<\/a><\/p>\n\n\n\n
What you need to know before using Tegsedi<\/h2>\n\n\n\nDo not use Tegsedi:<\/h2>\n\n\n\n- if you are allergic to inotersen or any of the other ingredients of this medicine (listed in section 6).<\/li>
- if tests show that you have a very low number of platelets (the blood cells that help the blood to clot).<\/li>
- if tests of kidney function or protein in the urine show signs of severe kidney problems.<\/li>
- if you have severely impaired liver function.<\/li><\/ul>\n\n\n\n
Warnings and precautions<\/h2>\n\n\n\n
Before you can start treatment with Tegsedi, the doctor will check\u00a0blood cells, liver function, kidney function, and protein levels in the urine.\u00a0You will only receive treatment with Tegsedi if all test results are at acceptable levels.\u00a0The doctor will repeat these tests regularly during treatment.<\/p>\n\n\n\n
Thrombocytopenia<\/p>\n\n\n\n
Tegsedi can reduce the number of\u00a0blood cells\u00a0responsible for clotting the blood (\u00a0platelets\u00a0), which can lead to a condition called\u00a0thrombocytopenia\u00a0(see section 4).\u00a0If you don’t have enough\u00a0platelets, as in\u00a0thrombocytopenia, the blood may not clot quickly enough to stop a bleed.\u00a0This can lead to bruising as well as other more serious problems such as extensive bleeding and internal bleeding.\u00a0The doctor will check the number of\u00a0platelets\u00a0in the blood before treatment and regularly during treatment with Tegsedi.\u00a0If you stop taking Tegsedi, blood levels should be checked for 8 weeks after stopping treatment.<\/p>\n\n\n\n
If you are taking other medicines that can reduce the number of\u00a0blood platelets\u00a0or prevent the blood from clotting, e.g.\u00a0acetylsalicylic acid, clopidogrel,\u00a0warfarin,\u00a0heparin, rivaroxaban, and dabigatran, you must tell the doctor before using Tegsedi.<\/p>\n\n\n\n
You should see a doctor immediately if you get unexplained bruising or a rash with small red spots on the skin (called\u00a0petechiae\u00a0), bleeding from a cut on the skin that does not stop or oozes, bleeding from the gums or nose, blood in the urine or stool, bleeding in the whites of the eyes.\u00a0Seek immediate help if you have a stiff neck or unusual and severe headaches, as these symptoms may be caused by bleeding in the brain.<\/p>\n\n\n\n
Glomerulonephritis\/kidney problems<\/p>\n\n\n\n
Glomerulonephritis is a condition of the kidneys that means they don’t work properly due to inflammation and kidney damage. Some patients treated with inotersen have developed this condition. Symptoms of glomerulonephritis are foamy urine, pink or brown colored urine, blood in the urine and you urinating less than usual.<\/p>\n\n\n\n
Some patients treated with inotersen have also developed deterioration of kidney function without having had\u00a0glomerulonephritis.<\/p>\n\n\n\n
The doctor will check kidney function before treatment and regularly during treatment with Tegsedi.\u00a0If you stop taking Tegsedi, your kidney function should be checked for 8 weeks after stopping treatment.\u00a0If you develop\u00a0glomerulonephritis, you will receive treatment for this.<\/p>\n\n\n\n
Tell the doctor if you are using medicines that damage the kidneys or affect kidney function, e.g.\u00a0sulfonamides, aldosterone antagonists, and certain types of pain<\/a> relievers.<\/p>\n\n\n\nVitamin A deficiency<\/p>\n\n\n\n
Tegsedi can reduce the body’s levels of vitamin A (also called retinol). The doctor will check these levels and if they are already low they should be corrected and any symptoms addressed before you start treatment with Tegsedi. Symptoms of vitamin A deficiency include:<\/p>\n\n\n\n
- dry eyes, reduced vision, reduced night vision, or blurred vision.<\/li><\/ul>\n\n\n\n
If you have vision problems or other eye problems while using Tegsedi, talk to your doctor. If necessary, the doctor can refer you to an eye specialist for a check-up.<\/p>\n\n\n\n
The doctor may ask you to take vitamin A supplements daily during treatment with Tegsedi.<\/p>\n\n\n\n
Both too high and too low levels of vitamin A can damage fetal development. Fertile women must therefore rule out pregnancy before starting treatment with Tegsedi and use an effective contraceptive method (see the section ” Pregnancy and breast-feeding”<\/em> below).<\/p>\n\n\n\nIf you are planning to become pregnant, stop taking inotersen including vitamin A supplements. Make sure your vitamin A levels have returned to normal before trying to conceive.<\/p>\n\n\n\n
