DROXIA- hydroxyurea capsule

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

hydroxyurea (UNII: X6Q56QN5QC) (hydroxyurea - UNII:X6Q56QN5QC)

から入手可能:

H2-Pharma LLC

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

DROXIA is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in patients with sickle cell anemia with recurrent moderate to severe painful crises. DROXIA is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation. DROXIA can cause fetal harm based on findings from animal studies and the drug’s mechanism of action [see Clinical Pharmacology (12.1)] . There are no data with DROXIA use in pregnant women to inform a drug-associated risk. In animal reproduction studies, administration of hydroxyurea to pregnant rats and rabbits during organogenesis produced embryotoxic and teratogenic effects at doses 0.8 times and 0.3 times, respectively, the maximum recommended human daily dose on a mg/m2 basis (see Data) . Advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated with DROXIA. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively. Hydroxyurea has been demonstrated to be a potent teratogen in a wide variety of animal models, including mice, hamsters, cats, miniature swine, dogs, and monkeys at doses within 1-fold of the human dose given on a mg/m2 basis. Hydroxyurea is embryotoxic and causes fetal malformations (partially ossified cranial bones, absence of eye sockets, hydrocephaly, bipartite sternebrae, missing lumbar vertebrae) at 180 mg/kg/day (about 0.8 times the maximum recommended human daily dose on a mg/m2 basis) in rats and at 30 mg/kg/day (about 0.3 times the maximum recommended human daily dose on a mg/m2 basis) in rabbits. Embryotoxicity was characterized by decreased fetal viability, reduced live litter sizes, and developmental delays. Hydroxyurea crosses the placenta. Single doses of ≥375 mg/kg (about 1.7 times the maximum recommended human daily dose on a mg/m2 basis) to rats caused growth retardation and impaired learning ability. Hydroxyurea is excreted in human milk. Because of the potential for serious adverse reactions in a breastfed infant from hydroxyurea, including carcinogenicity, discontinue breastfeeding during treatment with DROXIA. Verify the pregnancy status of females of reproductive potential prior to initiating DROXIA therapy. DROXIA can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)] . Advise females of reproductive potential to use effective contraception during and after treatment with DROXIA for at least 6 months after therapy. Advise females to immediately report pregnancy. DROXIA may damage spermatozoa and testicular tissue, resulting in possible genetic abnormalities. Males with female sexual partners of reproductive potential should use effective contraception during and after treatment with DROXIA for at least 1 year after therapy [see Nonclinical Toxicology (13.1)] . Based on findings in animals and humans, male fertility may be compromised by treatment with DROXIA. Azoospermia or oligospermia, sometimes reversible, has been observed in men. Inform male patients about the possibility of sperm conservation before the start of therapy [see Adverse Reactions (6) and Nonclinical Toxicology (13.1)] . Safety and effectiveness in pediatric patients have not been established. Clinical studies of DROXIA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients may be more sensitive to the effects of hydroxyurea and may require a lower dose regimen. Hydroxyurea is excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Dosage and Administration (2.2)] . The exposure to hydroxyurea is higher in patients with creatinine clearance of less than 60 mL/min. Reduce dosage and closely monitor the hematologic parameters when DROXIA is to be administered to these patients [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)] . There are no data that support specific guidance for dosage adjustment in patients with hepatic impairment. Close monitoring of hematologic parameters is advised in these patients.

製品概要:

