Tacrolimus Injection

IMPORTANT WARNING:

Tacrolimus injection should only be given under the supervision of a doctor who is experienced in treating people who have had an organ transplant and in prescribing medications that decrease the activity of the immune system.

Tacrolimus injection decreases the activity of your immune system. This may increase the risk that you will get a serious infection. If you experience any of the following symptoms, call your doctor immediately: sore throat; cough; fever; extreme tiredness; flu-like symptoms; warm, red, or painful skin; or other signs of infection.

When your immune system is not working normally, there may be a greater risk that you will develop cancer, especially lymphoma (a type of cancer that begins in the cells of the immune system). The longer you receive tacrolimus injection or other medications that decrease the activity of the immune system, and the higher your doses of these medications, the more this risk may increase. If you experience any of the following symptoms of lymphoma, call your doctor immediately: swollen lymph nodes in the neck, armpits, or groin; weight loss; fever; night sweats; excessive tiredness or weakness; cough; trouble breathing; chest pain; or pain, swelling, or fullness in the stomach area.

Talk to your doctor about the risks of receiving tacrolimus injection.

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.

Are there OTHER USES for this medicine?

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

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.

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. Be sure to mention any of the following: amphotericin B (Abelcet, Ambisome, Amphotec); antacids; certain antibiotics including aminoglycosides such as amikacin, gentamicin, neomycin (Neo-Fradin), streptomycin, and tobramycin (Tobi), and macrolides such as clarithromycin (Biaxin), erythromycin (EES, E-Mycin, Erythrocin), and troleandomycin (TAO) (not available in the US); antifungal medications such as clotrimazole (Lotrimin, Mycelex), fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral) and voriconazole (Vfend); bromocriptine (Parlodel); calcium channel blockers such as diltiazem (Cardizem), nicardipine (Cardene), nifedipine (Adalat, Procardia), and verapamil (Calan, Covera, Isoptin); caspofungin (Cancidas); chloramphenicol; cimetidine (Tagamet); cisapride (Propulsid) (not available in the U.S.); cisplatin (Platinol); danazol (Danocrine); certain diuretics ('water pills'); ganciclovir (Cytovene); hormonal contraceptives (birth control pills, patches, rings, inserts, or injections); HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir); lansoprazole (Prevacid); certain medications for seizures such as carbamazepine (Tegretol), phenobarbital, and phenytoin (Dilantin); methylprednisolone (Medrol); metoclopramide (Reglan); nefazodone; omeprazole (Prilosec); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); and sirolimus (Rapamune). Your doctor may need to change the doses of your medications or monitor you more carefully for side effects. Many other medications may interact with tacrolimus, so tell your doctor about all the medications you are taking, even those that do not appear on this list.

• 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.

• tell your doctor and pharmacist what herbal products you are taking, especially St. John's wort.

• 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.

• 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 (http://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.