Information about Envarsis XR (Tacrolimus)
Envarsis XR is the extended-release formulation of tacrolimus, a medication used primarily to prevent organ rejection following kidney or liver transplants. It works by suppressing the immune system to prevent it from attacking the transplanted organ. Tacrolimus is an immunosuppressant that inhibits the activation of T-cells, a type of white blood cell involved in the immune response. The extended-release version of Envarsis XR allows for more convenient dosing by requiring fewer daily doses compared to immediate-release tacrolimus.
Product Highlights
- Envarsis XR is mainly prescribed to prevent the rejection of transplanted organs such as kidneys and livers. It is a critical part of the immunosuppressive therapy regimen following organ transplants.
- Envarsis XR may also be used off-label for treating autoimmune diseases such as rheumatoid arthritis and dermatologic conditions like atopic dermatitis, although this is not its primary approved use.
Key Ingredient
Key Benefits
- Envarsis XR helps maintain transplant success by reducing the likelihood of the body rejecting a transplanted organ.
- The extended-release formulation allows for once-daily administration, which improves medication adherence and simplifies the patient's daily routine.
- By specifically targeting T-cell activation, tacrolimus provides effective immunosuppression with fewer effects on other immune system components.
- When taken properly, Envarsis XR significantly reduces the risk of acute organ rejection after kidney or liver transplants.
- Proper management with Envarsis XR is associated with better long-term outcomes and graft survival in transplant recipients.
Direction of Use
- The typical starting dose of Envarsis XR depends on the transplant type and individual response. It is often 0.1–0.2 mg/kg of body weight per day, administered once daily.
- Take the capsules whole with a glass of water. Do not crush, chew, or split the capsules.
- It is recommended to take Envarsis XR consistently with respect to food (i.e., always with or always without food) to maintain stable blood levels.
- If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take two doses at once to make up for a missed dose.
- Regular blood tests are required to monitor tacrolimus levels, kidney function, and potential side effects. Dosages are often adjusted based on blood levels.
Safety Concerns
- Because Envarsis XR suppresses the immune system, there is an increased risk of infections. Patients should take precautions to avoid exposure to infections.
- Tacrolimus can affect kidney function, so kidney function should be monitored regularly. It can cause acute or chronic kidney damage, especially at higher doses.
- High levels of tacrolimus can lead to nervous system side effects such as tremors, headaches, seizures, or confusion.
- Some patients may experience nausea, vomiting, diarrhea, or abdominal discomfort, particularly in the initial stages of treatment.
- Envarsis XR may cause or worsen high blood pressure. Regular monitoring of blood pressure is advised.
- Tacrolimus can affect potassium and magnesium levels, which requires monitoring and potentially supplementation.
- Tacrolimus can interact with a wide range of drugs, including other immunosuppressants, antibiotics, antifungals, and antiviral medications. It is crucial to inform the healthcare provider of all medications being taken.
Avoid Envarsis XR (Tacrolimus) If
- Do not use Envarsis XR if you are allergic to tacrolimus or any components of the formulation.
- Tacrolimus is metabolized in the liver, so patients with severe liver dysfunction should avoid this medication or use it under close supervision.
- Envarsis XR suppresses the immune system, making it more difficult to fight infections. Do not use it if you have an active, untreated infection.
- Tacrolimus is classified as a category C drug during pregnancy, meaning it should be used only if the potential benefits justify the risks. It is recommended to discuss with a healthcare provider before using it during pregnancy.
- Since tacrolimus can affect kidney function, it is contraindicated in patients with severe kidney disease unless carefully monitored by a healthcare professional.
- Avoid using Envarsis XR with drugs that significantly affect its metabolism or interact with it, such as certain antifungal agents (e.g., ketoconazole), antiviral medications (e.g., ritonavir), or other immunosuppressive drugs, unless directed by a healthcare provider.