DROXIA® (hydroxyurea capsules, USP) is supplied in HDPE bottles with a plastic safety screw cap. Each bottle contains 60 capsules. DROXIA is supplied in the following strengths: 200 mg opaque blue-green capsules, marked in black ink with “DROXIA ” and “200 ” (NDC 61269-402-60). 300 mg opaque purple capsules, marked in black ink with “DROXIA ” and “300 ” (NDC 61269-403-60). 400 mg opaque reddish-orange capsules, marked in black ink with “DROXIA ” and “400 ” (NDC 61269-404-60). Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep tightly closed. DROXIA is a cytotoxic drug. Follow applicable special handling and disposal procedures [see References (15)] . To decrease the risk of contact, advise caregivers to wear disposable gloves when handling DROXIA or bottles containing DROXIA. Wash hands with soap and water before and after contact with the bottle or capsules when handling DROXIA. Do not open DROXIA capsules. Avoid exposure to crushed or opened capsules. If contact with crushed or opened capsules occurs on the skin, wash affected area immediately and thoroughly with soap and water. If contact with crushed or opened capsules occurs on the eye(s), the affected area should be flushed thoroughly with water or isotonic eyewash designated for that purpose for at least 15 minutes. If the powder from the capsule is spilled, immediately wipe it up with a damp disposable towel and discard in a closed container, such as a plastic bag; as should the empty capsules. The spill areas should then be cleaned three times using a detergent solution followed by clean water. Keep the medication away from children and pets. Contact your doctor for instructions on how to dispose of outdated capsules.

認証ステータス:

New Drug Application

情報リーフレット

DROXIA- HYDROXYUREA CAPSULE
H2-Pharma LLC
----------
Medication Guide
DROXIA® (drock-SEE-yuh)
(hydroxyurea)
capsules
What is the most important information I should know about DROXIA?
DROXIA can cause serious side effects including:
•
Low blood counts are common with DROXIA, 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 during treatment with DROXIA. Your healthcare
provider may change your
dose or tell you to stop taking DROXIA if you have low blood cell
counts. Tell your healthcare
provider right away if you get any of the following symptoms:
•
Fever
•
feeling very tired
•
chills
•
shortness of breath
•
body aches
•
bleeding or unexplained bruising
•
Cancer. Some people have developed cancer, such as leukemia and skin
cancer, after taking
DROXIA 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.
•
DROXIA can harm your unborn baby.
For females taking DROXIA who can become pregnant:
•
You should talk with your healthcare provider about the risks of
DROXIA to your unborn baby.
•
You should use effective birth control during treatment with DROXIA
and for at least 6 months
after treatment.
•
Your healthcare provider will perform a pregnancy test before you
start treatment with DROXIA.
•
You should avoid becoming pregnant during treatment with DROXIA. Tell
your healthcare
provider right away if you become pregnant or think you may be
pregnant.
For males taking DROXIA:
•
DROXIA can affect your sperm. If you have a female sexual partner who
can become pregnant,
you should use a condom during treatment with DROXIA and for at least
1 year after treatment.
DROXIA may cause fertility problems in males. Talk to your healthcare
provider if this is a concern for
you.
See "Wh

製品の特徴

DROXIA- HYDROXYUREA CAPSULE
H2-PHARMA LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DROXIA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DROXIA.
DROXIA (HYDROXYUREA) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1967
WARNING: MYELOSUPPRESSION AND MALIGNANCIES
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
_Myelosuppression_: DROXIA may cause severe myelosuppression. Do not
give if bone marrow function
is markedly depressed. Monitor blood counts at baseline and throughout
treatment. Interrupt
treatment and reduce dose as necessary. (5.1)
_Malignancies:_ DROXIA is carcinogenic. Advise sun protection and
monitor patients for malignancies.
(5.3)
RECENT MAJOR CHANGES
Warnings and Precautions, Laboratory Test Interference (5.10) 11/2023
Drug Interactions, Laboratory Test Interference (7.2) 11/2023
INDICATIONS AND USAGE
DROXIA is an antimetabolite indicated to reduce the frequency of
painful crises and to reduce the need for
blood transfusions in patients with sickle cell anemia with recurrent
moderate to severe painful crises. (1)
DOSAGE AND ADMINISTRATION
Initial dose: 15 mg/kg once daily. Monitor the patient’s blood count
every two weeks. (2.1)
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. (2.1)
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. (2.1)
Renal impairment: Reduce the dose of DROXIA by 50% in patients with
creatinine clearance less than 60
mL/min. (2.2, 8.6, 12.3)
DOSAGE FORMS AND STRENGTHS
•Capsules: 200 mg, 300 mg, and 400 mg (3)
CONTRAINDICATIONS
• In patients who have demonstrated a previous hypersensitivity to
hydroxyurea or any other componen