Anakinra

Anakinra is a prescription medication used to treat adults with moderate to severe rheumatoid arthritis (RA) when other drugs have not worked. It is also used to treat neonatal onset multisystem inflammatory disease (NOMID). NOMID is a rare disorder that causes persistent inflammation and tissue damage primarily affecting the nervous system, skin, and joints.

Anakinra belongs to a group of drugs called biological response modifiers, which inactivate a substance that causes some of the symptoms of RA and NOMID. By binding to IL-1, anakinra can help reduce the symptoms of rheumatoid arthritis, along with the physical damage to the joints, and help patients with NOMID.

This medication comes in an injectable form to be given once daily, just under the skin.

Common side effects of anakinra include redness at the injection site, nausea, and headache.

Anakinra is a prescription medicine used:

• to reduce the signs and symptoms and slow the damage of moderate to severe active rheumatoid arthritis (RA) in people age 18 years and older when 1 or more other drugs for RA have not worked.
• in the treatment of a severe form of Cryopyrin-Associated Periodic Syndromes (CAPS) called Neonatal-Onset Multisystem Inflammatory Disease (NOMID).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Anakinra may be found in some form under the following brand names:

• Kineret

Anakinra may cause serious side effects. See "Drug Precautions" section.

The most common side effects of anakinra include:

• injection site skin reactions. The symptoms of injection site skin reactions may include:
  • redness
  • swelling
  • bruising
  • itching
  • stinging

Most injection site reactions are mild, occur early during treatment, and last about 2 to 4 weeks. Injection site reactions have been observed less frequently in people with NOMID.

• headache
• nausea and vomiting
• joint pain
• fever
• feeling like you have the flu
• sore throat or runny nose
• sinus infection
• pain in your stomach area

These are not all of the possible side effects of anakinra. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Tell your healthcare provider if you take other medicines that affect your immune system.

Especially, tell your healthcare provider if you use:

• Enbrel (etanercept)
• Humira (adalimumab)
• Remicade (infliximab)

This is not a complete list of anakinra drug interactions. Ask your doctor or pharmacist for more information.

Do not take anakinra if you have an allergy to:

• proteins made from bacterial cells (E. coli). Ask your healthcare provider if you are not sure.
• any of the ingredients in anakinra.

Anakinra may cause serious side effects, including:

• serious infections. Anakinra may lower your ability to fight infections. During your treatment with anakinra, call your healthcare provider right away if you:
  • get an infection
  • have any sign of an infection including a fever or chills
  • have any open sores on your body
• low white blood cell count (neutropenia). Anakinra may cause you to have a lower number of certain white blood cells (neutrophils). Neutrophils are important in fighting infections. You should have blood tests before starting treatment with anakinra, then monthly for 3 months. After the first 3 months you should have your blood tested every 3 months for up to 1 year.
• allergic reactions. Stop using anakinra and call your healthcare provider or get emergency help right away if you have any of these symptoms of an allergic reaction:
  • swelling of your face, lips, mouth or tongue
  • trouble breathing
  • wheezing
  • severe itching
  • skin rash, redness, or swelling outside of the injection site area
  • dizziness or fainting
  • fast heartbeat or pounding in your chest (tachycardia)
  • sweating

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of anakinra there are no specific foods that you must exclude from your diet when receiving anakinra.

Before you take anakinra, tell your healthcare provider if you:

• have an infection, a history of infections that keep coming back or other problems that can increase your risk of infections.
• have an allergy to rubber or latex. The needle cover on the prefilled syringe contains latex. Do not handle the needle cover if you are allergic to latex.
• have kidney problems.
• are scheduled to receive any vaccines. People using anakinra should not receive live vaccines.
• are pregnant or breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category B. There are no well-done studies that have been done in humans with anakinra. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if anakinra passes into your breast milk. You and your healthcare provider should decide if you will take anakinra or breastfeed.

Take anakinra exactly as your healthcare provider tells you to.

• You may not have to use all of the liquid medicine in the prefilled syringe. Your healthcare provider will show you how to find the correct dose of anakinra for you or your child.
• Anakinra is given by injection under your skin.
• Inject anakinra at about the same time each day.
• If you have a kidney problem your healthcare provider may need to change how often you take your anakinra injections.
• If you miss a dose of anakinra, talk to your healthcare provider to find out when you should take your next injection.

Instructions for Use

Supplies you will need to give your anakinra injection:

• 1 anakinra prefilled syringe
• 1 alcohol wipe
• 1 dry sterile gauze or tissue
• 1 puncture-resistant sharps disposal container

Each anakinra dose comes in a prefilled glass syringe. There are 7 syringes in each new anakinra box, 1 for each day of the week. Use a new anakinra syringe each day. Use the anakinra prefilled syringe that matches the day of the week until all 7 syringes are used.

Setting up for your injection:

Step 1. Take the carton containing the prefilled syringes of anakinra out of the refrigerator. Remove the prefilled syringe from the box that matches the day of the week. Put the carton containing the remaining prefilled syringes back in the refrigerator.

Step 2. Find a clean, flat work surface, such as a table.

Step 3. Check the expiration date on the syringe label. If the expiration date has passed, do not use the syringe. Contact your pharmacist or call 1-866-773-5274 for assistance.

Step 4. Let the liquid medicine in the anakinra prefilled syringe warm to room temperature for 30 minutes before your injection. Do not remove the needle cover during this time.

Do not shake the prefilled syringe. If the liquid medicine in the prefilled syringe is foamy, let the prefilled syringe sit for a few minutes until the foam goes away.

