Class: Biologic Therapy

Generic Name: anakinra

Trade Name: Kineret®

How is this drug used? Kineret is approved for adults to reduce the signs and symptoms and slow the damage of moderate to severe rheumatoid arthritis (RA) when one or more other drugs have not worked, and to treat people with Neonatal-Onset Multisystem Inflammatory Disease (NOMID).

What is the mechanism of action? Kineret is an immunosuppressant that works by suppressing the immune system to prevent it from damaging tissues and joints. The immune system helps protect the body from harmful substances such as infectious agents and bacteria. In people with RA, however, the immune system attacks and destroys normal tissue—namely, the tissue around the joints. This leads to inflammation and damage to the cartilage and bone and causes pain. Specifically, Kineret blocks the action of a certain protein to decrease the proliferation of rapidly dividing cells that cause inflammation.

How is Kineret given (administered)? Kineret is administered daily by subcutaneous injection at approximately the same time every day. Dosage frequency may be altered if you have kidney problems. Call your healthcare provider if you miss a dose to be informed on when you will administer your next injection.

How are patients monitored? Patients should have complete blood counts (CBC), including platelet counts, before treatment with Kineret, then monthly for three months, then every three months thereafter for one year.

What are the most common side effects of treatment with Kineret?

• Injection site reaction
• Worsening of RA, if you already have RA
• Headache
• Nausea and vomiting
• Diarrhea
• Joint pain
• Fever
• Felling like you have the flu
• Sore throat or runny nose
• Sinus infection
• Pain in stomach area
• Fatigue

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

Are there any special precautions patients should be aware of before starting treatment?

• Do not use Kineret if you are allergic to proteins made from bacteria called E. Coli, or if you’re allergic to anakinra or any of the ingredients in Kineret.
• Kineret may lower your ability to fight infections. It is not known if treatment with medicines that cause immunosuppression, like Kineret, affect your risk of getting cancer.
• Kineret may cause you to have a lower number of certain white blood cells that help fight infection. Be sure to stay on the prescribed

What should patients tell their healthcare provider before using Kineret?

Before using 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 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.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines and all herbal supplements as Kineret and other medicines may affect each other and cause serious side effects. Especially tell your doctor if you:

• Take any Tumor Necrosis Factor (TNF) blockers.

When should patients notify their physician?

Contact your healthcare professional immediately if you have signs of any of the following:

• Serious infection: Fever, chills; unusual tiredness; warm, red, or painful skin; or open sores on your body.
• Allergic reaction: Swelling of face, lips, mouth or tongue; trouble breathing; wheezing; severe itching; dizziness or fainting; hives or rash; fast heartbeat or pounding in your chest; sweating.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated on 01/17.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

DISCLAIMER OF WARRANTIES

CANCERCONNECT.COM SPECIFICALLY DISCLAIMS AND EXCLUDES ALL EXPRESSED OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES AS TO QUALITY, ACCURACY (INCLUDING TYPOGRAPHICAL ERRORS), MERCHANTABILITY, OR FITNESS FOR ANY PARTICULAR PURPOSE OF THE INFORMATION CONTAINED HEREIN. CANCERCONNECT.COM DISCLAIMS ALL LIABILITY OR DAMAGES ARISING FROM ANY USE OF THE INFORMATION.

The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.