Envarsus PA

Brand Name

Envarsus PA

Common Name

tacrolimus capsules

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are any nutrients depleted by this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

How does this medication work? What will it do for me?

Tacrolimus belongs to the class of medications called immunosuppressants. It is used in addition to other medications to prevent the body's rejection of an allogeneic (from a donor) transplanted kidney, liver, or heart or to treat the body's rejection of a transplanted kidney or liver.

It may also be used to treat rheumatoid arthritis when the usual therapies have failed to work. Tacrolimus works by lowering the activity of white blood cells in the body (the cells that attack substances foreign to the body).

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

For kidney or liver transplants, the dose of tacrolimus varies according to the circumstances and will be determined by your doctor.

Tacrolimus is usually taken once every 24 hours. You should try to take your dose of tacrolimus at the same time every day. Ask your transplant nurse or pharmacist about a dosing schedule that fits your lifestyle.

Swallow the tablets whole with fluid. Do not chew, crush, or divide the tablets. It is recommended that you take this medication at least 1 hour before or 2 hours after a meal, preferably in the morning. Tacrolimus should not be taken with grapefruit, grapefruit juice, or alcohol.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by the doctor. If even a few doses of tacrolimus are missed, your body may reject your transplanted organ. If you miss a dose of this medication, take it as soon as you remember it. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Ask your doctor ahead of time what you should do about missed doses. Be sure to order your medication refills well ahead of time.

Tacrolimus is often given with other medications. Make sure you talk to your doctor about whether you need to stop or continue taking any other immunosuppressive medications.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

0.75 mg
Each white-to-off‐white, oval‐shaped, extended-release tablet, debossed with "0.75" on one side and "TCS" on the other side, contains 0.75 mg of tacrolimus. Nonmedicinal ingredients: butylated hydroxytoluene, dimethicone, hypromellose, lactose monohydrate, magnesium stearate, poloxamer 188, polyethylene glycol, and tartaric acid.

0.75 mg
Each white-to-off‐white, oval-shaped, extended-release tablet, debossed with "1" on one side and "TCS" on the other side, contains 1 mg of tacrolimus. Nonmedicinal ingredients: butylated hydroxytoluene, dimethicone, hypromellose, lactose monohydrate, magnesium stearate, poloxamer 188, polyethylene glycol, and tartaric acid.

0.75 mg
Each white-to-off‐white, oval‐shaped, extended-release tablet, debossed with "4" on one side and "TCS" on the other side, contains 4 mg of tacrolimus. Nonmedicinal ingredients: butylated hydroxytoluene, dimethicone, hypromellose, lactose monohydrate, magnesium stearate, poloxamer 188, polyethylene glycol, and tartaric acid.

Who should NOT take this medication?

Do not take tacrolimus if you:

• are allergic to tacrolimus or any ingredients of the medication
• are allergic to HCO-60 (polyoxyl 60 hydrogenated castor oil [injection formulation only])

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• constipation
• diarrhea
• difficulty sleeping or nightmares
• headache
• tiredness or fatigue
• trembling
• weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• anxiety
• cold or flu-like symptoms (such as fever or sore throat)
• fever
• high blood pressure
• mouth sores
• palpitations (unusual heartbeats that may cause a pounding or fluttering feeling in the chest)
• possible signs of cancer (e.g., a sore that does not heal; changes in bladder or bowel habits; lumps or thickened areas on the breast or other body areas; night sweats; severe, persistent headaches; swollen glands; trouble swallowing, unexplained stomach upset, nagging cough or hoarseness; unusual bleeding or discharge)
• rapid heartbeat
• shortness of breath or difficulty breathing
• signs of electrolyte imbalance (e.g., muscle pain or cramps, weakness, irregular heartbeat, lack of coordination, thirst, confusion)
• signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• signs of progressive multifocal leukoencephalopathy (e.g., personality changes, progressive weakness on one side of the body, changes in memory, confusion)
• signs of posterior encephalopathy syndrome (e.g., headache, seizures, visual disturbances, altered mental state)
• signs of reduced red blood cells (e.g., fatigue, general feeling of being unwell, weakness, dizziness, fainting, pale skin, pale stool)
• swelling in your hands, feet, arms, or legs
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
• vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

• chest pain
• convulsions (seizures)
• signs of a hole in the digestive system (e.g., severe abdominal pain, burning pain, nausea, vomiting, chills or fever)
• signs of heart problems (e.g., chest pain; dizziness; fainting; low or no pulse; nausea; pain spreading from the shoulder, down the arm, neck, or back; sweating; shortness of breath)
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
• symptoms of infection of the blood (e.g., confusion, fever, low body temperature, fast breathing, fast heart rate)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are any nutrients depleted by this medication?

