Common questions about Siklos®
Siklos® is an antimetabolite, indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in adults and pediatric patients, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crises.
Yes. Siklos® received FDA approval 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 non-interventional cohort study, the European Sickle Cell Disease prospective Cohort study, ESCORT-HU, in which 405 pediatric patients ages 2 to <18 were enrolled.
Among the 405 pediatric patients treated with Siklos®, 274 were children (2-11) and 108 were adolescents (12-16). Please see Clinical Trial Experience. Continuous follow-up of the growth of treated children is recommended. Pediatric patients aged 2-16 years had a higher risk of neutropenia than patients more than 16 years old. The safety and effectiveness of Siklos® have not been established in pediatric patients less than 2 years of age.
The safety and effectiveness of Siklos has been established in the adult population with sickle cell anemia with recurrent moderate to severe painful crises. Use of Siklos is supported by evident from a non-interventional cohort study, the European Sickle Cell Disease prospective Cohort Study, ESCORT-HU, in which 1,077 adult patients were enrolled. Please see Clinical Trial Experience.
Among the adult patients, the most common adverse reactions to Siklos were infections, headache, and dry skin.
Siklos® dosing is based on patient’s actual or ideal weight, whichever is less. Specific parameters (blood counts) must be monitored throughout treatment with Siklos® and dosing must be adjusted accordingly. Complete dosing recommendations based on blood count are available in the Prescribing Information.
Siklos® tablets should be taken once daily, at the same time each day, with a glass of water. For patients who are not able to swallow the tablets, these can be dispersed immediately before use in a small quantity of water in a teaspoon. Important: Siklos® is a cytotoxic drug. Therefore, parents/caregivers must be instructed to follow applicable special handling and disposal procedures provided in the Instructions for Use.
Patient blood counts must be monitored throughout treatment with Siklos® so that dosing can be adjusted accordingly. Complete dosing recommendations based on blood count are available in the Full Prescribing Information.
The most common adverse reactions to Siklos® (incidence > 10%) include infections and neutropenia in children and infections and headache and dry skin in adults. Other adverse reactions include:
- Myelosuppression - see section 5.1 of PI
- Malignancies - see section 5.2 of PI
- Embryo-fetal toxicity - see section 5.3 of PI
- Vasculitic toxicities (including leg ulcers) - see section 5.4 of PI
- Risks with concomitant use of antiretroviral drugs - see section 5.5 of PI
- Risk with concomitant use of live virus vaccine - see section 5.6 of PI
- Macrocytosis - see section 5.7 of PI
- Test Interference - see section 5.8 of PI
- Hemolytic Anemia - see section 5.9 of PI
Patients with commercial insurance have two options that could allow them to pay as little as $0 for their Siklos® prescription:
Option 1: If they wish to fill the prescription at a local retail pharmacy, e-prescribe or instruct them to bring the prescription to a retail pharmacy, where savings will be applied automatically through the Siklos® eVoucher program – no coupon necessary.
Option 2: If they wish to fill the prescription through a mail order pharmacy, simply prescribe Siklos® through the Siklos At Home® program by phone, fax, or ePrescribe using this Siklos At Home™ Order Form
The Siklos At Home® program offers the convenience of free home delivery (minimum purchase of $99 required), on-staff pharmacists to answer patients’ product questions, assistance with prior authorizations and monthly refill reminders.
Questions? Call 1-844-716-HOME (4663)
For patients with no commercial insurance or whose insurance does not cover Siklos®
Cash payers could pay as little as:
- Siklos® 100 mg tablets: $99 for 60 tablets or $149 for 90 tablets
- Siklos® 1,000 mg tablets: $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 the cost of prescription medications can present a challenge. That is why we created our Patient Assistance Program. If you have patients who cannot afford their Siklos® prescription, they may be eligible to receive Siklos® at no charge through our Patient Assistance Program. Please use this Enrollment Application to apply on behalf of your patient.