DROXIA- hydroxyurea capsule 
H2-Pharma LLC


 Medication Guide
DROXIA® (drock-SEE-yuh)

What is the most important information I should know about DROXIA?
DROXIA can cause serious side effects including:

  •  Fever
  •  feeling very tired
  •  chills
  •  shortness of breath
  •  body aches
  •  bleeding or unexplained bruising

For females taking DROXIA who can become pregnant:

 For males taking DROXIA:

 DROXIA 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 DROXIA?" for more information about side effects.

What is DROXIA?
DROXIA is a prescription medicine that is used to reduce the frequency of painful crises and reduce the need for blood transfusions in people with sickle cell anemia with recurrent moderate to severe painful crises.
It is not known if DROXIA is safe and effective in children.

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

Before taking DROXIA, tell your healthcare provider about all of your medical conditions, including if you:

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 DROXIA?

What are the possible side effects of DROXIA?
DROXIA may cause serious side effects, including:

  •  fever                      
  •  shortness of breath
  •  cough

The most common side effects of DROXIA include:

These are not all the possible side effects of DROXIA.
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 DROXIA?

Keep DROXIA and all medicines out of the reach of children. Keep DROXIA away from pets.

General information about the safe and effective use of DROXIA
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DROXIA for a condition for which it was not prescribed. Do not give DROXIA 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 DROXIA that is written for health professionals.

What are the ingredients of DROXIA?
Active ingredient: hydroxyurea
Inactive ingredients: citric acid, gelatin, lactose, magnesium stearate, sodium phosphate, titanium dioxide, and capsule colorants: FD&C Blue No. 1 and FD&C Green No. 3 (200 mg capsules); D&C Red No. 28, D&C Red No. 33, and FD&C Blue No. 1 (300 mg capsules); D&C Red No. 28, D&C Red No. 33, and D&C Yellow No. 10 (400 mg capsules).

Distributed by:
H2-Pharma, LLC, Montgomery, AL 36117, USA

Licensed by:
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489
Greifswald, Germany
© 2023 CHEPLAPHARM Arzneimittel GmbH. All rights
For more information call 1-888-877-5884.

This Medication Guide has been approved by the U.S. Food and Drug Administration.                           

                                                                                                       Revised: November 2023

Revised: 12/2023
H2-Pharma LLC