WARNING

Envarsus XR is a medication primarily used to prevent organ rejection in transplant patients. Like any medication, it carries certain risks and side effects. Some potential risks associated with taking Envarsus XR include:

• Immune Suppression: Envarsus XR works by suppressing the immune system to prevent it from attacking the transplanted organ. While this is necessary to prevent rejection, it also increases the risk of infections and certain cancers.
• Infections: Because Envarsus XR weakens the immune system, patients are more susceptible to infections. This can include bacterial, viral, fungal, and parasitic infections.
• Renal Toxicity: Envarsus XR may cause kidney damage or impair kidney function, particularly at higher doses. Patients may experience changes in urine output, swelling, or signs of kidney dysfunction.
• Metabolic Effects: Envarsus XR can cause metabolic disturbances such as high blood sugar levels (hyperglycemia), which may lead to diabetes or exacerbate existing diabetes. It can also affect electrolyte levels and cholesterol levels.
• Gastrointestinal Issues: Common side effects of Envarsus XR include nausea, vomiting, diarrhea, and abdominal pain. These symptoms can range from mild to severe and may require medical attention.
• Neurological Effects: Some patients may experience neurological side effects such as headaches, tremors, insomnia, or mood changes while taking Envarsus XR.
• Bone Marrow Suppression: Envarsus XR can suppress the bone marrow’s ability to produce blood cells, leading to anemia, leukopenia (low white blood cell count), or thrombocytopenia (low platelet count).
• Allergic Reactions: In rare cases, patients may experience allergic reactions to Envarsus XR, which can manifest as rash, itching, swelling, or difficulty breathing. These reactions require immediate medical attention.

It’s essential for patients taking Envarsus XR to be closely monitored by their healthcare providers for any signs of complications or side effects. They should also follow their prescribed dosage regimen and report any unusual symptoms promptly.

Why is this medication prescribed?

Envarsus XR is prescribed primarily to prevent organ rejection in patients who have undergone kidney transplantation. It contains the active ingredient tacrolimus, which belongs to a class of medications called immunosuppressants. These drugs work by suppressing the body’s immune response, preventing it from attacking and rejecting the transplanted organ.

How should this medicine be used?

Here’s how Envarsus XR is typically used:

• Dosage: The dosage of Envarsus XR varies depending on factors such as the patient’s weight, kidney function, and other medications they may be taking. It’s crucial to follow the dosage instructions provided by the healthcare provider carefully.
• Administration: Envarsus XR is usually taken orally, once daily, on an empty stomach. It’s important to take it consistently at the same time each day to maintain steady levels of the medication in the blood.
• Swallowing: The tablets should be swallowed whole and not crushed, chewed, or broken. Breaking the tablet can interfere with the extended-release mechanism and lead to an incorrect dose being released into the body.
• Monitoring: Patients taking Envarsus XR require regular monitoring of their kidney function, blood pressure, blood sugar levels, and blood tacrolimus levels. This helps ensure that the medication is effective and that doses can be adjusted as needed to maintain therapeutic levels while minimizing side effects.
• Interactions: Envarsus XR can interact with various medications, including other immunosuppressants, antibiotics, antifungals, and certain herbal supplements. Patients should inform their healthcare provider about all medications, supplements, and over-the-counter drugs they are taking to avoid potentially harmful interactions.
• Adherence: It’s crucial for patients to adhere to their prescribed Envarsus XR regimen consistently. Missing doses or taking the medication inconsistently can increase the risk of organ rejection or other complications.
• Duration: Patients typically need to take Envarsus XR for the rest of their lives to prevent organ rejection effectively. However, the dosage may be adjusted over time based on individual response and tolerability.

Patients should consult their healthcare provider for specific dosing instructions and any questions or concerns about taking Envarsus XR. It’s essential to follow their guidance closely to ensure the best possible outcomes following transplantation.

Other uses for this medicine

Envarsus XR, containing the active ingredient tacrolimus, is primarily used for preventing organ rejection in transplant recipients. However, it may also be prescribed for other conditions under the guidance of a healthcare provider. Some off-label uses of Envarsus XR may include treating certain autoimmune diseases such as rheumatoid arthritis or psoriasis, as well as in the management of certain skin conditions.

What special precautions should I follow?

Regarding special precautions for Envarsus XR, here are some key considerations:

• Medical History: Before starting Envarsus XR, patients should inform their healthcare provider about their complete medical history, including any allergies, kidney or liver problems, high blood pressure, diabetes, infections, or previous reactions to tacrolimus or other medications.
• Pregnancy and Breastfeeding: Envarsus XR may harm an unborn baby, so it’s important for pregnant individuals to discuss the risks and benefits with their healthcare provider before taking the medication. Similarly, it’s recommended to avoid breastfeeding while taking Envarsus XR, as tacrolimus may pass into breast milk and could potentially harm a nursing infant.
• Immunizations: Patients should avoid receiving live vaccines while taking Envarsus XR, as immunosuppressant medications can weaken the body’s response to vaccines and increase the risk of infection. However, non-live vaccines may be administered as recommended by the healthcare provider.
• Monitoring: Regular monitoring of kidney function, blood pressure, blood sugar levels, and blood tacrolimus levels is essential while taking Envarsus XR. Healthcare providers may also monitor for signs of organ rejection or infection.
• Interactions: Envarsus XR can interact with various medications, including other immunosuppressants, antibiotics, antifungals, and certain herbal supplements. Patients should inform their healthcare provider about all medications, supplements, and over-the-counter drugs they are taking to avoid potentially harmful interactions.
• Avoid Grapefruit Juice: Consumption of grapefruit juice should be avoided while taking Envarsus XR, as it can increase tacrolimus levels in the blood and potentially lead to toxicity.
• Storage: Envarsus XR should be stored at room temperature away from moisture and heat. It’s essential to keep the medication out of reach of children and pets.

