What is Siklos®?
Siklos® is an FDA-approved prescription medication that reduces the frequency of painful crises and 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.
It is not known if Siklos® is safe and effective in children less than 2 years of age.
Hydroxyurea is a medicine that can reduce:
- complications from sickle cell disease
- painful crises
- episodes of acute chest syndrome
- blood transfusions
- hospital stays
Hydroxyurea is considered the "gold standard" treatment for sickle cell disease.
Hydroxyurea has helped many people with sickle cell disease, and it may help you! Talk with your doctor!
Click here to learn more about hydroxyurea.
Yes, the US Food and Drug Administration (FDA) approved Siklos® in December 2017 for children 2 years and older and in December 2021, the FDA approved Siklos® for adults.
The safety and effectiveness of Siklos ® have been established in both adults and children 2 years and older with sickle cell anemia with recurrent moderate to severe painful crises.
After 12 months of Siklos® treatment, all these SCD events decreased for both children and adults:
- Painful crises/Vaso-occlusive episodes
- Acute Chest Syndrome
- Hospitalizations
- Blood transfusions
Click here to learn more about how Siklos® helps.
WARNING: LOW BLOOD CELL COUNT and CANCER
See Full Prescribing Information for complete Boxed Warning.Low blood cell counts are common with Siklos®, including low red blood cells, white blood cells, and platelets, and can be severe and life threatening. If your white blood cell count becomes very low, you are at increased risk for infection. Your healthcare provider will check your blood cell counts before and every 2 weeks during treatment with Siklos®. Your healthcare provider may change your dose or tell you to stop taking Siklos® if you have low blood cell counts. Tell your healthcare provider right away if you get any of the following symptoms: fever or chills; shortness of breath; body aches; unusual headache; feeling very tired; bleeding or unexplained bruising.
Cancer. Some people have developed cancer, such as leukemia and skin cancer, after taking Siklos® for a long time. Your healthcare provider will check you for cancer. You should protect your skin from the sun using sunblock, hats, and sun-protective clothing.
The most common side effects of Siklos® in children include: infections and low white blood cells.
The most common side effects of Siklos® in adults include: infections, headache, and dry skin.
- Small*
- Scored
- Breakable
- Dissolvable in water or swallow whole with a glass of water
- 1,000 mg Strengths
- Flexible Dosing
- No compounding needed
It is the ONLY hydroxyurea medication that comes in a 1,000 mg strengths tablet.
Click here to learn more about the benefits of Siklos®.
*Can be broken into smaller parts
Siklos® is the ONLY dissolvable hydroxyurea medication.
Switch to Siklos® - no compounding needed!
Siklos® is the ONLY breakable/dissolvable hydroxyurea medication.
Switch to Siklos® - break the Siklos® tablets into smaller pieces or dissolve in water.
Siklos® is the ONLY hydroxyurea medication that comes in a 1,000 mg strengths tablet.
Switch to Siklos® - take fewer HU pills daily!
The ONLY hydroxyurea medication that can be taken 2 different ways:
- Dissolve in a small amount of water in a teaspoon immediately before use
- Swallow the tablet whole with a glass of water
- Tablets can be broken into smaller pieces if needed
It is important to take Siklos® once every day, at the same time each day, with a glass of water to get the most benefit from your hydroxyurea treatment.
Siklos® tablets must be handled with care. Follow applicable special handling and disposal procedures.
Click here for more information on how to take Siklos®.
If you or your child struggle with swallowing pills or capsules, the dose can be dissolved in a small amount of water in a teaspoon immediately before use. The tablet dissolves within about 1 minute.
Please read and follow these Siklos® Dissolving Instructions .
Hydroxyurea may take time to work. Don’t be discouraged! It may take time for your doctor to determine the appropriate dose for you or your child.
Regular doctor visits while on Siklos ® are very important to ensure that the treatment is working as expected and to check for any potential side effects.
Your doctor will check your blood cell counts before and every 2 weeks during treatment with Siklos®. Your doctor may change your dose or tell you to stop temporarily taking Siklos®if you have low blood cell counts.
Tell your doctor right away if you get any of the following symptoms:
- Fever or chills
- Body aches
- Feeling very tired
- Shortness of breath
- Unusual headache
- Bleeding or unexplained bruising
Click here to learn more.
- Low blood cell counts are common with Siklos®, including low red blood cells, white blood cells, and platelets, and can be severe and life threatening. If your white blood cell count becomes very low, you are at increased risk for infection. Your healthcare provider will check your blood cell counts before and every 2 weeks during treatment with Siklos®. Your healthcare provider may change your dose or tell you to stop taking Siklos® if you have low blood cell counts. Tell your healthcare provider right away if you get any of the following symptoms: fever or chills; shortness of breath; body aches; unusual headache; feeling very tired; bleeding or unexplained bruising.
