Deferasirox 125mg /250mg/ 500mg Dispersible Tablets (Defra taj)

Deferasirox Dispersible Tablets (DefraTaj)
100,125,250,400 & 500 MG
Each dispersible tablet contains: Deferasirox. 100 mg, Excipients Q.S.
Each dispersible tablet contains: Deferasirox. 125 mg, Excipients Q.S.
Each dispersible tablet contains: Deferasirox. 250 mg, Excipients Q.S.
Each dispersible tablet contains: Deferasirox. 400 mg, Excipients Q.S.
Each dispersible tablet contains: Deferasirox. 500 mg, Excipients Q.S.

Across a range of anemias, unlock the benefits of once-daily oral DefraTaj® in treating chronic iron overload

DefraTaj (deferasirox) binds to iron and removes it from the blood stream. DefraTajis used to treat iron overload caused by blood transfusions in adults and children at least 2 years old.
DefraTaj is a tridentate ligand that binds iron with high affinity, forming a 2:1 complex that is excreted in bile and eliminated primarily via the feces.
DefraTaj is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassemia major aged 6 years and older.

DefraTaj is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:

  • in patients with beta thalassemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years
  • in patients with beta thalassemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older
  • in patients with other anemias aged 2 years and older

DefraTaj is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non−transfusion−dependent thalassemia syndromes aged 10 years and older.

Contraindications:

DefraTaj is contraindicated in:

  • patients with hypersensitivity to the active substance or the following excipients: lactose monohydrate; crospovidone type A; cellulose, microcrystalline; povidone; sodium lauryl sulfate; silica, colloidal anhydrous; magnesium stearate
  • combination with other iron chelator therapies as the safety of such combinations has not been established
  • patients with estimated creatinine clearance <60 ml/min

Warning
Data in children with NTDT are very limited. As a consequence, DefraTaj therapy should be closely monitored to detect side effects and to follow iron burden in the pediatric population. In addition, before treating heavily iron-overloaded children with NTDT with DefraTaj, the physician should be aware that the consequences of long-term exposure in such patients are currently not known.
Starting DefraTaj® treatment in NTDT patients with chronic iron overload

Measure iron overload with liver iron concentration (LIC)
LIC is the preferred method of iron overload determination and should be used wherever available. Caution should be taken during chelation therapy to minimize the risk of overchelation in all patients.
One course of treatment with DefraTaj is recommended for patients with NTDT who achieve a satisfactory iron level.

Measure iron overload with liver iron concentration (LIC)
LIC is the preferred method of iron overload determination and should be used wherever available. Caution should be taken during chelation therapy to minimize the risk of overchelation in all patients.

One course of treatment with DefraTaj is recommended for patients with NTDT who achieve a satisfactory iron level.

What is DefraTaj?
DefraTaj (deferasirox) binds to iron and removes it from the blood stream. DefraTaj is used to treat iron overload caused by blood transfusions in adults and children at least 2 years old. DefraTaj is also used to treat chronic iron overload syndrome caused by a genetic blood disorder in adults and children who are at least 10 years old.

Important information
You should not use DefraTajif you have severe kidney or liver disease, advanced cancer, a blood cell or bone marrow disorder, or low levels of platelets in your blood.

Deferasirox can harm your liver or kidneys. Stop using DefraTaj and call your doctor at once if you have swelling, rapid weight gain, shortness of breath, pain in your upper stomach, loss of appetite, pain in your side or lower back, little or no urinating, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). Deferasirox may also cause stomach or intestinal bleeding. Call your doctor at once if you have symptoms of stomach bleeding such as bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds. While you are taking DefraTaj, do not take antacids that contain aluminum, such as Amphojel, Gaviscon, Maalox, Mi-Acid, Mylanta, Rulox, and others.

Before taking this medicine You should not use DefraTaj if you are allergic to deferasirox, or if you have: severe liver or kidney disease;
advanced cancer; a bone marrow disorder; or low levels of platelets in your blood.
To make sure DefraTaj is safe for you, tell your doctor if you have:
kidney disease; liver disease; anemia (low red blood cells); cancer (especially blood cell cancer such as leukemia); a stomach ulcer; a history of stomach or intestinal bleeding; vision or hearing problems; or a weak immune system caused by disease (such as cancer, HIV, or AIDS), or by receiving steroids, chemotherapy, or radiation. It is not known whether DefraTaj will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

DefraTaj can make birth control pills less effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

It is not known whether deferasirox passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking DefraTaj.

