Odefsey (Rilpivirine, Emtricitabine, and Tenofovir alafenamide) is a combination of three antiretroviral drugs that are used to treat certain patients with HIV-1 infections.
Odefsey (Rilpivirine, emtricitabine, and tenofovir alafenamide) Uses:
-
HIV-1 infection:
- It is indicated for the treatment of HIV-1 infection (as a complete regimen) in patients who are:
- 12 years of age or older as initial therapy
- No antiretroviral treatment history with HIV-1 RNA copies of 100,000 copies/mL or less; or
- To replace a stable antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) for 6 months or more with no history of treatment failure and no known substitutions associated with resistance to the individual components.
- It is indicated for the treatment of HIV-1 infection (as a complete regimen) in patients who are:
-
Limitations of use:
- More rilpivirine-treated patients with no history of antiretroviral treatment with HIV-1 RNA >100,000 copies/mL experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to rilpivirine-treated patients with HIV-1 RNA ≤100,000 copies/mL.
Odefsey (Rilpivirine, Emtricitabine, and Tenofovir alafenamide) Dose in Adults
Odefsey (Rilpivirine, Emtricitabine, and Tenofovir alafenamide) Dose in the treatment of HIV-1 infection:
- Oral: One tablet once daily.
Odefsey (Rilpivirine, Emtricitabine, and Tenofovir alafenamide) Dose in Childrens
Note: Test for hepatitis B infection before starting therapy, and baseline estimated creatinine clearance, urine glucose, and urine protein should also be assessed in all patients.
Odefsey (Rilpivirine, Emtricitabine, and Tenofovir alafenamide) Dose in the treatment of HIV-1 infection:
-
Ages <12 years or weight <35 kg:
- Not recommended; the product is a fixed-dose combination
-
Children ≥12 years and Adolescents weighing ≥35 kg:
- Oral: One tablet once a day
Pregnancy Risk Category: C
- According to the Health and Human Services (HHS), Perinatal HIV Guidelines, data on the use of combination therapy in pregnant women with antiretroviral-naive status is not available.
- If effective viral suppression is achieved, adequate drug exposure, good tolerance, and no contraindications to use during pregnancy, stable antiretroviral treatment (ART) can be continued.
- For more information, refer to the individual monographs.
Use of rilpivirine, estrogen, and tenofovir-alafenamide during lactation:
- Breast milk contains emtricitabine, which excretes in breastmilk. However, it is unknown if breast milk contains rilpivirine and tenofovir alafenamide.
Dose in Kidney Disease:
- CrCl ≥30 mL/minute: No dosage adjustment required.
- CrCl <30 mL/minute: Not recommended.
Dose in Liver disease:
- Mild to moderate impairment (Child-Pugh class A or B): No dosage adjustments required.
- Severe impairment (Child-Pugh class C): Manufacturer has not provided any dose adjustment in labeling
Side Effects of Odefsey (Rilpivirine, emtricitabine, and tenofovir alafenamide):
-
Central Nervous System:
- Headache
- Sleep Disorder
- Abnormal Dreams
-
Gastrointestinal:
- Diarrhea
- Nausea
- Flatulence
-
Neuromuscular & Skeletal:
- Decreased Bone Mineral Density
Frequency of side effects not defined:
-
Endocrine:
- Decreased HDL Cholesterol
- Decreased LDL Cholesterol
- Decreased Serum Cholesterol
- Decreased Serum Triglycerides
- Increased HDL Cholesterol
- Increased LDL Cholesterol
- Increased Serum Cholesterol
- Increased Serum Triglycerides
Contraindications to Odefsey (Rilpivirine, emtricitabine, and tenofovir alafenamide):
It is contraindicated if used with any of the following drugs:
- Carbamazepine
- Systemic dexamethasone (>1 dosage)
- Oxcarbazepine
- Phenobarbital
- Phenytoin
- Proton pump inhibitors (PPIs) (eg, dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole)
- Rifampin
- Rifapentine
- St John's Wort.
Canadian labeling: Additional contraindications not in US labeling
- Hypersensitivity to emtricitabine or rilpivirine, or any other component of the formulation
Warnings and Precautions
-
Depressive disorders:
- Patients receiving Rilpivirine treatment may experience neuropsychiatric symptoms.
