"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.
(eculizumab) Solution for Intravenous Infusion
SERIOUS MENINGOCOCCAL INFECTIONS
Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early [see WARNINGS AND PRECAUTIONS].
- Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
- Immunize patients with meningococcal vaccines least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection. [see WARNINGS AND PRECAUTIONS for additional guidance on the management of the risk of meningococcal infection].
- Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.
Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS, prescribers must enroll in the program [see WARNINGS AND PRECAUTIONS]. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1888-765-4747) or at solirisrems.com.
Soliris, a complement inhibitor, is a formulation of eculizumab which is a recombinant humanized monoclonal IgG2/4κ antibody produced by murine myeloma cell culture and purified by standard bioprocess technology. Eculizumab contains human constant regions from human IgG2 sequences and human IgG4 sequences and murine complementarity-determining regions grafted onto the human framework light-and heavy-chain variable regions. Eculizumab is composed of two 448 amino acid heavy chains and two 214 amino acid light chains and has a molecular weight of approximately 148 kDa.
Soliris is a sterile, clear, colorless, preservative-free 10 mg/mL solution for intravenous infusion and is supplied in 30-mL single-dose vials. The product is formulated at pH 7 and each vial contains 300 mg of eculizumab, 13.8 mg sodium phosphate monobasic, 53.4 mg sodium phosphate dibasic, 263.1 mg sodium chloride, 6.6 mg polysorbate 80 (vegetable origin) and Water for Injection, USP.
What are the possible side effects of eculizumab (Soliris)?
Seek emergency medical attention or call your doctor right away if you notice any of these symptoms of meningitis:
- headache and fever with nausea or vomiting;
- high fever (103 degrees or higher), body aches, flu symptoms;
- confusion, increased sensitivity to light; or
- stiffness in your neck or back.
With your medication you will receive a Patient Safety Card listing the symptoms of meningococcal infection. Carry this card with you at all times.
Get emergency medical help if you have any of these signs of an allergic reaction:...
What are the precautions when taking eculizumab (Soliris)?
Before using eculizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/recent infection (especially of meningitis or other infection caused by the bacteria Neisseria meningitidis), vaccination history (especially for meningitis).
Before having surgery, tell your doctor or dentist that you are using this medication.
You may be vaccinated against certain infections before starting this medication. Do not have other immunizations/vaccinations without the consent of your doctor,...
Last reviewed on RxList: 1/30/2017
This monograph has been modified to include the generic and brand name in many instances.
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