Tacrolimus (Page 11 of 12)

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, deliriums, or tremors [see Warnings and Precautions ( 5.8)].

17.7 Hyperkalemia

Inform patients that Tacrolimus 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 ( 5.9)].

17.8 Hypertension

Inform patients that tacrolimus can cause high blood pressure which may require treatment with anti-hypertensive therapy [see Warnings and Precautions ( 5.10)].

17.9 Drug Interactions

Instruct patients to tell their health care 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 [see Drug Interactions ( 7)].

17.10 Pregnant Women and Nursing Mothers

Instruct patients to tell their healthcare provider if they plan to become pregnant or breast-feed their infant [see USe in Specific Populations ( 8.1, 8.3)]

17.11 Immunizations

Inform patients that tacrolimus can interfere with the usual response to immunizations and that they should avoid live vaccines [see Warnings and Precautions ( 5.16)].

Rx Only

Product of USA

Manufactured By:
Belcher Pharmaceuticals, LLC
Largo, FL-33777

Marketed By:
Belcher Pharmaceuticals, LLC
Largo, FL-33777

Revised: January 2020 R-2001

PATIENT INFORMATION

Tacrolimus capsules, USP

Read this Patient Information before you start taking TACROLIMUS and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about TACROLIMUS?

Tacrolimus can cause serious side effects, including:

1. Increased risk of cancer. People who take Tacrolimus have an increased risk of getting some kinds of cancer, including skin and lymph gland cancer (lymphoma).
2. Increased risk of infection. TACROLIMUS is a medicine that affects your immune system. Tacrolimus can lower the ability of your immune system to fight infections. Serious infections can happen in people receiving Tacrolimus that can cause death. Call your doctor right away if you have symptoms of an infection such as:
• fever
• sweats or chills
• cough or flu-like symptoms
• muscle aches
• warm, red, or painful areas on your skin

What is TACROLIMUS?
TACROLIMUS is a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney, liver, or heart transplant and TACROLIMUS is not for use with medicines called cyclosporines (Gengraf®, Neoral®, and Sandimune®).
TACROLIMUS is not for use with a medicine called sirolimus (Rapamune®) in people who have had a liver or heart transplants.
It is not known if TACROLIMUS is safe and effective when used with sirolimus in people who have had kidney transplants.
It is not known if TACROLIMUS is safe and effective in children who have had a kidney or heart transplants.

Who Should Not Take TACROLIMUS?

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

What should I tell my doctor before taking TACROLIMUS?

Before you take TACROLIMUS, tell your doctor if you:

•plan to receive any live vaccines

•have or have had liver, kidney or heart problems

•are pregnant or plan to become pregnant. TACROLIMUS may harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.

•Are breastfeeding or plan to breastfeed. TACROLIMUS can pass into your breast milk. You and your doctor should decide if you will take TACROLIMUS or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take:

•cyclosporine (Gengraf ® , Neoral ® , and Sandimune ®)

•sirolimus (Rapamune ®)

•nelfinavir (Viracept ®)

•telaprevir (Incivek™)

•boceprevir (Victrelis™)

•amiodarone (Cordarone™, Nexterone™, Pacerone™)

Ask your doctor or pharmacist if you are not sure if you take any of the medicines listed above.

TACROLIMUS may affect the way other medicines work, and other medicines may affect how TACROLIMUS works.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I take TACROLIMUS?

•Take TACROLIMUS exactly as your doctor tells you to take it.

•Your doctor will tell you how many TACROLIMUS to take and when to take them.

•Your doctor may change your TACROLIMUS capsules dose if needed. Do not stop taking or change your dose of TACROLIMUS without talking to your doctor.

•Take TACROLIMUS with or without food.

•Take TACROLIMUS capsules the same way every day. For example, if you choose to take TACROLIMUS with food, you should always take TACROLIMUS capsules with food.

•Take TACROLIMUS 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 at the same time each day helps to keep enough medicine in your body to give your transplanted organ the around-the-clock medicine it needs.

Do not eat grapefruit or drink grapefruit juice while taking TACROLIMUS.

•If you take too much TACROLIMUS, call your doctor or go to the nearest hospital emergency room right away.

What should I avoid while taking TACROLIMUS ?

