Anifrolumab
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From MedlinePlus, U.S. National Library of Medicine
Specialty pharmacy: therapy management checklist, storage and cold chain, dosing calendar, Medicare Part D coverage.
Type I Interferon Receptor Antagonist
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Important Administration Information SAPHNELO is intended for use under the guidance of a healthcare provider and may be administered as an intravenous infusion or as a subcutaneous injection. SAPHNELO vials are for intravenous use only and must be diluted prior to intravenous administration [see Dosage and Administration ] .
SAPHNELO prefilled syringe and autoinjector (SAPHNELO PEN) are for subcutaneous use only [see Dosage and Administration ] .
Recommended Dosage The recommended dosage of SAPHNELO is:
300 mg, administered as an intravenous infusion over a 30‑minute period every 4 weeks; or
120 mg, administered as a subcutaneous injection once every week. Missed Dose If a planned intravenous infusion is missed, administer SAPHNELO as soon as possible. Maintain a minimum interval of 14 days between infusions. If a planned subcutaneous dose is missed, instruct the patient to administer SAPHNELO as soon as they remember.
Thereafter, instruct the patient to start a new weekly schedule from the day the missed dose was administered or resume dosing on their usual day of administration, providing a minimum interval of 3 days between subcutaneous injections.
Intravenous Preparation and Administration Instructions SAPHNELO is supplied as a single-dose vial. Prepare the diluted infusion solution using aseptic technique, by the following procedure: 1. Visually inspect the vial for particulate matter and discoloration. SAPHNELO is a clear to opalescent, colorless to slightly yellow, solution.
Discard the vial if the solution is cloudy, discolored or visible particles are observed. Do not shake the vial. 2. Withdraw and discard 2 mL of solution from a 50 mL or 100 mL 0.9% Sodium Chloride Injection, USP infusion bag. 3. Withdraw 2 mL of solution from the vial of SAPHNELO and add it to the infusion bag. Mix the solution by gentle inversion.
Do not shake. 4. Each vial is intended for one time use only. Discard any unused portion remaining in the vial. 5. Administer the infusion solution immediately after preparation. 6. If the infusion solution is not administered immediately, store the diluted solution of SAPHNELO at room temperature 59°F to 77°F (15°C to 25°C) for up to 4 hours, or refrigerated 36°F to 46°F (2°C to 8°C) for up to 24 hours.
Do not freeze. Protect from light. If refrigerated, allow the diluted SAPHNELO solution to reach room temperature prior to administration. 7. Administer the infusion solution intravenously over a 30-minute period through an infusion line containing a sterile, low-protein binding 0.2 to 15 micron in-line or add-on filter. 8.
To ensure the complete dose of SAPHNELO has been administered, flush the entire infusion line with 25 mL of 0.9% Sodium Chloride Injection, USP at the end of the infusion. 9. Do not co-administer other medicinal products through the same infusion line. 10. Dispose of any unused medicinal product or waste material in accordance with local requirements .
Subcutaneous Preparation and Administration Instructions The SAPHNELO prefilled syringe and autoinjector (SAPHNELO PEN) are for subcutaneous use. 1. Comprehensive instructions for subcutaneous administration of SAPHNELO using the prefilled syringe or autoinjector are provided in the ‘Instructions for Use’. 2. Patients/caregivers may administer SAPHNELO prefilled syringe/SAPHNELO PEN after proper training in the subcutaneous injection technique and after the healthcare provider determines it is appropriate. 3.
Prior to administration, remove SAPHNELO from the refrigerator and allow it to come to room temperature for 60 minutes. 4. Visually inspect SAPHNELO for particulate matter and discoloration prior to administration. SAPHNELO is a clear to opalescent, colorless to slightly yellow, solution. Discard the prefilled syringe or autoinjector if the solution is cloudy, discolored or visible particles are observed. 5.
Administer the subcutaneous injection into the thigh or abdomen, avoiding the 5 cm (approximately 2 inches) area around the navel. The upper arm can also be used if a healthcare professional or caregiver administers the injection. 6. Do not inject into areas where the skin is tender, bruised, erythematous or hardened. When injecting in the same region, advise patients to use an injection site at least 3 cm (1‑inch) away from the last injection site. 7.
Dispose of any unused medicinal product or waste material in accordance with local requirements.
Switching Between Intravenous and Subcutaneous Administration When transitioning patients from intravenous administration to subcutaneous administration of SAPHNELO, administer the first subcutaneous injection approximately 2 weeks after the last intravenous infusion. When transitioning patients from subcutaneous administration to intravenous administration of SAPHNELO, administer the first intravenous infusion approximately 3 to 4 weeks after the last subcutaneous injection.
Drug interactions
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- Anifrolumab
Label text (1 paragraph)
No formal drug interaction trials have been conducted.
Contraindications
4 CONTRAINDICATIONS 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 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
ELikelihood score E: Unlikely cause of clinically apparent liver injury.
Anifrolumab is a human monoclonal antibody to the type 1 interferon receptor which is used in the therapy of moderate-to-severe systemic lupus erythematous. Anifrolumab has been linked to a low incidence of transient serum enzyme elevations during therapy and has not been linked to instances of clinically apparent liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to SAPHNELO during pregnancy. For more information about the registry or to report a pregnancy while on SAPHNELO, healthcare providers should contact AstraZeneca at 1‑877‑693‑9268 or https://anifrolumabpregnancyandbreastfeedingstudy.us/ . Risk Summary The limited human data with SAPHNELO use in pregnant women are insufficient to inform on drug‑associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcome.
Monoclonal IgG antibodies are known to be actively transported across the placenta as pregnancy progresses; therefore, anifrolumab‑fnia exposure to the fetus may be greater during the third trimester of pregnancy. In an enhanced pre- and post-natal development study with pregnant cynomolgus monkeys that received intravenous administration of anifrolumab-fnia, there was no evidence of embryotoxicity or fetal malformations with exposures up to approximately 28‑times the exposure at the maximum recommended human dose (MRHD) on an Area Under Curve (AUC) basis (see Data ) . All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk : Pregnant women with SLE are at increased risk of adverse pregnancy outcomes, including worsening of the underlying disease, premature birth, miscarriage, and intrauterine growth restriction. Maternal lupus nephritis increases the risk of hypertension and preeclampsia/eclampsia.
Passage of maternal autoantibodies across the placenta may result in adverse neonatal outcomes, including neonatal lupus and congenital heart block. Data Animal Data : In an enhanced pre- and post-natal development study, pregnant cynomolgus monkeys received anifrolumab-fnia at intravenous doses of 30 or 60 mg/kg once every 2 weeks from confirmation of pregnancy at Gestation Day 20, throughout the gestation period, and continuing until 1‑month post-partum (approximately Lactation Day 28). There was no evidence of anifrolumab-fnia related maternal toxicity, embryo-fetal toxicity, or post-natal developmental effects.
No anifrolumab-fnia related effect on T-cell-dependent antibody response in the infants was…
Breastfeeding (LactMed)
Anifrolumab concentration in milk was very low in one mother, consistent with it being a large protein molecule with a molecular weight of 148,000 Da. It is also likely to be partially destroyed in the infant’s gastrointestinal tract and absorption by the infant is probably minimal. An infant exposed during pregnancy and breastfeeding had no adverse effects. Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant. Until more data become available, anifrolumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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