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Exjade

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Exjade uses



Dosage and Administration, Administration (2.3)

5/2017

Warnings and Precautions, Hypersensitivity (5.6)

8/2016

Warnings and Precautions, Severe Skin Reactions (5.7)

8/2016

WARNING: RENAL FAILURE, HEPATIC FAILURE, AND GASTROINTESTINAL HEMORRHAGE

Renal Failure


Hepatic Failure


Gastrointestinal Hemorrhage


WARNING: RENAL FAILURE, HEPATIC FAILURE, AND GASTROINTESTINAL HEMORRHAGE

See full prescribing information for complete boxed warning.

Exjade may cause serious and fatal:


Exjade therapy requires close patient monitoring, including laboratory tests of renal and hepatic function. (5)

1 INDICATIONS AND USAGE

Exjade is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. This indication is approved under accelerated approval based on a reduction of liver iron concentrations and serum ferritin levels. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Exjade is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L. This indication is approved under accelerated approval based on a reduction of liver iron concentrations (to less than 5 mg Fe/g dw) and serum ferritin levels. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. (1.2)

Limitations of Use

Controlled clinical trials of Exjade in patients with myelodysplastic syndromes (MDS) and chronic iron overload due to blood transfusion have not been performed. (1.3)

The safety and efficacy of Exjade when administered with other iron chelation therapy have not been established. (1.3)

1.1 Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload)

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 approved under accelerated approval based on a reduction of liver iron concentrations and serum ferritin levels . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

1.2 Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes

Exjade is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia syndromes and with a liver iron concentration (LIC) of at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) and a serum ferritin greater than 300 mcg/L. This indication is approved under accelerated approval based on a reduction of liver iron concentrations (to less than 5 mg Fe/g dw) and serum ferritin levels . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

1.3 Limitations of Use

Controlled clinical trials of Exjade with myelodysplastic syndromes (MDS) and chronic iron overload due to blood transfusions have not been performed .

The safety and efficacy of Exjade when administered with other iron chelation therapy have not been established.

2 DOSAGE AND ADMINISTRATION

2.1 Transfusional Iron Overload

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 14 mg per kg body weight orally, once daily. Calculate doses (mg per kg per day) to the nearest whole tablet or nearest whole sachet content for granules. Changes in weight of pediatric patients over time must be taken into account when calculating the dose.

After commencing therapy, monitor serum ferritin monthly and adjust the dose of Exjade, if necessary, every 3 to 6 months based on serum ferritin trends. Make dose adjustments in steps of 3.5 or 7 mg per kg and tailor adjustments to the individual patient’s response and therapeutic goals. In patients not adequately controlled with doses of 21 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 28 mg per kg may be considered. Doses above 28 mg per kg are not recommended.

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

2.2 Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes

Exjade therapy should only be considered when a patient with NTDT syndrome has an LIC of at least 5 mg Fe/g dw and a serum ferritin greater than 300 mcg/L.

Prior to starting therapy, obtain:


Initiating therapy:


During therapy:


Restart treatment when the LIC rises again to more than 5 mg Fe/g dw.

2.3 Administration

Swallow Exjade tablets once daily with water or other liquids, preferably at the same time each day. Take Exjade tablets on an empty stomach or with a light meal (contains less than 7% fat content and approximately 250 calories). Examples of light meals include 1 whole wheat English muffin, 1 packet jelly (0.5 ounces), and skim milk (8 fluid ounces) or a turkey sandwich (2 oz. turkey on whole wheat bread w/ lettuce, tomato, and 1 packet mustard). Do not take Exjade tablets with aluminum-containing antacid products . For patients who have difficulty swallowing whole tablets, Exjade tablets may be crushed and mixed with soft foods (e.g., yogurt or apple sauce) immediately prior to use and administered orally. Commercial crushers with serrated surfaces should be avoided for crushing a single 90 mg tablet. The dose should be immediately and completely consumed and not stored for future use.

Take Exjade Sprinkle granules on an empty stomach or with a light meal . Administer Exjade Sprinkle granules by sprinkling the full dose on soft food (e.g. yogurt or apple sauce) immediately prior to use and administered orally. Exjade Sprinkle granules should be taken once a day, preferably at the same time each day. Do not take Exjade Sprinkle granules with aluminum-containing antacid products .

For patients who are currently on chelation therapy with Exjade tablets for oral suspension and converting to Exjade, the dose should be about 30% lower, rounded to the nearest whole tablet or nearest whole sachet content for granules. The table below provides additional information on dosing conversion to Exjade.

EXJADE

Tablets for oral suspension

(white round tablet)

Exjade

Tablets

(film coated blue oval tablet)

Exjade Sprinkle

Granules

(white to almost white granules)

Transfusion-Dependent Iron Overload
Starting Dose 20 mg/kg/day 14 mg/kg/day
Titration Increments 5–10 mg/kg 3.5–7 mg/kg
Maximum Dose 40 mg/kg/day 28 mg/kg/day
Non-Transfusion-Dependent Thalassemia Syndromes
Starting Dose 10 mg/kg/day 7 mg/kg/day
Titration Increments 5–10 mg/kg 3.5–7 mg/kg
Maximum Dose 20 mg/kg/day 14 mg/kg/day

2.4 Use in Patients with Baseline Hepatic or Renal Impairment

Patients with Baseline Hepatic Impairment

Mild hepatic impairment: No dose adjustment is necessary.

