Prograf Intravenous

Generic Name: tacrolimus (Intravenous route)

ta-KROE-li-mus

Intravenous route(Solution)

Increased susceptibility to infection and the possible development of lymphoma and other malignancies may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe, and they should have complete information requisite for the follow-up of the patient .

Commonly used brand name(s)

In the U.S.

• Prograf

Available Dosage Forms:

• Solution

Therapeutic Class: Immune Suppressant

Pharmacologic Class: Calcineurin Inhibitor

Uses For Prograf

Tacrolimus injection is used together with other medicines to prevent the body from rejecting a transplanted organ (e.g., kidney, liver, or heart). This medicine may be used with steroids, azathioprine (Imuran®), or mycophenolate mofetil (Cellcept®). Tacrolimus belongs to a group of medicines known as immunosuppressive agents.

When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ. Tacrolimus works by suppressing the immune system to prevent the white blood cells from trying to get rid of the transplanted organ.

Tacrolimus is a very strong medicine. It can cause side effects that can be very serious, such as kidney problems. It may also decrease the body's ability to fight infections. You and your doctor should talk about the benefits of this medicine as well as the risks of using it.

This medicine is to be given only by or under the direct supervision of a doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although not specifically included in the product labeling, tacrolimus is used in certain patients with the following medical conditions:

• Bone marrow transplant.


• Pancreas transplant.

Before Using Prograf

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of tacrolimus injection in children with liver transplants.

Appropriate studies have not been performed on the relationship of age to the effects of tacrolimus injection in children with kidney and heart transplants. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tacrolimus injection in the elderly. However, elderly patients are more likely to have kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving tacrolimus injection.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac


• Acemetacin


• Alclofenac


• Amikacin


• Amiloride


• Amiodarone


• Apazone


• Atazanavir


• Bacillus of Calmette and Guerin Vaccine, Live


• Basiliximab


• Benoxaprofen


• Bromfenac


• Bufexamac


• Carbamazepine


• Carprofen


• Caspofungin


• Cisplatin


• Clometacin


• Clonixin


• Colchicine


• Crizotinib


• Cyclosporine


• Darunavir


• Dexketoprofen


• Dibekacin


• Diclofenac


• Diflunisal


• Dipyrone


• Droxicam


• Efavirenz


• Etodolac


• Etofenamate


• Etravirine


• Felbinac


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Gentamicin


• Ibuprofen


• Indomethacin


• Indoprofen


• Infliximab


• Isoxicam


• Itraconazole


• Kanamycin


• Ketoprofen


• Ketorolac


• Lornoxicam


• Measles Virus Vaccine, Live


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Mumps Virus Vaccine, Live


• Nabumetone


• Naproxen


• Nefazodone


• Nelfinavir


• Neomycin


• Netilmicin


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Oxyphenbutazone


• Pazopanib


• Phenobarbital


• Phenylbutazone


• Phenytoin


• Pirazolac


• Piroxicam


• Pirprofen


• Poliovirus Vaccine, Live


• Posaconazole


• Propyphenazone


• Proquazone


• Rifabutin


• Rifampin


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Sirolimus


• Smallpox Vaccine


• Spironolactone


• St John's Wort


• Streptomycin


• Sulindac


• Suprofen


• Telaprevir


• Tenidap


• Tenofovir


• Tenoxicam


• Tiaprofenic Acid


• Tobramycin


• Tolmetin


• Triamterene


• Typhoid Vaccine


• Varicella Virus Vaccine


• Vemurafenib


• Voriconazole


• Yellow Fever Vaccine


• Zomepirac

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amprenavir


• Chloramphenicol


• Clarithromycin


• Clotrimazole


• Dalfopristin


• Danazol


• Diltiazem


• Erythromycin


• Fluconazole


• Fosphenytoin


• Ketoconazole


• Metoclopramide


• Metronidazole


• Mibefradil


• Nevirapine


• Nifedipine


• Quinupristin


• Rifapentine


• Ritonavir


• Saquinavir


• Schisandra sphenanthera


• Theophylline

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to polyoxyl 60 hydrogenated castor oil—Should not be used in patients with this condition.

• Diabetes or


• Hyperkalemia (high potassium in the blood) or


• Hypertension (high blood pressure) or


• Myocardial hypertrophy (heart is larger than normal), history of or


• Paresthesias (numbness or tingling in the hands, arms, legs, or feet), history of or


• Seizures (convulsions), history of or


• Tremors—Use with caution. May make these conditions worse.

• Infection, active (eg, bacteria, fungus, or virus)—May decrease your body's ability to fight an infection.

