Make Sure Your Patients Are Informed
The Patient Safety Information Card
You will need to provide your patient with a Patient Safety Information Card to carry with them at all times. This safety card contains important safety information that your patient needs to be aware of before they are given Soliris® and during their treatment with Soliris. Remind them to show this card to any doctor involved in their treatment.
Soliris treatment may reduce your patients’ natural resistance to infections, especially meningococcal infection, which requires immediate medical attention.
Tell your patient that if they cannot reach their doctor, go to an emergency room immediately and show them the Patient Safety Information Card. Even if they stop using Soliris, they should keep their Patient Safety Card with them for 3 months after the last Soliris dose, since side effects may occur a long time after their last dose of Soliris.
Soliris has a proven safety profile
- The most common adverse events were headache, nasopharyngitis, back pain, nausea, and fatigue1,2
- Most patients reporting fatigue as an adverse event demonstrated meaningful improvements as measured by objective instruments2,3
- Increased incidence of headaches occurred only during the first two Soliris infusions and may indicate rapid availability of nitric oxide3
- Antibodies against Soliris rarely developed during 6 months of treatment1
Important safety information
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
Soliris increases the risk of meningococcal infections
- Vaccinate patients with a meningococcal vaccine at least 2 weeks prior to receiving the first dose of Soliris; revaccinate according to current medical guidelines for vaccine use
- Monitor patients for early signs of meningococcal infections, evaluate immediately if infection is suspected, and treat with antibiotics if necessary
Indications and usage
Soliris is indicated for treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
Contraindications
Do not initiate Soliris in patients:
- with unresolved serious Neisseria meningitidis infection
- who are not currently vaccinated against Neisseria meningitidis
Warnings and precautions
Other infections: Soliris blocks terminal complement; therefore patients may have increased susceptibility to infections, especially with encapsulated bacteria. Use caution when administering Soliris to patients with any systemic infection.
Monitoring after Soliris discontinuation
If serious hemolysis occurs after Soliris discontinuation, consider the following procedures/treatments: blood transfusion (packed RBCs), or exchange transfusion if the PNH RBCs are >50% of the total RBCs by flow cytometry; anticoagulation; corticosteroids; or reinstitution of Soliris.
In clinical studies, 16 of 196 PNH patients discontinued treatment with Soliris. Patients were followed for evidence of worsening hemolysis and no serious hemolysis was observed.
Infusion reactions
As with all protein products, administration of Soliris may result in infusion reactions, including anaphylaxis or other hypersensitivity reactions.
Thrombosis prevention and management
The effect of withdrawal of anticoagulant therapy during Soliris treatment has not been established. Therefore, treatment with Soliris should not alter anticoagulant management.