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FULL PRESCRIBING INFORMATION

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IMPORTANT SAFETY INFORMATION

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INDICATION AND IMPORTANT SAFETY INFORMATION FOR PROGRAF

PROGRAF® (tacrolimus) injection

PROGRAF® (tacrolimus) capsules

PROGRAF® Granules (tacrolimus for oral suspension)


INDICATION


PROGRAF is indicated for the prophylaxis of organ rejection, in adult and pediatric patients receiving allogeneic kidney transplant, liver transplants, and heart transplant, in combination with other immunosuppressants.

IMPORTANT SAFETY INFORMATION

WARNING: MALIGNANCIES AND SERIOUS INFECTIONS
See full prescribing information for complete boxed warning.

Increased risk for developing serious infections and malignancies with PROGRAF or other immunosuppressants that may lead to hospitalization or death.

CONTRAINDICATIONS

PROGRAF is contraindicated in patients with a hypersensitivity to tacrolimus. PROGRAF injection is contraindicated in patients with a hypersensitivity to HCO-60 (polyoxyl 60 hydrogenated castor oil).

WARNINGS AND PRECAUTIONS
Lymphoma and Other Malignancies

Patients receiving immunosuppressants, including PROGRAF, are at increased risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent. As usual for patients with increased risk for skin cancer, examine patients for skin changes: exposure to sunlight and UV light should be limited by wearing protective clothing and using a broad spectrum sunscreen with a high protection factor. Post-transplant lymphoproliferative disorder (PTLD) has been reported in immunosuppressed organ transplant recipients. The risk of PTLD appears greatest in those individuals who are Epstein-Barr Virus (EBV) seronegative, a population that includes many young children. Monitor EBV serology during treatment.

Serious Infections

Patients receiving immunosuppressants, including PROGRAF, are at increased risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections. These infections may lead to serious, including fatal, outcomes. Serious viral infections reported include:

  • Polyoma virus-associated nephropathy (PVAN), mostly due to BK virus infection
  • JC virus-associated progressive multifocal leukoencephalopathy (PML)
  • Cytomegalovirus infections: CMV seronegative transplant patients who receive an organ from a CMV seropositive donor disease are at higher risk of developing CMV viremia and CMV disease.

Monitor for the development of infection and adjust the immunosuppressive regimen to balance the risk of rejection with the risk of infection.

Not Interchangeable With Extended-Release Tacrolimus Products - Medication Errors

Medication errors, including substitution and dispensing errors, between tacrolimus immediate-release products and tacrolimus extended-release products were reported outside the U.S. This led to serious adverse reactions, including graft rejection, or other adverse reactions due to under-or over-exposure to tacrolimus. PROGRAF is not interchangeable or substitutable for tacrolimus extended-release products. Changes between tacrolimus immediate-release and extended-release dosage forms must occur under physician supervision. Instruct patients and caregivers to recognize the appearance of PROGRAF dosage forms and to confirm with the healthcare provider if a different product is dispensed.

New Onset Diabetes After Transplant

PROGRAF was shown to cause new onset diabetes mellitus in clinical trials of kidney, liver, and heart transplantation. New onset diabetes after transplantation may be reversible in some patients. African-American and Hispanic kidney transplant patients are at an increased risk. Blood glucose concentrations should be monitored closely in patients using PROGRAF.

Nephrotoxicity

PROGRAF, like other calcineurin-inhibitors, can cause acute or chronic nephrotoxicity. Nephrotoxicity was reported in clinical trials. Consider dosage reduction in patients with elevated serum creatinine and tacrolimus whole blood trough concentrations greater than the recommended range. The risk for nephrotoxicity may increase when PROGRAF is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). Monitor renal function and consider dosage reduction if nephrotoxicity occurs.

Neurotoxicity

PROGRAF may cause a spectrum of neurotoxicities. The most severe neurotoxicities include posterior reversible encephalopathy syndrome (PRES), delirium, seizure and coma. Others include tremors, paresthesias, headache, mental status changes, and changes in motor and sensory functions. As symptoms may be associated with tacrolimus whole blood trough concentrations at or above the recommended range, monitor for neurologic symptoms and consider dosage reduction or discontinuation of PROGRAF if neurotoxicity occurs.

Hyperkalemia

Hyperkalemia has been reported with PROGRAF use. Serum potassium levels should be monitored. Careful consideration should be given prior to use of other agents also associated with hyperkalemia. Monitor serum potassium levels periodically during treatment.

Hypertension

Hypertension is a common adverse effect of PROGRAF therapy and may require antihypertensive therapy. Careful consideration should be given prior to use of antihypertensive agents associated with hyperkalemia (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin receptor blockers). Calcium-channel blocking agents may increase tacrolimus blood concentrations and therefore require dosage reduction of PROGRAF.

Anaphylactic Reactions

Anaphylactic reactions have occurred with injectables containing castor oil derivatives, including IV PROGRAF. PROGRAF injection should be reserved for patients who are unable to take PROGRAF orally. Monitor patients for anaphylaxis when using the intravenous route of administration.

Not Recommended for Use with Sirolimus

PROGRAF is not recommended for use with sirolimus:

  • The use of sirolimus with PROGRAF in studies of de novo liver transplant patients was associated with an excess mortality, graft loss, and hepatic artery thrombosis, and is not recommended.
  • The use of sirolimus (2 mg per day) with PROGRAF in heart transplant patients in a U.S. study was associated with increased risk of renal function impairment, wound healing complications, and insulin-dependent post-transplant diabetes mellitus, and is not recommended.

Interactions with CYP3A Inhibitors and Inducers

When coadministering PROGRAF with strong CYP3A4-inhibitors (e.g., telaprevir, boceprevir, ritonavir, ketoconazole, itraconazole, voriconazole, clarithromycin) and strong inducers (e.g., rifampin, rifabutin) adjustments in the dosing regimen of PROGRAF and subsequent frequent monitoring of tacrolimus whole blood trough concentrations and tacrolimus-associated adverse reactions are recommended.

