25 mg film-coated tabletPRESCRIBING INFORMATION
rilpivirine (as rilpivirine hydrochloride)
Please refer to Summary of Product Characteristics (SmPC) before prescribing.
The EDURANT® SmPCs are available at:
Please click the following product name to access the full SmPC
EDURANT® 25 mg tablets
In combination with other antiretroviral medicinal products for treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients 12 years of age and older with a viral load ≤ 100,000 HIV-1 RNA copies/ml. Genotypic resistance testing should guide use of EDURANT®.
DOSAGE & ADMINISTRATION:
Therapy should be initiated by physician experienced in management of HIV infection.
Adults and adolescents: One 25 mg tablet orally once daily with a meal.
In patients receiving rifabutin, increase dose to 50mg once daily; decrease to 25mg once daily when rifabutin stopped.
Elderly: No dose adjustment required. Limited information available. Use with caution.
Children: No data available < 12 years.
Renal impairment: Caution with severe renal impairment or end-stage renal disease.
Hepatic impairment: Caution with moderate hepatic impairment. Not recommended with severe hepatic impairment.
Hypersensitivity to active substance or any excipients. Do not co-administer with the anticonvulsants (carbamazepine, oxcarbazepine, phenobarbital, phenytoin); antimycobacterials (rifampicin, rifapentine); proton pump inhibitors (e.g. omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole); systemic dexamethasone (except as a single dose treatment) and St. John’s wort.
SPECIAL WARNINGS & PRECAUTIONS:
Advise patients that current antiretroviral therapy does not cure HIV and precautions should be taken to avoid transmission.
Virological failure and development of resistance: Not evaluated in patients with previous virologic failure to any other antiretroviral. As with other antiretroviral medicinal products, resistance testing should guide use of EDURANT®.
Adolescents (12 to <18years): only treat with EDURANT® if good adherence, suboptimal adherence can lead to resistance.
Cardiovascular: Caution when co-administered with medicinal products with known risk of Torsade de Pointes.
Immune reconstitution syndrome (IRS): Inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions or aggravation of symptoms in patients with severe immune deficiency at start of combination antiretroviral therapy (CART). Autoimmune disorders reported to occur in the setting of IRS.
Pregnancy: lower exposure to rilpivirine observed; monitor viral load closely or switch to another ART regimen.
Contains lactose: do not take if galactose intolerant, Lapp lactase deficient or have glucose-galactose malabsorption.
Very common: increased total or LDL cholesterol (fasted), insomnia, headache, dizziness, nausea, increased pancreatic amylase or transaminases.
Common: decreased white blood cell count, decreased haemoglobin, decreased platelet count, decreased appetite, increased triglycerides (fasted), abnormal dreams, depression, sleep disorders, depressed mood, somnolence, abdominal pain, vomiting, increased lipase, abdominal discomfort, dry mouth, increased bilirubin, rash, fatigue.
Other side effects: Immune reactivation syndrome.
Refer to SmPC for other side effects.
Not to be used during pregnancy unless clearly needed. No reproductive toxicity in animals.
Mothers should not breastfeed due to possible HIV transmission and potential adverse reactions.
(Adult data only).
Use with caution when co-administering with other medicinal products that induce CYP3A or increase gastric pH; potential to reduce therapeutic effect of EDURANT®.
Co-administration with CYP3A inhibitors can increase plasma concentrations of EDURANT®. May increase exposure of drugs transported by P-glycoprotein that are more sensitive to intestinal P-gp inhibition e.g. dabigatran etexilate. Consider use of alternatives such as azithromycin in place of clarithromycin and erythromycin.
Co-administration with rifabutin, see 'Dosage and Administration'.
Only use once daily dosed H2-receptor antagonists with strict dosing schedule; take H2-receptor antagonist 12 hours before or 4 hours after EDURANT®. Caution with antacids; only use at least 2 hours before or 4 hours after EDURANT®.
Clinical monitoring recommended with methadone, as may need to adjust maintenance therapy.
Refer to SmPC for full details of interactions.
LEGAL CATEGORY: POM.
PRESENTATIONS, PACK SIZES, MARKETING AUTHORISATION NUMBER(S) & BASIC NHS COSTS
|PACK SIZE(S)||MARKETING AUTHORISATION NUMBER(S)||BASIC NHS COST(S)|
1 bottle containing
MARKETING AUTHORISATION HOLDER: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.
FURTHER INFORMATION AVAILABLE FROM: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK.
Prescribing information last revised: August 2017