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Odefsey

emtricitabine / rilpivirine / tenofovir

Used for HIV Treatment

Odefsey is a single-tablet-regimen containing 3 HIV antiretrovirals (ARVs), rilpivirine (Edurant), emtricitabine (Emtriva), and tenofovir AF (Vemlidy). It's similar to Complera, but contains a newer version of tenofovir which causes less harmful effects on your kidneys and bones.

Reviewed by:

Hope Chang, PharmD, AAHIVP

Michelle Nguyen, PharmD

Last reviewed on April 1, 2021

Basics Side effects Pros & cons Pharmacist tips FAQs Warnings Dosage Cost Alternatives Latest news Images Prices Medicare

What is Odefsey?

What is Odefsey used for?

HIV treatment

How Odefsey works

Odefsey contains an non-nucleoside reverse transcriptase inhibitor (NNRTI) (rilpivirine) and two nucleoside reverse transcriptase inhibitors (NRTIs) (emtricitabine, tenofovir). These 3 medications work together to prevent the virus from making copies of itself in your body.

Drug Facts

Common BrandsOdefsey

Drug ClassHIV ARV Combo

Controlled Substance ClassificationNot a controlled medication

Generic StatusNo lower-cost generic available

AvailabilityPrescription only

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Avg retail price

$13728.00(save 18.32%)

GoodRx discount

$11212.64

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What are the side effects of Odefsey?

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

Headache (2%)
Sleep problems (2%)

Other Side Effects

Gas
Strange, abnormal dreams
Diarrhea
Nausea

Source: FDA

The following side effects have also been reported

Side effects that you should report to your care team as soon as possible:

Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
High lactic acid level—muscle pain or cramps, stomach pain, trouble breathing, general discomfort and fatigue
Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
Rash, fever, and swollen lymph nodes
Thoughts of suicide or self-harm, worsening mood, feelings of depression

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

Diarrhea
Dizziness
Headache
Nausea
Trouble sleeping
Vivid dreams or nightmares

Pros and cons of Odefsey

Pros

1 tablet once a day is a full HIV regimen

Safer for your kidneys and bones when compared to Complera

Can be used in pregnancy at the same dose

Contains tenofovir, which is also a first-choice treatment option for hepatitis B

Not too many side effects

Cons

Must be taken with a light meal

Dose can't be adjusted

Can't be used if the amount of virus (viral load) is too high

There are many medication interactions and it can't be taken with some medications used to treat tuberculosis, seizures, and stomach acid.

Not a first-choice treatment option for people new to HIV medications

Pharmacist tips for Odefsey

Take Odefsey with a meal at the same time everyday, so the amount of medication in your body can stay the same.

Contact your pharmacy for refills when you have about a week left of medication. You never want to run out of your HIV ARVs. Some people will keep a "stash" of their medications in case of emergencies. Do not share HIV ARVs with friends or family if you run out of medication.

Make sure your healthcare providers have a full list of the medications you are taking. Since Odefsey interacts with a lot of other medications, sometimes the dose has to be increased.

Over-the-counter medications used to treat indigestion, acid reflux, or heartburn can lower the amount of Odefsey that is absorbed by your stomach. Do not take proton pump inhibitors, like omeprazole (Prilosec), while taking Odefsey. You can take H2RAs, like famotidine (Pepcid), 12 hours before or 4 hours after Odefsey and antacids, like Tums, 2 hours before or 4 hours after Odefsey.

Talk to your provider if you become pregnant or have plans on becoming pregnant. You can continue to take Odefsey during your pregnancy, but your provider may choose to monitor your viral load more closely while you are pregnant.

Frequently asked questions about Odefsey

Is Odefsey better than Complera?

Odefsey and Complera are both good single-tablet-regimens used for the treatment of HIV. The main difference is that Odefsey has a newer form of tenofovir, which is safer for bones and kidneys. On the other hand, Complera has been used more often in pregnant patients.

Does it matter what kind of meal I eat with Odefsey?

Odefsey should be taken with a meal that contains fat and has at least 400 calories. Typically protein and meal-replacement shakes are not a substitute for a meal.

Can Odefsey be taken alone?