QT Prolongation

PROGRAF may prolong the QT/QTc interval and may cause Torsade de Pointes. Avoid PROGRAF in patients with congenital long QT prolongation syndrome. In patients with congestive heart failure, bradyarrhythmias, those taking certain antiarrhythmic medications or other medicinal products that lead to QT prolongation, and those with electrolyte disturbances such as hypokalemia, hypocalcemia, or hypomagnesemia, consider obtaining electrocardiograms and monitoring electrolytes (magnesium, potassium, calcium) periodically during treatment. When coadministering PROGRAF with other substrates and/or inhibitors of CYP3A4 that also have the potential to prolong the QT interval, a reduction in PROGRAF dose, frequent monitoring of tacrolimus whole blood concentrations, and monitoring for QT prolongation is recommended. Use of PROGRAF with amiodarone has been reported to result in increased tacrolimus whole blood concentrations with or without concurrent QT prolongation.

Myocardial hypertrophy

Myocardial hypertrophy has been reported in infants, children, and adults, particularly those with high tacrolimus trough concentrations. This condition appears reversible in most cases following dose reduction or discontinuance of therapy. In patients who develop renal failure or clinical manifestations of ventricular dysfunction while receiving PROGRAF therapy, echocardiographic evaluation should be considered. If myocardial hypertrophy is diagnosed, dosage reduction or discontinuation of PROGRAF should be considered.

Immunizations

Whenever possible, administer the complete complement of vaccines before transplantation and treatment with PROGRAF. The use of live vaccines should be avoided during treatment with tacrolimus; examples include (not limited to) the following: intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines. Inactivated vaccines noted to be safe for administration after transplantation may not be sufficiently immunogenic during treatment with PROGRAF.

Pure Red Cell Aplasia

Cases of pure red cell aplasia (PRCA) have been reported in patients treated with tacrolimus. If PRCA is diagnosed, discontinuation of PROGRAF should be considered.

ADVERSE REACTIONS

Kidney Transplant: The most common adverse reactions (≥ 30%) were infection, tremor, hypertension, abnormal renal function, constipation, diarrhea, headache, abdominal pain, insomnia, nausea, hypomagnesemia, urinary tract infection, hypophosphatemia, peripheral edema, asthenia, pain, hyperlipidemia, hyperkalemia, and anemia. Based on reported adverse reactions terms related to decreased renal function, nephrotoxicity was reported in approximately 52% of kidney transplantation patients.
Liver Transplant: The most common adverse reactions (≥ 40%) were tremor, headache, diarrhea, hypertension, nausea, abnormal renal function, abdominal pain, insomnia, paresthesia, anemia, pain, fever, asthenia, hyperkalemia, hypomagnesemia, and hyperglycemia. Based on reported adverse reactions terms related to decreased renal function, nephrotoxicity was reported in approximately 40% and 36% of liver transplantation patients receiving PROGRAF in the U.S. and European randomized trials.
Heart Transplant: The most common adverse reactions (≥ 15%) were abnormal renal function, hypertension, diabetes mellitus, CMV infection, tremor, hyperglycemia, leukopenia, infection, anemia, bronchitis, pericardial effusion, urinary tract infection and hyperlipemia. Based on reported adverse reaction terms related to decreased renal function, nephrotoxicity was reported in approximately 59% of heart transplantation patients in the European trial.

SPECIFIC POPULATIONS

Pregnancy:

Risk Summary
Tacrolimus can cause fetal harm when administered to a pregnant woman. Data from postmarketing surveillance and Transplantation Pregnancy Registry International (TPRI) suggest that infants exposed to tacrolimus in utero are at a risk of prematurity, birth defects/congenital anomalies, low birth weight, and fetal distress. Advise pregnant women of the potential risk to the fetus. PROGRAF may increase hyperglycemia in pregnant women with diabetes (including gestational diabetes). Monitor maternal blood glucose levels regularly. PROGRAF may exacerbate hypertension in pregnant women and increase pre-eclampsia. Monitor and control blood pressure. Renal dysfunction, transient neonatal hyperkalemia and low birth weight have been reported at the time of delivery in infants of mothers taking PROGRAF. There is an increased risk for premature delivery (< 37 weeks) following transplantation and maternal exposure to PROGRAF.

Lactation:

Risk Summary
Controlled lactation studies have not been conducted in humans; however, tacrolimus has been reported to be present in human milk. The effects of tacrolimus on the breastfed infant, or on milk production, have not been assessed.

Females and Males of Reproductive Potential: PROGRAF can cause fetal harm when administered to pregnant women. Advise female and male patients of reproductive potential to speak to their healthcare provider on family planning options including appropriate contraception prior to starting treatment with PROGRAF.

Pediatric Use: The safety and effectiveness of PROGRAF have been established in pediatric liver, kidney, and heart transplant patients.

Hepatic/Renal Impaired Patients: Patients should be administered the lowest recommended starting dose, with close monitoring of tacrolimus trough concentrations and renal function, and appropriate dosage adjustments.

Race or Ethnicity: African-American patients may need to be titrated to higher dosages to attain comparable trough concentrations compared to Caucasian patients.

PLEASE CLICK HERE FOR FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNING, FOR PROGRAF.

 

 


INDICATION AND IMPORTANT SAFETY INFORMATION FOR ASTAGRAF XL

ASTAGRAF XL® (tacrolimus extended-release capsules)


Indication:

ASTAGRAF XL is indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants in adult and pediatric patients who can swallow capsules intact.

IMPORTANT SAFETY INFORMATION

WARNING: MALIGNANCIES AND SERIOUS INFECTIONS IN TRANSPLANT PATIENTS; and INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS

  • Increased risk for developing serious infections and malignancies with ASTAGRAF XL or other immunosuppressants that may lead to hospitalization or death.
  • Increased mortality in female liver transplant patients with ASTAGRAF XL. ASTAGRAF XL is not approved for use in liver transplantation.

