DEFERIPRONE tablet, coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

DEFERIPRONE (UNII: 2BTY8KH53L) (DEFERIPRONE - UNII:2BTY8KH53L)

Tilgængelig fra:

Hikma Pharmaceuticals USA Inc.

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. Limitations of Use: Pediatric use information is approved for Chiesi USA, Inc.’s FERRIPROX® (deferiprone) tablets. However, due to Chiesi USA, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Deferiprone tablets are contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulations. The following reactions have been reported in association with the administration of deferiprone: Henoch-Schönlein purpura; urticaria; and periorbital edema with skin rash [see Adverse Reactions (6.2)] . Risk Summary: In animal reproduction studies, oral administration of deferiprone to pregnant rats and rabbits during organogenesis at doses 33% and 49%, respectively, of the maximum recommended human dose (MRHD) resulted in structural abnormalities, embryo-fetal mortality and alterations to growth (see Data ). The limited available data from deferiprone use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. Based on evidence and developmental toxicity in animal studies, deferiprone tablets can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. 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 of miscarriage is 2-4% and 15-20%, respectively. Data: Human Data: Post-marketing data available from 39 pregnancies of deferiprone-treated patients and 10 pregnancies of partners of deferiprone-treated patients are as follows: Of the 39 pregnancies in deferiprone-treated patients, 23 resulted in healthy newborns, 6 ended in spontaneous abortion, 9 had unknown outcomes, and 1 infant was born with anal atresia, nephroptosis, ventricular septal defect, hemivertebra and urethral fistula. Of the 10 pregnancies in partners of deferiprone-treated patients, 5 resulted in healthy newborns, 1 resulted in a healthy newborn with slight hypospadias, 1 was electively terminated, 1 resulted in the intrauterine death of twins, and 2 had unknown outcomes. Animal Data: During organogenesis, pregnant rats and rabbits received deferiprone at oral doses of 0, 30, 80 or 200 mg/kg/day, and 0, 10, 50, or 150 mg/kg/day, respectively. The daily dose was administered as two equal divided doses approximately 7 hours apart. Doses of 200 mg/kg/day in rats and 150 mg/kg/day in rabbits, approximately 33% and 49% of the MRHD, respectively, resulted in increased post-implantation loss and reduced fetal weights in the presence of maternal toxicity (reduced maternal body weight and body weight gain in both rats and rabbits; abnormal large placenta at low incidence in rats). The 200 mg/kg/day dose in rats resulted in external, visceral and skeletal fetal malformations, such as cranial malformations, cleft palate, limb malrotation, anal atresia, internal hydrocephaly, anophthalmia, and fused bones. The dose of 150 mg/kg/day in rabbits resulted in external fetal malformations (partially opened eyes) and minor blood vessel and skeletal variations. In rats, malformations including micrognathia and persistent ductus arteriosus could be observed in the absence of maternal toxicity at doses equal to or greater than 30 and 80 mg/kg/day, approximately 5% and 13% of the MHRD, respectively. Risk Summary: There is no information regarding the presence of deferiprone in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in the breastfed child, including the potential for tumorigenicity shown for deferiprone in animal studies, advise patients that breastfeeding is not recommended during treatment with deferiprone tablets, and for at least 2 weeks after the last dose. Pregnancy Testing: Pregnancy testing is recommended for females of reproductive potential prior to initiating deferiprone tablets. Contraception: Females: Deferiprone tablets can cause embryo-fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)] . Advise female patients of reproductive potential to use effective contraception during treatment with deferiprone tablets and for at least 6 months after the last dose. Males: Based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with deferiprone tablets and for at least 3 months after the last dose [see Nonclinical Toxicology (13.1)] . Safety and effectiveness of deferiprone tablets have not been established in pediatric patients with chronic iron overload due to blood transfusions who are less than 8 years of age. Pediatric use information is approved for Chiesi USA, Inc.’s FERRIPROX® (deferiprone) tablets. However, due to Chiesi USA, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information . Clinical studies of deferiprone did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Produkt oversigt:

Deferiprone Tablets, 500 mg: Deferiprone tablets are white to off-white, modified capsule shaped, biconvex, film coated tablets, debossed with 54 [score] 422 on one side and plain on the other side. They are provided in a 100 count and 300 count HDPE bottle with a child-resistant cap. NDC 0054-0576-25: Bottle of 100 Tablets NDC 0054-0576-28: Bottle of 300 Tablets Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

Hikma Pharmaceuticals USA Inc.
----------
Medication Guide
Deferiprone (de fer’ i prone) Tablets
What is the most important information I should know about deferiprone
tablets?
Deferiprone tablets can cause serious side effects, including a very
low white blood cell count. One type
of white blood cell that is important for fighting infections is
called a neutrophil. If your neutrophil count
is low (neutropenia), you may be at risk of developing a serious
infection that can lead to death.
Neutropenia is common with deferiprone tablets and can become severe
in some people. Severe
neutropenia is known as agranulocytosis. If you develop
agranulocytosis, you will be at risk of
developing serious infections that can lead to death.
Your healthcare provider will do a blood test before you start
deferiprone tablets and regularly during
treatment to check your neutrophil count. If you develop neutropenia,
your healthcare provider should
check your blood counts every day until your white blood cell count
improves. Your healthcare provider
may temporarily stop treatment with deferiprone tablets if you develop
neutropenia or infection.
Stop taking deferiprone tablets and call your healthcare provider or
get medical help right away if you
develop any of these symptoms of infection:
•
fever
•
sore throat or mouth sores
•
flu-like symptoms
•
chills and severe shaking
It is important for you to have your white blood cell count checked
within 24 hours of developing
symptoms of an infection to see if you have severe neutropenia
(agranulocytosis). Do not delay getting
medical care if you are unable to reach your healthcare provider.
See “What are the possible side effects of deferiprone tablets?”
for more information about side effects.
What are deferiprone tablets?
Deferiprone tablets are a prescription medicine used to treat iron
overload from blood transfusions in
adults with thalassemia syndromes when current iron removal
(chelation) therapy does not work well
enough.
It is not known if deferiprone tablets are safe

Produktets egenskaber

DEFERIPRONE- DEFERIPRONE TABLET, COATED
HIKMA PHARMACEUTICALS USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEFERIPRONE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DEFERIPRONE TABLETS.
DEFERIPRONE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2011
WARNING: AGRANULOCYTOSIS AND NEUTROPENIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
•
•
INDICATIONS AND USAGE
Deferipronetablets are an iron chelator indicated for the treatment of
transfusional iron overload in adult
patients with thalassemia syndromes when current chelation therapy is
inadequate. (1)
_Limitations of Use:_
Safety and effectiveness have not been established for the treatment
of transfusional iron overload in
patients with myelodysplastic syndrome or in patients with Diamond
Blackfan anemia.
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
Hypersensitivity to deferiprone or to any of the excipients in the
formulations. (4)
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HIKMA PHARMACEUTICALS
USA INC. AT 1-
800-962-8364 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
DEFERIPRONE TABLETS CAN CAUSE AGRANULOCYTOSIS THAT CAN LEAD TO SERIOUS
INFECTIONS
AND DEATH. NEUTROPENIA MAY PRECEDE THE DEVELOPMENT OF AGRANULOCYTOSIS.
(5.1)
MEASURE THE ABSOLUTE NEUTROPHIL COUNT (ANC) BEFORE STARTING
DEFERIPRONE TABLETS
AND MONITOR REGULARLY WHILE ON THERAPY. (5.1)
INTERRUPT DEFERIPRONE TABLETS THERAPY IF NEUTROPENIA DEVELOPS. (5.1)
INTERRUPT DEFERIPRONE TABLETS IF INFECTION DEVELOPS AND MONITOR THE
ANC MORE
FREQUENTLY. (5.1)
ADVISE PATIENTS TAKING DEFERIPRONE TABLETS TO REPORT IMMEDIATELY ANY
SYMPTOMS
INDICATIVE OF INFECTION. (5.1)
Deferiprone Tablets are available in a 500 mg formulation. (2.1)
To prevent medication errors, before prescribing and dispensing,
ensure that the tablet formulation is
appropriate for the dosing