ANIFROLUMAB Drug Interactions: What You Need to Know

INTERACTIONS No formal drug interaction studies have been conducted.

SAPHNELO is contraindicated in patients with a history of anaphylaxis with anifrolumab-fnia [see Warnings and Precautions (5.2) ] . SAPHNELO is contraindicated in patients with a history of anaphylaxis with anifrolumab-fnia. ( 4 )

AND PRECAUTIONS

• Serious Infections: Serious and sometimes fatal infections have occurred in patients receiving SAPHNELO. SAPHNELO increases the risk of respiratory infections and herpes zoster. Avoid initiating treatment during an active infection. Consider the individual benefit-risk if using in patients with severe or chronic infections. Consider interrupting therapy with SAPHNELO if patients develop a new infection during treatment. ( 5.1 )
• Hypersensitivity Reactions Including Anaphylaxis: Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported. ( 5.2 )
• Malignancy: Consider the individual benefit-risk in patients with known risk factors for malignancy prior to prescribing SAPHNELO. ( 5.3 )
• Immunizations: Avoid use of live or live-attenuated vaccines in patients receiving SAPHNELO. ( 5.4 )
• Not Recommended for Use with Other Biologic Therapies. ( 5.5 )

5.1 Serious Infections Serious and sometimes fatal infections (including COVID‑19) have occurred in patients receiving immunosuppressive agents, including SAPHNELO. Overall, the incidence of serious infections in controlled trials was similar in patients receiving SAPHNELO compared with placebo, whereas fatal infections occurred more frequently in patients receiving SAPHNELO <span class="opacity-50 text-xs">[see Adverse Reactions (6.1) ]</span> . In controlled trials, SAPHNELO increased the risk of respiratory infections and herpes zoster (disseminated herpes zoster events have been reported) <span class="opacity-50 text-xs">[see Adverse Reactions (6.1) ]</span> . Consider the benefit and risk of administering SAPHNELO in patients with a chronic infection, a history of recurrent infections, or known risk factors for infection. Avoid initiating treatment with SAPHNELO in patients with any clinically significant active infection until the infection resolves or is adequately treated. Instruct patients 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 anti-infective therapy, monitor the patient closely and consider interrupting SAPHNELO therapy until the infection resolves .

5.2 Hypersensitivity Reactions Including Anaphylaxis Serious hypersensitivity reactions (including anaphylaxis) have been reported following SAPHNELO administration <span class="opacity-50 text-xs">[see Contraindication (4) ]</span> . Events of angioedema have also been reported <span class="opacity-50 text-xs">[see Adverse Reactions (6.1) ]</span> . Other hypersensitivity reactions and infusion-related reactions have occurred following administration of SAPHNELO <span class="opacity-50 text-xs">[see Adverse Reactions (6.1) ]</span> . Consider pre-medication before infusion of SAPHNELO for patients with a history of these reactions. SAPHNELO should be administered by healthcare providers prepared to manage hypersensitivity reactions, including anaphylaxis, and infusion-related reactions. If a serious infusion-related or hypersensitivity reaction (e.g., anaphylaxis) occurs, immediately interrupt the administration of SAPHNELO and initiate appropriate therapy.

5.3 Malignancy There is an increased risk of malignancies with the use of immunosuppressants. The impact of SAPHNELO treatment on the potential development of malignancies is not known. Consider the individual benefit-risk in patients with known risk factors for the development or reoccurrence of malignancy prior to prescribing SAPHNELO. In patients who develop malignancies, consider the benefit-risk of continued treatment with SAPHNELO.

5.4 Immunizations Update immunizations, according to current immunization guidelines, prior to initiating SAPHNELO therapy. Avoid concurrent use of live or live-attenuated vaccines in patients treated with SAPHNELO.

5.5 Not Recommended for Concomitant Use with Other Biologic Therapies SAPHNELO has not been studied in combination with other biologic therapies, including B-cell-targeted therapies. Therefore, use of SAPHNELO is not recommended for use in combination with biologic therapies.