Tacrolimus (Page 15 of 16)

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

17.1 Administration

Advise the patient or caregiver to:

  • Inspect their tacrolimus capsules medicine when they receive a new prescription and before taking it. If the appearance of the capsule 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 they have the right medicine. Other tacrolimus products cannot be substituted for tacrolimus capsules.
  • Take tacrolimus capsules at the same 12-hour intervals every day to achieve consistent blood concentrations.
  • Take tacrolimus Ccapsules consistently either with or without food because the presence and composition of food decreases the bioavailability of Tacrolimus Capsules.
  • Not to eat grapefruit or drink grapefruit juice in combination with tacrolimus capsules [see Drug Interactions ( 7.2)].

17.2 Development of Lymphoma and Other Malignancies

Inform patients they are at 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 using a broad spectrum with a high protection factor [see Boxed Warnings and Warnings and Precautions ( 5.1)].

17.3 Increased Risk of Infection

Inform patients they are at 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 [see Boxed Warnings and Warnings and Precautions ( 5.2)]

17.4 New Onset Diabetes After Transplant

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

17.5 Nephrotoxicity

Inform patients that Tacrolimus capsules 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 [see Warnings and Precautions ( 5.5)].

17.6 Neurotoxicity

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

17.7 Hyperkalemia

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

17.8 Hypertension

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

17.9 Drug Interactions

Instruct patients to tell their healthcare providers when they start or stop taking all the medicines, including prescription medicines and non-prescription medicines, natural or herbal remedies, nutritional supplements, and vitamins. Advise patients to avoid grapefruit and grapefruit juice [see Drug Interactions ( 7)].

17.10 Pregnancy, Lactation and Infertility

Inform women of childbearing potential that tacrolimus capsules 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 [see Use 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/[see Use in Specific Populations ( 8.1)].

Based on animal studies, tacrolimus capsules may affect fertility in males and females [see Nonclinical Toxicology ( 13.1)].

17.11 Myocardial Hypertrophy

Inform patients to report symptoms of tiredness, swelling, and/or shortness of breath (heart failure).

17.12 Immunizations

Inform patients that tacrolimus capsules can interfere with the usual response to immunizations and that they should avoid live vaccines [see Warnings and Precautions ( 5.14)].

Rx only

Manufactured by:
Panacea Biotec Pharma Limited
Malpur, Baddi,
Distt. Solan (H.P.) – 173205, India

Mfg.Lic.No: MB/05/203

Distributed by:
Bionpharma Inc., 600 Alexander Road,
Princeton, NJ 08540, USA.

All other trademarks and registered trademarks are the property of their respective owners.
Resource Number: L5678

Item Code: PPIT081C
Revised Date: October 2020

Patient Information

Tacrolimus Capsules, USP
(ta-KROE-li-mus)

Read this Patient Information before you start taking tacrolimus capsules 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 tacrolimus capsules ask your healthcare provider or pharmacist.

What is the most important information I should know about tacrolimus capsules?

Tacrolimus capsules can cause serious side effects, including:

Increased risk of cancer. People who take tacrolimus capsules have an increased risk of getting some kinds of cancer, including skin and lymph gland cancer (lymphoma).
Increased risk of infection . Tacrolimus capsules is a medicine that affects your immune system. Tacrolimus capsules can lower the ability of your immune system to fight infections. Serious infections can happen in people receiving tacrolimus capsules that can cause death. Call your healthcare provider right away if you have any symptoms of an infection, including:

  • fever
  • muscle aches
  • sweats or chills
  • warm, red, or painful areas on your skin
  • cough or flu-like symptoms

What is tacrolimus capsules?

  • Tacrolimus capsules is a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney, liver, or heart transplant.
  • Tacrolimus capsules are types of tacrolimus immediate-release drugs and they are not the same as tacrolimus extended-release tablets or tacrolimus extended-release capsules. Your healthcare provider should decide what medicine is right for you.

Who should not take tacrolimus Capsules?

Do not take tacrolimus Capsules if you are allergic to tacrolimus or any of the ingredients in tacrolimus capsules. See the end of this leaflet for a complete list of ingredients in tacrolimus capsules.

What should I tell my healthcare provider before taking tacrolimus Capsules?

