Droxia

What is Droxia?

• Droxia (hydroxyurea capsule) is an antimetabolite 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.

• Siklos (hydroxyurea tablet) is also 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.

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Hydroxyurea

What are the uses of this medicine?

• Droxia (hydroxyurea capsule) 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.

How does this medicine work?

• The mechanisms by which Droxia produces its beneficial effects in patients with sickle cell anemia (SCA) are uncertain.
• Hydroxyurea also increases the production of fetal hemoglobin, via an unknown mechanism of action, which increases overall hemoglobin levels and decreases sickling in patients with sickle cell anemia.
• In controlled clinical trials, hydroxyurea has been shown to increase hemoglobin concentrations, decrease transfusion requirements and lessen painful crises in patients with sickle cell disease.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• who are allergic to hydroxyurea or any of the ingredients in Droxia.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• Be sure to mention any of the following:
• certain medications for HIV (human immunodeficiency virus) such as didanosine (Videx) and stavudine (Zerit) and interferon (Actimmune, Avonex, Betaseron, Infergen, Intron A, others).
• Hydroxyurea may interfere with Uric Acid, Urea, or Lactic Acid Assays. Falsely elevated results of these in patients treated with hydroxyurea.

Is this medicine FDA approved?

• Hydroxyurea was first approved for use in the United States in 1967 as an antineoplastic agent for therapy of melanoma, chronic myelogenous leukemia, ovarian carcinoma, and head and neck cancers. The indications were expanded to sickle cell disease in 1998, which is the major indication for its use at present.

How should this medicine be used?

Recommended dosage: Initial dose:

• 15 mg/kg once daily. Monitor the patient’s blood count every two weeks.
• The dose may be increased by 5 mg/kg/day every 12 weeks until a maximum tolerated dose or 35 mg/kg/day is reached if blood counts are in an acceptable range.
• The dose is not increased if blood counts are between the acceptable range and toxic.
• Discontinue Droxia until hematologic recovery if blood counts are considered toxic.
• Treatment may then be resumed after reducing the dose by 2.5 mg/kg/day from the dose associated with hematological toxicity.

Renal impairment:

• Reduce the dose of Droxia by 50% in patients with creatinine clearance less than 60 mL/min.

Administration:

• Droxia is taken 1 time a day.
• Droxia capsules must be handled with care.
• Do NOT open, break, or chew the capsules.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 200 mg, 300 mg, and 400 mg

This medicine is available in fallowing brand namesː

• Droxia

What side effects can this medication cause?

The most common side effects of this medicine include:

• reduced blood counts
• bleeding
• mouth ulcers
• nausea
• diarrhea or constipation
• loss of appetite

Droxia may cause serious side effects, including:

• Low blood counts
• Cancer
• Skin ulcers and death of tissue
• Enlarged red blood cells
• Hemolytic Anemia
• Respiratory problems

What special precautions should I follow?

• Hydroxyurea causes severe myelosuppression. Monitor blood counts throughout treatment. If hemolysis persists, discontinue Droxia.
• Droxia Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception.
• Cases of hemolytic anemia in patients treated with hydroxyurea for myeloproliferative diseases have been reported. In the setting of confirmed diagnosis of hemolytic anemia and in the absence of other causes, discontinue Droxia.
• Hydroxyurea is a human carcinogen. In patients receiving long-term hydroxyurea for myeloproliferative disorders, secondary leukemia has been reported. All patients using Droxia should be followed up on a long-term basis with regular blood counts to detect development of leukemia.
• Cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene, have occurred in patients with myeloproliferative disorders during therapy with hydroxyurea. Institute treatment and discontinue Droxia if this occurs.
• Avoid live vaccine use in a patient taking Droxia.
• Pancreatitis, hepatotoxicity, and neuropathy have occurred. Monitor for signs and symptoms in patients with HIV infection using antiretroviral drugs; discontinue Droxia and implement treatment.
• Interference with Uric Acid, Urea, or Lactic Acid Assays is possible, rendering falsely elevated results of these in patients treated with hydroxyurea.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Soreness
• violet erythema
• edema on palms and soles followed by scaling of hands and feet
• severe generalized hyperpigmentation of the skin
• stomatitis

Treatment of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Droxia can cause fetal harm based on findings from animal studies and the drug’s mechanism of action.
• Advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated with Droxia.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• 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).

Who manufactures and distributes this medicine?

• Manufactured for: Bristol-Myers Squibb Company, Princeton, New Jersey USA

What should I know about storage and disposal of this medication?

• Store Droxia at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep the Droxia bottle tightly closed.
• Call your healthcare provider for instructions on how to throw away (dispose of) Droxia that is out of date.

• Dailymed label info on Droxia
• FDA Droxia

Droxia Resources
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