UPTRAVI- selexipag tablet, coated UPTRAVI TITRATION PACK- selexipag kit UPTRAVI- selexipag injection, powder, for solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

SELEXIPAG (UNII: 5EXC0E384L) (SELEXIPAG - UNII:5EXC0E384L)

제공처:

Actelion Pharmaceuticals US, Inc.

INN (국제 이름):

SELEXIPAG

구성:

SELEXIPAG 200 ug

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

UPTRAVI is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH. Effectiveness of UPTRAVI tablets was established in a long-term study in PAH patients with WHO Functional Class II–III symptoms. Patients had idiopathic and heritable PAH (58%), PAH associated with connective tissue disease (29%), PAH associated with congenital heart disease with repaired shunts (10%) [see Clinical Studies (14.1)] . Hypersensitivity to the active substance or to any of the excipients. Concomitant use of strong inhibitors of CYP2C8 (e.g., gemfibrozil) [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)] . Risk Summary There are no adequate and well-controlled studies with UPTRAVI in pregnant women. Animal reproduction studies performed with selexipag showed no clinically relevant effects on embryofetal developmen

제품 요약:

UPTRAVI ® (selexipag) film-coated, round tablets are supplied in the following configurations: UPTRAVI ® (selexipag) tablets are also supplied in a Titration Pack [NDC 66215-628-20] that includes a 140-count bottle of 200-mcg tablets and a 60-count bottle of 800-mcg tablets. Store at 20°C to 25°C (68°F to 77°F). 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. UPTRAVI ® (selexipag) for injection, for intravenous use, is supplied in a 10 mL Type I glass vial closed by a stopper and sealed with an aluminum flip-off button, containing 1800 mcg of selexipag [NDC 66215-718-01]. UPTRAVI (selexipag) for injection is available in cartons containing 1 single-dose vial. Storage conditions for UPTRAVI for injection: Store the original carton containing glass vial in a refrigerator at 2°C to 8°C (36ºF to 46ºF) until use in order to protect from light.

승인 상태:

New Drug Application

제품 특성 요약

UPTRAVI- SELEXIPAG TABLET, COATED
UPTRAVI TITRATION PACK- SELEXIPAG
UPTRAVI- SELEXIPAG INJECTION, POWDER, FOR SOLUTION
ACTELION PHARMACEUTICALS US, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
UPTRAVI SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR UPTRAVI.
UPTRAVI (SELEXIPAG) TABLETS, FOR ORAL USE
UPTRAVI (SELEXIPAG) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2015
RECENT MAJOR CHANGES
Contraindications ( 4)
10/2021
INDICATIONS AND USAGE
UPTRAVI is a prostacyclin receptor agonist indicated for the treatment
of pulmonary arterial
hypertension (PAH, WHO Group I) to delay disease progression and
reduce the risk of hospitalization for
PAH. ( 1.1)
DOSAGE AND ADMINISTRATION
UPTRAVI tablets starting dose: 200 mcg twice daily. ( 2.1)
Increase the dose by 200 mcg twice daily at weekly intervals to the
highest tolerated dose up to 1600
mcg twice daily. ( 2.1)
Maintenance dose is determined by tolerability. ( 2.1)
Moderate hepatic impairment: Starting dose 200 mcg once daily,
increase the dose by 200 mcg once
daily at weekly intervals to the highest tolerated dose up to 1600
mcg. ( 2.5)
UPTRAVI for injection dose is determined by the patient's current dose
of UPTRAVI tablets. Administer
UPTRAVI for injection by intravenous infusion, twice daily. ( 2.2)
See Full Prescribing Information for instructions on preparation and
administration. ( 2.3).
DOSAGE FORMS AND STRENGTHS
Tablets: 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1000 mcg, 1200 mcg, 1400
mcg, 1600 mcg. ( 3)
For Injection: 1800 mcg of selexipag as a lyophilized powder in a
single-dose vial for reconstitution and
dilution. ( 3)
CONTRAINDICATIONS
Concomitant use with strong CYP2C8 inhibitors. ( 4, 7.1, 12.3)
Hypersensitivity to the active substance or to any of the excipients.
( 4)
WARNINGS AND PRECAUTIONS
Pulmonary edema in patients with pulmonary veno-occlusive disease. If
confirmed, discontinue treatment.
( 5.1)
ADVERSE REACTIONS
Adverse reactions occurring more frequentl