Indications for TEMIXYS:
In combination with other antiretroviral agents for treatment of HIV-1 infection in adults and children weighing ≥35kg.
Adults and Children:
<35kg: not established. ≥35kg: 1 tab once daily.
Post-treatment exacerbations of hepatitis B.
Test for HBV before starting antiretroviral therapy. Discontinuation of anti-HBV therapy may be associated with severe acute exacerbations of hepatitis B. Closely monitor patients co-infected with HBV and HIV for several months after stopping treatment; if appropriate, resumption of anti-HBV therapy may be warranted (esp. in advanced liver disease or cirrhosis). Underlying hepatitis B or C; monitor for hepatotoxicity. Suspend therapy if lactic acidosis or hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Monitor SCr, CrCl, urine glucose, urine protein, and serum phosphorus (in chronic kidney disease) prior to and during therapy. History of pancreatitis, or other significant risk factors; discontinue immediately if occurs. History of pathologic bone fracture or other risk factors for osteoporosis or bone loss: consider monitoring bone mineral density (BMD); calcium/vitamin D supplement may be beneficial. Renal impairment (CrCl <50mL/min) or ESRD requiring hemodialysis: not recommended. Elderly. Pregnancy. Nursing mothers: not recommended.
Nucleoside/nucleotide analogue (reverse transcriptase inhibitors).
Avoid concomitant adefovir dipivoxil, sorbitol-containing drugs. Caution with drugs eliminated by active organic cationic secretion (eg, trimethoprim). Monitor for toxicity (eg, hepatic decompensation) with interferon-alfa ± ribavirin; reduce or discontinue one or both drugs as needed. Potentiates didanosine; monitor for adverse reactions and discontinue if occurs. Concomitant atazanavir 300mg: give with ritonavir. Tenofovir levels increased by lopinavir/ritonavir, atazanavir/ritonavir, darunavir/ritonavir, ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir: monitor for adverse reactions and discontinue if occurs. Concomitant ledipasvir/sofosbuvir: if without protease inhibitor/ritonavir or protease inhibitor/cobicistat combination: monitor; if with protease inhibitor/ritonavir or protease inhibitor/cobicistat combination: consider alternative HCV or antiretroviral therapy; if coadministration necessary, monitor. Avoid concomitant or recent use of nephrotoxic agents. Monitor drugs that decrease renal function or compete for renal tubular secretion (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, high-dose or multiple NSAIDs); consider alternatives to NSAIDs.
Rash, headache, pain, depression, diarrhea; hepatotoxicity, hypersensitivity reactions, pancreatitis, decreased BMD, new onset or worsening renal impairment, immune reconstitution syndrome.
Register pregnant patients exposed to Temixys by calling (800) 258-4263.