Envarsus XR
(Tacrolimus ER)-
All Strengths
-
0.75mg
-
1mg
-
4mg
Envarsus XR 0.75mg
Extended Release TabletsMarketed as Envarsus Prolonged Release in United Kingdom
Envarsus XR Drug Information
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You can easily place an order on our website in under 5 minutes. First you need to set up an account with us, create a payment method, and send us your prescriptions. Alternatively, you can order by downloading our order form or by placing an order over the phone. Delivery can take approximately 2 weeks to North America, and 4 weeks to other countries.
Envarsus XR Overview
Tacrolimus is used with other medications to prevent rejection of a kidney transplant. Envarsus XR belongs to a class of drugs known as immunosuppressants. It works by weakening your body's defense system (immune system) to help your body accept the new organ as if it were your own.
Envarsus XR Warnings
Tacrolimus lowers the body's ability to fight an infection/disease (immunosuppression). This effect may increase your risk of developing an infection or certain types of cancer (such as skin cancer, lymphoma). To reduce the risk of these serious side effects, take Envarsus XR at the lowest effective dose as directed by your doctor. Keep all medical and laboratory appointments.unusual skin changes, change in the appearance/size of moles, unusual growths/lumps, swollen glands, night sweats, unexplained weight loss, signs of infection (such as sore throat that doesn't go away, fever). Envarsus XR may increase the risk of death when Envarsus XR is used by women to prevent organ rejection after a liver transplant. Discuss the risks and benefits of Envarsus XR with the doctor.
How to Use Envarsus XR
Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking tacrolimus and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take Envarsus XR by mouth on an empty stomach (1 hour before or 2 hours after a meal) as directed by your doctor, usually once daily in the morning. Talk to your doctor about how to take Envarsus XR if you have nausea or an upset stomach. Swallow the medication whole. Do not crush or chew. Doing so can release all of the drug at once, increasing the risk of side effects. Dosage of Envarsus XR is based on your weight, medical condition, blood test results (for example, tacrolimus trough levels), response to treatment, and previous dose of tacrolimus (if switching from the form of Envarsus XR that is taken twice daily). Tacrolimus is available in different formulations (such as immediate and extended-release). Do not switch between different forms of tacrolimus without consulting your doctor. Do not increase your dose or take Envarsus XR more often without your doctor's approval. Your condition will not improve any faster and the risk of serious side effects may be increased. Also, do not stop taking Envarsus XR without your doctor's approval. Take Envarsus XR regularly in order to get the most benefit from it. It is important to take all doses on time to keep the amount of medicine in your body at a constant level. Remember to take it at the same time each day. Avoid eating grapefruit or drinking grapefruit juice while being treated with Envarsus XR unless your doctor instructs you otherwise. Grapefruit can increase the amount of certain medications in your bloodstream. Consult your doctor or pharmacist for more details. Since Envarsus XR can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle Envarsus XR or breathe the dust from the tablets. Tell your doctor if your condition worsens.
Envarsus XR Precautions
Before taking tacrolimus, tell your doctor or pharmacist if you are allergic to it; or to other macrolide medications (such as sirolimus); or if you have any other allergies. Envarsus XR may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using Envarsus XR, tell your doctor or pharmacist your medical history,mineral imbalances (such as high potassium), kidney disease, any recent/current infections, cancer, liver disease, high blood pressure, diabetes. Tacrolimus may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using tacrolimus,certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death). Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using tacrolimus safely. Envarsus XR may increase your risk of developing skin cancer. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tacrolimus can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details. Tell your health care professional that you are using tacrolimus before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose). Envarsus XR may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the side effects of Envarsus XR, especially QT prolongation (see above). Since Envarsus XR can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle Envarsus XR or breathe the dust from the tablets. Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using tacrolimus. Tacrolimus may harm an unborn baby. Men and women using Envarsus XR should ask about reliable forms of birth control before and while using Envarsus XR. If you or your partner become pregnant, talk to your doctor right away about the risks and benefits of Envarsus XR. Do not stop taking Envarsus XR unless directed by your doctor. Envarsus XR passes into breast milk and the effect on a nursing infant is unknown. Discuss the risks and benefits with your doctor before breast-feeding.
Envarsus XR Misdose
If you take the extended-If you miss a dose of Envarsus XR, take it as soon as you remember. If it is more than 14 hours after the time you would usually take it, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. If you take the extended-If you miss a dose of Envarsus XR, take it as soon as you remember. If it is more than 15 hours after the time you would usually take it, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Envarsus XR Interactions
See also How to Use section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.aluminum/magnesium antacid, cyclosporine, sirolimus, temsirolimus, ziprasidone, other drugs that may increase the level of potassium in the blood (such as "water pills" including amiloride, spironolactone), other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab). Avoid alcohol when using Envarsus XR because it may cause the medication to be released too quickly and increase the risk of side effects. Other medications can affect the removal of tacrolimus from your body, which may affect how tacrolimus works. Examples include cimetidine, danazol, nefazodone, ethinyl estradiol, methylprednisolone, St. John's wort, azole antifungals (such as itraconazole/voriconazole), HIV protease inhibitors (such as nelfinavir), rifamycins (such as rifampin, rifabutin), ritonavir, certain anti-seizure drugs (such as phenobarbital, phenytoin), among others.
