Edurant 25 mg Tablets

Rilpivirine tablets are a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 12 years of age and older and weighing at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL. ( 1.1 ). Limitations of Use: • More rilpivirine treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to rilpivirine treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL. …

• One 25 mg rilpivirine tablet taken once daily with a meal for patients weighing at least 35 kg. • Do not substitute rilpivirine tablets and EDURANT PED tablets for oral suspension on a milligram-per-milligram basis due to differing pharmacokinetic profiles. • See full prescribing information for dosing information when used in combination with cabotegravir. • For pregnant patients who are already on a stable rilpivirine regimen prior to pregnancy and who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) the recommended dosage
• In adults and pediatric patients weighing more than 35 kg is one 25 mg tablet once daily taken orally with a meal. • Rifabutin coadministration: Take two 25 mg tablets of rilpivirine once daily with a meal for the duration of the rifabutin coadministration
• Overview of Dosage Form Rilpivirine tablets are available in : • Rilpivirine 25 mg film-coated tablets for adults and pediatric patients weighing at least 35 kg
• Do not substitute rilpivirine tablets and EDURANT PED tablets for oral suspension on a milligram-per-milligram basis due to differing pharmacokinetic profiles. [see Warnings and Precautions ]
• Take rilpivirine tablets once daily with a meal in combination with other antiretrovirals [see Clinical Pharmacology ]
• Additional pediatric use information is approved for Janssen Products LP's Edurant (Rilpivirine) tablets
• However, due to Janssen Products LP's marketing exclusivity rights, this drug product is not labeled with that information. …

Rilpivirine 25 mg Film-Coated Tablets 25 mg white to off-white, round, biconvex film coated tablets debossed with ‘5L’ on one side and plain on other side. Each tablet contains 27.5 mg of rilpivirine hydrochloride, which is equivalent to 25 mg of rilpivirine. Rilpivirine: 25 mg tablets ( 3 )

• The safety and effectiveness of rilpivirine has been established
• For the treatment of HIV-1 infection in treatment-naïve
• Pediatric patients 12 years of age and older and weighing at least 35 kg
• Use of rilpivirine in this population is supported by two trials: TMC278-C213 and MOCHA
• Trial TMC278-C213 TMC278-C213 was a single arm, open-label, Phase 2 trial in antiretroviral treatment-naïve HIV-1 infected pediatric subjects, and was divided into two Cohorts. …

Clinical studies of rilpivirine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, caution should be exercised in the administration and monitoring of rilpivirine in elderly patients reflecting the greater frequency of decreased renal and hepatic function, and of concomitant disease or other drug therapy.

• Advise the patient to read the FDA-approved patient labeling (Patient Information)
• Severe Skin and Hypersensitivity Reactions Advise patients to immediately contact their healthcare provider if they develop a rash
• Instruct patients to immediately stop taking rilpivirine and seek medical attention if they develop a rash associated with any of the following symptoms as it may be a sign of more serious reactions such as DRESS severe hypersensitivity: fever, blisters, mucosal involvement, eye inflammation (conjunctivitis), severe allergic reaction causing a swelling of the face, eyes, lips, mouth, tongue or throat, which may lead to difficulty swallowing or breathing, and any signs and symptom …

Rilpivirine is contraindicated for coadministration with the drugs in Table 2 for which significant decreases in rilpivirine plasma concentrations may occur due to CYP3A enzyme induction or gastric pH increase, which may result in loss of virologic response and possible resistance to rilpivirine or to the class of NNRTIs [see Drug Interactions (7) and Clinical Pharmacology (12.3) ]. …

Rilpivirine is primarily metabolized by cytochrome P450 (CYP)3A, and drugs that induce or inhibit CYP3A may thus affect the clearance of rilpivirine. Coadministration of rilpivirine and drugs that induce CYP3A may result in decreased plasma concentrations of rilpivirine and loss of virologic response and possible resistance to rilpivirine or to the class of NNRTIs. Coadministration of rilpivirine and drugs that inhibit CYP3A may result in increased plasma concentrations of rilpivirine. …

• Skin and Hypersensitivity Reactions: Severe skin and hypersensitivity reactions have been reported during postmarketing experience, including cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), with rilpivirine-containing regimens. Immediately discontinue treatment if hypersensitivity or rash with systemic symptoms or elevations in hepatic serum biochemistries develop and closely monitor clinical status, including hepatic serum biochemistries. ( 5.1 ) • Hepatotoxicity: Hepatic adverse events have been reported in patients with underlying liver disease, including hepatitis B or C virus co-infection, or in patients with elevated baseline transaminases. …

The following adverse reactions are discussed below and in other sections of the labeling: • Skin and Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] • Hepatotoxicity [see Warnings and Precautions (5.2) ] • Depressive Disorders [see Warnings and Precautions (5.3) ] The most common adverse reactions to rilpivirine (incidence >2%) of at least moderate to severe intensity (≥ Grade 2) were depressive disorders, headache, insomnia and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Laurus Generics Inc. at 1-833-3-LAURUS (1-833-352-8787) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to rilpivirine during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) 1-800-258-4263. …

There is no specific antidote for overdose with rilpivirine. Human experience of overdose with rilpivirine is limited. Treatment of overdose with rilpivirine consists of general supportive measures including monitoring of vital signs and ECG (QT interval) as well as observation of the clinical status of the patient. It is advisable to contact a poison control center to obtain the latest recommendations for the management of an overdose. Since rilpivirine is highly bound to plasma protein, dialysis is unlikely to result in significant removal of the active substance.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.