Tegsedi
Tegsedi (inotersen) is a medication used for the treatment of polyneuropathy (a condition where your nerves are damaged) due to hereditary transthyretin-mediated amyloidosis (hATTR). It's given as an injection under the skin once per week and has a lot of potential risks and side effects.
What is Tegsedi (inotersen)?
What is Tegsedi (inotersen) used for?
- Polyneuropathy from hereditary transthyretin-mediated amyloidosis (hATTR)
How Tegsedi (inotersen) works
Your liver makes a protein called transthyretin (TTR). In people with hereditary transthyretin-mediated amyloidosis (hATTR), the gene that makes TTR has a mutation that causes the protein to fold incorrectly into an unusual shape. This unusual shape causes TTR proteins to clump together in clusters called amyloid fibrils. Once amyloid fibrils are formed, they travel throughout your body and can cause damage to your organs and nerves.
Tegsedi (inotersen) is a type of molecule called an antisense oligonucleotide. It works by preventing the creation of misshapened TTR proteins, which lowers the amount of amyloid that builds up.
Drug facts
Side effects of Tegsedi (inotersen)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Injection site reactions (bruising, redness, bleeding, pain, hardness, itching, swelling; 49%)
- Nausea (31%)
- Headache (26%)
- Fatigue (25%)
- Low platelet count (24%)
- Fever (20%)
- Swelling in hands, feet, or ankles (19%)
- Chills (18%)
- Low red blood cells (17%)
- Vomiting (15%)
- Muscle pain (15%)
Less Common Side Effects
- Worsening kidney problems
- Liver damage
- Abnormal heart rhythm
- Joint pain
- Low appetite
- Feeling faint
- Feeling "pins and needles"
- Shortness of breath
- Sudden low blood pressure when standing from a sitting or lying position (orthostatic hypotension)
- Flu-like symptoms
- Bruising
Tegsedi (inotersen) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Low platelet count: unusual bleeding or bruising, bleeding that lasts for a long time, difficulty stopping bleeds, blood in vomit, urine, or stool, dizziness, lightheadedness
- Kidney damage: puffy face, dark or brown-colored urine, urinating less frequently, swelling of ankles, frequent urination at night, bubbly or foamy urine, lack of appetite
- Liver damage: yellowing of your skin or the whites of your eyes, fatigue, low appetite, nausea, vomiting, stomach discomfort
- Stroke: sudden trouble speaking, droopy face, sudden confusion, numbness or weakness in the face, arm, or leg
- Allergic reaction: chest pain, chills, flushing, joint or muscle pain, flu-like symptoms, difficulty swallowing, redness in the palms of your hands, jerking movements
Pros and cons of Tegsedi (inotersen)
Pros
- Works well to treat nerve symptoms of hATTR
- Given once per week
- Available as prefilled syringes
- Can be kept at room temperature for up to 6 weeks, which is convenient if you're traveling
- Available through a REMS program to make sure it's as safe for you as possible
Cons
- Needs to be injected under the skin
- Might be difficult for some people to administer correctly
- Can potentially cause serious side effects, such as bleeding, kidney, and liver problems
- Can't be used in children younger than 18 years old
- Brand-name medication only, which can be expensive
Pharmacist tips for Tegsedi (inotersen)
- You'll need to get some tests done before starting Tegsedi (inotersen) and during your treatment to make sure it's as safe for you as possible. Make sure you know when you need to go in for your lab tests and mark those dates on your calendar.
- Tell your provider about all the medications you're taking or planning to take, especially those that raise your bleeding risk (e.g., antiplatelets, anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs)) or those that can cause kidney problems. Don't start any new medications while taking Tegsedi (inotersen) without talking to your provider or pharmacist first.
- Keep the Tegsedi (inotersen) syringes in the original container and store it in the refrigerator away from light. You can store the syringes at room temperature for up to 6 weeks, but don't let them reach temperatures above 86 degrees Fahrenheit. After 6 weeks, throw the syringes away.
How to use Tegsedi (inotersen)
- Make sure your provider or pharmacist teaches you how to give yourself Tegsedi (inotersen) injections so that you avoid accidentally hurting yourself or wasting the medication. Read the instructions on how to give the injection under your skin. Contact your provider or pharmacist if you have any questions on how to use this medication.
