FABHALTA- iptacopan capsule

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

IPTACOPAN HYDROCHLORIDE (UNII: XW5CK7C6YH) (IPTACOPAN - UNII:8E05T07Z6W)

Dostupné s:

Novartis Pharmaceuticals Corporation

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

FABHALTA is indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). FABHALTA is contraindicated: - in patients with serious hypersensitivity to iptacopan or any of the excipients. - for initiation in patients with unresolved serious infection caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type B. Risk Summary Available data from clinical trials with FABHALTA use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with untreated PNH in pregnancy (see Clinical Considerations) . The use of FABHALTA in pregnant women or women planning to become pregnant may be considered following an assessment of the risks and benefits. In animal reproduction studies, oral administration of iptacopan to pregnant rats and rabbits during organogenesis at exposures 4 to 6-times the human exposure (based on AUC) at the maximum recommended human dose (MRHD) of 200 mg twice daily did not induce embryo or fetal toxicity (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 major birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk PNH in pregnancy is associated with adverse maternal outcomes, including worsening cytopenias, thrombosis, infections, bleeding, miscarriages, increased maternal mortality, and adverse fetal outcomes, including fetal death and premature delivery. Data Animal Data In an embryo-fetal development study in rats, oral administration of iptacopan during organogenesis did not cause embryo-fetal toxicity when given up to the highest dose of 1,000 mg/kg/day, which corresponds to 4-times the MRHD based on AUC. In an embryo-fetal development study in rabbits, oral administration of iptacopan during organogenesis did not cause embryo-fetal toxicity when given up to the highest dose of 450 mg/kg/day, which corresponds to 6-times the MRHD based on AUC. In a pre- and postnatal development study in rats, oral administration of iptacopan during gestation, parturition, and lactation did not cause adverse effects in offspring when given up to the highest dose of 1,000 mg/kg/day, which corresponds to 4-times the MRHD based on AUC. Risk Summary There are no data on the presence of iptacopan or its metabolite in either human or animal milk, the effects on the breastfed child or on milk production. Since many medicinal products are secreted into human milk, and because of the potential for serious adverse reactions in a breastfed child, breastfeeding should be discontinued during treatment and for 5 days after the final dose. Safety and effectiveness in pediatric patients with PNH have not been established. There were 29 PNH patients 65 years of age and older in APPLY-PNH and APPOINT-PNH [see Clinical Studies (14)] . Of the total number of FABHALTA-treated patients during the 24-week treatment period in these studies, 21 (20.6%) were 65 years of age and older, while 7 (6.9%) were 75 years of age and older. Clinical studies of FABHALTA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. The use of FABHALTA is not recommended in patients with severe renal impairment (estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 ) with or without hemodialysis. No dose adjustment is required in patients with mild (eGFR 60 to < 90 mL/min/1.73 m2 ) or moderate (eGFR 30 to < 60 mL/min/1.73 m2 ) renal impairment [see Clinical Pharmacology (12.3)] . The use of FABHALTA is not recommended in patients with severe hepatic impairment (Child-Pugh class C). No dose adjustment is required for patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment [see Clinical Pharmacology (12.3)] .

Přehled produktů:

200 mg capsules: pale yellow opaque hard capsules, imprinted with “LNP200” on one half and “NVR” on the other half, packaged in a high-density polyethylene (HDPE) bottle with induction seal and child-resistant cap. Each bottle contains 60 capsules (NDC 0078-1189-20). Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Stav Autorizace:

New Drug Application

Informace pro uživatele

FABHALTA- IPTACOPAN CAPSULE
Novartis Pharmaceuticals Corporation
----------
This Medication Guide has been approved by the U.S.
Food and Drug Administration.
Revised: 3/2024
MEDICATION GUIDE
FABHALTA® (fab hal’ tah)
(iptacopan)
capsules, for oral use
What is the most important information I should know about FABHALTA?
FABHALTA is a medicine that affects part of your immune system.
FABHALTA may lower the ability
of your immune system to fight infections.
•
FABHALTA increases your chance of getting serious infections caused by
encapsulated bacteria,
including Streptococcus pneumoniae, Neisseria meningitidis, and
Haemophilus influenzae type B.
These serious infections may quickly become life-threatening or fatal
if not recognized and
treated early.
•
You must complete or be up to date with the vaccines against
Streptococcus pneumoniae
and Neisseria meningitidis at least 2 weeks before your first dose of
FABHALTA.
•
If you have not completed your vaccinations and FABHALTA must be
started right away,
you should receive the required vaccinations as soon as possible.
•
If you have not been vaccinated and FABHALTA must be started right
away, you should
also receive antibiotics to take for as long as your healthcare
provider tells you.
•
If you have been vaccinated against these bacteria in the past, you
might need additional
vaccinations before starting FABHALTA. Your healthcare provider will
decide if you
need additional vaccinations.
•
Vaccines do not prevent all infections caused by encapsulated
bacteria. Call your
healthcare provider or get emergency medical care right away if you
have any of these
signs and symptoms of a serious infection:
▪ fever with or without shivers or chills
▪ fever with chest pain and cough
▪ fever with high heart rate
▪ headache and fever
▪ confusion
▪ clammy skin
▪ fever and a rash
▪ fever with breathlessness/fast
breathing
▪ headache with nausea or vomiting
▪ headache with stiff neck or stiff back
▪ body aches with flu-like symptoms
▪ eyes sensitive t

Charakteristika produktu

FABHALTA- IPTACOPAN CAPSULE
NOVARTIS PHARMACEUTICALS CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FABHALTA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FABHALTA.
FABHALTA (IPTACOPAN) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2023
WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
FABHALTA INCREASES THE RISK OF SERIOUS AND LIFE-THREATENING INFECTIONS
CAUSED BY
ENCAPSULATED BACTERIA, INCLUDING _STREPTOCOCCUS PNEUMONIAE, NEISSERIA
MENINGITIDIS,_
AND _HAEMOPHILUS INFLUENZAE_ TYPE B.
COMPLETE OR UPDATE VACCINATION FOR ENCAPSULATED BACTERIA AT LEAST 2
WEEKS PRIOR TO
THE FIRST DOSE OF FABHALTA, UNLESS THE RISKS OF DELAYING FABHALTA
OUTWEIGH THE RISK
OF DEVELOPING A SERIOUS INFECTION. COMPLY WITH THE MOST CURRENT
ADVISORY COMMITTEE
ON IMMUNIZATION PRACTICES (ACIP) RECOMMENDATIONS FOR VACCINATIONS
AGAINST
ENCAPSULATED BACTERIA IN PATIENTS RECEIVING A COMPLEMENT INHIBITOR.
(5.1)
PATIENTS RECEIVING FABHALTA ARE AT INCREASED RISK FOR INVASIVE DISEASE
CAUSED BY
ENCAPSULATED BACTERIA, EVEN IF THEY DEVELOP ANTIBODIES FOLLOWING
VACCINATION.
MONITOR PATIENTS FOR EARLY SIGNS AND SYMPTOMS OF SERIOUS INFECTIONS
AND EVALUATE
IMMEDIATELY IF INFECTION IS SUSPECTED. (5.1)
FABHALTA IS AVAILABLE ONLY THROUGH A RESTRICTED PROGRAM UNDER A RISK
EVALUATION AND
MITIGATION STRATEGY (REMS) CALLED FABHALTA REMS. (5.2)
RECENT MAJOR CHANGES
Dosage and Administration (2.1)
3/2024
INDICATIONS AND USAGE
FABHALTA is a complement factor B inhibitor, indicated for the
treatment of adults with paroxysmal
nocturnal hemoglobinuria (PNH). (1)
DOSAGE AND ADMINISTRATION
200 mg orally twice daily with or without food. (2.2)
DOSAGE FORMS AND STRENGTHS
Capsules: 200 mg (3)
CONTRAINDICATIONS
Serious hypersensitivity to iptacopan or any of the excipients. (4)
Initiation in patients with unresolved serious infection caused by
encapsulated bacteria. (4)
WARNINGS AND PRECAUTIONS
Monitoring of PNH