Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Patient groups excluded from clinical studies: Anifrolumab has not been studied in combination with other biologic therapies, including B-cell-targeted therapies. Therefore, treatment with anifrolumab is not recommended in combination with biologic therapies.
Anifrolumab has not been studied in patients with severe active central nervous system lupus or severe active lupus nephritis (see Pharmacology: Pharmacodynamics under Actions).
Hypersensitivity: Serious hypersensitivity reactions including anaphylaxis have been reported following administration of anifrolumab (see Adverse Reactions).
In the placebo-controlled clinical trials, serious hypersensitivity reactions (including angioedema) were reported for 0.6% of patients receiving anifrolumab.
In patients with a history of infusion-related reactions and/or hypersensitivity, premedication (e.g., an antihistamine) may be administered before the infusion of anifrolumab (see Dosage & Administration).
If a serious infusion-related or hypersensitivity reaction (e.g., anaphylaxis) occurs, administration of anifrolumab should be interrupted immediately, and appropriate therapy initiated.
Infections: Anifrolumab increases the risk of respiratory infections and herpes zoster (disseminated herpes zoster events have been observed), see Adverse Reactions. SLE patients also taking immunosuppressants may be at higher risk of herpes zoster infections.
In controlled-clinical trials serious and sometimes fatal infections have occurred, including in patients receiving anifrolumab.
Due to the mechanism of action, anifrolumab should be used with caution in patients with a chronic infection, a history of recurrent infections, or known risk factors for infection. Treatment with anifrolumab should not be initiated in patients with any clinically significant active infection until the infection resolves or is adequately treated. Patients should be instructed to seek medical advice if signs or symptoms of clinically significant infection occur. If a patient develops an infection, or is not responding to standard therapy, they should be closely monitored and careful consideration given to interrupting anifrolumab therapy until the infection resolves.
Studies in patients with a history of primary immunodeficiency have not been conducted.
The placebo-controlled clinical trials excluded patients with a history of active TB or latent TB in whom an adequate course of treatment could not be confirmed. Anti-tuberculosis (anti-TB) therapy should be considered prior to initiation of anifrolumab in patients with untreated latent TB. Anifrolumab should not be administered to patients with active TB.
Immunisations: No data are available on the immune response to vaccines.
Prior to initiating therapy, completion of all appropriate immunisations should be considered according to current immunisation guidelines. Concurrent use of live or attenuated vaccines should be avoided in patients treated with anifrolumab.
Malignancy: The impact of treatment with anifrolumab on the potential development of malignancies is not known. Studies in patients with a history of malignancy have not been conducted; however, patients with squamous or basal cell skin cancers and uterine cervical cancer that had been fully excised or adequately treated were eligible for enrolment in the SLE clinical trials.
In the placebo-controlled clinical trials, at any dose, malignant neoplasm (including non-melanoma skin cancers) was reported for 1.2% patients receiving anifrolumab, compared to 0.6% patients receiving placebo (EAIR: 1.2 and 0.7 per 100 patient years, respectively). Malignancies excluding non-melanoma skin cancers were observed in 0.7% and 0.6% of patients receiving anifrolumab and placebo, respectively. In patients receiving anifrolumab, breast and squamous cell carcinoma were the malignancies observed in more than one patient.
Individual benefit-risk should be considered in patients with known risk factors for the development or reoccurrence of malignancy. Caution should be exercised when considering continuing therapy for patients who develop malignancy.
Effects on ability to drive and use machines: Saphnelo has no or negligible influence on the ability to drive and use machines.