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OCALIVA is a brand name for Obeticholic Acid, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: OCALIVA® (obeticholic acid) 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…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment 08/2022 7 WARNINGS AND PRECAUTIONS 08/2022 OCALIVA (Obeticholic Acid) Tablets Page 3 of 34 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
RECENT MAJOR LABEL CHANGES .......................................................................................... 2 TABLE OF CONTENTS ............................................................................................................
3 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................... 5 1 INDICATIONS .............................................................................................................
1 Pediatrics.................................................................................................................. 2 Geriatrics ..................................................................................................................
5 2 CONTRAINDICATIONS................................................................................................ 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 6 4 DOSAGE AND ADMINISTRATION................................................................................
1 Dosing Considerations ............................................................................................. 2 Recommended Dose and Dosage Adjustment ........................................................ 4 Administration .........................................................................................................
5 Missed Dose ............................................................................................................. 8 5 OVERDOSAGE............................................................................................................
8
]. Severe pruritus was defined as intense or widespread itching, interfering with activities of daily living, or causing severe sleep disturbance, or intolerable discomfort, and typically requiring medical interventions. In the subgroup of patients in the OCALIVA titration arm who increased their dosage from 5 mg once daily to 10 mg once daily after 6 months of treatment (n=33), the incidence of severe pruritus was 0% from Months 0 to 6 and 15% from Months 6 to 12.
The median time to onset of severe pruritus was 11, 158, and 75 days for patients in the OCALIVA 10 mg, OCALIVA titration, and placebo arms, respectively. Management strategies include the addition of bile acid binding resins or antihistamines, OCALIVA dosage reduction, and/or temporary interruption of OCALIVA dosing [see 4 DOSAGE AND ADMINISTRATION].
1 Pregnant Women The limited available human data on the use of obeticholic acid during pregnancy are not sufficient to inform a drug-associated risk. In animal reproduction studies, no developmental abnormalities or fetal harm was observed when pregnant rats or rabbits were administered obeticholic acid during the period of organogenesis at exposures approximately 13-times and 6-times human exposures, respectively, at the maximum recommended human dose (MRHD) of 10 mg [see 16 NON-CLINICAL TOXICOLOGY].
2 Breast-feeding There is no information on the presence of obeticholic acid in human milk, the effects on the breast-fed infant or the effects on milk production. The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for OCALIVA and any potential adverse effects on the breast-fed infant from OCALIVA or from the underlying maternal condition.
3 Pediatrics (< 16 years of age) The safety and effectiveness of OCALIVA in pediatric patients have not been established. 4 Geriatrics (≥ 65 years of age) Of the 201 patients in clinical trials of OCALIVA who received the recommended dosage (5 mg or 10 mg once daily), 41 (20%) were 65 years of age and older, while 9 (4%) were 75 years of age and older.
08/2022 OCALIVA (Obeticholic Acid) Tablets Page 3 of 34 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..........................................................................................
2 TABLE OF CONTENTS ............................................................................................................ 3 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................
5 1 INDICATIONS ............................................................................................................. 1 Pediatrics..................................................................................................................
2 Geriatrics .................................................................................................................. 5 2 CONTRAINDICATIONS................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 6 4 DOSAGE AND ADMINISTRATION................................................................................ 1 Dosing Considerations .............................................................................................
2 Recommended Dose and Dosage Adjustment ........................................................ 4 Administration ......................................................................................................... 5 Missed Dose .............................................................................................................
8 5 OVERDOSAGE............................................................................................................ 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 8 7 WARNINGS AND PRECAUTIONS .................................................................................
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No overall differences in safety or effectiveness were observed between these subjects and subjects less than 65 years of age, but greater sensitivity of some older individuals cannot be ruled out. 1 Adverse Reaction Overview A total of 432 patients with PBC were studied in three double-blind placebo-controlled Phase II and III clinical trials.
Of these patients, 290 were treated with OCALIVA for at least 6 months, 232 were treated for at least 12 months, and 70 were treated for at least 2 years. There were 131 patients who received OCALIVA 10 mg once daily and 70 who received OCALIVA 5 mg once daily.
The most common adverse drug reactions reported in double-blind clinical trials (frequency ≥ 5%) were pruritus, fatigue, constipation, oropharyngeal pain and arthralgia. Pruritus decreased with lower initial doses of OCA, and was manageable with temporary interruptions of treatment, alternate dosing strategies, and/or antipruritic treatments, including antihistamines and bile acid sequestrants [see 7 WARNINGS AND PRECAUTIONS].
