Saphnelo

Saphnelo (anifrolumab) is a prescription biologic medicine used to treat moderate to severe systemic lupus erythematosus (SLE or lupus) in adults. It is used in combination with other lupus medicines.

Saphnelo is an IFN-1 receptor antagonist that works by blocking type I interferon, a protein that drives inflammation in SLE. By blocking the IFN-1 receptor, Saphnelo helps reduce the body's overactive immune and inflammatory response, which helps reduce overall disease activity and flares, and improving skin rashes, joint pain, and swelling.

Saphnelo can be self-administered as a subcutaneous injection once weekly using the Saphnelo Pen or pre-filled syringe. It may also be administered as an intravenous (IV) infusion over 30 minutes once every four weeks by your healthcare professional.

It is not recommended for use in severe active lupus nephritis (kidney involvement) or severe active central nervous system lupus.

Saphnelo works by blocking type 1 interferon (IFN-1), a protein that contributes to the immune system attacking otherwise healthy tissue in patients with lupus. By blocking IFN-1 activity, Saphnelo helps reduce overall disease activity and may help improve symptoms of SLE.

Saphnelo belongs to the drug class known as type I interferon (IFN) receptor antagonists and is a monoclonal antibody

Saphnelo FDA approval was granted on July 30, 2021, after positive results from Trial 1 (NCT01438489 MUSE), Trial 2 (NCT02446912 TULIP‑1), and Trial 3 (NCT02446899 TULIP‑2).

Clinical trials from the TULIP and MUSE programs demonstrated that Saphnelo significantly reduced disease activity compared with standard therapy alone and led to higher rates of remission.

TULIP-2 Clinical Trial Results

In the phase 3 TULIP-2 clinical trial, Saphnelo showed measurable benefits compared with placebo:

• Improved lupus disease activity: 48% achieved a BICLA response vs 32% with placebo, a 16-point improvement
• Greater benefit in high interferon patients: 48% vs 31%, a 17-point improvement
• Reduced steroid use: 52% lowered glucocorticoids to ≤7.5 mg/day vs 30% - a 22-point improvement
• Improved lupus skin symptoms: 49% had at least 50% improvement in CLASI activity vs 25%, a 24-point improvement

IV Infusion

• Saphnelo can be given as an IV infusion through a vein, usually over about 30 minutes.
• It is typically administered once every 4 weeks, although your doctor may adjust the schedule depending on your response.

Subcutaneous Injection

• Saphnelo Pen and prefilled syringe are given as a subcutaneous injection (injection under the skin)
• The recommended subcutaneous dosage is 120 mg once every week
• Before administration, the Saphnelo Pen and prefilled syringe should be removed from the refrigerator and allowed to reach room temperature for 60 minutes.

If you miss an appointment, call your healthcare provider as soon as possible to reschedule.

Serious Infections: This medicine has caused serious and sometimes fatal infections in some people. It increases the risk of respiratory infections and herpes zoster. Do not start this medicine during an active infection, and consider the risk-benefit if using it with severe or chronic infections. Consider interrupting treatment with this infusion if a new infection develops during treatment.

Serious allergic reactions: Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with this medicine.

Malignancy: Consider the individual benefit-risk in patients with known risk factors for cancer before prescribing this infusion.

Immunizations: Avoid live or live-attenuated vaccines during treatment with this medicine

Saphnelo is not recommended with other biologic therapies.

Do not use this medicine if you are allergic to anifrolumab-fnia or any inactive ingredient in the injection.(See the Ingredients section below for the full list.)

Before receiving Saphnelo, tell your healthcare provider if you:

• Have or may have an infection, or experience frequent infections. You should not receive Saphnelo during an active infection unless your healthcare provider instructs you to.
• Have or have had any type of cancer, as immunosuppressive medicines may increase cancer risk.
• Are receiving other biologic therapies or monoclonal antibodies.

Make sure you are up to date on all vaccines before you start using this medicine. You should not receive live vaccines during treatment with Saphnelo.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant, as it is not known if Saphnelo will harm your unborn baby.

