Anifrolumab

What is Anifrolumab?

• Anifrolumab (Saphnelo) is a type I interferon (IFN) receptor antagonist used to treat moderate-to severe systemic lupus erythematosus along with standard therapy.

What are the uses of this medicine?

• Anifrolumab (Saphnelo) used to treat adults with moderate to severe systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines.
• Saphnelo contains anifrolumab-fnia which is in a group of medicines called monoclonal antibodies.
• Lupus is a disease of the immune system (the body system that fights infection).
• When given together with other medicines for lupus, Saphnelo may help to reduce your lupus disease activity more than other lupus medicines alone.

Limitations of Use:

• It is not known if Saphnelo is effective in people with severe active lupus nephritis or central nervous system lupus.

How does this medicine work?

• 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 systemic lupus erythematosus (SLE).
• Approximately 60-80% of adult patients with active SLE express elevated levels of type I IFN inducible genes.

Who Should Not Use this medicine ?

• This medicine cannot be used in patients who:
• are allergic to anifrolumab-fnia or any of the ingredients in Saphnelo.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted.
• Saphnelo may affect the way other medicines work, and other medicines may affect how Saphnelo works.

Is this medicine FDA approved?

• Anifrolumab was approved for medical use in the United States in July 2021.

How should this medicine be used?

Recommended dosage:

• The recommended dosage of Saphnelo is 300 mg, administered as an intravenous infusion over a 30-minute period, every 4 weeks.

Administration:

• Your healthcare provider will give you Saphnelo through a needle placed in a vein (IV or intravenous infusion). It takes about 30 minutes to give you the full dose of Saphnelo.
• Saphnelo is usually given 1 time every 4 weeks.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 300 mg/2 mL (150 mg/mL) in a single-dose vial.

This medicine is available in fallowing brand namesː

• Saphnelo

What side effects can this medication cause?

The most common side effects of this medicine include:

• upper respiratory infections
• infusion reactions
• cough
• bronchitis
• shingles (herpes zoster)

TIVDAK can cause serious side effects, including:

• Serious Infections
• Allergic (hypersensitivity) reactions
• Cancer

What special precautions should I follow?

• 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.
• Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported. Consider the benefit and risk of administering Saphnelo in patients with a chronic infection, a history of recurrent infections, or known risk factors for infection. Avoid initiating treatment with Saphnelo in patients with any clinically significant active infection until the infection resolves or is adequately treated.
• There is an increased risk of malignancies with the use of immunosuppressants. Consider the individual benefit-risk in patients with known risk factors for malignancy prior to prescribing Saphnelo.
• Avoid concurrent use of live or live-attenuated vaccines in patients treated with Saphnelo.
• Saphnelo has not been studied in combination with other biologic therapies, including B-cell-targeted therapies. Therefore, use of Saphnelo is not recommended for use in combination with biologic therapies.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• It is not known if Saphnelo will harm your unborn baby.
• If you become pregnant while receiving Saphnelo, talk to your healthcare provider.
• A pregnancy exposure registry monitors pregnancy outcomes in women exposed to Saphnelo. You can find out more information about the registry by calling AstraZeneca at 1-877-693-9268.

Can this medicine be used in children?

• It is not known if Saphnelo is safe and effective in children under 18 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: anifrolumab-fnia
• Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, L-lysine hydrochloride, trehalose dihydrate, polysorbate 80 and Water for Injection.

Who manufactures and distributes this medicine?

• The drug was developed by MedImmune, a unit of AstraZeneca. The pharmaceutical company chose to move anifrolumab instead of sifalimumab into phase III trials for lupus in 2015.
• Manufactured by: AstraZeneca AB Södertälje, Sweden SE
• Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Anifrolumab
• FDA Anifrolumab

Anifrolumab Resources
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