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Complera (Generic Emtricitabine, Rilpivirine, and Tenofovir)

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Warning

Complera is a combination medication used to treat HIV. It contains three antiretroviral drugs: emtricitabine, rilpivirine, and tenofovir. While it can be effective in managing HIV, there are some risks and side effects associated with it:

  • Gastrointestinal Issues: Nausea, diarrhea, and abdominal pain are common.
  • Rash: Some people might develop skin rashes, which could be severe.
  • Liver Problems: Liver function issues or hepatitis can occur, especially in those with pre-existing liver conditions.
  • Kidney Issues: Tenofovir can affect kidney function, so monitoring is necessary.
  • Bone Density Loss: Long-term use can lead to decreased bone mineral density.
  • Drug Interactions: Complera can interact with other medications, potentially reducing its effectiveness or causing side effects.

Regular monitoring by a healthcare provider is crucial to manage these risks and adjust treatment as needed.

Why is this medication prescribed?

Complera is a medication used in the treatment of HIV (Human Immunodeficiency Virus) infection. It combines three antiretroviral drugs:

  • Emtricitabine (a nucleoside reverse transcriptase inhibitor, or NRTI)
  • Rilpivirine (a non-nucleoside reverse transcriptase inhibitor, or NNRTI)
  • Tenofovir disoproxil fumarate (another NRTI)

These drugs work together to help reduce the amount of HIV in the blood, improve immune function, and prevent the progression to AIDS.

How should this medicine be used?

Here’s how Complera should be used:

  • Dosage: Typically, the standard dose is one tablet taken once daily with a meal. This helps increase the absorption of the medication.
  • Consistency: Take Complera at the same time every day to maintain a consistent level of the drug in your system.
  • Food: It is important to take Complera with a meal, as taking it on an empty stomach can reduce its effectiveness and increase the risk of side effects.
  • Missed Doses: If you miss a dose, take it as soon as you remember, unless it’s almost time for your next dose. Do not take two doses at the same time to make up for a missed dose.
  • Regular Monitoring: Routine check-ups with your healthcare provider are essential to monitor your viral load, assess side effects, and check for any drug interactions.
  • Adherence: Adhering to the prescribed regimen is crucial for the effectiveness of the treatment and to prevent the development of drug-resistant strains of HIV.

Always follow your healthcare provider’s instructions and consult them with any questions or concerns about using Complera.

Other uses for this medicine

Complera is specifically approved for the treatment of HIV-1 infection and is not used for other conditions. It is not intended for the prevention of HIV infection (pre-exposure prophylaxis) or for treating other types of infections or conditions.

What special precautions should I follow?

Complera is a medication used to treat HIV-1 infection. It combines three antiretroviral drugs: emtricitabine, tenofovir disoproxil fumarate, and rilpivirine. Here are some special precautions to keep in mind while taking Complera:

  • Food and Drink: Take Complera with a meal. The presence of food helps with the absorption of the rilpivirine component, which is crucial for the medication’s effectiveness.
  • Interactions with Other Medications: Inform your healthcare provider about all the medications you’re taking, including over-the-counter drugs and supplements. Complera can interact with various drugs, including those used for heartburn or acid reflux (e.g., antacids, H2 blockers, or proton pump inhibitors).
  • Liver Function: If you have liver problems, such as hepatitis B or C, discuss this with your doctor. Complera can affect liver function, and you might need regular liver function tests.
  • Kidney Function: Regular monitoring of kidney function may be necessary, especially if you have a history of kidney issues or are taking other medications that affect the kidneys.
  • Bone Health: Tenofovir, one of the components of Complera, can affect bone density over long-term use. Your healthcare provider may monitor your bone health, especially if you have a history of bone issues or are at higher risk for osteoporosis.
  • Immune System Effects: Be aware of the possibility of immune reconstitution inflammatory syndrome (IRIS), which can occur when the immune system starts to recover and becomes overly active. This is something to watch for if you start feeling unwell after beginning treatment.
  • Pregnancy: If you are pregnant or planning to become pregnant, consult your healthcare provider. The safety of Complera during pregnancy should be evaluated, and your doctor can help weigh the benefits and risks.
  • Adherence: It’s important to take Complera exactly as prescribed. Missing doses or not taking it with food as directed can affect its effectiveness and increase the risk of developing drug resistance.
  • HIV Resistance: Regular follow-up appointments with your healthcare provider are crucial to monitor your response to the medication and to check for any potential resistance.

Always consult with your healthcare provider for personalized advice and follow their recommendations closely.

What special dietary instructions should I follow?

    • Meal Requirement: Take Complera with a meal. This enhances the absorption of the medication and helps reduce gastrointestinal side effects. It is typically advised to take Complera with a meal containing at least 400 calories.
    • Moderation: While not strictly restricted, it is advisable to use alcohol in moderation as it may exacerbate side effects or interact with other medications.

