Loading…
EDURANT is a brand name for Rilpivirine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: EDURANT® (rilpivirine), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment- naïve adult and pediatric patients 12 years of age and older (and weighing ≥35 kg) with HIV-1 RNA less than or equal to 100,000…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Viral load must be determined prior to initiation of therapy. Therapy must not be initiated in patients with a viral load ≥100,000 copies/mL. • Edurant must always be given in combination with other antiretroviral medicinal products.
• Edurant must always be given with a meal. 3 Pharmacokinetics). Geriatric Patients Clinical studies of Edurant did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from adult subjects <65 years of age.
3 Pharmacokinetics, Pediatrics). Pediatric (less than 12 years of age or <35 kg) The safety and efficacy of Edurant in children less than 12 years of age or weighing <35 kg has not been established. 3 Pharmacokinetics, Pediatrics). Pregnancy and Postpartum The recommended dose of Edurant in pregnant patients is one 25 mg tablet once daily taken with a meal.
3 Pharmacokinetics, Pregnancy and Breast-feeding). Hepatic Impairment Edurant has not been studied in patients with severe hepatic impairment (Child-Pugh score C) and the use of Edurant is not recommended in this population. No dose adjustment of Edurant is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.
3 Pharmacokinetics, Hepatic Insufficiency). Renal Impairment Edurant has not been studied in patients with renal impairment. Caution should be exercised when administering Edurant to patients with severe renal impairment or end-stage renal disease whose drug absorption, distribution and metabolism may be altered secondary to renal dysfunction.
0 Page 6 of 44 impairment. 3 Pharmacokinetics, Renal Insufficiency). Dose adjustment with Rifabutin coadministration For patients concomitantly receiving rifabutin, the Edurant dose should be increased to 50 mg (two tablets of 25 mg each) once daily, taken with a meal.
4 Drug-Drug Interactions). 4 Administration • Edurant tablets should be swallowed whole with water. • Edurant must be taken with a meal. 5 Missed Dose If the patient misses a dose of Edurant within 12 hours of the time it is usually taken, the patient should take Edurant with a meal as soon as possible, and then take the next dose of Edurant at the regularly scheduled time.
If a patient misses a dose of Edurant by more than 12 hours, the patient should not take the missed dose, but resume the usual dosing schedule.
). 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. 1 Pregnant Women No well-controlled clinical or pharmacokinetic studies of Edurant use in pregnant women have been conducted.
Studies in animals have shown no evidence of relevant embryonic or fetal toxicity or an effect on reproductive function (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicity). 0 Page 11 of 44 There was no teratogenicity with rilpivirine in rats and rabbits.
The exposures at the embryo- fetal No Observed Adverse Effects Levels (NOAELs) in rats and rabbits were respectively 15 and 70 times higher than the exposure in humans at the recommended therapeutic dose (see 16 NON-CLINICAL TOXICOLOGY; Reproductive and Developmental Toxicity).
Edurant should not be used during pregnancy unless the potential benefits outweigh the potential risks. Antiretroviral Pregnancy Registry To monitor maternal-fetal outcomes of pregnant women exposed to Edurant, an Antiretroviral Pregnancy Registry has been established.
Physicians are encouraged to register patients by calling 1-800-258-4263. Rilpivirine in combination with a background regimen was evaluated in a clinical trial of 19 pregnant women during the second and third trimesters, and postpartum.
The pharmacokinetic data demonstrate that total exposure (AUC) to rilpivirine as a part of an antiretroviral regimen was approximately 30% lower during pregnancy compared with postpartum (6-12 weeks). Virologic response was preserved throughout the trial period.
3 Pharmacokinetics, Hepatic Insufficiency). Renal Impairment Edurant has not been studied in patients with renal impairment. Caution should be exercised when administering Edurant to patients with severe renal impairment or end-stage renal disease whose drug absorption, distribution and metabolism may be altered secondary to renal dysfunction.
0 Page 6 of 44 impairment. 3 Pharmacokinetics, Renal Insufficiency). Dose adjustment with Rifabutin coadministration For patients concomitantly receiving rifabutin, the Edurant dose should be increased to 50 mg (two tablets of 25 mg each) once daily, taken with a meal.
4 Drug-Drug Interactions). 4 Administration • Edurant tablets should be swallowed whole with water. • Edurant must be taken with a meal. 5 Missed Dose If the patient misses a dose of Edurant within 12 hours of the time it is usually taken, the patient should take Edurant with a meal as soon as possible, and then take the next dose of Edurant at the regularly scheduled time.
If a patient misses a dose of Edurant by more than 12 hours, the patient should not take the missed dose, but resume the usual dosing schedule. 5 OVERDOSAGE There is no specific antidote for overdose with Edurant. Human experience of overdose with Edurant is limited.
Treatment of overdose with Edurant 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. Since rilpivirine is highly protein bound to plasma protein, dialysis is unlikely to result in significant removal of the active substance.
For management of a suspected drug overdose, contact your regional poison control centre. s, lactose monohydrate, magnesium stearate, polyethylene glycol 3000, polysorbate 20, povidone K30, silicified microcrystalline cellulose, titanium dioxide and triacetin.
