OPSUMIT- macitentan tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

MACITENTAN (UNII: Z9K9Y9WMVL) (MACITENTAN - UNII:Z9K9Y9WMVL)

제공처:

Actelion Pharmaceuticals US, Inc.

INN (국제 이름):

macitentan

구성:

macitentan 10 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

OPSUMIT is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to reduce the risks of disease progression and hospitalization for PAH. Effectiveness was established in a long-term study in PAH patients with predominantly WHO Functional Class II–III symptoms treated for an average of 2 years. Patients had idiopathic and heritable PAH (57%), PAH caused by connective tissue disorders (31%), and PAH caused by congenital heart disease with repaired shunts (8%) [see Clinical Studies (14.1)] . OPSUMIT may cause fetal harm when administered to a pregnant woman. OPSUMIT is contraindicated in females who are pregnant. OPSUMIT was consistently shown to have teratogenic effects when administered to animals. If OPSUMIT is used during pregnancy, advise the patient of the potential risk to a fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)] . OPSUMIT is contraindicated in patients with a history of a hypersensitivity reaction to macitentan or any component of the product [see Adverse Reactions (6.2)] . Risk Summary Based on data from animal reproduction studies, OPSUMIT may cause embryo-fetal toxicity, including birth defects and fetal death, when administered to a pregnant female and is contraindicated during pregnancy. There are risks to the mother and the fetus associated with pulmonary arterial hypertension in pregnancy [see Clinical Considerations] . There are limited data on OPSUMIT use in pregnant women. Macitentan was teratogenic in rabbits and rats at all doses tested. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise the patient of the risk to a fetus [see Contraindications (4.1)] . 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 Considerations Disease-associated Maternal and/or Embryo/Fetal Risk In patients with pulmonary arterial hypertension, pregnancy is associated with an increased rate of maternal and fetal morbidity and mortality, including spontaneous abortion, intrauterine growth restriction and premature labor. Data Animal Data In both rabbits and rats, there were cardiovascular and mandibular arch fusion abnormalities. Administration of macitentan to female rats from late pregnancy through lactation caused reduced pup survival and impairment of the male fertility of the offspring at all dose levels tested. Risk Summary There are no data on the presence of macitentan in human milk, the effects on the breastfed infant, or the effect on milk production. Because of the potential for serious adverse reactions in breastfed infants from OPSUMIT advise women not to breastfeed during treatment with OPSUMIT. Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating OPSUMIT, monthly during treatment and one month after stopping treatment with OPSUMIT. The patient should contact her physician immediately for pregnancy testing if onset of menses is delayed or pregnancy is suspected. If the pregnancy test is positive, the physician and patient must discuss the risks to her, the pregnancy, and the fetus [see Warnings and Precautions (5.1), and Dosage and Administration (2.2) and Contraindication (4.1)] . Contraception Female patients of reproductive potential must use acceptable methods of contraception during treatment with OPSUMIT and for 1 month after treatment with OPSUMIT. Patients may choose one highly effective form of contraception (intrauterine devices (IUD), contraceptive implants or tubal sterilization) or a combination of methods (hormone method with a barrier method or two barrier methods). If a partner's vasectomy is the chosen method of contraception, a hormone or barrier method must be used along with this method. Counsel patients on pregnancy planning and prevention, including emergency contraception, or designate counseling by another healthcare provider trained in contraceptive counseling [see Warnings and Precautions (5.1)] . Infertility Based on findings in animals, OPSUMIT may impair fertility in males of reproductive potential. It is not known whether effects on fertility would be reversible [see Warnings and Precautions (5.7), Adverse Reactions (6.1) and Nonclinical Toxicology (13.1)] . The safety and efficacy of OPSUMIT in children have not been established. Of the total number of subjects in the clinical study of OPSUMIT for PAH, 14% were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

제품 요약:

OPSUMIT ® (macitentan) tablets are 10 mg white, film-coated, bi-convex debossed with "10" on both sides and supplied as follows: 15 count /PVC/ PE/PVDC aluminum foil blisters in carton (NDC 66215-501-15) 30 count white high-density polyethylene bottle in carton (NDC 66215-501-30) Store at 20ºC to 25ºC (68ºF to 77ºF). Excursions are permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature] . Keep out of reach of children.