Moderate (Child-Pugh B) hepatic impairment: Reduce the starting dose by 50%.

Severe (Child-Pugh C) hepatic impairment: Avoid Exjade tablets or Exjade Sprinkle granules .

Patients with Baseline Renal Impairment

For patients with CLcr 40 to 60 mL/min, reduce the starting dose by 50% . Do not use Exjade in patients with serum creatinine greater than two times the age-appropriate upper limit of normal (ULN) or CLcr less than 40 mL/min .

2.5 Dose Modifications for Increases in Serum Creatinine

For serum creatinine increases while receiving Exjade modify the dose as follows:

Transfusional Iron Overload

Adults and Adolescents (ages 16 years and older):


Pediatric Patients (ages 2 to 15 years):


All Patients (regardless of age):


Non-Transfusion-Dependent Thalassemia Syndromes

Adults and Adolescents (ages 16 years and older):


Pediatric Patients (ages 10 to 15 years):


All Patients (regardless of age):

2.6 Dose Modifications Based on Concomitant Medications

UDP-glucuronosyltransferases (UGT) Inducers

Concomitant use of UGT inducers decreases systemic exposure. Avoid the concomitant use of strong UGT inducers (e.g., rifampicin, phenytoin, phenobarbital, ritonavir). If you must administer Exjade tablets or Exjade Sprinkle granules with a strong UGT inducer, consider increasing the initial dose by 50%, and monitor serum ferritin levels and clinical responses for further dose modification .

Bile Acid Sequestrants

Concomitant use of bile acid sequestrants decreases systemic exposure. Avoid the concomitant use of bile acid sequestrants (e.g., cholestyramine, colesevelam, colestipol). If you must administer Exjade tablets or Exjade Sprinkle granules with a bile acid sequestrant, consider increasing the initial dose by 50%, and monitor serum ferritin levels and clinical responses for further dose modification .

3 DOSAGE FORMS AND STRENGTHS


Tablets: 90 mg, 180 mg, 360 mg. (3)

Granules: 90 mg, 180 mg, 360 mg. (3)

4 CONTRAINDICATIONS

Exjade is contraindicated in patients with:

5 WARNINGS AND PRECAUTIONS

5.1 Renal Toxicity, Renal Failure, and Proteinuria

JADENU 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, deferasirox-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 deferasirox-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 .

5.2 Hepatic Toxicity and Failure

Exjade can cause hepatic injury, fatal in some patients. In Study 1, 4 patients discontinued Exjade because of hepatic toxicity (drug-induced hepatitis in 2 patients and increased serum transaminases in 2 additional patients). Hepatic toxicity appears to be more common in patients greater than 55 years of age. Hepatic failure was more common in patients with significant comorbidities, including liver cirrhosis and multiorgan failure .

Measure transaminases (AST and ALT) and bilirubin in all patients before the initiation of treatment and every 2 weeks during the first month and at least monthly thereafter. Consider dose modifications or interruption of treatment for severe or persistent elevations.

Avoid the use of Exjade in patients with severe (Child-Pugh C) hepatic impairment. Reduce the starting dose in patients with moderate (Child-Pugh B) hepatic impairment . Patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment may be at higher risk for hepatic toxicity.

5.3 Gastrointestinal (GI) Ulceration, Hemorrhage, and Perforation

GI hemorrhage, including deaths, has been reported, especially in elderly patients who had advanced hematologic malignancies and/or low platelet counts. Nonfatal upper GI irritation, ulceration and hemorrhage have been reported in patients, including children and adolescents, receiving Exjade . Monitor for signs and symptoms of GI ulceration and hemorrhage during Exjade therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. The risk of gastrointestinal hemorrhage may be increased when administering Exjade in combination with drugs that have ulcerogenic or hemorrhagic potential, such as nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, oral bisphosphonates, or anticoagulants. There have been reports of ulcers complicated with gastrointestinal perforation (including fatal outcome) .

5.4 Bone Marrow Suppression

Neutropenia, agranulocytosis, worsening anemia, and thrombocytopenia, including fatal events, have been reported in patients treated with Exjade. Preexisting hematologic disorders may increase this risk. Monitor blood counts in all patients. Interrupt treatment with Exjade in patients who develop cytopenias until the cause of the cytopenia has been determined. Exjade is contraindicated in patients with platelet counts below 50 x 109/L.

5.5 Increased Risk of Toxicity in the Elderly

Exjade has been associated with serious and fatal adverse reactions in the postmarketing setting, predominantly in elderly patients. Monitor elderly patients treated with Exjade more frequently for toxicity .

5.6 Hypersensitivity

Exjade may cause serious hypersensitivity reactions (such as anaphylaxis and angioedema), with the onset of the reaction usually occurring within the first month of treatment. If reactions are severe, discontinue Exjade and institute appropriate medical intervention. Exjade is contraindicated in patients with known hypersensitivity to Exjade products and should not be reintroduced in patients who have experienced previous hypersensitivity reactions on Exjade products due to the risk of anaphylactic shock.

5.7 Severe Skin Reactions

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), and erythema multiforme, have been reported during Exjade therapy . The risk of other skin reactions including DRESS (drug reaction with eosinophilia and systemic symptoms) cannot be excluded. If severe skin reactions are suspected, discontinue Exjade immediately and do not reintroduce Exjade therapy.