CONTRAINDICATIONS

ASTAGRAF XL is contraindicated in patients with known hypersensitivity to tacrolimus.

WARNINGS AND PRECAUTIONS

Lymphoma and Other Malignancies

Immunosuppressants, including ASTAGRAF XL, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent. Examine patients for skin changes and advise to avoid or limit exposure to sunlight and UV light by wearing protective clothing and using a broad spectrum sunscreen with a high protection factor.

Post-transplant lymphoproliferative disorder (PTLD), associated with Epstein-Barr Virus (EBV), has been reported in immunosuppressed organ transplant patients. The risk of PTLD appears greatest in patients who are EBV seronegative, a population which includes many young children. Monitor EBV serology during treatment.

Serious Infections

Immunosuppressants, including ASTAGRAF XL, increase the risk of developing bacterial, viral, fungal and protozoal infections, including opportunistic infections. These infections may lead to serious, including fatal, outcomes. Serious viral infections reported include:

  • Polyomavirus-associated nephropathy (especially due to BK virus infection)
  • JC virus-associated progressive multifocal leukoencephalopathy (PML)
  • Cytomegalovirus (CMV) infections: CMV seronegative transplant patients who receive an organ from a CMV seropositive donor are at highest risk of CMV viremia and CMV disease.

Monitor for the development of infection and adjust the immunosuppressive regimen to balance the risk of rejection with the risk of infection.

Increased Mortality in Female Liver Transplant Patients

In a liver transplant study, mortality at 12 months was higher among female patients treated with ASTAGRAF XL compared to female patients treated with tacrolimus immediate-release product. ASTAGRAF XL is not approved for the prophylaxis of organ rejection in patients who received a liver transplant.

Not Interchangeable with Other Tacrolimus Products – Medication Errors

Medication errors, including substitution and dispensing errors, between tacrolimus immediate-release products and ASTAGRAF XL (tacrolimus extended-release capsules) were reported outside the U.S. This led to serious adverse reactions, including graft rejection, or other adverse reactions due to under- or over-exposure to tacrolimus. ASTAGRAF XL is not interchangeable or substitutable for tacrolimus extended-release tablets, tacrolimus immediate-release capsules or tacrolimus for oral suspension. Changes between tacrolimus immediate-release and extended-release dosage forms must occur under physician supervision. Instruct patients and caregivers to recognize the appearance of ASTAGRAF XL capsules and to confirm with the healthcare provider if a different product is dispensed or if dosing instructions have changed.

New Onset Diabetes After Transplant

ASTAGRAF XL caused new onset diabetes after transplant (NODAT) in kidney transplant patients, which may be reversible in some patients. African-American and Hispanic kidney transplant patients are at an increased risk. Monitor blood glucose concentrations and treat appropriately.

Nephrotoxicity due to ASTAGRAF XL and Drug Interactions

ASTAGRAF XL, like other calcineurin-inhibitors, can cause acute or chronic nephrotoxicity. Consider dosage reduction in patients with elevated serum creatinine and tacrolimus whole blood trough concentrations greater than the recommended range.

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). Monitor renal function and consider dosage reduction if nephrotoxicity occurs.

Neurotoxicity

ASTAGRAF XL may cause a spectrum of neurotoxicities. The most severe neurotoxicities include posterior reversible encephalopathy syndrome (PRES), delirium, seizure and coma; others include tremors, paresthesias, headache, mental status changes, and changes in motor and sensory functions. As symptoms may be associated with tacrolimus whole blood trough concentrations at or above the recommended range, monitor for neurologic symptoms and consider dosage reduction or discontinuation of ASTAGRAF XL if neurotoxicity occurs.

Hyperkalemia

Mild to severe hyperkalemia, which may require treatment, has been reported with tacrolimus including ASTAGRAF XL. Concomitant use of agents associated with hyperkalemia (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin receptor blockers) may increase the risk for hyperkalemia. Monitor serum potassium levels periodically during treatment.

Hypertension

Hypertension is a common adverse effect of ASTAGRAF XL and may require antihypertensive therapy. Some antihypertensive drugs can increase the risk for hyperkalemia. Calcium-channel blocking agents may increase tacrolimus blood concentrations and require dosage reduction of ASTAGRAF XL.

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors

The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. In contrast, the concomitant use of strong CYP3A inhibitors may decrease the metabolism of tacrolimus, leading to higher whole blood trough concentrations and greater risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation). Therefore, adjust ASTAGRAF XL dose and monitor tacrolimus whole blood trough concentrations when coadministering ASTAGRAF XL with strong CYP3A4 inhibitors (e.g., including, but not limited to, telaprevir, boceprevir, ritonavir, ketoconazole, itraconazole, voriconazole, clarithromycin) or strong CYP3A inducers (e.g., including, but not limited to, rifampin, rifabutin).

QT Prolongation

ASTAGRAF XL may prolong the QT/QTc interval and may cause Torsade de Pointes. Avoid ASTAGRAF XL in patients with congenital long QT syndrome. Consider obtaining electrocardiograms and monitoring electrolytes (magnesium, potassium, calcium) periodically during treatment in patients with congestive heart failure, bradyarrhythmias, those taking certain antiarrhythmic medications or other products that lead to QT prolongation, and those with electrolyte disturbances such as hypokalemia, hypocalcemia, or hypomagnesemia.

When coadministering ASTAGRAF XL with other substrates and/or inhibitors of CYP3A, especially those that also have the potential to prolong the QT interval, a reduction in ASTAGRAF XL dosage, monitoring of tacrolimus whole blood concentrations, and monitoring for QT prolongation is recommended.

Immunizations

Whenever possible, administer the complete complement of vaccines before transplantation and treatment with ASTAGRAF XL. Avoid the use of live attenuated vaccines during treatment with ASTAGRAF XL (e.g., intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines). Inactivated vaccines noted to be safe for administration after transplantation may not be sufficiently immunogenic during treatment with ASTAGRAF XL.

