Anakinra

Name: Anakinra

What should I know about storage and disposal of this medication?

Keep syringes and injection supplies out of the reach of children. Store anakinra syringes in the refrigerator. Do not freeze. Protect from light. Do not use a syringe that has been at room temperature for more than 24 hours.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What is the dosage for anakinra?

  • The dose of anakinra for rheumatoid arthritis is one subcutaneous injection of 100 mg daily. The dose should be administered at approximately the same time every day.
  • The dose for treating neonatal-onset multisystem inflammatory disease (NOMID) is 1-2 mg/kg daily up to a maximum dose of 8 mg/kg.

Description

Kineret (anakinra) is a recombinant, nonglycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra). Kineret differs from native human IL-1Ra in that it has the addition of a single methionine residue at its amino terminus. Kineret consists of 153 amino acids and has a molecular weight of 17.3 kilodaltons. It is produced by recombinant DNA technology using an E coli bacterial expression system.

Kineret is supplied in single use prefilled glass syringes with 27 gauge needles as a sterile, clear, colorless-to-white, preservative free solution for daily subcutaneous (SC) administration. The solution may contain trace amounts of small, translucent-to-white amorphous proteinaceous particles. Each prefilled glass syringe contains: 0.67 mL (100 mg) of anakinra in a solution (pH 6.5) containing disodium EDTA (0.12 mg), sodium chloride (5.48 mg), anhydrous citric acid (1.29 mg), and polysorbate 80 (0.70 mg) in Water for Injection, USP.

Patient information

Kineret®
(KIN-eh-ret)
(anakinra) for Injection, for Subcutaneous Use

Read this Patient Information before you start using Kineret and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is Kineret?

Kineret is a prescription medicine called an interleukin-1 receptor antagonist (IL-1ra) 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.
  • Treat people with a form of Cryopyrin-Associated Periodic Syndromes (CAPS) called Neonatal-Onset Multisystem Inflammatory Disease (NOMID)
    Kineret is not for children with Juvenile Rheumatoid Arthritis

Who should not use Kineret?

Do not use Kineret if you are allergic to:

  • proteins made from bacteria called E.Coli. Ask your healthcare provider if you are not sure.
  • anakinra or any of the ingredients in Kineret. See the end of this leaflet for a complete list of ingredients in Kineret.

What should I tell my healthcare provider before using Kineret?

Before you use Kineret, 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 inner 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 Kineret should not receive live vaccines.
  • are pregnant or plan to become pregnant. It is not known if Kineret will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Kineret passes into your breast milk. You and your healthcare provider should decide if you will use Kineret or breastfeed.

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

Kineret and other medicines may affect each other and cause serious side effects.

Especially, tell your healthcare provider if you take certain other medicines that:

  • affect your immune system called Tumor Necrosis Factor (TNF) blockers

Ask your healthcare provider for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new prescription.

How should I use Kineret?

  • Read the Instructions for Use at the end of this Patient Information for information about the right way to use Kineret.
  • Use Kineret 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 Kineret for you or your child.
  • Kineret is given by injection under your skin.
  • Inject Kineret at about the same time each day.
  • If you have a kidney problem your healthcare provider may need to change how often you use your Kineret injections.
  • If you miss a dose of Kineret, talk to your healthcare provider to find out when you should use your next injection.

What are the possible side effects of Kineret?

Kineret may cause serious side effects, including:

  • serious infections. Kineret may lower your ability to fight infections. During your treatment with Kineret, 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
      You may get an infection if you receive live vaccines while you use Kineret. You should not receive live vaccines while you use Kineret.
  • allergic reactions. Stop using Kineret 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
  • decreased ability of your body to fight infections (immunosuppression). It is not known if treatment with medicines that cause immunosuppression, like Kineret, affect your risk of getting cancer.
  • low white blood cell count (neutropenia). Kineret 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 Kineret, then monthly for 3 months. After the first 3 months you should have your blood tested every 3 months for up to 1 year.

