What is anakinra (injectable)?
Anakinra reduces the actions of chemicals in the body that are involved in inflammatory and
immune responses.
Anakinra is used to treat the symptoms of moderate to severe rheumatoid arthritis in patients
who have had an inadequate response to one or more antirheumatic drugs. Anakinra may be used in
combination with other antirheumatic medications.
Anakinra may also be used for purposes other than those listed in this medication guide.
What should I discuss with my healthcare provider before taking anakinra (injectable)?
In rare cases, people receiving anakinra have developed serious infections. Notify your
doctor immediately if you develop a fever, flu-like symptoms, or any other sign of infection. Treatment
with anakinra should not be started in patients with active infections or those taking other medicines that
may suppress the immune system. The use of anakinra in combination with etanercept (Enbrel),
infliximab (Remicade), adalimumab (Humira), or other medicines used to treat rheumatoid arthritis, may
also increase the risk of a serious infection.
Do not use anakinra without first talking to your doctor if you
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are currently taking etanercept (Enbrel), infliximab (Remicade), or
adalimumab (Humira) to treat rheumatoid arthritis;
-
have an active infection or a history of recurrent infection;
-
have recently been exposed to varicella (chickenpox) virus;
-
have a bone marrow disease;
-
have a suppressed immune system due to a medical
condition or treatment with medication;
-
have recently received a live vaccine; or
-
have kidney disease.
You may not be able to use anakinra, or you may require a dosage
adjustment or special monitoring during treatment.
Anakinra is in the FDA pregnancy category B. This means that it is not expected to harm an
unborn baby. Do not use anakinra without first talking to your doctor if you are pregnant or could
become pregnant during treatment.
It is not known whether anakinra passes into breast milk. Do not use anakinra without first
talking to your doctor if you are breast-feeding a baby.
The safety and effectiveness of anakinra have not been established for pediatric patients.
How should I take anakinra (injectable)?
Use anakinra exactly as directed by your doctor. If you do not understand these directions, ask
your doctor, nurse, or pharmacist to explain them to you.
Anakinra is used as a subcutaneous (under the skin) injection only. Your doctor or nurse will
give you detailed instructions on how and where to inject anakinra. Do not inject this medication if you
are unsure how.
Anakinra is usually injected once a day. The dose should be injected at approximately the same
time every day.
The medication may be allowed to reach room temperature by removing it from the refrigerator
about 60 to 90 minutes before administration. This may reduce discomfort during or following the
injection.
The medication can be injected into the outer thighs, stomach, back of the upper arms, or
buttocks. Rotate the injection site daily to reduce the possibility of soreness or redness. The area of the
body being injected does not need to change daily, however each injection site should be at least one
inch from the previous day's injection site.
Do not inject anakinra if it is discolored, cloudy, or if it has particles in it. Do not shake the
prefilled syringe and do not use anakinra beyond the expiration date shown on the carton. If the solution
appears foamy, allow it to sit for a few minutes until it clears.
This medication does not contain a preservative. Therefore, throw away any medication
remaining in the syringe after a dose. Do not save the medication for later use.
Never reuse a needle or syringe. Dispose of all needles and syringes in an appropriate,
puncture-resistant disposal container.
Your doctor may want you to have blood tests or other medical evaluations during treatment
with anakinra to monitor progress and side effects.
Anakinra should be used on a regular basis to get the most benefit.
Store anakinra in the refrigerator (36 to 46 degrees Fahrenheit/2 to 8 degrees Celsius)
away from moisture, heat and light. Do not allow anakinra to freeze.
What happens if I miss a dose of anakinra (injectable)?
Notify your healthcare provider if you miss a dose of this medication.
Where can I get more information about anakinra (injectable)?
Your pharmacist has information about anakinra (injectable) written for health professionals that you may read.
What are the possible side effects of anakinra (injectable)?
If you experience an allergic reaction (difficulty breathing; closing of the throat; swelling of
your lips, tongue, or face; or hives), stop using anakinra, and seek emergency medical attention.
In rare cases, people receiving anakinra have developed serious infections. Notify your
doctor immediately if you develop a fever, flu-like symptoms, or any other sign of infection.
Other less serious side effects may be more likely to occur. Continue to use anakinra and notify
your doctor if you experience
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nausea or diarrhea;
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a headache;
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sinus irritation or infection; or
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redness, bruising, pain, or swelling at the injection site.
Side effects other than those listed here may also occur. Talk to your doctor
about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about anakinra (injectable)?
In rare cases, people receiving anakinra have developed serious infections. Notify your
doctor immediately if you develop a fever, flu-like symptoms, or any other sign of infection. Treatment
with anakinra should not be started in patients with active infections or those taking other medicines that
may suppress the immune system. The use of anakinra in combination with etanercept (Enbrel),
infliximab (Remicade), adalimumab (Humira), or other medicines used to treat rheumatoid arthritis, may
also increase the risk of a serious infection.
What should I avoid while taking anakinra (injectable)?
Anakinra has been associated with an increased incidence of infection. Avoid contact with
people who have colds, the flu, or other contagious illnesses [e.g., varicella (chickenpox) and others]
and do not receive vaccines that contain live strains of a virus (e.g., live oral polio vaccine) during
treatment with anakinra. In addition, avoid contact with individuals who have recently been vaccinated
with a live vaccine. There is a chance that the virus can be passed on to you.
What other drugs will affect anakinra (injectable)?
Do not receive "live" vaccines during treatment with anakinra without first talking to your
doctor. Administration of a live vaccine may result in an inadequate immune response or infection.
Before using anakinra, talk to your doctor if you are taking
You may not be able to use anakinra, or you may require a dosage
adjustment or special monitoring during treatment if you are taking any of the medicines listed above.
Drugs other than those listed here may also interact with anakinra. Talk to your doctor and
pharmacist before taking any prescription or over-the-counter medicines, including herbal products.
What happens if I have an overdose of anakinra (injectable)?