5.8 Skin Rash

Rashes may occur during Exjade treatment . For rashes of mild to moderate severity, Exjade may be continued without dose adjustment, since the rash often resolves spontaneously. In severe cases, interrupt treatment with Exjade. Reintroduction at a lower dose with escalation may be considered after resolution of the rash.

5.9 Auditory and Ocular Abnormalities

Auditory disturbances, and ocular disturbances (lens opacities, cataracts, elevations in intraocular pressure, and retinal disorders) were reported at a frequency of less than 1% with Exjade therapy in the clinical studies. Perform auditory and ophthalmic testing (including slit lamp examinations and dilated fundoscopy) before starting Exjade treatment and thereafter at regular intervals (every 12 months). If disturbances are noted, monitor more frequently. Consider dose reduction or interruption.

5.10 Overchelation

For patients with transfusional iron overload, measure serum ferritin monthly to assess for possible overchelation of iron. If the serum ferritin falls below 500 mcg/L, consider interrupting therapy with Exjade, since overchelation may increase Exjade toxicity .

For patients with NTDT, measure LIC by liver biopsy or by using an FDA-cleared or approved method for monitoring patients receiving Exjade therapy every 6 months on treatment. Interrupt Exjade administration when the LIC is less than 3 mg Fe/g dw. Measure serum ferritin monthly, and if the serum ferritin falls below 300 mcg/L, interrupt Exjade and obtain a confirmatory LIC .

6 ADVERSE REACTIONS

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


In patients with transfusional iron overload, the most frequently occurring (greater than 5%) adverse reactions are diarrhea, vomiting, nausea, abdominal pain, skin rashes, and increases in serum creatinine. In deferasirox-treated patients with NTDT syndromes, the most frequently occurring (greater than 5%) adverse reactions are diarrhea, rash and nausea. (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 drug and may not reflect the rates observed in practice. Exjade was evaluated in healthy volunteer trials. Currently, there are no clinical data in patients with Exjade tablets and Exjade Sprinkle granules. Exjade contains the same active ingredient as Exjade (deferasirox) tablets for oral suspension. The following adverse reactions have been reported with Exjade tablets for oral suspension.

Transfusional Iron Overload

A total of 700 adult and pediatric patients were treated with Exjade for 48 weeks in premarketing studies. These included 469 patients with beta-thalassemia, 99 with rare anemias, and 132 with sickle cell disease. Of these patients, 45% were male, 70% were Caucasian and 292 patients were less than 16 years of age. In the sickle cell disease population, 89% of patients were black. Median treatment duration among the sickle cell patients was 51 weeks. Of the 700 patients treated, 469 (403 beta-thalassemia and 66 rare anemias) were entered into extensions of the original clinical protocols. In ongoing extension studies, median durations of treatment were 88 to 205 weeks.

Six hundred twenty-seven patients with MDS were enrolled across 5 uncontrolled trials. These studies varied in duration from 1 to 5 years. The discontinuation rate across studies in the first year was 46% (AEs 20%, withdrawal of consent 10%, death 8%, other 4%, lab abnormalities 3%, and lack of efficacy 1%). Among 47 patients enrolled in the study of 5-year duration, 10 remained on Exjade at the completion of the study.

Table 1 displays adverse reactions occurring in greater than 5% of deferasirox-treated beta-thalassemia patients (Study 1), sickle cell disease patients (Study 3), and patients with MDS (MDS pool). Abdominal pain, nausea, vomiting, diarrhea, skin rashes, and increases in serum creatinine were the most frequent adverse reactions reported with a suspected relationship to Exjade. Gastrointestinal symptoms, increases in serum creatinine, and skin rash were dose related.

*Adverse reaction frequencies are based on adverse events reported regardless of relationship to study drug.

**Includes ‘abdominal pain’, ‘abdominal pain lower’, and ‘abdominal pain upper’ which were reported as adverse events.

***Includes ‘blood creatinine increased’ and ‘blood creatinine abnormal’ which were reported as adverse events. Also see Table 2.
Study 1

(Beta-thalassemia)

Study 3

(Sickle Cell Disease)

MDS Pool
Preferred Term Exjade

N=296

n (%)

Deferoxamine

N=290

n (%)

Exjade

N=132

n (%)

Deferoxamine

N=63

n (%)

Exjade

N=627

n (%)

Abdominal Pain** 63 (21) 41 (14) 37 (28) 9 (14) 145 (23)
Diarrhea 35 (12) 21 (7) 26 (20) 3 (5) 297 (47)
Creatinine Increased*** 33 (11) 0 (0) 9 (7) 0 89 (14)
Nausea 31 (11) 14 (5) 30 (23) 7 (11) 161 (26)
Vomiting 30 (10) 28 (10) 28 (21) 10 (16) 83 (13)
Rash 25 (8) 9 (3) 14 (11) 3 (5) 83 (13)

In Study 1, a total of 113 (38%) patients treated with Exjade had increases in serum creatinine greater than 33% above baseline on 2 separate occasions (Table 2) and 25 (8%) patients required dose reductions. Increases in serum creatinine appeared to be dose related . In this study, 17 (6%) patients treated with Exjade developed elevations in SGPT/ALT levels greater than 5 times the ULN at 2 consecutive visits. Of these, 2 patients had liver biopsy proven drug-induced hepatitis and both discontinued Exjade therapy . An additional 2 patients, who did not have elevations in SGPT/ALT greater than 5 times the ULN, discontinued Exjade because of increased SGPT/ALT. Increases in transaminases did not appear to be dose related. Adverse reactions that led to discontinuations included abnormal liver function tests (2 patients) and drug-induced hepatitis (2 patients), skin rash, glycosuria/proteinuria, Henoch Schönlein purpura, hyperactivity/insomnia, drug fever, and cataract (1 patient each).