Saphnelo may affect your baby's immune system, but having SLE during pregnancy may cause complications such as worsened lupus, dangerously high blood pressure (eclampsia), premature birth, miscarriage, or growth problems in the unborn baby. SLE in the mother may also cause lupus or heart problems to develop in the newborn. The benefit of treating SLE may outweigh any risks to the baby.

Pregnancy Exposure Registry. A pregnancy exposure registry monitors pregnancy outcomes in women who have used this medicine. You can find out more information about the Saphnelo pregnancy registry by calling AstraZeneca at 1-877-693-9268 or visiting https://anifrolumabpregnancyandbreastfeedingstudy.us/

Breastfeeding

If you are breastfeeding or planning to breastfeed while on Saphnelo, you should talk to your healthcare professional, as it is not known if this medicine passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while receiving this medicine.

Common Side Effects

May include:

• Upper respiratory infections
• Infusion reactions
• Cough
• Shingles (herpes zoster)
• Bronchitis

Serious Side Effects

Serious Infections. It can lower your immune system’s ability to fight infections, increasing the risk of respiratory infections and shingles. Infections (including COVID-19) could be serious, leading to hospitalization or death.Call your healthcare provider right away if you experience:

• Fever, chills, or sweating
• Muscle aches
• Cough or shortness of breath
• Burning or frequent urination
• Diarrhea or stomach pain
• Warm, red, or painful skin lesions

Allergic (Hypersensitivity) Reactions. These can occur during or after the infusion. Seek emergency help if you experience:

• Swelling of the face, mouth, or tongue
• Dizziness or fainting
• Difficulty breathing
• Lightheadedness or low blood pressure

Cancer Risk. Because Saphnelo affects the immune system, it may slightly increase the risk of certain cancers.

Also, see the Warnings and Precautions section.

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Avoid receiving a "live" vaccine. The vaccine may not work as well while you are using anifrolumab. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Usual Saphnelo Adult Intravenous Dose for Systemic Lupus Erythematosus:

• 300 mg intravenous infusion given over 30 minutes every 4 weeks.
• Available as 300 mg/2 mL (150 mg/mL) single-dose vial.

Usual Saphnelo Adult Subcutaneous Dose for Systemic Lupus Erythematosus:

• 120 mg once every week, as a subcutaneous injection
• Available as 120 mg/0.8 mL in a single-dose prefilled syringe or single-dose autoinjector (Saphnelo Pen)

This medicine is not recommended for patients with severe active lupus nephritis or severe active central nervous system lupus, as the efficacy in these patients has not been evaluated.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your injection.

If a planned infusion of this medicine is missed, it should be given as soon as possible, but maintain a minimum interval of 14 days between infusions.

If you miss your subcutaneous dose, inject a dose as soon as you remember. Then, continue to inject 1 time each week based on the new day it was injected or at your regularly scheduled time as long as there are at least 3 days between the doses. In case you are not sure when to inject, call your healthcare provider.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Many drugs can interact with Saphnelo, and some drugs should not be used at the same time. Tell your doctor about all other medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

HCPs and patients often use the Saphnelo Package Insert (PI) for more detailed information about this medicine. The Package Insert contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interactions, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Prescribing Information (PI) or FDA label.

• Store in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. If needed, the prefilled syringe or autoinjector can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 7 days in the original carton to protect from light. After it has reached room temperature, do not return to the refrigerator. Throw away if not used within 7 days at room temperature.
• Do not freeze. Do not shake. Do not expose to heat.

Active ingredient: anifrolumab-fnia

Inactive ingredients: Intravenous infusion: L-histidine, L-histidine hydrochloride monohydrate, L-lysine hydrochloride, trehalose dihydrate, polysorbate 80 and Water for Injection. Subcutaneous injection: histidine, L-histidine hydrochloride monohydrate, lysine hydrochloride, polysorbate 80, trehalose, and Water for Injection.

The Saphnelo prefilled syringe and autoinjector are not made with natural rubber latex.

Manufactured by: AstraZeneca AB Södertälje, Sweden SE-15185.

Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850.