Pure Red Cell Aplasia

Cases of pure red cell aplasia (PRCA) have been reported in patients treated with tacrolimus. All of these patients reported risk factors for PRCA such as parvovirus B19 infection, underlying disease, or concomitant medications associated with PRCA. A mechanism for tacrolimus-induced PRCA has not been elucidated. If PRCA is diagnosed, consider discontinuation of ASTAGRAF XL.

ADVERSE REACTIONS

Kidney transplant patients through one year post-transplant: The most common adverse reactions (≥ 30%) were diarrhea (45%), constipation (40%), nausea (36%), peripheral edema (36%), tremor (35%), and anemia (33%).

Pediatrics
De novo pediatric transplant patients started on 0.3 mg/kg daily of tacrolimus product, given once daily for ASTAGRAF XL and divided into two doses for PROGRAF. Thirteen (13) pediatric patients completed 52 weeks on ASTAGRAF XL. The most common adverse reactions were diarrhea [7/13 (54%)], increased blood creatinine [6/13 (46%)], hypertension [3/13 (23%)], cough [4/13 (31%)], and upper respiratory tract infection [4/13 (31%)].

Stable pediatric allograft recipients 5 to 16 years of age were converted 1:1 (mg:mg) from PROGRAF to ASTAGRAF XL. Seventy-six (76) pediatric patients completed at least one year of ASTAGRAF XL-based treatment. The most common adverse reactions were diarrhea (13.9%), headache (13.9%), and cough (11.4%).

SPECIFIC POPULATIONS

Pregnancy:

Risk Summary
Tacrolimus can cause fetal harm when administered to a pregnant woman. Data from postmarketing surveillance and Transplantation Pregnancy Registry International (TPRI) suggest that infants exposed to tacrolimus in utero are at a risk of prematurity, birth defects/congenital anomalies, low birth weight, and fetal distress. Advise pregnant women of the potential risk to the fetus. ASTAGRAF XL may increase hyperglycemia in pregnant women with diabetes (including gestational diabetes). Monitor maternal blood glucose levels regularly. ASTAGRAF XL may exacerbate hypertension in pregnant women and increase pre-eclampsia. Monitor and control blood pressure. Renal dysfunction, transient neonatal hyperkalemia and low birth weight have been reported at the time of delivery in infants of mothers taking ASTAGRAF XL. There is an increased risk for premature delivery (< 37 weeks) following transplantation and maternal exposure to ASTAGRAF XL.

Lactation:

Risk Summary
Controlled lactation studies have not been conducted in humans; however, tacrolimus has been reported to be present in human milk. The effects of tacrolimus on the breastfed infant, or on milk production, have not been assessed.

Females and Males of Reproductive Potential: ASTAGRAF XL can cause fetal harm when administered to pregnant women. Advise female and male patients of reproductive potential to speak to their healthcare provider on family planning options including appropriate contraception prior to starting treatment with ASTAGRAF XL.

Pediatric Use: The safety and effectiveness of ASTAGRAF XL in pediatric kidney transplant patients have been established. Use of ASTAGRAF XL in pediatric kidney transplant patients is based on adequate and well-controlled studies of ASTAGRAF XL in adult kidney transplant patients and supported by pharmacokinetic and safety data of ASTAGRAF XL in pediatric transplant patients 4 years of age and older who are able to swallow capsules intact.

Hepatic/Renal Impaired Patients: Patients should be administered the lowest recommended starting dose, with close monitoring of tacrolimus trough concentrations and renal function, and appropriate dosage adjustments.

Race or Ethnicity: African-American patients may need to be titrated to higher dosages to attain comparable trough concentrations compared to Caucasian patients.

PLEASE CLICK HERE FOR FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNING, FOR ASTAGRAF XL.

 

 


What is PROGRAF?

  • PROGRAF is a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney, liver, or heart transplant.
  • PROGRAF capsules and PROGRAF Granules are types of tacrolimus immediate-release drugs and they are not the same as tacrolimus extended-release tablets or tacrolimus extended-release capsules. Your healthcare provider should decide what medicine is right for you.

IMPORTANT SAFETY INFORMATION


What is the most important information I should know about PROGRAF?

PROGRAF can cause serious side effects, including:

  1. Increased risk of cancer. People who take PROGRAF have an increased risk of getting some kinds of cancer, including skin and lymph gland cancer (lymphoma).
  2. Increased risk of infection. PROGRAF is a medicine that affects your immune system. PROGRAF can lower the ability of your immune system to fight infections. Serious infections can happen in people receiving PROGRAF that can cause death. Call your healthcare provider right away if you have any symptoms of an infection, including:
    • Fever
    • sweats or chills
    • cough or flu-like symptoms
    • muscle aches
    • warm, red, or painful areas on your skin

Do not take PROGRAF if you are allergic to tacrolimus or any of the ingredients in PROGRAF.

What should I tell my healthcare provider before taking PROGRAF?

Before you take PROGRAF, tell your healthcare provider about all of your medical conditions, including if you:

  • plan to receive any live vaccines (people taking PROGRAF should not receive live vaccines)
  • have or have had liver, kidney or heart problems
  • are pregnant or plan to become pregnant. PROGRAF can harm your unborn baby.
    • If you are able to become pregnant, you should use effective birth control before and during treatment with PROGRAF. Talk to your healthcare provider before starting treatment with PROGRAF about birth control methods that may be right for you.
    • Males who have female partners who are able to become pregnant should also use effective birth control before and during treatment with PROGRAF. Talk to your healthcare provider before starting treatment with PROGRAF about birth control methods that may be right for you.
  • are breastfeeding or plan to breastfeed. PROGRAF passes into your breast milk. You and your healthcare provider should decide if you will breastfeed while taking PROGRAF.

