RELYVRIO Powder for oral suspension (2022)

Βιβλιογραφική αναφορά

Συγγραφείς

Amylyx Pharmaceuticals Inc

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1. Indications and Usage

RELYVRIO is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults.

2. Dosage and Administration

2.1 Recommended Dosage The recommended initial dosage of RELYVRIO for oral suspension is 1 packet (3 g sodium phenylbutyrate and 1 g taurursodiol) daily for the first 3 weeks. After 3 weeks, increase to ...

3. Dosage Forms and Strengths

For oral suspension: white to yellow powder provided in single-dose packets each containing 3 g sodium phenylbutyrate and 1 g taurursodiol.

4. Contraindications

None.

5. Warnings and Precautions

5.1 Risk in Patients with Enterohepatic Circulation Disorders, Pancreatic Disorders, or Intestinal Disorders RELYVRIO contains taurursodiol, which is a bile acid. In patients with disorders that interfere ...

6. Adverse Reactions

The following clinically significant adverse reactions are described elsewhere in the labeling: Risk in Patients with Enterohepatic Circulation Disorders, Pancreatic Disorders, or Intestinal Disorders ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

7. Drug Interactions

7.1 Potential for Other Drugs to Affect RELYVRIO Bile Acid Sequestering Agents Bile acid sequestering agents (e.g., cholestyramine, colestipol, colesevelam) may interfere with the absorption of bile acids ...

8.1. Pregnancy

Risk Summary There are no available data on RELYVRIO use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal ...

8.2. Lactation

Risk Summary There are no data on the presence of sodium phenylbutyrate or taurursodiol in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. The developmental ...

8.4. Pediatric Use

Safety and effectiveness of RELYVRIO in pediatric patients have not been established.

8.5. Geriatric Use

Of the 89 patients with ALS who received RELYVRIO in Study 1, 25 patients (28%) were 65 years of age or older, while 4 patients (4.5%) were 75 years of age and older with the oldest patient being 79 years ...

8.6. Renal Impairment

No dose adjustment is needed for patients with mild renal impairment. Avoid use in patients with moderate or severe renal impairment [see Clinical Pharmacology (12.3)].

8.7. Hepatic Impairment

No dose adjustment is needed for patients with mild hepatic impairment. Avoid use in patients with moderate or severe hepatic impairment [see Clinical Pharmacology (12.3)].

11. Description

RELYVRIO contains two active ingredients: sodium phenylbutyrate and taurursodiol. The chemical designation for phenylbutyrate is 4-phenyl butyric acid sodium salt. Its molecular formula is C10 ...

12.1. Mechanism of Action

The mechanism by which RELYVRIO exerts its therapeutic effects in patients with ALS is unknown.

12.2. Pharmacodynamics

Cardiac Electrophysiology At the maximum recommended dose, RELYVRIO does not cause large mean increases (>20 ms) in the QT interval.

12.3. Pharmacokinetics

Absorption Following oral administration of a single dose of RELYVRIO in healthy subjects under fasting conditions, sodium phenylbutyrate reaches a median Tmax of 0.5 hour. Taurursodiol reaches ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Studies to assess the carcinogenic potential of RELYVRIO have not been conducted. Mutagenesis The combination of sodium phenylbutyrate and taurursodiol (3:1 ratio of sodium phenylbutyrate ...

14. Clinical Studies

14.1 Clinical Efficacy The efficacy of RELYVRIO for the treatment of ALS was demonstrated in a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study that evaluated RELYVRIO ...

16.1. How Supplied

RELYVRIO for oral suspension is supplied in single-dose packets of white to yellow powder containing 3 g sodium phenylbutyrate and 1 g taurursodiol as follows: Carton of 7 single-dose packets (NDC 73063-035-04) ...

16.2. Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. See Dosage and Administration (2.2) for storage of ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). Administration Instruct patients or caregivers to empty the contents of one packet in a cup containing 8 ounces of room ...