ENVARSUS XR contains the active ingredient tacrolimus in an anhydrous form. Tacrolimus is a calcineurin-inhibitor immunosuppressant. The drug is formulated as extended-release tablets intended for oral administration with dosage strengths of 0.75 mg, 1 mg, and 4 mg. Key inactive ingredients include hypromellose, lactose monohydrate, and polyethylene glycol.

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. Do not take this medication with grapefruit juice. Take it in the morning on an empty stomach, at least 1 hour before and 2 hours after food. Keep taking it unless your care team tells you to stop. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can within 15 hours. If it has been more than 15 hours after your missed dose, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date. To get rid of medications that are no longer needed or have expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Dizziness, loss of balance or coordination, confusion or trouble speaking -Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue -Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing -High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision -High potassium level—muscle weakness, fast or irregular heartbeat -Increase in blood pressure -Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell -Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet -Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing -Stomach pain, bloody diarrhea, pale skin, unusual weakness or fatigue, decrease in the amount of urine, which may be signs of hemolytic uremic syndrome -Sudden and severe headache, confusion, change in vision, seizures, which may be signs of posterior reversible encephalopathy syndrome (PRES) -TTP—purple spots on the skin or inside the mouth, pale skin, yellowing skin or eyes, unusual weakness or fatigue, fever, fast or irregular heartbeat, confusion, change in vision, trouble speaking, trouble walking Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome): -Constipation -Diarrhea -Pain, tingling, or numbness in the hands or feet -Tremors or shaking -Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Diabetes -Heart disease -High blood pressure -Immune system problems -Infection -Kidney disease -Liver disease -Recent or upcoming vaccine -An unusual or allergic reaction to tacrolimus, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following: -Cidofovir -Cisapride -Cyclosporine -Dronedarone -Fluconazole -Grapefruit juice -Ketoconazole -Levoketoconazole -Live virus vaccines -Mifepristone -Pimozide -Saquinavir -Thioridazine -Ziprasidone This medication may also interact with the following: -Cannabidiol -Certain antibiotics, such as clarithromycin, gentamicin, neomycin, rifabutin, rifampin -Certain antivirals for HIV or hepatitis -Certain medications for blood pressure, heart disease, irregular heartbeat, such as diltiazem, enalapril, losartan -Certain medications for fungal infections, such as amphotericin B, caspofungin, itraconazole, voriconazole -Cisplatin -Cyclosporine -Diuretics -Ganciclovir -Letermovir -Other medications that cause heart rhythm changes, such as amiodarone -Sirolimus -St. John's wort This medication may affect how other medications work, and other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. You will need blood work done while you are taking this medication. Your condition will be monitored carefully while you are receiving this medication. It is important not to miss any appointments. This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick. Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects. A reliable form of contraception is recommended before starting and while taking this medication. Talk to your care team about reliable forms of contraception. Males who take this medication must use a condom during sex. Tell your care team right away if your partner becomes pregnant while you are taking this medication. Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancers if you take this medication. This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps or tanning beds/booths. This medication may increase blood sugar. The risk may be higher in patients who already have diabetes. Ask your care team what you can do to lower your risk of diabetes while taking this medication. Avoid taking medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever.

What are the most serious risks of this medication?

If you get this medicine for an organ transplant, it should be started in the hospital, a clinic, or in a healthcare treatment setting. Taking this medicine can increase the risk of getting cancer. This medicine can lower your body’s ability to fight infections. You may get more infections while taking this medicine. Any infection you get could become serious and even deadly. This medicine should only be given by a healthcare provider who has experience in the use of transplant drugs.