In Study 3, a total of 48 (36%) patients treated with Exjade had increases in serum creatinine greater than 33% above baseline on 2 separate occasions (Table 2) . Of the patients who experienced creatinine increases in Study 3, 8 deferasirox-treated patients required dose reductions. In this study, 5 patients in the Exjade group developed elevations in SGPT/ALT levels greater than 5 times the ULN at 2 consecutive visits and 1 patient subsequently had Exjade permanently discontinued. Four additional patients discontinued due to adverse reactions with a suspected relationship to study drug, including diarrhea, pancreatitis associated with gallstones, atypical tuberculosis, and skin rash.

In the MDS pool, in the first year, a total of 229 (37%) patients treated with Exjade had increases in serum creatinine greater than 33% above baseline on 2 consecutive occasions (Table 2) and 8 (3.5%) patients permanently discontinued . A total of 5 (0.8%) patients developed SGPT/ALT levels greater than 5 times the ULN at 2 consecutive visits. The most frequent adverse reactions that led to discontinuation included increases in serum creatinine, diarrhea, nausea, rash, and vomiting. Death was reported in the first year in 52 (8%) of patients .

Study 1

(Beta-thalassemia)

Study 3

(Sickle Cell Disease)

MDS Pool
Laboratory Parameter Exjade

N=296

n (%)

Deferoxamine

N=290

n (%)

Exjade

N=132

n (%)

Deferoxamine

N=63

n (%)

Exjade

N=627

n (%)

Serum Creatinine
Creatinine increase >33% at 2 consecutive postbaseline visits 113 (38) 41 (14) 48 (36) 14 (22) 229 (37)
Creatinine increase >33% and >ULN at 2 consecutive postbaseline visits 7 (2) 1 (0) 3 (2) 2 (3) 126 (20)
SGPT/ALT
SGPT/ALT >5 x ULN at 2 postbaseline visits 25 (8) 7 (2) 2 (2) 0 9 (1)
SGPT/ALT >5 x ULN at 2 consecutive postbaseline visits 17 (6) 5 (2) 5 (4) 0 5 (1)

Non-Transfusion-Dependent Thalassemia Syndromes

In Study 4, 110 patients with NTDT received 1 year of treatment with Exjade 5 or 10 mg/kg/day and 56 patients received placebo in a double-blind, randomized trial. In Study 5, 130 of the patients who completed Study 4 were treated with open-label Exjade at 5, 10, or 20 mg/kg/day (depending on the baseline LIC) for 1 year . Table 3 displays adverse reactions occurring in greater than 5% in any group. The most frequent adverse reactions with a suspected relationship to study drug were nausea, rash, and diarrhea.

Study 4 Study 5
Exjade Placebo Exjade
N=110 N=56 N=130
n (%) n (%) n (%)
Any adverse reaction 31 (28) 9 (16) 27 (21)
Nausea 7 (6) 4 (7) 2 (2)
Rash 7 (6) 1 (2) 2 (2)
Diarrhea 5 (5) 1 (2) 7 (5)

In Study 4, 1 patient in the placebo 10 mg/kg/day group experienced an ALT increase to greater than 5 times ULN and greater than 2 times baseline (Table 4). Three deferasirox-treated patients (all in the 10 mg/kg/day group) had 2 consecutive serum creatinine level increases greater than 33% from baseline and greater than ULN. Serum creatinine returned to normal in all 3 patients (in 1 spontaneously and in the other 2 after drug interruption). Two additional cases of ALT increase and 2 additional cases of serum creatinine increase were observed in the 1-year extension of Study 4.

Study 4 Study 5
Exjade Placebo Exjade
N=110 N=56 N=130
Laboratory Parameter n (%) n (%) n (%)
Serum creatinine (>33% increase from baseline and >ULN at ≥2 consecutive postbaseline values) 3 (3) 0 2 (2)
SGPT/ALT (>5 x ULN and >2 x baseline) 1 (1) 1 (2) 2 (2)

Proteinuria

In clinical studies, urine protein was measured monthly. Intermittent proteinuria (urine protein/creatinine ratio greater than 0.6 mg/mg) occurred in 18.6% of deferasirox-treated patients compared to 7.2% of deferoxamine-treated patients in Study 1 .

Other Adverse Reactions

In the population of more than 5,000 patients with transfusional iron overload who have been treated with Exjade during clinical trials, adverse reactions occurring in 0.1% to 1% of patients included gastritis, edema, sleep disorder, pigmentation disorder, dizziness, anxiety, maculopathy, cholelithiasis, pyrexia, fatigue, laryngeal pain, cataract, hearing loss, gastrointestinal hemorrhage, gastric ulcer (including multiple ulcers), duodenal ulcer, renal tubular disorder (Fanconi’s syndrome), and acute pancreatitis (with and without underlying biliary conditions). Adverse reactions occurring in 0.01% to 0.1% of patients included optic neuritis, esophagitis, and erythema multiforme. Adverse reactions which most frequently led to dose interruption or dose adjustment during clinical trials were rash, gastrointestinal disorders, infections, increased serum creatinine, and increased serum transaminases.

