Saphnelo (anifrolumab) for sale – Buy Saphnelo (anifrolumab) Online
What is Saphnelo (anifrolumab) for?
Saphnelo (anifrolumab) is a first-in-class type I interferon receptor antibody with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.[1]
It is available in vial form, each containing 300 mg/2 mL (150 mg/mL) anifrolumab.[1]
How does Saphnelo (anifrolumab) work?
SLE is an autoimmune disease, the most common form of lupus. In SLE patients, the immune system produces antibodies that can attack any part of the body. SLE can affect multiple organs and damage them.[2]
Anifrolumab can block type I interferons (IFN), which are proteins made by the immune system, which are one of the main triggers of tissue damage and progression of the disease. The majority of SLE patients have increased type I IFN signaling, which is associated with symptoms and severity of the disease.[2]
Where has Saphnelo (anifrolumab) been approved?
Saphnelo (anifrolumab) was approved for the treatment of people with SLE by:[3]
The Food and Drug Administration (FDA), USA on August 2, 2021.Saphnelo (anifrolumab) was approved under Priority Review and was previously granted Fast Track designation by the FDA in 2016.[3]
Saphnelo is also under regulatory review for SLE in the EU and Japan. A Phase 3 trial in SLE patients using subcutaneous (under the skin) delivery has been started and additional Phase 3 trials are planned for lupus nephritis, cutaneous lupus erythematosus and myositis.[3]
Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.
How is Saphnelo (anifrolumab) taken?
The standard dosage is:[1]
300 mg given through a needle placed in a vein (IV or intravenous infusion) once every 4 weeks.It takes about 30 minutes to administer the full dose.[1]
Avoid the use of live or live-attenuated vaccines during treatment with Saphnelo (anifrolumab).[1]
Saphnelo (anifrolumab) is not recommended for use in combination with other biologic therapies, including B-cell targeted therapies.[1]
Complete information about Saphnelo (anifrolumab) dosage and administration can be found in the official prescribing information listed in our references section.[1]
Note: Please consult with your treating doctor for personalised dosing.
Are there any known adverse reactions or side effects of Saphnelo (anifrolumab)?
Common adverse reactions
The most common side effects (≥5% of patients) listed in the prescribing information include:[1]
- upper respiratory infections
- infusion reactions
- cough
- bronchitis
- shingles (herpes zoster)
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:[1]
- serious infections
- allergic (hypersensitivity) reactions
- cancer
Use in a specific population
It is not (yet) known if Saphnelo (anifrolumab) can cause major birth defects or miscarriage. Females who are able to become pregnant are advised to inform their treating doctor if they intend to become pregnant during therapy, suspect they are pregnant or become pregnant while receiving this medicine.[1]
The safety and efficacy of Saphnelo (anifrolumab) in patients younger than 18 years of age has not been established.[1]
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.[1]
References
1. Full prescribing information [FDA]: Saphnelo (anifrolumab) [PDF]
AstraZeneca, Aug 2021
2. Lupus Research Alliance Applauds U.S. FDA Approval of AstraZeneca’s anifrolumab-fnia (Saphnelo™) for Systemic Lupus Erythematosus (SLE)
Lupusresearch.org, Aug 2021
3. Saphnelo (anifrolumab) approved in the US for moderate to severe systemic lupus erythematosus
AstraZeneca, Aug 2021
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