Patients should follow their healthcare provider’s instructions carefully and report any unusual symptoms or side effects while taking Envarsus XR. It’s important to maintain open communication with the healthcare team to ensure safe and effective treatment.

What special dietary instructions should I follow?

Special Dietary Instructions:

• Consistent Diet: Try to maintain a consistent diet while taking Envarsus XR, as changes in diet can affect the absorption and effectiveness of the medication.
• Avoid Grapefruit Juice: As mentioned earlier, avoid consuming grapefruit juice while taking Envarsus XR.
• Balanced Diet: Aim for a balanced diet rich in fruits, vegetables, whole grains, and lean proteins to support overall health and well-being.

What should I do if I forget a dose?

• Take it as soon as you remember: If you miss a dose and remember within a few hours of the scheduled time, take the missed dose immediately.
• Skip the missed dose if it’s closer to the next dose: If it’s almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double up on doses to make up for a missed one.
• Consult your healthcare provider: If you’re unsure about what to do or if you frequently forget doses, consult your healthcare provider for guidance. They may offer strategies to help you remember your medication or adjust your dosing schedule if necessary.

What side effects can this medication cause?

Envarsus XR, like any medication, can cause side effects in some individuals. Common side effects associated with Envarsus XR may include:

• Increased susceptibility to infections: Since Envarsus XR suppresses the immune system, patients may be at a higher risk of developing infections such as urinary tract infections, respiratory infections, and opportunistic infections.
• Gastrointestinal disturbances: Nausea, vomiting, diarrhea, and abdominal discomfort are common gastrointestinal side effects of Envarsus XR.
• Tremors: Some individuals may experience tremors or shaking of the hands while taking Envarsus XR.
• Headaches: Headaches are another common side effect reported by some patients.
• High blood pressure: Envarsus XR may cause or exacerbate high blood pressure in some individuals.
• Changes in kidney function: Envarsus XR can affect kidney function, leading to changes in urine output, electrolyte imbalances, and potential kidney damage.
• Metabolic disturbances: Metabolic effects such as hyperglycemia (high blood sugar levels), hyperkalemia (high potassium levels), and hyperlipidemia (elevated cholesterol levels) may occur with Envarsus XR use.
• Neurological effects: Some patients may experience neurological side effects such as insomnia, mood changes, confusion, or dizziness.
• Skin reactions: Skin rash, itching, or other allergic reactions may occur in rare cases.

It’s important to note that not all individuals will experience these side effects, and the severity and frequency of side effects can vary from person to person. Additionally, some side effects may require medical attention, while others may resolve on their own as the body adjusts to the medication.

Patients should report any new or worsening symptoms to their healthcare provider promptly. In some cases, adjustments to the dosage or medication regimen may be necessary to minimize side effects while maintaining effective immunosuppression.

What should I know about storage and disposal of this medication?

Storage and Disposal:

• Storage: Store Envarsus XR at room temperature, away from moisture and heat. Avoid storing it in the bathroom or near the kitchen sink. Keep it out of reach of children and pets.
• Disposal: Dispose of unused or expired Envarsus XR properly according to local regulations or guidelines. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Ask your pharmacist or healthcare provider about the proper disposal methods.

In case of emergency/overdose

• In case of emergency: If you suspect an overdose or experience severe symptoms such as difficulty breathing, loss of consciousness, or seizures, seek immediate medical attention by calling emergency services (e.g., 911 in the United States) or going to the nearest emergency room.
• Overdose symptoms: Symptoms of Envarsus XR overdose may include nausea, vomiting, diarrhea, confusion, tremors, seizures, and changes in heart rate. It’s crucial to seek medical help promptly if an overdose is suspected.

What other information should I know?

• Regular monitoring: Follow up with your healthcare provider regularly for monitoring of kidney function, blood pressure, blood sugar levels, and blood tacrolimus levels. This helps ensure the medication is effective and safe for you.
• Avoiding grapefruit juice: As mentioned earlier, avoid consuming grapefruit juice while taking Envarsus XR, as it can increase tacrolimus levels in the blood and potentially lead to toxicity.
• Informing healthcare providers: Inform all healthcare providers involved in your care, including doctors, dentists, and pharmacists, that you are taking Envarsus XR. This is important to prevent potential drug interactions and ensure coordinated care.
• Patient education: Stay informed about your medication, including its purpose, dosage, potential side effects, and precautions. Ask your healthcare provider any questions you may have to ensure safe and effective use of Envarsus XR.

By following these guidelines and staying informed, you can maximize the benefits of Envarsus XR while minimizing potential risks and complications. If you have any concerns or questions about your medication, don’t hesitate to discuss them with your healthcare provider.