- Cancer. Some people have developed cancer, such as leukemia and skin cancer, after taking Siklos® for a long time. Your healthcare provider will check you for cancer. You should protect your skin from the sun using sunblock, hats, and sun-protective clothing.
- Siklos® can harm your unborn baby. For females taking Siklos® who can become pregnant:
- You should talk with your healthcare provider about the risks of Siklos® to your unborn baby.
- You should use effective birth control during treatment with Siklos® and for at least 6 months after treatment with Siklos®.
- Your healthcare provider will perform a pregnancy test before you start treatment with Siklos®. Tell your healthcare provider right away if you become pregnant or think you may be pregnant.
- For males taking Siklos®: Siklos ® can affect your sperm. If you have a female sexual partner who can become pregnant, you should use effective birth control during treatment with Siklos® and for at least 6 months after treatment. Siklos® may cause fertility problems in males. Talk to your healthcare provider if this is a concern for you.
Siklos® may cause serious side effects, including:
- Skin ulcers, including leg ulcers, and death of skin tissue (gangrene) have happened in people who take Siklos®. This has happened most often in people who receive interferon therapy or have a history of interferon therapy. Your healthcare provider will decrease your dose or stop treatment with Siklos®if you develop any skin ulcers.
- Enlarged red blood cells (macrocytosis). Macrocytosis is common in people who take Siklos®and can make it difficult to detect a decrease of folic acid. Your healthcare provider may prescribe a folic acid supplement for you.
- Hemolytic Anemia, the fast breakdown of red blood cells, has happened in people who take Siklos®. Tell your healthcare provider I you develop yellowing of your skin (jaundice) or blood in your urine. Your healthcare provider may do blood tests if you have persistent or worsening anemia not related to sickle cell anemia.
The most common side effects of Siklos ® in children is infections and low blood cell counts.
The most common side effects of Siklos ® in adults is infections, headache, and dry skin.
These are not all the possible side effects of Siklos ®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Click here for more Important Safety Information.
If you take too much Siklos®, call your doctor or go to the nearest hospital emergency room right away.
It is important to take Siklos® once every day, at the same time each day, with a glass of water to get the most benefit from your hydroxyurea treatment.
Please see the Resources section of this website for contact information for various sickle cell disease associations and advocacy groups.
Siklos® is covered by many State Medicaid programs as well as many commercial insurance plans.
If you have commercial insurance, there are 2 easy ways to pay as little as $0* for your or your child’s Siklos® prescription!
Click here for the Siklos® copay card.
Option 1: Fill Prescription at a Local Retail Pharmacy
Simply present an eligible Siklos ® prescription at a participating pharmacy and your Siklos®eVoucher will be applied automatically – no coupon necessary.
If your pharmacy does not participate in the eVoucher program, that is fine! Just bring in a copy or show an electronic copy of the Copay Card to your pharmacist.
Option 2: Mail Order Pharmacy
Ask your doctor to fax, call, or e-prescribe your or your child’s Siklos® prescription through the Siklos at Home® program
Click here for the Siklos at Home® Patient Info Card.
If you do not have commercial insurance or your insurance does not cover Siklos®, Siklos at Home® offers:
- 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*
Click here for more information on our Savings Programs!
*See Terms and Conditions
Medunik USA believes that every patient with sickle cell disease has the right to access safe and effective medications. 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 a Siklos® prescription, you or your child may be eligible to receive Siklos® at no charge.
For more information, click here.
Download the Enrollment Form.
INDICATION AND IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION
WARNING: LOW BLOOD CELL COUNT and CANCER
See Full Prescribing Information for complete Boxed Warning.Low blood cell counts are common with SIKLOS, including low red blood cells, white blood cells, and platelets, and can be severe and life threatening. If your white blood cell count becomes very low, you are at increased risk for infection. Your healthcare provider will check your blood cell counts before and every 2 weeks during treatment with SIKLOS. Your healthcare provider may change your dose or tell you to stop taking SIKLOS if you have low blood cell counts. Tell your healthcare provider right away if you get any of the following symptoms: fever or chills; shortness of breath; body aches; unusual headache; feeling very tired; bleeding or unexplained bruising.
Cancer. Some people have developed cancer, such as leukemia and skin cancer, after taking SIKLOS for a long time. Your healthcare provider will check you for cancer. You should protect your skin from the sun using sunblock, hats, and sun-protective clothing.
