SAPHNELO 300 mg/2mL
Anifrolumab-fnia · INJECTION, SOLUTION · AstraZeneca Pharmaceuticals LP
SAPHNELO is a injection, solution containing anifrolumab-fnia at 300 mg/2mL, taken intravenous. Manufactured by AstraZeneca Pharmaceuticals LP.
Key Facts
- Brand Name
- SAPHNELO
- Generic Name
- Anifrolumab-fnia
- NDC Code (Product)
0310-3040- Manufacturer
- AstraZeneca Pharmaceuticals LP
- Strength
- 300 mg/2mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA761123
- Drug Class
- Type I Interferon Receptor Antagonist [EPC]
- Marketing Start
- 07/30/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE SAPHNELO 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 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 & Administration
2 DOSAGE AND ADMINISTRATION • 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 …
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 )
Drug Interactions
7 DRUG INTERACTIONS No formal drug interaction trials have been conducted.
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. 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 …
Frequently Asked Questions
What is SAPHNELO used for?
SAPHNELO contains Anifrolumab-fnia. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is SAPHNELO a controlled substance?
SAPHNELO is not classified as a controlled substance by the DEA.
What is the generic name for SAPHNELO?
The generic name for SAPHNELO is Anifrolumab-fnia. There are no other listed brand versions of Anifrolumab-fnia.
What is the NDC code for SAPHNELO 300 mg/2mL?
The NDC (National Drug Code) for SAPHNELO 300 mg/2mL is 0310-3040, listed by AstraZeneca Pharmaceuticals LP.
Other SAPHNELO Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)