승인 상태:

New Drug Application

환자 정보 전단

Actelion Pharmaceuticals US, Inc.
----------
MEDICATION GUIDE
OPSUMIT ® (OP-SUM-IT)
(MACITENTAN)
TABLETS
This Medication Guide has been approved by the
U.S. Food and Drug Administration.
Revised: 03/2024
Read this Medication Guide for OPSUMIT before you start taking OPSUMIT
and each time you get a refill.
There may be new information. This Medication Guide does not take the
place of talking with your
healthcare provider about your medical condition or your treatment.
What is the most important information I should know about OPSUMIT?
•
Serious birth defects.
OPSUMIT can cause serious birth defects if taken during pregnancy.
•
Females must not be pregnant when they start taking OPSUMIT or become
pregnant during
treatment with OPSUMIT.
•
Females who are able to get pregnant must have a negative pregnancy
test before beginning
treatment with OPSUMIT, each month during treatment with OPSUMIT and 1
month after stopping
OPSUMIT. Talk to your healthcare provider about your menstrual cycle.
Your healthcare provider
will decide when to do the pregnancy test, and will order a pregnancy
test for you depending on your
menstrual cycle.
•
Females who are able to get pregnant are females who:
•
have entered puberty, even if they have not started their menstrual
period, and
•
have a uterus, and
•
have not gone through menopause. Menopause means that you have not had
a
menstrual period for at least 12 months for natural reasons, or that
you have had your
ovaries removed.
•
Females who are not able to get pregnant are females who:
•
have not yet entered puberty, or
•
do not have a uterus, or
•
have gone through menopause. Menopause means that you have not had a
menstrual
period for at least 12 months for natural reasons, or that you have
had your ovaries
removed, or
•
are infertile for other medical reasons and this infertility is
permanent and cannot be
reversed.
Females who are able to get pregnant must use two acceptable forms of
birth control during treatment with
OPSUMIT, and for one month after stopp

제품 특성 요약

OPSUMIT- MACITENTAN TABLET, FILM COATED
ACTELION PHARMACEUTICALS US, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OPSUMIT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OPSUMIT.
OPSUMIT
(MACITENTAN) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2013
WARNING: EMBRYO-FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
DO NOT ADMINISTER OPSUMIT TO A PREGNANT FEMALE BECAUSE IT MAY CAUSE
FETAL HARM (
4.1, 5.1, 8.1).
FEMALES OF REPRODUCTIVE POTENTIAL: EXCLUDE PREGNANCY BEFORE START OF
TREATMENT,
MONTHLY DURING TREATMENT, AND 1 MONTH AFTER STOPPING TREATMENT.
PREVENT
PREGNANCY DURING TREATMENT AND FOR ONE MONTH AFTER TREATMENT BY USING
ACCEPTABLE
METHODS OF CONTRACEPTION ( 2.2, 8.3).
FOR ALL FEMALE PATIENTS, OPSUMIT IS AVAILABLE ONLY THROUGH A
RESTRICTED PROGRAM
CALLED THE MACITENTAN- CONTAINING PRODUCTS RISK EVALUATION AND
MITIGATION STRATEGY
(REMS) ( 5.2).
INDICATIONS AND USAGE
OPSUMIT is an endothelin receptor antagonist (ERA) indicated for the
treatment of pulmonary arterial
hypertension (PAH, WHO Group I) to reduce the risks of disease
progression and hospitalization for PAH (
1.1).
DOSAGE AND ADMINISTRATION
10 mg once daily _._Doses higher than 10 mg once daily have not been
studied in patients with PAH and
are not recommended ( 2.1).
DOSAGE FORMS AND STRENGTHS
Tablet: 10 mg ( 3)
CONTRAINDICATIONS
Pregnancy ( 4.1)
Hypersensitivity ( 4.2)
WARNINGS AND PRECAUTIONS
ERAs cause hepatotoxicity and liver failure. Obtain baseline liver
enzymes and monitor as clinically
indicated ( 5.3).
Fluid retention may require intervention ( 5.4)
Decreases in hemoglobin ( 5.5).
Pulmonary edema in patients with pulmonary veno-occlusive disease. If
confirmed, discontinue
treatment ( 5.6).
Decreases in sperm count have been observed in patients taking ERAs (
5.7).
ADVERSE REACTIONS
Most common adverse reactions (more frequent than placebo by ≥3%)
are anemia,
nasopharyngitis/pharyngitis, bronchitis, headache, influenza, and