In the event of an unplanned pregnancy, you should stop taking inotersen.\u00a0However, due to Tegsedi’s prolonged activity, your reduced levels of\u00a0vitamin\u00a0A may persist.\u00a0It is not known whether continued supplementation of 3,000 IU of\u00a0vitamin\u00a0A per day is harmful to the fetus during the first\u00a0trimester\u00a0of pregnancy, but this\u00a0dose\u00a0should not be exceeded.\u00a0You should continue\u00a0vitamin\u00a0A supplementation during the second and third\u00a0trimesters of pregnancy if\u00a0vitamin\u00a0A levels\u00a0have not yet returned to normal, as there is an increased risk of\u00a0vitamin\u00a0A deficiency during the third trimester.<\/p>\n\n\n\n
Liver transplant rejection<\/p>\n\n\n\n
Talk to your doctor before using TEGSEDI if you have had a liver transplant. Cases of liver transplant rejection have been reported in patients treated with Tegsedi. Your doctor will check you regularly for this during treatment with Tegsedi.<\/a><\/p>\n\n\n\nChildren and young people<\/h2>\n\n\n\n
Tegsedi should not be used in children or adolescents under 18 years of age.<\/a><\/p>\n\n\n\nOther medicines and Tegsedi<\/h2>\n\n\n\n
Tell your doctor or pharmacist if you are taking, have recently taken, or might be taking any other medicines.\u00a0You must tell the doctor if you are already being treated with any of the following:<\/p>\n\n\n\n
- Medicines to prevent blood clots or reduce the number of\u00a0platelets\u00a0in the blood, e.g.\u00a0aspirin,\u00a0heparin,\u00a0warfarin, clopidogrel, rivaroxaban, and dabigatran.<\/li>
- Medicines that can change kidney function or damage the kidneys, e.g.\u00a0sulfonamides\u00a0(used as\u00a0antibacterial\u00a0agents), anilides (used to treat fever<\/a>, aches<\/a>, and pain<\/a>), aldosterone antagonists (used as\u00a0diuretics\u00a0), and natural opium alkaloids and other\u00a0opioids\u00a0(used to treat pain).<\/li><\/ul>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult a doctor before using this medicine.<\/p>\n\n\n\n
Fertile women<\/p>\n\n\n\n
Tegsedi reduces the level of vitamin A in the body. Vitamin A is important for normal fetal development during pregnancy. It is not known whether vitamin A supplementation can compensate for the risk of vitamin A deficiency affecting the unborn child (see \u201cWarnings and precautions\u201d<\/em> above). If you are a fertile woman, you must use an effective contraceptive method and possible pregnancy must be ruled out before starting treatment with Tegsedi.<\/p>\n\n\n\nPregnancy<\/p>\n\n\n\n
You should not use Tegsedi if you are pregnant unless your doctor has specifically advised you to do so.\u00a0If you are a\u00a0fertile\u00a0woman, you must use an effective method of contraception.<\/p>\n\n\n\n
Breast-feeding<\/p>\n\n\n\n
Tegsedi can pass into breast milk. You should contact your doctor to determine whether you should either stop breastfeeding or stop treatment with Tegsedi.<\/a><\/p>\n\n\n\nDriving ability and use of machinery<\/h2>\n\n\n\n
The use of Tegsedi has not been shown to affect the ability to drive or use machines.<\/p>\n\n\n\n
How to use Tegsedi<\/h2>\n\n\n\n
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n
The recommended dose is a dose corresponding to 284 mg of inotersen.<\/p>\n\n\n\n
Dose er should be administered once per week. All subsequent doses should be injected once a week, on the same day of the week each week.<\/p>\n\n\n\n
Route of administration and method of administration<\/p>\n\n\n\n
Tegsedi is only intended for injection under the skin ( subcutaneous use).<\/p>\n\n\n\n
Instructions for use<\/p>\n\n\n\n
Before using the pre-filled syringe, your doctor or caregiver should show you how to use it correctly. If you or your caregiver have questions, contact the doctor.<\/p>\n\n\n\n
Read the instructions for use before you start using the pre-filled syringe and each time you get a new prescription. There may be new information.<\/p>\n\n\n\n![\"The](\"https:\/\/www.fass.se\/imaging\/resources\/83a3e9d0-c530-45fc-8427-8a47268a092b\" "\\"The")
<\/a><\/figure>\n\n\n\n![\"Warnings](\"https:\/\/www.fass.se\/imaging\/resources\/cf7c788c-5d44-4cd5-8cd2-f866c78889e5\" "\\"Warnings")
<\/a><\/figure>\n\n\n\n![\"Select](\"https:\/\/www.fass.se\/imaging\/resources\/1079f777-c9bf-400e-86b6-b16c15588b40\" "\\"Select")