- Before using Tegsedi (inotersen), take the medication out of the refrigerator and lay it on a flat surface at room temperature to warm up. This will take about 30 minutes. Don't try to warm it up any other way, such as with a microwave or hot water, because doing so can damage your medication.
- Always check that the medication is clear and colorless or pale yellow before using it. If it's cloudy, discolored, or has particles in it, don't use it. Ask your provider or pharmacist about getting a replacement.
- Wash your hands with soap and water and clean the injection site with an alcohol swab before injecting Tegsedi (inotersen). This will prevent contamination (infection). If you accidentally drop your syringe, don't use it and contact your provider.
- After slowly injecting Tegsedi (inotersen), it's important to continue to hold the plunger down all the way for at least 5 seconds so you don't lose any medication. When you slowly lift the plunger up again, the needle should spring back into the syringe for safety.
- After injecting Tegsedi (inotersen), throw away the syringe in a sharps container or something made of heavy-duty plastic, such as an empty milk carton or laundry detergent bottle. This lowers the risk of needlestick injuries. Don't throw them away in your trash can. The syringes are single-dose syringes, so you must throw away the remainder of the medication after each use. When your sharps container is almost full, close it tightly with the cap. For more information on how to throw away your sharps container safely and guidance for your specific state, visit the FDA's website.
Common questions about Tegsedi (inotersen)
Since Tegsedi (inotersen) can put you at risk for serious bleeding and kidney problems, it's only available through a restricted Risk Evaluation and Mitigation Strategy (REMS) program) called the Tegsedi REMS program. All providers who prescribe Tegsedi (inotersen), pharmacies that dispense the medication, and people who need to use the injection must be registered with the REMS program. This is to make sure the medication is distributed and taken under the safest conditions possible for you.
You can inject Tegsedi (inotersen) under the skin in either your stomach, front of your thigh, or outer area of your upper arm. Never inject the medication into your muscle or vein. If injecting in the upper arm, have another person give you the injection, because it'll be hard for you to reach this area and give yourself the injection correctly. If you're injecting into your stomach area, don't inject at the waistline or at other sites where there could be pressure or rubbing from clothing. Also, make sure to inject at least 2 inches away from your belly button. To lower the risk of bruising and irritation, rotate between different injection sites for each dose so that the same site isn't used repeatedly. Don't inject into skin with tattoos, scars, skin problems, or any kind of injury to avoid further damaging your skin. If you have other questions about how to inject Tegsedi (inotersen), speak to your pharmacist or provider.
Yes. Because Tegsedi (inotersen) can cause side effects that affect different parts of your body, your provider will order tests to check your health before you start this medication and also regularly throughout treatment. Some tests you can expect include those that check your liver and kidney health, as well as your platelet level. Ask your provider if you have any questions about these tests.
If you miss a dose of Tegsedi (inotersen), you should take the dose as soon as you remember, unless the next dose is within 2 days. If this is the case, skip the missed dose, and take the next scheduled dose on your normal scheduled day. Don't double up on the dose to make up for the missed dose, since this can put you at risk for side effects. If you miss a dose and you aren't sure what to do, contact your provider or pharmacist.
There isn't enough information to know if Tegsedi (inotersen) is safe to take during pregnancy. In some animal studies, this medication caused harm to pregnant mothers and their babies. If you're pregnant or thinking of becoming pregnant, talk with your provider about the risks and benefits of using this medication during pregnancy. If you're pregnant and are prescribed Tegsedi (inotersen), it's recommended you enroll in a pregnancy registry that monitors your and your baby's health outcomes. Contact the registry by calling 1-877-465-7510 or by visiting the registry website.
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Risks and warnings for Tegsedi (inotersen)
Tegsedi (inotersen) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Low platelet counts leading to bleeding
- Risk factors: Taking Tegsedi (inotersen) together with medications that raise your bleeding risk
Tegsedi (inotersen) can lower your platelet count (thrombocytopenia). Platelets are cells in your blood that clump together to form clots to stop bleeding. A low platelet count puts you at high risk for severe bleeding. Your risk is higher if you're taking Tegsedi (inotersen) with other medications that raise your bleeding risk, such as aspirin or warfarin (Coumadin).
