SPHERUSOL

Patient Information

Detecting Your Immunity to Valley Fever

This information does not take the place of speaking with your health care provider. More information about SPHERUSOL, including the full Prescribing Information, can be obtained at www.nielsenbiosciences.com or by calling toll-free 1-855-855-1212.

Detecting an immune response 

The immune response is how your body recognizes and defends itself against organisms that can cause diseases like Valley Fever.

SPHERUSOL is a skin test performed if your doctor has determined you have a history of Valley Fever (pulmonary coccidioidomycosis). The purpose of the test is to see if you have developed an immune response to the fungus (Coccidioides) that causes Valley Fever.

  • A positive SPHERUSOL skin test means that your body has produced an immune response due to a current or past Valley Fever infection.
  • Not all people who have or have had a Valley Fever infection will develop a positive skin test. This may be because:

o   The Valley Fever infection is early

o   The Valley Fever infection is severe

o   Other infections or conditions interfere with the immune response

o   Certain drugs that affect the immune system can interfere with the immune response

  • SPHERUSOL is approved for use in patients 18 to 64 years of age.

How the test works

  • Once SPHERUSOL is in the skin, your body’s immune system recognizes SPHERUSOL as being like the fungus that causes Valley Fever.
  • If you have been infected with Valley Fever before or are currently, your immune response will cause a raised, firm area or bump that may be surrounded by redness at the injection site within 2 days.
  • You need to be sure to return to your test provider to have the test site examined in 2 days.

How the test is given

  • A small amount of SPHERUSOL is injected into the top layer of your skin, much like the skin test for tuberculosis or like some allergy tests.
  • After the test, it is normal for your health care provider to ask you to stay for at least 20 minutes for observation. This practice is to make sure you don’t have any immediate allergic symptoms to the test.

Important rules to remember

  • Do not scratch or itch the test site.
  • Do not cover the test site with a bandage or wrapping.
  • Call your health care provider if you have any questions or concerns about any signs or symptoms you experience after receiving SPHERUSOL.

How the test is read

  • Your health care provider will examine you 48 hours (2 days) after your test to see if you have developed a raised, firm area or bump on your skin of a certain size. Be sure to schedule a return visit to your health care provider so this examination can occur.
  • You should not measure the test on your own.
  • If a measurement of 5 millimeters is obtained (about the size of Lincoln’s head on a penny), it means you have tested positive. In studies using SPHERUSOL, a positive response was typically the size of a dime (17 mm), though larger sizes were seen (up to 39 mm or about 1 1/2 inches).

What to expect after the test

  • Some redness is likely to occur and to remain for a few days.
  • If you develop a bump, it should get smaller and go away within about 7 days.
  • Contact your health care provider if the redness and/or the bump are still visible longer than 7 days after your test.

IMPORTANT SAFETY INFORMATION

If you are positive, you can expect a small area of swelling typically the size of a dime or a quarter over about 1-2 days. You should contact your health care provider if you experience severe pain or rapid or larger swelling at the site.

You should seek immediate medical attention if you experience the following signs that may be a serious or life-threatening condition:

o   Difficulty breathing

o   Wheezing

o   Hives or rash

o   Itching over major areas of your body

Your health care provider should keep you under observation for at least 20 minutes after you receive SPHERUSOL to see if you develop signs of a severe allergic reaction.

You should not receive SPHERUSOL if you have had a severe allergic reaction (anaphylaxis) to SPHERUSOL or the ingredients in SPHERUSOL such as the preservative phenol or very low levels of thimerosal.

You should tell your health care provider if you are taking drugs known as beta blockers as they might interfere with treatments for severe reactions.

You should tell your health care provider if you have a condition or you are taking drugs that affect your immune system.

Most of the patients in clinical studies experienced some effects at the site including: itching, swelling, and/or pain within 7 days of the test.