Yes, Odefsey is a single-tablet-regimen that can be taken alone for the treatment of HIV. For some people who might have a resistant type of HIV, they may have to take other HIV ARVs in addition to Odefsey. Talk to your provider if you have questions about your HIV regimen.

What happens if I stop taking Odefsey?

If you stop taking Odefsey without starting an HIV ARV combo replacement, the HIV virus can start to grow and harm your immune system. If you also happen to have hepatitis B, this virus may also flare up and harm your liver.

What should I do if I miss a dose of Odefsey?

If you realize you forgot your dose of Odefsey, take it as soon as you remember as long as it hasn't been more than 12 hours from your regularly scheduled dose. If more than 12 hours have passed, and it's closer in time to your next dose, skip the missed dose and wait until your regularly scheduled time. Never double up on doses.

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What are the risks and warnings for Odefsey?

Odefsey can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

WORSENING OF HEPATITIS B

Risk factors: Hepatitis B virus (HBV) | Stopping Odefsey

People who have stopped taking Odefsey have had severe worsening of their hepatitis B. Don't stop taking Odefsey unless instructed by your healthcare provider. If you are instructed to stop the medication, or switch to a different antiviral medication, make sure you get your labs drawn regularly. This is how your provider will monitor your liver and HBV.

LIVER PROBLEMS AND TOXICITY

Risk factors: History of liver disease | Hepatitis B or C infection | Obesity | Women

Although rare, NRTIs including emtricitabine and tenofovir can cause a life-threatening liver problem called lactic acidosis with hepatic steatosis. Some people also have changes in their liver tests after starting Odefsey, due to rilpivirine. It's more common in people who have some type of liver disease or infection. Odefsey is not recommended for people who have moderate to severe liver conditions. Your provider will check your liver before you start Odefsey and will order blood tests to monitor your liver while you are taking the medication. Symptoms of liver problems can include appetite loss, stomach pain, muscle pain, fast and shallow breathing, extreme tiredness, and sudden weakness. Stop taking Odefsey and go to the emergency room right away if this happens.

DEPRESSION AND CHANGES IN MOOD

Risk factors: History of mental health problems

Odefsey has been associated with negative thoughts, depression, and thoughts of suicide. If your mood starts to change while taking Odefsey, let your provider know. If you start thinking about wanting to harm yourself, seek medical attention right away.

KIDNEY PROBLEMS

Risk factors: History of kidney damage | Concurrent use of other drugs known to harm kidneys

Some people taking Odefsey have developed kidney problems. Sometimes it happens right after starting the medication. For others the damage is over time. It's recommended to avoid other medications that can also harm the kidney, like high doses of anti-inflammatory drugs called NSAIDs (Motrin/Advil, Aleve, Mobic, Voltaren, etc.). Make sure you get your labs drawn regularly so your provider can check on your kidneys.

BONE PROBLEMS

Risk factors: History of bone fractures | Osteoporosis

Odefsey can lower your bone mineral density and weaken your bones. This can lead to osteoporosis and raise your risk of fractures. Many people take calcium and vitamin D supplements to help prevent this. Your provider may order additional tests to check your bone density if you have a fracture or other risk factors for bone problems.

IMMUNE RECONSTITUTION SYNDROME

Risk factors: Weakened immune system | Current untreated infection

HIV attacks your immune system. Over time, if the virus isn't treated your body may become defenseless against bacterial and fungal infection. Your HIV medications are very good at killing the virus, and when the number of viruses goes down, your immune system gets started making more cells. Once your immune system gets better, it will start to fight off any infections you might have, which can lead to a lot of inflammation. Even though it's a good thing that your immune system is getting better, too much inflammation can be bad. Your healthcare provider might check for underlying infections (sometimes called opportunistic infections) before starting Odefsey especially if it is your first time taking HIV medications. Call your provider if you experience fever, difficulty breathing, or sudden changes to your health after starting Odefsey.

Odefsey dosage forms

The average cost for 90 tablets of 200mg/25mg/25mg of Odefsey is $11212.64 with a free GoodRx coupon. This is 18.32% off the average retail price of $13728.00.