Patient information: uses, side effects, how to take - Siklos

What is the most important information I should know about SIKLOS?

SIKLOS can cause serious side effects including:

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
body aches
feeling very tired

shortness of breath
unusual headache
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.

See " What are the possible side effects of SIKLOS? " for more information about side effects.

What is SIKLOS?

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.

Do not take SIKLOS if you are allergic to hydroxyurea or any of the ingredients in SIKLOS. See the end of this Medication Guide for a list of the ingredients in SIKLOS.

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
have leg wounds or ulcers
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. Hydroxyurea may affect your sensor glucose results and may lead to low blood sugar (hypoglycemia). 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.

How should I take SIKLOS?

Read the Instructions for Use at the end of this Medication Guide for step-by-step instructions on how to prepare a dose of SIKLOS. If you have any questions, talk to your healthcare provider or pharmacist.

Take SIKLOS exactly as your healthcare provider tells you to take it.
Take SIKLOS 1 time a day at the same time each day.
Swallow the tablet(s) with a glass of water. If you are not able to swallow SIKLOS tablets, you can dissolve your prescribed dose in a small amount of water in a teaspoon and swallow right away.
SIKLOS is supplied as 100 mg tablets and 1,000 mg tablets. The SIKLOS tablets have separation lines (score lines) and can be broken at these score lines to provide smaller doses.
- Each 100 mg tablet can be divided into 2 equal parts (each part is 50 mg).
- Each 1,000 mg tablet can be divided into 4 equal parts (each part is 250 mg).
Your healthcare provider will tell you how many tablets or parts of a tablet you should take.
SIKLOS tablets must be handled with care. To decrease the risk of exposure, you or your caregivers should do the following when handling SIKLOS:
- Wear disposable gloves when handling SIKLOS or bottles containing SIKLOS. Wash your hands with soap and water before and after handling SIKLOS tablets or bottles containing SIKLOS.
- Avoid contact with crushed tablets. If contact with crushed tablets happens on the skin, wash the skin area right away and thoroughly with soap and water. If contact with crushed tablets happens in the eyes, flush the eyes thoroughly with water or isotonic eyewash used for that purpose for at least 15 minutes.
- Powder spilled from the broken tablet should be wiped up with a damp disposable towel which must be thrown away in a closed container such as a plastic bag to avoid ingestion of powder by other people. The spill areas should then be cleaned using a detergent solution followed by clean water.
If you take too much SIKLOS, call your healthcare provider or go to the nearest hospital emergency room right away.

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 if 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.

The most common side effects of SIKLOS in children include:

infections
low white blood cells

The most common side effects of SIKLOS in adults include:

infections
headache
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.

How should I store SIKLOS?

Store SIKLOS at room temperature between 68°F to 77°F (20°C to 25°C).
Keep the SIKLOS bottle tightly closed.
Broken SIKLOS tablets must be stored in the bottle and must be used within three months.

Keep SIKLOS and all medicines out of the reach of children.

General information about the safe and effective use of SIKLOS.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SIKLOS for a condition for which it was not prescribed. Do not give SIKLOS to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about SIKLOS that is written for health professionals.

What are the ingredients of SIKLOS?

Active ingredient:hydroxyurea

Inactive ingredients:silicified microcrystalline cellulose, sodium stearyl fumarate, and film-coating agent amino methacrylate copolymer.

Distributed by: Medunik USA, 2 Research Way, suite 1B, Princeton, NJ 08540.

Manufactured for:. Theravia : 16 rue Montrosier 92200 Neuilly-sur-Seine, France

Manufactured by: Delpharm Lille, 22 rue de Toufflers 59452 Lys Lez Lannoy France.

SIKLOS is a trademark of Theravia.For more information, call 1-844-884-5520.

INSTRUCTIONS FOR USE

SIKLOS (See – k – los)

(hydroxyurea)

tablets

Read this Instructions for Use before you start taking SIKLOS and each time you get a refill. There may be new information. This Instructions for Use does not take the place of talking to your healthcare provider about your medical condition or treatment. You and your healthcare provider should talk about SIKLOS when you start taking it and at regular checkups.