•While you take TACROLIMUS you should not receive any live vaccines such as:

∘flu vaccine through your nose

∘measles

∘mumps

∘rubella

∘polio by mouth

∘BCG (TB vaccine)

∘yellow fever

∘chicken pox (varicella)

∘typhoid

•Avoid exposure to sunlight and UV light such as tanning machines. Wear protective clothing and use a sunscreen.

What are the possible side effects of TACROLIMUS

TACROLIMUS may cause serious side effects, including:

See “What is the most important information I should know about TACROLIMUS ?”

high blood sugar (diabetes). Your doctor may do certain tests to check for diabetes while you take TACROLIMUS. Call your doctor right away if you have:

∘frequent urination

∘increased thirst or hunger

∘blurred vision∘confusion

∘drowsiness

∘loss of appetite

∘fruity smell on your breath

∘nausea, vomiting, or stomach pain

kidney problems. Your doctor may do certain tests to check your kidney function while you take TACROLIMUS.

nervous system problems. Call your doctor right away if you get any of these symptoms while taking TACROLIMUS. These could be signs of a serious nervous system problem:

∘confusion

∘coma

∘muscle tremors

∘numbness and tingling

∘headache

∘seizures

∘vision changes

high levels of potassium in your blood. Your doctor may do certain tests to check your potassium level while you take TACROLIMUS.

high blood pressure. Your doctor will monitor your blood pressure while you take TACROLIMUS.

heart problems (myocardial hypertrophy). Tell your doctor right away if you get any of these symptoms of heart problems while taking TACROLIMUS:

∘shortness of breath

∘chest pain

∘feel lightheaded

∘feel faint

The most common side effects of TACROLIMUS in people receiving kidney transplant are:

•infection

•tremors (shaking of the body)

•high blood pressure

•kidney problems

•constipation

•diarrhea

•headache

•stomach pain

•trouble sleeping

•nausea

•low levels of phosphate in your blood

•swelling of the hands, ankles, or legs

•weakness

•pain

•high levels of fat in your blood

•high levels of potassium in your blood

•low red blood cell count (anemia)

The most common side effects of TACROLIMUS in people receiving liver transplants are:

•shaking of the body tremors

•headache

•diarrhea

•high blood pressure

•nausea

•kidney problems

•stomach pain

•trouble sleeping

•numbness or tingling in your hands or feet

•anemia

•pain

•fever

•weakness

•high levels of potassium in the blood

•low levels of magnesium in the blood

The most common side effects of TACROLIMUS for heart transplant patients are:

•kidney problems

•high blood pressure

Tell your doctor 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. For more information, ask your doctor 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 TACROLIMUS?

•Store tacrolimus at 59°F to 86°F (15°C to 30°C).

•Safely throw away medicine that is out of date or no longer needed.

Keep TACROLIMUS and all medicines out of reach of children.

General information about the safe and effective use of TACROLIMUS

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TACROLIMUS for a condition for which it was not prescribed. Do not give TACROLIMUS to other people, even if they have the same symptoms that you have. It may harm them.

How Does TACROLIMUS Protect My New Organ?

The body’s immune system protects the body against anything that it does not recognize as part of the body. For example, when the immune system detects a virus or bacteria it tries to get rid of it to prevent infection. When a person has a liver, kidney, or heart transplant, the immune system does not recognize the new organ as a part of the body and tries to get rid of it, too. This is called “rejection”. TACROLIMUS protects your new organ by slowing down the body’s immune system.

This Patient Information leaflet summarizes the most important information about TACROLIMUS. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about TACROLIMUS that is written for health professionals. For more information,go to www.belcherpharma.com/us or call 1-727-471-0850.

What are the ingredients in TACROLIMUS?

Active ingredient: TACROLIMUS

Inactive ingredients: Anhydrous Lactose, hypromellose, croscarmellose sodium, magnesium stearate, gelatin, titanium dioxide and ferric oxide.

Non-volatile components of the ink are Shellac Glaze, Iron Oxide Red, and Simethicone USP.

Trademarks are the property of their respective owners.

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

Manufactured By:
Belcher Pharmaceuticals, LLC
Largo, FL-33777

Markated By:
Belcher Pharmaceuticals, LLC
Largo, FL-33777

Revised: January 2020

L54I R-2001

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