Generic Name: Prograf
What is Prograf?
When voriconazole is discontinued, tacrolimus concentrations should be carefully monitored and the dose increased as needed. In all cases, renal function in these patients should be carefully monitored. Vorinostat: Vorinostat therapy is associated with a risk of QT prolongation. Vorinostat should be used with caution if given with other agents that may prolong the QT interval including tacrolimus.
Yellow Fever Vaccine, Live: Live virus vaccines should generally not be administered to an immunosuppressed patient. Zileuton: Zileuton is metabolized by the cytochrome P450 isoenzyme 3A4 and could potentially compete with other CYP3A4 substrates, including tacrolimus.
Ziprasidone: According to the manufacturer, ziprasidone is contraindicated with any drugs that list QT prolongation as a pharmacodynamic effect when this effect has been described within the contraindications or bolded or boxed warnings of the official labeling for such drugs.
Clinical trial data indicate that ziprasidone causes QT prolongation. In one study, ziprasidone increased the QT interval 10 msec more than placebo at the maximum recommended dosage. Comparative data with other antipsychotics have shown that the mean QTc interval prolongation occurring with ziprasidone exceeds that of haloperidol, quetiapine, olanzapine, and risperidone, but is less than that which occurs with thioridazine. Given the potential for QT prolongation, ziprasidone is contraindicated for use with drugs that are known to cause QT prolongation with potential for torsades de pointes including tacrolimus.
The experience with topical tacrolimus in pregnant women is too limited to permit assessment of safety of its use during pregnancy.
The use of live attenuated vaccines should be avoided see section 4. Limited data from organ transplant recipients show no evidence of an increased risk of adverse effects on the course and outcome of pregnancy under tacrolimus treatment compared with other immunosuppressive medicinal products. However, cases of spontaneous abortion have been reported. To date, no other relevant epidemiological data are available. Due to the need of treatment, tacrolimus can be considered in pregnant women when there is no safer alternative and when the perceived benefit justifies the potential risk to the foetus.
In case of in utero exposure, monitoring of the newborn for the potential adverse effects of tacrolimus is recommended in particular the effects on the kidneys. In rats and rabbits, tacrolimus caused embryofoetal toxicity at doses which demonstrated maternal toxicity see section 5.
Breast-feedingHuman data demonstrate that tacrolimus is excreted into breast milk. As detrimental effects on the newborn cannot be excluded, women should not breast-feed whilst receiving Prograf. FertilityA negative effect of tacrolimus on male fertility in the form of reduced sperm counts and motility was observed in rats see section 5.
This effect may be enhanced if Prograf is administered in association with alcohol. Oral administration appears to be associated with a lower incidence of adverse drug reactions compared with intravenous use. Infections and infestationsAs is well known for other potent immunosuppressive agents, patients receiving tacrolimus are frequently at increased risk for infections viral, bacterial, fungal, protozoal.
Neoplasms benign, malignant and unspecified incl.
How should I take Prograf?
Vancomycin: Concomitant use of parenteral vancomycin with other nephrotoxic drugs, such as tacrolimus, can lead to additive nephrotoxicity. Monitor renal function closely and adjust vancomycin or tacrolimus doses according to serum concentrations. Vandetanib can prolong the QT interval in a concentration-dependent manner. If coadministration is necessary, an ECG is needed, as well as more frequent monitoring of the QT interval. Also, when tacrolimus is administered with other substrates of CYP3A4, such as vandetanib, consider reducing the tacrolimus dose and closely monitor tacrolimus whole blood concentrations.
Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. Vedolizumab: The concomitant use of vedolizumab and immunosuppressives or immunomodulating agents may further increase the risk of infections, including progressive multifocal leukoencephalopathy and other opportunistic infections, over the risk observed with use of vedolizumab alone.
What should I avoid while taking Prograf?
Keep Prograf and all medicines out of reach of children. Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections.
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.
Prograf side effects
As mycophenolic acid is metabolized by UDPGT, increased concentrations of mycophenolic acid would be anticipated see Mechanism of Action. Nonsteroidal antiinflammatory drugs: NSAIDs should be used with caution in patients receiving immunosuppressives as they may mask fever, pain, swelling and other signs and symptoms of an infection.
The combination may also increase the risk of developing angioedema. Norfloxacin: Due to an increased risk for QT prolongation and torsade de pointes TdPcaution is advised when administering tacrolimus with norfloxacin. Nortriptyline: Tacrolimus has been associated with QT prolongation.
Octreotide: Due to a possible risk for QT prolongation and torsade de pointes TdPoctreotide and tacrolimus should be used together cautiously. Arrhythmias, sinus bradycardia, and conduction disturbances have occurred during octreotide therapy warranting more cautious monitoring during octreotide administration in higher risk patients with cardiac disease. Since bradycardia is a risk factor for development of TdP, the potential occurrence of bradycardia during octreotide administration could theoretically increase the risk of TdP in patients receiving drugs that prolong the QT interval.
Common Prograf ide effects may include:
Tacrolimus may also affect the metabolism of these hormonal contraceptives.
Levalbuterol: Tacrolimus causes QT prolongation.
Astellas Cares is a trademark of Astellas Pharma US, Inc.
Subsequent increased whole blood concentrations of tacrolimus may lead to nephrotoxicity or other side effects.
Heart Transplantation Two open-label, randomized, comparative trials evaluated the safety and efficacy of Prograf-based and cyclosporine-based immunosuppression in primary orthotopic heart transplantation. Prograf can cause serious side effects, including: 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.
Where can I get more information?
Lithium: Lithium should be used cautiously with tacrolimus.
When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as tacrolimus.