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.
Side Effects Of 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. 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 do 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 Evaluation 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.
Warnings & Precautions
Do not use 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 complete list of ingredients.
Before you start using TEGSEDI, tell your healthcare provider about all your medical conditions, including if you:
• have or had bleeding problems
• have or had kidney problems
• have received a liver transplant
• are pregnant or plan to become pregnant. It is not known if it can harm your unborn baby.
• There is a registry for women who become pregnant during treatment with TEGSEDI. If you become pregnant while taking it, talk to your healthcare provider about registering with the TEGSEDI Pregnancy Exposure Registry.
The purpose of this registry is to collect information about your health and your baby’s health.
Dosage Of Tegsedi
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 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 it.
• 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.
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 it 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.
All information has been provided courtesy of MedLinePlus from the National Library of Medicine and from the FDA.