Envarsus XR Side Effects
What are Envarsus XR side effects?
Side effects are physical, mental or emotional symptoms which occur in addition to or outside of the desired effect of a therapeutic treatment such as an over-the-counter or prescribed drug or medication. Side effects from Envarsus XR may occur at the beginning or at the end of treatment and may also depend on the length of time an individual remains on the treatment. Side effects, also known as adverse effects, are generally more likely to occur when starting treatment. Individuals may also experience side effects from Envarsus XR as a result of an interaction with other medications.
Side Effects of Envarsus XR
The side effects of Envarsus XR may vary in number and intensity for many different reasons. Factors such as age, weight, gender and ethnicity may influence the side effects of Envarsus XR. Also, an individual’s state of general physical health and seriousness of the disease or illness as well as an increase or decrease in dosage may lead to side effects. Further, side effects from Envarsus XR may also occur as a result of an interaction with certain herbal supplements, foods or drinks.
Prescription drug side effects can be serious and may cause patients to stop the treatment. However, when side effects from the use of a prescription drug, such as Envarsus XR, do occur a patient should consult their physician. A physician may prescribe an additional treatment in order to control the symptoms or an adjustment in the dosage may be made. In addition, changes to diet, exercise or other lifestyle activities may help to lessen the side effects of Envarsus XR.
By understanding side effects and the factors which may influence the occurrence of side effects patients are empowered to take an active role in their care. Patients who have specific questions about the side effects of Envarsus XR, or any other medication, should contact their physician. General information about Envarsus XR and the side effects associated with Envarsus XR are described in the following:
Common Envarsus XR Side Effects
Severe
- infection
- hypomagnesemia
- hyperkalemia
- anemia
- leukopenia
- blood dyscrasias
- CNS toxicity
- pleural effusions
- nephrotoxicity
- seizure disorder
- insomnia
- hyperglycemia
- kidney disease with reduction in GFR
Less Severe
- acute confusion
- symptoms of anxiety
- nightmares
- agitation
- depression
- gastrointestinal irritation
- constipation
- pruritus of skin
- hallucinations
- dizziness
- general weakness
- tremor
- skin rash
- peripheral edema
- anorexia
- headache disorder
- nausea
- vomiting
- diarrhea
- nervousness
- diabetes mellitus
Less Frequent Envarsus XR Side Effects
Severe
- hypertension
- cardiomyopathy
- osteoporosis
- hypokalemia
- dyspnea
- hypercortisolism
- fungal infection
Less Severe
- hypertriglyceridemia
- hyperlipidemia
- visual changes
- tinnitus
- cramps
- hyperhidrosis
- paresthesia
- chest pain
- urinary tract infection
- pain
- dyspepsia
- acute abdominal pain
- abdominal distension
- aphthous stomatitis
- peripheral neuropathy
- hypoesthesia
Rare or Very Rare Envarsus XR Side Effects
Severe
- malignant lymphoma
- hemolytic uremic syndrome
- anaphylaxis
- idiopathic thrombocytopenic purpura
- pancytopenia
- squamous cell carcinoma
- torsades de pointes
- prolonged QT interval
- transient blindness
- left ventricular hypertrophy
- gastric ulcer
- gastroenteritis
- hepatitis
- acute pancreatitis
- renal failure
- Stevens-Johnson syndrome
- posterior reversible encephalopathy syndrome
- post-transplant lymphoproliferative disease
- progressive multifocal leukoencephalopathy
- interstitial lung disease
- thrombocytopenic disorder
- toxic epidermal necrolysis
- abnormal ECG
- disseminated intravascular coagulation
- abnormal hepatic function tests
- viral infection
- BK polyomavirus reactivation nephropathy
- pure red cell aplasia
- agranulocytosis
- hemolytic anemia
- neutropenic disorder
- thrombotic thrombocytopenic purpura
- cytomegalovirus disease
- chronic heart failure
- bradycardia
- gastrointestinal perforation
- vision loss
- biliary obstruction
- cholangitis
- hepatic necrosis
- deep venous thrombosis
- ventricular fibrillation
- hemiparesis
- rhabdomyolysis
- hemorrhage
- pulmonary hypertension
- hemorrhagic cystitis
- urinary retention
- aphasia
- paralysis
- coma
- pulmonary thromboembolism
- leukocytosis
- atrial fibrillation
- atrial flutter
- hypertrophic cardiomyopathy
- pericardial effusion
- angina
- supraventricular premature beats
- optic neuropathy
- basal cell carcinoma of skin
- flaccid paralysis
- graft-versus-host disease
- elevated serum amylase
- hypoprothrombinemia
Less Severe
- hearing loss
- glycosuria
- impaired wound healing
- mood changes
- photophobia
- myalgia
- arthritis
- skin pigmentation enhancement
- pain in extremities
- skin photosensitivity
- rhinitis
- hiccups
- urinary incontinence
- altered mental status
- drowsy
- dysarthria
- syncope
- delirium
- hematuria
- tachycardia
- gastritis
- urticaria
- hirsutism
Envarsus XR Storage
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard Envarsus XR when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
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