INFORMED CONSENT FOR THE ADMINISTRATION OF BENLYSTA
Patient Name:______Account Number______
Date of Birth:______
I, ______, voluntarily consent to the administration of Benlysta
For the purpose of______on ______
(Diagnosis) Name of Patient or Authorized Party
Dr. ______has explained to me that Benlysta may have undesirable side effects as well as beneficial effects. I understand that the side effects listed below may be associated with the administration of Benlysta.
BENLYSTA (belimumab) THERAPY
I am recommending that you take Benlysta for your systemic lupus (SLE). It is a new
medicine used to treat systemic lupus. It blocks the activity of an inflammatory agent, Blys.
Blysstimulates the production of B-cells. B-cells are involved in the production of antibodies which are believed to be overly active in SLE.
Benlysta is given by intravenous infusion in our office or the hospital every 2 weeks
times 3 and then every 4 weeks. SLE patients may continue other standard SLE therapy while on Benlysta. Whileyou are taking this drug it is very important that you are monitored very
closely with blood counts and regular evaluations by your rheumatologist. In the interest of your
well-being, I can only prescribe this medicine if you comply with these examinations.
It is important that you understand the potential side effects of Benlysta before starting
therapy:
- Allergic (hypersensitivity) and infusion reactions. Serious allergic or infusionsreactions can happen on the day of or the day after receiving Benlysta. Symptoms of an allergic infusion reaction may include: itching, swelling of the face, lips, mouth, tongue, or throat, trouble breathing, anxiousness, low blood pressure, dizziness or fainting, headache, nausea, skin rash, redness, or swelling.
- The most common side effects of Benlysta include: nausea, diarrhea, fever, stuffy or runny nose, sore throat, cough (bronchitis), trouble sleeping, leg or arm pain, headache (migraine),urinary tract infection, decreased white blood cell count (leucopenia), vomiting, stomach pain.
- There appears to be an increased risk of developing serious or fatal infections while you are on Benlysta. You should inform your doctor immediately if you develop a
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fever or other symptoms such as chills, pain or burning with urination, urinating often, bloody diarrhea, coughing up mucus suggesting an infection. Patients with ongoing or chronic infections like tuberculosis (TB) cannot receive Benlysta infusions. Please notify us if you have a positive skin test or a history of being treated for TB.
- The efficacy of Benlysta has not been evaluated in patients withsevere active lupus nephritis or severe active central nervous system lupus.
- Benlysta has not been studied in combination with other biologics or intravenous Cyclophosphamide. Use ofBenlysta is not recommended in these situations.
- Benlysta does not appear to decrease blood counts or affect vital organs such as the liver. However, it is still necessary to check your basic blood work on a regular basis since Benlysta is a relatively new medicine.
- The long-term consequences of Benlysta infusions, such as lymphoma or other malignancies are unknown at this time.
- Benlysta and pregnancy: There is currently no information available on the risk of fetal harm or infertility. To be safe it is recommended that pregnant or nursing mothers and woman trying to conceive should not receive Benlysta infusions.
- Mental Health problems and suicidal thoughts. Symptoms of mental health problems can include: Thoughts of suicide or dying, attempt to commit suicide, trouble sleeping (insomnia), new or worse anxiety, new or worse depression, action on dangerous impulses, other unusual changes in your behavior or mood, thoughts of hurting yourself or others
- Immunizations: Live vaccines should not be given concurrently with Benlysta.
- Race: Initial studies indicate Benlysta may be less effective for African-Americans. Current studies are being conducted, but results may not be available for years.
In summary, Benlysta is a potent and effective drug in the treatment of SLE that may limit or stop symptoms of SLE. If used with caution and in the care of your rheumatologist, the benefits outweigh the risks described above. However, should you have any questions or problems while taking this drug, please feel free to call and discuss them with me.
I have been given the opportunity to ask questions about my (the patient’s) condition, alternatives for treatment, risk of non-treatment, benefits of treatment and the risk and hazards involved, and I am satisfied that I have sufficient information to give this informed consent. I understand that I am free to withdraw my permission for Therapy at any time without prejudice to my continued care.
Benlysta may reduce the activity of the immune system. Medicines that affect the immune system may increase the risk of certain cancers.
Signed______Witness______
Date______Physician______