The most common side effects of Kineret include:

  • injection site skin reactions. The symptoms of injection site skin reactions may include:
    • redness
    • itching
    • swelling
    • stinging
    • bruising
      Most injection site reactions are mild, happen early during treatment, and last about 14 to 28 days. Injection site reactions have been observed less frequently in people with NOMID.
  • rheumatoid arthritis (RA) gets worse even with treatment, if you already have RA
  • headache
  • nausea and vomiting
  • diarrhea
  • joint pain
  • fever
  • feeling like you have the flu
  • sore throat or runny nose
  • sinus infection
  • pain in your stomach area

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Kineret. 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.

How should I store Kineret?

  • Store Kineret in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • Do not freeze or shake Kineret.
  • Keep Kineret in its original carton and away from light.

Keep Kineret and all medicines out of the reach of children.

General Information about the safe and effective use of Kineret.

Medicines are sometimes prescribed for purposes other than those listed in a patient leaflet. Do not use Kineret for a condition for which it was not prescribed. Do not give Kineret to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Kineret. If you would like more information about Kineret, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Kineret that is written for health professionals.

For more information go to www.kineretrx.com or call 1-866-773-5274.

What are the ingredients in Kineret?

Active ingredients: anakinra

Inactive ingredients: disodium EDTA, sodium chloride, anhydrous citric acid, and polysorbate 80 in Water for Injection, USP

Instructions for Use

Kineret®
(KIN-eh-ret)
(anakinra) for injection, for subcutaneous use

Read this Instructions for Use before you start using Kineret and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Supplies you will need to give your Kineret injection: See Figure A.

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

Figure A

Each Kineret dose comes in a prefilled glass syringe. There are 7 syringes in each new Kineret box, 1 for each day of the week. Use a new Kineret syringe each day. Use the Kineret 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 Kineret 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. See Figure B. If the expiration date has passed, do not use the syringe. Call your pharmacist or call 1-866-773-5274 for assistance.

Figure B

Step 4. Take the Kineret prefilled syringe out of the refrigerator and leave it in room temperature for 30 minutes before your injection. 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 Kineret prefilled syringe.

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

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

Preparing your correct dose of Kineret:

  • Preparing a 100 mg dose of Kineret:
  • Hold the syringe barrel and pull the cover straight off the needle. See Figure C. Do not touch the needle or push the plunger. Throw away the needle cover.

Figure C

  • 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.
  • Carefully place the barrel of the syringe on the table until you are ready to inject. Do not let the needle touch the table. Do not recap the needle.

How to prepare a dose of Kineret less than 100 mg:

  • Hold the syringe in 1 hand with the needle pointing straight upwards. See Figure D. Put your thumb on the plunger rod and push slowly until you see a tiny liquid drop at the tip of the needle.

Figure D

  • 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. See Figure E. Make sure the needle does not touch the gauze or tissue.

Figure E

  • 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 Kineret dose your healthcare provider has prescribed. The liquid that was pushed out of the needle will be absorbed by the gauze or tissue. See Figure E.
  • If you are not able to select the correct dose of Kineret, throw away the syringe and use a new one.
  • Carefully place the barrel of the syringe on the table until you are ready to inject. Do not let the needle touch the table. Do not recap the needle.

Selecting and preparing the injection site:

Step 7. Choose an injection site. See Figure F.

Recommended injection sites for adults and children include:

  • outer area of the upper arms
  • abdomen (except the 2-inch area around the belly button)
  • front of the middle thighs
  • upper outer areas of the buttocks

Figure F

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

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

Giving your injection:

Step 8. Gently pinch a fold of skin at the cleaned injection site.

Step 9. With your other hand, 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. See Figure G.

Figure G

Step 10. After the needle is inserted into the skin‚ slowly push the plunger all the way down to inject Kineret. See Figure H.

Figure H

Step 11. When the syringe is empty, pull the needle out of the skin while carefully keeping the needle at the same angle as inserted. See Figure I

Figure I

Step 12. Place a dry cotton ball or gauze pad over the injection site and press for several seconds. See Figure J. 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.

Figure J

Important Information about your Kineret prefilled syringe:

  • Use each Kineret prefilled syringe only 1 time. Do not use a syringe more than 1 time. Do not 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 Kineret 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 Kineret prefilled syringes.

