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Kocitaf

Kocitaf

Manufacturer:

Mylan

Distributor:

Atlanta Medicare
Concise Prescribing Info
Contents
Dolutegravir 50 mg, emtricitabine 200 mg, tenofovir alafenamide 25 mg
Indications/Uses
HIV-1 in adult & adolescent ≥12 yr weighing at least 40 kg.
Dosage/Direction for Use
1 tab once daily. Missed dose w/in 18 hr of the time: Take 1 tab as soon as possible & resume normal dosing schedule. If >18 hr, patient should not take missed dose & resume usual dosing schedule.
Administration
May be taken with or without food: Do not chew/crush/split. For patients w/ integrase class resistance, preferably taken w/ food.
Contraindications
Hypersensitivity. Co-administration w/ dofetilide & organic cation transporter substrates.
Special Precautions
Intergrase class resistance. Discontinue treatment if signs & symptoms of hypersensitivity reactions develop; if there is evidence of worsening liver disease. Monitor clinical status eg, liver aminotransferases & bilirubin. Patients w/ chronic hepatitis B or C treated w/ antiretroviral therapy. Co-infection w/ HIV-1 & HCV. Closely monitor patients co-infected w/ HIV & HBV for at least several mth upon discontinuation of treatment. Do not administer in concomitant use w/ drugs containing tenofovir disoproxil (as fumarate), lamivudine or adefovir dipivoxil. Patients w/ significant underlying liver disorders. Monitor patients w/ preexisting liver dysfunction during combination of antiretroviral therapy (CART) & consider discontinuation or interruption of treatment upon worsening of liver disease. Wt gain & increase in blood lipids & glucose levels may occur. Mitochondrial dysfunction in HIV negative infants exposed in utero &/or postnatally to nucleoside analogues. Perform clinical & laboratory follow-up & investigate for possible mitochondrial dysfunction in childn (including HIV-negative childn), exposed in utero to nucleoside & nucleotide analogues. Immune reactivation syndrome in HIV infected patients treated w/ CART. Avoid treatment in antiretroviral-experienced patients w/ HIV-1 harboring the K65R mutation. Triple nucleoside therapy. Closely observe patients for opportunistic infections. Avoid co-administration w/ Mg- or Al-containing antacid, Fe & Ca supplements, multivitamins & inducing agents, etavirine (w/o boosted PIs), tipranavir/ritonavir, rifampicin, St. John's wort & certain antiepileptics. Consider dose adjustment of metformin when starting & stopping co-administration of dolutegravir; monitor renal function during treatment. Increased risk of lactic acidosis in patients w/ moderate renal impairment (CrCl 45-59 mL/min). Osteonecrosis in patients w/ advanced HIV disease &/or long-term CART exposure. Nephrotoxicity. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not recommended w/ certain anticonvulsants (eg, carbamazepine, oxcarbazepine, phenobarb & phenytoin), antimycobacterials (eg, rifampicin, rifabutin, rifapentine), boceprevir, telaprevir, St. John's wort & HIV PIs other than atazanavir, lopinavir & darunavir; medicinal products containing tenofovir disoproxil (as fumarate), emtricitabine, lamivudine or adefovir dipivoxil. Do not initiate in patients w/ estimated CrCl <30 mL/min. Severe hepatic impairment (Child-Pugh Class C). Perform pregnancy testing prior to initiation of treatment in adolescents & adults of childbearing potential. Use effective contraception during treatment. May affect ability to drive and operate machinery. Avoid use of dolutegravir from the time of conception until the 1st trimester of pregnancy. Lactation. Childn <12 yr, or weighing <40 kg. Elderly ≥65 yr.
Adverse Reactions
Nausea. Abnormal dreams, insomnia, depression; headache, dizziness; diarrhoea, vomiting, abdominal pain & discomfort, flatulence; rash, pruritus; fatigue; ALT, AST or creatine phosphokinase elevations.
Drug Interactions
Dolutegravir: Increased AUC, Cmax & Ct w/ lopinavir/ritonavir + etravirine, rilpivirine, PIs (atazanavir, atazanavir/ritonavir), other antivirals (eg, telaprevir, boceprevir, daclastavir), prednisone. Increased conc of dofetelide. Increase AUC & Cmax of metformin. Decreased AUC, Cmax & Ct w/ etravirine w/o boosted PIs, darunavir/ritonavir & etravirine, tipranavir/ritonavir, fosamprenavir, carbamazepine, rifampicin, rifabutin. Decreased conc w/ nevirapine, oxcarbazepine, phenytoin, phenobarb, St. John's wort. Decreased AUC & Cmax w/ Mg- or Al-containing antacids. Decreased AUC, Cmax, C24 w/ Ca & Fe supplements, & multivitamins. Tenofovir alafenamide: Increased plasma conc w/ ketoconazole, itraconazole, fluconazole, isavuconazole. May decrease plasma conc w/ rifabutin, rifampicin, rifapentine, oxcarbazepine, phenobarb, phenytoin & St. John's wort. Concomitant use w/ boceprevir, telaprevir. May increase AUC, Cmax, Cmin of ledipasvir & AUC & Cmax of sofosbuvir. Increased AUC & Cmax w/ atazanavir/cobicistat, atazanavir/ritonavir, darunavir/cobicistat, darunavir/ritonavir. Increased AUC & Cmax of setraline. Increased plasma conc w/ ciclosporin.
MIMS Class
ATC Classification
J05AR17 - emtricitabine and tenofovir alafenamide ; Belongs to the class of antivirals for treatment of HIV infections, combinations.
Presentation/Packing
Form
Kocitaf film-coated tab
Packing/Price
1 × 30's
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