Edurant tablets are supplied as white to off-white, film-coated, round, biconvex, tablets for oral administration containing rilpivirine hydrochloride equivalent to 25 mg of rilpivirine. 0 Page 7 of 44 Each tablet is debossed with “TMC” on one side and “25” on the other side.
• Edurant is contraindicated in patients who are hypersensitive to rilpivirine or to any ingredient in the formulation. For a complete listing of ingredients, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Co-administration of Edurant is contraindicated with drugs which induce CYP3A enzymes or increase gastric pH as this may result in significant decreases in the plasma concentrations of rilpivirine, a loss of virologic response and possible resistance to Edurant and to the NNRTI class of antiretrovirals.
These drugs are listed in Table 1 (see 9 DRUG INTERACTIONS).
Table 1:
Drugs that are contraindicated with Edurant Drug Class Drugs within class that are contraindicated with Edurant Anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin Antimycobacterials rifapentine, rifampin Glucocorticoids systemic dexamethasone (more than a single dose) Herbal products St.
0 Page 5 of 44
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
No mother to child transmission occurred in all 10 infants born to the mothers who completed the trial and for whom the HIV status was available. Rilpivirine was well tolerated during pregnancy and postpartum. There were no new safety findings compared with the known safety profile of rilpivirine in HIV-1 infected adults.
3 Pharmacokinetics, Pregnancy and Breast-feeding). 2 Breast-feeding It is not known whether rilpivirine is secreted in human milk. Because of both the potential for HIV transmission and the potential for adverse reactions in nursing infants, mothers should be instructed not to breast-feed if they are receiving Edurant (see 16 NON-CLINICAL TOXICOLOGY; Reproductive and Developmental Toxicity).
3 Pediatrics Pediatrics (<12 years of age): Safety and effectiveness in pediatric patients less than 12 years of age has not been established. 4 Geriatrics Geriatrics (>65 years of age): Clinical studies of Edurant did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from adult subjects <65 years of age.
Edurant should be used with caution in this population. 1 Adverse Reaction Overview The safety assessment of Edurant at Week 48 and Week 96 is based on pooled data from 686 patients in the Phase III controlled trials TMC278-C209 (ECHO) and TMC278-C215 (THRIVE) in antiretroviral treatment-naïve HIV-1 infected adult patients who received Edurant (25 mg once daily) (see 14 CLINICAL TRIALS).
3 weeks. 7%. 0%) (see Table 2). 0 Page 12 of 44 weeks. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Clinical ADRs of at least moderate intensity or greater (≥Grade 2) reported in adult subjects treated with Edurant are presented in Table 2.
5%) N = total number of subjects per treatment group; BR = background regimen 1. Includes adverse reactions at least possibly, probably, or very likely related to the drug. 2.
Intensities are defined as follows:
Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating with inability to work […]
Edurant tablets are packaged in high-density polyethylene (HDPE) bottles in the following configuration: 25 mg tablets - bottles of 30. 7 WARNINGS AND PRECAUTIONS General Transmission of HIV Patients should be advised that current antiretroviral therapy does not cure HIV.
Appropriate precautions to prevent the transmission of HIV should continue to be employed. Virologic failure and development of resistance In the pooled analysis from the Phase III trials, more Edurant-treated subjects with baseline HIV-1 RNA >100,000 copies/mL experienced virologic failure compared to subjects with HIV-1 RNA ≤100,000 copies/mL at baseline (see 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance, and 15 MICROBIOLOGY, Resistance and Cross-resistance).
Regardless of HIV-1 RNA at the start of therapy, more Edurant-treated subjects with CD4+ cell count less than 200 cells/mm3 at the start of therapy experienced virologic failure compared to subjects with CD4+ cell count greater than or equal to 200 cells/mm3 (see 14 CLINICAL TRIALS).
The observed virologic failure rate in Edurant-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to the control (efavirenz) (see 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance, and 15 MICROBIOLOGY, Resistance and Cross-resistance).
More subjects treated with Edurant developed tenofovir and lamivudine/emtricitabine associated resistance compared to the control (see 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance and 15 MICROBIOLOGY, Resistance, Cross-resistance).
Interactions with medicinal products Caution should be exercised when prescribing Edurant (rilpivirine) with drugs that may reduce the exposure of rilpivirine (see 2 CONTRAINDICATIONS and 9 DRUG INTERACTIONS). As with other antiretroviral medicinal products, resistance testing should guide the use of Edurant (see 15 MICROBIOLOGY).
Carcinogenesis and Mutagenesis Rilpivirine induced benign and malignant tumors in the liver of mice and rats. These tumors are caused by the enzyme induction that rilpivirine caused in these species which may be rodent- specific. In rats rilpivirine caused benign and malignant tumors of the thyroid follicular cells.
These tumors are the result of continuous stimulation of the follicular cells due to the increased clearance of thyroxine caused by rilpivirine in this species. This effect is considered rat specific. 2 Pharmacodynamics). In healthy subjects, rilpivirine has been associated with prolongation of the QT interval of the […]