ORILISSA Film-coated tablet (2021)
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AbbVie Inc.
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1. Indications and Usage
ORILISSA is indicated for the management of moderate to severe pain associated with endometriosis. <u>Limitation of Use:</u> Limit the duration of use based on the dose and coexisting condition (see Table ...
2. Dosage and Administration
2.1 Important Dosing Information Exclude pregnancy before starting ORILISSA or start ORILISSA within 7 days from the onset of menses. Take ORILISSA at approximately the same time each day, with or without ...
3. Dosage Forms and Strengths
The 150 mg tablets are light pink, oblong, film-coated tablets with EL 150 debossed on one side. Each tablet contains 155.2 mg of elagolix sodium equivalent to 150 mg of elagolix. The 200 mg tablets are ...
4. Contraindications
ORILISSA is contraindicated in women: Who are pregnant <em>[see Use in Specific Populations (8.1)]</em>. Exposure to ORILISSA early in pregnancy may increase the risk of early pregnancy loss. With known ...
5. Warnings and Precautions
5.1 Bone Loss ORILISSA causes a dose-dependent decrease in bone mineral density (BMD). BMD loss is greater with increasing duration of use and may not be completely reversible after stopping treatment ...
6. Adverse Reactions
The following serious adverse reactions are discussed elsewhere in labeling: Bone loss <em>[see Warnings and Precautions (5.1)]</em> Change in menstrual bleeding pattern and reduced ability to recognize ...
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 ...
6.2. Postmarketing Experience
The following adverse reactions have been identified during post-approval use of ORILISSA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...
7. Drug Interactions
7.1 Potential for ORILISSA to Affect Other Drugs Elagolix is: A weak to moderate inducer of cytochrome P450 (CYP) 3A. Co-administration with ORILISSA may decrease plasma concentrations of drugs that are ...
8.1. Pregnancy
Pregnancy Exposure Registry There is a pregnancy registry that monitors outcomes in women who become pregnant while treated with ORILISSA. Pregnant patients should be encouraged to enroll by calling 1-833-782-7241. ...
8.2. Lactation
Risk Summary There is no information on the presence of elagolix or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. There are no adequate animal data ...
8.3. Females and Males of Reproductive Potential
Based on the mechanism of action, there is a risk of early pregnancy loss if ORILISSA is administered to a pregnant woman <em>[see Use in Specific Populations (8.1), Clinical Pharmacology (12.1)]</em> ...
8.4. Pediatric Use
Safety and effectiveness of ORILISSA in pediatric patients have not been established.
8.6. Renal Impairment
No dose adjustment of ORILISSA is required in women with any degree of renal impairment or end-stage renal disease (including women on dialysis) <em>[see Clinical Pharmacology (12.3)]</em>.
8.7. Hepatic Impairment
No dosage adjustment of ORILISSA is required for women with mild hepatic impairment (Child-Pugh A). Only the 150 mg once daily regimen is recommended for women with moderate hepatic impairment (Child-Pugh ...
10. Overdosage
In case of overdose, monitor the patient for any signs or symptoms of adverse reactions and initiate appropriate symptomatic treatment, as needed.
11. Description
ORILISSA (elagolix) tablets for oral administration contain elagolix sodium, the sodium salt of the active moiety elagolix. Elagolix sodium is a nonpeptide small molecule, GnRH receptor antagonist. Elagolix ...
12.1. Mechanism of Action
ORILISSA is a GnRH receptor antagonist that inhibits endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. Administration of ORILISSA results in dose-dependent suppression ...
12.2. Pharmacodynamics
Effect on Ovulation and Estradiol In a 3-menstrual cycle study in healthy women, ORILISSA 150 mg once daily and 200 mg twice daily resulted in an ovulation rate of approximately 50% and 32%, respectively. ...
12.3. Pharmacokinetics
The pharmacokinetic properties of ORILISSA in healthy subjects are summarized in Table 8. The steady state pharmacokinetic parameters under fasting conditions are summarized in Table 9. <b>Table 8. Pharmacokinetic ...
12.5. Pharmacogenomics
Hepatic uptake of elagolix involves the OATP 1B1 transporter protein. Higher plasma concentrations of elagolix have been observed in patients who have two reduced function alleles of the gene that encodes ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Two-year carcinogenicity studies conducted in mice (50, 150, or 500 mg/kg/day) and rats (150, 300, or 800 mg/kg/day) that administered elagolix by the dietary route revealed no increase in tumors in mice ...
14. Clinical Studies
The efficacy of ORILISSA 150 mg once daily and 200 mg twice daily for the management of moderate to severe pain associated with endometriosis was demonstrated in two multinational double-blind, placebo-controlled ...
16.1. How Supplied
ORILISSA tablets are available in two strengths: 150 mg and 200 mg, which are equivalent to 155.2 mg and 207.0 mg of elagolix sodium, respectively. ORILISSA 150 mg tablets are light pink, oblong, film-coated ...
16.2. Storage and Handling
Store at 2°C to 30°C (36°F to 86°F). Dispose unused medication via a take-back option if available. Otherwise, follow FDA instructions for disposing medication in the household trash, www.fda.gov/drugdisposal. ...
17. Patient Counseling Information
Advise patients to read the FDA-approved patient labeling (Medication Guide). Bone Loss Inform patients about the risk of bone loss. Advise patients that supplementary calcium and vitamin D may be beneficial ...