WHAT IS THE MOST IMPORTANT INFORMATION YOU SHOULD KNOW ABOUT SIKLOS?
- SIKLOS can harm your unborn baby.
- For females taking SIKLOS who can become pregnant:
- You should talk with your healthcare provider about the risks of SIKLOS to your unborn baby.
- You should use effective birth control during treatment with SIKLOS and for at least 6 months after treatment with SIKLOS.
- Your healthcare provider will perform a pregnancy test before you start treatment with SIKLOS. Tell your healthcare provider right away if you become pregnant or think you may be pregnant.
- For males taking SIKLOS: SIKLOS can affect your sperm. If you have a female sexual partner who can become pregnant, you should use effective birth control during treatment with SIKLOS and for at least 6 months after treatment.
- SIKLOS may cause fertility problems in males. Talk to your healthcare provider if this is a concern for you.
WHO SHOULD NOT TAKE SIKLOS
Do not take SIKLOS if you are allergic to hydroxyurea or any of the ingredients in SIKLOS. See the Medication Guide for a list of the ingredients in SIKLOS.
WHAT SHOULD YOU TELL YOUR HEALTH CARE PROVIDER BEFORE TAKING SIKLOS?
Tell your healthcare provider about all of your medical conditions, including if you:
- have kidney problems or are receiving hemodialysis
- have liver problems
- have human immunodeficiency virus (HIV) or take HIV medicines. Taking SIKLOS with certain HIV medicines can cause serious reactions and may lead to death.
- have increased levels of uric acid in your blood (hyperuricemia)
- have a history of receiving interferon therapy or are currently receiving interferon therapy
- plan to receive any vaccinations. You should not receive “live vaccines” during treatment with SIKLOS.
- are pregnant or plan to become pregnant. See "What is the most important information I should know about SIKLOS?"
- are breastfeeding or plan to breastfeed. It is not known if SIKLOS can pass into your breast milk. Do not breastfeed during treatment with SIKLOS.
- are using a continuous glucose monitor (CGM) to test your blood glucose. Talk to the healthcare provider that prescribed your CGM about whether it is safe to use while you are taking SIKLOS.
- Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF SIKLOS?
SIKLOS may cause serious side effects, including:
See "What is the most important information I should know about SIKLOS"
- Skin ulcers, including leg ulcers, and death of skin tissue (gangrene) have happened in people who take SIKLOS. This has happened most often in people who receive interferon therapy or have a history of interferon therapy. Your healthcare provider will decrease your dose or stop treatment with SIKLOS if you develop any skin ulcers.
- Enlarged red blood cells (macrocytosis). Macrocytosis is common in people who take SIKLOS and can make it difficult to detect a decrease of folic acid. Your healthcare provider may prescribe a folic acid supplement for you.
- Hemolytic Anemia, the fast breakdown of red blood cells, has happened in people who take SIKLOS. Tell your healthcare provider I you develop yellowing of your skin (jaundice) or blood in your urine. Your healthcare provider may do blood tests if you have persistent or worsening anemia not related to sickle cell anemia.
The most common side effects of SIKLOS in children include: infections and low white blood cells.
The most common side effects of SIKLOS in adults include: infections, headache, and dry skin.
These are not all the possible side effects of SIKLOS.
You are encouraged to report negative side effects of prescription drugs to the FDA at fda.gov/medwatch, or 1-800-FDA-1088.
Please read the Full Prescribing Information, including Boxed Warning, Medication Guide and Instructions for Use, at SIKLOSusa.com.
SIKLOS is a 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. It is not known if SIKLOS is safe and effective in children less than 2 years of age.
INDICATION AND IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION
WARNING: LOW BLOOD CELL COUNT and CANCER
See Full Prescribing Information for complete Boxed Warning.Low blood cell counts are common with SIKLOS, including low red blood cells, white blood cells, and platelets, and can be severe and life threatening. If your white blood cell count becomes very low, you are at increased risk for infection. Your healthcare provider will check your blood cell counts before and every 2 weeks during treatment with SIKLOS. Your healthcare provider may change your dose or tell you to stop taking SIKLOS if you have low blood cell counts. Tell your healthcare provider right away if you get any of the following symptoms: fever or chills; shortness of breath; body aches; unusual headache; feeling very tired; bleeding or unexplained bruising.
Cancer. Some people have developed cancer, such as leukemia and skin cancer, after taking SIKLOS for a long time. Your healthcare provider will check you for cancer. You should protect your skin from the sun using sunblock, hats, and sun-protective clothing.
SIKLOS is a 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. It is not known if SIKLOS is safe and effective in children less than 2 years of age.