Asunra

Asunra400 mg

Tablet

Deferasirox

Novartis (Bangladesh) Ltd.

Product Code : 1505
MRP 187.68
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Medicine overview

Indications of Asunra 400 mg

Asunra 400 mg is indicated for the treatment of chronic iron overload due to blood transfusions in adult and paediatric patients (aged 2 years and over).

Theropeutic Class

Antidote preparations

Pharmacology

Asunra 400 mg 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 Asunra 400 mg has very low affinity for zinc and copper there are variable decreases in the serum concentration of these trace metals after the administration of Asunra 400 mg. The clinical significance of these decreases is uncertain.

Dosage of Asunra 400 mg

2 years children & Adult Dose:Chronic Iron overload: Initially, 20 mg/kg daily. Adjust dosage every 3-6 months as needed based on trends in serum ferritin concentrations (monitor monthly). Adjust dosage in increments of 5 or 10 mg/kg daily (up to maximum dosage of 30 mg/kg daily) according to the patient’s clinical response and therapeutic goals. Consider temporarily interrupting therapy if serum ferritin concentrations are consistently <500 mcg/L.

Administration of Asunra 400 mg

Asunra 400 mg must be taken once daily on an empty stomach at least 30 minutes before food, preferably at the same time each day. The tablets are dispersed by stirring in a glass of water or apple or orange juice (100 to 200 mL) until a line suspension is obtained. After the suspension has been swallowed, any residue must be resuspended in a small volume of water or juice and swallowed. The tablets must not be chewed or swallowed whole. Dispersion in carbonated drinks or milk is not recommended due to foaming and slow dispersion, respectively.

Interaction of Asunra 400 mg

May chelate Al when used with Al-containing antacids. Decreased exposure with colestyramine and potent inducers of UGT enzymes (e.g. carbamazepine, rifampicin, phenytoin). May increase serum concentration of CYP1A2 (e.g. duloxetine, theophylline) and CYP2C8 (e.g. repaglinide, paclitaxel) substrates, and decrease serum concentrations of CYP3A4 substrates (e.g. ciclosporin, hormonal contraceptives, simvastatin).

Contraindications

Creatinine clearance <40 mL/min or serum creatinine >2 times the age-appropriate upper limit of normal. High risk myelodysplastic syndrome (MDS) patients and patients with other hematological and non-hematological malignancies who are not expected to benefit from chelation therapy due to the rapid progression of their disease. Hypersensitivity to the active substance or to any of the excipients.

Side Effects of Asunra 400 mg

Serum creatinine increase, Abdominal pain, Nausea, Vomiting, Diarrhea, Proteinuria, Pyrexia, Headache, Cough , Nasopharyngitis, Pharyngolaryngeal pain, Influenza, Rash, Respiratory tract infection, Bronchitis, ALT increased, Arthralgia, back pain, Acute tonsillitis, Rhinitis, Fatigue, Ear infection, Transaminitis, Urticaria, Anaphylaxis, Angioedema, Cytopenias, including agranulocytosis, neutropenia and thrombocytopenia; leukocytoclastic vasculitis

Pregnancy & Lactation

Pregnancy: No clinical data on exposed pregnancies are available for Asunra 400 mg. Studies in animals have shown some reproductive toxicity at maternally toxic doses. The potential risk for humans is unknown. As a precaution, it is recommended that Asunra 400 mg not be used during pregnancy unless clearly necessary.Breast-feeding: In animal studies, Asunra 400 mg was found to be rapidly and extensively secreted into maternal milk. No effect on the offspring was noted. It is not known if Asunra 400 mg is secreted into human milk. Breast-feeding while taking Asunra 400 mg is not recommended.

Precautions & Warnings

Moderate hepatic impairment. Children. Pregnancy and lactation.

Overdose Effects of Asunra 400 mg

Single doses up to 40 mg/kg in normal subjects have been well tolerated. Acute signs of overdose may include nausea, vomiting, headache, and diarrhea. Overdose may be treated by induction of emesis or by gastric lavage, and by symptomatic treatment.

Storage Conditions

Store at 25° C. Protect from moisture.

Use In Special Populations

Dosage Modification for Adverse Renal Effects: Interrupt therapy if a progressive increase in SCR (Serum Creatinine Concentration) beyond the ULN occurs. Once SCR returns to within normal limits, reinitiate therapy at a lower dosage followed by gradual dosage escalation if clinical beneht is expected to outweigh potential risks. Reduce dosage by 10 mg/kg daily if SCR at 2 consecutive visits increases to a level >33% above the average pretreatment value and the increase cannot be attributed to other causes.Dosage Modifcation for Adverse Hepatic Effects: Consider dosage adjustment or interruption of therapy in patients with severe, persistent, progressive, or unexplained elevations of liver function test results.

Reconstitution

Completely disperse tab by stirring in water, orange or apple juice. Disperse 1 gm in 210 ml of liq. Following admin, any residue should be resuspended in a small vol of liq.

Drug Classes

Antidote preparations

Mode Of Action

Asunra 400 mg 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 Asunra 400 mg has very low affinity for zinc and copper there are variable decreases in the serum concentration of these trace metals after the administration of Asunra 400 mg. The clinical significance of these decreases is uncertain.

Pregnancy

Pregnancy: No clinical data on exposed pregnancies are available for Asunra 400 mg. Studies in animals have shown some reproductive toxicity at maternally toxic doses. The potential risk for humans is unknown. As a precaution, it is recommended that Asunra 400 mg not be used during pregnancy unless clearly necessary.Breast-feeding: In animal studies, Asunra 400 mg was found to be rapidly and extensively secreted into maternal milk. No effect on the offspring was noted. It is not known if Asunra 400 mg is secreted into human milk. Breast-feeding while taking Asunra 400 mg is not recommended.

Pediatric Uses

Dosage Modification for Adverse Renal Effects: Interrupt therapy if a progressive increase in SCR (Serum Creatinine Concentration) beyond the ULN occurs. Once SCR returns to within normal limits, reinitiate therapy at a lower dosage followed by gradual dosage escalation if clinical beneht is expected to outweigh potential risks. Reduce dosage by 10 mg/kg daily if SCR at 2 consecutive visits increases to a level >33% above the average pretreatment value and the increase cannot be attributed to other causes.Dosage Modifcation for Adverse Hepatic Effects: Consider dosage adjustment or interruption of therapy in patients with severe, persistent, progressive, or unexplained elevations of liver function test results.
Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.