Cimduo and Temixys
3TC/TDF lamivudine/tenofovir DF
Standard DoseOne tablet once daily without regard to food for adults and children weighing at least 77 pounds (35 kg). Tablet contains 300 mg lamivudine (3TC) and 300 mg tenofovir disoproxil fumarate (TDF). Must be taken in combination with another antiretroviral(s) that does not contain the medications (or their equivalents) in this drug combination.
Take missed dose as soon as possible, unless it is closer to the time of your next dose. Do not double up on your next dose.
Dosing frequency needs to be adjusted for people with decreased kidney function. Cimduo and Temixys should not be used if CrCl is less than 50 mL/min or if you are on dialysis.
- See the individual drugs contained in Cimduo and Temixys: Epivir and Viread.
- See package insert for more complete information on potential side effects and interactions.
ManufacturerMylan Specialty L.P.
Temixys: Not available on formulary used
Potential Side Effects and Toxicity
Most common adverse events (in more than 10% of people taking it) are headache (14%), pain (13%), depression (11%), diarrhea (11%), and rash (18%) (when studied in combination with efavirenz). TDF is associated with long-term decreases in bone mineral density (BMD). BMD monitoring should be considered in people who have a history of bone fracture due to disease or are at risk for osteopenia or osteoporosis. While calcium and vitamin D levels can be checked to assess the need for these supplements, talk with your provider before starting on your own. TDF can cause kidney toxicities. Tell your provider about any pain in extremities, persistent or worsening bone pain and fractures, with or without muscular pain or weakness, as well as any concerning changes in urinary habits, as these could be signs of bone or kidney problems. Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in all individuals with mild kidney impairment. Prior to initiation, people should be tested for hepatitis B virus (HBV) infection. Severe exacerbations of hepatitis B have been reported in people co-infected with HBV who have discontinued medication (due to elimination of both lamivudine and TDF, which also treat hepatitis B). Monitor liver enzymes closely in people co-infected with HBV and, if appropriate, initiation of anti-hepatitis B therapy may be warranted upon discontinuation. Call your health care provider right away if you develop any of the following signs or symptoms of hepatitis: yellowing of the skin or whites of the eyes; dark or tea-colored urine; pale-colored bowel movements; nausea or vomiting; loss of appetite; or pain, aching, or tenderness on the right side below the ribs. Contains lactose, which can cause some abdominal discomfort, especially in people sensitive to lactose. Read weight discussion in the online version of this page.
Potential Drug Interactions
Do not take with Descovy, Emtriva, Epivir-HBV, Hepsera, Truvada, Vemlidy, or Viread, which are used for the treatment of hepatitis B. Tenofovir DF decreases the concentration levels of Reyataz, therefore when Reyataz is taken with Cimduo or Temixys, it is recommended that Reyataz 300 mg be taken with Norvir 100 mg (all as a single daily dose with food). In addition, Reyataz/Norvir, Prezista/Norvir, and Kaletra increase tenofovir DF concentrations; therefore, it is recommended patients be monitored for TDF-associated adverse events, particularly decreases in kidney function. Avoid taking with drugs that negatively affect the kidneys, including chronic use or high doses of anti-inflammatory drugs for pain such as Advil or Motrin (ibuprofen) and Aleve (naproxen). Avoid administration of sorbitol with Cimduo and Temixys. Hepatic (liver) decompensation, some fatal, has occurred when using lamivudine and interferon alfa (with or without ribavirin) for hepatitis C (HCV) treatment. (Of note, interferon alfa is no longer used for the treatment of hepatitis C.) Cimduo and Temixys may be used with HCV drugs Harvoni or Zepatier, depending on the third drug in the HIV regimen; monitor for tenofovir toxicities if used with Epclusa. Tell your provider or pharmacist about all medications, herbals, and supplements you are taking or thinking of taking, prescribed or not, as there are other drug interactions not listed here.
Cimduo and Temixys are slightly different versions of Truvada, but contain 3TC instead of Truvada’s FTC. The two meds are essentially equivalent. The niche for these medications is that they may be a cheaper option for some insurance plans because they contain generic drugs. They also allow for some new or unique co-formulations (such as with Delstrigo, Symfi, and Symfi Lo). TDF is falling out of favor since the newer formulation tenofovir alafenamide (TAF) was approved. TAF is safer on kidneys and bones than TDF. Unlike Truvada, Cimduo and Temixys are not approved for PrEP (HIV prevention). DHHS treatment guidelines recommend Cimduo, Temixys, Truvada, or Descovy (which contains TAF) over Epzicom as the preferred NRTI component for initial therapy (unless Epzicom is paired with Tivicay). Kidney function must be monitored before and during treatment and these may not be a good option for people with underlying kidney problems. When the virologic efficacy of Cimduo was compared to Truvada (each combined with Sustiva or nevirapine or a boosted PI) in a study, Cimduo was associated with higher rates of virologic failure compared to Truvada when paired with an NNRTI; however, there was no difference in the rates of virologic failure when paired with a boosted PI. Cimduo and Temixys are recommended by DHHS as one of the preferred NRTI combination components of an ART regimen during pregnancy. Pregnant individuals can voluntarily enroll in the Antiretroviral Pregnancy Registry through their provider; go to apregistry.com.
Dr. Melanie Thompson:
Tenofovir disoproxil fumarate (TDF) rose to predominance as a backbone because of lower toxicity than AZT and the “d-drugs” (d4T, ddI, ddC) and its high genetic barrier to resistance. It also has potent activity against hepatitis B. Today it is almost always given with FTC or 3TC as in Truvada, Cimduo, and Temixys. Generic TDF now is combined with generic 3TC in Cimduo and Temixys, essentially the same drugs made by different generic manufacturers. Technically as combination drugs, they are “brand” drugs. This gets me on my soapbox about egregious pricing for drugs. Copay cards allow companies to maintain very high drug prices while making them affordable enough for people to actually take them. So, while these prices are less than that of Truvada, they pack in an outsized profit for the maker. TDF/3TC combinations are not approved for PrEP.
Activist Michael Broder:
Cimduo and Temixys were both approved in 2018 and are fixed-dose combinations (FDCs) of two NRTIs. They come from different manufacturers: Cimduo from Mylan Pharmaceuticals and Temixys from Celltrion. This combination was not possible when these drugs were under patent, because they were made by competing drug companies. After both drugs went off patent, generic drug companies could mix and match. Cimduo and Temixys are basically branded generic versions of Truvada, as the emtricitabine in Truvada is closely chemically related to lamivudine (you did not hear me say “knock-off”). Why do we need both Cimduo and Temixys? Medically, we don’t. These are simply competing brands of more-or-less equivalent products, a little like Coke and Pepsi, or Nike and Reebok. Gilead’s patent on emtricitabine expired last fall, and there are already over a dozen FDA approved generics available. As HIV drugs start to go generic, trust your provider to know what’s what—but verify.