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Safety & tolerability

Safety and tolerability established in the ELATIVE® trial1

Common adverse reactions occurring in the ELATIVE trial1,a

Adverse reactionb

UDCA alone 
(n=53) 
%

IQIRVO + UDCA 
(n=108) 
%

Weight gainc

21% (11)

23% (25)

Diarrhea

9% (5)

11% (12)

Abdominal painc

6% (3)

11% (12)

Nausea

6% (3)

11% (12)

Vomiting

2% (1)

11% (12)

Arthralgia

4% (2)

8% (9)

Constipation

2% (1)

8% (9)

Muscle painc

2% (1)

7% (8)

Fracturec

0

6% (7)

Gastroesophageal reflux disease

2% (1)

6% (7)

Dry mouth

2% (1)

5% (5)

Weight loss

0

5% (5)

Rashc

4% (2)

5% (5)

No new safety signals in OLE2

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97% of patients who completed ELATIVE rolled over into the open-label extension2,3

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No new safety signals were identified in the 3-year OLE trial2

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Most common treatment-emergent adverse events in the OLE trial were abdominal pain, diarrhea, nausea, and vomiting2

Adverse events leading to study discontinuation in the ELATIVE trial were similar between the IQIRVO (10%) and UDCA-alone (9%) groups3

    Bone markers in the ELATIVE trial2

    In a post hoc analysis, bone mineral density, biomarkers of bone turnover, and frequency of bone fractures were assessed in patients receiving IQIRVO and UDCA alone.

    Baseline characteristics assessments revealed that greater proportions of patients on IQIRVO had a medical history of osteopenia and osteoporosis compared to those on UDCA alone.

    LS mean changes from baseline in BMD T-scores 
    by region at week 52

    Chart showing LS mean change from baseline to week 52 in bone mineral density T-scores in the femoral neck Chart showing LS mean change from baseline to week 52 in bone mineral density T-scores in the femoral neck
    Chart showing LS mean change from baseline to week 52 in bone mineral density T-scores in the lumbar bone Chart showing LS mean change from baseline to week 52 in bone mineral density T-scores in the lumbar bone
    Chart showing LS mean change from baseline to week 52 in bone mineral density T-scores in the total hip Chart showing LS mean change from baseline to week 52 in bone mineral density T-scores in the total hip

    LS mean changes from baseline in CTX and P1NP at week 52

    Chart showing CTX LS mean change from baseline to week 52 Chart showing CTX LS mean change from baseline to week 52
    Chart showing P1NP LS mean change from baseline to week 52 Chart showing P1NP LS mean change from baseline to week 52

    Seven patients receiving IQIRVO had bone fractures, of whom 6 patients had an associated accidental fall resulting in fractures consistent with those typically experienced by patients with PBC; all patients had a confounding medical history. No patients receiving UDCA alone had bone fractures.

      IQIRVO has no impact on renal function1

      In an analysis of renal health in patients in the ELATIVE trial, eGFR was calculated over 52 weeks as a measure of renal function.2

      Median eGFR was similar between patients receiving IQIRVO and UDCA alone and remained stable through week 52.2

      IQIRVO has no impact on renal function and does not require dose adjustment for renal impairment.1

      No new safety signals in OLE2

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      97% of patients who completed ELATIVE rolled over into the open-label extension2,3

      Blue IQIRVO checkmark icon

      No new safety signals were identified in the 3-year OLE trial2

      Blue IQIRVO checkmark icon

      Most common treatment-emergent adverse events in the OLE trial were abdominal pain, diarrhea, nausea, and vomiting2

      Adverse events leading to study discontinuation in the ELATIVE trial were similar between the IQIRVO (10%) and UDCA-alone (9%) groups3

      Set expectations for your patients about possible side effects and that
      there may be an adjustment period when starting IQIRVO1,2

      GI symptoms with IQIRVO are typically mild to moderate and resolve within the first 15 days1,2

      Learn about the support that IPSEN CARES® can provide

      aIncluded 8 patients (5%) who were intolerant to UDCA and initiated treatment as monotherapy: 6 patients (5%) in the IQIRVO arm and 2 patients (4%) in the placebo arm.1

      bOccurring in greater than or equal to 5% of patients in the IQIRVO treatment arm and at an incidence greater than or equal to 1% higher than in the placebo treatment arm.1

      cWeight gain, abdominal pain, muscle pain, fracture, and rash include other related terms.1

      BMD=bone mineral density; CfB=change from baseline; CI=confidence interval; CTX=carboxy terminal crosslinked telopeptides of type 1 collagen; eGFR=estimated glomerular filtration rate; GI=gastrointestinal; LS=least squares; OLE=open-label extension; P1NP=type 1 procollagen peptide; UDCA=ursodeoxycholic acid.

      References: 1. IQIRVO [package insert]. Ipsen Biopharmaceuticals, Inc. Cambridge, MA. 2. Data on file. Ipsen Biopharmaceuticals, Inc. 3. Kowdley KV, Bowlus CL, Levy C, et al; ELATIVE Study Investigators’ Group. Efficacy and safety of elafibranor in primary biliary cholangitis. N Engl J Med. 2024;390(9):795-805, suppl.