• Kidney disease or


• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Prograf

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

You will only receive this medicine for a few days. Then your doctor will switch you to the oral (by mouth) form of tacrolimus.

This medicine comes with a patient information insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions While Using Prograf

It is very important that your doctor check your progress while you are receiving this medicine to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Tacrolimus injection may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor or nurse right away if you have itching; hives; hoarseness; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive this medicine.

This medicine may increase your risk of getting skin cancer or cancer of the lymph system (lymphoma). Talk to your doctor if you have concerns about this risk.

This medicine may increase your risk of developing infections. Avoid being near people who are sick while you are receiving this medicine. Wash your hands often. Tell your doctor if you have any kind of infection before you start using this medicine. Tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

While you are being treated with tacrolimus, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Tacrolimus may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

This medicine may increase your risk for developing a rare and serious virus infection with the BK polyoma virus. This virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you are having more than one of these symptoms: bloody urine; a decreased frequency or amount of urine; increased thirst; loss of appetite; lower back or side pain; nausea; swelling of the face, fingers, or lower legs; trouble with breathing; unusual tiredness or weakness; vomiting; or weight gain.

This medicine may increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you are having more than one of these symptoms: vision changes, loss of coordination, clumsiness, confusion, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.

This medicine may cause serious nervous system problems. Tell your doctor right away if you have the following symptoms while using this medicine: blurred vision, dizziness, headache, mental changes, seizures, high blood pressure, or a fast heartbeat.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain; confusion; difficulty with breathing; irregular heartbeat; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs.

Tacrolimus may cause a condition called pure red cell aplasia (PRCA). This is a very rare condition where the body no longer makes red blood cells and the patient has severe anemia. Check with your doctor right away if you have a fever and sore throat; pale skin; unusual bleeding or bruising; or unusual tiredness or weakness.

Prograf Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Abdominal or stomach pain


• abnormal dreams


• agitation


• anxiety


• chills


• confusion


• convulsions (seizures)


• diarrhea


• dizziness


• fever and sore throat


• flu-like symptoms


• frequent urination


• headache


• infection


• itching


• loss of appetite


• loss of energy or weakness


• mental depression


• muscle trembling or twitching


• nausea


• nervousness


• pale skin


• seeing or hearing things that are not there


• shortness of breath


• skin rash


• swelling of the feet or lower legs


• tingling


• trembling and shaking of the hands


• trouble with sleeping


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting

Less common

• Blurred vision


• chest pain


• increased sensitivity to pain


• muscle cramps


• numbness or pain in the legs


• ringing in the ears


• sweating

Rare

• Enlarged heart


• flushing of the face or neck


• general feeling of discomfort or illness


• weight loss


• wheezing

Incidence not known

• Black, tarry stools


• blistering, peeling, or loosening of the skin


• bloating


• bloody urine


• blurred vision


• constipation


• cough


• drowsiness


• fainting


• fast, slow, or irregular heartbeat


• heartburn


• increased blood pressure


• increased thirst


• indigestion


• joint or muscle pain


• lightheadedness


• loss of appetite


• lower back or side pain


• nausea


• pinpoint red spots on skin


• pounding or rapid pulse


• red, irritated eyes


• red skin lesions, often with a purple center


• shortness of breath


• skin sores


• stomach pain


• troubled breathing


• ulcers or white spots in mouth or on lips


• weakness


• weight gain


• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach


• belching


• difficulty with moving


• lack or loss of strength


• muscle pain or stiffness


• unable to sleep

Less common

• Body aches or pain


• burning or stinging of the skin


• cracks in the skin


• crying


• delusions


• dementia


• depersonalization


• dysphoria


• euphoria


• excessive muscle tone


• feeling of constant movement of self or surroundings


• feeling that others are watching you or controlling your behavior


• feeling that others can hear your thoughts


• increased sensitivity of the skin to sunlight


• large, flat, blue or purplish patches in the skin


• loss of strength or energy


• muscle tension or tightness


• painful blisters on the trunk of the body


• painful cold sores or blisters on the lips, nose, eyes, or genitals


• paranoia


• quick to react or overreact emotionally


• rapidly changing moods


• redness or other discoloration of the skin


• restlessness


• scaly skin


• sensation of spinning


• severe mood or mental changes


• severe sunburn


• sleepiness or unusual drowsiness


• sore mouth or tongue


• sores on the skin


• swelling or inflammation of the mouth


• tender, swollen glands in the neck


• unusual behavior


• white patches in the mouth, tongue, or throat

Incidence not known

• Change in color vision


• decreased weight


• difficulty seeing at night


• feeling hot and cold


• hearing loss


• sudden sweating

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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