- Patients can experience depression, low mood, dysphoria, and mood changes.
- It may be necessary to consult a psychiatrist promptly.
- If the suicide risk is greater, it may be necessary to change the antiviral treatment regimen.
-
Hepatotoxicity:
- Patients who have had a history of hepatitis B or C, or any other liver-related disease, may be at risk for hepatotoxicity when Rilpivirine is administered.
- Hepatotoxicity refers to a significant increase in liver enzymes. It can occur in patients who have no other risk factors for liver disease.
- It is important to monitor the liver function test results at baseline as well as periodically, if necessary.
-
Hypersensitivity
- There are many symptoms that can cause hypersensitivity.
- These may range from mild skin rash to severe reactions such as SJS or TEN. It may cause severe hypersensitivity reactions, including skin reactions such as blisters, mucosal involvement, and facial and lip swelling.
- Sometimes, skin reactions can be accompanied by constitutional symptoms such as fever or organ dysfunction like hepatic transaminitis.
- Patients should be closely monitored, and treatment must be stopped if hypersensitivity reactions develop.
-
Immune reconstitution syndrome:
- After antiretroviral treatment, immune reconstitution syndrome can occur.
- This is characterized by an exaggerated reaction to indolent infectious diseases such as tuberculosis or fungal infections after ART has been initiated.
- In therapy, other immune-mediated diseases such as Graves disease and polymyositis may also develop.
- It may be necessary to provide the appropriate treatment.
-
Lactic acidosis/hepatomegaly:
- A nucleoside analog could cause severe hepatomegaly and lactic acidosis with steatosis
- If the patient displays any of these symptoms, discontinue treatment
-
QT-interval prolongation:
- Supra-therapeutic doses (75 mg daily, 300 mg daily) of rilpivirine may prolong the QTc interval in the ECG.
- If the patient is at greater risk for Torsades, de pointes, alternate therapy may be offered.
-
Nephrotoxicity:
- Tenofovir products can cause renal toxicity, such as acute renal failure or Fanconi syndrome. The risk factor is higher with Tenofovir.
- Before starting therapy, monitor renal function, including serum creatinine and estimated CrCl (chronic kidney disease patients), serum phosphorus, urine protein, and glucose
- If the patient has impaired renal function or Fanconi syndrome, discontinue treatment.
-
Chronic Hepatitis B: [US-Boxed Warning]
- Stopping antiretroviral treatment may lead to severe HBV complications.
- It is not recommended for the treatment of chronic liver disease B.
- The safety and efficacy of HBD/HIV co-infection are not established
- Monitor your liver closely, both clinically as well as in laboratory settings, several months after stopping this drug.
- Anti-hepatitis B therapy may be prescribed for patients suffering from advanced liver disease or cirrhosis.
- Before starting treatment, all HIV-positive patients should be tested for HBV.
-
Pre-existing Renal impairment
- If CrCl is 30mL/minute, do not use it.
