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Envarsus XR Information

Envarsus XR (Tacrolimus Prolonged Release) is used for the prevention of organ rejection in adult and pediatric patients receiving a kidney transplant. This includes patients starting the medication immediately following their surgery and stable conversion patients who are being switched from immediate-release tacrolimus formulations. It is primarily used for kidney transplants; tacrolimus can also be used for transplants of other organs, such as the lungs and the heart. Its active ingredient is tacrolimus, a calcineurin inhibitor. It typically works by inhibiting calcineurin, a protein involved in the immune response, thereby suppressing immune activity and reducing the risk of organ rejection after transplantation.

Organ rejection occurs because your immune system is programmed to identify and destroy foreign tissue, such as a transplanted kidney, which it perceives as a foreign threat similar to a virus or bacteria. T-lymphocytes are the primary drivers of this cellular attack, and if left unchecked, they can cause inflammation and irreversible damage to the new organ. Envarsus XR helps by selectively reducing this specific part of the immune response. Because it uses a proprietary MeltDose delivery system, the medication is released slowly throughout the day, maintaining a more consistent blood level. This steady presence is likely to provide continuous protection against the immune system's attempts to reject the kidney, while potentially reducing some of the side effects associated with the sharp spikes in drug concentration seen with older, twice-daily formulations.

Envarsus XR Side Effects

Common mild side effects of this medication include shaking, headache, diarrhea, mild nausea and vomiting, stomach discomfort, loss of appetite, trouble sleeping, and numbness or tingling of the hands and feet. Contact your doctor if these mild side effects persist or worsen.

Contact your doctor immediately if you experience any serious side effects, including the following:
• Allergic reactions such as breathing difficulties, body itching, body rash, skin blistering, swelling of the face, mouth, tongue, lips, or throat;
• Anemia (low red blood cells) with symptoms like dizziness, pale skin, unusual tiredness or weakness, shortness of breath;
• Blood clotting problems;
• Electrolyte imbalances like high levels of potassium in your blood with symptoms such as muscle weakness, irregular heartbeat;
• High blood pressure;
• High blood sugar with symptoms like frequent urination, confusion, fruity smell on your breath, and increased thirst or hunger;
• Kidney problems;
• Nervous system problems such as confusion, numbness and tingling, vision changes, and tremors

Inform your doctor about any other side effects you notice that are not listed here.

Envarsus XR Precautions

Do not use this medicine if you are allergic to tacrolimus or any other ingredients in Envarsus XR. Before using this medication, ensure you inform your doctor about any medical conditions you previously or currently have, including the following:
• Cancer;
• Current infections;
• Diabetes;
• Diarrhea;
• Electrolyte imbalances such as high levels of potassium;
• Gastrointestinal problems;
• Heart disease;
• High blood pressure;
• Kidney disease;
• Liver disease;
• Reversible posterior leukoencephalopathy syndrome (RPLS)

Talk to your doctor about whether any vaccines you are scheduled to take should not be used with this medication, as tacrolimus can render some vaccines ineffective. Live vaccines should be avoided while taking this medication. Limit your skin's exposure to sunlight and wear sunscreen and protective clothing when outdoors, as this medication can make your skin more sensitive to sunlight. Tacrolimus crosses the placenta and can affect the developing baby, causing low birth weight, birth defects, and premature birth. This medication is not recommended for use during pregnancy unless the benefit to the mother outweighs the risk to the fetus. Women of reproductive age and men who have female partners of reproductive age should use effective birth control methods while taking this medication. Tacrolimus is excreted in human milk, though the concentrations appear to be relatively low. Because of the potential for serious adverse reactions in the infant (like immunosuppression), the usual recommendation is often to either discontinue breastfeeding or the drug, depending on the necessity of the medication to the mother. Envarsus XR is not suitable for use in children and adolescents. Do not drive or use tools or machines if you feel dizzy or sleepy, or if you have difficulty seeing clearly after taking Envarsus XR. These effects are more frequent if you also drink alcohol.

Concurrent use of tacrolimus with nonsteroidal anti-inflammatory drugs (like ibuprofen), aminoglycosides, or amphotericin B can increase the risk of renal failure. Therefore, make sure you inform your doctor about all the medications, including herbal medications and supplements, you are taking before starting Envarsus XR to prevent drug interactions. Take your Envarsus XR tablets once daily at the same time every morning as prescribed by your doctor. Swallow the tablet whole, as crushing or chewing it ruins the MeltDose release mechanism. Ensure you take the medication on an empty stomach, ideally one hour before or two hours after you eat. Avoid taking grapefruit and grapefruit juice to prevent the risk of dangerous spikes in your tacrolimus blood levels. Store this medication in a cool, dry place, protect it from light and moisture, and keep it out of reach of children.

Do I need a prescription to order Envarsus XR?

Yes, a prescription is required from your physician to order Envarsus XR.