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Only Available By Prescription
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Tegsedi (inotersen) is a prescription medication used to treat hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adults. This rare and progressive disease is caused by the buildup of abnormal proteins in tissues and organs, which can lead to severe health complications. Tegsedi works by reducing the production of the abnormal protein, thereby slowing disease progression and improving symptoms.
| Fact Table | |
|---|---|
| Formula | C230H305N61O122P18S18 |
| License | FDA approved |
| Bioavailability | 80% (subcutaneous) |
| Legal status | Prescription only |
| Chemical Name | Inotersen |
| Elimination half-life | 32 days |
| Dosage (Strength) | 284 mg/1.5 mL |
| Pregnancy | Consult Doctor |
| Brands | Tegsedi |
| Protein binding | 94% |
| PubChem CID | 118357151 |
| MedlinePlus | a618052 |
| ChEBI | 145996 |
| ATC code | N07XX13 |
| DrugBank | DB14543 |
| KEGG | D11018 |
| Routes of administration | Subcutaneous injection |
Dosage: Tegsedi is administered via subcutaneous injection. The recommended dose is 284 mg once a week for the first 3 weeks, followed by 284 mg every 2 weeks.
Administration: Injections should be given in the abdomen or thigh. Rotate injection sites to avoid irritation.
Storage: Store unopened vials in the refrigerator between 36°F and 46°F (2°C to 8°C). Do not freeze. Once a vial is in use, it can be kept at room temperature for up to 14 days.
Active Ingredient: Inotersen
Inactive Ingredients: Sodium chloride, sodium citrate, and other stabilizers. The formulation may include additional components specific to the manufacturer's preparation.
Allergies: Inform your healthcare provider if you have a known allergy to inotersen or any other components of Tegsedi.
Kidney Function: Regular monitoring of kidney function is required, as Tegsedi can affect kidney health.
Pregnancy and Breastfeeding: The safety of Tegsedi during pregnancy or breastfeeding has not been fully established. Consult your healthcare provider if you are pregnant, plan to become pregnant, or are breastfeeding.
Drug Interactions: Inform your healthcare provider of all medications and supplements you are taking. Tegsedi may interact with other drugs, including certain blood thinners and medications that affect kidney function.
Food Interactions: There are no known significant interactions with food. However, discuss dietary concerns with your healthcare provider if you have specific questions.
Common Side Effects:
Serious Side Effects:
Managing Side Effects: Contact your healthcare provider if you experience severe or persistent side effects. Regular monitoring may be required to manage and mitigate potential issues.
For those seeking to buy Tegsedi, consult your healthcare provider or pharmacist for information on cost and availability. They can provide guidance on purchasing options and help address any questions regarding the expense of the medication. If you're concerned about Inotersen side effects, your healthcare provider can offer detailed information and support.
What is Tegsedi used for?
Tegsedi (inotersen) is used to treat adults with polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis). This rare genetic condition leads to the accumulation of abnormal protein deposits in nerves and other tissues, causing nerve damage and other symptoms.
Is Tegsedi still available?
Yes, Tegsedi is still available in the markets where it has been approved. However, its availability might vary by country or region, so it's important to check with a healthcare provider or local pharmacy.
How effective is Tegsedi?
Clinical trials have shown that Tegsedi is effective in slowing the progression of polyneuropathy in patients with hATTR amyloidosis. It has been shown to reduce symptoms and improve quality of life in many patients, although individual results may vary.
Where is Tegsedi approved?
Tegsedi is approved in several countries, including the United States, European Union member states, Canada, and Brazil. Each country's regulatory authority has approved it for use based on the condition it treats and the evidence supporting its effectiveness.
How is Tegsedi administered?
Tegsedi is administered as a subcutaneous injection, meaning it is injected under the skin. Patients typically receive the injection once a week, and it can be self-administered after proper training.
What are the common side effects of Tegsedi?
Common side effects of Tegsedi include injection site reactions, nausea, headache, and fatigue. Some patients may also experience reduced platelet counts, which can increase the risk of bleeding, and kidney problems.
Who should not use Tegsedi?
Tegsedi is not recommended for patients with a history of serious hypersensitivity to the drug or its components. It is also contraindicated in patients with significantly reduced platelet counts or severe kidney disease. A healthcare provider will determine if Tegsedi is safe based on an individual’s medical history.
How does Tegsedi work?
Tegsedi works by targeting and reducing the production of transthyretin (TTR) protein in the liver. By lowering TTR levels, it helps reduce the formation of amyloid deposits in tissues, which is the underlying cause of the symptoms in hATTR amyloidosis.
What monitoring is required when taking Tegsedi?
Patients taking Tegsedi require regular blood tests to monitor platelet counts and kidney function, as these can be affected by the medication. These tests are typically done every week or every two weeks during treatment.
Can Tegsedi be used with other medications?
Tegsedi may interact with other medications, particularly those that affect blood clotting or kidney function. It's important for patients to inform their healthcare provider about all medications they are taking to avoid potential interactions.
