Uses
What is Saphnelo used for?
Saphnelo (anifrolumab) is commonly used for the treatment of 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 healthcare 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 certain disorders, such as lupus.
How is Saphnelo supplied (dosage forms)?
Saphnelo is available in an injectable form that is given by a healthcare provider.
How should I store Saphnelo?
Saphnelo is usually given by a healthcare provider in a hospital or clinic. You will not store it at home.
Side Effects
What are the most common side effects of Saphnelo?
The most common side effects of Saphnelo are listed below. Tell your healthcare 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, 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 healthcare 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. 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, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Cancer. Some people who have used other medicines that suppress the immune system, like Saphnelo, have developed cancer. It is not clear if Saphnelo increases the risk for cancer. Let your healthcare 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 healthcare 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, red, 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?
This medicine is given as an infusion into the vein (IV) by a healthcare professional in a healthcare facility.
What should I tell my healthcare provider before using Saphnelo?
Tell your healthcare 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 determine if Saphnelo is right for you.
In particular, make sure that you discuss any of the following.
Cancer. Before starting Saphnelo, let your healthcare provider know if you or anyone in your immediate family has a history of cancer.
Risk for Infection. Before starting Saphnelo, it is important to talk to your healthcare provider about any serious infections you have had in the past as well as any infections you have currently. You should also let your healthcare 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 healthcare 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 healthcare 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 either right before receiving Saphnelo or once you have started using it. Your healthcare 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 healthcare provider know if you have any of these symptoms.
Pregnancy. It is not known if or how Saphnelo could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you 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 healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should use Saphnelo while breastfeeding.
How can I get more information about Saphnelo?
For more information about Saphnelo, you can visit the manufacturer’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)?
Always tell your healthcare 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 healthcare 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.