Description
Anifrolumab-fnia injection is used to treat moderate to severe systemic lupus erythematosus (SLE) in patients who are also receiving other lupus treatments. It is a monoclonal antibody that changes the immune system to help control lupus symptoms.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of anifrolumab-fnia injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of anifrolumab-fnia injection in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abatacept
- Adalimumab
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Alefacept
- Anakinra
- Bacillus of Calmette and Guerin Vaccine, Live
- Brodalumab
- Certolizumab Pegol
- Cholera Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Ebola Zaire Vaccine, Live
- Etanercept
- Golimumab
- Guselkumab
- Infliximab
- Influenza Virus Vaccine, Live
- Ixekizumab
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Natalizumab
- Poliovirus Vaccine, Live
- Risankizumab
- Rituximab
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Sarilumab
- Secukinumab
- Smallpox Monkeypox Vaccine
- Tildrakizumab
- Tocilizumab
- Tofacitinib
- Typhoid Vaccine, Live
- Ustekinumab
- Varicella Virus Vaccine, Live
- Vedolizumab
- Yellow Fever Vaccine
- Zoster Vaccine, Live
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Cancer, history of—Use with caution. May make this condition worse.
- Central nervous system lupus, severe active or
- Lupus nephritis, severe active—Use is not recommended in patients with these conditions.
- Infection or
- Weak immune system—May decrease your body's ability to fight infection.
Proper Use
This medicine is available in 3 forms: an autoinjector, a prefilled syringe, and a vial (glass container).
Vial: A nurse or other trained health professional will give you this medicine in a medical facility. It is given through an IV catheter placed into one of your veins. It must be given slowly, so the IV will have to remain in place for at least 30 minutes. It is usually given every 4 weeks.
Prefilled syringe or autoinjector: Anifrolumab-fnia injection may also be given as a shot under you skin, usually in the stomach, thighs, or upper arms.
This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems. Do not inject into skin areas that are damaged, discolored, tender, red, bruised, scaly, hard, or has scars or tattoos.
Allow the autoinjector or prefilled syringe to warm to room temperature for 60 minutes before using it. Do not warm it using any heat sources (eg, direct sunlight, hot water, or microwave).
Check the liquid in the autoinjector or prefilled syringe. It should be clear and colorless to slightly yellow. Do not use if it is frozen, discolored, cloudy, or has particles in it. Do not use the syringe if it is damaged or has been dropped. Do not shake.
To use the autoinjector:
- Wash your hands with soap and water before and after using this medicine.
- Do not remove the cap until you are ready to inject.
- Pull off the cap. Do not touch the green needle guard or needle inside. Do not recap.
- Place the green needle guard flat against the skin at a 90 degree angle. Press down firmly and hold against the skin. You may hear a first "click" which means the injection has started. The green plunger will move down in the viewing window. Hold down firmly for about 15 seconds. You may hear a second "click" at the end of injection. Check the viewing window to make sure the green plunger completely fills the window.
To use the prefilled syringe:
- Wash your hands with soap and water before and after using this medicine.
- Pull off the needle cover. Do not twist or wiggle to remove it. Do not touch the plunger or plunger head while removing the needle cover. Do not touch or recap the needle.
- Hold the syringe with one hand. Do not pull back on the plunger at any time. Using the other hand, gently pinch the skin. Insert the needle into the pinched skin at a 45 degree angle.
- Push down the plunger head. Keep pushing firmly on the plunger head until it is fully down as far as it will go.
- Slowly let go of the plunger head until the needle guard covers the needle.
If you are switching from intravenous (given through a vein) to subcutaneous (given under the skin), inject the first injection under the skin 2 weeks after the last injection through a vein.
If you are switching from subcutaneous (given under the skin) to intravenous (given through a vein), the first injection through the vein will be given 3 to 4 weeks after the last injection under the skin.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form (solution):
- For moderate to severe systemic lupus erythematosus:
- Adults—120 milligrams (mg) injected under the skin once every week.
- Children—Use and dose must be determined by your doctor.
- For moderate to severe systemic lupus erythematosus:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose, inject the dose as soon as you remember. Then, continue to inject once a week based on the new day the medicine was injected or at your regular scheduled time as long as there are at least 3 days between the doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
If needed, you may store the autoinjector or prefilled syringe at room temperature for up to 7 days. Do not put it back in the refrigerator. Throw it away if it has been out of the refrigerator for more than 7 days.
Throw away used syringes in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check your progress closely and at regular visits to make sure this medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.
Tell your doctor if you are pregnant or planning to become pregnant during treatment with this medicine.
Do not have any live vaccines (immunizations) while you are being treated with anifrolumab-fnia. Check with your doctor before having any vaccines.
This medicine may increase your risk of serious infections, including lung infections, herpes zoster, or COVID-19. Check with your doctor right away if you have cough, fever, painful blisters on the trunk of the body, sneezing, or sore throat.
Anifrolumab-fnia may cause infusion reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting, after receiving this medicine.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.
Using this medicine may increase your risk of getting cancer. Talk to your doctor if you have concerns about this risk.
Tell your doctor if you are also receiving other biologic treatments.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Back pain
- chest tightness
- chills
- cough or hoarseness
- cough producing mucus
- diarrhea
- fever
- flushing
- headache
- loss of taste or smell
- lower back or side pain
- muscle or body pain
- nausea and vomiting
- painful blisters on the trunk of the body
- painful or difficult urination
- stuffy or runny nose
- trouble breathing
- weakness
Less common
- Difficulty swallowing
- dizziness
- fast heartbeat
- hives, itching, skin rash
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Ear congestion
- loss of voice
- muscle aches
- sneezing
- sore throat
- tender, swollen glands in the neck
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20520346
