SAPHNELO™ (anifrolumab-fnia) injection
Drug UPDATES: [Drug information (pdf)]
- Administer the infusion solution intravenously over a 30-minute period through an infusion line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.
- Upon completion of the infusion, flush the infusion set with 25 mL of 0.9% Sodium Chloride Injection, USP to ensure that all of the solution for infusion has been administered.
The recommended dosage of SAPHNELO is 300 mg, administered as an intravenous infusion over a 30-minute period, every 4 weeks.
- 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.
- Withdraw and discard 2 mL of solution from a 100 mL 0.9% Sodium Chloride Injection, USP infusion bag
- 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.
- Each vial is intended for one time use only. Discard any unused portion remaining in the vial.
- Administer the infusion solution immediately after preparation.
- Stability: 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.
- Do not co-administer other medicinal products through the same infusion line.
- Dispose of any unused medicinal product or waste material in accordance with local requirements.
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.
Anifrolumab-fnia is a human IgG1κ monoclonal antibody that binds to subunit 1 of the type I interferon receptor (IFNAR) with high specificity and affinity. This binding inhibits type I IFN signaling, thereby blocking the biologic activity of type I IFNs. Anifrolumab-fnia also induces the internalization of IFNAR1, thereby reducing the levels of cell surface IFNAR1 available for receptor assembly. Blockade of receptor mediated type I IFN signaling inhibits IFN responsive gene expression as well as downstream inflammatory and immunological processes. Inhibition of type I IFN blocks plasma cell differentiation and normalizes peripheral T-cell subsets.
Type I IFNs play a role in the pathogenesis of SLE. Approximately 60-80% of adult patients with active SLE express elevated levels of type I IFN inducible genes.
SAPHNELO (anifrolumab-fnia) is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy.
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 contraindicated in patients with a history of anaphylaxis with anifrolumab-fnia.
WARNINGS 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.
- Hypersensitivity Reactions Including Anaphylaxis: Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported.
- Malignancy: Consider the individual benefit-risk in patients with known risk factors for malignancy prior to prescribing SAPHNELO.
- Immunization: Avoid use of live or live-attenuated vaccines in patients receiving SAPHNELO.
- Not Recommended for Use with Other Biologic Therapies.
- Drug information (pdf)
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.
See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide. Drug information (pdf)
2.1 Dosage Recommendations
SAPHNELO must be diluted prior to intravenous administration
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:
- 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.
- Withdraw and discard 2 mL of solution from a 100 mL 0.9% Sodium Chloride Injection, USP infusion bag
- 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.
- Each vial is intended for one time use only. Discard any unused portion remaining in the vial.
- Administer the infusion solution immediately after preparation.
- 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.
- Administer the infusion solution intravenously over a 30-minute period through an infusion line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.
- Upon completion of the infusion, flush the infusion set with 25 mL of 0.9% Sodium Chloride Injection, USP to ensure that all of the solution for infusion has been administered.
- Do not co-administer other medicinal products through the same infusion line.
- Dispose of any unused medicinal product or waste material in accordance with local requirements.
Injection: 300 mg/2 mL (150 mg/mL) as a clear to opalescent, colorless to slightly yellow, solution in a single-dose vial.
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.