Important Information:

Wash your hands with soap and water before and after handling SIKLOS tablets or bottles containing SIKLOS.
Wear disposable gloves when handling SIKLOS tablets or bottles containing SIKLOS.
Take SIKLOS 1 time a day at the same time each day.
Powder spilled from a broken tablet should be wiped up right away with a damp disposable paper towel and thrown away in a closed container, such as a plastic bag to avoid harm to other people. The spill area should then be cleaned using a detergent solution followed by clean water.
When the tablet is broken, avoid touching the broken surfaces.
If contact with crushed tablets happens on the skin, wash the skin area right away and thoroughly with soap and water.
If contact with crushed tablets happens in the eyes, flush the eyes thoroughly with water or isotonic eyewash used for that purpose for at least 15 minutes.

SIKLOS is supplied in 2 different strengths:

SIKLOS 100 mg tablethas one separation line (score line) and can be broken at this score line to provide smaller doses. Each 100 mg tablet can be divided into 2 equal parts (each part is 50 mg).

SIKLOS 1,000 mg tablethas three separation lines (score lines) and can be broken at these score lines to provide smaller doses. Each 1,000 mg tablet can be divided into 4 equal parts (each part is 250 mg).

SIKLOS tablet breaking instructions

You will need the following supplies to break a SIKLOS tablet:

SIKLOS tablets
A damp disposable paper towel
A tablet cutter
Disposable gloves

Step 1:Place a damp disposable paper towel on a flat surface where the tablets will be broken.
Step 2:Wash and dry your hands before handling SIKLOS tablets or bottles containing the tablets.
Step 3:Check your prescribed dose. You may need more than 1 tablet to get your prescribed dose.
Step 4:Put on disposable gloves.
Step 5:Remove the SIKLOS tablet out of the bottle needed to get your dose.
Step 6:Use your index fingers and thumbs to hold each end of the SIKLOS tablet.
SIKLOS 100 mg	side view	side view between fingers and thumbs
SIKLOS 1,000 mg	side view	side view between fingers and thumbs
Step 7:While holding the ends of the SIKLOS tablet, push down on the tablet to break the tablet on the score line to get your prescribed dose. SIKLOS 100 mg tablets can be broken as:
Whole tablet
top view	side view
1/2 of a tablet for a dose of 50 mg of SIKLOS:
a whole tablet for a dose of 100 mg of SIKLOS (no breaking needed):
SIKLOS 1,000 mg tablets can be broken as:
Whole tablet
Top view	side view
1/4 of a tablet for a dose of 250 mg of SIKLOS:
1/2 of a tablet for a dose of 500 mg of SIKLOS:
3/4 of a tablet for a dose of 750 mg of SIKLOS:
a whole tablet for a dose of 1,000 mg of SIKLOS (no breaking needed):
Note: You may need to use a tablet cutter.
Step 8:Take your prescribed dose by swallowing it with a glass of water. Important:If you have difficulty swallowing SIKLOS tablets, please stop here and follow the instructions below, "For people who cannot swallow SIKLOS tablets".
Step 9:Throw away the damp disposable paper towel in the trash. Pull off disposable gloves and throw away in the trash.


Wash and dry your hands.
Step 10:Store any unused broken tablets in the bottle and put the bottle back in the box. Broken tablets must be used within three months.

For people who cannot swallow SIKLOS tablets

You will need the following supplies to prepare and take your dose by dissolving the tablet:

Your bottle of SIKLOS tablets
- Note:If you need to break your tablets, use the SIKLOS Tablet Breaking Instructions aboveto get your prescribed dose beforeyou begin the steps below.
A teaspoon
Water to dissolve tablets

Step 1:Get your prescribed dose of SIKLOS tablets. Put your prescribed dose of SIKLOS tablets onto the teaspoon.

SIKLOS 100 mg tablet	SIKLOS 1,000 mg tablet (broken)
Step 2:Add a small amount of water to the teaspoon. The tablet dissolves within about 1 minute.

SIKLOS 100 mg tablet

SIKLOS 1,000 mg tablet (broken)
Step 3:Swallow the mixture right away.
Step 4:After you take your prescribed dose of SIKLOS tablets, drink a glass of water. When you are finished drinking a glass of water, continue to Step 9 and Step 10 above.