Tell your healthcare provider about all the medicines you take, and when you start a new medicine or stop taking a medicine, including prescription and over-the-counter medicines; vitamins; natural, herbal or nutritional supplements. Especially tell your healthcare provider if you take:

  • sirolimus (RAPAMUNE®)
  • cyclosporine (GENGRAF®, NEORAL®, and SANDIMMUNE®)
  • medicines called aminoglycosides that are used to treat bacterial infections
  • ganciclovir (CYTOVENE® IV, VALCYTE®)
  • amphotericin B (ABELCET®, AMBISOME®)
  • cisplatin
  • antiviral medicines called nucleoside reverse transcriptase inhibitors
  • antiviral medicines called protease inhibitors
  • water pill (diuretic)
  • medicine to treat high blood pressure
  • nelfinavir (VIRACEPT®)
  • telaprevir (INCIVEK®)
  • boceprevir
  • ritonavir (KALETRA®, NORVIR®, TECHNIVIE, VIEKIRA PAK®, VIEKIRA XR)
  • letermovir (PREVYMIS)
  • ketoconazole
  • itraconazole (ONMEL®, SPORANOX®)
  • voriconazole (VFEND®)
  • clarithromycin (BIAXIN®, BIAXIN® XL, PREVPAC®)
  • rifampin (RIFADIN®, RIFAMATE®, RIFATER®, RIMACTANE®)
  • rifabutin (MYCOBUTIN®)
  • amiodarone (NEXTERONE®, PACERONE®)

Ask your healthcare provider or pharmacist if you are not sure if you take any of the medicines listed above. PROGRAF may affect the way other medicines work, and other medicines may affect how PROGRAF works. Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How Should I Take PROGRAF?

  • Do not eat grapefruit or drink grapefruit juice while taking PROGRAF.
  • Take PROGRAF exactly as your healthcare provider tells you to take it.
  • Your healthcare provider may change your PROGRAF dose if needed. Do not stop taking or change your dose of PROGRAF without talking to your healthcare provider.
  • Take PROGRAF with or without food, the same way every day. For example, if you choose to take PROGRAF with food, you should always take PROGRAF with food.
  • Take PROGRAF at the same time each day, 12 hours apart. For example, if you take your first dose at 7:00 a.m., you should take your second dose at 7:00 p.m. Taking PROGRAF at the same time each day helps to keep the amount of medicine in your body at a steady level.
  • If you take too much PROGRAF, call your healthcare provider or go to the nearest hospital emergency room right away.

PROGRAF capsules:

  • Do not open or crush PROGRAF capsules.

PROGRAF Granules:

  • Children who have trouble swallowing capsules can be given PROGRAF Granules.
  • Give the dose of PROGRAF Granules right after preparing. Do not save prepared PROGRAF Granules as a liquid to take at a later time.
  • See the Instructions for Use at the end of the Patient Information for detailed instructions about how to mix and give PROGRAF Granules as a liquid.
  • If you get the granules, or prepared oral suspension on your skin, wash the area well with soap and water.
  • If you get the granules, or prepared oral suspension in your eyes, rinse with plain water.

What should I avoid while taking PROGRAF?

  • While you take PROGRAF you should not receive any live vaccines.
  • Limit the amount of time you spend in sunlight and avoid exposure to ultraviolet (UV) light, such as tanning machines. Wear protective clothing and use a sunscreen with a high sun protection factor (SPF).

PROGRAF may cause serious side effects, including:

  • problems from medicine errors. People who take PROGRAF have sometimes been given the wrong type of tacrolimus product. Tacrolimus extended-release medicines are not the same as PROGRAF capsules or granules and cannot be substituted for each other, unless specifically prescribed by your healthcare provider, who will send you to get blood tacrolimus levels at a lab. Check your PROGRAF when you get a new prescription and before you take it to make sure you have received PROGRAF capsules or PROGRAF Granules. Check with the pharmacist and call your healthcare provider if you think you were given the wrong medicine.

  • high blood sugar (diabetes). Your healthcare provider may do blood tests to check for diabetes. Call your healthcare provider right away if you have any symptoms of high blood sugar, including:

    • frequent urination
    • increased thirst or hunger
    • blurred vision
    • confusion
    • drowsiness
    • loss of appetite
    • fruity smell on your breath
    • nausea, vomiting, or stomach pain
  • kidney problems. Kidney problems are a serious and common side effect of PROGRAF. Your healthcare provider may do blood tests to check your kidney function.

  • nervous system problems. Nervous system problems are a serious and common side effect of PROGRAF. Call your healthcare provider right away if you get any of these symptoms that could be signs of a serious nervous system problem:

    • headache
    • confusion
    • seizures
    • changes in your vision
    • changes in behavior
    • coma
    • tremors
    • numbness and tingling
  • high levels of potassium in your blood. Your healthcare provider may do blood tests to check your potassium level.

  • high blood pressure. High blood pressure is a serious and common side effect of PROGRAF. Your healthcare provider will monitor your blood pressure and may prescribe blood pressure medicine for you, if needed. Your healthcare provider may instruct you to check your blood pressure at home.

  • changes in the electrical activity of your heart (QT prolongation).

  • heart problems (myocardial hypertrophy). Tell your healthcare provider right away if you get any of these symptoms of heart problems:

    • shortness of breath
    • chest pain
    • feel lightheaded
    • feel faint
  • severe low red blood cell count (anemia).

The most common side effects of PROGRAF in people who have received a kidney, liver or heart transplant are:

  • infections in general, including cytomegalovirus (CMV) infection
  • tremors (shaking of the body)
  • constipation
  • diarrhea
  • headache
  • stomach pain
  • trouble sleeping
  • nausea
  • high blood sugar (diabetes)
  • low levels of magnesium in your blood
  • low levels of phosphate in your blood
  • swelling of the hands, legs, ankles, or feet
  • weakness
  • pain
  • high levels of fat in your blood
  • high levels of potassium in your blood
  • low red blood cell count (anemia)
  • low white blood cell count
  • fever
  • numbness or tingling in your hands and feet
  • inflammation of your airway (bronchitis)
  • fluid around your heart

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of PROGRAF. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects.

