Common questions about Siklos®
Siklos® is the only FDA-approved prescription medicine that is used to reduce the frequency of painful crises and reduce the need for blood transfusions in adults and children 2 years of age and older with sickle cell anemia with recurrent moderate to severe painful crises.
The US Food and Drug Administration (FDA) approved Siklos® in December 2017.
The safety and effectiveness of Siklos® have been established in pediatric patients aged 2-18 years with sickle cell anemia with recurrent moderate to severe painful crises. Use of Siklos® in these age groups is supported by evidence from a reliable scientific study (ESCORT-HU), in which 405 pediatric patients ages 2 to under 18 were enrolled. Among the 405 pediatric patients treated with Siklos® in this study, 274 were children (2-11) and 108 were adolescents (12-16).
It is not known if Siklos® is safe and effective in children less than 2 years of age.
Siklos was also studied in adults with sickle cell disease. After 12 months of Siklos treatment, the episodes of painful crises, hospitalizations, acute chest syndrome and blood tranfusions decreased.
The results of a reliable scientific study (ESCORT-HU) showed that among pediatric patients who had not previously been treated with hydroxyurea (the active ingredient in Siklos®), the percentage of patients who experienced at least one “painful crisis”, one episode of acute chest syndrome (pneumonia), one hospitalization due to sickle cell disease, or one blood transfusion decreased after 12 months of treatment with Siklos®.
Siklos® tablets should be taken once daily, at the same time each day, with a glass of water. Before handling Siklos®, please read and follow these SIKLOS® HANDLING and BREAKING INSTRUCTIONS.
For patients who are not able to swallow Siklos® tablets, their dose can be dissolved in a teaspoon of water immediately before use. Please read and follow these SIKLOS® DISSOLVING INSTRUCTIONS.
Patient blood counts must be monitored by their healthcare provider throughout treatment with Siklos® so that dosing can be adjusted accordingly. Please see Full Prescribing Information.
Please see the Resources tab on this website for contact information for various sickle cell disease associations and advocacy groups.
- If you have commercial insurance, there are two easy ways to pay as little as $0 for a Siklos® prescription:
Option 1: If you wish to fill the prescription at a local retail pharmacy.
Simply present an eligible Siklos® prescription to your pharmacist, Siklos® eVoucher savings will be applied automatically —no coupon necessary.
Option 2: If you wish to fill the prescription through a mail order pharmacy.
Ask your or your child’s healthcare professional to fax, call or e-prescribe Siklos® through the Siklos At Home® program. In addition to saving on the prescription costs, the Siklos At Home® program also offers the convenience of free home delivery (minimum purchase of $99), on-staff pharmacists to answer your product questions, assistance with insurance benefit verification and monthly refill reminders.
- If you do not have commercial insurance or your commercial insurance does not cover Siklos® (i.e. cash payers):
- Siklos® 100 mg tablets: pay as little as $99 for 60 tablets or $149 for 90 tablets
- Siklos® 1,000 mg tablets: pay as little as $16.50/tablet
Medunik USA believes that every patient with sickle cell disease has the right to access safe and effective medication. We understand that, at times, the cost of prescription medications can be a challenge. That is why we created our Patient Assistance Program. If you cannot afford the Siklos® prescription, you or your child may be eligible to receive Siklos® at no charge through our Patient Assistance Program.
To apply, please follow these steps, download and follow the instructions on this Enrollment Application.