SAVELLA- milnacipran hydrochloride tablet, film coated SAVELLA- milnacipran hydrochloride kit

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

milnacipran hydrochloride (UNII: RNZ43O5WW5) (milnacipran - UNII:G56VK1HF36)

Mevcut itibaren:

Allergan, Inc.

INN (International Adı):

milnacipran hydrochloride

Kompozisyon:

milnacipran hydrochloride 12.5 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

SAVELLA is indicated for the management of fibromyalgia.  SAVELLA is not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )] . The use of MAOIs intended to treat psychiatric disorders with SAVELLA or within 5 days of stopping treatment with SAVELLA is contraindicated because of an increased risk of serotonin syndrome. The use of SAVELLA within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.2 )] . Starting SAVELLA in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration ( 2.6 ), Warnings and Precautions ( 5.2 )] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to SAVELLA during pregnancy.  Physicians are advised to recommend that pregnant patients taking SAVELLA enroll in the Savella Pregnancy Registry. Enrollment is voluntary and may be initiated by pregnant patients or their healthcare providers by contacting the registry at 1-877-643-3010 or by email at [e-mail]. Data forms may also be downloaded from the registry website at www.savellapregnancyregistry.com. Risk Summary Based on data from published observational studies, exposure to SNRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions ( 5.2 )] . The available data on SAVELLA use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks associated with exposure to serotonin and norepinephrine reuptake inhibitors (SNRIs) and selective-serotonin reuptake inhibitors (SSRIs), including SAVELLA, during pregnancy (see Clinical Considerations). Animal reproduction studies have been performed in rats, rabbits and mice. Milnacipran was shown to increase embryofetal and perinatal lethality in rats and the incidence of a minor skeletal variation in rabbits at doses below (rat) or approximately equal to (rabbit) the maximum recommended human dose (MRHD) of 200 mg/day on a mg/m2 basis. No effects were seen in mice when treated with milnacipran during the period of organogenesis at doses up to 3 times the MHRD on a mg/m2 basis (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. Clinical Consideration Maternal adverse reactions Use of SAVELLA in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions ( 5.9 )]. Fetal/Neonatal   adverse reactions Neonates exposed to SNRIs or SSRIs, including SAVELLA, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These findings are consistent with either direct toxic effect of SSRIs and SNRIs or possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see   Warnings and Precautions ( 5.2 , 5.7 )]. Data Animal Data Studies were conducted in rats, rabbits and mice with dosing of milnacipran during the period of organogenesis. In rats, milnacipran was shown to increase embryofetal lethality at doses of 5 mg/kg/day (0.25 times the MRHD on a mg/m2 basis). In rabbits, dose-dependent increases in the incidence of the skeletal variation of an extra single rib were observed in several pups from multiple litters in the absence of maternal toxicity at 15 mg/kg/day (1.5 times the MRHD on a mg/m2 basis). The clinical significance of this finding is unknown. In mice, no embryotoxic or teratogenic effects were seen at doses up to 125 mg/kg/day (3 times the MHRD on a mg/m2 basis). With peri- and postnatal exposure to oral milnacipran in rats, decreases in viability and body weight were observed on Postpartum Day 4 at a dose of 5 mg/kg/day (approximately 0.25 times the MRHD on a mg/m2 basis). The no-effect dose for maternal and offspring toxicity was 2.5 mg/kg/day (approximately 0.1 times the MRHD on a mg/m2 basis). Risk Summary Milnacipran is present in human milk [see Data] . There are no reports on the effects of milnacipran on the breastfed child and on milk production/excretion. However, there are reports of agitation, irritability, poor feeding, and poor weight gain in infants exposed to SSRIs or SNRIs through breast milk (see Clinical Considerations). The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SAVELLA and any potential adverse effects on the breastfed child from SAVELLA or from the underlying maternal conditions. Clinical Considerations Monitor infants exposed to milnacipran for agitation, irritability, poor feeding and poor weight gain. Data Human Data Milnacipran is present in the milk of lactating women treated with milnacipran. In a lactation pharmacokinetic study with milnacipran, a single, oral dose of 50 mg milnacipran HCl tablet was administered to 8 lactating women who were at least 12 weeks postpartum and weaning their infants. The milk/plasma AUC ratio of milnacipran was 1.85 ± 0.38. The maximum estimated weight adjusted daily infant dose for milnacipran from breast milk (assuming mean milk consumption of 150 mL/kg/day) was 5% of the maternal dose based on peak plasma concentrations.   Safety and effectiveness of SAVELLA in a fibromyalgia pediatric population below the age of 18 have not been established [see Boxed Warning , Indications and Usage ( 1 ),   and Warnings and Precautions ( 5.1 )] . The use of SAVELLA is not recommended in pediatric patients. In controlled clinical studies of SAVELLA, 402 patients were 60 years or older, and no overall differences in safety and efficacy were observed between these patients and younger patients. In view of the predominant excretion of unchanged milnacipran via kidneys and the expected decrease in renal function with age, renal function should be considered prior to use of SAVELLA in the elderly [see Dosage and Administration ( 2.2 )] . SNRIs, SSRIs, and SAVELLA, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event [see Warnings and Precautions ( 5.8 )] . Milnacipran is not a controlled substance. Milnacipran did not produce behavioral signs indicative of abuse potential in animal or human studies. Milnacipran produces physical dependence, as evidenced by the emergence of withdrawal symptoms following drug discontinuation, similar to other SNRIs and SSRIs. These withdrawal symptoms can be severe. Thus, taper SAVELLA and do not abruptly discontinue after extended use [see Warnings and Precautions ( 5.7 )] .

