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LYVDELZI is a brand name for Seladelpar, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: LYVDELZI (seladelpar) is indicated for the treatment of primary biliary cholangitis (PBC), in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in adults unable to tolerate UDCA. Marketing authorization with conditions for this indication is based…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Obtain baseline liver clinical and laboratory assessments at treatment initiation with LYVDELZI. See 7 WARNINGS AND PRECAUTIONS. 2 Recommended Dose and Dosage Adjustment The recommended dosage of LYVDELZI is 10 mg taken orally once daily with or without food.
Pediatrics (<18 years of age) The safety and efficacy of LYVDELZI in patients younger than 18 years of age have not been established. Health Canada has not authorized an indication for pediatric use. Geriatrics (>65 years of age) No dose adjustment of LYVDELZI is required for elderly patients.
Product Monograph Page 5 of 27 LYVDELZI seladelpar capsules Renal Impairment No dose adjustment of LYVDELZI is required in patients with mild, moderate, or severe renal impairment (estimated glomerular filtration rate [eGFR] ≥ 15 mL/min).
LYVDELZI has not been studied in patients with end stage renal disease (ESRD) on dialysis. Hepatic Impairment No dose adjustment of LYVDELZI is required in patients with mild hepatic impairment (Child-Pugh A). The safety and efficacy of LYVDELZI in patients with decompensated cirrhosis have not been established.
Monitor patients with cirrhosis for evidence of decompensation. Consider discontinuing LYVDELZI if the patient progresses to moderate or severe hepatic impairment (Child-Pugh B or C). Use of LYVDELZI is not recommended in patients who have or develop decompensated cirrhosis.
4 Administration The recommended dose of LYVDELZI is one capsule (10 mg) taken orally once daily with or without food. Administer LYVDELZI at least 4 hours before or 4 hours after taking a bile acid sequestrant, or at as great an interval as possible.
4 Drug-Drug Interactions. 5 Missed Dose If a dose of LYVDELZI is missed, the missed dose should be taken at the next scheduled time point. A double dose should not be taken to make up for the missed dose.
1 Adverse Reaction Overview Assessment of adverse reactions is based on data from the pivotal study (CB8025-32048 [RESPONSE]) in which 128 patients with PBC received 10 mg LYVDELZI once daily. 3%). No severe adverse events occurred in >1% of patients treated with LYVDELZI in RESPONSE.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse event 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 event information from clinical trials may be useful in identifying and approximating rates of adverse drug events in real-world use. In the Phase 3 study (CB8025-32048 [RESPONSE]), 193 patients were randomized (2:1) to receive either LYVDELZI 10 mg (n=128) or placebo (n=65) once daily for 52 weeks.
3 weeks in the LYVDELZI and placebo groups respectively. LYVDELZI or placebo was administered in combination with UDCA in 94% of patients and as monotherapy in 6% of patients who were unable to tolerate UDCA. 2% in the placebo arm. A total of 118 patients completed 1 year of treatment with LYVDELZI 10 mg.
The most common adverse reactions occurring in ≥ 5% of patients and with greater frequency than Product Monograph Page 9 of 27 LYVDELZI seladelpar capsules placebo in the LYVDELZI treatment arm are shown in Table 2. 3 Less Common Clinical Trial Adverse Reactions (<5%) Adverse reactions occurring at a frequency of <5% of patients are presented below.
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Serum Creatinine Dose dependent increases in serum creatinine have been observed in LYVDELZI-treated patients. 2% in patients taking placebo.
Reductions in eGFR of at least 25% associated with increases in serum creatinine were observed in 10% (n=12) of LYVDELZI-treated patients, compared to 2% (n=1) of placebo-treated patients. Increases in serum creatinine and declines in eGFR were not progressive and returned towards baseline with ongoing LYVDELZI treatment.
2 Recommended Dose and Dosage Adjustment The recommended dosage of LYVDELZI is 10 mg taken orally once daily with or without food. Pediatrics (<18 years of age) The safety and efficacy of LYVDELZI in patients younger than 18 years of age have not been established.
Health Canada has not authorized an indication for pediatric use. Geriatrics (>65 years of age) No dose adjustment of LYVDELZI is required for elderly patients. Product Monograph Page 5 of 27 LYVDELZI seladelpar capsules Renal Impairment No dose adjustment of LYVDELZI is required in patients with mild, moderate, or severe renal impairment (estimated glomerular filtration rate [eGFR] ≥ 15 mL/min).
