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Exjade

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Overview

What is Exjade?

Exjade(deferasirox) is an iron chelating agent. Exjade tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is:

Deferasirox is a white to slightly yellow powder. Its molecular formula is CHNO and its molecular weight is 373.4.

Inactive Ingredients:



What does Exjade look like?



What are the available doses of Exjade?

Tablets for oral suspension: 125 mg, 250 mg, 500 mg. ()

What should I talk to my health care provider before I take Exjade?

How should I use Exjade?

Exjade is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. This indication is based on a reduction of liver iron concentrations and serum ferritin levels . An improvement in survival or disease-related symptoms has not been established .

Exjade 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 mL/kg of packed red blood cells (e.g., at least 20 units of packed red blood cells for a 40 kg person or more in individuals weighing more than 40 kg), and a serum ferritin consistently greater than 1000 mcg/L.

Prior to starting therapy, obtain:

The recommended initial dose of Exjade for patients 2 years of age and older is 20 mg per kg body weight orally, once daily. Calculate doses (mg per kg per day) to the nearest whole tablet.

After commencing therapy, monitor serum ferritin monthly and adjust the dose of Exjade, if necessary, every 3-6 months based on serum ferritin trends. Make dose adjustments in steps of 5 or 10 mg per kg and tailor adjustments to the individual patient’s response and therapeutic goals. In patients not adequately controlled with doses of 30 mg per kg (e.g., serum ferritin levels persistently above 2500 mcg/L and not showing a decreasing trend over time), doses of up to 40 mg per kg may be considered. Doses above 40 mg per kg are not recommended.

If the serum ferritin falls consistently below 500 mcg/L, consider temporarily interrupting therapy with Exjade .


What interacts with Exjade?

Sorry No Records found


What are the warnings of Exjade?

Sorry No Records found


What are the precautions of Exjade?

Sorry No Records found


What are the side effects of Exjade?

Sorry No records found


What should I look out for while using Exjade?

Exjade is contraindicated in patients with:

Renal Failure

Hepatic Failure

Gastrointestinal Hemorrhage


What might happen if I take too much Exjade?

Cases of overdose (2-3 times the prescribed dose for several weeks) have been reported. In 1 case, this resulted in hepatitis which resolved without long-term consequences after a dose interruption. Single doses up to 80 mg per kg per day in iron overloaded beta-thalassemic patients have been tolerated with nausea and diarrhea noted. In healthy volunteers, single doses of up to 40 mg per kg per day were tolerated. There is no specific antidote for Exjade. In case of overdose, induce vomiting and employ gastric lavage.


How should I store and handle Exjade?