Rilpivirine, emtricitabine, and tenofovir alafenamide: Drug Interaction
|
Acyclovir-Valacyclovir |
May increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Acyclovir-Valacyclovir. |
|
Aminoglycosides |
May increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Aminoglycosides. |
|
Bosentan |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Cabozantinib |
MRP2 Inhibitors may increase the serum concentration of Cabozantinib. |
|
Cidofovir |
May increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Cidofovir. |
|
Cobicistat |
May enhance the adverse/toxic effect of Tenofovir Products. More specifically, cobicistat may impair proper tenofovir monitoring and dosing. |
|
CYP3A4 Inducers (Moderate) |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
CYP3A4 Inhibitors (Strong) |
May increase the serum concentration of Rilpivirine. |
|
Darunavir |
May increase the serum concentration of Rilpivirine. |
|
Deferasirox |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Erdafitinib |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Ganciclovir-Valganciclovir |
Tenofovir Products may increase the serum concentration of Ganciclovir-Valganciclovir. Ganciclovir-Valganciclovir may increase the serum concentration of Tenofovir Products. |
|
Haloperidol |
QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTcprolonging effect of Haloperidol. |
|
Ivosidenib |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Ketoconazole (Systemic) |
May increase the serum concentration of Rilpivirine. Rilpivirine may decrease the serum concentration of Ketoconazole (Systemic). |
|
Levomethadone |
Reverse Transcriptase Inhibitors (Non-Nucleoside) may decrease the serum concentration of Levomethadone. Management: Levomethadone dosage adjustments will likely be required with efavirenz and nevirapine, and may be necessary with rilpivirine as well. |
|
Lopinavir |
May increase the serum concentration of Rilpivirine. |
|
Methadone |
Reverse Transcriptase Inhibitors (Non-Nucleoside) may increase the metabolism of Methadone. Management: Methadone dosage adjustments will likely be required with efavirenz and nevirapine, and may be necessary with rilpivirine as well. |
|
Orlistat |
May decrease the serum concentration of Antiretroviral Agents. |
|
QT-prolonging Agents (Highest Risk) |
QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. |
|
Sarilumab |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Siltuximab |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Sofosbuvir |
May increase the serum concentration of Tenofovir Alafenamide. |
|
Tocilizumab |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Risk Factor D (Consider therapy modification) |
|
|
Antacids |
May decrease the serum concentration of Rilpivirine. Management: Administer antacids at least 2 hours before or 4 hours after rilpivirine. Administer antacids at least 6 hours before or 4 hours after the rilpivirine/dolutegravir combination product. |
|
CYP3A4 Inducers (Strong) |
|
|
Dabrafenib |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). |
|
Diclofenac (Systemic) |
May enhance the nephrotoxic effect of Tenofovir Products. Management: Seek alternatives to this combination whenever possible. Avoid use of tenofovir with multiple NSAIDs or any NSAID given at a high dose. |
|
Didanosine |
Rilpivirine may decrease the absorption of Didanosine. More specifically, simultaneous coadministration of these drugs creates a conflict between recommendations to administer with (rilpivirine) and without (didanosine) food. Didanosine may decrease the absorption of Rilpivirine. More specifically, simultaneous coadministration of these drugs creates a conflict between recommendations to administer with (rilpivirine) and without (didanosine) food. Management: Administer didanosine on an empty stomach at least 2 hours before or 4 hours after rilpivirine, due to the requirement that rilpivirine be administered with food. |
|
Enzalutamide |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. |
|
Histamine H2 Receptor Antagonists |
May decrease the serum concentration of Rilpivirine. Management: Administer histamine H2 receptor antagonists at least 12 hours before or 4 hours after rilpivirine. |
|
Lorlatinib |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Avoid concurrent use of lorlatinib with any CYP3A4 substrates for which a minimal decrease in serum concentrations of the CYP3A4 substrate could lead to therapeutic failure and serious clinical consequences. |
|
Macrolide Antibiotics |