Fatigue occurred at a similar incidence in the OCA and placebo treatment arms. Clinically significant or serious, hepatic findings (including increased transaminases and bilirubin and signs and symptoms of hepatic decompensation such as jaundice) were observed in subjects with PBC mainly at higher doses of OCA (25 to 50 mg/day), and generally within the first 1 to 3 months of treatment [see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX].
Although Health Canada has not authorized an indication for pediatric use, 7 pediatric patients with biliary atresia and successful hepatoportoenterostomy were treated with OCALIVA in an ongoing open label, dose finding Phase II clinical trial.
Two patients experienced three serious adverse events, which were assessed as unlikely or not related to the treatment. 3 mg OCALIVA once daily for three months, experienced sepsis due to pneumococcus. This patient was later hospitalized for a planned liver transplant due to worsening liver function, 34 days after receiving the last dose of OCALIVA.
3 mg of OCALIVA for four months was hospitalized with suspected pancreatitis. 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. OCALIVA (Obeticholic Acid) Tablets Page 13 of 34 The most common adverse reactions in occurring in ≥ 1% of patients in either OCALIVA treatment arm and at an incidence greater than the placebo treatment arm in the Phase II and Phase III clinical trials are shown in Table 2.
Table 2:
Most Common Treatment-Emergent Adverse Reactions [1] by System Organ Class in Adult Patients with PBC in the Phase II and Phase III Clinical Trials System Organ Class/ Preferred Term, n (%) Total OCA (N=306) Subjects[2] Placebo (N=134) Subjects[2] All TE Adverse Events Skin and subcutaneous tissue disorders Pruritus 209 (68%) 54 (40%) Rash 11 (4%) 4 (3%) Dry skin 7 (2%) 2 (1%) Eczema 6 (2%) 1 (<1%) Erythema 5 (2%) 0 Gastrointestinal disorders Constipation 22 (7%) 7 (5%) Abdominal discomfort 6 (2%) 1 (<1%) Faeces discoloured 4 (1%) 1 (<1%) Infections and infestations Influenza 12 (4%) 4 (3%) Sinusitis 8 (3%) 2 (1%) Bronchitis 7 (2%) 0 Cystitis 5 (2%) 0 Tooth abscess 5 (2%) 0 General disorders and administration site conditions Fatigue 44 (14%) 18 (13%) Oedema peripheral 11 (4%) 2 (1%) Pyrexia 8 (3%) 3 […]
1 Special Populations ................................................................................................ 1 Pregnant Women ............................................................................................. 2 Breast-feeding ..................................................................................................
3 Pediatrics (< 16 years of age) ........................................................................... 4 Geriatrics (≥ 65 years of age) ........................................................................... 12 8 ADVERSE REACTIONS...............................................................................................
1 Adverse Reaction Overview ................................................................................... 2 Clinical Trial Adverse Reactions ............................................................................. 5 Post-Market Adverse Reactions.............................................................................
15 9 DRUG INTERACTIONS .............................................................................................. 2 Drug Interactions Overview ................................................................................... 3 Drug-Behavioural Interactions ...............................................................................
4 Drug-Drug Interactions .......................................................................................... 5 Drug-Food Interactions .......................................................................................... 6 Drug-Herb Interactions ..........................................................................................
7 Drug-Laboratory Test Interactions......................................................................... 17 10 CLINICAL PHARMACOLOGY ...................................................................................... 1 Mechanism of Action .......................................................................................
2 Pharmacodynamics .......................................................................................... 3 Pharmacokinetics ............................................................................................. 18 11 STORAGE, STABILITY AND DISPOSAL ........................................................................
20 PART II: SCIENTIFIC INFORMATION ..................................................................................... 21 13 PHARMACEUTICAL INFORMATION .......................................................................... 21 14 CLINICAL TRIALS ......................................................................................................
1 Trial Design and Study Demographics ............................................................. 2 Study Results .................................................................................................... 22 15 MICROBIOLOGY ......................................................................................................
25 16 NON-CLINICAL TOXICOLOGY .................................................................................... 25 PATIENT MEDICATION INFORMATION ................................................................................ 29 OCALIVA (Obeticholic Acid) Tablets Page 5 of 34 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS OCALIVA® (obeticholic acid) 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 randomized, placebo- controlled, phase III study that assessed alkaline […]