hey use TEGSEDI.
Pregnancy
Instruct patients that if they are pregnant or plan to become pregnant while taking TEGSEDI they should inform their healthcare provider. Advise female patients of childbearing potential of the potential risk to the fetus [see Use in Specific Populations (8.1)].
For more information about TEGSEDI, go to www.TEGSEDIREMS.com or call 1-844-483-4736
Distributed by:
Akcea Therapeutics, Inc.
Boston, MA 02210
TEGSEDI is a trademark of Akcea Therapeutics, Inc.
MEDICATION GUIDE
This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 10/2018
MEDICATION GUIDE
TEGSEDI (Teg-SED-ee)
(inotersen)
injection, for subcutaneous use
What is the most important information I should know about TEGSEDI?
TEGSEDI can cause serious side effects, including:
low platelet counts (thrombocytopenia). TEGSEDI may cause the number of platelets in your blood to be reduced. This is a common side effect of TEGSEDI. When your platelet count is too low, your body cannot form clots. You could have serious bleeding that could lead to death. Call your healthcare provider immediately if you have:
unusual bruising or a rash of tiny reddish-purple spots, often on the lower legs
bleeding from skin cuts that does not stop or oozes
bleeding from your gums or nose
blood in your urine or stools
bleeding into the whites of your eyes
sudden severe headaches or neck stiffness
vomiting or coughing up blood
abnormal or heavy periods (menstrual bleeding)
kidney inflammation (glomerulonephritis).Your kidneys may stop working properly. Glomerulonephritis can lead to severe kidney damage and kidney failure that needs dialysis. Call your healthcare provider immediately if you have:
puffiness or swelling in your face, feet or hands
new onset or worsening shortness of breath and coughing
blood in your urine or brown urine
foamy urine (proteinuria)
passed less urine than usual
Your healthcare provider will do laboratory tests to check your platelet count and kidneys before you start TEGSEDI and while you are using it. Your healthcare provider should also do laboratory tests for 8 weeks after you stop TEGSEDI. It is important that you make sure you get these laboratory tests done.
Because of the risk of serious bleeding caused by low platelet counts and because of the risk of kidney problems, TEGSEDI is available only through a restricted program called the TEGSEDI Risk eva luation and Mitigation (REMS) Program.
Before you begin using TEGSEDI, you must enroll in the TEGSEDI REMS Program. Talk to your healthcare provider about how to enroll in the TEGSEDI REMS Program.
You must agree to get your laboratory testing done while you are in the TEGSEDI REMS Program.
You can only get TEGSEDI from a certified pharmacy that participates in the TEGSEDI REMS Program. Your healthcare provider can give you information on how to find a certified pharmacy.
For more information, including a list of certified pharmacies go to www.TEGSEDIREMS.com or call 1-844-483-4736.
What is TEGSEDI?
TEGSEDI is a medicine used to treat the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. It is not known if TEGSEDI is safe and effective in children.
Do not use TEGSEDI if you have:
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. See the end of this Medication Guide for a comp |