Ürün özeti:

12.5-mg tablets: Blue, round, film-coated tablets, debossed with “F” on one side and “L” on the reverse side Bottles of 60:                                NDC 0456-1512-60 10X10 Unit Dose:                        NDC 0456-1512-63 25-mg tablets: White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse side Bottles of 60:                                NDC 0456-1525-60 10X10 Unit Dose:                        NDC 0456-1525-63 50-mg tablets: White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse side Bottles of 60:                                NDC 0456-1550-60 10X10 Unit Dose:                        NDC 0456-1550-63 100-mg tablets: Pink, oval-shaped, film-coated tablets, debossed with “FL” on one side and “100” on the reverse side Bottles of 60:                                NDC 0456-1510-60 10X10 Unit Dose:                        NDC 0456-1510-63 Titration Pack: 4-Week Titration Pack:               NDC 0456-1500-55 Blister package containing 55 tablets: 5 x 12.5-mg tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets. Storage Store at 25°C (77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F) [See USP Controlled Room Temperature] .

Yetkilendirme durumu:

New Drug Application

Bilgilendirme broşürü

SAVELLA- MILNACIPRAN HYDROCHLORIDE
Allergan, Inc.
----------
FDA-Approved Medication Guide
MEDICATION GUIDE
SAVELLA® (Sa-vel-la)
(milnacipran HCl)
Tablets
SAVELLA is not used to treat depression, but it acts like medicines
that are used to treat
depression (antidepressants) and other psychiatric disorders.
Read the Medication Guide that comes with SAVELLA® before you start
taking it and
each time you get a refill. There may be new information. This
Medication Guide does
not take the place of talking to your healthcare provider about your
medical condition or
treatment. Talk with your healthcare provider if there is something
you do not understand
or want to learn more about.
What is the most important information I should know about SAVELLA?
SAVELLA and antidepressant medicines may cause serious side effects,
including:
1. Suicidal thoughts or actions:
•
SAVELLA and antidepressant medicines may increase suicidal thoughts or
actions in some children, teenagers, and young adults within the first
few months
of treatment or when the dose is changed.
•
Depression or other serious mental illnesses are the most important
causes of
suicidal thoughts or actions. Watch for these changes and call your
healthcare
provider right away if you notice:
•
New or sudden changes, in mood, behavior, thoughts, or feelings,
especially if severe.
•
Pay particular attention to such changes when SAVELLA is started or
when the dose is changed.
•
Keep all follow-up visits with your healthcare provider and call
between
visits if you are worried about symptoms.
Call your healthcare provider right away or go to the nearest hospital
emergency room if
you have any of the following symptoms, especially if they are new,
worse, or worry
you:
• attempts to commit suicide
• feeling agitated, restless, angry or irritable
• acting on dangerous impulses
• trouble sleeping (insomnia)
• acting aggressive, being angry, or
violent
• an increase in activity or talking more than
what is normal for you
• thoughts about suicide or dyin

Ürün özellikleri

SAVELLA- MILNACIPRAN HYDROCHLORIDE TABLET, FILM COATED
SAVELLA- MILNACIPRAN HYDROCHLORIDE
ALLERGAN, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SAVELLA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SAVELLA.
SAVELLA® (MILNACIPRAN HCL) TABLETS
INITIAL U.S. APPROVAL: 2009
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
INCREASED RISK OF SUICIDAL IDEATION, THINKING, AND BEHAVIOR IN
CHILDREN, ADOLESCENTS,
AND YOUNG ADULTS TAKING ANTIDEPRESSANTS FOR MAJOR DEPRESSIVE DISORDER
(MDD) AND
OTHER PSYCHIATRIC DISORDERS (5.1).
SAVELLA IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS (1, 8.4).
RECENT MAJOR CHANGES
Warnings and Precautions (5.2, 5.9)08/2023
INDICATIONS AND USAGE
SAVELLA is a selective serotonin and norepinephrine reuptake inhibitor
(SNRI) indicated for the
management of fibromyalgia (1).
SAVELLA is not approved for use in pediatric patients (1).
DOSAGE AND ADMINISTRATION
Administer SAVELLA in two divided doses per day (2.1).
Based on efficacy and tolerability, dosing may be titrated according
to the following schedule (2.1):
Day 1: 12.5 mg once
Days 2-3: 25 mg/day (12.5 mg twice daily)
Days 4-7: 50 mg/day (25 mg twice daily)
After Day 7: 100 mg/day (50 mg twice daily)
Recommended dose is 100 mg/day (2.1).
May be increased to 200 mg/day based on individual patient response
(2.1).
Adjust dose in patients with severe renal impairment (2.2).
DOSAGE FORMS AND STRENGTHS
Tablets: 12.5 mg, 25 mg, 50 mg, 100 mg (3)
CONTRAINDICATIONS
Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat
psychiatric disorders with
SAVELLA or within 5 days of stopping treatment with SAVELLA. Do not
use SAVELLA within 14 days of
stopping an MAOI intended to treat psychiatric disorders. In addition,
do not start SAVELLA in a patient
who is being treated with linezolid or intravenous methylene blue
(4.1, 5.2).
WARNINGS AND PRECAUTIONS
Suicidality: Monitor for worsening of depressive symp