Rilpivirine Tablet: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Rilpivirine Tablet (Edurant) is a prescription antiviral medicine belonging to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class. It is used together with other HIV medicines to treat HIV-1 infection and does not cure HIV or AIDS. It is taken once daily with a meal and is available as film-coated tablets and as tablets for oral suspension for younger patients.

What is Rilpivirine Tablet

Edurant is a prescription antiviral medicine used with other HIV medicines to treat HIV-1 infection. It belongs to a class of drugs called NNRTIs. It does not cure HIV or AIDS.

Rilpivirine Tablet uses

• Treatment of HIV-1 infection in combination with other antiretroviral agents in treatment-naive patients 2 years of age and older and weighing at least 14 kg (depending on formulation) with HIV-1 RNA less than or equal to 100,000 copies/mL
• Used in combination with VOCABRIA (cabotegravir) for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35 kg who are virologically suppressed on a stable regimen

Benefits of Rilpivirine Tablet

• May help reduce the amount of HIV in the blood (viral load)
• May help increase CD4+ (T) cell counts, which can improve immune function and reduce the risk of opportunistic infections
• Supports long-term viral suppression
• Helps protect immune-system function
• Provides convenient once-daily oral dosing
• Helps reduce HIV-related complications when treatment is effective

How Rilpivirine Tablet works

Rilpivirine blocks an enzyme called HIV-1 reverse transcriptase that the virus needs to multiply, through non-competitive inhibition. It does not affect human cellular DNA polymerases.

Rilpivirine Tablet dosage

Take once daily with a meal; a protein drink or yogurt alone does not replace a meal. This medicine must always be used in combination with other antiretroviral drugs. Swallow tablets whole with water; do not alter the dose or stop therapy without consulting your doctor.

For the oral suspension tablets: disperse in drinking water and take immediately with a meal; do not crush, chew, or swallow whole.

If an H2-receptor antagonist (such as famotidine, cimetidine, nizatidine, or ranitidine) is taken, take it at least 12 hours before or at least 4 hours after this medicine. If antacids are taken, take them at least 2 hours before or at least 4 hours after this medicine.

If a dose is missed within 12 hours of the usual time, take it with a meal as soon as possible, then resume the normal schedule; if missed by more than 12 hours, skip the missed dose and resume the normal schedule. Do not take extra doses to make up for a missed dose.

When used with oral cabotegravir, take both medicines once a day at about the same time with a meal.

Available forms and strengths

• 25 mg film-coated tablets
• 2.5 mg tablets for oral suspension (EDURANT PED)

Side effects of Rilpivirine Tablet

Common

• Depression
• Headache
• Trouble sleeping (insomnia)
• Rash
• Abnormal dreams
• Nausea
• Abdominal pain
• Fatigue
• Dizziness
• Decreased appetite

Serious

• Severe skin rash or allergic reaction, including DRESS (fever, blisters, mucosal involvement, conjunctivitis, facial swelling)
• Liver problems (jaundice, dark urine, loss of appetite, nausea, vomiting, pain in right side of stomach area)
• Severe depression, suicidal thoughts, or suicide attempts
• Immune reconstitution syndrome (new signs or symptoms of infection after starting treatment)
• Kidney problems such as nephrotic syndrome

Warnings and precautions

• Severe skin and allergic reactions, including DRESS, have occurred. Stop the medicine and seek medical help right away if a rash occurs with fever, blisters, mouth sores, swelling of the face, or signs of liver problems.
• Liver problems have occurred, including in people with no prior liver disease. People with hepatitis B or C infection are at higher risk and should have liver function monitored.
• Severe depression, including suicidal thoughts and suicide attempts, has been reported. Seek immediate medical help for severe depressive symptoms.
• This medicine must not be taken with certain other drugs because it can cause large decreases in drug levels, leading to loss of effectiveness and possible drug resistance.
• This medicine should not be combined with other drugs in its same class (NNRTIs).
• Caution is advised when combining this medicine with drugs known to have a risk of a serious heart rhythm problem called torsade de pointes.
• Immune reconstitution syndrome can occur, where the immune system responds to hidden infections after starting treatment, sometimes months later.
• It is not known if this medicine will harm an unborn baby. Tell your doctor if you are or plan to become pregnant; lower drug levels were seen during pregnancy, so viral load should be monitored closely.
• Women with HIV should not breastfeed due to risk of passing HIV to the baby and other potential risks.
• No dose adjustment is needed for mild or moderate kidney impairment, but caution and closer monitoring are needed in severe kidney impairment or end-stage kidney disease.
• No dose adjustment is needed for mild or moderate liver impairment; this medicine has not been studied in severe liver impairment.
• Heavy alcohol use may worsen liver-related concerns.
• Avoid driving if dizziness or fatigue occurs.

Storage

• Store at room temperature between 68°F to 77°F (20°C to 25°C), with excursions permitted to 59°-86°F (15°-30°C)
• Keep tablets in the original bottle to protect from light
• Keep oral suspension tablets in the original package to protect from light and moisture
• Keep out of the reach of children

When to see a doctor

• Stop taking this medicine and get medical help right away if you develop a rash along with fever, tiredness, muscle or joint aches, difficulty breathing or swallowing, blisters, mouth sores, swelling of the face, lips, tongue or throat, or redness/swelling of the eyes.
• Call your healthcare provider right away if you notice yellowing of your skin or eyes, light colored stools, dark or tea-colored urine, loss of appetite, pain on the right side of your stomach area, or nausea or vomiting, as these can be signs of liver problems.
• Call your healthcare provider right away if you feel sad, hopeless, anxious, restless, or have thoughts of hurting yourself.
• Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine, as this could be a sign of immune reconstitution syndrome.
• If you take too much of this medicine, call your healthcare provider or go to the nearest hospital emergency room right away.

Alternatives

• Dolutegravir-based regimens
• Bictegravir-based regimens
• Raltegravir-based regimens