Disposal of your Kineret syringes:

  • Put your used syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose syringes 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. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
  • 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.
  • Throw away the wet gauze or tissue with your syringe and clean the table surface with a fresh swab.

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Anakinra Interactions

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.

Anakinra Dosage

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.

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What is anakinra?

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 adults. Anakinra may also help slow the progress of the disease. Anakinra is usually given after other arthritis medications have been tried without successful treatment of symptoms.

Anakinra is also used in newborn babies to treat a rare genetic condition called neonatal onset multisystem inflammatory disease (NOMID). NOMID is a form of cryopyrin-associated periodic syndromes (CAPS). This condition causes uncontrolled inflammation in many parts of the body, including the skin, joints, and central nervous system.

Anakinra may also be used for purposes not listed in this medication guide.

How should I use anakinra?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Anakinra is injected under the skin. You may be shown how to use injections at home. Do not inject this medicine yourself if you do not understand how to use the injection and properly dispose of used needles and syringes.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Anakinra is usually given once per day, or once every other day. Follow your doctor's instructions. Inject your dose at the same time of day when you use the medicine.

Your care provider will show you the best places on your body to inject anakinra. Use a different place each time you give an injection. Do not inject into the same place two times in a row. Each injection should be given at least 1 inch away from where you last injected the medicine.

Do not shake the prefilled syringe or you may ruin the medicine. Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors, looks cloudy, or has particles in it. Call your pharmacist for new medication.

Each prefilled syringe of anakinra is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Use anakinra regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Call your doctor if your arthritis symptoms do not improve, or if they get worse while using anakinra.

Anakinra can lower blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. You will need regular medical tests to be sure this medicine is not causing harmful effects. Your doctor may also want to check your blood cells for several months after you stop using anakinra. Visit your doctor regularly.

Store in the refrigerator, do not freeze. Protect from light.

Throw away any unused medicine after the expiration date on the label has passed.

What should I avoid while using anakinra?

Do not receive a "live" vaccine while using anakinra, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Anakinra dosing information

Usual Adult Dose for Rheumatoid Arthritis:

100 mg subcutaneously once daily

Comments:
-The dose should be administered at approximately the same time every day.
-Alternating the injection site is recommended to avoid discomfort at the site of injection.

Use: Rheumatoid Arthritis (RA): To reduce symptoms and slow the progression of structural damage in moderately to severely active RA, in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs (DMARDs)

Usual Adult Dose for Cryopyrin-Associated Periodic Syndrome:

Initial dose: 1 to 2 mg/kg subcutaneously daily
Maximum dose: 8 mg/kg subcutaneously daily

Comments:
-Doses should be adjusted in 0.5 to 1.0 mg/kg increments.
-Once daily administration is generally recommended, but the dose may be split into twice daily administrations.
-Each syringe is intended for a single use. A new syringe must be used for each dose. Any unused portion after each dose should be discarded.
-The therapeutic response is primarily reflected by reduction in symptoms such as fever, rash, joint pain, and headache, but also in inflammatory serum markers (CRP/SAA levels), or occurrence of flares.

Use: Cryopyrin-Associated Periodic Syndromes (CAPS): Treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID)

Usual Pediatric Dose for Cryopyrin-Associated Periodic Syndrome:

Initial dose: 1 to 2 mg/kg subcutaneously daily
Maximum dose: 8 mg/kg subcutaneously daily

Comments:
-Doses should be adjusted 0.5 to 1.0 mg/kg increments.
-Once daily administration is generally recommended, but the dose may be split into twice daily administrations.
-Each syringe is intended for a single use. A new syringe must be used for each dose. Any unused portion after each dose should be discarded.
-The therapeutic response is primarily reflected by reduction in symptoms such as fever, rash, joint pain, and headache, but also in inflammatory serum markers (CRP/SAA levels), or occurrence of flares.

