Saphnelo
Pronunciation: saf-NEH-low
Generic name: anifrolumab-fnia
Dosage form: injection, for intravenous use
Drug class: Selective immunosuppressants
What is Saphnelo?
Saphnelo (anifrolumab) is a prescription medicine used for moderate to severe systemic lupus erythematosus (SLE or lupus) as an add-on treatment to other lupus medicines. Saphnelo helps reduce the body's overactive immune and inflammatory response, which improves symptoms of SLE.
Saphnelo is a monoclonal antibody that works by blocking a protein called type I interferon (IFN-1), which has a role in causing the immune system to attack otherwise healthy tissue. Saphnelo drug class is a type I interferon (IFN) receptor antagonist.
Saphnelo is administered as an intravenous (IV) infusion usually once every 4 weeks.
What is Saphnelo used for?
Saphnelo is FDA-approved to be used by adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.
It is not recommended for severe active lupus nephritis or severe active central nervous system lupus and is not approved for use by anyone younger than 18 years old.
Saphnelo FDA approval was granted on July 30, 2021, after positive results from Trial 1 (NCT01438489), Trial 2 (NCT02446912), and Trial 3 (NCT02446899).
Warnings and Precautions
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.
Before receiving this medicine
You should not use this medicine if you are allergic to the active ingredient anifrolumab-fnia or any of the inactive ingredients in the injection. There is a complete list of ingredients at the bottom of this page.
Before you receive Saphnelo, it is important to tell your healthcare provider about all of your medical conditions, especially if you:
- may have an infection or have infections that keep coming back. If you have an infection, you should not receive Saphnelo unless your doctor or other healthcare provider tells you to. See the Side Effects section below for a list of infection symptoms.
- have or have had any type of cancer, as there is an increased risk of cancer with the use of immunosuppressants.
- are receiving other biologic medicines 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.
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.
How will I receive Saphnelo?
- Saphnelo is a solution your healthcare provider will give you through a needle placed in a vein (IV or intravenous infusion). It takes about 30 minutes to give you the full dose.
- Saphnelo is usually given once every 4 weeks, but your doctor will decide how often you have this medicine depending on how your body responds to it.
- This medicine helps to control SLE but does not cure it.
- If you miss an appointment, call your healthcare provider as soon as possible to reschedule your appointment.
Saphnelo dosing information
Usual Saphnelo Adult 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.
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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Saphnelo side effects
Common side effects
Common Saphnelo side effects may include upper respiratory infections, infusion reactions, cough, shingles (herpes zoster), and bronchitis.
Serious side effects
Saphnelo may cause serious side effects, including:
Serious Infections. This medicine can lower the ability of your immune system to fight infections. You may be at a higher risk of developing respiratory infections and shingles (herpes zoster) during treatment. Infections could be serious, leading to hospitalization or death. Tell your healthcare provider right away if you have any of the following symptoms of an infection:
- fever, sweating, or chills
- muscle aches
- cough
- shortness of breath
- burning when urinating
- urinating more often
- diarrhea or stomach pain
- warm, red, or painful skin or sores on your body.
Allergic (hypersensitivity) reactions, including anaphylaxis. Serious allergic reactions can happen during or after you get your infusion. Tell your healthcare provider or get emergency help right away if you have any of the following symptoms of a serious allergic reaction:
- swelling of your face, mouth, and tongue
- fainting or dizziness
- breathing problems
- feeling lightheaded (low blood pressure)
Cancer. Saphnelo may reduce the activity of your immune system. Medicines that affect the immune system may increase your 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.
Related/similar drugs
What should I avoid while receiving this medicine?
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).
What other drugs will affect this medicine?
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.
Saphnelo Package Insert
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 Interaction, 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.
Storage
- 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.
Ingredients
Active ingredient: anifrolumab-fnia
Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, L-lysine hydrochloride, trehalose dihydrate, polysorbate 80 and Water for Injection.
Company
- Manufactured by: AstraZeneca AB Södertälje, Sweden SE-15185.
- Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850.
Saphnelo Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Saphnelo.
Saphnelo (anifrolumab-fnia) - AstraZeneca AB
| Formulation type | Strength |
|---|---|
| Single-Dose Vial | 300 mg/2 mL (150 mg/mL) |
Popular FAQ
How long does it take for Saphnelo to work?
Saphnelo starts to block interferon receptors as soon as it is administered, but it may take about 3 to 6 months of regular monthly injections before you notice the full effects of the medication and noticeable symptom relief. The endpoint of most trials was an improvement in disease activity after 52 weeks which was significantly improved in 62% to 100% of trial participants, depending on the trial.
What is the difference between Benlysta and Saphnelo?
Both Benlysta and Saphnelo are targeted treatments that may be used to treat systemic lupus erythematosus (SLE) in addition to standard therapy. But their approved indications, recommended target age groups, and the way they work, differ. They are the only two medicines to have been approved to treat SLE since the 1950s.
Continue readingIs Saphnelo a chemo drug or immunosuppressant?
Saphnelo is not chemotherapy (chemotherapy works by targeting actively dividing cells), but it is an immunosuppressant because it is a human monoclonal antibody that specifically targets the type I interferon receptor, inhibiting the activity of type 1 interferons. SLE is characterized by an activation of the interferon system which leads to almost continuous immune system activity, and the typical symptoms of SLE such as fatigue; joint pain, stiffness, and swelling; and the butterfly-shaped rash on the face.
How long does a Saphnelo infusion take?
A Saphnelo infusion takes about 30 minutes to administer. The medicine is diluted into an infusion bag by your healthcare provider, and while you are seated, the infusion mixture will run into your vein through a needle (this is called an intravenous infusion). A Saphnelo infusion is usually given at doctor’s office, a hospital, or an infusion center.
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