Because of this risk, your provider will check your platelet count through blood tests before and regularly during treatment with Tegsedi (inotersen). If your platelet count is too low, you might need to stop the medication for a period of time. Since you might need to be treated with a corticosteroid for severely low platelet counts if it happens, it's recommended to avoid Tegsedi (inotersen) if you can't take corticosteroids. Seek medical help right away if you have any symptoms of thrombocytopenia, such as unusual bleeding, bleeding that lasts for a long time, difficulty stopping bleeds, easy bruising, or blood in your vomit, urine, or stool. Speak to your provider if you have concerns.
Kidney damage (glomerulonephritis)
- Risk factors: Taking Tegsedi (inotersen) together with medications that can damage your kidneys
Tegsedi (inotersen) can cause a kidney condition called glomerulonephritis. This is when the filtering part of your kidneys become inflamed, which can lead to kidney problems including kidney failure requiring dialysis. Your risk is higher if you're taking Tegsedi (inotersen) with other medications that can damage your kidneys, such as NSAIDs, losartan (Cozaar), lisinopril (Prinivil), and penicillin antibiotics.
Your provider will ask you to do blood tests before and during treatment with Tegsedi (inotersen) to make sure your kidney is working properly. Contact your provider if you get symptoms of glomerulonephritis or kidney problems, such as dark or brown-colored urine, urinating less than usual, bubbly or foamy urine, loss of appetite, or swelling in your ankles or face. If you're diagnosed with glomerulonephritis or another kidney problem, you'll need to stop taking Tegsedi (inotersen) and you might need to receive treatment with immunosuppressant medications. Because of this possible need for treatment for kidney problems, it's recommended to avoid Tegsedi (inotersen) if you can't take immunosuppressants.
Must enroll in the Tegsedi REMS program
Because of the risks of bleeding and kidney damage, Tegsedi (inotersen) is only available through a restricted program called the Tegsedi REMS Program. Providers, pharmacies, and people who are prescribed Tegsedi (inotersen) must enroll in this program to make sure the medication is used safely. Make sure you read the Medication Guide if you've been prescribed this medication.
Liver damage
- Risk factors: History of liver transplant
Tegsedi (inotersen) can cause serious liver damage. If you've had a liver transplant, Tegsedi (inotersen) might cause your body to reject your liver. You'll need to get regular blood tests done before and during treatment (about every 4 months) to make sure your liver is working properly. Get medical attention right away if you notice yellowing of your skin or the whites of your eyes, fatigue, low appetite, stomach discomfort, nausea, or vomiting. If this happens, you might need to stop using Tegsedi (inotersen) to prevent further liver damage.
Allergic reaction
It's possible for you to have an allergic reaction after receiving Tegsedi (inotersen). It usually happens within 2 hours of injecting the medication. These allergic reactions might include headache, chest pain, chills, flushing (feeling warm all of a sudden), joint or muscle pain, flu-like symptoms, difficulty swallowing, redness in the palms of your hands, or uncontrollable jerking movements. Contact your provider or get medical help right away if you experience any of these symptoms.
Low vitamin A levels
Tegsedi (inotersen) can lower your blood vitamin A levels. It's best to take a vitamin A supplement at the recommended daily dose while taking Tegsedi (inotersen). If you're pregnant, speak to your provider about what dose of vitamin A is right for you, because having too much or too little vitamin A can affect the development of your baby. Don't take more than the maximum recommended daily dose to try and raise your vitamin A levels, because this can lead to side effects like nausea, dizziness, or headache. Contact your provider if you get night blindness, because this is an early symptom of very low vitamin A.
Rare stroke and immune system problems
Although very rare, Tegsedi (inotersen) might cause a stroke. Call 911 if you experience sudden neck or face pain, trouble speaking, droopy face, sudden confusion, or numbness or weakness in the face, arm, or leg.
Tegsedi (inotersen) might also cause serious inflammation and immune system problems. This can happen anywhere in your body, including your kidneys or blood vessels. Contact your provider right away if you notice a change in your walking pattern (gait), back pain, weight loss, headache, vomiting, or trouble speaking after starting treatment with Tegsedi (inotersen).
Tegsedi (inotersen) dosage
Typical dosage for Tegsedi (inotersen)
The typical dose is 284 mg injected under the skin once per week.
Tegsedi (inotersen) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Tegsedi (inotersen) will not be safe for you to take.
- Low platelet count
- History of glomerulonephritis (kidney damage) from Tegsedi (inotersen)
