MEDICATION GUIDE
ENVARSUS XR® (En var' sus XR)
(tacrolimus extended-release tablets)
for oral use
|
| Read this Medication Guide before you start taking ENVARSUS XR and each time you get a refill.
There may be new information. This information does not take the place of talking with your healthcare
provider about your medical condition or your treatment. If you have any questions about ENVARSUS
XR, ask your healthcare provider or pharmacist. |
|
What is the most important information I should know about ENVARSUS XR?
ENVARSUS XR can cause serious side effects, including:
-
Increased risk of cancer. People who take ENVARSUS XR have an increased risk of getting some kinds of cancer, including skin and lymph gland cancer (lymphoma).
-
Increased risk of infection. ENVARSUS XR is a medicine that affects your immune system. ENVARSUS XR can lower the ability of your immune system to fight infections. Serious infections can happen in people receiving ENVARSUS XR that can cause death.
Call your healthcare provider right away if you have symptoms of an infection such as:
|
|
|
- cough or flu-like symptoms
- muscle aches
|
- warm, red, or painful areas on your skin
|
|
What is ENVARSUS XR?
- ENVARSUS XR is a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney transplant.
- ENVARSUS XR is an extended-release tablet and is not the same as tacrolimus extended-release
capsules, tacrolimus immediate-release capsules or tacrolimus for oral suspension. Your healthcare
provider should decide what medicine is right for you.
It is not known if Envarsus XR is safe and effective in children.
|
|
Who should not take ENVARSUS XR?
Do not take ENVARSUS XR if you:
- are allergic to tacrolimus or any of the ingredients in ENVARSUS XR. See the end of this Medication Guide for a complete list of ingredients in ENVARSUS XR.
|
|
What should I tell my doctor before taking ENVARSUS XR?
Before you take ENVARSUS XR, tell your healthcare provider about all your medication conditions, including if you:
- plan to receive any live vaccines. Ask your healthcare provider if you are not sure if your vaccine
is a live vaccine.
- have or have had liver, kidney or heart problems.
- are pregnant or plan to become pregnant. ENVARSUS XR may harm your unborn baby.
- If you are able to become pregnant, you should use effective birth control before and during
treatment with ENVARSUS XR. Talk to your healthcare provider about birth control methods
that may be right for you.
- Males who have female partners that are able to become pregnant should also use effective
birth control before and during treatment with ENVARSUS XR. Talk to your healthcare
provider before starting treatment with ENVARSUS XR about birth control methods that may
be right for you.
- There is a pregnancy registry for females who become pregnant and males who have fathered
a pregnancy during treatment with ENVARSUS XR. The purpose of this registry is to collect
information about your health and of your baby. To enroll in this voluntary registry, call 1-877-
955-6877 or register at https://www.transplantpregnancyregistry.org.
- are breastfeeding or plan to breastfeed. ENVARSUS XR passes into your breast milk. You and
your healthcare provider should decide if you will breastfeed while taking ENVARSUS XR
Tell your healthcare provider about all the medicines you take, including prescription and
over-the-counter medicines, vitamins, natural, herbal or nutritional supplements.
ENVARSUS XR may affect the way other medicines work, and other medicines may affect
how ENVARSUS XR works.
Especially tell your healthcare provider if you take:
- sirolimus (RAPAMUNE):
- everolimus
- cyclosporine (GENGRAF, NEORAL, and SANDIMMUNE)
- medicines called aminoglycosides that are used to treat bacterial infections
- ganciclovir (CYTOVENE IV, VALCYTE)
- amphotericin B (ABELCET, AMBISOME)
- cisplatin
- antiviral medicines called nucleoside reverse transcriptase inhibitors
- antiviral medicines called protease inhibitors
- water pill (diuretic)
- medicine to treat high blood pressure
- erythromycin
- danazol
- ethyinyl estradiol
- cimetidine
- lansoprazole
- omeprazole
- azole antifungals
- imatinib
- nilotinib
- nelfinavir (VIRACEPT)
- telaprevir (INCIVEK)
- boceprevir)
- ritonavir (PAXLOVID, KALETRA, NORVIR, TECHNIVIE, VIEKIRA PAK, VIEKIRA XR)
- letermovir (PREVYMIS)
- ketoconazole
- itraconazole (ONMEL, SPORANOX)
- voriconazole (VFEND)
- posaconazole
- caspofungin (CANCIDAS)
- clarithromycin (BIAXIN, BIAXIN XL, PREVPAC)
- troleandomycin
- chloramphenicol
- nefazodone
- Schisandra sphenanthera extracts
- cobicistat
- rifampin (RIFADIN, RIFAMATE, RIFATER, RIMACTANE)
- rifabutin (MYCOBUTIN)
- medicine to treat seizures (phenytoin, carbamazepine, phenobarbital
- St. John’s Wort
- amiodarone (NEXTERONE, PACERONE)
- cannabidiol (EPIDIOLEX)
- magnesium and aluminum hydroxide antacids
- metoclopramide
- methylprednisolone
- prednisone
Ask your healthcare provider or pharmacist if you are not sure if you take any of the medicines listed above. ENVARSUS XR may affect the way other medicines work, and other medicines may affect how ENVARSUS XR works.
Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
|
|
How should I take ENVARSUS XR?
- Take ENVARSUS XR exactly as your healthcare provider tells you to take it.
- Your healthcare provider may change your dose of ENVARSUS XR if needed. Do not stop taking or
change your dose of ENVARSUS XR without talking to your healthcare provider.
