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ENVARSUS XR- tacrolimus tablet, extended release


  1. Patient Information
  2. Advise Patients To:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

17.1 Administration

Advise Patients To: 

  • Inspect their ENVARSUS XR medicine when they receive a new prescription and before taking it. If the appearance of the tablet is not the same as usual, or if dosage instructions have changed, advise patients to contact their healthcare provider as soon as possible to make sure that you have the right medicine. Other tacrolimus products cannot be substituted for ENVARSUS XR[seeWarnings and Precautions (5.3)].
  • Take once-daily ENVARSUS XR at the same time every day (preferably in the morning) on an empty stomach. at least 1 hour before or at least 2 hours after a meal to ensure consistent and maximum possible drug concentrations in the blood.
  • Swallow tablet whole with liquid, preferably water. Do not chew, divide or crush tablet.
  • Avoid alcoholic beverages, grapefruit, and grapefruit juice while on ENVARSUS XR[seeDosage and Administration (2.1)andDrug Interactions (7.2)].
  • Take a missed dose as soon as possible but not more than 15 hours after the scheduled time (i.e., for a missed 8 AM dose, take it no later than 10 PM). Beyond the 15-hour timeframe, instruct the patient to wait until the usual scheduled time the following morning to take the next regularly scheduled dose. Do not take two doses at the same time[seeDosage and Administration (2.1)].

17.2 Development of Lymphoma and Other Malignancies

Inform patients that they are at an increased risk of developing lymphomas and other malignancies, particularly of the skin, due to immunosuppression. Advise patients to limit exposure to sunlight and ultraviolet (UV) light by wearing protective clothing and use a sunscreen with a high protection factor[seeBoxed WarningandWarnings and Precautions (5.1)].

17.3 Increased Risk of Infection

Inform patients that they are at an increased risk of developing a variety of infections, including opportunistic infections, due to immunosuppression and to contact their physician if they develop any symptoms of infection such as fever, sweats or chills, cough or flu-like symptoms, muscle aches, or warm, red, painful areas on the skin[seeBoxed WarningandWarnings and Precautions (5.2)].

17.4 New Onset Diabetes After Transplant

Inform patients that ENVARSUS XR can cause diabetes mellitus and should be advised to contact their physician if they develop frequent urination, increased thirst or hunger[seeWarnings and Precautions (5.4)].

17.5 Nephrotoxicity

Inform patients that ENVARSUS XR can have toxic effects on the kidney that should be monitored. Advise patients to attend all visits and complete all blood tests ordered by their medical team[seeWarnings and Precautions (5.5)].

17.6 Neurotoxicity

Inform patients that they are at risk of developing adverse neurologic effects including seizure, altered mental status, and tremor. Advise patients to contact their physician should they develop vision changes, delirium, or tremors[seeWarnings and Precautions (5.6)].

17.7 Hyperkalemia

Inform patients that ENVARSUS XR can cause hyperkalemia. Monitoring of potassium levels may be necessary, especially with concomitant use of other drugs known to cause hyperkalemia[seeWarnings and Precautions (5.7)].

17.8 Hypertension

Inform patients that ENVARSUS XR can cause high blood pressure which may require treatment with anti-hypertensive therapy. Advise patients to monitor their blood pressure[seeWarnings and Precautions (5.8)].

17.9 Drug Interactions

Instruct patients to tell their healthcare providers when they start or stop taking any concomitant medications, including prescription and non-prescription medicines, natural or herbal remedies, dietary supplements and vitamins. Some medications could alter tacrolimus concentrations in the blood and thus may require the adjustment of the dosage of ENVARSUS XR. Advise patients to avoid grapefruit, grapefruit juice and alcoholic beverages[seeWarnings and Precautions (5.9)andDrug Interactions (7)].

17.10 Pregnancy, Lactation and Infertility

Inform women of childbearing potential that ENVARSUS XR can harm the fetus. Instruct male and female patients to discuss with their healthcare provider family planning options including appropriate contraception. Also discuss with pregnant patients the risks and benefits of breastfeeding their infant[seeUse in Specific Populations (8.1,8.2,8.3)].

Encourage female transplant patients who become pregnant and male patients who have fathered a pregnancy, exposed to immunosuppressants including tacrolimus, to enroll in the voluntary Transplantation Pregnancy Registry International. To enroll or register, patients can call the toll-free number 1-877-955-6877 or https://www.transplantpregnancyregistry.org.

Based on animal studies, ENVARSUS XR may affect fertility in males and females[seeNonclinical Toxicology (13.1)].

17.11 Immunizations

Inform patients that ENVARSUS XR can interfere with the usual response to immunizations and that they should avoid live vaccines[seeWarnings and Precautions (5.11)].

Product of Germany

Manufactured by:
Rottendorf Pharma GmbH
59320 Ennigerloh
North Rhine-Westphalia
Germany

Manufactured for:
Veloxis Pharmaceuticals, Inc.
Cary, North Carolina 27513
United States



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