Complera, illustration of tablet form (not a photo of the actual pack)

Illustrative image.

Complera

Emtricitabine; Rilpivirine Hydrochloride;Tenofovir Disoproxil Fumarate

Prescription required

$5400.00

200mg/25mg/300mg · 3 × 30 tablets · 3 months supply

BrandBranded medicine

$1800.00 per month

How long a supply?

1 month$1800.00 a month
3 months$1800.00 a month
6 months$1800.00 a month
Supplied from Canada

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Annual cost

$21600a year at this pack size

Prescription required

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FDA boxed warningPosttreatment acute exacerbation of hepatitis b

Severe acute exacerbations of hepatitis B virus (HBV) have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), two of the components of COMPLERA.

Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue COMPLERA. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Read this with the rest of the clinical information

About Complera

Overview

Complera is a combination tablet containing emtricitabine, rilpivirine hydrochloride and tenofovir disoproxil fumarate. It is a complete treatment regimen for HIV-1 infection in adults and children weighing at least 35 kg who meet specific treatment-history and viral-load criteria. It may be used as a first treatment or to replace a stable regimen when HIV-1 is suppressed, subject to the label’s criteria. Its three antiretroviral ingredients inhibit reverse transcriptase, an enzyme HIV-1 uses to make copies of itself.

What it treats

Complera is used as a complete treatment regimen for HIV-1 infection in adults and children weighing at least 35 kg: - As initial treatment for people who have not previously received antiretroviral treatment and have an HIV-1 viral load of 100,000 copies/mL or less. - To replace a stable antiretroviral regimen used for at least 6 months in people whose HIV-1 viral load is below 50 copies/mL, with no treatment failure and no known resistance to any component of Complera.

Safety information

Side effects

Common side effects reported with Complera’s ingredients include diarrhoea, nausea, tiredness, headache, dizziness, depression, difficulty sleeping, abnormal dreams and rash. Serious side effects include severe skin or allergic reactions, liver injury, severe depression, new or worsening kidney problems including acute kidney failure, bone loss and problems with bone mineralisation. Other serious risks include lactic acidosis (a build-up of lactic acid in the blood), severe liver enlargement with fat build-up, and immune reconstitution syndrome, where changes in the immune system may require further assessment and treatment. Severe worsening of hepatitis B can occur in people who have both HIV-1 and hepatitis B. Contact a doctor immediately for severe depression or a suspected severe skin or allergic reaction. Treatment must be stopped immediately if a hypersensitivity reaction occurs, or if a rash develops with symptoms affecting the rest of the body or raised liver blood tests. Contact a doctor promptly about other suspected serious side effects. Taking Complera with medicines known to prolong the heart’s QT interval may increase the risk of a serious abnormal heart rhythm called Torsade de Pointes. Concurrent or recent use of medicines that can damage the kidneys should be avoided.

FDA boxed warning

Posttreatment acute exacerbation of hepatitis b

Severe acute exacerbations of hepatitis B virus (HBV) have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), two of the components of COMPLERA.

Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue COMPLERA. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.

When to call your doctor

- Seek medical attention immediately for a severe rash, or a rash accompanied by other symptoms affecting your body. - Seek medical attention immediately for severe depression.

If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.

Before taking this medicine

Do not take Complera with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, systemic dexamethasone given more than once, St John’s wort, or proton pump inhibitors such as dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole or rabeprazole. These combinations can reduce its effectiveness and may lead to drug resistance. Conditions requiring caution include liver disease, raised liver test results, kidney problems, severe depression, and a history of fractures caused by weakened bones or other risk factors for osteoporosis or bone loss. Liver tests and, where appropriate, bone density monitoring may be needed. Avoid use with medicines that can damage the kidneys, including those used recently. Medicines known to prolong the heart’s QTc interval may increase the risk of a serious abnormal heart rhythm called Torsade de Pointes. Severe skin and allergic reactions, including DRESS, have been reported. Stop treatment and seek immediate medical care if a severe allergic reaction occurs, or if a rash develops with symptoms affecting the rest of the body or raised liver tests. Severe depression requires immediate medical assessment. Treatment must also be stopped if symptoms or test results suggest lactic acid buildup or serious liver toxicity. Immune system changes during treatment may require further assessment and treatment. During pregnancy, close viral load monitoring is needed because rilpivirine exposure may be lower. Breastfeeding is not recommended because of the potential for HIV-1 transmission. Complera is not recommended for patients weighing less than 35 kg.

Interactions

Complera is a complete treatment regimen for HIV-1. Taking it with other antiretroviral medicines used to treat HIV-1 is not recommended. Ask your doctor to check the full prescribing information for important drug interactions before and during treatment.

Using Complera

Dosing

Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.

Storage

Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.

Clinical information on this page is summarised from the US FDA label COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.] (DailyMed, retrieved 19 September 2026).

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