Prograf (Tacrolimus) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 3, 2012

Prograf

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Introduction to high blood pressure and kidney disease

The kidneys play a key role in keeping a person's blood pressure in a healthy range, and blood pressure, in turn, can affect the health of the kidneys. High blood pressure, also called hypertension, can damage the kidneys and lead to chronic kidney disease (CKD).

What is high blood pressure?

Blood pressure measures the force of blood against the walls of the blood vessels. Extra fluid in the body increases the amount of fluid in blood vessels and makes blood pressure higher. Narrow, stiff, or clogged blood vessels also raise blood pressure.

Hypertension can result from too much fluid in normal blood vessels or from normal fluid in narrow, stiff, or clogged blood vessels.

People with high blood pressure should see their doctor regularly.

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PROGRAF®
(tacrolimus)

WARNING

MALIGNANCIES AND SERIOUS INFECTIONS

Increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression [see WARNINGS AND PRECAUTIONS].
Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections [see WARNINGS AND PRECAUTIONS].
Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Prograf. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

Prograf is available for oral administration as capsules (tacrolimus capsules) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus. Inactive ingredients include lactose monohydrate, hypromellose, croscarmellose sodium, and magnesium stearate. The 0.5 mg capsule shell contains gelatin, titanium dioxide and ferric oxide, the 1 mg capsule shell contains gelatin and titanium dioxide, and the 5 mg capsule shell contains gelatin, titanium dioxide and ferric oxide. Prograf is also available as a sterile solution (tacrolimus injection) containing the equivalent of 5 mg anhydrous tacrolimus in 1 mL for administration by intravenous infusion only. Each mL contains polyoxyl 60 hydrogenated castor oil (HCO-60), 200 mg, and dehydrated alcohol, USP, 80.0% v/v. Prograf injection must be diluted with 0.9% Sodium Chloride Injection or 5% Dextrose Injection before use.

Tacrolimus, previously known as FK506, is the active ingredient in Prograf. Tacrolimus is a macrolide immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S- [3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]

oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate.

The chemical structure of tacrolimus is:

PROGRAF® (tacrolimus) Structural Formula Illustration

Tacrolimus has an empirical formula of C₄₄H₆₉NO₁₂•H₂O and a formula weight of 822.03. Tacrolimus appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol, and very soluble in methanol and chloroform.

What are the possible side effects of tacrolimus (Prograf)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

pain in the lower back or side;
urinating less than usual or not at all;
painful urination, blood in your urine;
problems with your vision, speech, or coordination;
tremor (shaking), headache, confusion, numbness or tingly feeling;
pale...

Read All Potential Side Effects and See Pictures of Prograf »

What are the precautions when taking tacrolimus (Prograf)?

Before taking tacrolimus, tell your doctor or pharmacist if you are allergic to it; or to other macrolide medications (e.g., sirolimus, erythromycin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: mineral imbalances (e.g., high potassium), kidney disease, any recent/current infections, cancer, liver disease, high blood pressure, diabetes.

Tacrolimus may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe...

Read All Potential Precautions of Prograf »

Last reviewed on RxList: 8/1/2011
This monograph has been modified to include the generic and brand name in many instances.