mtricitabine / rilpivirine / tenofovir
Complera is a single-tablet regimen containing 3 HIV antiretrovirals (ARVs), rilpivirine (Edurant), emtricitabine (Emtriva), and tenofovir disoproxil fumarate (Viread). It's no longer a first-choice treatment option due to newer agents with fewer side effects.
What is Complera?
What is Complera used for?
- HIV treatment
How Complera works
Complera 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
Side effects of Complera
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
- Change in mood, depression (2%)
- Headache (2%)
- Trouble sleeping, insomnia (2%)
Less Common Side Effects
- Abnormal, strange dreams
- Dizziness
- Nausea
- Rash
The following Complera 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
- Bone pain
- 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
- Muscle pain
- Muscle weakness
- 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):
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Pros and cons of Complera
Pros
- 1 tablet once a day is a full HIV regimen
- Can be used in pregnancy at the same dose
- Contains tenofovir, which is also a first-choice treatment option for hepatitis B
- Causes less abnormal dreams when compared to a similar medication Atripla
- Not associated with weight gain
Cons
- Must be taken with food
- Not recommended for people with kidney problems since the 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.
- Can lead to kidney and bone problems
Pharmacist tips for Complera
- Take Complera at the same time everyday, so the amount of medication in your body can stay the same.
- Take each dose with a meal that's at least 400 calories. Taking it on an empty stomach can lead to lower levels of medication. Protein and nutrition shakes cannot replace a meal.
- Make sure your healthcare providers have a full list of the medications you are taking. Since Complera 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 Complera that is absorbed by your stomach. Do not take proton pump inhibitors, like omeprazole (Prilosec), while taking Complera. You can take H2RAs, like famotidine (Pepcid), 12 hours before or 4 hours after Complera and antacids, like Tums, 2 hours before or 4 hours after Complera.
- Talk to your provider if you become pregnant or have plans on becoming pregnant. You can continue to take Complera during your pregnancy, but your provider may choose to monitor your viral load more closely while you are pregnant.
Common questions about Complera
Complera must be taken with food to make sure the right amount of medication is absorbed by your body. The manufacturer recommends that the medication be taken with at least a light meal, about 400 calories. A protein drink is not a substitute for food.
Yes, Complera 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 Complera. Talk to your provider if you ever have questions about your HIV regimen.
If you stop taking Complera 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.
If you realize you forgot your dose of Complera, 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.
Though Complera can be taken during pregnancy, it's not recommended to breastfeed while taking the medication. In general, women with HIV are not recommended to breastfeed since HIV can be passed to the child in breast milk.
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Risks and warnings for Complera
Complera 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 Complera
People who have stopped taking Complera have had severe worsening of their hepatitis B. Don't stop taking Complera 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 Complera, due to rilpivirine. It's more common in people who have some type of liver disease or infection. Complera is not recommended for people who have moderate to severe liver conditions. Your provider will check your liver before you start Complera 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 Complera and go to the emergency room right away if this happens.
DEPRESSION AND CHANGES IN MOOD
- Risk factors: History of mental health problems
Complera has been associated with negative thoughts, depression, and thoughts of suicide. If your mood starts to change while taking Complera, 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 Complera 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
Complera 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 Complera 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 Complera.
Complera dosage
Tablet| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 200mg/25mg/300mg | 30 tablets | $1,046.31 | $34.88 |
Typical dosage for Complera
The recommended dose for adults and children weighing more than 35 kg is 1 tablet once a day with food.
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