Hydroxycarbamide

Hydroxyurea

250MG, 500MG capsuleVereinigte StaatenIm HandelZugelassen am 18. Aug. 1995

Inhalt auf Englisch

Anwendungsgebiete

Hydroxyurea capsules, USP is indicated for the treatment of: Resistant chronic myeloid leukemia. Locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation. Hydroxyurea capsules, USP is an antimetabolite indicated for the treatment of:

Resistant chronic myeloid leukemia. (1)
Locally advanced squamous cell carcinomas of the head and neck, (excluding lip) in combination with concurrent chemoradiation. (1)

Gegenanzeigen

Hydroxyurea capsules is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation.

In patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation. (4)

Warnhinweise und Vorsichtsmaßnahmen

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) Hemolytic anemia: Monitor blood counts throughout treatment. If hemolysis persists, discontinue Hydroxyurea. (5.2) Malignancies: Advise protection from sun exposure and monitor for secondary malignancies. ( 5.3) Embryo-Fetal toxicity: Can cause fetal harm.

Advise of potential risk to a fetus and use of effective contraception. ( 5.4 , 8.1 , 8.3 ) Vasculitic toxicities: Discontinue hydroxyurea and initiate treatment if this occurs. (5.5) Live Vaccinations: Avoid live vaccine use in a patient taking hydroxyurea capsules. (5.6) Risks with concomitant use of antiretroviral drugs: Pancreatitis, hepatotoxicity, and neuropathy have occurred. Monitor for signs and symptoms in patients with HIV infection using antiretroviral drugs; discontinue hydroxyurea capsules and implement treatment.

(5.7) Radiation recall: Monitor for skin erythema in patients who previously received radiation and manage symptomatically. (5.8)

Anwendungsgebiete

Resistant chronic myeloid leukemia. (1)
Locally advanced squamous cell carcinomas of the head and neck, (excluding lip) in combination with concurrent chemoradiation. (1)

Warnhinweise und Vorsichtsmaßnahmen

(5.7) Radiation recall: Monitor for skin erythema in patients who previously received radiation and manage symptomatically. (5.8)

Wechselwirkungen

Antiretroviral drugs (7.1) Laboratory Test Interference. (7.2)

7.1Increased Toxicity with Concomitant Use of Antiretroviral Drugs Pancreatitis

In patients with HIV infection during therapy with hydroxyurea and didanosine, with or without stavudine, fatal and nonfatal pancreatitis have occurred. Hydroxyurea is not indicated for the treatment of HIV infection; however, if patients with HIV infection are treated with hydroxyurea, and in particular, in combination with didanosine and/or stavudine, close monitoring for signs and symptoms of pancreatitis is recommended.

Permanently discontinue therapy with hydroxyurea in patients who develop signs and symptoms of pancreatitis. Hepatotoxicity Hepatotoxicity and hepatic failure resulting in death have been reported during postmarketing surveillance in patients with HIV infection treated with hydroxyurea and other antiretroviral drugs. Fatal hepatic events were reported most often in patients treated with the combination of hydroxyurea, didanosine, and stavudine.

Avoid this combination. Peripheral Neuropathy Peripheral neuropathy, which was severe in some cases, has been reported in patients with HIV infection receiving hydroxyurea in combination with antiretroviral drugs, including didanosine, with or without stavudine.

7.2Laboratory Test Interference Interference with Uric Acid, Urea, or Lactic Acid Assays

Studies have shown that there is an analytical interference of hydroxyurea with the enzymes (urease, uricase, and lactate dehydrogenase) used in the determination of urea, uric acid, and lactic acid, rendering falsely elevated results of these in patients treated with hydroxyurea. Interference with Continuous Glucose Monitoring Systems Hydroxyurea may falsely elevate sensor glucose results from certain continuous glucose monitoring (CGM) systems and may lead to hypoglycemia if sensor glucose results are relied upon to dose insulin.

If a patient using a CGM is to be prescribed hydroxyurea, consult with the CGM prescriber about alternative glucose monitoring methods.