LYVDELZI has not been studied in patients with end stage renal disease (ESRD) on dialysis. Hepatic Impairment No dose adjustment of LYVDELZI is required in patients with mild hepatic impairment (Child-Pugh A). The safety and efficacy of LYVDELZI in patients with decompensated cirrhosis have not been established.
Monitor patients with cirrhosis for evidence of decompensation. Consider discontinuing LYVDELZI if the patient progresses to moderate or severe hepatic impairment (Child-Pugh B or C). Use of LYVDELZI is not recommended in patients who have or develop decompensated cirrhosis.
4 Administration The recommended dose of LYVDELZI is one capsule (10 mg) taken orally once daily with or without food. Administer LYVDELZI at least 4 hours before or 4 hours after taking a bile acid sequestrant, or at as great an interval as possible.
4 Drug-Drug Interactions. 5 Missed Dose If a dose of LYVDELZI is missed, the missed dose should be taken at the next scheduled time point. A double dose should not be taken to make up for the missed dose. 5 OVERDOSAGE PBC patients who received 5-times the recommended dosage or 20-times the recommended dosage of LYVDELZI experienced an increase in liver transaminases, muscle pain, and/or elevations in creatine phosphokinase, which resolved upon LYVDELZI discontinuation [see 7 WARNINGS AND PRECAUTIONS].
LYVDELZI is contraindicated in patients who are hypersensitive to seladelpar or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
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None of the patients experienced an eGFR decline of 50% or more. None of the patients required discontinuation of LYVDELZI and there were no clinical findings associated with the observed changes in serum creatinine or eGFR.
There is no specific treatment for overdose with LYVDELZI. General supportive care of the patient is indicated, as appropriate. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage. Because seladelpar is highly bound to plasma proteins, hemodialysis should not be considered.
For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764- 7669). Product Monograph Page 6 of 27 LYVDELZI seladelpar capsules 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging LYVDELZI capsules are opaque, hard gelatin capsules, size 1, with a light gray opaque body and a dark blue opaque cap, printed with “CBAY”in white ink on the cap and “10” in black ink on the body, containing white to off-white solid.
LYVDELZI 10 mg capsules are packaged in a high-density polyethylene (HDPE) bottle closed with a polypropylene child-resistant cap lined with an induction seal. Each bottle contains 30 capsules. 7 WARNINGS AND PRECAUTIONS Driving and Operating Machinery No studies on the effects of LYVDELZI on the ability to drive and use machines have been performed.
Endocrine and Metabolism Co-administration with other medicinal products Co-administration of probenecid with LYVDELZI is not recommended. 4 Drug-Drug Interactions. Hepatic/Biliary Liver Test Abnormalities LYVDELZI has been associated with dose-related increases in serum transaminase (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) levels greater than 3-times upper limit of normal (ULN) in PBC patients receiving 50 mg once daily (5-times higher than the recommended dosage) and 200 mg (20-times higher than the recommended dosage) once daily.
Transaminase levels returned to pretreatment levels upon LYVDELZI discontinuation. LYVDELZI 10 mg once daily did not show a similar pattern for increases in transaminase levels [see 5 OVERDOSAGE]. 1 mg seladelpar lysine dihydrate) Capsule Core: Butylated Hydroxytoluene, Colloidal Silicon Dioxide, Croscarmellose Sodium, Magnesium Stearate, Mannitol, Microcrystalline Cellulose.
Capsule Shell:
Black Iron Oxide, Gelatin, FD&C Blue #2, Red Iron Oxide, Titanium Dioxide, Yellow Iron Oxide.
Black Ink:
Black Iron Oxide, Potassium Hydroxide, Propylene Glycol, Shellac.
White Ink:
Povidone, Propylene Glycol, Shellac, Sodium Hydroxide, Titanium Dioxide. Product Monograph Page 7 of 27 LYVDELZI seladelpar capsules thereafter according to routine patient management. , jaundice, right upper quadrant pain, eosinophilia).
Consider permanent discontinuation if liver tests worsen after restarting LYVDELZI. Biliary Obstruction Avoid use of LYVDELZI in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt LYVDELZI and treat as clinically indicated.
Liver Transplant LYVDELZI’s effects are uncertain in PBC patients post liver transplant as such patients were excluded from the clinical studies. 9% (n=5) of LYVDELZI-treated patients compared to no placebo-treated patients in the RESPONSE trial.
Consider the risk of fracture in the care of patients treated with LYVDELZI and manage bone health according to the standard of care. 3 Less Common Clinical Trial Adverse Reactions (<5%).
Reproductive Health:
Female and Male Potential Fertility There are no data on the effects of […]