Anifrolimab-Fnia: uses, dosing, side effects & brands
Anifrolimab-Fnia is a medicine sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Available as
- Injectable
- Sold as
- Saphnelo
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How anifrolimab-fnia is dosed
From the FDA label for Saphnelo (application BLA761451). Other anifrolimab-fnia products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
The recommended intravenous dosage is 300 mg every 4 weeks. ( 2.2 ) • The recommended subcutaneous dosage is 120 mg once every week. ( 2.2 ) • See Full Prescribing Information for complete preparation and administration information. ( 2.3 , 2.4 ) 2.1 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 (2.3) ] . SAPHNELO prefilled syringe and autoinjector (SAPHNELO PEN) are for subcutaneous use only [see Dosage and Administration (2.4) ] . 2.2 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…
Anifrolimab-Fnia side effects
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. Adverse Reactions with Intravenous Administration The safety of SAPHNELO was assessed in adult patients with moderate to severe SLE who received SAPHNELO 300 mg by intravenous infusion every 4 weeks (N=459) for 52 weeks, compared to placebo (N=466) in controlled clinical trials (Trials 1, 2 and 3) [see Clinical Studies (14.1) ]. 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…
Who shouldn’t take anifrolimab-fnia
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 )
Anifrolimab-Fnia drug interactions
No formal drug interaction trials have been conducted.
Every anifrolimab-fnia product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Saphnelo.
Related calculators
Frequently asked questions
What is anifrolimab-fnia?
Saphnelo (Anifrolimab-Fnia) is a medication supplied as an injection, solution.
Can you take anifrolimab-fnia with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run anifrolimab-fnia against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does anifrolimab-fnia come in?
Across the brands we track, anifrolimab-fnia is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic anifrolimab-fnia?
We do not currently list a generic-labelled anifrolimab-fnia product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Anifrolimab-Fnia: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/anifrolimab-fnia
- MLA
- “Anifrolimab-Fnia: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/anifrolimab-fnia.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for anifrolimab-fnia on DailyMed (NIH) ↗.