Hydroxyurea is carcinogenic in humans; new primary malignancy (e.g., leukemia and skin cancer) has been reported in patients receiving long-term hydroxyurea for both myeloproliferative disorders and sickle cell disease. Kaliurang Km.9, Gondangan, Desa Sardonoharjo. Prophylactic administration of folic acid is recommended. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. Improvement in symptoms begins about two weeks after starting oral hydroxyurea, and is maximal after eight weeks. Alpha interferons: (Moderate) Additive myelosuppressive effects may be seen when alpha interferons are given concurrently with other myelosuppressive agents, such as antineoplastic agents or immunosuppressives. This page cannot be displayed because your browser has been configured to If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA. Additionally, pediatric patients have an increased risk of myelosuppression at the time of dosage adjustment due to the change in body weight requiring modification of daily dose. In patients receiving hydroxyurea for sickle cell anemia, withhold therapy when neutrophil count is <2000/mm3, the platelet count is <80,000/mm3, the hemoglobin concentration is <4.5 g/dL, or the reticulocyte count is <80,000/mm3 with a hemoglobin concentration of <9 g/dL. Use actual or ideal body weight (whichever is less) for dosing. TabletsAvailable in 100 mg and 1,000 mg tablet strengths. Since the effects of hydroxyurea may be partially reversed in vitro by ferrous iron and iron-chelating agents may increase cytotoxicity, a nonheme iron cofactor is necessary for this process. Prophylactic administration of folic acid is recommended. Before taking hydroxyurea, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Treatment with hydroxyurea should not be initiated if bone marrow function is markedly depressed. Consider the risk of secondary malignancy compared with the benefit of hydroxyurea therapy. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Stimulates production and increases concentrations of fetal hemoglobin (HbF). Major Moderate Minor Unknown 1500 mg/m2 PO as part of the 8-in-1 regimen (vincristine 1.5 mg/m2 IV, lomustine 75 mg/m2 PO [or carmustine 75 mg/m2 PO], procarbazine 75 mg/m2 PO, cisplatin 60 mg/m2 IV [with mannitol and hydration], cytarabine 300 mg/m2 IV, cyclophosphamide 300 mg/m2 IV, and methylprednisolone 300 mg/m2 IV) with each drug given for 3 doses/day on day 1 given every 4 or 6 weeks for 6 or 8 cycles following an induction period with 2 cycles of 8-in-1 (14 days apart) has been studied in pediatric patients with primitive neuroectodermal tumors (PNT) in clinical trials. Hydroxyurea administration may cause laboratory test interference of urea, uric acid, and lactic acid assays resulting in falsely elevated results. Betamethasone: (Minor) Because systemically administered corticosteroids exhibit immunosuppressive effects when given in high doses and/or for extended periods, additive effects may be seen with other immunosuppressives or antineoplastic agents. Hydroxyurea administered in doses of 3000 to 4500 mg/week PO was compared to methotrexate 15 to 20 mg/week PO in a study of 30 patients with moderate to severe chronic plaque psoriasis. VA class: AN300. Importance of informing patients of other important precautionary information. Palifermin: (Moderate) Palifermin should not be administered within 24 hours before, during infusion of, or within 24 hours after administration of antineoplastic agents. Close monitoring for clinical manifestations of pancreatitis and hepatotoxicity is necessary in patients with HIV infection receiving hydroxyurea, especially when the drug is administered in combination with didanosine and/or stavudine. If blood cell count is in an acceptable range, dosage may be increased in increments of 5 mg/kg daily once every 12 weeks to a maximum tolerated dosage of up to 35 mg/kg daily. Clozapine: (Major) It is unclear if concurrent use of other drugs known to cause neutropenia (e.g., antineoplastic agents) increases the risk or severity of clozapine-induced neutropenia. Treatment of resistant chronic myelogenous leukemia (CML). The cellular concentration of M2 is variable throughout the cell cycle but peaks during the S-phase. Penicillin G Procaine: (Moderate) Coadministration of penicillin G procaine with oxidizing agents, such as hydroxyurea, may increase the risk of developing methemoglobinemia. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Bupivacaine: (Moderate) Coadministration of bupivacaine with oxidizing agents, such as hydroxyurea, may increase the risk of developing methemoglobinemia. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. Obtain fetal hemoglobin (HbF) concentrations every 3 to 4 months; monitor for an increase in HbF of at least 2-fold over baseline. Cortisone: (Minor) Because systemically administered corticosteroids exhibit immunosuppressive effects when given in high doses and/or for extended periods, additive effects may be seen with other immunosuppressives or antineoplastic agents. May cause fetal harm; teratogenicity and embryotoxicity demonstrated in animals. This enzyme is responsible for converting ribonucleotides to deoxyribonucleotide triphosphates (dNTPs), which are critical to DNA synthesis and repair. 35 mg/kg/day PO for sickle cell disease. Hydroxyurea can cause severe myelosuppression. Consider deferring the skin test until completion of the immunosuppressive therapy. Lidocaine: (Moderate) Coadministration of lidocaine with oxidizing agents, such as hydroxyurea, may increase the risk of developing methemoglobinemia. If hematologic recovery does not occur promptly during combined hydroxyurea and radiation therapy, irradiation may be interrupted. If methemoglobinemia occurs or is suspected, discontinue lidocaine and any other oxidizing agents. Blood counts within an acceptable range are defined as neutrophil count at least 2,500 cells/mm3, platelet count at least 95,000 cells/mm3, hemoglobin concentration higher than 5.3 g/dL, and a reticulocyte count at least 95,000 cells/mm3 if the hemoglobin concentration is less than 9 g/dL. Depending on the severity of symptoms, patients may respond to supportive care; more severe symptoms may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen. You and/or your caregiver should wear disposable gloves when handling this medication or its container. Monitor patients closely for signs and symptoms of methemoglobinemia if coadministration is necessary. An adequate trial period for determining the antineoplastic effectiveness is 6 weeks. This medication is used by people with sickle cell anemia to reduce the number of painful crises caused by the disease and to reduce the need for blood transfusions. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. Use sunscreen and wear protective clothing when outdoors. Hydoxyurea causes immediate inhibition of DNA synthesis but does not affect RNA or protein synthesis. Up to 60% of an oral dose undergoes conversion through saturable hepatic metabolism and a minor pathway of degradation by urease found in intestinal bacteria. 124 131. In vitro hydroxyurea also induces the activity of cellular kinases that phosphorylate NRTIs, potentially further enhancing their activity. Importance of informing patients that hydroxyurea powder (contained in the capsules) should not be allowed to come in contact with skin or mucous membranes. While you are being treated with hydroxyurea, do not have any immunizations (vaccinations) without your doctor's approval. Monitor hematologic status carefully before initiation of therapy and repeatedly during therapy. All others delivered live, healthy infants without congenital anomalies. CapsulesMay be taken with or without food; the affect of food on hydroxyurea absorption has not been studied.Swallow capsules whole; do not cut or crush capsules. (See Geriatric Patients under Dosage and Administration.). Hydroxyurea causes an accumulation of cells at the G1/S-phase or the early S-phase of the cell cycle, which leads to cell death. Max: 35 mg/kg/day. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The M2 protein is the catalytic subunit and contains a nonheme iron complex. Prophylactic administration of folic acid is recommended. For Healthcare Professionals Applies to hydroxyurea: compounding powder, oral capsule, oral tablet. Serious toxicities included infection and grade 34 neutropenia and thrombocytopenia. Interactions Dosage What is hydroxyurea? When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. The reduction in digoxin tablet absorption has resulted in plasma concentrations that are 50% of pretreatment levels and has been clinically significant in some patients. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. Hydroxyurea exerts its affects on cells in the S-phase, especially cells rapidly synthesizing DNA. Hydroxyurea is used to treat chronic myeloid leukemia, ovarian cancer, and certain types of skin cancer (squamous cell cancer of the head and neck). Didanosine, ddI: (Major) While there have been reports that the combined use of hydroxyurea and didanosine may result in an increased immune response for up to 1 year, the combined use of these drugs is associated with an increased incidence of didanosine-associated adverse effects, including pancreatitis and peripheral neuropathy. Floxuridine: (Minor) Neurotoxicity may occur to a significant extent during concomitant administration of floxuridine and hydroxyurea. Fluorouracil, 5-FU: (Minor) High levels of deoxyuridine monophosphate have been associated with resistance to fluorouracil, 5-FU. All patients received postoperative RT with 54 Gy delivered in 30 fractions (1.8 Gy/fraction) over 6 weeks. Safety and efficacy have not been established. Talk to your pharmacist for more details. Destroys the tyrosyl free radical that is formed as the catalytic center of ribonucleoside diphosphate reductase, the enzyme that catalyzes the reductive conversion of ribonucleotides to deoxyribonucleotides; this conversion is a critical and probably rate-limiting step in the synthesis of DNA. In patients receiving hydroxyurea for antineoplastic therapy, withhold therapy when leukocyte count is <2500/mm3 or platelet count is <100,000/mm3. Written by ASHP. Nausea, vomiting, loss of appetite, mouth sores, diarrhea, or constipation may occur. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. In addition, as HbF concentrations increase, the concentration of HbS decreases providing a sparing effect. Prednisolone: (Minor) Because systemically administered corticosteroids exhibit immunosuppressive effects when given in high doses and/or for extended periods, additive effects may be seen with other immunosuppressives or antineoplastic agents. Bupivacaine; Lidocaine: (Moderate) Coadministration of bupivacaine with oxidizing agents, such as hydroxyurea, may increase the risk of developing methemoglobinemia. If methemoglobinemia occurs or is suspected, discontinue penicillin G procaine and any other oxidizing agents. Hydroxyurea potentiates the effect of NRTIs, especially adenosine analogs such as didanosine, ddI, by reducing the competition for binding sites. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. Does Hydroxyurea interact with other drugs you are taking? Females of reproductive potential should avoid pregnancy; apprise women of the potential hazard to the fetus. (1-4) To determine process issues that may contribute to these barriers we sought to: 1) describe how providers monitor and adjust HU dosing in children with SCD in clinical practice and 2) identify providers . Most patients (n = 208) were aged 60 years or older and all patients also received supportive care. disable JavaScript, also known as "Active Scripting". Importance of contacting clinician for instructions on how to discard unused or expired drug. Obtain fetal hemoglobin (HbF) concentrations every 3 to 4 months; monitor for an increase in HbF of at least 2-fold over baseline. If cutaneous vasculitic ulcerations occur, discontinue hydroxyurea therapy and initiate alternative cytoreductive therapy as indicated. Depending on the severity of symptoms, patients may respond to supportive care; more severe symptoms may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen. Fluticasone; Salmeterol: (Minor) Because systemically administered corticosteroids exhibit immunosuppressive effects when given in high doses and/or for extended periods, additive effects may be seen with other immunosuppressives or antineoplastic agents. Patients at some institutions receive doses of hydroxyurea as high as 35 mg/kg/day. Smallpox Vaccine, Vaccinia Vaccine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Kapanewon Ngaglik merupakan kawasan penyangga pengembangan (aglomerasi) kota Yogyakarta ke arah utara, dengan pusat pemerintahan terletak di Jl. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If you miss a dose, take it as soon as you remember. 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