General information about the safe and effective use of PROGRAF.

  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use PROGRAF for a condition for which it was not prescribed. Do not give PROGRAF to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about PROGRAF that is written for health professionals.
  • The Patient Information leaflet summarizes the most important information about PROGRAF. If you would like more information, talk to your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1‑800‑FDA‑1088.

Please see the Patient Information and full Prescribing Information, including Boxed Warning, for PROGRAF.


What is ASTAGRAF XL?

  • ASTAGRAF XL is a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney transplant.
  • ASTAGRAF XL is an extended-release capsule and is not the same as tacrolimus immediate-release capsules, tacrolimus for oral suspension or tacrolimus extended-release tablets. Your healthcare provider should decide what medicine is right for you.

IMPORTANT SAFETY INFORMATION


What is the most important information I should know about ASTAGRAF XL?

ASTAGRAF XL can cause serious side effects, including:

  • Increased risk of cancer. People who take ASTAGRAF XL have an increased risk of getting some kinds of cancer, including skin and lymph gland cancer (lymphoma).

  • Increased risk of infection. ASTAGRAF XL is a medicine that affects your immune system. ASTAGRAF XL can lower the ability of your immune system to fight infections. Serious infections can happen in people receiving ASTAGRAF XL that can cause death. Call your healthcare provider right away if you have symptoms of an infection such as:

    • fever
    • sweats or chills
    • cough or flu-like symptoms
    • muscle aches
    • warm, red or painful areas on your skin
  • Increased risk of death in females who have had a liver transplant. You should not take ASTAGRAF XL if you have had a liver transplant without talking to your healthcare provider.

Who should not take ASTAGRAF XL?

Do not take ASTAGRAF XL if you are allergic to tacrolimus or any of the ingredients in ASTAGRAF XL.

What should I tell my healthcare provider before taking ASTAGRAF XL?

Before you take ASTAGRAF XL tell your healthcare provider if you:

  • plan to receive any live vaccines.
  • have or have had liver, kidney or heart problems, or have any other medical conditions.
  • are pregnant or plan to become pregnant. ASTAGRAF XL may harm your unborn baby.
    • If you are able to become pregnant, you should use effective birth control before and during treatment with ASTAGRAF XL. Talk to your healthcare provider before starting treatment with ASTAGRAF XL about birth control methods that may be right for you.
    • Males who have female partners who are able to become pregnant should also use effective birth control before and during treatment with ASTAGRAF XL. Talk to your healthcare provider before starting treatment with ASTAGRAF XL about birth control methods that may be right for you.
  • are breastfeeding or plan to breastfeed. ASTAGRAF XL passes into your breast milk. You and your healthcare provider should decide if you will breastfeed while taking ASTAGRAF XL.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, natural, herbal or nutritional supplements. ASTAGRAF XL may affect the way other medicines work, and other medicines may affect how ASTAGRAF XL works.

How should I take ASTAGRAF XL?

  • Take ASTAGRAF XL exactly as your healthcare provider tells you to take it.
  • Your healthcare provider may change your dose if needed. Do not stop taking or change your dose of ASTAGRAF XL without talking to your healthcare provider.
  • Take ASTAGRAF XL capsules whole. Do not break, crush, chew or dissolve ASTAGRAF XL capsules before swallowing. If you cannot swallow ASTAGRAF XL capsules whole, tell your healthcare provider.
  • Take ASTAGRAF XL at the same time each morning, preferably on an empty stomach at least one hour before, or at least two hours after, you have eaten a meal.
  • If you miss your dose of ASTAGRAF XL, it should be taken as soon as possible, but no longer than 14 hours after your regularly scheduled time. If it is longer than 14 hours, the missed dose should be skipped and the next dose should be taken the following morning at your regularly scheduled time. Do not take two doses at the same time.
  • If you take too much ASTAGRAF XL, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking ASTAGRAF XL?

  • Live vaccines such as flu vaccine through your nose, measles, mumps, rubella, polio by mouth, TB vaccine, yellow fever, chicken pox or typhoid.
  • Exposure to sunlight and UV light such as tanning machines. Wear protective clothing and use a sunscreen.
  • You should not eat grapefruit or drink grapefruit juice while taking ASTAGRAF XL.
  • You should not drink alcohol when taking ASTAGRAF XL.

What are the possible side effects of ASTAGRAF XL?

ASTAGRAF XL may cause serious side effects, including:

  • See "What is the most important information I should know about ASTAGRAF XL?"

  • Problems from medication errors such as graft rejection and other serious reactions. People who take ASTAGRAF XL have sometimes been given the wrong medicine, because some medicines have the same ingredient (tacrolimus) as ASTAGRAF XL. Serious reactions have happened including graft rejection. Check your ASTAGRAF XL when you get a new prescription to make sure you have received the right medicine.

    • Call your healthcare provider right away if you think you were given the wrong medicine
    • Ask your healthcare provider or pharmacist if you are not sure what ASTAGRAF XL should look like.
  • high blood sugar (diabetes). Your healthcare provider may do certain tests to check for diabetes. Call your healthcare provider right away if you have:

    • frequent urination
    • increased thirst or hunger
    • blurred vision
    • confusion
    • drowsiness
    • loss of appetite
    • fruity smell on your breath
    • nausea, vomiting, or stomach pain
  • kidney problems. Kidney problems are serious and common side effects of ASTAGRAF XL. Your healthcare provider may do certain tests to check your kidney function while you take ASTAGRAF XL.

  • nervous system problems. Nervous system problems are a serious and common side effect of ASTAGRAF XL. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms while taking ASTAGRAF XL. These could be signs of serious nervous system problems:

    • confusion
    • changes in alertness
    • muscle tremors
    • numbness and tingling
    • headache
    • seizures
    • vision changes
  • high levels of potassium in your blood. Your healthcare provider may do certain tests to check your potassium level while you take ASTAGRAF XL.

