Anifrolumab-Fnia

FDA Drug Information • Also known as: Saphnelo

Brand Names: Saphnelo
Drug Class: Type I Interferon Receptor Antagonist [EPC]
Route: INTRAVENOUS
Dosage Form: INJECTION, SOLUTION
Product Type: HUMAN PRESCRIPTION DRUG

Description

11 DESCRIPTION Anifrolumab-fnia is a type I interferon (IFN) receptor antagonist, immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that is produced in mouse myeloma cells (NS0) by recombinant DNA technology. The molecular weight is approximately 148 kDa. SAPHNELO (anifrolumab-fnia) injection is a sterile, preservative‑free, clear to opalescent, colorless to slightly yellow, solution for intravenous use. SAPHNELO contains anifrolumab-fnia at a concentration of 150 mg/mL in a single-dose vial. Each vial contains 300 mg (150 mg/mL) of anifrolumab-fnia, L-histidine (3 mg), L-histidine hydrochloride monohydrate (6 mg), L-lysine hydrochloride (18 mg), polysorbate 80 (1 mg), trehalose dihydrate (98 mg), and Water for Injection, USP. The pH is 5.9.

What Is Anifrolumab-Fnia Used For?

1 INDICATIONS AND USAGE SAPHNELO (anifrolumab-fnia) is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy [see Clinical Studies (14) ] . Limitations of Use The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of SAPHNELO is not recommended in these situations. SAPHNELO is a type I interferon (IFN) receptor antagonist indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. ( 1 ) Limitations of Use: The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of SAPHNELO is not recommended in these situations. ( 1 )

Dosage and Administration

2 DOSAGE AND ADMINISTRATION The recommended dosage is 300 mg as an intravenous infusion over a 30‑minute period every 4 weeks. For complete dilution and intravenous administration instructions see Full Prescribing Information. ( 2.1 ) 2.1 Dosage Recommendations SAPHNELO must be diluted prior to intravenous administration [see Dosage and Administration (2.2) ] . The recommended dosage of SAPHNELO is 300 mg, administered as an intravenous infusion over a 30-minute period, every 4 weeks. Missed dose If a planned infusion is missed, administer SAPHNELO as soon as possible. Maintain a minimum interval of 14 days between infusions. 2.2 Instructions for Preparation and Administration 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 .

Side Effects (Adverse Reactions)

6 ADVERSE REACTIONS The following clinically significant adverse reactions are also discussed elsewhere in the labeling:

Serious Infections [see Warnings and Precautions (5.1) ]

Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions (5.2) ]

Malignancy [see Warnings and Precautions (5.3) ] Most common adverse drug reactions (incidence ≥5%) are nasopharyngitis, upper respiratory tract infections, bronchitis, infusion related reactions, herpes zoster and cough. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of SAPHNELO was assessed through 52 weeks in patients with moderate to severe SLE who received anifrolumab-fnia 300 mg by intravenous infusion every 4 weeks (N=459), compared to placebo (N=466) in controlled clinical trials (Trials 1, 2 and 3) [see Clinical Studies (14) ]. The population studied had a mean age of 41 years (range: 18 to 69), of which 93% were female, 60% White, 13% Black/African American, and 10% Asian. In the controlled-clinical trials, adverse reactions, irrespective of causality, were reported in 87% of patients receiving SAPHNELO and 79% of patients receiving placebo. Adverse reactions that occurred at greater than or equal to 2% incidence are shown in Table 1. Table 1 Adverse Reactions Occurring in ≥2% of Patients on SAPHNELO 300 mg (Trials 1, 2 and 3) at 52 weeks Adverse Reaction SAPHNELO (N=459) % Placebo (N=466) % Upper respiratory tract infection Upper respiratory tract infections (including Upper respiratory tract infections, Nasopharyngitis, Pharyngitis) 34 23 Bronchitis Bronchitis (including Bronchitis, Bronchitis viral, Tracheobronchitis) 11 5.2 Infusion‑related reactions 9.4 7.1 Herpes Zoster 6.1 1.3 Cough 5.0 3.2 Respiratory tract infection Respiratory tract infection (including Respiratory tract infection, Respiratory tract infection viral, Respiratory tract infection bacterial) 3.3 1.5 Hypersensitivity 2.8 0.6 All patients received standard therapy. Long-term Safety Patients who completed Trials 2 and 3 (Phase III feeder trials) were eligible to continue on treatment in a randomized, double-blind, placebo-controlled long-term extension (LTE) study, for an additional 3 years. The long-term safety of SAPHNELO was assessed in 257 patients who received anifrolumab-fnia 300 mg and 112 patients who received placebo in both a feeder trial and the LTE. Of these, 177 patients who received SAPHNELO (68.9%) and 52 patients who received placebo (46.4%) completed a total of 4 years on treatment. The overall long-term safety profile of SAPHNELO was consistent with Trials 1, 2 and 3. Specific Adverse Reactions Infections In the 52‑week controlled-clinical trials, infections were reported in a greater proportion of patients while on treatment with SAPHNELO compared to placebo (69.7% [320/459] versus 55.4% [258/466]), corresponding to exposure-adjusted incidence rates (EAIR) of 141.8 and 99.9 per 100 patient years (PY), respectively. Serious Infections In the 52‑week controlled-clinical trials, the incidence of serious infections while on treatment was 4.8% (22/459) in patients treated with SAPHNELO compared with 5.6% (26/466) in patients receiving placebo, corresponding to EAIR of 5.4 and 6.6 per 100 PY, respectively. The most frequent serious infection was pneumonia. In the 52‑week controlled-clinical trials, fatal infections occurred in 0.4% of patients receiving SAPHNELO and 0.2% of the patients receiving placebo. During the LTE study, the most common serious infections were COVID-19 and pneumonia. Herpes Zoster In the 52‑week controlled-clinical trials, the incidence of herpes zoster in...

Drug Interactions

7 DRUG INTERACTIONS No formal drug interaction studies 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 )

Pregnancy and Breastfeeding

8.1 Pregnancy Pregnancy Exposure Registry A pregnancy exposure registry monitors pregnancy outcomes in women exposed to SAPHNELO during pregnancy. For more information about the registry or to report a pregnancy while on SAPHNELO, contact AstraZeneca at 1‑877‑693‑9268. 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...

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING SAPHNELO (anifrolumab-fnia) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution for intravenous infusion. It is packaged in a 2 mL clear glass vial containing 300 mg/2 mL (150 mg/mL) of anifrolumab-fnia. SAPHNELO is available in a carton containing one single-dose vial (NDC-0310-3040-00). Store in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do not freeze. Do not shake.

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.