May increase the serum concentration of Rilpivirine. Management: Consider the use of azithromycin or another non-macrolide alternative when appropriate to avoid this potential interaction. Exceptions: Azithromycin (Systemic); Fidaxomicin; Roxithromycin; Spiramycin. |
|
Mitotane |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. |
|
Nonsteroidal Anti-Inflammatory Agents |
May enhance the nephrotoxic effect of Tenofovir Products. Management: Seek alternatives to these combinations whenever possible. Avoid use of tenofovir with multiple NSAIDs or any NSAID given at a high dose. |
|
Risk Factor X (Avoid combination) |
|
|
Adefovir |
May diminish the therapeutic effect of Tenofovir Products. Adefovir may increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Adefovir. |
|
Antihepaciviral Combination Products |
May increase the serum concentration of Rilpivirine. |
|
CarBAMazepine |
May decrease the serum concentration of Tenofovir Alafenamide. |
|
CarBAMazepine |
May decrease the serum concentration of Rilpivirine. |
|
Cladribine |
Agents that Undergo Intracellular Phosphorylation may diminish the therapeutic effect of Cladribine. |
|
Dexamethasone (Systemic) |
May decrease the serum concentration of Rilpivirine. |
|
Efavirenz |
Reverse Transcriptase Inhibitors (Non-Nucleoside) may increase the serum concentration of Efavirenz. Reverse Transcriptase Inhibitors (Non-Nucleoside) may decrease the serum concentration of Efavirenz. |
|
Ergonovine |
Reverse Transcriptase Inhibitors (Non-Nucleoside) may increase the serum concentration of Ergonovine. Specifically, this would be most likely with delavrdine, while other Non-Nucleoside Reverse Transcriptase Inhibitors may be more likely to decrease the concentration of Ergonovine. |
|
Etravirine |
Reverse Transcriptase Inhibitors (Non-Nucleoside) may decrease the serum concentration of Etravirine. This has been observed with the NNRTIs efavirenz and nevirapine. Reverse Transcriptase Inhibitors (Non-Nucleoside) may increase the serum concentration of Etravirine. This has been observed with delavirdine. |
|
Fosphenytoin |
May decrease the serum concentration of Rilpivirine. |
|
LamiVUDine |
May enhance the adverse/toxic effect of Emtricitabine. |
|
Oxcarbazepine |
May decrease the serum concentration of Rilpivirine. |
|
Oxcarbazepine |
May decrease the serum concentration of Tenofovir Alafenamide. |
|
PHENobarbital |
May decrease the serum concentration of Rilpivirine. |
|
PHENobarbital |
May decrease the serum concentration of Tenofovir Alafenamide. |
|
Phenytoin |
May decrease the serum concentration of Rilpivirine. |
|
Primidone |
May decrease the serum concentration of Rilpivirine. |
|
Primidone |
May decrease the serum concentration of Tenofovir Alafenamide. |
|
Proton Pump Inhibitors |
May decrease the serum concentration of Rilpivirine. |
|
Reverse Transcriptase Inhibitors (Non-Nucleoside) |
May increase the serum concentration of Rilpivirine. This mechanism applies to coadministration of delavirdine. Reverse Transcriptase Inhibitors (Non-Nucleoside) may decrease the serum concentration of Rilpivirine. This mechanism applies to coadministration of efavirenz, etravirine, and nevirapine. |
|
Rifabutin |
May decrease the serum concentration of Tenofovir Alafenamide. |
|
RifAMPin |
May decrease the serum concentration of Tenofovir Alafenamide. |
|
Rifapentine |
May decrease the serum concentration of Tenofovir Alafenamide. |
|
Saquinavir |
May enhance the arrhythmogenic effect of Rilpivirine. Saquinavir may increase the serum concentration of Rilpivirine. |
|
St John's Wort |
May decrease the serum concentration of Tenofovir Alafenamide. |
|
Tipranavir |
May decrease the serum concentration of Tenofovir Alafenamide. |
Rilpivirine, emtricitabine, and tenofovir alafenamide: Drug Interaction
|
Acyclovir-Valacyclovir |
May increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Acyclovir-Valacyclovir. |
|
Aminoglycosides |
May increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Aminoglycosides. |
|
Bosentan |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Cabozantinib |
MRP2 Inhibitors may increase the serum concentration of Cabozantinib. |
|
Cidofovir |
May increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Cidofovir. |
|
Cobicistat |
May enhance the adverse/toxic effect of Tenofovir Products. More specifically, cobicistat may impair proper tenofovir monitoring and dosing. |
|
CYP3A4 Inducers (Moderate) |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
CYP3A4 Inhibitors (Strong) |
May increase the serum concentration of Rilpivirine. |
