detect [1%:<40 kg: 35 mg once daily 40 kg: 50 mg once daily Treatment naive or treatment-experienced INSTI-naive when coadministered with carbamazepine, efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir or rifampin: 30 to> <40 kg: 35 mg twice daily 40 kg: 50 mg twice daily HIV-1 nonoccupational postexposure prophylaxis (nPEP) (off-label use) : Adolescents 13 years ( 40 kg): Refer to adult dosing. Dosing: Renal Impairment Treatment-naive or treatment-experienced INSTI-naive: Mild, moderate, or severe impairment: No dosage adjustment necessary. INSTI-experienced with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance: CrCl 30 mL/minute: No dosage adjustment necessary. CrCl> <30 mL/minute: There are no dosage adjustments provided in the manufacturer s labeling; use with caution since the reduction in dolutegravir concentrations may result in loss of therapeutic effect and development of resistance to dolutegravir or other coadministered antiretroviral agents. ESRD including hemodialysis: There are no dosage adjustments provided in the manufacturer s labeling (has not been studied). Dosing: Hepatic Impairment Mild-to-moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary. Severe impairment (Child-Pugh class C): Use is not recommended (has not been studied). Administration Administer without regard to meals. Administer 2 hours before or 6 hours after cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Alternatively, dolutegravir and supplements containing calcium or iron can be taken together with food. Dietary Considerations Take 2 hours before or 6 hours after cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Alternatively, dolutegravir and supplements containing calcium or iron can be taken together with food. Storage Store at 25 C (77 F); excursions permitted 15 C to 30 C (59 F to 86 F). Drug Interactions Aluminum Hydroxide: May decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral aluminum hydroxide. Consider therapy modification Calcium Salts: May decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral calcium. Alternatively, dolutegravir and oral calcium can be taken together with food. Consider therapy modification CarBAMazepine: May decrease the serum concentration of Dolutegravir. Management: Increase dolutegravir dose to 50 mg twice daily when used together with carbamazepine. Patients with known or suspected integrase strand inhibitor resistance should use an alternative to carbamazepine when possible. Consider therapy modification Dofetilide: Dolutegravir may increase the serum concentration of Dofetilide. Avoid combination Efavirenz: May decrease the serum concentration of Dolutegravir. Management: Increase dolutegravir dose to 50 mg twice daily in adults or children. Consider alternatives to efavirenz for INSTI experienced patients with clinically suspected INSTI resistance or certain INSTI associated resistance substitutions. Consider therapy modification Etravirine: May decrease the serum concentration of Dolutegravir. Management: US recommends avoiding the use of etravirine with dolutegravir unless used with atazanavir/ritonavir, darunavir/ritonavir or lopinavir/ritonavir. Canada recommends increasing dolutegravir to 50 mg twice daily when used with etravirine without a boosted PI Consider therapy modification Fosamprenavir: May decrease the serum concentration of Dolutegravir. Specifically, Fosamprenavir/Ritonavir may decrease the serum concentration of Dolutegravir. The individual contributions of Fosamprenavir and Ritonavir to this effect are unknown. Management: Increase dolutegravir to 50 mg twice daily in adults and pediatric patients (12 yrs or older and at least 40 kg). Seek alternatives to fosamprenavir/ritonavir in INSTI-experienced patients with suspected or certain INSTI resistance. Consider therapy modification Fosphenytoin-Phenytoin: May decrease the serum concentration of Dolutegravir. Avoid combination Iron Salts: May decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral iron. Alternatively, dolutegravir and oral iron can be taken together with food. Exceptions: Ferric Carboxymaltose; Ferric Gluconate; Ferric Hydroxide Polymaltose Complex; Ferric Pyrophosphate Citrate; Ferumoxytol; Iron Dextran Complex; Iron Isomaltoside; Iron Sucrose. Consider therapy modification Magnesium Salts: May decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral magnesium salts. Consider therapy modification MetFORMIN: Dolutegravir may increase the serum concentration of MetFORMIN. Management: Limit the daily metformin dose to 1,000 mg when used together with dolutegravir. Metformin dose adjustments may also be needed upon discontinuation of dolutegravir. Monitor patient response to metformin closely. Consider therapy modification Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after the dose of a multivitamin that contains polyvalent cations (e.g., calcium, iron, magnesium, selenium, zinc). Alternatively, dolutegravir and multivitamins can be taken together with food. Consider therapy modification Multivitamins/Minerals (with AE, No Iron): May decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after the dose of a multivitamin that contains polyvalent cations (e.g., calcium, iron, magnesium, selenium, zinc). Alternatively, dolutegravir and multivitamins can be taken together with food. Consider therapy modification Nevirapine: May decrease the serum concentration of Dolutegravir. Avoid combination Orlistat: May decrease the serum concentration of Antiretroviral Agents. Monitor therapy OXcarbazepine: May decrease the serum concentration of Dolutegravir. Avoid combination PHENobarbital: May decrease the serum concentration of Dolutegravir. Avoid combination Primidone: May decrease the serum concentration of Dolutegravir. Specifically, the Primidone metabolite phenobarbital may decrease Dolutegravir serum concentrations. Avoid combination RifAMPin: May decrease the