Symtuza

Symtuza

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, tenofovir alafenamide 10 mg
Indications/Uses
HIV-1 infection in adults ≥18 yr.
Dosage/Direction for Use
Adult ≥18 yr 1 tab once daily. Antiretroviral therapy-naïve patient 1 tab once daily. Antiretroviral therapy-experienced patient 1 tab once daily.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Severe (Child-Pugh Class C) hepatic impairment. Co-administration w/ carbamazepine, phenobarb, phenytoin; rifampicin; lopinavir/ritonavir; St. John's wort (Hypericum perforatum); alfuzosin; amiodarone, dronedarone, quinidine, ranolazine; colchicine when used in patients w/ renal &/or hepatic impairment; ergot derivatives (eg, dihydroergotamine, ergometrine, ergotamine, methylergonovine); pimozide, quetiapine, sertindole, lurasidone; triazolam, midazolam administered orally; sildenafil when used for the treatment of pulmonary arterial HTN, avanafil, simvastatin, lovastatin & lomitapide; dabigatran, ticagrelor.
Special Precautions
Severe skin reactions; discontinue immediately if signs or symptoms of severe skin reactions develop. Should not be used in treatment-experienced patients w/ ≥1 DRV-RAMs or w/ HIV-1 RNA ≥100,000 copies/mL or CD4+ cell count <100 cells x 106/L. Increased risk for liver function abnormalities in patients w/ pre-existing liver dysfunction, including chronic active hepatitis B or C. Reports of mitochondrial dysfunction in HIV negative infants following exposure in utero &/or postnatally to nucleoside analogues. Potential risk of nephrotoxicity resulting from chronic exposure to low levels of tenofovir. Cobicistat decreases estimated CrCl due to inhibition of tubular secretion of creatinine. Increased bleeding in patients w/ hemophilia type A & B treated w/ HIV PIs. Patients w/ known sulfonamide allergy. Increase in wt & blood lipid & glucose levels. Reports of osteonecrosis particularly in patients w/ advanced HIV disease &/or long-term exposure to combination antiretroviral therapy (CART). Immune reactivation syndrome. Opportunistic infections may continue to develop. Do not co-administer w/ other antiretroviral agents; medicinal products requiring pharmacokinetic enhancement w/ ritonavir or cobicistat; medicinal products containing tenofovir disoproxil (as fumarate, phosphate, or succinate), lamivudine, or adefovir dipivoxil used for HBV infection treatment. Caution in mild or moderate hepatic impairment. Should not be initiated in patients w/ eGFR <30 mL/min. Dizziness may occur & may affect ability to drive & use machines. Should not be initiated during pregnancy. Do not breastfeed while on treatment. Elderly ≥65 yr. Should not be used in childn <3 yr.
Adverse Reactions
Headache; diarrhoea, nausea; rash. Anaemia; anorexia, DM, hypercholesterolaemia, increased LDL, hypertriglyceridaemia, hyperlipidaemia; abnormal dreams; dizziness; vomiting, abdominal pain & distension, dyspepsia, flatulence, increased pancreatic enzymes; increased hepatic enzyme; pruritus, urticaria; arthralgia, myalgia; asthenia, fatigue; increased blood creatinine.
Drug Interactions
Darunavir & cobicistat: Increased plama conc of drugs that are primarily metabolized by CYP3A & CYP2D6 or are transported by P-gp. Lowered plasma conc w/ CYP3A inducers eg, efavirenz, carbamazepine, phenytoin, phenobarb, rifampicin, rifapentine, rifabutin, St. John's wort. Increased plasma conc w/ CYP3A inhibitors eg, azole antifungals. Emtricitabine: Co-administration w/ medicinal products that are eliminated by active tubular secretion may increase conc of emtricitabine, &/or the co-administered medicinal product. Tenofovir alafenamide: Decreased absorption leading to loss of effect & development of resistance w/ P-gp inducers eg, rifampicin, rifabutin, carbamazepine, phenobarb. Increased absorption & plasma conc w/ P-gp inhibitors eg, cobicistat, ritonavir, ciclosporin. Distribution may be affected by OATP1B1 & OATP1B3 inducers/inhibitors.
MIMS Class
ATC Classification
J05AR22 - emtricitabine, tenofovir alafenamide, darunavir and cobicistat ; Belongs to the class of antivirals for treatment of HIV infections, combinations.
Presentation/Packing
Form
Symtuza FC tab
Packing/Price
30's
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