6.2 Postmarketing Experience

The following adverse reactions have been spontaneously reported during post-approval use of Exjade in the transfusional iron overload setting. Because these reactions are reported voluntarily from a population of uncertain size, in which patients may have received concomitant medication, it is not always possible to reliably estimate frequency or establish a causal relationship to drug exposure.

Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome (SJS), leukocytoclastic vasculitis, urticaria, alopecia, toxic epidermal necrolysis (TEN)

Immune system disorders: hypersensitivity reactions (including anaphylactic reaction and angioedema)

Renal and urinary disorders: acute renal failure, tubulointerstitial nephritis

Hepatobiliary disorders: hepatic failure

Gastrointestinal disorders: gastrointestinal perforation

Blood and lymphatic system disorders: worsening anemia

7 DRUG INTERACTIONS

7.1 Aluminum Containing Antacid Preparations

The concomitant administration of Exjade and aluminum-containing antacid preparations has not been formally studied. Although Exjade has a lower affinity for aluminum than for iron, avoid use of Exjade with aluminum-containing antacid preparations.

7.2 Agents Metabolized by CYP3A4

Exjade may induce CYP3A4 resulting in a decrease in CYP3A4 substrate concentration when these drugs are coadministered. Closely monitor patients for signs of reduced effectiveness when Exjade is administered with drugs metabolized by CYP3A4 .

7.3 Agents Metabolized by CYP2C8

Exjade inhibits CYP2C8 resulting in an increase in CYP2C8 substrate (e.g., repaglinide and paclitaxel) concentration when these drugs are coadministered. If Exjade and repaglinide are used concomitantly, consider decreasing the dose of repaglinide and perform careful monitoring of blood glucose levels. Closely monitor patients for signs of exposure related toxicity when Exjade is coadministered with other CYP2C8 substrates .

7.4 Agents Metabolized by CYP1A2

Exjade inhibits CYP1A2 resulting in an increase in CYP1A2 substrate concentration when these drugs are coadministered. An increase in theophylline plasma concentrations could lead to clinically significant theophylline induced CNS or other adverse reactions. Avoid the concomitant use of theophylline or other CYP1A2 substrates with a narrow therapeutic index (e.g., tizanidine) with Exjade. Monitor theophylline concentrations and consider theophylline dose modification if you must coadminister theophylline with Exjade. Closely monitor patients for signs of exposure related toxicity when Exjade is coadministered with other drugs metabolized by CYP1A2 .

7.5 Agents Inducing UDP-glucuronosyltransferase (UGT) Metabolism

Exjade is a substrate of UGT1A1 and to a lesser extent UGT1A3. The concomitant use of Exjade with strong UGT inducers (e.g., rifampicin, phenytoin, phenobarbital, ritonavir) may result in a decrease in Exjade efficacy due to a possible decrease in Exjade concentration. Avoid the concomitant use of strong UGT inducers with Exjade. Consider increasing the initial dose of Exjade if you must coadminister these agents together .

7.6 Bile Acid Sequestrants

Avoid the concomitant use of bile acid sequestrants (e.g., cholestyramine, colesevelam, colestipol) with Exjade due to a possible decrease in Exjade concentration. If you must coadminister these agents together, consider increasing the initial dose of Exjade .

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no studies with the use of Exjade in pregnant women to inform drug-associated risks.

Administration of Exjade to rats during pregnancy resulted in decreased offspring viability and an increase in renal anomalies in male offspring at doses that were about or less than the recommended human dose on a mg/m2 basis. No fetal effects were noted in pregnant rabbits at doses equivalent to the human recommended dose on a mg/m2 basis. Exjade should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies.

Data

Animal Data

In embryo-fetal developmental studies, pregnant rats and rabbits received oral Exjade during the period of organogenesis at doses up to 100 mg/kg/day in rats and 50 mg/kg/day in rabbits (1.2 times the maximum recommended human dose (MRHD) on a mg/m2 basis). These doses resulted in maternal toxicity but no fetal harm was observed.

In a prenatal and postnatal developmental study, pregnant rats received oral Exjade daily from organogenesis through lactation day 20 at doses of 10, 30, and 90 mg/kg/day (0.1, 0.3, and 1.0 times the MRHD on a mg/m2 basis). Maternal toxicity, loss of litters, and decreased offspring viability occurred at 90 mg/kg/day (1.0 times the MRHD on a mg/m2 basis), and increases in renal anomalies in male offspring occurred at 30 mg/kg/day (0.3 times the MRHD on a mg/m2 basis).

8.2 Lactation

Risk Summary

No data are available regarding the presence of Exjade or its metabolites in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Exjade and its metabolites were excreted in rat milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Exjade and its metabolites, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4 Pediatric Use

Of the 700 patients with transfusional iron overload who received Exjade during clinical studies, 292 were pediatric patients 2 to less than 16 years of age with various congenital and acquired anemias, including 52 patients age 2 to less than 6 years, 121 patients age 6 to less than 12 years and 119 patients age 12 to less than 16 years. Seventy percent of these patients had beta-thalassemia. Children between the ages of 2 to less than 6 years have a systemic exposure to Exjade approximately 50% of that of adults . However, the safety and efficacy of Exjade in pediatric patients was similar to that of adult patients, and younger pediatric patients responded similarly to older pediatric patients. The recommended starting dose and dosing modification are the same for children and adults .

