Tacrolimus Injection

FK 506

WHY is this medicine prescribed?

Tacrolimus injection is used along with other medications to prevent rejection (attack of the transplanted organ by the transplant recipient's immune system) in people who have received kidney, liver, or heart transplants. Tacrolimus injection should only be used by people who are unable to take tacrolimus by mouth. Tacrolimus injection is in a class of medications called immunosupressants. It works by decreasing the activity of the immune system to prevent it from attacking the transplanted organ.

HOW should this medicine be used?

Tacrolimus injection comes as a solution (liquid) to be injected intravenously (into a vein) by a doctor or nurse in a hospital or medical facility. It is usually given as an ongoing infusion, beginning no sooner than 6 hours after transplant surgery and continuing until tacrolimus can be taken by mouth.

A doctor or nurse will watch you closely during the first 30 minutes of your treatment and then will monitor you often so that you can be treated quickly if you have a serious allergic reaction.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before receiving tacrolimus injection,

• tell your doctor and pharmacist if you are allergic to tacrolimus, any other medications, polyoxyl 60 hydrogenated castor oil (HCO-60) or other medications that contain castor oil. Ask your doctor or pharmacist if you do not know if a medication you are allergic to contains castor oil.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take while receiving tacrolimus injection. Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
• tell your doctor if you are receiving or have recently stopped receiving cyclosporine (Gengraf, Neoral, Sandimmune). If you were receiving cyclosporine, your doctor will probably not start to give you tacrolimus injection until 24 hours after you received your last dose of cyclosporine. If you stop receiving tacrolimus injection, your doctor will also tell you to wait 24 hours before starting to take cyclosporine.
• the following nonprescription or herbal products may interact with tacrolimus: St. John's wort; cimetidine (Tagamet); omeprazole (Prilosec); magnesium and aluminum hydroxide antacids. Be sure to let your doctor and pharmacist know that you are taking these medications before you start receiving tacrolimus. Do not start these medications while receiving tacrolimus without discussing with your healthcare provider.
• tell your doctor if you have or have ever had heart, kidney, or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving tacrolimus injection, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving tacrolimus injection.
• you should know that receiving tacrolimus injection may increase the risk that you will develop skin cancer. Protect yourself from skin cancer by avoiding unnecessary or prolonged exposure to sunlight or ultraviolet light (tanning beds) and wearing protective clothing, sunglasses, and sunscreen with a high skin protection factor (SPF).
• you should know that tacrolimus injection may cause high blood pressure. Your doctor will monitor your blood pressure carefully, and may prescribe medication to treat high blood pressure if it develops.
• you should know that there is a risk that you will develop diabetes during your treatment with tacrolimus injection. African American and Hispanic patients who have had kidney transplants have an especially high risk of developing diabetes during their treatment with tacrolimus injection. Tell your doctor if you or anyone in your family has or has ever had diabetes. If you experience any of the following symptoms, call your doctor immediately: excessive thirst; excessive hunger; frequent urination; blurred vision or confusion.
• do not have any vaccinations without talking to your doctor.

What SPECIAL DIETARY instructions should I follow?

Avoid eating grapefruit or drinking grapefruit juice while receiving tacrolimus injection.

What SIDE EFFECTS can this medicine cause?

Tacrolimus injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• uncontrollable shaking of a part of the body
• diarrhea
• constipation
• nausea
• vomiting
• heartburn
• stomach pain
• loss of appetite
• difficulty falling asleep or staying asleep
• dizziness
• weakness
• back or joint pain
• burning, numbness, pain or tingling in the hands or feet

Some side effects can be serious. If you experience any of the following symptoms, or those mentioned in the IMPORTANT WARNING section, call your doctor immediately:

• hives
• rash
• itching
• difficulty breathing or swallowing
• decreased urination
• pain or burning on urination
• swelling of the arms, hands, feet, ankles or lower legs
• weight gain
• unusual bleeding or bruising
• seizures
• coma (loss of consciousness for a period of time)

Tacrolimus injection may cause other side effects. Call your doctor if you have any unusual problems while you are receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• hives
• sleepiness

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to tacrolimus injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: February 15, 2018.