CIMDUO(lamivudine and tenofovir disoproxil fumarate)

CIMDUO Rx

Generic Name and Formulations:

Lamivudine 300mg, tenofovir disoproxil fumarate 300mg; tabs. 

Company:

Mylan Inc. 

Monograph added. 

Indications for CIMDUO:

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.

Boxed Warning:

Post-treatment acute exacerbations of hepatitis B. 

Warnings/Precautions:

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. Underlying hepatitis B or C; monitor for hepatotoxicity. Suspend therapy if lactic acidosis or hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Monitor CrCl (in all patients), serum creatinine, serum phosphorus, urine glucose and urine protein prior to initiation and periodically during therapy in patients at risk for renal impairment. History of pancreatitis, or other significant risk factors; discontinue immediately if occurs. History of pathologic fracture or risk factors of 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.

Pharmacological Class:

Nucleoside/nucleotide analogue (reverse transcriptase inhibitors).

Interactions:

Avoid concomitant 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. Concomitant atazanavir 300mg: give with ritonavir. Tenofovir levels increased by lopinavir/ritonavir, atazanavir/ritonavir, darunavir/ritonavir, ledipasvir/sofosbuvir, sofosbuvir/velpatasvir: monitor for toxicity 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. 

Adverse Reactions:

Rash, headache, pain, depression, diarrhea; hepatotoxicity, hypersensitivity reactions, pancreatitis, decreased BMD, new onset or worsening renal impairment, immune reconstitution syndrome, fat redistribution. 

Note:

Register pregnant patients exposed to Cimduo by calling (800) 258-4263.

Generic Availability:

NO

How Supplied:

Tabs—30, 90