Growth and development in patients with chronic iron overload due to blood transfusions were within normal limits in children followed for up to 5 years in clinical trials.

Sixteen pediatric patients (10 to less than 16 years of age) with chronic iron overload and NTDT were treated with Exjade in clinical studies. The safety and efficacy of Exjade in these children was similar to that seen in the adults. The recommended starting dose and dosing modification are the same for children and adults with chronic iron overload in NTDT .

Safety and effectiveness have not been established in pediatric patients with chronic iron overload due to blood transfusions who are less than 2 years of age or pediatric patients with chronic iron overload and NTDT who are less than 10 years of age.

8.5 Geriatric Use

Four hundred thirty-one patients greater than or equal to 65 years of age were studied in clinical trials of Exjade in the transfusional iron overload setting. Two hundred twenty-five of these patients were between 65 and 75 years of age while 206 were greater than or equal to 75 years of age. The majority of these patients had myelodysplastic syndrome (MDS) (n=393). In these trials, elderly patients experienced a higher frequency of adverse reactions than younger patients. Monitor elderly patients for early signs or symptoms of adverse reactions that may require a dose adjustment. Elderly patients are at increased risk for toxicity due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

8.6 Renal Impairment

For patients with creatinine clearance 40 to 60 mL/min, reduce the starting dose by 50% . Exjade is contraindicated in patients with a CLcr less than 40 mL/min or serum creatinine greater than two times the age-appropriate upper limit of normal (ULN) .

Exjade can cause renal failure. Monitor serum creatinine and calculate creatinine clearance during treatment in all patients. Reduce, interrupt or discontinue Exjade dosing based on increases in serum creatinine .

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 A) or moderate (Child-Pugh B) hepatic impairment for efficacy and adverse reactions that may require dose titration .

10 OVERDOSAGE

Cases of overdose (2 to 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 of Exjade up to 80 mg per kg per day with the tablet for oral suspension formulation in iron overloaded beta-thalassemic patients have been tolerated with nausea and diarrhea noted. In healthy subjects, single doses of up to 40 mg per kg per day with the tablet for oral suspension formulation were tolerated. There is no specific antidote for Exjade. In case of overdose, induce vomiting and employ gastric lavage.

11 DESCRIPTION

Exjade (deferasirox) is an iron chelating agent provided as a tablet for oral use. Exjade is designated chemically as 4-[3,5-bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]benzoic acid and has the following structural formula:

Study 2 was an open-label, noncomparative trial of efficacy and safety of Exjade tablets for oral suspension given for 1 year to patients with chronic anemias and transfusional hemosiderosis. Similar to Study 1, patients received 5, 10, 20, or 30 mg per kg per day of Exjade tablets for oral suspension based on baseline LIC.

A total of 184 patients were treated in this study: 85 patients with beta-thalassemia and 99 patients with other congenital or acquired anemias (myelodysplastic syndromes, n=47; Diamond-Blackfan syndrome, n=30; other, n=22). 19% of patients were less than 16 years of age and 16% were greater than or equal to 65 years of age. There was a reduction in the absolute LIC from baseline to end of study (-4.2 mg Fe/g dry weight).

Study 3 was a multicenter, open-label, randomized trial of the safety and efficacy of Exjade tablets for oral suspension relative to deferoxamine given for 1 year in patients with sickle cell disease and transfusional hemosiderosis. Patients were randomized to Exjade tablets for oral suspension at doses of 5, 10, 20, or 30 mg per kg per day or subcutaneous deferoxamine at doses of 20-60 mg per kg per day for 5 days per week according to baseline LIC.

A total of 195 patients were treated in this study: 132 with Exjade tablets for oral suspension and 63 with deferoxamine. Forty-four percent of patients were less than 16 years of age and 91% were black. At end of study, the mean change in LIC (as measured by magnetic susceptometry by a superconducting quantum interference device) in the per protocol-1 (PP-1) population, which consisted of patients who had at least 1 post-baseline LIC assessment, was -1.3 mg Fe/g dry weight for patients receiving Exjade tablets for oral suspension (n=113) and -0.7 mg Fe/g dry weight for patients receiving deferoxamine (n=54).

One-hundred five (105) patients with thalassemia major and cardiac iron overload were enrolled in a study assessing the change in cardiac MRI T2* value (measured in milliseconds, ms) before and after treatment with Exjade. Cardiac T2* values at baseline ranged from 5 to less than 20 ms. The geometric mean of cardiac T2* in the 68 patients who completed 3 years of Exjade tablets for oral suspension therapy increased from 11.98 ms at baseline to 17.12 ms at 3 years. Cardiac T2* values improved in patients with severe cardiac iron overload (less than 10 ms) and in those with mild to moderate cardiac iron overload (greater than or equal to 10 to less than 20 ms). The clinical significance of these observations is unknown.

