西罗莫司片注意事项

Things to note:

Anaphylaxis/Hypersensitivity Reactions: Anaphylaxis, angioedema, exfoliative dermatitis, and hypersensitivity vasculitis have been reported.

Angioedema: An increased risk has been reported with elevated levels of sirolimus tablets or with concomitant use of other drugs known to cause angioedema (such as ACE inhibitors). In some cases, angioedema resolves after stopping the drug or reducing the dose.

Infections: Immunosuppression may also increase the risk of infections, including activation of underlying viral infections (including BK virus-related nephropathy), fatal infections, and sepsis. Pneumocystis jiroveci pneumonia (PCP) should be prophylactically treated 1 year after transplantation, and cytomegalovirus (CMV) should be prophylactic 3 months after transplantation. Progressive multifocal leukoencephalopathy (PML), an opportunistic central nervous system infection caused by JC virus reactivation, has been reported in patients receiving immunosuppressive therapy. Clinical manifestations of PML include apathy, ataxia, cognitive deficits, confusion, and hemiplegia; promptly evaluate any patient who develops neurological changes; consider reducing the degree of immunosuppression in transplant patients while taking into account the risk of organ rejection. 

Interstitial Lung Disease: Cases (some fatal) of interstitial lung disease (e.g., pneumonia, bronchiolitis obliterans, organizing pneumonia, pulmonary fibrosis, etc.) have been observed; may be associated with pulmonary hypertension (including pulmonary hypertension). ILD can be relieved by reducing the dose or discontinuing treatment.

Hyperlipidemia: May increase blood lipids (cholesterol and triglycerides). Use with caution in patients with hyperlipidemia. Monitor cholesterol/lipids; if hyperlipidemia occurs, follow current management guidelines (diet, exercise, lipid-lowering agents). Antihyperlipidemic treatments may not be effective in achieving normal levels. 

Lymphocele/Effusion: Peripheral edema, lymphedema, ascites, and thoracic and pericardial effusions (including severe effusions and cardiac tamponade) have been reported; use with caution in patients with poor tolerance to fluid accumulation such as cardiovascular disease (heart failure or hypertension) and pulmonary disease.

Malignancy: Increased risk of skin cancer; limit sun and UV exposure; use appropriate sun protection. 

Proteinuria: Increased urinary protein excretion has been observed in renal transplant patients when converted from calcineurin inhibitors to sirolimus during maintenance therapy. Higher levels of proteinuria before switching to sirolimus tablets were associated with higher levels of proteinuria after switching. In some patients, proteinuria may reach nephrotic levels; nephrotic syndrome (new onset) has been reported. 

Renal function: Long-term combined use of sirolimus tablets and cyclosporine can increase serum creatinine and reduce glomerular filtration rate. Immunosuppressed patients are at increased risk for BK virus-associated nephropathy, which may impair renal function and lead to graft loss; consider reducing the burden of immunosuppression if there is evidence of worsening renal function. Use with caution in patients taking concomitant medications that may alter renal function.

Wound dehiscence/healing: May be associated with impaired wound dehiscence and healing; use caution in the perioperative period. Patients with body mass index (BMI) >30kg/㎡ are at increased risk of abnormal wound healing. 

Hepatic Impairment: Use with caution in patients with hepatic impairment; reduced maintenance dose recommended. 

Fetal toxicity: Effective contraception should be used before starting treatment with sirolimus tablets, during treatment and for 12 weeks after stopping treatment. During pregnancy, sirolimus tablets should be used only if the potential benefits outweigh the potential risks to the embryo/fetus.