Use: Cryopyrin-Associated Periodic Syndromes (CAPS): Treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID)

Interactions for Anakinra

Used concomitantly with methotrexate, sulfasalazine, hydroxychloroquine, gold, penicillamine, leflunomide, and/or azathioprine in clinical studies;1 3 13 specific drug interactions not evaluated in humans.1 11

Vaccines

Live virus vaccines should not be administered to patients receiving anakinra.1 Information is not available regarding whether anakinra would affect the rate of secondary transmission of vaccine virus following administration of a live virus vaccine or regarding any other effect of vaccination on patients receiving the drug.1

Information not available regarding effects of vaccination with inactivated vaccine.1

Specific Drugs

Drug

Interaction

Comments

Abatacept

Concomitant use not recommended; clinical experience insufficient to establish safety and efficacy16

Methotrexate

Pharmacokinetic interaction unlikely;1 no alterations in clearance or toxicologic profile of anakinra or methotrexate with concomitant administration in rats1

Tetanus toxoid

Immunologic response preserved in 1 study1

TNF blocking agents (e.g., adalimumab, etanercept, infliximab)

Increased incidence of adverse effects (serious infections, neutropenia) and no added clinical benefit reported with combined anakinra and etanercept therapy compared with etanercept alone1 14

Concomitant use not recommended1 14

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Pharmacologic Category

  • Antirheumatic, Disease Modifying
  • Interleukin-1 Receptor Antagonist

Adverse Reactions

>10%:

Central nervous system: Headache (12% to 14%)

Gastrointestinal: Vomiting (NOMID: 14%)

Immunologic: Antibody development (RA: 49%; neutralizing: 2%; no correlation of antibody development and adverse effects)

Infection: Infection (RA: 39%; serious infection: 2% to 3%; including cellulitis, pneumonia, and bone and joint infections)

Local: Injection site reaction (RA: 71%; mild: 73%; moderate: 24%; severe: 2% to 3%; NOMID: 16%; mild: 76%; moderate: 24%)

Neuromuscular & skeletal: Arthralgia (NOMID: 12%)

Respiratory: Nasopharyngitis (NOMID: 12%)

Miscellaneous: Fever (NOMID: 12%)

1% to 10%:

Gastrointestinal: Nausea (RA: 8%), diarrhea (RA: 7%)

Hematologic & oncologic: Eosinophilia (RA: 9%), decreased white blood cell count (RA: 8%), change in platelet count (RA; decreased: 2%

Frequency not defined:

Dermatologic: Skin rash (NOMID)

Endocrine & metabolic: Hypercholesterolemia (RA)

Respiratory: Upper respiratory tract infection (NOMID)

<1% (Limited to important or life-threatening): Hepatitis (noninfectious), hypersensitivity reaction (including anaphylaxis, angioedema, pruritus, skin rash, urticaria), increased serum transaminases, metastases (malignant lymphoma, malignant melanoma), opportunistic infection, thrombocytopenia (including severe)

Pregnancy Risk Factor B Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies.

Information related to the use of anakinra during pregnancy is limited (Makol 2011; Ostensen 2011). Specific guidelines for use in pregnancy are not available (Saag [ACR] 2008); use should not be continued during pregnancy until more data is available (Makol 2011; Ostensen 2011).

Women exposed to anakinra during pregnancy may contact the Organization of Teratology Information Services (OTIS), Rheumatoid Arthritis and Pregnancy Study at 1-877-311-8972.

Usual Adult Dose for Rheumatoid Arthritis

100 mg subcutaneously once daily

Comments:
-The dose should be administered at approximately the same time every day.
-Alternating the injection site is recommended to avoid discomfort at the site of injection.

Use: Rheumatoid Arthritis (RA): To reduce symptoms and slow the progression of structural damage in moderately to severely active RA, in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs (DMARDs)

Anakinra Breastfeeding Warnings

This drug is recombinant human interleukin-1 receptor antagonist (IL-1Ra). IL-1Ra is a normal component of human milk where it may play a role as an anti-inflammatory agent. No data exist on the excretion of this drug into breastmilk after exogenous administration. One infant was reportedly breastfed during maternal therapy with no obvious adverse effects. However, long-term follow-up data on infants breastfed during maternal use are not available.

Safety has not been established. Excreted into human milk: Unknown Excreted into animal milk: Data not available

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