What should I do if I forget a dose?

  • Take as Soon as Possible: If you remember within 12 hours of the missed dose, take it as soon as you remember. If it is less than 12 hours until your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
  • Avoid Overlapping Doses: Do not take two doses at the same time to make up for a missed dose.
  • Regular Check-ins: If you miss doses frequently or are unsure about what to do, contact your healthcare provider for guidance.

What side effects can this medication cause?

Complera, like any medication, can cause side effects. Here are some potential side effects associated with Complera:

Common Side Effects

  • Nausea: Feeling queasy or having an upset stomach.
  • Headache: A frequent or persistent headache.
  • Dizziness: Feeling lightheaded or unsteady.
  • Fatigue: Feeling unusually tired or weak.
  • Diarrhea: Loose or watery stools.
  • Rash: Skin changes or eruptions.

Less Common but Serious Side Effects

  • Allergic Reactions: Symptoms may include swelling of the face, lips, tongue, or throat, and difficulty breathing.
  • Liver Problems: Signs can include yellowing of the skin or eyes (jaundice), dark urine, pale stools, and persistent stomach pain.
  • Kidney Problems: Symptoms might include changes in urination, swelling in the legs or ankles, and fatigue.
  • Bone Density Loss: Long-term use of tenofovir (a component of Complera) may lead to decreased bone density, which could increase the risk of fractures.
  • Mental Health Effects: Depression, mood changes, or unusual thoughts and behaviors, especially with the rilpivirine component.
  • Immune Reconstitution Inflammatory Syndrome (IRIS): This can occur when the immune system starts to recover and becomes overly active, potentially leading to inflammatory reactions.

Rare but Serious Conditions

  • Pancreatitis: Inflammation of the pancreas, which can cause severe abdominal pain, nausea, and vomiting.
  • Lactic Acidosis: A rare but serious condition characterized by a build-up of lactic acid in the blood, leading to symptoms like muscle pain, weakness, and rapid breathing.

Monitoring and Management

  • Regular Check-ups: Regular blood tests and medical evaluations are important to monitor for any potential side effects and adjust treatment as needed.
  • Report Symptoms: Inform your healthcare provider if you experience any severe or unusual symptoms, as they may need to adjust your treatment or provide additional care.

Always consult your healthcare provider or pharmacist if you have concerns about side effects or need further guidance on managing them.

What should I know about storage and disposal of this medication?

Storage and Disposal

  • Storage:
    • Keep it Cool and Dry: Store Complera at room temperature, between 59°F and 77°F (15°C and 25°C). Keep it away from excess heat and moisture.
    • Original Container: Keep the medication in its original container with the lid tightly closed to protect it from light and moisture.
    • Out of Reach: Store Complera out of reach of children and pets to prevent accidental ingestion.
  • Disposal:
    • Do Not Flush: Do not flush Complera down the toilet or pour it into a drain unless instructed to do so by a specific disposal program.
    • Take-Back Programsv Check if there are any drug take-back programs or disposal sites in your area for safe medication disposal.
    • Household Disposal: If no take-back programs are available, you can dispose of Complera in your household trash by mixing it with an undesirable substance (e.g., used coffee grounds or cat litter) and placing the mixture in a sealed plastic bag or container to prevent leakage.

In case of emergency/overdose

  • Emergency:
    • Contact Emergency Services: If you suspect a severe allergic reaction or experience symptoms such as trouble breathing, swelling of the face or throat, or severe rash, seek immediate medical attention.
    • Poison Control: In case of an emergency or if you’re unsure about a reaction, contact your local poison control center or emergency services for guidance.
  • Overdose:
    • Signs of Overdose: Symptoms of an overdose may include severe nausea, vomiting, dizziness, or other severe side effects.
    • What to Do: If you suspect an overdose, contact your healthcare provider or poison control center immediately. You may need to go to the nearest emergency room for treatment.

What other information should I know?

  • Regular Check-ups: Keep up with regular medical appointments to monitor your progress, manage side effects, and adjust treatment if necessary.
  • Missed Dose: If you miss a dose of Complera, take it as soon as you remember, unless it’s almost time for your next dose. Do not double up on doses to make up for a missed one.
  • Drug Interactions: Inform your healthcare provider of any new medications or supplements you plan to start. Some medications can interact with Complera, affecting its efficacy or increasing the risk of side effects.
  • HIV Status: Regular monitoring of your HIV viral load and CD4 count is essential to ensure the medication is working effectively.
  • Side Effects: Be aware of common side effects, such as nausea, headache, or rash. Report any severe or unusual symptoms to your healthcare provider.
  • Lifestyle Considerations: Maintaining a healthy lifestyle, including a balanced diet and regular exercise, can support overall health and the effectiveness of your HIV treatment.

Always follow the specific instructions provided by your healthcare provider or pharmacist and reach out to them if you have any questions or concerns about your medication.

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