      Indication and Important Safety Information

      Indication

      IQIRVO® 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.

      This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

      Limitations of Use

      Use of IQIRVO is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).

      Important Safety Information

      Myalgia, Myopathy, and Rhabdomyolysis: Rhabdomyolysis resulting in acute kidney injury occurred in one IQIRVO-treated patient who had cirrhosis at baseline and was also taking a stable dose of an HMG-CoA reductase inhibitor (statin). Myalgia or myopathy, with or without CPK elevations, occurred in patients treated with IQIRVO alone or treated concomitantly with a stable dose of an HMG-CoA reductase inhibitor. Assess for myalgia and myopathy prior to IQIRVO initiation. Consider periodic assessment (clinical exam, CPK measurement) during treatment with IQIRVO, especially in those who have signs and symptoms of new onset or worsening of muscle pain or myopathy. Interrupt IQIRVO treatment if there is new onset or worsening of muscle pain, or myopathy, or rhabdomyolysis.

      Fractures: Fractures occurred in 6% of IQIRVO-treated patients compared to no placebo-treated patients. Consider the risk of fracture in the care of patients treated with IQIRVO and monitor bone health according to current standards of care.

      Adverse Effects on Fetal and Newborn Development: IQIRVO may cause fetal harm when administered during pregnancy. For females of reproductive potential, verify that the patient is not pregnant prior to initiation of therapy. Advise females of reproductive potential to use effective non-hormonal contraceptives or add a barrier method when using systemic hormonal contraceptives during treatment with IQIRVO and for 3 weeks following the last dose of IQIRVO.

      Drug-Induced Liver Injury: Drug-induced liver injury occurred in one patient who took IQIRVO 80 mg once daily and two patients who took IQIRVO at 1.5-times the recommended dosage, of which one presented with autoimmune-like hepatitis. The median time to onset of elevation in liver tests was 85 days. Obtain baseline clinical and laboratory assessments at treatment initiation with IQIRVO and monitor thereafter according to routine patient management. Interrupt IQIRVO treatment if liver tests (ALT, AST, total bilirubin [TB], and/or alkaline phosphatase [ALP]) worsen, or the patient develops signs and symptoms consistent with clinical hepatitis (e.g., jaundice, right upper quadrant pain, eosinophilia). Consider permanent discontinuation if liver tests worsen after restarting IQIRVO.

      Hypersensitivity Reactions: Hypersensitivity reactions have occurred in a clinical trial with IQIRVO at 1.5-times the recommended dosage. Three patients (0.2%) had rash or unspecified allergic reaction that occurred 2 to 30 days after IQIRVO initiation. 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. Monitor the patient until signs and symptoms resolve. If a hypersensitivity reaction recurs after IQIRVO rechallenge, then permanently discontinue IQIRVO.

      Biliary Obstruction: Avoid use of IQIRVO in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt IQIRVO and treat as clinically indicated.

      Drug-Drug Interactions

      IQIRVO may reduce the systemic exposure of progestin and ethinyl estradiol (CYP3A4 substrates), which may lead to contraceptive failure and/or an increase in breakthrough bleeding. Switch to effective non-hormonal contraceptives or add a barrier method when using hormonal contraceptives during treatment with IQIRVO and for at least 3 weeks after last dose.

      CPK elevation and/or myalgia occurred in patients on IQIRVO monotherapy. Co-administration of IQIRVO and HMG-CoA reductase inhibitors can increase the risk of myopathy. Monitor for signs and symptoms of muscle injury. Consider periodic assessment (clinical exam, CPK) during treatment. Interrupt IQIRVO treatment if there is new onset or worsening of muscle pain or myopathy.

      Co-administration of IQIRVO with rifampin, an inducer of metabolizing enzymes, may reduce the systemic exposure of elafibranor resulting in delayed or suboptimal biochemical response. Monitor the biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin during treatment with IQIRVO.

      Bile acid sequestrants may interfere with IQIRVO absorption and systemic exposure, which may reduce efficacy. Administer IQIRVO at least 4 hours before or after a bile acid sequestrant, or at as great an interval as possible.

      Use in Special Populations

      Pregnancy: Based on data from animal reproduction studies, IQIRVO may cause fetal harm when administered during pregnancy. There are insufficient data from human pregnancies exposed to IQIRVO to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Report pregnancies to Ipsen Biopharmaceuticals, Inc. adverse event reporting line at 1-855-463-5127 or https://www.ipsen.com/contact-us/.

      Lactation: There are no data available on the presence of IQIRVO or its metabolites in human milk, or on effects of the drug on the breastfed infant or the effects on milk production. 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.

      Females and Males of Reproductive Potential: IQIRVO may cause fetal harm when administered to pregnant women. Verify the pregnancy status of females of reproductive potential prior to initiating IQIRVO. Advise females of reproductive potential to use effective contraception during treatment with IQIRVO and for 3 weeks after the final dose.

      The most common adverse events occurring in ≥10% of patients were weight gain (23%), abdominal pain (11%), nausea (11%), vomiting (11%), and diarrhea (11%).

      You are encouraged to report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127.

      Please see full Prescribing Information for IQIRVO.