  • high blood pressure. High blood pressure is a serious and common side effect of ASTAGRAF XL. Your healthcare provider will monitor your blood pressure and may ask you to check your blood pressure at home.

  • changes in the electrical activity of your heart (QT prolongation).

  • severe low blood cell count (anemia).

The most common side effects of ASTAGRAF XL are diarrhea, constipation, nausea, swelling of the hands, ankles or legs, and tremors (shaking of the body).

These are not all the possible side effects of ASTAGRAF XL. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects.

General information about the safe and effective use of ASTAGRAF XL.

  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ASTAGRAF XL for a condition for which it was not prescribed. Do not give ASTAGRAF XL to other people, even if they have the same symptoms that you have. It may harm them.
  • The Medication Guide summarizes the most important information about ASTAGRAF XL. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about ASTAGRAF XL that is written for health professionals.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

Please see the accompanying Medication Guide and full Prescribing Information, including Boxed Warning, for ASTAGRAF XL.



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Glossary of Terms

A

Allocation

The process of determining how organs are distributed. Allocation includes the system of policies and guidelines that ensure organs are distributed in an equitable, ethical, and medically sound manner.

Allograft

An allograft is a transplant of an organ or tissue that comes from another person of the same species.

Antibody

A protein substance made by the body's immune system to attack a foreign substance, such as a transplanted organ. Because antibodies attack transplanted organs, transplant patients must take medications that reduce the body's ability to attack the transplanted organ. See anti-rejection medicine.

Antigen

A foreign substance, such as a transplanted organ or tissue, that triggers the body to reject it.

Anti-rejection medicine (immunosuppressive drugs)

Medicines that reduce the body's ability to reject a transplanted organ.

Arrhythmia

A condition in which the heart beats too slow, too fast, or with an irregular pattern.

B

Bile duct

The duct that carries bile from the liver and gallbladder to the small intestines (duodenum).

Biopsy

The removal of a small piece of tissue from your body for examination under a microscope.

Brain death

Brain death occurs when the brain is totally and irreversibly nonfunctional. Brain death can occur when the brain’s supply of oxygenated blood is too low, causing the brain cells to die.

C

Cadaveric donors

A person who has been declared dead and whose organ or organs and/or tissues have been donated for transplantation (also called deceased donor). 

Candidate

A patient who has been placed on the national waiting list for solid organ transplantation. 

Cardiac arrest

The heart suddenly stops beating.

Cardiomyopathy

Disease that increases the size of the heart muscle or makes it thicker than normal.

Catheter

A flexible tube that is used to remove body fluids or inject medicines into the body.

Cold ischemia time

The time an organ is without blood circulation and is kept cold—from the time the organ is removed from the donor to the time it is transplanted into the recipient. In surgery, the time between the chilling of an organ after its blood supply has been reduced or cut off and the time it is warmed by having its blood supply restored. This can occur while the organ is still in the body or after it is removed from the body if the organ is to be used for transplantation. 

Corticosteroid­

Medicine that slows down your body’s immune system and helps prevent your new organ from being rejected. It is also called a "steroid." A common corticosteroid is prednisone.

Creatinine

A substance found in the blood, urine, and muscle tissue. Your healthcare provider can measure your level of creatinine to determine how well your kidneys are working.

Crossmatching

A blood test performed before a transplant to find out if the specific donor organ to be transplanted is likely to be rejected by the prospective recipient. If the test is positive, the donor and recipient are incompatible and the transplant is unlikely to be performed with an organ from that donor.

d

Deceased donor

A person who has been declared dead and whose organs and/or tissues have been donated for transplantation (also called cadaveric donor). 

Designated requestor

Defined in the Centers for Medicare & Medicaid Conditions of Participation as an individual who has completed a course offered or approved by the OPO and designed in conjunction with the tissue and eye bank community in the methodology for approaching potential donor families and requesting organ donation. The interpretation of this rule allows for some degree of flexibility. 

Donation

The act of giving organ(s), tissue(s), or blood to someone else without compensation. 

Diabetes

A disease in which the pancreas does not produce enough insulin, preventing glucose in the blood from being processed properly. This results in high levels of glucose in the blood.

Dialysis

A mechanical process designed to remove toxic substances from the blood, including correcting the balance of fluids and chemicals in the body and removing waste when the kidneys are unable to do so. See hemodialysis and peritoneal dialysis. 

Donor registries

A confidential electronic database in which individuals can enter and store their wish to be an organ and tissue donor. Most registries have enrollment capacity through the department of motor vehicles and many also have online registry portals. Because registry information is accessible on a 24/7 basis to authorized procurement personnel, it is the safest and quickest way to determine if a deceased individual wanted to be a donor.

e

End-stage renal disease (ESRD)

The complete or almost complete failure of the kidneys to function. The kidneys can no longer remove waste, concentrate urine, or regulate many other important bodily functions.

g

Genetic disorder

A disease or disorder that is inherited.

Graft

A transplanted organ or tissue.

Graft survival

The length of time an organ functions successfully after being transplanted.

h

Heart

A muscular organ that pumps blood through the body. The heart can be donated and transplanted.

Hematocrit

A test that measures the number of red blood cells in the blood.

Hemodialysis

A treatment for kidney failure in which the patient's blood is passed through a filtering membrane to remove excess fluid and waste.

Hirsutism

Excessive hair growth on the face or body. A side effect of some anti-rejection medicines.

Histocompatibility

The examination or testing of antigens to determine if a donor organ will “match” and be compatible with a potential recipient. This routine test is often called tissue-typing and helps identify the most suitable recipient for a donated organ.

Human leukocyte antigens (HLA)

A genetically determined series of markers (molecules) located on human white blood cells (leukocytes) and on tissues that are inherited from both biological parents. HLA matching is important for compatibility between donor and recipient.

Hypertension

High blood pressure.

i

Idiopathic

Relating to an organ being damaged or destroyed by a disease or condition of unknown origin.