serum concentration of Dolutegravir. Management: Increase dolutegravir dose to 50 mg twice daily in adults or children. Consider alternatives to rifampin for INSTI experienced patients with clinically suspected INSTI resistance or certain INSTI associated resistance substitutions. Consider therapy modification Selenium: May decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral selenium. Consider therapy modification St John's Wort: May decrease the serum concentration of Dolutegravir. Avoid combination Sucralfate: May decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after sucralfate. Consider therapy modification Tipranavir: May decrease the serum concentration of Dolutegravir. Specifically, Tipranavir/Ritonavir may decrease the serum concentration of Dolutegravir. The individual contributions of Tipranavir and Ritonavir to this effect are unknown. Management: Increase dolutegravir dose to 50 mg twice daily in patients receiving tipranavir/ritonavir. Seek alternatives to tipranavir/ritonavir in INSTI experienced patients with suspected INSTI resistance or certain INSTI associated resistance substitutions. Consider therapy modification Zinc Salts: May decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral zinc salts. Consider therapy modification Adverse Reactions Adverse reactions reported with combination therapy.> 10% Endocrine & metabolic: Hyperglycemia ( 14%) Hepatic: Increased serum ALT ( 18%; includes patients with hepatitis B and/or C infections) 1% to 10%: Central nervous system: Insomnia ( 7%), fatigue ( 2%), headache ( 2%), suicidal ideation ( <2%), suicidal tendencies (> <2%), depression ( 1%) Dermatologic: Pruritus (> <2%) Gastrointestinal: Increased serum lipase (2% to 10%), diarrhea ( 2%), abdominal distress (> <2%), abdominal pain (> <2%), flatulence (> <2%), upper abdominal pain (> <2%), vomiting (> <2%), nausea ( 1%) Hematologic & oncologic: Neutropenia (3% to 4%; grades 3/4: 2%), leukopenia (2% to 3%) Hepatic: Increased serum AST ( 8%), hyperbilirubinemia ( 3%), hepatitis (> <2%) Hypersensitivity: Hypersensitivity reaction ( 1%) Neuromuscular & skeletal: Increased creatine phosphokinase (1% to 7%), myositis (> <2%) Renal: Renal insufficiency (> <2%)> <1% (Limited to important or life-threatening): Abnormal dreams, arthralgia, dizziness, immune reconstitution syndrome, increased serum creatinine, myalgia, skin rash Warnings/Precautions Concerns related to adverse effects: Fat redistribution: May cause redistribution of fat (eg, buffalo hump, peripheral wasting with increased abdominal girth, cushingoid appearance). Hypersensitivity reactions: Rash, constitutional findings, and organ dysfunction (eg, liver injury) have been reported. Discontinue immediately if signs of hypersensitivity (eg, severe rash, rash with fever, malaise, fatigue, muscle/joint aches, blistering or peeling of skin, oral blisters/lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema, difficulty breathing) occur. Monitor clinical status and liver function tests, and initiate supportive therapy as appropriate. If hypersensitivity occurs, do not reinitiate therapy with dolutegravir. 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. Increased liver function tests: Patients with underlying hepatic disease (such as hepatitis B or C coinfection) may be at increased risk of development or worsening of transaminase elevations; use with caution. Elevation in transaminases may be concurrent with development of immune reconstitution syndrome or hepatitis B reactivation (especially if antihepatitis therapy has been discontinued). Monitor transaminases at baseline and during therapy. Disease-related concerns: Hepatic impairment: Not recommended for use in patients with severe hepatic impairment (has not been studied). Renal impairment: Use with caution in INSTI-experienced patients with severe renal impairment; decreases in dolutegravir concentrations were observed and may result in loss of therapeutic effect and development of resistance to dolutegravir or other coadministered antiretroviral agents. Concurrent drug therapy issues: 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 Viral load, CD4 count, lipid profile; liver aminotransferases (baseline and during therapy); monitor for hypersensitivity Pregnancy Considerations It is not known if dolutegravir crosses the placenta. Data collected by the antiretroviral pregnancy registry are insufficient to evaluate 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 data are insufficient to recommend dolutegravir 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 headache or insomnia. Have patient report immediately to prescriber signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), muscle pain, joint pain, mouth sores, eye irritation, shortness of breath, severe loss of strength and energy, change in body fat, or 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 healthcare 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 dolutegravir Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Español 13 Reviews Add your own review/rating Drug class: integrase strand transfer inhibitor Consumer resources Dolutegravir Dolutegravir (Advanced Reading) Professional resources Dolutegravir Sodium (AHFS Monograph) Other brands: Tivicay 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 Dolutegravir Rating 13 User Reviews 8.0 /10 13 User Reviews 8.0 Rate it! Drug Class Integrase strand transfer inhibitor Related Drugs integrase strand transfer inhibitor Isentress , Tivicay , raltegravir , elvitegravir HIV Infection Truvada , Atripla , Norvir , Viread , Isentress , Prezista , Stribild , lamivudine , abacavir , tenofovir , Reyataz , Epzicom , ritonavir , Complera , emtricitabine , darunavir , Kaletra , Intelence , Sustiva , Epivir , efavirenz , nevirapine , atazanavir , raltegravir , Selzentry , More...} } to 15
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