JADENU Film-coated tablet / Granules (2020)
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Novartis Pharmaceuticals Corporation
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BOXED WARNING SECTION
<b>WARNING: RENAL FAILURE, HEPATIC FAILURE, and GASTROINTESTINAL HEMORRHAGE</b> <b>Renal Failure</b> <b>JADENU can cause acute renal failure and death, particularly in patients with comorbidities and those ...
1. Indications and Usage
1.1 Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload) JADENU is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) ...
2. Dosage and Administration
2.1 Transfusional Iron Overload JADENU therapy should only be considered when a patient has evidence of chronic transfusional iron overload. The evidence should include the transfusion of at least 100 ...
3. Dosage Forms and Strengths
<u>90 mg JADENU tablets:</u> Light blue oval biconvex film-coated tablet with beveled edges, debossed with NVR on one side and 90 on a slight upward slope in between two debossed curved lines on the other ...
4. Contraindications
JADENU is contraindicated in patients with: Estimated GFR less than 40 mL/min/1.73 m² <em>[see Dosage and Administration (2.5), Warnings and Precautions (5.1)]</em>; Poor performance status <em>[see Warnings ...
5. Warnings and Precautions
5.1 Acute Kidney Injury, Including Acute Renal Failure Requiring Dialysis and Renal Tubular Toxicity Including Fanconi Syndrome JADENU is contraindicated in patients with eGFR less than 40 mL/min/1.73 ...
6. Adverse Reactions
The following clinically significant adverse reactions are also discussed in other sections of the labeling: Acute Kidney Injury, Including Acute Renal Failure Requiring Dialysis, and Renal Tubular Toxicity ...
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...
6.2. Postmarketing Experience
The following adverse reactions have been spontaneously reported during post-approval use of deferasirox in the transfusional iron overload setting. Because these reactions are reported voluntarily from ...
7. Drug Interactions
7.1 Aluminum-Containing Antacid Preparations The concomitant administration of JADENU and aluminum-containing antacid preparations has not been formally studied. Although deferasirox has a lower affinity ...
8.1. Pregnancy
Risk Summary There are no studies with the use of JADENU in pregnant women to inform drug-associated risks. Administration of deferasirox to rats during pregnancy resulted in decreased offspring viability ...
8.2. Lactation
Risk Summary No data are available regarding the presence of JADENU or its metabolites in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production. Deferasirox ...
8.3. Females and Males of Reproductive Potential
Contraception Counsel patients to use non-hormonal method(s) of contraception since JADENU can render hormonal contraceptives ineffective <em>[see Drug Interactions (7.2)]</em>.
8.4. Pediatric Use
Transfusional Iron Overload The safety and effectiveness of JADENU have been established in pediatric patients 2 years of age and older for the treatment of transfusional iron overload <em>[see Dosage ...
8.5. Geriatric Use
Four hundred thirty-one (431) patients greater than or equal to 65 years of age were studied in clinical trials of deferasirox in the transfusional iron overload setting. Two hundred twenty-five (225) ...
8.6. Renal Impairment
JADENU is contraindicated in patients with eGFR less than 40 mL/min/1.73 m² <em>[see Contraindications (4)]</em>. For patients with renal impairment (eGFR 40 to 60 mL/min/1.73 m²), reduce the starting ...
8.7. Hepatic Impairment
Avoid use in patients with severe (Child-Pugh C) hepatic impairment. For patients with moderate (Child-Pugh B) hepatic impairment, reduce the starting dose by 50%. Closely monitor patients with mild (Child-Pugh ...
10. Overdosage
Cases of overdose (2 to 3 times the prescribed dose for several weeks) have been reported. In one case, this resulted in hepatitis which resolved without long-term consequences after a dose interruption. ...
11. Description
JADENU (deferasirox) is an iron-chelating agent provided as a tablet or granules for oral use. Deferasirox is designated chemically as 4-[3,5-bis(2-hydroxyphenyl)-1<em>H</em>-1,2,4-triazol-1-yl]benzoic ...
12.1. Mechanism of Action
JADENU (deferasirox) is an orally active chelator that is selective for iron (as Fe3+). It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio. Although deferasirox has very low affinity ...
12.2. Pharmacodynamics
Pharmacodynamic effects tested in an iron balance metabolic study with the tablet for oral suspension formulation showed that deferasirox (10, 20, and 40 mg per kg per day) was able to induce a mean net ...
12.3. Pharmacokinetics
Absorption Based on studies in patients with the tablet for oral suspension, deferasirox is absorbed following oral administration with median times to maximum plasma concentration (T<sub>max</sub>) of ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
A 104-week oral carcinogenicity study in Wistar rats showed no evidence of carcinogenicity from deferasirox at doses up to 60 mg/kg/day (0.7 times the MRHD on an mg/m² basis). A 26-week oral carcinogenicity ...
14. Clinical Studies
JADENU was evaluated in healthy subjects. There are no clinical data in patients with JADENU. JADENU contains the same active ingredient as Exjade (deferasirox) tablets for oral suspension. The following ...
16.1. How Supplied
JADENU 90 mg tablets are light blue in color, film-coated, oval biconvex tablets with beveled edges, debossed with NVR on one side and 90 on a slight upward slope in between two debossed curved lines on ...
16.2. Storage and Handling
Store JADENU tablets at 20°C-25°C (68°F-77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Store JADENU Sprinkle granules at 20°C ...
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Dosing Instructions Advise patients to take JADENU tablets with water or other liquids. Advise patients to swallow JADENU ...