There are no official guidelines to assist in answering this question. I will search for relevant research papers instead.
From the FDA Drug Label
Patients receiving immunosuppressants, including tacrolimus, 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.
The risk of skin cancer is increased with tacrolimus (Prograf) therapy due to its immunosuppressive effects. Key points to consider:
- The risk is related to the intensity and duration of immunosuppression.
- Patients should be examined for skin changes and take precautions to limit sun exposure. 1
From the Research
Risk of Skin Cancer with Tacrolimus Therapy
The risk of skin cancer associated with tacrolimus (Prograf) therapy is a topic of ongoing research and debate. Several studies have investigated this potential risk, with varying results.
- A cohort study published in 2021 2 found little evidence associating the use of topical calcineurin inhibitors, including tacrolimus, with skin cancer and lymphoma in adults.
- A review published in 2007 3 concluded that there was no scientific evidence of an increased incidence of skin cancer, lymphomas, or systemic immunosuppression in patients using topical calcineurin inhibitors.
- A case report published in 2006 4 suggested a potential causal relationship between topical use of tacrolimus and the development of a squamous cell carcinoma, although this finding is not conclusive.
- A study published in 2005 5 found no increased risk of non-melanoma skin cancer in patients with atopic dermatitis treated with topical tacrolimus ointment.
- An animal study published in 2011 6 found that tacrolimus ointment inhibited tumor induction in a mouse model of skin tumors, suggesting a potential protective effect.
Key Findings
- The majority of studies suggest that the risk of skin cancer associated with tacrolimus therapy is low or uncertain 2, 3, 5.
- Some studies have raised concerns about the potential for tacrolimus to increase the risk of skin cancer, particularly in the context of long-term use or in patients with pre-existing skin conditions 4.
- Animal studies have suggested that tacrolimus may have inhibitory effects on skin tumor induction 6.