OXICOLOGY (13)].
The safety of STELARA® has not been eva luated in patients who have a history of malignancy or who have a known malignancy.
There have been post-marketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving STELARA® who had pre-existing risk factors for developing non-melanoma skin cancer. All patients receiving STELARA® should be monitored for the appearance of non-melanoma skin cancer. Patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment should be followed closely [see ADVERSE REACTIONS (6.1)].
5.5 Hypersensitivity Reactions
Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with STELARA® [see ADVERSE REACTIONS (6.1, 6.3)]. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STELARA®.
5.6 Reversible Posterior Leukoencephalopathy Syndrome
One case of reversible posterior leukoencephalopathy syndrome (RPLS) was observed in clinical studies of psoriasis and psoriatic arthritis. The subject, who had received 12 doses of STELARA® over approximately two years, presented with headache, seizures and confusion. No additional STELARA® injections were administered and the subject fully recovered with appropriate treatment. No cases of RPLS were observed in clinical studies of Crohn's disease.
RPLS is a neurological disorder, which is not caused by demyelination or a known infectious agent. RPLS can present with headache, seizures, confusion and visual disturbances. Conditions with which it has been associated include preeclampsia, eclampsia, acute hypertension, cytotoxic agents and immunosuppressive therapy. Fatal outcomes have been reported.
If RPLS is suspected, administer appropriate treatment and discontinue STELARA®.
5.7 Immunizations
Prior to initiating therapy with STELARA®, patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with STELARA® should not receive live vaccines. BCG vaccines should not be given during treatment with STELARA® or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving STELARA® because of the potential risk for shedding from the household contact and transmission to patient.
Non-live vaccinations received during a course of STELARA® may not elicit an immune response sufficient to prevent disease.
5.8 Concomitant Therapies
In clinical studies of psoriasis the safety of STELARA® in combination with other immunosuppressive agents or phototherapy was not eva luated. Ultraviolet-induced skin cancers developed earlier and more frequently in mice genetically manipulated to be deficient in both IL-12 and IL-23 or IL-12 alone [see NONCLINICAL TOXICOLOGY (13.1)].
6 ADVERSE REACTIONS
The following serious adverse reactions are discussed elsewhere in the label:
Infections [see WARNINGS AND PRECAUTIONS (5.1)]
Malignancies [see WARNINGS AND PRECAUTIONS (5.4)]
Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS (5.5)]
Reversible Posterior Leukoencephalopathy Syndrome [see WARNINGS |
