"The Centers for Disease Control and Prevention has identified a cluster of newborns in Tennessee with late vitamin K deficiency bleeding (VKDB). VKDB is a serious, but preventable bleeding disorder that can cause bleeding in the brain. In each"...
- Patient Information:
Details with Side Effects
See FDA-approved patient labeling (Medication Guide).
Prior to treatment, patients should fully understand the risks and benefits of Soliris, in particular the risk of meningococcal infection. Ensure that patients receive the Medication Guide.
Patients should be informed that they are required to receive a meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris, if they have not previously been vaccinated. They are required to be revaccinated according to current medical guidelines for meningococcal vaccine use while on Soliris therapy. Patients should also be informed that vaccination may not prevent meningococcal infection. Patients should be educated about any of the signs and symptoms of meningococcal infection, and strongly advised to seek immediate medical attention if these signs or symptoms occur. These signs and symptoms are as follows:
- headache with nausea or vomiting
- headache and a fever
- headache with a stiff neck or stiff back
- fever of 103° F (39.4° C) or higher
- fever and a rash
- muscle aches with flu-like symptoms
- eyes sensitive to light
Patients should be informed that they will be given a Soliris Patient Safety Information Card that they should carry with them at all times. This card describes symptoms which, if experienced, should prompt the patient to immediately seek medical evaluation.
Patients should also be informed that there may be an increased risk of other types of infections, particularly those due to encapsulated bacteria. Parents or caregivers of children receiving Soliris for the treatment of aHUS should be informed that their child should be vaccinated against Streptococcus pneumoniae and Haemophilus influenza type b (Hib) according to current medical guidelines.
Patients with PNH should be informed that they may develop hemolysis due to PNH when Soliris is discontinued and that they will be monitored by their healthcare professional for at least 8 weeks following Soliris discontinuation. Patients with aHUS should be informed that there is a potential for TMA complications due to aHUS when Soliris is discontinued and that they will be monitored by their healthcare professional for at least 12 weeks following Soliris discontinuation. Patients who discontinue Soliris should be instructed to keep the Soliris Patient Safety Information Card with them for three months after the last Soliris dose, because the increased risk of meningococcal infection persists for several weeks following discontinuation of Soliris.
Last reviewed on RxList: 9/30/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Soliris Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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