"The US Food and Drug Administration (FDA) has approved Bayer AG's unmodified, full-length recombinant antihemophilic factor VIII product, Kovaltry, for the treatment of hemophilia A in children and adults, the company said.
Soliris Patient Information including How Should I Take
In this Article
- What is eculizumab (Soliris)?
- What are the possible side effects of eculizumab (Soliris)?
- What is the most important information I should know about eculizumab (Soliris)?
- What should I discuss with my health care provider before taking eculizumab (Soliris)?
- How is eculizumab given (Soliris)?
- What happens if I miss a dose (Soliris)?
- What happens if I overdose (Soliris)?
- What should I avoid while taking eculizumab (Soliris)?
- What other drugs will affect eculizumab (Soliris)?
- Where can I get more information?
What should I discuss with my health care provider before taking eculizumab (Soliris)?
Eculizumab affects your immune system, and using this medication may increase your risk of serious infection such as meningitis.
You must be vaccinated against meningococcal infection at least 2 weeks before you start treatment with eculizumab. Even if you have been vaccinated in the past, you may need a booster dose.
It is best to stay current on all of your vaccinations while you are using eculizumab, and your doctor may recommend other vaccines before or during treatment.
Children being treated with eculizumab may also need to be vaccinated against influenza or pneumonia before treatment begins.
You should not use this medication if you are allergic to eculizumab, if you have bacterial meningitis, or if you have not been vaccinated against meningitis.
To make sure you can safely use eculizumab, tell your doctor if you have a fever or any type of infection.
FDA pregnancy category C. It is not known whether eculizumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
It is not known whether eculizumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Eculizumab is available only under a special program called Soliris REMS. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.
How is eculizumab given (Soliris)?
Eculizumab is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.
Eculizumab is usually given once a week for 5 weeks, and then once every 2 weeks thereafter. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Eculizumab must be mixed in an IV bag with a liquid (diluent) before injecting it.
If you are using the injections at home, be sure you understand how to properly mix and store the medication. Do not shake the medication bottle or you may ruin the medicine. Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.
To reduce discomfort from your injection, allow the mixed medicine to reach room temperature before using, but never warm the medicine in hot water or a microwave. You may store the mixture at room temperature but you must use it within 24 hours or throw the mixture away.
You may have a reaction to the infusion (when the medicine is injected into the vein). If this happens, you may need to slow down the speed of your IV infusion, but the infusion should not take more than 2 hours to complete. A caregiver or family member should then watch you for at least 1 hour after your injection to make sure you have no further side effects.
Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.
Use a disposable needle only once, then throw away in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
Do not stop using eculizumab without first talking to your doctor. Stopping or interrupting your treatment could cause sudden and serious effects on your red blood cells.
If you stop using eculizumab for any reason, your blood may need to be tested on a regular basis for 8 to 12 weeks. Do not miss any scheduled visits to your doctor during this follow-up period.
Store unopened vials in their original carton in the refrigerator. Protect from light and do not freeze. Throw away any unused vials after the expiration date on the label has passed.
Additional Soliris Information
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