Some medications can affect vitamin and nutrient levels in the body. Below is a list of nutrient depletions associated with this medication. Talk to your doctor or pharmacist about whether taking a supplement is recommended or if you have any questions or concerns.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal heart rhythms: Tacrolimus may cause a heart rhythm problem called QT prolongation. If you have a history of QT prolongation, slow or irregular heartbeat, irregular heart rhythm, heart failure, heart attack, heart disease, are taking other medications known to cause QT prolongation, or have a family history of sudden cardiac death at less than 50 years of age, discuss with your doctor how this medication may affect your medical condition, or how your medical condition may affect the dosing and effectiveness of this medication. Your doctor will perform tests at regular intervals to monitor for any changes in your heart rhythm.

Blood pressure: Tacrolimus treatment commonly causes mild-to-moderate increases in blood pressure. Monitor your blood pressure, and inform your doctor if there is an indication that your blood pressure is rising.

Diabetes: Tacrolimus may cause an increase in blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication. Your doctor will help to monitor this, but be sure to report any signs of high blood sugar (e.g., increased thirst, urination, unusual tiredness) to your doctor.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Driving or operating machinery:Tacrolimus may cause drowsiness or otherwise affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how you are affected by this medication.

Gastrointestinal perforation: Tacrolimus has also been linked to serious digestive system problems, including gastrointestinal perforation (a tear or hole in the wall of the digestive tract). People who are taking corticosteroids or non-steroidal anti-inflammatory medications, have had recent abdominal surgery, or have had digestive system problems may be at increased risk of experiencing gastrointestinal perforation.

If you experience symptoms of a gastrointestinal perforation, such as severe stomach pain, fever, chills, nausea, or vomiting, seek immediate medical attention.

High potassium levels in the blood: Tacrolimus may cause an increase in potassium levels in the blood. Some foods (e.g., bananas or orange juice) and some medications may increase the risk of this problem. Be sure to tell your doctor and pharmacist about all the medications you are taking (including non-prescription medications) and to talk to them about potassium-rich foods.

Infections: Tacrolimus reduces resistance to infections and may delay healing. Ensure proper treatment to avoid infection (e.g., dental work, skin injury). Avoid activities that increase the risk of infection.

Because tacrolimus reduces the body's response to infection, conditions caused by bacteria or viruses that have been dormant in the body, such as chicken pox, hepatitis B, or tuberculosis may be reactivated.

Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness.

Kidneys: Tacrolimus may affect kidney function. Your doctor will monitor your kidney function with laboratory tests while you are taking this medication. Be sure to immediately report to your doctor any evidence of changes in kidney function such as changes in the appearance of urine, frequency of urination, and amount of urine produced.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Lymphoma and other cancers: People taking immunosuppressant medications, such as tacrolimus, are at increased risk of developing a type of cancer known as lymphoma and certain types of skin cancer. This risk is related to the intensity and duration of treatment with immunosuppressant medications rather than to one specific medication.

Possible warning signs of cancer include a change in bowel or bladder habits, sores that don't heal, unusual bleeding, change in appearance of a wart or mole, night sweats, a nagging cough, or persistent and severe headaches. If you experience any of these, let your doctor know right away. This may help to detect any cancers early in their development.

Nerves: Tacrolimus may affect nerve function and cause symptoms such as tremors and headaches. Be sure to report any changes to your doctor at once.

Red blood cell aplasia: Tacrolimus has been reported to cause the body to stop producing red blood cells. If you experience symptoms of reduced red blood cell count such as shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.

Reversible posterior leukoencephalopathy syndrome (RPLS): This is a rare disease of the brain that can occur when using tacrolimus. Make sure your doctor knows if you have experienced this condition before. If you experience signs and symptoms of RPLS, such as headache, seizures, change in awareness or consciousness or vision changes, contact your doctor immediately.

