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anakinra (Subcutaneous route)

an-a-KIN-ra

Commonly used brand name(s)

In the U.S.

  • Kineret

Available Dosage Forms:

  • Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Interleukin-1 Inhibitor

Uses For anakinra

Anakinra injection is used alone or together with other medicines to treat signs and symptoms of moderately to severely active rheumatoid arthritis in adult patients who have not been helped by other medicines (e.g., DMARDs). anakinra is also used to treat a rare genetic disorder called neonatal-onset multisystem inflammatory disease (NOMID). NOMID is the most severe form of a condition called cryopyrin-associated periodic syndrome (CAPS).

Slideshow: Drug Treatment for Rheumatoid Arthritis - What Are Your Options?

anakinra is available only with your doctor's prescription.

Before Using anakinra

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 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

Use of anakinra injection is not recommended in children with juvenile rheumatoid arthritis.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of anakinra injection in the elderly. However, anakinra may cause serious infections and kidney problems more often in the elderly, which may require caution and an adjustment in the dose for patients receiving anakinra injection.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

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.

Interactions with 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 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 anakinra 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
  • Certolizumab Pegol
  • Etanercept
  • Golimumab
  • Infliximab
  • Rilonacept

Interactions with Food/Tobacco/Alcohol

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 anakinra. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergy to E. coli-derived proteins or
  • Infection, active—Should not be used in patients with this condition.
  • Cancer or
  • Infection, chronic (long-term) or
  • Weak immune system—It is not known if anakinra will worsen these conditions.
  • Kidney disease—Higher blood levels of anakinra may result and your doctor may need to change your dose.
  • Tuberculosis, inactive—May increase risk of this condition to become active again.

Proper Use of anakinra

anakinra is given as a shot under your skin. Anakinra may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using anakinra at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.

anakinra comes with a Patient Information and Instructions for Use leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

If you use anakinra 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 or your child a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems.

Use a new needle, unopened prefilled syringe, or syringe each time you inject your medicine.

You might not use all of the medicine in each prefilled syringe. Use each syringe only one time. Do not save an open syringe. If the medicine in the syringe has changed color, or if you see particles in it, do not use it.

Use the medicine at the same time each day.

Throw the used needles away in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Dosing

The dose of anakinra 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 anakinra. 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 rheumatoid arthritis:
      • Adults—100 milligrams (mg) per day injected under the skin.
      • Children—Use is not recommended.
    • For neonatal-onset multisystem inflammatory disease (NOMID):
      • Adults and children—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 1 to 2 milligrams (mg) per kilogram (kg) of body weight injected under the skin per day. Your doctor may increase your dose as needed. However, the dose is usually not more than 8 mg per kg of body weight per day.

Missed Dose

If you miss a dose of anakinra, 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

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.

Do not shake the medicine. Protect it from light.

Precautions While Using anakinra

If you will be using anakinra for a long time, it is important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide whether you should continue to use it. Blood tests may be needed to check for unwanted effects.

Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

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).

Do not use anakinra together with the following: adalimumab (Humira®), certolizumab pegol (Cimzia®), etanercept (Enbrel®), golimumab (Simponi®), or infliximab (Remicade®).

Anakinra may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor right away if you or your child have a rash, itching, swelling of the face, throat, legs, or feet, troubled breathing, or chest pain after you receive the medicine.

anakinra may increase your risk of developing infections. Tell your doctor if you have any kind of infection before you start using anakinra. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you or your child have a latex allergy before you start using anakinra.

Do not have any live vaccines (immunizations) while you or your child are being treated with anakinra. Be sure to ask your child's doctor if you have any questions about this.

anakinra may cause severe tenderness and pain at the site of the injection. Contact your doctor right away if you notice any of these side effects at the injection site: bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth.

anakinra 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
  • Diarrhea
  • fever or chills
  • headache
  • itching, pain, redness, swelling, tenderness or warmth on the skin
  • joint pain
  • muscle aches and pains
  • nausea or vomiting
  • runny nose or sneezing
  • sore throat
Less common or rare
  • Difficulty with swallowing
  • hives, itching, or rash
  • swelling of the face or lips
  • unusual bruising or bleeding
  • unusual tiredness or weakness
Incidence not known
  • Dizziness
  • fast heartbeat
  • hives or welts
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • 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
  • Abdominal or stomach pain
  • 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.

See also: Side effects (in more detail)

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