Immune response

The body's natural defense against foreign objects or organisms that invade the body, such as bacteria or transplanted organs.

Immunosuppressant drugs (also called anti-rejection drugs)

Medication that causes the human body not to produce antibodies that normally fight off foreign material in the body. The production of these antibodies needs to be suppressed in order to permit the acceptance of a donor organ by the recipient's body.

Immunosuppression

A slowing down of the body’s immune system’s response by medicines that help prevent rejection of the transplanted organ.

Inflammation

A reaction that occurs as a result of infection or injury to cells.

Informed consent

The process of reaching a voluntary agreement based on a full disclosure and full understanding of what will take place. Informed consent often refers to the process of making decisions regarding participation in research as well as undergoing medical procedures, including the decision to donate the organs of a loved one.

k

Kidneys

A pair of organs that maintain proper water and electrolyte balance, regulate acid-base concentration, and filter metabolic waste, which is excreted as urine. Kidneys can be donated by deceased and living donors.

l

Laparoscopic nephrectomy

The removal of a kidney through small incisions using small surgical instruments through a tube-like device that has a tiny camera on it.

Liver

A large reddish-brown organ that secretes bile and is active in the formation of certain blood proteins and in the metabolism of carbohydrates, fats, and proteins. The liver, like the kidneys, assists in the removal of waste and toxins from the bloodstream. The liver can be donated by deceased donors, and a liver lobe (section) can be provided by a living donor to be transplanted. The donor's liver will grow to full size, as will the transplanted lobe.

Living donor

A person who donates an organ or tissue while alive.

Lymphocytotoxic crossmatch test

A blood test performed before the transplant to see if the transplant recipient will react to the donor organ. A positive crossmatch means there are antibodies that may cause rejection and, therefore, the donor organ is not suitable for transplantation.

m

Match

The degree of compatibility or likeness between a donor and a recipient.

Match run

The list that is generated when an organ donor's information is entered into the national waiting list computer system to identify potential recipients.

Metabolic disorder

A condition or disease related to dysfunction in the chemical processes and activities of the body (ie, metabolism).

n

National Organ Transplant Act (NOTA)

Passed by Congress in 1984, NOTA initiated the development of a national system of organ sharing and a scientific registry to collect and report transplant data. It also outlawed the sale of human organs in the United States.

o

Organ

A part of the body, made up of various tissues, which performs a particular function. Organs that can be transplanted include the heart, intestines, liver, lungs, kidneys, and pancreas.

Organ donation

Giving an organ or a part of an organ to be transplanted into another person. Organ donation can occur with a deceased donor, who can give kidneys, pancreas, liver, lungs, heart, and intestinal organs; and with a living donor, who can give a kidney or a portion of the liver, lung, or intestine.

Organ preservation

Methods used to maintain the quality of organs between removal from the donor and transplantation into the recipient. These methods include preservation solutions, pumps, and cold storage. Preservation times can vary from 2 to 48 hours depending on the type of organ being preserved.

Organ Procurement and Transplantation Network (OPTN)

In 1984, Congress passed the National Organ Transplant Act, which mandated the establishment of the OPTN and Scientific Registry of Transplant Recipients. The purpose of the OPTN is to improve the effectiveness of the nation's organ procurement, donation, and transplantation system by increasing the availability of and access to donor organs for patients with end-stage organ failure. The act stipulated that the network be a nonprofit, private sector entity whose members are all United States transplant centers, organ procurement organizations, and histocompatibility laboratories. The OPTN is administered by UNOS under contract to the U.S. Department of Health and Human Services.

Organ Procurement Organizations (OPO)

Local organizations throughout the United States, designated by the Centers for Medicare & Medicaid Services (CMS), that are responsible for increasing the number of registered donors in their service areas, and for coordinating the donation process when actual donors become available. OPOs evaluate potential donors, discuss donation with surviving family members, and arrange for the surgical removal and transport of donated organs. To increase donor registration, OPOs implement community outreach strategies to encourage people to sign up in their state donor registry. Find your local OPO.

Orthotopic transplant

A transplant in which an organ is removed and the transplanted organ is placed in the same location.

p

Peritoneal dialysis

A process of filtering waste using the peritoneal membrane inside the abdomen. The abdomen is filled with special solutions that help remove toxins. The solutions remain in the abdomen for a time and then are drained out. This form of dialysis can be performed at home, but must be done every day.

Procurement

The surgical procedure of removing an organ from a donor.

r

Recipient

The person receiving the donated organ or tissue.

Rejection (acute and chronic)

The body's way of protecting itself against a foreign invader, such as infectious germs. The body sees a transplanted organ as a foreign invader and attempts to destroy it. Acute rejection happens very quickly; chronic rejection is the slow failure of a donated organ to function.

Renal

Having to do with the kidneys.

s

Scientific Registry of Transplant Recipients (SRTR)

The purpose of the SRTR is to provide evaluation of clinical information about donors, transplant candidates and recipients, as well as patient and graft survival rates.

Status

The degree of medical urgency for patients awaiting heart or liver transplants.

Steroid

See Corticosteroid.

t

Tissue typing

A procedure in which the tissues of a prospective donor and recipient are tested to identify human leukocyte antigens (HLA).

Transplantation

The transfer of an organ from one person to another.

Transplant coordinator

A transplant center staff member responsible for managing the care and progress of potential transplant recipients before, during, and after the transplantation.

Transplant recipient

A person who has received an organ transplant.

u

United Network for Organ Sharing (UNOS)

The private, nonprofit membership organization that coordinates the national matching system. UNOS has established and continually strives to improve tools, systems, and quality processes.

v

Ventricle

The main chambers of the heart; left and right.

Virus

A type of germ that causes infection.

w

Waiting list

A national database maintained by the OPTN of all patients waiting for an organ transplant.

White blood cell

A type of cell in the blood that participates in immunity and inflammation.

x

Xenograft

An organ or tissue transplanted into a human from a non-human animal.