How should I take DefraTaj?
Take DefraTaj exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Your doctor may perform certain tests to make sure you do not have conditions that would prevent you from safely using DefraTaj.
Take this medicine at the same time every day.
Take DefraTaj on an empty stomach at least 30 minutes before eating.
Do not chew or crush the DefraTaj dispersible tablet and do not swallow it whole. Place the tablet into a glass of apple juice, orange juice, or water and allow the tablet to disperse in the liquid. The tablet will not dissolve completely. Drink this mixture right away. To make sure you get the entire dose, add a little more liquid to the same glass, swirl gently and drink right away.

If you take less than 1000 milligrams (1 gram) daily, dissolve the tablet in about one-half cup of apple juice, orange juice, or water. If you take more than 1000 milligrams daily, dissolve the tablet in about 1 cup of apple juice, orange juice, or water.

While using DefraTaj, you may need frequent blood tests. Your kidney or liver function may also need to be checked every 6 months, and you may need a liver biopsy.

Store at room temperature, away from moisture and heat.

DefraTaj side effects :
Get emergency medical help if you have any of these signs of an allergic reaction to DefraTaj: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using DefraTaj and call your doctor at once if you have: problems with vision or hearing;
kidney problems – urinating more or less than usual; painful or difficult urination; swelling in your feet or ankles; weakness, bone pain; feeling tired or short of breath; liver problems – nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); signs of stomach bleeding – bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; low blood cell counts – fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, rapid heart rate, pale skin, easy bruising, unusual bleeding, feeling light-headed; or severe skin reaction – fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Serious side effects may be more likely in older adults.
Common DefraTaj side effects may include: nausea, vomiting, stomach pain; diarrhea; or skin rash.

Usual Adult Dose for:
Iron Overload
Thalassemia
Usual Pediatric Dose for:
Iron Overload
Thalassemia
Additional dosage information:
Renal Dose Adjustments
Liver Dose Adjustments
Dose Adjustments
Precautions
Dialysis

Other Comments Usual Adult Dose for Iron Overload

DefraTaj(R): Initial dose: 20 mg/kg, orally, once a day – calculate dose to the nearest whole tablet
Monitor serum ferritin monthly: Adjust dose every 3 to 6 months, by 5 to 10 mg/kg, based on serum ferritin trends

Maximum dose: 40 mg/kg
Comments: -Only consider therapy when evidence of chronic transfusional overload exists (e.g. transfusion of at least 100 mL/kg packed red blood cells and a serum ferritin consistently greater than 1000 mcg/L).

-Prior to treatment, obtain serum ferritin level, baseline serum creatinine in duplicate and determine creatinine clearance, serum transaminases, bilirubin, and baseline auditory and ophthalmic examinations.

-Tailor dose to patient response and therapeutic goals.
Use: Transfusional iron overload
Usual Adult Dose for Thalassemia

DefraTaj(R):
Initial dose: 10 mg/kg, orally, once a day – calculate dose to the nearest whole tablet
-If baseline liver iron concentration (LIC) is over 15 Fe/g dw, consider increasing dose to 20 mg/kg/day after 4 weeks
Maximum dose: 20 mg/kg/day
After 6 months therapy:

-If LIC remains above 7 mg Fe/g dw: increase to 20 mg/kg/day
-If LIC is 3 to 7 mg Fe/g dw: Continue at no more than 10 mg/kg/day

Presentation
DefraTaj® Deferasirox Dispersible Tablets,
100,125,250,400 & 500 MG

Deferasirox Dispersible Tablets  100            ALU- ALU Blister pack of 10 tablets
Deferasirox Dispersible Tablets  125            ALU- ALU Blister pack of 10 tablets
Deferasirox Dispersible Tablets  250            ALU- ALU Blister pack of 10 tablets
Deferasirox Dispersible Tablets  400            ALU- ALU Blister pack of 10 tablets
Deferasirox Dispersible Tablets  500            ALU- ALU Blister pack of 10 tablets

Storage

Store Deferasirox 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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Taj Generics (Taj Pharma) provides a wide range of products to the Indian market, including an extensive range of generics and specialty products; Our products cover a vast array of therapeutic categories, and we offer an extensive range of dosage forms and delivery systems including oral solids, controlled-release, steriles, injectables, topicals, liquids, transdermals, semi-solids and high-potency products. Our Generics portfolio offers over 1500 products in the major therapeutic areas of gastro-intestinal, cardiovascular, pain management, oncology, anti-infectives, paediatrics and dermatology.