<\/a><\/figure>\n\n\n\n![\"Injection\"](\"https:\/\/www.fass.se\/imaging\/resources\/fc7a6661-9d50-44f4-ac07-8f30fe15629e\" "\\"Injection\\"\/")
<\/a><\/figure>\n\n\n\n![\"Start](\"https:\/\/www.fass.se\/imaging\/resources\/d06a102c-6be8-4667-b739-bc7b4511a0b4\" "\\"Start")
<\/a><\/figure>\n\n\n\n![\"End](\"https:\/\/www.fass.se\/imaging\/resources\/0f7d50db-2f6c-443d-ab44-85aaedf95f61\" "\\"End")
<\/a><\/figure>\n\n\n\nIf you have used too much Tegsedi<\/h2>\n\n\n\n
- if you are allergic to inotersen or any of the other ingredients of this medicine (listed in section 6).<\/li>
- if tests show that you have a very low number of platelets (the blood cells that help the blood to clot).<\/li>
- if tests of kidney function or protein in the urine show signs of severe kidney problems.<\/li>
- if you have severely impaired liver function.<\/li><\/ul>\n\n\n\n
Warnings and precautions<\/h2>\n\n\n\n
Before you can start treatment with Tegsedi, the doctor will check\u00a0blood cells, liver function, kidney function, and protein levels in the urine.\u00a0You will only receive treatment with Tegsedi if all test results are at acceptable levels.\u00a0The doctor will repeat these tests regularly during treatment.<\/p>\n\n\n\n
Thrombocytopenia<\/p>\n\n\n\n
Tegsedi can reduce the number of\u00a0blood cells\u00a0responsible for clotting the blood (\u00a0platelets\u00a0), which can lead to a condition called\u00a0thrombocytopenia\u00a0(see section 4).\u00a0If you don’t have enough\u00a0platelets, as in\u00a0thrombocytopenia, the blood may not clot quickly enough to stop a bleed.\u00a0This can lead to bruising as well as other more serious problems such as extensive bleeding and internal bleeding.\u00a0The doctor will check the number of\u00a0platelets\u00a0in the blood before treatment and regularly during treatment with Tegsedi.\u00a0If you stop taking Tegsedi, blood levels should be checked for 8 weeks after stopping treatment.<\/p>\n\n\n\n
If you are taking other medicines that can reduce the number of\u00a0blood platelets\u00a0or prevent the blood from clotting, e.g.\u00a0acetylsalicylic acid, clopidogrel,\u00a0warfarin,\u00a0heparin, rivaroxaban, and dabigatran, you must tell the doctor before using Tegsedi.<\/p>\n\n\n\n
You should see a doctor immediately if you get unexplained bruising or a rash with small red spots on the skin (called\u00a0petechiae\u00a0), bleeding from a cut on the skin that does not stop or oozes, bleeding from the gums or nose, blood in the urine or stool, bleeding in the whites of the eyes.\u00a0Seek immediate help if you have a stiff neck or unusual and severe headaches, as these symptoms may be caused by bleeding in the brain.<\/p>\n\n\n\n
Glomerulonephritis\/kidney problems<\/p>\n\n\n\n
Glomerulonephritis is a condition of the kidneys that means they don’t work properly due to inflammation and kidney damage. Some patients treated with inotersen have developed this condition. Symptoms of glomerulonephritis are foamy urine, pink or brown colored urine, blood in the urine and you urinating less than usual.<\/p>\n\n\n\n
Some patients treated with inotersen have also developed deterioration of kidney function without having had\u00a0glomerulonephritis.<\/p>\n\n\n\n
The doctor will check kidney function before treatment and regularly during treatment with Tegsedi.\u00a0If you stop taking Tegsedi, your kidney function should be checked for 8 weeks after stopping treatment.\u00a0If you develop\u00a0glomerulonephritis, you will receive treatment for this.<\/p>\n\n\n\n
Tell the doctor if you are using medicines that damage the kidneys or affect kidney function, e.g.\u00a0sulfonamides, aldosterone antagonists, and certain types of pain<\/a> relievers.<\/p>\n\n\n\n
Vitamin A deficiency<\/p>\n\n\n\n
Tegsedi can reduce the body’s levels of vitamin A (also called retinol). The doctor will check these levels and if they are already low they should be corrected and any symptoms addressed before you start treatment with Tegsedi. Symptoms of vitamin A deficiency include:<\/p>\n\n\n\n
- dry eyes, reduced vision, reduced night vision, or blurred vision.<\/li><\/ul>\n\n\n\n
If you have vision problems or other eye problems while using Tegsedi, talk to your doctor. If necessary, the doctor can refer you to an eye specialist for a check-up.<\/p>\n\n\n\n
The doctor may ask you to take vitamin A supplements daily during treatment with Tegsedi.<\/p>\n\n\n\n
