TARPEYO- budesonide capsule, delayed release

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

budesonide (UNII: Q3OKS62Q6X) (budesonide - UNII:Q3OKS62Q6X)

Tillgänglig från:

Calliditas Therapeutics AB

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

TARPEYO is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. TARPEYO is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of TARPEYO. Serious hypersensitivity reactions, including anaphylaxis have occurred with other budesonide formulations. Risk Summary The available data from published case series, epidemiological studies and reviews with oral budesonide use in pregnant women have not identified 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 IgA Nephropathy. Infants exposed to in-utero corticosteroids, including budesonide, are at risk for hypoadrenalism (see Clinical Considerations) . In animal reproduction studies with pregnant rats and rabbits, administration of subcutaneous budesonide during organogenesis at doses approximately 0.3 times or 0.03 times, respectively, the maximum recommended human dose (MRHD), resulted in increased fetal loss, decreased pup weights, and skeletal abnormalities. Maternal toxicity was observed in both rats and rabbits at these dose levels (see Data) . The estimated background risk of major birth defects and miscarriage of 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% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk IgA nephropathy in pregnancy is associated with adverse maternal outcomes, including increased rates of cesarean section, pregnancy-induced hypertension, pre-eclampsia and preterm delivery, and adverse fetal/neonatal outcomes, including stillbirth and low birth weight. Fetal/Neonatal Adverse Reactions Hypoadrenalism may occur in infants born to mothers receiving corticosteroids during pregnancy. Infants should be carefully observed for signs of hypoadrenalism, such as poor feeding, irritability, weakness, and vomiting, and managed accordingly [see Warnings and Precautions (5.1)]. Data Animal Data Budesonide was teratogenic and embryo-lethal in rabbits and rats. In an embryo-fetal development study in pregnant rats dosed subcutaneously with budesonide during the period of organogenesis on gestation days 6 to 15 there were effects on fetal development and survival at subcutaneous doses up to approximately 500 mcg/kg in rats (approximately 0.3 times the maximum recommended human dose (MRHD) on a body surface area basis). In an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis on gestation days 6 to 18, there was an increase in maternal abortion, and effects on fetal development and reduction in litter weights at subcutaneous doses from approximately 25 mcg/kg (approximately 0.03 times the MRHD on a body surface area basis). Maternal toxicity, including reduction in body weight gain, was observed at subcutaneous doses of 5 mcg/kg in rabbits (approximately 0.006 times the maximum recommended human dose on a body surface area basis) and 500 mcg/kg in rats (approximately 0.3 times the maximum recommended human dose on a body surface area basis). In a peri- and post-natal development study, subcutaneous treatment of pregnant rats with budesonide during the period from Day 15 post coitum to Day 21 post partum, budesonide had no effects on delivery, but did have an effect on growth and development of offspring. In addition, offspring survival was reduced and surviving offspring had decreased mean body weights at birth and during lactation at exposures ≥ 0.012 times the MRHD (on a mg/m2 basis at maternal subcutaneous doses of 20 mcg/kg/day and higher). These findings occurred in the presence of maternal toxicity. Risk Summary Breastfeeding is not expected to result in significant exposure of the infant to TARPEYO. Lactation studies have not been conducted with oral budesonide, including TARPEYO, and no information is available on the effects of the drug on the breastfed infant or the effects on the drug on milk production. One published study reports that budesonide is present in human milk following maternal inhalation of budesonide (see Data). Routine monitoring of linear growth in infants is recommended with chronic use of budesonide in the nursing mother. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TARPEYO and any potential adverse effects on the breastfed infant from TARPEYO, or from the underlying maternal condition. Data One published study reports that budesonide is present in human milk following maternal inhalation of budesonide, which resulted in infant doses approximately 0.3% to 1% of the maternal weight-adjusted dosage and a milk to plasma ratio was approximately 0.5. Budesonide was not detected in plasma, and no adverse events were noted in the breastfed infants following maternal use of inhaled budesonide. Assuming a daily average milk intake of about 150 mL/kg/day and a milk to plasma ratio of 0.5, the estimated oral dose of budesonide for a 5 kg infant is expected to be less than 2 mcg/day for a maternal dose of 16 mg TARPEYO. Assuming 100% bio-availability in the infant this is about 0.1% of the maternal dose and about 3% of the highest inhaled dose used clinically for asthma in infants. The safety and efficacy of TARPEYO in pediatric patients have not been established. Clinical studies of TARPEYO 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. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Patients with moderate to severe hepatic impairment (Child-Pugh Class B and C, respectively) could be at an increased risk of hypercorticism and adrenal axis suppression due to an increased systemic exposure to budesonide [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)] . Avoid use in patients with severe hepatic impairments (Child-Pugh Class C). Monitor for increased signs and/or symptoms of hypercorticism in patients with moderate hepatic impairment (Child-Pugh Class B).

Produktsammanfattning:

TARPEYO (budesonide) delayed release capsules 4 mg, are white opaque- coated capsules marked with “CAL10 4 MG” in black ink on the body of the capsule. They are supplied as follows: NDC 81749-004-01: Bottles of 120 capsules. Child-resistant cap. Store at 20-25°C (68 - 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Keep container tightly closed. Protect from moisture.

Bemyndigande status:

New Drug Application

Produktens egenskaper

TARPEYO- BUDESONIDE CAPSULE, DELAYED RELEASE
CALLIDITAS THERAPEUTICS AB
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TARPEYO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TARPEYO.
TARPEYO (BUDESONIDE) DELAYED RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
TARPEYO is a corticosteroid indicated to reduce the loss of kidney
function in adults with primary
immunoglobulin A nephropathy (IgAN) who are at risk for disease
progression. (1)
DOSAGE AND ADMINISTRATION
The recommended dosage is 16 mg administered orally once daily, in the
morning at least 1 hour
before a meal. (2)
Swallow whole. Do not open, crush or chew. (2)
When discontinuing, reduce dosage to 8 mg once daily for the last two
weeks. (2, 5.1)
DOSAGE FORMS AND STRENGTHS
Delayed release capsules: 4 mg (3)
CONTRAINDICATIONS
Hypersensitivity to budesonide or any of the ingredients in TARPEYO.
(4)
WARNINGS AND PRECAUTIONS
Hypercorticism and Adrenal Axis Suppression: Follow general warnings
concerning corticosteroids,
patients with hepatic impairment may be at increased risk. Taper upon
discontinuation. (2, 5.1, 8.6,
12.3)
Risks of immunosuppression: Avoid use in patients with active or
quiescent tuberculosis infection,
untreated fungal, bacterial, systemic viral or parasitic infections,
or ocular herpes simplex. May affect
vaccine efficacy. (5.2)
Other Corticosteroid Effects: Monitor patients with concomitant
conditions where corticosteroids may
have unwanted effects (e.g., hypertension, diabetes mellitus). (5.3)
ADVERSE REACTIONS
Most common adverse reactions ( ≥5%) are peripheral edema,
hypertension, muscle spasms, acne,
headache, upper respiratory tract infection, face edema, weight
increased, dyspepsia, dermatitis,
arthralgia, white blood cell count increased. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT CALLIDITAS THERAPEUTICS
AT 1-844-IGA-
0011 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Potent CYP3A4 Inh