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IQIRVO is a brand name for Elafibranor, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: IQIRVO® (elafibranor) is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. Marketing authorization with conditions for this indication is based on a…
Verbatim from this product's HC label. Tap a section to expand.
and 7: WARNINGS AND PRECAUTIONS). • Hypersensitive to this drug or to any ingredient in the formulation, including any non - medicinal ingredient, or component of the container. For a complete listing (see
Liver Transplant Elafibranor’s effects are more uncertain in PBC patients with liver transplants, as such patients were excluded from the clinical studies. Injury Fractures occurred in 6% (n=7) of IQIRVO-treated patients compared to no placebo-treated patient [see Adverse Reactions].
Consider the risk of fracture in the care of patients treated with IQIRVO and manage bone health according to the standard of care. Monitoring and Laboratory Tests Increases in blood creatine phosphokinase (CPK) have been reported in patients receiving IQIRVO (4% in the IQIRVO group compared to 0% in the placebo group) (see 8 ADVERSE REACTIONS).
In addition to these reported CPK increases, one case of rhabdomyolysis and likely secondary acute kidney injury occurred in the pivotal phase 3 study in a patient with cirrhosis and ongoing treatment with an HMG-CoA reductase inhibitor.
CPK should be evaluated prior to treatment initiation and thereafter according to routine patient management. Periodic CPK measurements may be considered in patients starting treatment with IQIRVO, especially those on concomitant HMG-CoA reductase inhibitors.
Due to the risk of rhabdomyolysis, IQIRVO only should be administered together with HMG CoA reductase inhibitors when strictly indicated. 4 Drug-drug interactions. Patients on IQIRVO should be advised to report any unexplained muscle symptoms such as pain, soreness, or weakness to their healthcare provider.
If increases in CPK or unexplained signs and symptoms of muscle injury are observed, prompt investigation of the cause is recommended, and treatment interruption should be considered. 5-times the recommended dosage. 2%) had rash or unspecified allergic reaction that occurred 2 to 30 days after IQIRVO initiation with positive dechallenges and rechallenges.
Hypersensitivity reactions resolved after discontinuation of IQIRVO and treatment with steroids and/or antihistamines. If a severe hypersensitivity reaction occurs, permanently discontinue IQIRVO. If a mild or moderate hypersensitivity reaction occurs, interrupt IQIRVO and treat promptly.
) -evaluate for muscle pain/myopathy and consider measuring baseline creatinine phosphokinase (CPK, sometimes called “CK”) (see 7 WARNINGS AND PRECAUTIONS). 2 Recommended Dose and Dosage Adjustment The recommended dosage of IQIRVO is 80 mg once daily.
There are no requirements for dose adjustment for patients with renal impairment or mild or moderate hepatic impairment. Health Canada has not authorized an indication for pediatric use. 4 Administration IQIRVO should be taken orally once daily with or without food (see 10 CLINICAL PHARMACOLOGY).
Administer IQIRVO at least 4 hours before or 4 hours after administering a bile acid sequestrant, or at as great an interval as possible. 4 Drug-drug interactions. 5 Missed Dose If a dose of IQIRVO is missed, instruct patients to skip the missed dose and take the subsequent dose at the next scheduled time point.
The patient should not take a double dose to make up for the missed dose. 5 OVERDOSAGE In the event of suspected overdose, patients should be carefully observed, and appropriate symptomatic treatment and supportive care should be initiated.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1– Dosage Forms, Strengths, Composition and Packaging IQIRVO 80 mg film-coated tablets are orange, round, approximately 8 mm diameter, and identified with “ELA 80” on one side.
IQIRVO 80 mg tablets are packaged in 40 mL high-density polyethylene (HDPE) bottle with a polypropylene child-resistant screw cap with integrated desiccant unit. The bottle is then packed into an outer carton. Each bottle contains 30 film-coated tablets.
