If you search this, or a few other, MS sites, you will quickly learn that I was not cheering the approval of Lemtrada. Now, I am actively cheering for the best outcomes of all Lemtrada patients. While I believe Lemtrada has the chance to be a miracle to many patients, it will also be problematic for other patients. Now that it is approved, I can only hope and pray for Lemtrada patients, that they will see the benefits without any negative effects. I believe the media, and many others, promote treatments without fully explaining potential risks. This morning I was sent a link to the Lemtrada prescribing information and I want to share that information with you. I have attempted to provide an unbiased summary of Genzyme's document about pre & post infusion testing and the most common side effects. I will refrain from any commentary, but will reply to specific comments or questions asked.
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For patients, that previously received Lemtrada did all of the above testing or information get conveyed to you?
For patients considering Lemtrada, has your doctor followed the complete safety protocol as briefly outlined below?
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Pre & Post Treatment Monitoring
- Were you screened for tuberculosis, HBV and HCV? Did they check your last screening of HPV?
- Was your thyroid tested? Your thyroids should be retested every 3 months, for 4 years after your final infusion.
- Did you have a screening MRI for PML? Did your doctor cover the signs & symptoms of PML and discuss what should happen if you develop new PML signs?
- Did any of you have a immunization, (flu, shingles or other) in the past 6 weeks?
- Did you get a CBC w/differential? Urinalysis? These tests should be repeated every month for 4 years after the last treatment.
- Did anyone have an active infection? This is grounds for considering a delay in Lemtrada treatment.
- Are any of you on the recommended anti-viral prophylaxis?
- Were any of you "stable" on your current medication, if so, do you realize Lemtrada was NOT recommended?
- Did you realize that you signed up for follow up testing and screenings for 4 years after your final dose?
- Are you, or are you considering, getting pregnant? In the next 16 months after the intial dose? Sixty percent of pregnancies reported between Cycle 1 and Cycle 2 were spontaneously or electively aborted. Of the remaining forty percent, 2 had preterm pregnancies, 14 had spontaneous abortions, 5 had elective abortions, 1 still birth and 11 pregnancies had unknown outcomes. All that said, Lemtrada is not recommended for pregnant women, or for 4 months after your last dose.
- It is not known whether Lemtrada is excreted in human milk.
- In addition to the birth issues, pregnant women had special risks of Immune, Autommune and/or Thyroid Disorders.
- It is not known if patients 65 years or older, have any, similar or increased risks than other patients.
Side Effects
Like all medicines, LEMTRADA can cause side effects.
Very common side effects (reported in at least 10% of clinical trials patients) which often occur during or shortly after a single infusion or treatment course include:
Other common side effects (reported between 5-10% of clinical trial patients) include:
Information extracted directly from the Genzyme here article located here: http://www.genzyme.ca/thera/docs/ca_...lemtradapi.pdf.
************************************************** **********************************************
For patients, that previously received Lemtrada did all of the above testing or information get conveyed to you?
For patients considering Lemtrada, has your doctor followed the complete safety protocol as briefly outlined below?
************************************************** *********************************************
*
Pre & Post Treatment Monitoring
- Were you screened for tuberculosis, HBV and HCV? Did they check your last screening of HPV?
- Was your thyroid tested? Your thyroids should be retested every 3 months, for 4 years after your final infusion.
- Did you have a screening MRI for PML? Did your doctor cover the signs & symptoms of PML and discuss what should happen if you develop new PML signs?
- Did any of you have a immunization, (flu, shingles or other) in the past 6 weeks?
- Did you get a CBC w/differential? Urinalysis? These tests should be repeated every month for 4 years after the last treatment.
- Did anyone have an active infection? This is grounds for considering a delay in Lemtrada treatment.
- Are any of you on the recommended anti-viral prophylaxis?
- Were any of you "stable" on your current medication, if so, do you realize Lemtrada was NOT recommended?
- Did you realize that you signed up for follow up testing and screenings for 4 years after your final dose?
- Are you, or are you considering, getting pregnant? In the next 16 months after the intial dose? Sixty percent of pregnancies reported between Cycle 1 and Cycle 2 were spontaneously or electively aborted. Of the remaining forty percent, 2 had preterm pregnancies, 14 had spontaneous abortions, 5 had elective abortions, 1 still birth and 11 pregnancies had unknown outcomes. All that said, Lemtrada is not recommended for pregnant women, or for 4 months after your last dose.
- It is not known whether Lemtrada is excreted in human milk.
- In addition to the birth issues, pregnant women had special risks of Immune, Autommune and/or Thyroid Disorders.
- It is not known if patients 65 years or older, have any, similar or increased risks than other patients.
Side Effects
Like all medicines, LEMTRADA can cause side effects.
Very common side effects (reported in at least 10% of clinical trials patients) which often occur during or shortly after a single infusion or treatment course include:
- Headache
- Dizziness
- Rash, Hives, Itching
- Fever
- Nausea, vomiting
- Difficulty sleeping
- Back pain, joint pain, pain in arms or legs
- Upper respiratory tract infection/cough, cold
- Urinary tract infection
- Chills
- Sore throat or mouth pain
- Feeling tired
- Bruising
- Tingling sensation
- Diarrhea
Other common side effects (reported between 5-10% of clinical trial patients) include:
- Decrease of white blood cells (lymphocytes)
- Fast or irregular heartbeat (palpitations), chest discomfort
- Indigestion (heartburn), stomach pain, constipation
- Flu, flu-like illness
- Muscular pain, muscular weakness, muscle spasms, neck pain
- Swelling of the arms and/or legs
- Weakness
- Oral herpes
- Altered taste, numbness, blurred vision
- Depression, anxiety
- Cough, difficulty breathing or shortness of breath
- Bronchitis
- Body rash, redness of the skin
- Reddening of the face and neck
- Under-active thyroid gland
- Nose bleeds
Information extracted directly from the Genzyme here article located here: http://www.genzyme.ca/thera/docs/ca_...lemtradapi.pdf.
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