Vaccinations: Vaccines that are given during treatment with tacrolimus may not be as effective as expected. Also, people taking this medication should not receive certain vaccines. Talk to your doctor about whether any vaccines you are scheduled to take should not be used with this medication.

Pregnancy:  Tacrolimus crosses the placenta and can affect the developing baby, causing low birth weight, birth defects, and premature birth. Tacrolimus can cause increased blood sugar for people with diabetes and it can also cause increased blood pressure.

This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately. People who could become pregnant should use a reliable form of birth control during treatment and for 6 weeks after stopping treatment.

Breast-feeding: This medication passes into breast milk. Breast-feeding is not recommended while taking tacrolimus. If you are breast-feeding and taking tacrolimus, it may affect your baby. Talk to your doctor.

What other drugs could interact with this medication?

There may be an interaction between tacrolimus and any of the following:

• 5-ASA medications (e.g.,  mesalamine, olsalazine, sulfasalazine)
• alcohol
• aliskiren
• alprazolam
• aminoglycoside antibiotics (e.g., amikacin, gentamicin, tobramycin)
• amiodarone
• angiotensin converting enzyme inhibitors (ACEIs; captopril, ramipril)
• angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
• antacids (e.g., aluminum hydroxide, magnesium hydroxide)
• antiarrhythmics (e.g., amiodarone, dronedarone, procainamide, propafenone)
• antifungal medications (e.g., ketoconazole, clotrimazole, itraconazole, fluconazole, voriconazole)
• antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
• apalutamide
• aprepitant
• avacopan
• BCG
• bicalutamide
• birth control pills
• bosentan
• bromocriptine
• calcium channel blockers (e.g., amlodipine, diltiazem, verapamil, nifedipine)
• cannabis
• carvedilol
• chlorzoxazone
• cimetidine
• cinacalcet
• cobicistat
• colchicine
• corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
• cyclosporine
• danazol
• darolutamide
• deferiprone
• denosumab
• diabetes medications (e.g., acarbose, canagliflozin, dulaglutide, glyburide, insulin, linagliptin. metformin, rosiglitazone, sitagliptin)
• disopyramide
• echinacea
• elagolix
• enzalutamide
• eplerenone
• everolimus
• fenofibrate
• fingolimod
• flibanserin
• fluvoxamine
• ginkgo biloba
• grapefruit juice
• H2 antagonists (e.g., cimetidine, famotidine)
• hepatitis C antivirals (e.g., elbasvir, grazoprevir, ledipasvir, sofosbuvir, velpatasvir, voxilaprevir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine, rilpivirine)
• HIV protease inhibitors (e.g., atazanavir, darunavir, lopinavir, ritonavir, tipranavir)
• isoniazid
• leflunomide
• letermovir
• lomitapide
• lumacaftor and ivacaftor
• macrolide antibiotics (e.g., azithromycin, erythromycin, clarithromycin)
• maribavir
• methadone
• metoclopramide
• mifepristone
• modafinil
• natalizumab
• nirmatrelvir
• non-steroidal anti-inflammatory medications (NSAIDs; e.g., celecoxib, diclofenac, ibuprofen, naproxen)
• ocrelizumab
• ofatumumab
• ozanimod
• pimecrolimus
• propiverine
• potassium-sparing diuretics (e.g., amiloride, spironolactone, triamterene)
• protein kinase inhibitors (e.g., crizotinib, dabrafenib, imatinib, nilotinib, tofacitinib)
• proton pump inhibitors (e.g., lansoprazole, omeprazole)
• quinolone antibiotics (e.g., ciprofloxacin, levofloxacin)
• ranolazine
• rifabutin
• rifampin
• St. John's wort
• seizure medications (e.g., carbamazepine, clobazam, oxcarbazepine, phenobarbital, phenytoin, primidone, rufinamide)
• sevelamer
• sildenafil
• siponimod
• sirolimus
• solriamfetol
• sotalol
• tacrolimus (topical)
• tecovirimat
• telotristat
• temsirolimus
• testosterone
• tezacaftor
• vaccines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Envarsus-PA