EDURANT PACKAGE INSERT PDF

Generic Name: rilpivirine hydrochloride Dosage Form: tablet, film coated. Medically reviewed by Drugs. Last updated on May 1, The recommended dosage of Edurant in patients 12 years of age and older and weighing at least 35 kg is one 25 mg tablet taken orally once daily with a meal [see Use in Specific Populations 8.

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Generic Name: rilpivirine hydrochloride Dosage Form: tablet, film coated. Medically reviewed by Drugs. Last updated on May 1, The recommended dosage of Edurant in patients 12 years of age and older and weighing at least 35 kg is one 25 mg tablet taken orally once daily with a meal [see Use in Specific Populations 8.

For pregnant patients who are already on a stable Edurant regimen prior to pregnancy and who are virologically suppressed HIV-1 RNA less than 50 copies per mL the recommended dosage is one 25 mg tablet once daily taken orally with a meal. Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely [see Use in Specific Populations 8.

If Edurant is coadministered with rifabutin, the Edurant dose should be increased to 50 mg two tablets of 25 mg each once daily, taken with a meal. When rifabutin coadministration is stopped, the Edurant dose should be decreased to 25 mg once daily, taken with a meal [see Drug Interactions 7 and Clinical Pharmacology Each tablet contains Edurant is contraindicated for coadministration with the drugs in Table 1 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 Edurant or to the class of NNRTIs [see Drug Interactions 7 and Clinical Pharmacology Severe skin and hypersensitivity reactions have been reported during the postmarketing experience, including cases of Drug Reaction with Eosinophilia and Systemic Symptoms DRESS , with rilpivirine-containing regimens.

While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries.

No Grade 4 rash was reported. Overall, most rashes were Grade 1 or 2 and occurred in the first four to six weeks of therapy [see Adverse Reactions 6 and 6. Discontinue Edurant immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, including but not limited to, severe rash or rash accompanied by fever, blisters, mucosal involvement, conjunctivitis, facial edema, angioedema, hepatitis or eosinophilia. Clinical status including laboratory parameters should be monitored and appropriate therapy should be initiated.

Hepatic adverse events have been reported in patients receiving a rilpivirine-containing regimen. Patients with underlying hepatitis B or C virus infection, or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations with use of Edurant. A few cases of hepatic toxicity have been reported in adult patients receiving a rilpivirine-containing regimen who had no pre-existing hepatic disease or other identifiable risk factors.

Appropriate laboratory testing prior to initiating therapy and monitoring for hepatotoxicity during therapy with Edurant is recommended in patients with underlying hepatic disease such as hepatitis B or C virus infection, or in patients with marked elevations in transaminases prior to treatment initiation. Liver enzyme monitoring should also be considered for patients without pre-existing hepatic dysfunction or other risk factors. The adverse reaction depressive disorders depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, suicidal ideation has been reported with Edurant.

Patients with severe depressive symptoms should seek immediate medical evaluation to assess the possibility that the symptoms are related to Edurant, and if so, to determine whether the risks of continued therapy outweigh the benefits. Most events were mild or moderate in severity. Suicidal ideation was reported in 4 subjects in each arm while suicide attempt was reported in 2 subjects in the Edurant arm.

The incidence of Grade 3 and 4 depressive disorders regardless of causality was 5. None of the subjects discontinued due to depressive disorders. Suicidal ideation and suicide attempt were reported in 1 subject. The concomitant use of Edurant and other drugs may result in potentially significant drug interactions, some of which may lead to [see Dosage and Administration 2.

In healthy subjects, 75 mg once daily and mg once daily 3 times and 12 times the dose in Edurant have been shown to prolong the QTc interval of the electrocardiogram. Consider alternatives to Edurant when coadministered with a drug that is known to have a risk of torsade de pointes [see Drug Interactions 7 and Clinical Pharmacology See Table 5 for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations.

Consider the potential for drug interactions prior to and during Edurant therapy and review concomitant medications during Edurant therapy. The mechanism and long-term consequences of these events are currently unknown. A causal relationship has not been established.

Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including Edurant. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia or tuberculosis , which may necessitate further evaluation and treatment.

The following adverse reactions are discussed below and in other sections of the labeling:. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The median duration of exposure for patients in the Edurant arm and efavirenz arm was Most ADRs occurred in the first 48 weeks of treatment. Rash led to discontinuation in 1 0. Selected laboratory abnormalities are included in Table 3. Some adverse events have been included because of investigator's assessment of potential causal relationship and were considered serious or have been reported in more than 1 subject treated with Edurant.

Renal and Urinary Disorders : glomerulonephritis membranous, glomerulonephritis mesangioproliferative, nephrolithiasis. The percentage of subjects treated with Edurant or efavirenz in the Phase 3 trials with selected laboratory abnormalities Grades 1 to 4 , representing worst Grade toxicity are shown in Table 3. In the pooled Phase 3 trials, at Week 96, there was an overall mean change from baseline in basal cortisol of Of the subjects who developed an abnormal micrograms ACTH stimulation test during the trial, fourteen subjects in the Edurant group and nine subjects in the efavirenz group had an abnormal micrograms ACTH stimulation test at Week Overall, there were no serious adverse events, deaths, or treatment discontinuations that could clearly be attributed to adrenal insufficiency.