Exjade is provided as 125 mg, 250 mg, and 500 mg tablets for oral suspension.125 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “125” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0468-15)250 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “250” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0469-15)500 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “500” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0470-15)Store Exjade tablets at 25°C (77°F); excursions are permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Protect from moisture.Exjade is provided as 125 mg, 250 mg, and 500 mg tablets for oral suspension.125 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “125” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0468-15)250 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “250” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0469-15)500 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “500” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0470-15)Store Exjade tablets at 25°C (77°F); excursions are permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Protect from moisture.Exjade is provided as 125 mg, 250 mg, and 500 mg tablets for oral suspension.125 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “125” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0468-15)250 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “250” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0469-15)500 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “500” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0470-15)Store Exjade tablets at 25°C (77°F); excursions are permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Protect from moisture.Exjade is provided as 125 mg, 250 mg, and 500 mg tablets for oral suspension.125 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “125” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0468-15)250 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “250” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0469-15)500 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “500” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0470-15)Store Exjade tablets at 25°C (77°F); excursions are permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Protect from moisture.Exjade is provided as 125 mg, 250 mg, and 500 mg tablets for oral suspension.125 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “125” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0468-15)250 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “250” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0469-15)500 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “500” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0470-15)Store Exjade tablets at 25°C (77°F); excursions are permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Protect from moisture.Exjade is provided as 125 mg, 250 mg, and 500 mg tablets for oral suspension.125 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “125” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0468-15)250 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “250” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0469-15)500 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “500” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0470-15)Store Exjade tablets at 25°C (77°F); excursions are permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Protect from moisture.Exjade is provided as 125 mg, 250 mg, and 500 mg tablets for oral suspension.125 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “125” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0468-15)250 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “250” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0469-15)500 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “500” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0470-15)Store Exjade tablets at 25°C (77°F); excursions are permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Protect from moisture.Exjade is provided as 125 mg, 250 mg, and 500 mg tablets for oral suspension.125 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “125” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0468-15)250 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “250” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0469-15)500 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “500” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0470-15)Store Exjade tablets at 25°C (77°F); excursions are permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Protect from moisture.Exjade is provided as 125 mg, 250 mg, and 500 mg tablets for oral suspension.125 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “125” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0468-15)250 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “250” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0469-15)500 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “500” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0470-15)Store Exjade tablets at 25°C (77°F); excursions are permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Protect from moisture.Exjade is provided as 125 mg, 250 mg, and 500 mg tablets for oral suspension.125 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “125” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0468-15)250 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “250” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0469-15)500 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “500” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0470-15)Store Exjade tablets at 25°C (77°F); excursions are permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Protect from moisture.Exjade is provided as 125 mg, 250 mg, and 500 mg tablets for oral suspension.125 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “125” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0468-15)250 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “250” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0469-15)500 mgOff-white, round, flat tablet with beveled edge and imprinted with “J” and “500” on one side and “NVR” on the other.Bottles of 30 tablets………………………………………………………………..(NDC 0078-0470-15)Store Exjade tablets at 25°C (77°F); excursions are permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Protect from moisture.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Exjade(deferasirox) is an orally active chelator that is selective for iron (as Fe). It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio. Although deferasirox has very low affinity for zinc and copper there are variable decreases in the serum concentration of these trace metals after the administration of deferasirox. The clinical significance of these decreases is uncertain.

Non-Clinical Toxicology
Exjade is contraindicated in patients with:

Renal Failure

Hepatic Failure

Gastrointestinal Hemorrhage

The pharmacokinetic profile of temazepam does not appear to be altered by orally administered cimetidine dosed according to labeling.

Exjade can cause acute renal failure, fatal in some patients and requiring dialysis in others. Postmarketing experience showed that most fatalities occurred in patients with multiple comorbidities and who were in advanced stages of their hematological disorders. In the clinical trials, Exjade-treated patients experienced dose-dependent increases in serum creatinine. In patients with transfusional iron overload, these increases in creatinine occurred at a greater frequency compared to deferoxamine-treated patients (38% versus 14%, respectively, in Study 1 and 36% versus 22%, respectively, in Study 3) .

Measure serum creatinine in duplicate (due to variations in measurements) and determine the CLCr (estimated by the Cockcroft-Gault method) before initiating therapy in all patients in order to establish a reliable pretreatment baseline. Monitor serum creatinine weekly during the first month after initiation or modification of therapy and at least monthly thereafter. Monitor serum creatinine and/or CLCr more frequently if creatinine levels are increasing. Dose reduction, interruption, or discontinuation based on increases in serum creatinine may be necessary .

Exjade is contraindicated in patients with CLCr less than 40 mL/minute or serum creatinine greater than 2 times the age appropriate ULN.

Renal tubular damage, including Fanconi’s Syndrome, has been reported in patients treated with Exjade, most commonly in children and adolescents with beta-thalassemia and serum ferritin levels less than 1500 mcg/L.

Intermittent proteinuria (urine protein/creatinine ratio greater than 0.6 mg/mg) occurred in 18.6% of Exjade-treated patients compared to 7.2% of deferoxamine-treated patients in Study 1. In clinical trials in patients with transfusional iron overload, Exjade was temporarily withheld until the urine protein/creatinine ratio fell below 0.6 mg/mg. Monthly monitoring for proteinuria is recommended. The mechanism and clinical significance of the proteinuria are uncertain .

The following adverse reactions are also discussed in other sections of the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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