tender, red, hard, or tattooed.

Use this medication regularly to get the most benefit from it. To help you remember, inject this medication on the same day each week.

Learn how to store and discard medical supplies safely.

Side Effects

Side Effects

See also Warning section.

Bruising, redness, itching, pain, or swelling at the injection site may occur. Nausea, vomiting, headache, fever, decreased appetite, numbness/tingling, or tiredness may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: back pain, unexpected change in walking, symptoms of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine).

Get medical help right away if you have any very serious side effects, including: symptoms of stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion).

This medication decreases vitamin A levels in your blood. Ask your doctor about taking a vitamin A supplement. Tell your doctor right away if you develop signs of a lack of vitamin A, especially vision changes such as dry eyes, blurred vision, or trouble seeing in dim light (night blindness).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, muscle/joint pain, flushing/chills, chest pain, trouble swallowing, redness on palms of your hands.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Precautions

Before using inotersen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood problems, kidney problems, liver transplant.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may interfere with certain lab tests (such as platelet counts), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

Overdose

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as kidney function, complete blood count, liver function, urine tests) must be done before you start using this medication and while you are using it. Keep all medical and lab appointments.

Missed Dose

If you miss a dose, use it as soon as you remember unless your next scheduled dose is within 2 days. If your next scheduled dose is within 2 days, skip the missed dose. Use your next dose on your regular day. Do not double the dose to catch up.

Storage

Store in the original package in the refrigerator away from moisture. Do not freeze. This medication can also be stored at room temperature for up to 6 weeks. Use/discard medication kept at room temperature within 6 weeks. Protect from light. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised October 2019. Copyright(c) 2019 First Databank, Inc.

Images

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.