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Saphnelo is a brand name for Anifrolumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite standard therapy.
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated and supervised by a physician experienced in the treatment of SLE. Posology The recommended dose is 300 mg, administered as an intravenous infusion over a 30-minute period, every 4 weeks. 4). Missed dose If a planned infusion is missed, treatment should be administered as soon as possible.
A minimum interval of 14 days should be maintained between doses. 3 Special populations Elderly No dose adjustment is required. 2). Renal impairment No dose adjustment is required. 2). 2). Paediatric population The safety and efficacy of Saphnelo in children and adolescents (aged <18 years old) have not yet been established.
No data are available. Method of administration For intravenous use. Saphnelo must not be administered as an intravenous push or bolus injection. 2 to 15 micron in-line or add-on filter. The infusion rate may be slowed or interrupted if the patient develops an infusion reaction.
9%) solution for injection to ensure that all of the solution for infusion has been administered. Do not co-administer any other medicinal products through the same infusion line. 6. Transitioning between routes of administration If transitioning a patient from subcutaneous administration to intravenous administration, the first intravenous infusion should be administered approximately 3 to 4 weeks after the last subcutaneous dose.
If transitioning a patient from intravenous administration to subcutaneous administration, the first subcutaneous injection should be administered approximately 2 weeks after the last intravenous dose.
8. SLE patients also taking immunosuppressants may be at higher risk of herpes zoster infections. In controlled-clinical trials serious and sometimes fatal infections (including pneumonia) 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 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. 5). 5 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.
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. 4 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. 1). 8). 5% of patients receiving anifrolumab. 2). , anaphylaxis) occurs, administration of anifrolumab should be interrupted immediately, and appropriate therapy initiated.
8. SLE patients also taking immunosuppressants may be at higher risk of herpes zoster infections. In controlled-clinical trials serious and sometimes fatal infections (including pneumonia) 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 Prior to initiating therapy, completion of all appropriate immunisations should be considered according to current immunisation guidelines.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5 events per 100 patient years [PY], respectively). 5% 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.
5 mg/ml. Polysorbates may cause allergic reactions. 5 Interaction with other medicinal products and other forms of interaction No interaction studies have been performed. Anifrolumab is not expected to undergo metabolism by hepatic enzymes or renal elimination.
The formation of some CYP450 enzymes is suppressed by increased levels of certain cytokines during chronic inflammation. Anifrolumab modestly suppresses the levels of some cytokines; the impact on CYP450 activity is unknown. , warfarin), therapeutic monitoring is recommended.
Immune response Non-live vaccines Immune response to non-live seasonal influenza vaccine was assessed in a small number of adult patients with moderate to severe SLE in an exploratory study. Humoral antibody responses induced by seasonal influenza virus vaccination were numerically comparable between patients receiving anifrolumab in addition to standard of care and those receiving standard of care alone.
4). 6 Fertility, pregnancy and lactation Pregnancy There are limited data (less than 300 pregnancy outcomes) from the use of Saphnelo in pregnant women. 3). 6 Saphnelo is not recommended during pregnancy and in women of childbearing potential not using contraception, unless the possible benefit justifies the potential risk.
Breast-feeding It is not known whether anifrolumab is excreted in human milk. 3). A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue from Saphnelo therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility There are no fertility data in humans. 3). 7 Effects on ability to drive and use machines Saphnelo has no or negligible influence on the ability to drive and use machines. 0%). 4%). Tabulated list of adverse reactions Adverse reactions reported from controlled clinical trials and post-marketing data are classified by MedDRA System Organ Class (SOC), see Table 1.
Within each SOC, preferred terms are arranged by decreasing […]
Concurrent use of live or attenuated vaccines should be avoided in patients treated with anifrolumab. 5). 5 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.
5 events per 100 patient years [PY], respectively). 5% 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.
5 mg/ml. Polysorbates may cause allergic reactions.