Tacrolimus Extended-Release Tablets

What is this medication?

TACROLIMUS (ta KROE li mus) is used to stop your body from attacking or rejecting your transplanted kidney.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ENVARSUS

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

They need to know if you have any of these conditions:

• diabetes (high blood sugar)
• 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 medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine 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 medicine. Swallow the tablets whole. Take this medicine in the morning on an empty stomach, at least 1 hour before or 2 hours after food. Keep taking it unless your health care provider tells you to stop.

Do not take this medicine with grapefruit juice.

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 health care provider about the use of this medicine 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.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• astemizole
• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole
• cidofovir
• cisapride
• cyclosporine
• dronedarone
• droperidol
• grapefruit juice
• grepafloxacin
• live virus vaccines
• mesoridazine
• pimozide
• probucol
• ombitasvir; paritaprevir; ritonavir
• saquinavir
• thioridazine
• ziprasidone

This medicine may also interact with the following medications:

• alcohol and medicines that contain alcohol
• amiodarone
• bromocriptine
• certain antibiotics like aminoglycosides, chloramphenicol, clarithromycin, erythromycin, rifabutin, rifampin, troleandomycin
• certain antivirals for HIV or hepatitis
• certain calcium channel blockers like diltiazem, nicardipine, nifedipine, verapamil
• certain medicines for fungal infections like amphotericin B, caspofungin, clotrimazole
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• certain medicines for stomach problems like antacids, cimetidine, famotidine, lansoprazole, metoclopramide, omeprazole
• certain supplements that contain schisandra sphenanthera extracts
• cisplatin
• danazol
• diuretics
• ethinyl estradiol
• ganciclovir
• nefazodone
• other medicines that prolong the QT interval (an abnormal heart rhythm)
• sirolimus
• St. John's wort
• steroid medicines like prednisone, cortisone, methylprednisone
• vaccines

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 health care provider for regular checks on your progress. You will need blood work done while you are taking this medicine. Your condition will be monitored carefully while you are receiving this medicine. It is important not to miss any appointments.

This medicine may increase your risk of getting an infection. Call your health care provider 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.

Do not become pregnant while taking this medicine. Women should use birth control before and during tacrolimus therapy. There is potential for serious harm to an unborn child. Talk to your health care provider for more information.

Males who get this medicine must use a condom during sex with females who can get pregnant. If you get a woman pregnant, there is potential for serious harm to an unborn child. Tell your health care provider right away if you think your partner might be pregnant.

Talk to your health care provider about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.

This medicine 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 use sunscreen. Do not use sun lamps or tanning beds/booths.

This medicine may increase blood sugar. Ask your health care provider if changes in diet or medicines are needed if you have diabetes.

Avoid taking medicines that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your health care provider. These medicines may hide a fever.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• chest pain
• heartbeat rhythm changes (trouble breathing; chest pain; dizziness; fast, irregular heartbeat; feeling faint or lightheaded, falls)
• high blood sugar (increased hunger, thirst or urination; unusually weak or tired, blurry vision)
• high potassium levels (chest pain; fast irregular heartbeat; muscle weakness)
• increase in blood pressure
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• kidney injury (trouble passing urine or change in the amount of urine)
• low red blood cell counts (trouble breathing; feeling faint; lightheaded, falls; unusually weak or tired)
• low magnesium levels (fast, irregular heartbeat; muscle cramp or pain; muscle weakness; tremors; seizures)
• low phosphorus levels (loss of appetite, muscle weakness)
• nervous system problem (headache, confusion, seizures, changes in vision, changes in behavior, coma, or tremors)
• pain, tingling, numbness in the hands or feet

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• constipation
• diarrhea
• edema (sudden weight gain; swelling of the ankles, feet, hands or other unusual swelling)
• stomach pain
• 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.

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 medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, take the medicine out of the container. Mix the medicine 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.