Six hundred twenty-seven patients with MDS were enrolled across 5 uncontrolled trials. Two hundred thirty-nine of the 627 patients were enrolled in trials that limited enrollment to patients with IPSS Low or Intermediate 1 risk MDS and the remaining 388 patients were enrolled in trials that did not specify MDS risk stratification but required a life expectancy of greater than 1 year. Planned duration of treatment in these trials ranged from 1 year (365 patients) to 5 years (47 patients). These trials evaluated the effects of Exjade tablets for oral suspension therapy on parameters of iron overload, including LIC (125 patients) and serum ferritin (627 patients). Percent of patients completing planned duration of treatment was 51% in the largest 1 year study, 52% in the 3-year study and 22% in the 5 year study. The major causes for treatment discontinuation were withdrawal of consent, adverse reaction, and death. Over 1 year of follow-up across these pooled studies, mean change in serum ferritin was -332.8 (±2615.59) mcg/L (n=593) and mean change in LIC was -5.9 (±8.32) mg Fe/g dw (n=68). Results of these pooled studies in 627 patients with MDS suggest a progressive decrease in serum ferritin and LIC beyond 1 year in those patients who are able to continue Exjade tablets for oral suspension. No controlled trials have been performed to demonstrate that these reductions improve morbidity or mortality in patients with MDS. Adverse reactions with Exjade tablets for oral suspension therapy occur more frequently in older patients . In elderly patients, including those with MDS, individualize the decision to remove accumulated iron based on clinical circumstances and the anticipated clinical benefit and risks of Exjade tablets for oral suspension therapy.

Non-Transfusion-Dependent Thalassemia

Study 4 was a randomized, double-blind, placebo-controlled trial of treatment with Exjade tablets for oral suspension for patients 10 years of age or older with NTDT syndromes and iron overload. Eligible patients had an LIC of at least 5 mg Fe/g dw measured by R2 MRI and a serum ferritin exceeding 300 mcg/L at screening (2 consecutive values at least 14 days apart from each other). A total of 166 patients were randomized, 55 to the Exjade tablets for oral suspension 5 mg/kg/day dose group, 55 to the Exjade tablets for oral suspension 10 mg/kg/day dose group, and 56 to placebo (28 to each matching placebo group). Doses could be increased after 6 months if the LIC exceeded 7 mg Fe/g dw and the LIC reduction from baseline was less than 15%. The patients enrolled included 89 males and 77 females. The underlying disease was beta-thalassemia intermedia in 95 (57%) patients, HbE beta-thalassemia in 49 (30%) patients, and alpha-thalassemia in 22 (13%) patients. There were 17 pediatric patients in the study. Caucasians comprised 57% of the study population and Asians comprised 42%. The median baseline LIC (range) for all patients was 12.1 (2.6 to 49.1) mg Fe/g dw. Follow-up was for 1 year. The primary efficacy endpoint of change in LIC from baseline to Week 52 was statistically significant in favor of both Exjade dose groups compared with placebo (p less than or equal to 0.001) (Table 5). Furthermore, a statistically significant dose effect of Exjade was observed in favor of the 10 mg/kg/day dose group (10 versus 5 mg/kg/day, p=0.009). In a descriptive analysis, the target LIC (less than 5 mg Fe/g dw) was reached by 15 (27%) of 55 patients in the 10 mg/kg/day arm, 8 (15%) of 55 patients in the 5 mg/kg/day arm and 2 (4%) of 56 patients in the combined placebo groups.

1Randomized dose in Study 4 or assigned starting dose in Study 5

2Least square mean change for Study 4
Exjade tablets for oral suspension Starting Dose1
Placebo 5 mg/kg/day 10 mg/kg/day 20 mg/kg/day
Study 42
Number of Patients n=54 n=51 n=54 -
Mean LIC at Baseline (mg Fe/g dw) 16.1 13.4 14.4 -
Mean Change (mg Fe/g dw) +0.4 -2.0 -3.8 -
(95% Confidence Interval) (-0.6, +1.3) (-2.9, -1.0) (-4.8, -2.9) -
Study 5
Number of Patients - n=8 n=77 n=43
Mean LIC at Baseline (mg Fe/g dw) - 5.6 8.8 23.5
Mean Change (mg Fe/g dw) - -1.5 -2.8 -9.1
(95% Confidence Interval) - (-3.7, +0.7) (-3.4, -2.2) (-11.0, -7.3)

Study 5 was an open-label trial of Exjade tablets for oral suspension for the treatment of patients previously enrolled on Study 4, including cross-over to active treatment for those previously treated with placebo. The starting dose of Exjade tablets for oral suspension in Study 5 was assigned based on the patient’s LIC at completion of Study 4, being 20 mg/kg/day for an LIC exceeding 15 mg Fe/g dw, 10 mg/kg/day for LIC 3 to 15 mg Fe/g dw, and observation if the LIC was less than 3 mg Fe/g dw. Patients could continue on 5 mg/kg/day if they had previously exhibited at least a 30% reduction in LIC. Doses could be increased to a maximum of 20 mg/kg/day after 6 months if the LIC was more than 7 mg Fe/g dw and the LIC reduction from baseline was less than 15%. The primary efficacy endpoint in Study 5 was the proportion of patients achieving an LIC less than 5 mg Fe/g dw. A total of 133 patients were enrolled. Twenty patients began Study 5 with an LIC less than 5 mg Fe/g dw. Of the 113 patients with a baseline LIC of at least 5 mg Fe/g dw in Study 5, the target LIC (less than 5 mg Fe/g dw) was reached by 39 (35%). The responders included 4 (10%) of 39 patients treated at 20 mg/kg/day for a baseline LIC exceeding 15 mg Fe/g dw, and 31 (51%) of 61 patients treated at 10 mg/kg/day for a baseline LIC between 5 and 15 mg Fe/g dw. The absolute change in LIC at Week 52 by starting dose is shown in Table 5.