|
Darunavir |
May increase the serum concentration of Rilpivirine. |
|
Deferasirox |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Erdafitinib |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Ganciclovir-Valganciclovir |
Tenofovir Products may increase the serum concentration of Ganciclovir-Valganciclovir. Ganciclovir-Valganciclovir may increase the serum concentration of Tenofovir Products. |
|
Haloperidol |
QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTcprolonging effect of Haloperidol. |
|
Ivosidenib |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Ketoconazole (Systemic) |
May increase the serum concentration of Rilpivirine. Rilpivirine may decrease the serum concentration of Ketoconazole (Systemic). |
|
Levomethadone |
Reverse Transcriptase Inhibitors (Non-Nucleoside) may decrease the serum concentration of Levomethadone. Management: Levomethadone dosage adjustments will likely be required with efavirenz and nevirapine, and may be necessary with rilpivirine as well. |
|
Lopinavir |
May increase the serum concentration of Rilpivirine. |
|
Methadone |
Reverse Transcriptase Inhibitors (Non-Nucleoside) may increase the metabolism of Methadone. Management: Methadone dosage adjustments will likely be required with efavirenz and nevirapine, and may be necessary with rilpivirine as well. |
|
Orlistat |
May decrease the serum concentration of Antiretroviral Agents. |
|
QT-prolonging Agents (Highest Risk) |
QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. |
|
Sarilumab |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Siltuximab |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Sofosbuvir |
May increase the serum concentration of Tenofovir Alafenamide. |
|
Tocilizumab |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Risk Factor D (Consider therapy modification) |
|
|
Antacids |
May decrease the serum concentration of Rilpivirine. Management: Administer antacids at least 2 hours before or 4 hours after rilpivirine. Administer antacids at least 6 hours before or 4 hours after the rilpivirine/dolutegravir combination product. |
|
CYP3A4 Inducers (Strong) |
|
|
Dabrafenib |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). |
|
Diclofenac (Systemic) |
May enhance the nephrotoxic effect of Tenofovir Products. Management: Seek alternatives to this combination whenever possible. Avoid use of tenofovir with multiple NSAIDs or any NSAID given at a high dose. |
|
Didanosine |
Rilpivirine may decrease the absorption of Didanosine. More specifically, simultaneous coadministration of these drugs creates a conflict between recommendations to administer with (rilpivirine) and without (didanosine) food. Didanosine may decrease the absorption of Rilpivirine. More specifically, simultaneous coadministration of these drugs creates a conflict between recommendations to administer with (rilpivirine) and without (didanosine) food. Management: Administer didanosine on an empty stomach at least 2 hours before or 4 hours after rilpivirine, due to the requirement that rilpivirine be administered with food. |
|
Enzalutamide |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. |
|
Histamine H2 Receptor Antagonists |
May decrease the serum concentration of Rilpivirine. Management: Administer histamine H2 receptor antagonists at least 12 hours before or 4 hours after rilpivirine. |
|
Lorlatinib |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Avoid concurrent use of lorlatinib with any CYP3A4 substrates for which a minimal decrease in serum concentrations of the CYP3A4 substrate could lead to therapeutic failure and serious clinical consequences. |
|
Macrolide Antibiotics |
May increase the serum concentration of Rilpivirine. Management: Consider the use of azithromycin or another non-macrolide alternative when appropriate to avoid this potential interaction. Exceptions: Azithromycin (Systemic); Fidaxomicin; Roxithromycin; Spiramycin. |
|
Mitotane |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. |
|
Nonsteroidal Anti-Inflammatory Agents |
May enhance the nephrotoxic effect of Tenofovir Products. Management: Seek alternatives to these combinations whenever possible. Avoid use of tenofovir with multiple NSAIDs or any NSAID given at a high dose. |
|
Risk Factor X (Avoid combination) |
|
|
Adefovir |
May diminish the therapeutic effect of Tenofovir Products. Adefovir may increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Adefovir. |
|
Antihepaciviral Combination Products |
May increase the serum concentration of Rilpivirine. |
