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tivicay-new drug approved by us fda

tivicay-new drug approved by us fda

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  • 1. TIVICAY® (TIV-eh-kay) (Dolutegravir)
  • 2. Date of Approval: August 12, 2013 Approved by :U.S. Food and Drug Administration (FDA) Company: ViiV Healthcare Generic Name : Dolutegravir Brand Name: Tivicay Other Names: DTG Drug Class: Integrase Inhibitors Approved Use: Treatment of HIV Infection Chemical structure: Molecular Weight: 419.3821
  • 3. DOSAGE AND ADMINISTRATION: TIVICAY tablets may be taken with or without food. For Adults : 50 mg tablet once a d for people on HIV therapy for the first time . Twice-daily dosing in people who have viral resistance to Isentress and elvitegravir. Expected to have no food restriction Alternative combinations that do not include metabolic inducers should be considered where possible
  • 4. Pediatric Patients : Age 12 years and older and weighing at least 40 kg – 50 mg p/o -OD. Efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavi r, or rifampin - 50 mg twice daily. Safety and efficacy of TIVICAY have not been established in pediatric patients younger than 12 years or weighing less than 40 kg, or in pediatric patients who are INSTI-experienced with documented or clinically suspected resistance to other INSTIs (raltegravir, elvitegravir).
  • 5. DOSAGE FORMS AND STRENGTHS TIVICAY 50-mg tablets are yellow, round, filmcoated, biconvex tablets . Each tablet contains 50 mg of dolutegravir (as dolutegravir sodium) Pharmacokinetics Absorption Peak plasma time: 2-3 hr Peak plasma concentration: 3.67-4.15 mcg/l Distribution Protein bound: ≥98.9% Vd : 17.4 L; 4-232 ng/mL (CSF)
  • 6. Metabolism : Metabolized by UGT1A1 with some contribution from CYP3A Elimination : Half-life: 14 hr Clearance: 1 L/hr Excretion: 53% feces (unchanged); 31% urine (as ether glucuronide, benzylic carbon, or N-dealkylation product); <1% urine (unchanged)
  • 7. Mechanism of Action Inhibits catalytic activity of HIV-1 integrase, an HIV encoded enzyme required for viral replication
  • 8. Adverse effects  Abnormal liver function in participants co-infected with hepatitis B and / or C  Fat Redistribution 1-10% •Hyperglycemia (<1-7%) •Insomnia (<1-3%) •Headache (<1-2%) •GI disorders (<2%) •Fatigue (<2%) •Hepatitis (<2%)
  • 9. • Myositis (<2%) • Renal impairment (<2%) Pruritus (<2%) Nausea (<1-1%) <1% Abnormal dreams Dizziness Diarrhea Rash Vertigo
  • 10. CONTRAINDICATIONS Coadministration of TIVICAY with dofetilide is contraindicated due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events Pregnancy: Pregnancy category B. Breastfeeding: Breastfeeding is NOT recommended
  • 11.  Drug Interactions Co-administration of TIVICAY with drugs that are strong inducers of UGT1A1 and/or CYP3A4 may result in reduced plasma concentrations of dolutegravir and require dose adjustments of TIVICAY. -TIVICAY should be taken 2 hours before or 6 hours after taking cation-containing antacids or laxatives, sucralfate, oral iron supplements, oral calcium supplements, or buffered medications.
  • 12. Anti-seizure medicines: oxcarbazepine • phenytoin • phenobarbital • carbamazepine  a medicine that contains metformin rifampin
  • 13. Overdose There is no known specific treatment for overdose with TIVICAY. If overdose occurs, the patient should be monitored and standard supportive treatment applied as required. As dolutegravir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.
  • 14. Patient Information Hypersensitivity Reactions Effects on Serum Liver Biochemistries in Patients With Hepatitis B or C Co-infection Patients should be advised to avoid doing things that can spread HIV-1 infection to others. • Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades. • Practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.
  • 15. • Female patients should be advised not to breastfeed To inform their physician or pharmacist if they develop any unusual symptom, or if any known symptom persists or worsens. If missed a dose - should take it as soon as they remember. If they do not remember until it is within 4 hours of the time for the next dose, they should be instructed to skip the missed dose and go back to the regular schedule.