Objectives. There Aren t Enough Hours in the Day

Transcription

1 There Aren t Enough Hours in the Day Medication monitoring and communication of results Objectives Review the types of testing being ordered on patients receiving therapies other than platforms Discuss how that information is being relayed to patients Determine methods of improving clarity of meaning behind test results

2 Safety Monitoring *Disclaimer: FDA required testing is in Red. For the sake of discussion, safety monitoring schedules specifically used by Carolinas Medical System MS Center are listed in gray. Safety Monitoring Certain monitoring is required by the FDA and is listed in the Package Insert Many practitioners order other blood tests regularly for monitoring that is not required by the FDA. With increasing complexity of MS therapies, monitoring has become much more time consuming

3 Natalizumab (Tysabri) JC Virus antibody testing every 6 months in patients who are JC Virus negative In patients who have been on therapy for more than 2 years, JC Virus testing every 3 months CBC with diff, LFT every 6 months while on therapy. Fingolimod (Gilenya) Obtain CBC & LFT within 6 months of initiating treatment Monitor for macular edema prior to initiation of therapy and 3-4 months after FDO VZV titer prior to initiating treatment CBC with diff, LFT at month 3 and 6 and every 6 months while on therapy

4 Teriflunomide (Aubagio) CBC, LFT, TB test prior to treatment initiation If applicable, pregnancy test before starting Liver Function Testing monthly for the first 6 months on therapy. CBC with diff, LFT, BUN/Cr at months 3 and 6 and every 6 months while on therapy. Dimethyl Fumarate CBC with diff every 6 months JC Virus antibody testing, CD4, and CD8 counts every 6 months while on therapy

5 Alemtuzumab (Lemtrada) The following tests must be done 30 days prior to treatment initiation and monthly for 48 months following last infusion: CBC with differential Serum Creatinine Urinalysis with cell count TSH (at initiation and q 3 months thereafter) Alemtuzumab (Lemtrada) Baseline and yearly skin exams to monitor for Melanoma Baseline and yearly PAP smears Prior to dosing, we also obtain VZV titer, JC Virus antibody testing, if negative, Hep B, TB testing, HIV testing, Chest x-ray.

6 Transparency Updates We needed a way to keep patients updated on the following topics: Safety Updates A way to consistently cover the same information with each patient. Individual test results Our requirements for monitoring while on medications A way to monitor ongoing labs.

7 Fingolimod (Gilenya) Consent Medication name: Gilenya (Fingolimod) Gilenya is an oral medication and works by sequestering one particular type of white blood cee, lymphocytes, within the lymph nodes. Therefore, your lymphocyte count will decrease; however, this process is reversible and lymphocyte counts typically return to normal in approximately 2 months after discontinuing this medication. Gilenya has been FDA approved for the treatment of relapsing forms of multiple sclerosis. Potential side effects of this medication are: Cardiac: Gilenya decreases the heart rate, particular after the first dose. Approximately 5% of patients develop an irregular heart rhythm, arrhythmia, in particular with the first dose. For this reason the first dose of medication is given under close observation in order to monitor your blood pressure and heart rate. Certain medications may increase this risk and therefore it is important for you to discuss all of your medications with your doctor and should update our office if there is any change in your medications prior to starting your first dose of Gilenya. Infections: Respiratory infections: From the initial clinical trials a slightly higher rate of respiratory infections were seen with this medication. Shingles/Herpes infection: There appears to be an increased risk of developing shingles while taking Gilenya. If you develop shingles while on this medication you should contact our office immediately. You should NOT get the shingles vaccine, or any other live vaccination, while taking Gilenya. Taking steroids while on Gilenya may increase this risk and is not generally advised. Since the release of this medication, there have been cases of life threatening disseminated shingles and herpes encephalitis. Progressive multifocal leukoencephalopathy (PML): There have been cases of PML in patients treated with Gilenya. PML is a brain infection caused by the JC virus. JC virus is ubiquitous and present in more than 50% of persons; however, this virus does not typically cause any infection unless someone is immunosuppressed. PML is often disabling and can be life threatening. PML is often disabling and can be life threatening. There is no known treatment or prevention for PML. Fingolimod (Gilenya) Consent There is no data regarding how the JC virus antibody test may impact the risk of PML with Gilenya specifically Meningitis/Encephalitis: There have been isolated cases of other brain infections and meningitis such as cryptococcal meningitis. Macular edema: Approximately 0.5% of patients developed macular edema, a swelling in the retina that can cause difficulty with vision. You need to have an eye exam before your first dose and four months later to monitor for this potential side effect. Skin cancer: There have been reports of skin cancer in patients on Gilenya. The rate of basal cell carcinoma was reported at approximately 2% (versus 1% in the placebo arm). Other: May lead to a sustained mild increase in blood pressure. Some patients developed mild liver injury and regular blood testing should be done to evaluate the liver. Pulmonary function decreased in some patients taking Gilenya. Tell your provider if you have a history of lung disease or smoking. There are case reports of PRES, posterior reversible encephalopathy syndrome, which can cause confusion, headaches and/or seizures. Pregnancy and Gilenya Patients should not become pregnant while taking Gilenya or for two months after stopping the medication. There have been case reports of birth defects reported while taking Gilenya but it is unclear if this occurs at a higher than expected rate or is associated with this medication. We recommend having a pregnancy test prior to starting this medication, if applicable. Recommended monitoring Prior to starting medication: Labs: complete blood counts, liver function test, VZV titer, pregnancy test (if applicable) Ophthalmology examination Baseline EKG Baseline dermatology visit for skin examination. First dose monitoring: Patients must receive their first dose of Gilenya under observation in order to monitor their heart and blood pressure. Monitoring typically lasts 6 hours but may be