Before you take tacrolimus capsules, tell your healthcare provider about all of your medical conditions, including if you:

  • plan to receive any live vaccines. People taking tacrolimus capsules should not receive live vaccines
  • have or have had liver, kidney, or heart problems.
  • are pregnant or plan to become pregnant. Tacrolimus capsules can harm your unborn baby.
  • If you are able to become pregnant, you should use effective birth control before and during treatment with tacrolimus capsules. Talk to your healthcare provider before starting treatment with tacrolimus capsules about birth control methods that may be right for you.
  • Males who have female partners who are able to become pregnant should also use effective birth control before and during treatment with tacrolimus capsules. Talk to your healthcare provider before starting treatment with tacrolimus capsules 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 tacrolimus capsules, USP. The purpose of this registry is to collect information about the health of you and your baby. To enroll in this voluntary registry, call 1-877-955-6877 or go to https://www.transplantpregnancyregistry.org/.
  • are breastfeeding or plan to breastfeed. Tacrolimus Capsules passes into your breast milk. You and your healthcare provider should decide if you will breastfeed while taking tacrolimus Capsules.

Tell your healthcare provider about all the medicines you take, and when you start a new medicine or stop taking a medicine, including prescription and over-the-counter medicines, vitamins, natural, herbal or nutritional supplements.

Especially tell your healthcare provider if you take:

  • sirolimus (RAPAMUNE)
  • 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
  • nelfinavir (VIRACEPT)
  • telaprevir (INCIVEK)
  • boceprevir
  • ritonavir (KALETRA, NORVIR, TECHNIVIE, VIEKIRA PAK, VIEKIRA XR)
  • letermovir (PREVYMIS)
  • ketoconazole
  • itraconazole (ONMEL, SPORANOX)
  • voriconazole (VFEND)
  • clarithromycin (BIAXIN, BIAXIN XL, PREVPAC)
  • rifampin (RIFADIN, RIFAMATE, RIFATER, RIMACTANE)
  • rifabutin (MYCOBUTIN)
  • amiodarone (NEXTERONE, PACERONE)

Ask your healthcare provider or pharmacist if you are not sure if you take any of the medicines listed above. Tacrolimus capsules may affect the way other medicines work, and other medicines may affect how tacrolimus capsules 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 tacrolimus capsules?

  • Take tacrolimus capsules exactly as your healthcare provider tells you to take it.
  • Your healthcare provider will tell you how much tacrolimus capsules to take and when to take it.
  • Your healthcare provider may change your tacrolimus capsules dose if needed. Do not stop taking or change your dose of tacrolimus capsules without talking to your healthcare provider.
  • Take tacrolimus capsules with or without food.
  • Take tacrolimus capsules the same way every day. For example, if you choose to take tacrolimus capsules with food, you should always take tacrolimus capsules with food.
  • Take tacrolimus capsules at the same time each day, 12 hours apart. For example, if you take your first dose at 7:00 a.m., you should take your second dose at 7:00 p.m.
  • Taking tacrolimus capsules at the same time each day helps to keep the amount of medicine in your body at a steady level.
  • Do not eat graperuit or drink grapefruit juice while taking tacrolimus capsules.
  • If you take too much tacrolimus capsules, call your healthcare provider or go to the nearest hospital emergency room right away.

Tacrolimus capsules:

Do not open or crush tacrolimus capsules.

What should I avoid while taking tacrolimus capsules?

While you take tacrolimus capsules you should not receive any live vaccines.
Limit the amount of time you spend in sunlight and avoid exposure to ultraviolet (UV) light, such as tanning machines. Wear protective clothing and use a sunscreen with a high sun protection factor (SPF).

What are the possible side effects of tacrolimus Capsules?

