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.
HIV treatment
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.
Source:Â FDA
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Discouragement
feeling sad or empty
irritability
lack of appetite
loss of interest or pleasure
mental depression
thoughts of killing oneself
tiredness
trouble concentrating
trouble sleeping
Less common
Body aches or pain
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
chills
difficulty with breathing
ear congestion
headache
loss of voice
runny or stuffy nose
tightness in the chest
unsteadiness or awkwardness
unusual tiredness or weakness
weakness in the arms, hands, legs, or feet
Incidence not known
Agitation
bloody or cloudy urine
bone pain
confusion
dark urine
decreased appetite
decreased urination
difficulty swallowing
dizziness
fast heartbeat
fast, shallow breathing
hostility
increased thirst
indigestion
irritability
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
light-colored stools
muscle pain or cramps
muscle tenderness, wasting, or weakness
pain in the stomach, side, or abdomen, possibly radiating to the back
rapid weight gain
seizures
sleepiness
stomach discomfort
swelling of the face, ankles, hands, feet, or lower legs
unusual drowsiness, dullness, or feeling of sluggishness
vomiting
yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Abnormal dreams
Less common
Back pain
belching
difficulty with moving
pain in the joints
pain or tenderness around the eyes and cheekbones
stomach discomfort or upset
Incidence not known
Lack or loss of strength
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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
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
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.
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.
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.
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.
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.
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.
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.
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.
Dosage | Quantity | Price as low as | Price per unit |
---|---|---|---|
200mg/25mg/300mg | 30 tablets | $3742.87 | $124.76 |
The recommended dose for adults and children weighing more than 35 kg is 1 tablet once a day with food.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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