Reviews (28)Overview: Saphnelo is used to treat lupus. It can help reduce symptoms by blocking certain signals in your immune system. Common side effects may include infection in the nose or throat, sore throat, or common cold symptoms, or cough. Saphnelo may increase your risk of infections such as respiratory infections, shingles, or COVID. Some infections can be serious, so tell your health care provider right away if you have symptoms such as fever, chills, shortness of breath, muscle aches, painful urination, or skin sores. Saphnelo can be given by a health care provider as an infusion into a vein or as an under-the-skin injection that you or a caregiver can give at home.
Uses
What is Saphnelo used for?
Saphnelo (anifrolumab) is commonly used to treat moderate to severe systemic lupus erythematosus (SLE).
Learn more about Saphnelo for Lupus.
Saphnelo may also be used for other conditions as determined by your health care provider.
How does Saphnelo work (mechanism of action)?
Type I interferon (IFN) is a substance in the body that helps to activate the immune system. People with certain autoimmune conditions, such as lupus, may have too much of this substance, which can cause swelling (inflammation) and increase symptoms.
Saphnelo is a type of medicine called a monoclonal antibody. It works by blocking the activity of type I IFN. This can help to reduce the activity of the immune system and reduce symptoms in people with lupus.
How is Saphnelo supplied (dosage forms)?
Saphnelo is available as an intravenous (IV) injection that is given by a health care provider.
It is also available as a subcutaneous (under the skin) injection in the following forms that you or a caregiver may give.
- 120 mg/0.8 mL single-dose prefilled syringe
- 120 mg/0.8 mL single-dose autoinjector pen
How should I store Saphnelo?
Store Saphnelo prefilled syringes and autoinjector pens in the refrigerator, between 36 F and 46 F (2 C and 8 C), in the original carton to protect from light. If needed, you can keep them at room temperature, between 68 F and 77 F (20 C and 25 C), for up to 7 days in the original carton. If Saphnelo has been stored at room temperature, it should not be put back in the refrigerator and should be thrown away if not used within 7 days.
Side Effects
What are the most common side effects of Saphnelo?
The most common side effects of Saphnelo are listed below. Tell your health care provider if you have any of these side effects that bother you.
- Infection in the nose or throat, sore throat, or common cold symptoms
- Chest cold (bronchitis)
- Reactions while receiving the dose as an infusion, such as headache, nausea, vomiting, tiredness, and dizziness
- Shingles (herpes zoster)
- Cough
There may be other side effects of Saphnelo that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Saphnelo?
While less common, the most serious side effects of Saphnelo are described below, along with what to do if they happen.
Severe Allergic Reactions. Saphnelo may cause allergic reactions, which can be serious. Stop using Saphnelo and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching or skin rash
- Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Cancer. Some people have had cancer after using medicines that affect the immune system, including Saphnelo. It is not known if Saphnelo increases cancer risk. Let your health care provider know if you or your family has a history of cancer.
Infection. Saphnelo can increase the risk of infections, including serious infections. It can also make current infections worse. Call your health care provider if you have an infection or any of the following symptoms.
- Burning or stinging when you pee
- Having to pee more often than usual
- Cough or coughing up mucus
- Trouble breathing
- Muscle aches
- Diarrhea or stomach pain
- Fever, sweats, or chills
- Warm, irritated, or painful skin or sores
Warnings & Precautions
Who should not use Saphnelo?
Allergies to Ingredients. People who are allergic to any of the following should not use Saphnelo.
- Anifrolumab
- Saphnelo
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Saphnelo.
What should I know about Saphnelo before using it?
Do not use Saphnelo unless it has been prescribed to you by a health care provider. Use it as prescribed.
Do not share Saphnelo with other people, even if they have the same condition as you. It may harm them.
Keep Saphnelo out of the reach of children. Since this medicine may be kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator.
There are multiple forms of Saphnelo available. If you are using Saphnelo at home, read and follow the instructions for the product you have and make sure you understand how to prepare and use it properly. If you have any questions, talk to your health care provider.
Keep all appointments with your health care provider, including visits for blood tests, so they can monitor your health and make sure the medicine is working safely.
What should I tell my health care provider before using Saphnelo?
Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Saphnelo is right for you.
In particular, make sure that you discuss any of the following.
Cancer. Before starting Saphnelo, let your health care provider know if you or anyone in your family has a history of cancer.
Risk for Infection. Before starting Saphnelo, it is important to talk to your health care provider about any serious infections you have had in the past as well as any infections you have currently. You should also let your health care provider know if you have an infection that keeps coming back.
Other Medicines and Supplements. Saphnelo should not be used while you are using certain other medicines. Before using Saphnelo, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Vaccines. Let your health care provider know if you have recently received or are scheduled to receive any vaccinations. There are certain vaccines (live vaccines) that you should not receive right before starting Saphnelo or during treatment. Your health care provider will confirm whether any upcoming vaccinations are safe.
Severe Lupus Symptoms in the Kidneys or Central Nervous System. Saphnelo is not recommended for use in people who have a severe form of lupus that affects the central nervous system (CNS), which can cause symptoms such as seizures and strokes. It is also not recommended in people who have a severe form of a kidney condition caused by lupus, called lupus nephritis. Before starting Saphnelo, let your health care provider know if you have any of these symptoms.
Pregnancy. It is not known if or how Saphnelo could affect pregnancy or harm a fetus. Tell your health care provider if you are or plan to become pregnant. Your health care provider will let you know if you should use Saphnelo while you are pregnant or trying to get pregnant. If you become pregnant while using Saphnelo, you can register for the pregnancy registry by calling 877‑693‑9268. This registry collects safety information about the use of Saphnelo during pregnancy.
Breastfeeding. It is not known if Saphnelo passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use Saphnelo while breastfeeding.
How can I get more information about Saphnelo?
For more information about Saphnelo, you can visit the drugmaker's website at www.saphnelo.com or call them at 800-236-9933.
Interactions
Does Saphnelo interact with foods or drinks?
There are no known interactions between Saphnelo and foods or drinks.
It is unknown if drinking alcohol will affect Saphnelo.
Does Saphnelo interact with other medicines (drug interactions)?
Saphnelo may interact with certain medicines or vaccines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. In particular, make sure that you discuss if you are using a type of medicine called a biologic or monoclonal antibody to treat your condition.
This may not be a complete list of medicines that can interact with Saphnelo. Always check with your health care provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Saphnelo?
If you or someone else has used too much Saphnelo, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Saphnelo?
If you miss an appointment to get your Saphnelo dose, call to make another appointment as soon as possible.
If you use Saphnelo at home and miss a dose, inject it as soon as you remember. Then continue weekly injections on your new schedule, or return to your usual day if there are at least 3 days between doses. If you are not sure what to do, call your health care provider for next steps.
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