8 Fingolimod (Gilenya) Consent extended if there are any concerns such as a lower heart rate or irregular heart rhythm develops. Maintenance monitoring: Labs: complete blood counts, liver function test every 6 months Ophthalmology examination at 3-4 months after starting Gilenya and may be recommended yearly thereafter Yearly dermatology visit for skin exam These are the risks associated with this medication based on our current information. We continue to learn new information regarding medications and safety information may change over time. patient signature date physician signature date Tysabri JCV and Index results Dear **** Your JC virus antibody test from (date) returned as positive with an index of ***. Based on our current information regarding this test, your risk of progressive multifocal leukoencephalopathy (PML) associated with this medication is as follows: JCV antibody index < months 1 in 16, months 1 in 1,961 > 48 months 1 in 1,724 JCV antibody index < months 1 in 9, months 1 in 1,316 > 48 months 1 in 1,020 JCV antibody index < months 1 in 5, months 1 in 885 > 48 months 1 in 730 JCV antibody index > months 1 in months 1 in 113 > 48 months 1 in 99 If you have been treated with other immunosuppressive medications in the past (ie, Cytoxan, methotrexate, novantrone, cellcept, imuran, etc) then the risk is higher and increases to approximately 1 in 80 after 2 years on this medication. As you know, PML is a brain infection caused by the JC virus. Many people have been exposed to the JC virus and a positive JC antibody result does not mean that you have PML but rather simply informs us of the risk of PML. PML can be life threatening and is often disabling. It is recommended that we repeat the JC virus antibody test every 6 months in order to continue to assess the risk associated with this medication. If you have any questions or concerns regarding this result please contact our clinic at We would be happy to schedule an appointment with your provider to discuss further if needed. Sincerely, MS Center Staff

9 JCV results for Gilenya pts Gilenya and JC virus Carolinas HealthCare System Dear **** Your JC virus antibody test from (date) returned as positive/negative. This test was performed because of recent cases of progressive multifocal leukoencephalopathy (PML) reported in patients taking Gilenya. Overall, there are approximately 120,000 patients treated with Gilenya. At this point it is unclear how the JC virus status may impact the risk of PML as this test has only been studied in patients taking Tysabri. PML is a brain infection caused by the JC virus. JC virus is common and approximately half of all individuals will test positive for the JC virus antibody. A positive JC virus antibody does NOT mean that one has PML but rather may be used to help your physician predict the risk of PML. It is our goal to continue to update our patients about this issue as PML is a serious concern that is often disabling and can be life threatening. If you have any questions or concerns regarding this result please contact our clinic at We would be happy to schedule an appointment with your provider to discuss further if needed. Sincerely, MS Center Staff Monitoring Spreadsheets

10 Let s talk about it Question 1 How does your practice ensure that patients are getting monthly LFTs with Teriflunomide (Aubagio) for the first 6 months of therapy?

11 Question 2 For those who monitor lymphocyte counts, CD4/CD8, what do you do when a patient s counts are low? Do you keep patients off medication until counts improve? Who is responsible for keeping track of blood work and adherence to monitoring? How often are these patients being seen in the office? Question 3 Who is responsible for ensuring patients are receiving monthly alemtuzumab (Lemtrada) blood work? How are results being tracked over time?

12 Case Studies Mary Mary is a 35-year-old Caucasian female who was diagnosed with MS at the age of 29. She failed therapy with glatiramir acetate and IFN B-1a before starting therapy with natalizumab 3 years ago. She has consistently tested JCV antibody negative. She has been stable on natalizumab with no relapses and no new or enhancing MRI lesions.

13 Question 1 How often do you see Mary in the office for face to face appointments? (not including infusions) A. Every month B. Every 3 months C. Every 6 months D. Annually Question 2 How is she notified of her JCV antibody results? A. By Mail B. Through Chart messaging/ C. By phone D. At her appointments

14 Question 3 What happens if she converts to JC Virus positive? A. Notify her by Mail B. Notify her through chart messaging/ C. Call her to discuss D. Have her come in for an appointment Question 4 Are you discussing Index results with your patients? A. Yes, through dialogue over phone or in office B. Yes, through written communication C. No

15 Chad Chad is a 39-year-old African American male who has been taking Dimethyl Fumarate since 2014 Chad is seeing you today for the first time in over a year. Chad reports taking Tecfidera twice daily consistently. His last CBC with diff was completely normal in December Chad Continued You get the results of Chad s CBC with diff the morning following his appointment. His WBC is 2.4 and his ALC is 450. What do you do? A. Stop DMF and remain off medication until counts improve. B. Have him repeat this test in 2 weeks. C. Start him on another medication. D. Continue DMF.

16 Julie Julie is a 26-year-old mother of 2 small children who was diagnosed with MS in Her disease not controlled with an injectable medication. Julie was completely opposed to using Tysabri because of PML risk despite being JC Virus negative. She ultimately decided to start fingolimod because no PML had been associated with it. Julie Continued -Julie is seen for an office visit and you provide safety updates for fingolimod, which include telling her about the cases of PML that have been reported. -She doesn t want to change medications, but she does want to have her JC Virus status rechecked. -You receive her results 2 weeks later and she is JC Virus positive with an index of 2.54.

17 Question #1 How do you share lab result information with Julie? A. Call her and discuss B. Send her a letter C. Send her an through chart messaging. D. Wait until next appointment to give her these results. Conclusion

18 COMMUNICATION! We will continue to have safety updates with as our current treatment armamentarium. With new drugs come new concerns The role of the MS nurse will continue to require innovation in communicating effectively with patients. Thank you!