Prepared by Drs. Ed Hsiao, Mona Al Mukaddam, Fred Kaplan and Bob Pignolo

As flu season will soon be upon us, the IFOPA is sharing this important update that has been prepared by Drs. Ed Hsiao, Mona Al Mukaddam, Fred Kaplan and Bob Pignolo for FOP patients living in the United States. Please share this document with your physician.

The Centers for Disease Control and Prevention (CDC) recommend flu vaccinations by the end of October, so as you begin thinking about flu vaccinations, there are some important changes this year that you should be aware of. Transdermal and intradermal flu vaccines* will not be available this year in the U.S. The only U.S.-approved and available forms of flu vaccinations are those administered by intramuscular (IM) injection or a live attenuated intranasal form.

As you are likely aware, the live attenuated intranasal form of the flu vaccine (Flumist^®) does have a history of flares in some patients living with FOP. We do NOT recommend the intranasal vaccine for this reason.

At this time, we recommend that people living with FOP receive the flu vaccine using a modified protocol where the regular flu vaccine is given subcutaneously.** Although there is no clear data as to how efficacious this will be, prior studies suggest that there will be some efficacy despite being administered in a different route. Consultation with various physicians and the CDC suggest that this is currently the best option for this year. Note that this will likely require a physician or physician’s office to administer the flu vaccine, as many places (i.e. pharmacies) will not deviate from their normal protocol.

• For children, have one dose (0.25 ml) of the intramuscular vaccine administered subcutaneously.

• For adults, either have two doses of the pediatric dose (0.25 ml) intramuscular vaccine administered subcutaneously, at two different locations. Alternatively, have the regular adult dose (0.5 ml) split and administered as two separate subcutaneous injections at two different locations. The locations do not need to be far apart – injection 0.5 ml subcutaneously in any location is just uncomfortable.

It is NOT recommended to take the vaccine intramuscularly.

For all vaccines in persons living with FOP, it is recommended that a site be chosen near a joint or muscle group that has already been affected. That way, if a flare does develop, it is less likely to result in loss of mobility. For all patients, it is recommended to take a dose of acetaminophen or ibuprofen with the vaccine to help with any discomfort the vaccine may cause.

Family members living in the same home and caretakers should get the intramuscular flu vaccination as soon as possible. The nasal flu spray is NOT recommended for those in close contact with FOP patients.

Please keep in mind that those living with FOP should avoid flu immunizations during an active flare-up – even a subcutaneous vaccine should NOT be given anywhere.

If a person living with FOP or anyone living with or caregiving for a person with FOP develops symptoms suggestive of the flu, they should get prompt evaluation and consider antiviral treatment (i.e. Tamiflu^®).

If your provider has any questions, please have them reach out to your FOP doctor.

Prevention

Everyone should practice everyday preventive actions to stop the spread of germs.

• Try to avoid close contact with sick people.
• While sick, limit contact with others as much as possible to keep from infecting them.
• If you are sick with flu symptoms, CDC recommends that you stay home for at least 24 hours after your fever is gone except to get medical care or for other necessities. (Your fever should be gone for 24 hours without the use of a fever-reducing medicine.)
• Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.
• Wash your hands often with soap and water. If soap and water are not available, use an alcohol-based hand rub.
• Avoid touching your eyes, nose and mouth. Germs spread this way.
• Clean and disinfect surfaces and objects that may be contaminated with germs like the flu.
• See Everyday Preventive Actions and Nonpharmaceutical Interventions (NPIs) for more information about actions – apart from getting vaccinated and taking medicine – that people and communities can take to help slow the spread of illnesses like influenza (flu).

* Transdermal is a route of administration wherein active ingredients are delivered across the skin for systemic distribution. Examples include transdermal patches used for medicine delivery. Intradermal injection is the injection of a substance into the dermis, just below the epidermis. This route has the longest absorption time as compared to subcutaneous injections and intramuscular injections. As a result, it is used for sensitivity tests, like tuberculin and allergy tests, and for local anesthesia. 

** A subcutaneous injection is administered as a bolus into the subcutis, the layer of skin directly below the dermis and epidermis, collectively referred to as the cutis. Subcutaneous injections are highly effective in administering vaccines and medications such as insulin, morphine, diacetylmorphine and goserelin.