Both too high and too low levels of vitamin A can damage fetal development. Fertile women must therefore rule out pregnancy before starting treatment with Tegsedi and use an effective contraceptive method (see the section ” Pregnancy and breast-feeding”<\/em> below).<\/p>\n\n\n\n
If you are planning to become pregnant, stop taking inotersen including vitamin A supplements. Make sure your vitamin A levels have returned to normal before trying to conceive.<\/p>\n\n\n\n
In the event of an unplanned pregnancy, you should stop taking inotersen.\u00a0However, due to Tegsedi’s prolonged activity, your reduced levels of\u00a0vitamin\u00a0A may persist.\u00a0It is not known whether continued supplementation of 3,000 IU of\u00a0vitamin\u00a0A per day is harmful to the fetus during the first\u00a0trimester\u00a0of pregnancy, but this\u00a0dose\u00a0should not be exceeded.\u00a0You should continue\u00a0vitamin\u00a0A supplementation during the second and third\u00a0trimesters of pregnancy if\u00a0vitamin\u00a0A levels\u00a0have not yet returned to normal, as there is an increased risk of\u00a0vitamin\u00a0A deficiency during the third trimester.<\/p>\n\n\n\n
Liver transplant rejection<\/p>\n\n\n\n
Talk to your doctor before using TEGSEDI if you have had a liver transplant. Cases of liver transplant rejection have been reported in patients treated with Tegsedi. Your doctor will check you regularly for this during treatment with Tegsedi.<\/a><\/p>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
Tegsedi should not be used in children or adolescents under 18 years of age.<\/a><\/p>\n\n\n\n
Other medicines and Tegsedi<\/h2>\n\n\n\n
Tell your doctor or pharmacist if you are taking, have recently taken, or might be taking any other medicines.\u00a0You must tell the doctor if you are already being treated with any of the following:<\/p>\n\n\n\n
- Medicines to prevent blood clots or reduce the number of\u00a0platelets\u00a0in the blood, e.g.\u00a0aspirin,\u00a0heparin,\u00a0warfarin, clopidogrel, rivaroxaban, and dabigatran.<\/li>
- Medicines that can change kidney function or damage the kidneys, e.g.\u00a0sulfonamides\u00a0(used as\u00a0antibacterial\u00a0agents), anilides (used to treat fever<\/a>, aches<\/a>, and pain<\/a>), aldosterone antagonists (used as\u00a0diuretics\u00a0), and natural opium alkaloids and other\u00a0opioids\u00a0(used to treat pain).<\/li><\/ul>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult a doctor before using this medicine.<\/p>\n\n\n\n
Fertile women<\/p>\n\n\n\n
Tegsedi reduces the level of vitamin A in the body. Vitamin A is important for normal fetal development during pregnancy. It is not known whether vitamin A supplementation can compensate for the risk of vitamin A deficiency affecting the unborn child (see \u201cWarnings and precautions\u201d<\/em> above). If you are a fertile woman, you must use an effective contraceptive method and possible pregnancy must be ruled out before starting treatment with Tegsedi.<\/p>\n\n\n\n
Pregnancy<\/p>\n\n\n\n
You should not use Tegsedi if you are pregnant unless your doctor has specifically advised you to do so.\u00a0If you are a\u00a0fertile\u00a0woman, you must use an effective method of contraception.<\/p>\n\n\n\n
Breast-feeding<\/p>\n\n\n\n
Tegsedi can pass into breast milk. You should contact your doctor to determine whether you should either stop breastfeeding or stop treatment with Tegsedi.<\/a><\/p>\n\n\n\n
Driving ability and use of machinery<\/h2>\n\n\n\n
The use of Tegsedi has not been shown to affect the ability to drive or use machines.<\/p>\n\n\n\n
How to use Tegsedi<\/h2>\n\n\n\n
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n
The recommended dose is a dose corresponding to 284 mg of inotersen.<\/p>\n\n\n\n
Dose er should be administered once per week. All subsequent doses should be injected once a week, on the same day of the week each week.<\/p>\n\n\n\n
Route of administration and method of administration<\/p>\n\n\n\n
Tegsedi is only intended for injection under the skin ( subcutaneous use).<\/p>\n\n\n\n
Instructions for use<\/p>\n\n\n\n
Before using the pre-filled syringe, your doctor or caregiver should show you how to use it correctly. If you or your caregiver have questions, contact the doctor.<\/p>\n\n\n\n
Read the instructions for use before you start using the pre-filled syringe and each time you get a new prescription. There may be new information.<\/p>\n\n\n\n
If you have used too much Tegsedi<\/h2>\n\n\n\n
- dry eyes, reduced vision, reduced night vision, or blurred vision.<\/li><\/ul>\n\n\n\n