Figure 1. Changes in Liver Iron Concentration and Serum Ferritin Following Exjade (5 30 mg/kg per day) in Study 1.

16 HOW SUPPLIED/STORAGE AND HANDLING

Exjade 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 the other side. They are available in bottles of 30 tablets (NDC 0078-0654-15).

Exjade 180 mg tablets are medium blue in color, film-coated, oval biconvex tablet with beveled edges, debossed with ‘NVR’ on one side and ‘180’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0655-15).

Exjade 360 mg tablets are dark blue in color, film-coated, oval biconvex tablet with beveled edges, debossed with ‘NVR’ on one side and ‘360’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0656-15).

Store Exjade tablets at 25°C (77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F). Protect from moisture.

Exjade Sprinkle 90 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0727-15).

Exjade Sprinkle 180 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0713-15).

Exjade Sprinkle 360 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0720-15).

Store Exjade Sprinkle granules at 25°C (77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F). Protect from moisture.

17 PATIENT COUNSELING INFORMATION

Blood Testing

Advise patients that blood tests will be performed frequently to check for damage to kidneys, liver, or blood cells .

Gastrointestinal Ulceration and Hemorrhage

Caution patients about the potential for the development of GI ulcers or bleeding when taking Exjade in combination with drugs that have ulcerogenic or hemorrhagic potential, such as NSAIDs, corticosteroids, oral bisphosphonates, or anticoagulants .

Skin and Allergic Reactions

Skin rashes may occur during Exjade treatment and if severe, interrupt treatment. Serious allergic reactions (which include swelling of the throat) have been reported in patients taking Exjade, usually within the first month of treatment. If reactions are severe, advise patients to stop taking Exjade and contact their doctor immediately .

Auditory and Ocular Testing

Because auditory and ocular disturbances have been reported with Exjade, conduct auditory testing and ophthalmic testing before starting Exjade treatment and thereafter at regular intervals .

Drug Interactions

Caution patients not to take aluminum containing antacids and Exjade tablets or granules simultaneously .

Caution patients about potential loss of effectiveness of drugs metabolized by CYP3A4 (e.g., cyclosporine, simvastatin, hormonal contraceptive agents) when Exjade is administered with these drugs .

Caution patients about potential loss of effectiveness of Exjade when administered with drugs that are potent UGT inducers (e.g., rifampicin, phenytoin, phenobarbital, ritonavir). Based on serum ferritin levels and clinical response, consider increases in the dose of Exjade when concomitantly used with potent UGT inducers .

Caution patients about potential loss of effectiveness of Exjade when administered with drugs that are bile acid sequestrants (e.g., cholestyramine, colesevelam, colestipol). Based on serum ferritin levels and clinical response, consider increases in the dose of Exjade when concomitantly used with bile acid sequestrants .

Dosing Instructions

Advise patients to take Exjade tablets with water or other liquids. Advise patients to swallow Exjade tablets once daily with water or other liquids, preferably at the same time each day. Advise patients to take Exjade tablets on an empty stomach or with a light meal (contains less than 7% fat content and approximately 250 calories). Examples of light meals include 1 whole wheat English muffin, 1 packet jelly (0.5 ounces), and skim milk (8 fluid ounces) or a turkey sandwich (2 oz. turkey on whole wheat bread w/lettuce, tomato, and 1 packet mustard). For patients who have difficulty swallowing whole tablets, Exjade tablets may be crushed and mixed with soft foods (e.g., yogurt or apple sauce) immediately prior to use and administered orally. Advise against the use of commercial crushers with serrated surfaces for crushing a single 90 mg tablet. Advise patients to immediately and completely consume the dose and not store it for future use .

Advise patients to take Exjade Sprinkle granules by sprinkling the full dose on soft food (e.g., yogurt or apple sauce) immediately prior to use and administered orally. Advise patients to take Exjade Sprinkle granules once a day, preferably at the same time each day. Exjade Sprinkle granules may be taken on an empty stomach or with a light meal.

Handling Instructions

Advise patients to store Exjade in a dry, room-temperature environment .

Driving and Using Machines

Caution patients experiencing dizziness to avoid driving or operating machinery .

Distributed by:

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936

© Novartis

T2017-37

Exjade pharmaceutical active ingredients containing related brand and generic drugs:


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References

  1. Dailymed."JADENU (DEFERASIROX) TABLET, FILM COATED JADENU (DEFERASIROX) GRANULE [NOVARTIS PHARMACEUTICALS CORPORATION]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."DEFERASIROX: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "Deferasirox". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Exjade?

Depending on the reaction of the Exjade after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Exjade not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Exjade addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Exjade, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Exjade consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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One visitor reported doses

What is the dose of Exjade drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 201-500mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
201-500mg1
100.0%

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The information was verified by Dr. Rachana Salvi, MD Pharmacology


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