|
CarBAMazepine |
May decrease the serum concentration of Tenofovir Alafenamide. |
|
CarBAMazepine |
May decrease the serum concentration of Rilpivirine. |
|
Cladribine |
Agents that Undergo Intracellular Phosphorylation may diminish the therapeutic effect of Cladribine. |
|
Dexamethasone (Systemic) |
May decrease the serum concentration of Rilpivirine. |
|
Efavirenz |
Reverse Transcriptase Inhibitors (Non-Nucleoside) may increase the serum concentration of Efavirenz. Reverse Transcriptase Inhibitors (Non-Nucleoside) may decrease the serum concentration of Efavirenz. |
|
Ergonovine |
Reverse Transcriptase Inhibitors (Non-Nucleoside) may increase the serum concentration of Ergonovine. Specifically, this would be most likely with delavrdine, while other Non-Nucleoside Reverse Transcriptase Inhibitors may be more likely to decrease the concentration of Ergonovine. |
|
Etravirine |
Reverse Transcriptase Inhibitors (Non-Nucleoside) may decrease the serum concentration of Etravirine. This has been observed with the NNRTIs efavirenz and nevirapine. Reverse Transcriptase Inhibitors (Non-Nucleoside) may increase the serum concentration of Etravirine. This has been observed with delavirdine. |
|
Fosphenytoin |
May decrease the serum concentration of Rilpivirine. |
|
LamiVUDine |
May enhance the adverse/toxic effect of Emtricitabine. |
|
Oxcarbazepine |
May decrease the serum concentration of Rilpivirine. |
|
Oxcarbazepine |
May decrease the serum concentration of Tenofovir Alafenamide. |
|
PHENobarbital |
May decrease the serum concentration of Rilpivirine. |
|
PHENobarbital |
May decrease the serum concentration of Tenofovir Alafenamide. |
|
Phenytoin |
May decrease the serum concentration of Rilpivirine. |
|
Primidone |
May decrease the serum concentration of Rilpivirine. |
|
Primidone |
May decrease the serum concentration of Tenofovir Alafenamide. |
|
Proton Pump Inhibitors |
May decrease the serum concentration of Rilpivirine. |
|
Reverse Transcriptase Inhibitors (Non-Nucleoside) |
May increase the serum concentration of Rilpivirine. This mechanism applies to coadministration of delavirdine. Reverse Transcriptase Inhibitors (Non-Nucleoside) may decrease the serum concentration of Rilpivirine. This mechanism applies to coadministration of efavirenz, etravirine, and nevirapine. |
|
Rifabutin |
May decrease the serum concentration of Tenofovir Alafenamide. |
|
RifAMPin |
May decrease the serum concentration of Tenofovir Alafenamide. |
|
Rifapentine |
May decrease the serum concentration of Tenofovir Alafenamide. |
|
Saquinavir |
May enhance the arrhythmogenic effect of Rilpivirine. Saquinavir may increase the serum concentration of Rilpivirine. |
|
St John's Wort |
May decrease the serum concentration of Tenofovir Alafenamide. |
|
Tipranavir |
May decrease the serum concentration of Tenofovir Alafenamide. |
Monitoring parameters:
- CD4 count
- HIV RNA plasma levels
- Serum creatinine
- Estimated creatinine clearance
- Serum phosphorus (chronic kidney disease patients)
- Urine glucose
- Urine protein (before starting the therapy and during the therapy when clinically indicated)
- Liver function tests
- Bone density (patients with a history of bone fracture or have risk factors for bone loss);
- Fever
- Skin reactions, and/or hypersensitivity reactions
- HBV testing (before starting therapy)
- Patients with HIV and HBV coinfection should be monitored for several months following therapy discontinuation.
How to administer Odefsey (Rilpivirine, emtricitabine, and tenofovir alafenamide)?
Oral: Take with a meal.
Mechanism of action of Odefsey (Rilpivirine, emtricitabine, and tenofovir alafenamide):
- It is a combination of nucleoside, nucleoside, and nucleotide reverse transcriptionase inhibitor
- Non-nucleoside reverse transcriptase inhibitor, Rilpivirine, inhibits HIV-1 reproduction by inducing DNA polymerase RNA-dependent or DNA-dependent.
- For antiviral activity, it does not require intracellular protein phosphorylation
- Emtricitabine can be used as a cytosine analog.
- Tenofovir alafenamide fumarate (TAF), is an analog to adenosine 5-'-monophosphate.
The drug inhibits HIV viral replication by interfering with HIV RNA-dependent DNA polymerase activities. See individual agents (Rilpivirine, Emtricitabine, and Tenofovir alafenamide)
International Brand Names of Rilpivirine, emtricitabine, and tenofovir alafenamide:
- Odefsey
Rilpivirine, emtricitabine, and tenofovir alafenamide Brands Names in Pakistan:
No Brands Available in Pakistan.
 Injection.webp)