The clinical significance of the higher abnormal rate of micrograms ACTH stimulation tests in the Edurant group is not known. In the pooled Phase 3 trials, an increase in serum creatinine was observed over the 96 weeks of treatment with Edurant.

Most of this increase occurred within the first four weeks of treatment, with a mean change of 0. In subjects who entered the trial with mild or moderate renal impairment, the serum creatinine increase observed was similar to that seen in subjects with normal renal function.

These changes are not considered to be clinically relevant and no subject discontinued treatment due to increases in serum creatinine. Serum creatinine increases occurred regardless of the background N t RTI regimen. The clinical benefit of these findings has not been demonstrated. In subjects co-infected with hepatitis B or C virus receiving Edurant, the incidence of hepatic enzyme elevation was higher than in subjects receiving Edurant who were not co-infected.

This observation was the same in the efavirenz arm. The pharmacokinetic exposure of rilpivirine in co-infected subjects was comparable to that in subjects without co-infection. The median duration of exposure was There were no patients who discontinued treatment due to ADRs. No new ADRs were identified compared to those seen in adults.

ADRs were reported in nineteen pediatric subjects Most ADRs were Grade 1 or 2. The most common ADRs reported in at least 2 subjects regardless of severity include headache In trial TMC C, at Week 48, the overall mean change from baseline in basal cortisol showed an increase of 1. The clinical significance of the abnormal micrograms ACTH stimulation tests is not known. Adverse reactions have been identified during postmarketing experience in patients receiving a rilpivirine containing regimen.

Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Coadministration of Edurant 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 Edurant and drugs that inhibit CYP3A may result in increased plasma concentrations of rilpivirine. Coadministration of Edurant with drugs that increase gastric pH may result in decreased plasma concentrations of rilpivirine and loss of virologic response and possible resistance to rilpivirine or to the class of NNRTIs.

Edurant at a dose of 25 mg once daily is not likely to have a clinically relevant effect on the exposure of drugs metabolized by CYP enzymes. Drugs that are not recommended for coadministration with Edurant are also included in Table 5. In addition to the drugs included in Table 5, the interaction between Edurant and the following drugs was evaluated in clinical studies and no dose adjustment is needed for either drug [see Clinical Pharmacology Rilpivirine did not have a clinically significant effect on the pharmacokinetics of digoxin or metformin.

No clinically relevant drug-drug interaction is expected when Edurant is coadministered with maraviroc, ribavirin or the NRTIs abacavir, emtricitabine, lamivudine, stavudine and zidovudine.

There is limited information available on the potential for a pharmacodynamic interaction between rilpivirine and drugs that prolong the QTc interval of the electrocardiogram. In a study of healthy subjects, 75 mg once daily and mg once daily 3 times and 12 times the dose in Edurant have been shown to prolong the QTc interval of the electrocardiogram [see Clinical Pharmacology Consider alternatives to Edurant when coadministered with a drug with a known risk of torsade de pointes.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Edurant during pregnancy.

Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry APR Available data from the APR show no difference in the overall risk of birth defects for rilpivirine compared with the background rate for major birth defects of 2. The rate of miscarriage is not reported in the APR. The estimated background rate of miscarriage in clinically recognized pregnancies in the U. The background risk for major birth defects and miscarriage for the indicated population is unknown.

In a clinical trial, total rilpivirine exposures were generally lower during pregnancy compared to the postpartum period see Data. In animal reproduction studies, no evidence of adverse developmental outcomes was observed following oral administration of rilpivirine see Data.

During organogenesis, systemic exposures AUC to rilpivirine were up to 15 rats and 70 rabbits times the exposure in humans at the recommended daily dose of rilpivirine. In the rat pre- and post-natal developmental study, maternal systemic exposure AUC was approximately 63 times the exposure at the recommended daily dose of rilpivirine. Dose adjustments during pregnancy and the postpartum period. Based on the experience of HIVinfected pregnant women who completed a clinical trial through the postpartum period with a rilpivirine-based regimen, no dose adjustments are required for pregnant patients who are already on a stable Edurant regimen prior to pregnancy and who are virologically suppressed HIV-1 RNA less than 50 copies per mL.

The recommended dosage is one 25 mg tablet once daily taken orally with a meal. Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely [see Clinical Pharmacology Based on prospective reports to the APR of over exposures to rilpivirine during pregnancy resulting in live births, including over exposed during first trimester , there was no significant difference between the overall risk of birth defects with rilpivirine compared to the background birth defect rate of 2.

The prevalence of birth defects in live births was 1. Rilpivirine in combination with a background regimen was evaluated in a clinical trial of 19 HIV-1 infected pregnant women during the second and third trimesters and postpartum. Each of the women were on a rilpivirine-based regimen at the time of enrollment. Twelve subjects completed the trial through the postpartum period weeks after delivery and pregnancy outcomes are missing for six subjects.

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