Nebenwirkungen

Myelosuppression [see Warnings and Precautions (5.1) ]
Hemolytic anemia [see Warnings and Precautions (5.2) ]
Malignancies [see Warnings and Precautions (5.3) ]
Vasculitic toxicities [see Warnings and Precautions (5.5) ]
Risks with concomitant use of antiretroviral drugs [see Warnings and Precautions (5.7) ]
Radiation recall [see Warnings and Precautions (5.8) ]
Macrocytosis [see Warnings and Precautions (5.9) ]
Pulmonary Toxicity [see Warnings and Precautions (5.10) ] Most common adverse reactions (≥30%) are hematological, gastrointestinal symptoms, and anorexia. (6) To report SUSPECTED ADVERSE REACTIONS, contact Leading Pharma, LLC at 1-844-740-7500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Postmarketing Experience

The following adverse reactions have been identified during post-approval use of hydroxyurea capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency. Reproductive System and Breast disorders: azoospermia, and oligospermia Gastrointestinal disorders: stomatitis, nausea, vomiting, diarrhea, and constipation Metabolism and Nutrition disorders: anorexia, tumor lysis syndrome Skin and subcutaneous tissue disorders: maculopapular rash, skin ulceration, cutaneous lupus erythematosus, dermatomyositis-like skin changes, peripheral and facial erythema, hyperpigmentation, nail hyperpigmentation, atrophy of skin and nails, scaling, violet papules, and alopecia Renal and urinary disorders: dysuria, elevations in serum uric acid, blood urea nitrogen (BUN), and creatinine levels Nervous system disorders: headache, dizziness, drowsiness, disorientation, hallucinations, and convulsions General Disorders: fever, chills, malaise, edema, and asthenia Hepatobiliary disorders: elevation of hepatic enzymes, cholestasis, and hepatitis Respiratory disorders: diffuse pulmonary infiltrates, dyspnea, and pulmonary fibrosis, interstitial lung disease, pneumonitis, alveolitis, allergic alveolitis and cough Immune disorders: systemic lupus erythematosus Hypersensitivity: Drug-induced fever (pyrexia) (>39°C, >102°F) requiring hospitalization has been reported concurrently with gastrointestinal, pulmonary, musculoskeletal, hepatobiliary, dermatological or cardiovascular manifestations.

Onset typically occurred within 6 weeks of initiation and resolved upon discontinuation of hydroxyurea. Upon re-administration fever re- occurred typically within 24 hours. Blood and lymphatic system disorders: hemolytic anemia Adverse reactions observed with combined hydroxyurea and irradiation therapy are similar to those reported with the use of hydroxyurea or radiation treatment alone. These effects primarily include bone marrow depression (anemia and leukopenia), gastric irritation, and mucositis.

Almost all patients receiving an adequate course of combined hydroxyurea and irradiation therapy will demonstrate concurrent leukopenia. Platelet depression (<100,000 cells/mm3) has occurred in the presence of marked leukopenia. Hydroxyurea capsules may potentiate some adverse reactions usually seen with irradiation alone, such as gastric distress and mucositis.

Packung	Code	Status
HYDROXYUREA 500MG	ANDA213438-001	Prescription
HYDROXYUREA 500MG	ANDA218021-001	Prescription
HYDROXYUREA 250MG	ANDA075020-002	Discontinued
HYDROXYUREA 500MG	ANDA075020-001	Discontinued
HYDROXYUREA 500MG	ANDA074476-001	Discontinued
HYDROXYUREA 250MG	ANDA075143-002	Discontinued
HYDROXYUREA 500MG	ANDA075143-001	Prescription
HYDROXYUREA 500MG	ANDA075340-001	Prescription

Hydroxyurea

Anwendungsgebiete

Gegenanzeigen

Warnhinweise und Vorsichtsmaßnahmen

Zwei Arzneimittel in einer Frage?

Hydroxyurea

Anwendungsgebiete

Gegenanzeigen

Warnhinweise und Vorsichtsmaßnahmen

Zwei Arzneimittel in einer Frage?

5.2Hemolytic Anemia Cases

5.3Malignancies

5.5Vasculitic Toxicities

5.6Live Vaccinations

5.7Risks with Concomitant Use of Antiretroviral Drugs

5.8Radiation Recall

5.9Macrocytosis

5.10Pulmonary Toxicity

5.11Laboratory Test Interference Interference with Uric Acid, Urea, or Lactic Acid

5.3Malignancies

Wechselwirkungen

7.1Increased Toxicity with Concomitant Use of Antiretroviral Drugs Pancreatitis

7.2Laboratory Test Interference Interference with Uric Acid, Urea, or Lactic Acid Assays

Nebenwirkungen

6.1Postmarketing Experience

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