ting, stomach pain, being not hungry, yellowing of the skin, or having dark urine.
allergic reactions. TEGSEDI may cause serious allergic reactions. These allergic reactions often occur within 2 hours after injecting TEGSEDI. Get emergency help immediately if you have any symptoms of an allergic reaction including:
joint pain
chills
redness on palms of hands
muscle pain
chest pain
flushing
tremor or jerking movements
flu-like symptoms
high blood pressure
difficulty swallowing
eye problems (low vitamin A levels). Treatment with TEGSEDI will lower the Vitamin A levels in your blood. Your healthcare provider should tell you to take Vitamin A supplements while using TEGSEDI. Your healthcare provider will tell you how much to take. Call your healthcare provider if you get eye problems, such as having difficulty seeing at night or in low lit areas (night blindness). Your healthcare provider should send you to see an eye doctor (ophthalmologist).
The most common side effects of TEGSEDI include: injection site reactions (such as redness or pain at the injection site), nausea, headache, tiredness, low platelet counts (thrombocytopenia), and fever.
These are not all the possible side effects of TEGSEDI.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store TEGSEDI?
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.
General information about the safe and effective use of TEGSEDI
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TEGSEDI for a condition for which it has not been prescribed. Do not give TEGSEDI to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TEGSEDI that was written for health professionals.
What are the ingredients in TEGSEDI? Active ingredients: inotersen
Inactive ingredients: purified water (water for injection), hydrochloric acid and or sodium hydroxide for pH adjustment
Distributed by Akcea Therapeutics, Inc, Boston, MA
TEGSEDI is registered in the US Patent and Trademark Office© 2017
For more information about TEGSEDI, contact Akcea Therapeutics, Inc., at 1-844-483-4763 or go to www.TEGSEDIREMS.com.
INSTRUCTIONS FOR USE
This Instructions for Use has been approved by the U.S. Food and Drug Administration Issued:10/2018
TEGSEDI (Teg-SED-ee)
(inotersen) injection
for subcutaneous use
Instructions For Use
Introduction
Before using your TEGSEDI prefilled syringe, your healthcare provider should show you or your caregiver how to use it the right way. If you or your caregiver have any questions, ask your healthcare provider.
Read this Instructions for Use before you start using your TEGSEDI prefilled syringe and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
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