Kineret (anakinra) is an injectable medication used to treat rheumatoid arthritis (RA) when certain other medications haven't worked well. Kineret (anakinra) is unique in that it's the only FDA-approved RA medication that blocks a specific protein called interleukin-1 (IL-1) that's responsible for swelling and pain. Kineret (anakinra) can also be used to treat certain other auto-inflammatory conditions. It's injected under the skin, typically once daily.
In November of 2022, Kineret (anakinra) received Emergency Use Authorization (EUA) from the FDA to improve survival and shorten hospital stay for certain people hospitalized with coronavirus disease 19 (COVID-19).
Kineret (anakinra) is known as a biologic disease-modifying anti-rheumatic drug (DMARD). Specifically, it blocks a protein called interleukin-1 (IL-1). This is one of the proteins that cause inflammation.
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
RA:
NOMID:
Please note: The safety profile of Kineret (anakinra) in people treated for DIRA is similar to that of for NOMID.
RA:
NOMID:
Contact your healthcare provider immediately if you experience any of the following.
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
fever or chills
headache
itching, pain, redness, swelling, tenderness or warmth on the skin
joint pain
muscle aches and pains
nausea or vomiting
stomach pain
Less common
Difficulty with swallowing
swelling of the face or lips
unusual bruising or bleeding
unusual tiredness or weakness
Incidence not known
Black, tarry stools
bleeding gums
blood in the urine or stools
dizziness
fast heartbeat
hives or welts
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
pinpoint red spots on the skin
puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
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
Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
difficulty with moving
headache
muscle aches or stiffness
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.
A study showed Kineret (anakinra) can start to improve symptoms of RA in about 1 month. But in clinical trials, most people felt improvement in their RA symptoms within the first 3 months of starting Kineret (anakinra). If you still don't feel better after using Kineret (anakinra) for 3 months, contact your provider.
Ask your provider before you receive any vaccines while taking Kineret (anakinra). There's limited research about how Kineret (anakinra) might affect the way vaccines work. Data shows that this medication isn't likely to affect inactive vaccines. But because Kineret (anakinra) weakens your immune system, there's a risk that you can get sick from live vaccines. Examples of live vaccines include the FluMist Quadrivalent (live-attenuated influenza vaccine) nasal spray and the measles, mumps, rubella (MMR) vaccine. Check with your provider to make sure you're up-to-date with all vaccines before starting Kineret (anakinra).
There's limited research regarding whether Kineret (anakinra) is safe to take during pregnancy. Available data shows that Kineret (anakinra) didn't cause harm to mother or unborn baby during pregnancy. If you're pregnant or thinking of getting pregnant, talk to your provider about the risks and benefits of using Kineret (anakinra).
There's limited information about how Kineret (anakinra) might affect breastfeeding. Data shows this medication didn't cause obvious side effects in breastfed babies. But to be safe, don't breastfeed your baby while taking Kineret (anakinra) without talking to your provider first.
In November 2022, the FDA issued an emergency use authorization (EUA) allowing for the use of Kineret (anakinra) in hospitalized people with COVID-19 and pneumonia who are receiving oxygen and are at risk for respiratory failure. This EUA was based on a study that showed Kineret (anakinra) improved survival with shorter hospital stay for people with COVID-19. Refer to the fact sheet for more information on Kineret (anakinra) and its use to treat COVID-19. It's important to note that the EUA only allows Kineret (anakinra) to be used in people with COVID-19 who are in the hospital, so your provider can't prescribe it to you to use at home.
Kineret (anakinra) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Kineret (anakinra) can make it more difficult for your body to fight off infections. This raises your risk of bacterial, viral, or fungal infections. The risk is higher for people who are taking or have recently taken other medications that weaken the immune system. Additionally, Kineret (anakinra) might reactivate (wake up) certain viruses that are already in your body, such as tuberculosis (TB), which can be dangerous. If you develop an infection, your provider will likely ask you to stop taking Kineret (anakinra) until your body fights off the infection. Let your provider know if you experience symptoms of these infections, such as fever, cough, difficulty breathing, or weakness.
Kineret (anakinra) can sometimes cause your neutrophil (a type of white blood cell) count to drop. A low neutrophil count means your immune system might have more trouble fighting off an infection. Your provider will likely order blood work to check your neutrophil count before you start Kineret (anakinra). They'll continue to do so monthly during your first 3 months of treatment, and then every 3 months after that for up to a year.
Severe allergic reactions to Kineret (anakinra) are possible, including life-threatening reactions like facial swelling, shock, and anaphylaxis (closing of the throat). The risk of an allergic reaction is higher for people who are being treated for DIRA, especially during the first few weeks after starting Kineret (anakinra). If you notice dizziness, a choking sensation, nausea, swelling around your eyes, swelling of the lips or tongue, or difficulty breathing after using Kineret (anakinra), get medical attention right away.
There's limited information available on the effects of Kineret (anakinra) on your body's response to vaccines, including live vaccines. Make sure your shots are up-to-date before starting Kineret (anakinra). Talk with your provider before you receive any vaccines while receiving Kineret (anakinra) treatment. Avoid getting live vaccines while you're taking Kineret (anakinra) because there's a risk that you can get sick from them.
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 taking 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.
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Kineret (anakinra) will not be safe for you to take.