Tacrolimus capsules may cause serious side effects, including:

  • See “What is the most important information I should know about tacrolimus Capsules?”
  • problems from medicine errors. People who take tacrolimus capsules have sometimes been given the wrong type of tacrolimus product. Tacrolimus extended-release medicines are not the same as tacrolimus capsules and cannot be substituted for each other, unless specifically prescribed by your healthcare provider, who will send you to get blood tacrolimus levels at a lab. Check your tacrolimus capsules when you get a new prescription and before you take it to make sure you have received tacrolimus capsules.
  • Check with the pharmacist and call your healthcare provider if you think you were given the wrong medicine.
  • high blood sugar (diabetes). Your healthcare provider may do blood tests to check for diabetes while you take tacrolimus capsules. Call your healthcare provider right away if you have any symptoms of high blood sugar, including:
  • frequent urination
  • drowsiness
  • increased thirst or hunger
  • loss of appetite
  • blurred vision
  • fruity smell on your breath
  • confusion
  • nausea, vomiting, or stomach pain
  • kidney problems. Kidney problems are a serious and common side effect of tacrolimus capsules. Your healthcare provider may do blood tests to check your kidney function while you take tacrolimus capsules.
  • nervous system problems. Nervous system problems are a serious and common side effect of tacrolimus capsules. Call your healthcare provider right away if you get any of these symptoms while taking tacrolimus capsules. These could be signs of a serious nervous system problem:
  • headache
  • changes in behavior
  • confusion
  • coma
  • seizures
  • tremors
  • changes in your vision
  • numbness and tingling
  • high levels of potassium in your blood. Your healthcare provider may do blood tests to check your potassium level while you take tacrolimus capsules.
  • high blood pressure. High blood pressure is a serious and common side effect of tacrolimus capsules. Your healthcare provider will monitor your blood pressure while you take tacrolimus capsules and may prescribe blood pressure medicine for you, if needed. Your healthcare provider may instruct you to check your blood pressure at home.
  • changes in the electrical activity of your heart (QT prolongation).
  • heart problems (myocardial hypertrophy). Tell your healthcare provider right away if you get any of these symptoms of heart problems while taking tacrolimus capsules:
  • shortness of breath
  • feel lightheaded
  • chest pain
  • feel faint
  • severe low red blood cell count (anemia).
    The most common side effects of tacrolimus Capsules in people who have received a kidney, liver or heart transplant are:
  • infections in general, including cytomegalovirus (CMV) infection
  • swelling of the hands, legs, ankles, or feet
  • weakness
  • tremors(shaking of the body)
  • pain
  • constipation
  • high levels of fat in your blood
  • diarrhea
  • high levels of potassium in your blood
  • headache
  • low red blood cell count (anemia)
  • stomach pain
  • low white blood cell count
  • trouble sleeping
  • fever
  • nausea
  • numbness or tingling in your hands and feet
  • high blood sugar (diabetes)
  • inflammation of your airway (bronchitis)
  • low levels of magnesium in your blood
  • fluid around your heart
  • low levels of phosphate in your blood

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of tacrolimus capsules. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA­1088.

How should I store tacrolimus capsules?

tacrolimus capsules

  • Store Tacrolimus Capsules, USP at room temperature between 68°F to 77°F (20°C to 25°C).

Keep tacrolimus capsules and all medicines out of the reach of children.

General information about the safe and effective use of tacrolimus capsules.

  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use tacrolimus capsules for a condition for which it was not prescribed. Do not give tacrolimus capsules to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about tacrolimus capsules that is written for health professionals.
  • This Patient Information leaflet summarizes the most important information about tacrolimus capsules. If you would like more information, talk to your healthcare provider.

What are the ingredients in tacrolimus capsules?
Active ingredient: Tacrolimus USP

Inactive ingredients:

Tacrolimus capsules: croscarmellose sodium, hypromellose, lactose anhydrous, and magnesium stearate. The 0.5 mg capsule shell contains ferric oxide, gelatin, and titanium dioxide. The 1 mg capsule shell contains gelatin and titanium dioxide. The 5 mg capsule shell contains ferric oxide, gelatin, and titanium dioxide.

Manufactured by:
Panacea Biotec Pharma Limited, Malpur, Baddi,
Distt. Solan (H.P.) – 173205, India

All other trademarks and registered trademarks are the property of their respective owners.

Mfg.Lic.No: MB/05/203

Distributed by:
Bionpharma Inc., 600 Alexander Road, Princeton, NJ 08540, USA.

Item Code: PPIT082B

For more information, call Bionpharma, Inc. at 1-888-235-BION or 1-888-235-2466.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised Date: October 2020

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