7 WARNINGS AND PRECAUTIONS Hepatic/Biliary/Pancreatic Increases in liver biochemical tests including transaminases and bilirubin increase have been reported in 6% of patients receiving IQIRVO compared to 6% of patients receiving placebo.
Elafibranor tablets are contraindicated in patients who are • Pregnant, or at risk of pregnancy and not using effective contraception (see sections
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Monitor the patient until signs and symptoms resolve. If a hypersensitivity r eaction recurs after IQIRVO rechallenge, then permanently discontinue IQIRVO. 1 Pregnant Women) • Fertility No human data on the effect of elafibranor on fertility are available.
In animal studies of male and female rats administered elafibranor orally at clinically relevant doses prior to mating, throughout mating, and during gestation, lower fertility index, lower live fetuses and higher post- IQIRVO (elafibranor) tablets Page 8 of 27 implantation loss was observed (see Section 16 Reproductive and Developmental Toxicology).
1 Pregnant Women) For females of reproductive potential, verify that the patient is not pregnant prior to initiating IQIRVO. Advise females of reproductive potential to use effective contraception (non -hormonal) or add a barrier method of contraception when using hormonal contraceptives during treatment with IQIRVO and for 3 weeks after the last dose.
IQIRVO should be discontinued upon diagnosis of pregnancy. Further pregnancy care should be discussed with the patient’s healthcare provider. Paternal Exposure Data on the effect of paternal exposure on pregnancy is very limited. 1 Pregnant Women Based primarily on findings in pregnant animals, elafibranor may cause fetal harm when administered to a pregnant woman.
Studies in pregnant animals with elafibranor indicate adverse effects (fetal loss, malformations, stillbirths and/or perinatal deaths) at clinically relevant exposure. In 3 documented human pregnancies, 1 resulted in the birth of a healthy baby at term and 2, in women with associated risk factors, resulted in early spontaneous abortions.
Available human data are very limited. IQIRVO is contraindicated during pregnancy and in females of reproductive potential not using effective contraception because of potential harm to the fetus (see 7 WARNINGS AND PRECAUTIONS). 2 Breast-feeding Risk Summary There are no data available on the presence of elafibranor or its metabolites in human milk, or on effects of the drug on the breastfed infant or the effects on milk production.
1 Pregnant Women). It is unclear whether excretion of elafibranor or its metabolites in milk contributed to the adverse effects on offspring. IQIRVO is not recommended during breastfeeding and for at least 3 weeks following last dose of IQIRVO because the risk to breastfed child cannot be excluded.
3 Pediatrics No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 3 Pharmacokinetics). IQIRVO (elafibranor) tablets Page 9 of 27 Of the 108 patients treated with IQIRVO in the phase 3 study, the age of patients ranged from 36 to 76 years, with a mean age of 57 years; 22% were 65 and older.
There were no notable differences in safety and effectiveness of IQIRVO between these age groups. Because of limited clinical experience with IQIRVO in patients older than 75 years old, closer monitoring of adverse events in patients older than 75 years is recommended.
1 Adverse Reaction Overview The most commonly reported (>10%) adverse drug reactions associated with elafibranor in more than 10% of participants (n=108) were abdominal pain (11%), diarrhea (11%), nausea (11%) and vomiting (11%). These were non-serious and mild to moderate in severity.
The most common adverse drug […]
Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablet 80mg Elafibranor Anhydrous colloidal silica, Croscarmellose sodium, Iron oxide red, Iron oxide yellow, Macrogol, Magnesium stearate, Microcrystalline cellulose, Polyvinyl alcohol- part hydrolyzed, Povidone, Talc, Titanium dioxide.
IQIRVO (elafibranor) tablets Page 7 of 27 Clinical and laboratory assessment of liver function should be done prior to treatment initiation with IQIRVO and thereafter according to routine patient management. If increases in liver biochemical tests and/or liver dysfunction are observed prompt investigation of the cause is recommended and interruption of IQIRVO should be considered .
Biliary Obstruction Avoid IQIRVO use in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt IQIRVO and treat as clinically indicated [see