- Take ENVARSUS XR 1-time daily with fluid (preferably water) on an empty stomach, at least 1 hour
before or at least 2 hours after a meal, at the same time each day (preferably in the morning). Taking ENVARSUS XR at the same time each day helps to keep the amount of ENVARSUS XR in your body at a steady level.
- Take ENVARSUS XR tablets whole. Do not chew, divide, crush, or dissolve ENVARSUS XR tablets
before swallowing. If you cannot swallow ENVARSUS XR tablets whole, tell your healthcare provider.
- If you miss your dose of ENVARSUS XR, it should be taken as soon as possible, but no longer than 15
hours after missing your dose. If the time after missing your dose is more than 15 hours, the missed dose
should be skipped and the next dose should be taken the following morning at your regularly scheduled
time. Do not take 2 doses at the same time.
- If you take too much ENVARSUS XR, call your healthcare provider or go to the nearest hospital
emergency room right away.
|
|
What should I avoid while taking ENVARSUS XR?
- Live vaccines such as the flu vaccine through your nose, measles, mumps, rubella, polio by mouth, BCG (TB vaccine), yellow fever, chicken pox (varicella), or typhoid.
- Exposure to sunlight and UV light such as tanning machines. Wear protective clothing and use a sunscreen.
- You should not eat grapefruit or drink grapefruit juice while taking ENVARSUS XR.
- You should not drink alcohol while taking ENVARSUS XR.
|
|
What are the possible side effects of ENVARSUS XR?
ENVARSUS XR may cause serious side effects, including:
-
See “What the most important information I should know about ENVARSUS XR?”
-
problems from medication errors such as graft rejection and other serious reactions. People who take ENVARSUS XR have sometimes been given the wrong medicine because some medicines have the same ingredient (tacrolimus) as ENVARSUS XR. Check your ENVARSUS XR when you get a new prescription to make sure you have received the right medicine.
- Call your healthcare provider right away if you think you were given the wrong medicine.
- Ask your healthcare provider or pharmacist if you are not sure what ENVARSUS XR should look like.
-
high blood sugar (diabetes). High blood sugar is a serious, but common side effect of ENVARSUS XR. Your healthcare provider may do certain tests to check for diabetes while
you take ENVARSUS XR. Call your healthcare provider right away if you have:
|
|
- frequent urination
- confusion
- fruity smell on your breath
|
- increased thirst or hunger
- drowsiness
- nausea, vomiting, or stomach pain
|
- blurred vision
- loss of appetite
|
-
kidney problems. Kidney problems are serious, but common side effects of ENVARSUS XR. Your healthcare provider may do certain tests to check for kidney function while you take ENVARSUS XR.
-
nervous system problems. Nervous system problems are a serious, but common side effect of ENVARSUS XR. Call your healthcare provider right away if you get any of these symptoms while taking ENVARSUS XR:
-
high levels of potassium in your blood. High levels of potassium in your blood are a serious, but common side effect of ENVARSUS XR. Your healthcare provider may do certain tests to check your potassium level while you take ENVARSUS XR.
|
|
- confusion
- numbness and tingling
- vision changes
|
- coma
- headache
- muscle tremors
|
|
-
high blood pressure. High blood pressure is a serious, but common side effect of ENVARSUS XR. Your healthcare provider will monitor your blood pressure while you take ENVARSUS XR.
-
changes in the electrical activity of your heart (QT prolongation). Your healthcare provider may do certain tests to check your heart function while you take ENVARSUS XR.
-
severe low blood cell count (anemia). Your healthcare provider may stop your treatment with ENVARSUS XR if you develop a severe low blood cell count.
-
blood clotting problems: Tell your healthcare provider right away if you have fever and bruising under the skin that may appear as red dots, with or without unexplained tiredness, confusion, yellowing of the skin or eyes, decreased urination. When taken with sirolimus or everolimus, or when you develop certain infections, the risk of developing these symptoms may increase.
The most common side effects of ENVARSUS XR in people who received a kidney transplant are:
|
- diarrhea
- low red blood cell count (anemia)
|
- urinary tract infection
- constipation
|
- swelling in the arms, hands, or legs (peripheral edema)
|
|
The most common side effects of ENVARSUS XR in people who are switching from immediate-release tacrolimus to ENVARSUS XR are diarrhea and high blood creatinine.
These are not all the possible side effects of ENVARSUS XR. For more information, ask your healthcare
provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.
|
|
How should I store ENVARSUS XR?
- Store ENVARSUS XR at room temperature between 68 ºF to 77 ºF (20 °C to 25 ºC).
- Safely throw away medicine that is out of date or no longer needed.
Keep ENVARSUS XR and all medicines out of reach of children.
|
|
General information about the safe and effective use of ENVARSUS XR.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ENVARSUS XR for a condition for which it was not prescribed. Do not give ENVARSUS XR to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about ENVARSUS XR. If you would like
more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for
information about ENVARSUS XR that is written for health professionals.
|
|
What are the ingredients in ENVARSUS XR?
Active ingredient: tacrolimus USP.
Inactive ingredients: hypromellose USP, lactose monohydrate NF, polyethylene glycol NF, poloxamer NF, magnesium stearate NF, tartaric acid NF, butylated hydroxytoluene NF, and dimethicone NF.
Manufactured by: Rottendorf Pharma GmbH, 59320 Ennigerloh, North Rhine-Westphalia, Germany
Manufactured for: Veloxis Pharmaceuticals, Inc., Cary, North Carolina 27518, United States
For more information, go to www.ENVARSUSXR.com or call 1-844-Veloxis (1-844-835-6947).
|