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come across [2%),:<2%), insomnia (> <2%), suicidal ideation (> <2%) Dermatologic: Skin rash (> <2%) Gastrointestinal: Diarrhea (7%), nausea (4%), abdominal pain (> <2%), dyspepsia (> <2%), vomiting (> <2%) Immunologic: Immune reconstitution syndrome Warnings/Precautions Concerns related to adverse effects: Immune reconstitution syndrome: Patients may develop immune reconstitution syndrome resulting in the occurrence of an inflammatory response to an indolent or residual opportunistic infection during initial HIV treatment or activation of autoimmune disorders (eg, Graves disease, polymyositis, Guillain-Barré syndrome) later in therapy; further evaluation and treatment may be required. Disease-related concerns: Hepatic impairment: No dosage adjustment is required in mild or moderate (Child-Pugh class A or B) hepatic impairment. Use is not recommended in severe hepatic impairment (Child-Pugh class C); has not been studied in this population. Concurrent drug therapy issues: Appropriate use: Not recommended in combination with a protease inhibitor and cobicistat due to lack of dosing recommendations, potential suboptimal plasma concentrations, loss of therapeutic effect, or development of resistance. Administration of unboosted elvitegravir is not recommended (HHS [adult] 2015). Concurrent therapy: Avoid concurrent use with other elvitegravir-containing products. Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Monitoring Parameters CBC with differential, reticulocyte count, CD4 count, HIV RNA plasma levels, hepatic function tests, testing for HBV is recommended prior to the initiation of antiretroviral therapy. Pregnancy Risk Factor B Pregnancy Considerations Adverse events were not observed in animal reproduction studies. Data collected by the antiretroviral pregnancy registry are insufficient to evaluate placental transfer or human teratogenic risk. Maternal antiretroviral therapy may increase the risk of preterm delivery, although available information is conflicting possibly due to variability of maternal factors (disease severity; initiation of therapy); however, maternal antiretroviral medication should not be withheld due to concerns of preterm birth. Information related to stillbirth, low birth weight, and small for gestational age infants is limited. Long-term follow-up is recommended for all infants exposed to antiretroviral medications; children who develop significant organ system abnormalities of unknown etiology (particularly of the CNS or heart) should be evaluated for potential mitochondrial dysfunction. Combination antiretroviral therapy (cART) therapy is recommended for all HIV-infected pregnant women to keep the viral load below the limit of detection and reduce the risk of perinatal transmission. When HIV is diagnosed during pregnancy in a woman who has never received antiretroviral therapy, cART should begin as soon as possible after diagnosis. The Health and Human Services (HHS) Perinatal HIV Guidelines note that due to a lack of data, elvitegravir cannot be recommended as initial therapy in antiretroviral-naive pregnant women. Pharmacokinetic data are insufficient to make dosing recommendations during pregnancy. In general, women who become pregnant on a stable cART regimen may continue that regimen if viral suppression is effective, appropriate drug exposure can be achieved, contraindications for use in pregnancy are not present, and the regimen is well tolerated. Monitoring during pregnancy is more frequent than in non-pregnant adults; cART should be continued postpartum. For HIV-infected couples planning a pregnancy, maximum viral suppression with combination antiretroviral therapy (cART) is recommended prior to conception for the HIV-infected partner(s) and expert consultation is recommended; modification of therapy (if needed) and optimization of the woman s health should be done prior to conception. HIV-infected women not planning a pregnancy may use any available type of contraception, considering possible drug interactions and contraindications of the specific method. In addition, consistent use of condoms is also recommended (even during pregnancy) to prevent transmission of HIV or other sexually transmitted diseases. Health care providers are encouraged to enroll pregnant women exposed to antiretroviral medications as early in pregnancy as possible in the Antiretroviral Pregnancy Registry (1-800-258-4263 or www.APRegistry.com ). Health care providers caring for HIV-infected women and their infants may contact the National Perinatal HIV Hotline (888-448-8765) for clinical consultation (HHS [perinatal] 2016). Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience diarrhea. Have patient report immediately to prescriber signs of infection (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Next Interactions Print this page Add to My Med List More about elvitegravir Side Effects During Pregnancy or Breastfeeding Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: integrase strand transfer inhibitor Consumer resources Elvitegravir Elvitegravir (Advanced Reading) Professional resources Other brands: Vitekta Related treatment guides HIV Infection> ] Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Elvitegravir Rating No Reviews - Be the first! No Reviews - Be the first! 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