In the U.S.—

In Canada—

• Antirheumatic
• Biological response modifier

Anakinra ( an-a-KIN-rah) is used to treat moderate to severe symptoms of rheumatoid arthritis. It may relieve redness, pain, tenderness, and warmth in hands, feet, wrists, shoulders, elbows, and ankles. This medicine is used in patients 18 years of age or older. Anakinra will not cure the disease, but will help with the symptoms as long as you continue to take it.

This medicine is available only with your doctor's prescription, in the following dosage form:

Parenteral
• Injection (U.S. and Canada)

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 anakinra, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to anakinra. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, latex, or dyes.

Pregnancy—Anakinra has not been studied in pregnant women. However, anakinra has not been shown to cause birth defects or other problems in animal studies.

Breast-feeding— It is not known whether anakinra passes into human breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of anakinra in children with use in other age groups.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—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 anakinra, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Vaccines, live virus—These should not be taken while you are taking anakinra.
• Vaccines, inactivated virus or bacterial antigens —Vaccinations may not be effective if you are taking anakinra.

• Etanercept (e.g., Enbrel)—May cause serious infection when used together with anakinra

• Tumor necrosis factor (TNF) blocking agents (etanercept [e.g., Enbrel], infliximab [e.g., Remicade], and adalimumab [e.g., Humira])—May make condition worse

• Active infections—May be worsened by anakinra

• Asthma—Patients with asthma may be at higher risk of getting a serious infection when taking anakinra.

• Immunosuppression—Anakinra has not been studied in patients who have immune system problems. The effects of the medicine in these patients is not known

• Kidney disease—Higher blood levels of anakinra may occur

Your health care professional will teach you or your caregiver how to give the injection. You must demonstrate the procedure so that your health care professional knows you understand. Before taking the injection, check the medicine to make sure it is clear and doesn't have any particles in it. If it looks cloudy or discolored, or has any particles floating in it, you should throw it away. Do not shake the syringe. Give the entire dose and then throw away the syringe. Your health care professional will tell you how to dispose of your syringes. Do not reuse syringes. Do not keep part of a dose for later use. Take the medicine at the same time each day. If you have questions or problems with the procedure, call your health care professional.

Dosing—

Follow your doctor's orders or the directions on the label. If your dose is different, do not change it unless your doctor tells you to do so

• For injection dosage form
  • For rheumatoid arthritis:
    • Adults—100 milligrams (mg) a day injected under the skin.
    • Children—Use and dose must be determined by your doctor. Anakinra is not usually recommended for use in children.

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.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store in the refrigerator. However, keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Your body's ability to fight infection may be reduced while you are being treated with anakinra, it is very important that you call your doctor at the first signs of any infection (for example, if you get a fever or chills).

While you are being treated with anakinra, do not have any immunizations (vaccinations) without your doctor's approval.

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
  • Chest pain;  cough;  diarrhea;  fever or chills;  general feeling of discomfort or illness;  headache ;  itching, pain, redness, swelling, tenderness or warmth on skin;  joint pain;  loss of appetite;  muscle aches and pains;  nausea;  pain or tenderness around eyes and cheekbones;  redness, bruising pain at the injection site;  runny nose;  shivering ;  shortness of breath;  sneezing;  sore throat;  sweating;  tightness in chest;  trouble sleeping;  unusual tiredness or weakness;  vomiting;  wheezing 
  
  

• Less common or rare
  • Black, sticky stools;  difficulty in swallowing;  itching;  lower back pain or side pain;  painful or difficult urination;  pale skin;  rash; hives; swelling of face or lips;  ulcers, sores or white spots in mouth;  unusual bruising or bleeding  
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

• More common
  • Abdominal or stomach pain 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.