Make sure the liquid medicine in the prefilled syringe is clear and colorless. It is normal to see a small amount of tiny particles that are white, or that you can see through. Do not inject the medicine if it is cloudy or discolored, or has large or colored particles. Call your healthcare provider or pharmacist if you have any questions about your anakinra prefilled syringe.

Step 5. Gather all the supplies you will need for your injection.

Step 6. Wash your hands with soap and warm water.

Step 7. Preparing the correct dose of anakinra:

Note: If your healthcare provider prescribed a 100 mg dose of anakinra, go to the “How to prepare a 100 mg dose of anakinra” section below.

If your healthcare provider prescribed a 20 mg to 90 mg dose of anakinra, go to the “How to prepare a 20 mg to 90 mg dose of anakinra” section below.

How to prepare a 100 mg dose of anakinra:

Before you inject anakinra, do the following:

• Hold the syringe barrel and gently remove the cover from the needle without twisting. Pull straight. Do not touch the needle or push the plunger. Immediately throw away the needle cover.
• You may notice a small air bubble in the prefilled syringe. You do not have to remove the air bubble before injecting. Injecting the solution with the air bubble is harmless.
• You can now use the pre-filled syringe as described in the “Selecting and Preparing the Site” section and “Giving your injection” section below.

How to prepare a 20 mg to 90 mg dose of anakinra:

Before you inject anakinra, do the following:

• Hold the syringe barrel and gently remove the cover from the needle without twisting. Pull straight. Do not touch the needle or push the plunger. Immediately throw away the needle cover.
• Hold the syringe in 1 hand with the needle pointing straight upwards. Put your thumb on the plunger rod and push slowly until you see a tiny liquid drop at the tip of the needle.
• Turn the syringe so that the needle is now pointing downwards. Place a sterile gauze or tissue on a flat surface and hold the syringe above it with the needle pointing towards the gauze or tissue. Make sure the needle does not touch the gauze or tissue.
• Put your thumb on the plunger rod and push slowly until you can see that the top of the plunger has reached the correct number for your anakinra dose. The liquid that was pushed out of the needle will be absorbed by the gauze or tissue.
• If you are not able to select the correct dose of anakinra, throw away the syringe and use a new one.
• You can now use the pre-filled syringe as described in the “Selecting and preparing the injection site” section and “Giving your injection”section below.
• After your injection, throw away the wet gauze or tissue with your syringe and clean the table surface with a fresh swab.

Selecting and preparing the injection site:

Step 8. Choose an injection site.

Recommended injection sites for adults and children include:

• outer area of the upper arms
• abdomen (except the two-inch area around the belly button)
• front of the middle thighs
• upper outer areas of the buttocks

Choose a new site each time you use anakinra. Choosing a new site may help avoid soreness at 1 site. Do not inject anakinra into an area of skin that is tender, red, bruised, or hard. Avoid areas of skin with scars or stretch marks. Do not inject anakinra close to a vein that you can see under the surface of your skin. 

Step 9. Clean your injection site with an alcohol swab. Let the area dry completely.

Giving your injection:

Step 10. With your free hand, gently pinch a fold of skin at the cleaned injection site.

Step 11. Hold the syringe (like a pencil) at a 45 degree to 90 degree angle to the skin. With a quick, dart-like motion insert the needle into the skin.

Step 12. After the needle is inserted into the skin, slowly push the plunger all the way down to inject anakinra.

Step 13. When the syringe is empty, pull the needle out of the skin while carefully keeping the needle at the same angle as inserted.

Step 14. Place a dry cotton ball or gauze pad over the injection site and press for several seconds. Do not use an alcohol swab as it may cause stinging. If there is a little bleeding, you may cover the injection site with a small bandage.

Important Information about your anakinra prefilled syringe:

• Use each anakinra prefilled syringe only 1 time. The syringes should NEVER be reused. NEVER recap a needle.
• You may not have to use all of the liquid medicine in the prefilled syringe. Your healthcare provider will show you how to find the correct dose of anakinra for you or your child.
• If you notice that some medicine is left in the prefilled syringe, do not inject again with the same prefilled syringe.
• If you drop a prefilled syringe, do not use it. The glass syringe may be broken, or the needle may be bent or dirty. Throw away the prefilled syringe and replace it with a new one. Take a new prefilled syringe from what would be the last day of the week in your current box. For example, if you start on Wednesday, the last day of the week in your series is Tuesday. After using all the remaining prefilled syringes in your current box, start your next box of anakinra prefilled syringes.

Disposal of the syringe and supplies:

• Put your used syringes and any gauze or tissue with anakinra solution in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) syringes and any gauze or tissue with anakinra solution in your household trash.
• If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
  • upright and stable during use
  • leak-resistant
  • properly labeled to warn of hazardous waste inside the container
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. 
• Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

The recommended dose of anakinra for the treatment of patients with rheumatoid arthritis (RA) is 100 mg given by injection just under the skin (subcutaneously) once daily.

The recommended starting dose of anakinra for NOMID patients is 1 to 2 mg/kg injected just under the skin, once daily. The maximum recommended dose is 8 mg/kg daily. The dose can be split into twice daily doses.

If you take too much anakinra call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If anakinra is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store anakinra in its original carton in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Do not freeze or shake anakinra.
• Keep anakinra away from light.
• When traveling, make sure you store anakinra at the correct temperature.
• Keep anakinra and all medicines out of the reach of children.