Blog United Kingdom: Tacrolimus Intravenous

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 tacrolimus

Tacrolimus injection is used together with other medicines to prevent the body from rejecting a transplanted organ (e.g., kidney, liver, or heart). tacrolimus 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 tacrolimus as well as the risks of using it.

tacrolimus 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 tacrolimus

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 tacrolimus, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to tacrolimus 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 tacrolimus, 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 tacrolimus 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 tacrolimus 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 tacrolimus 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.

Proper Use of tacrolimus

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

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

tacrolimus 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 tacrolimus

It is very important that your doctor check your progress while you are receiving tacrolimus to make sure that tacrolimus 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 tacrolimus.

tacrolimus 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.

tacrolimus may increase your risk of developing infections. Avoid being near people who are sick while you are receiving tacrolimus. Wash your hands often. Tell your doctor if you have any kind of infection before you start using tacrolimus. 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.

tacrolimus 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.

tacrolimus 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.

tacrolimus may cause serious nervous system problems. Tell your doctor right away if you have the following symptoms while using tacrolimus: 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 tacrolimus. 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.

tacrolimus 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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Blog United Kingdom

Friday, May 18, 2012

Tacrolimus Intravenous