Deferasirox (Tablets, Capsules) Instructions for Use
ATC Code
V03AC03 (Deferasirox)
Active Substance
Deferasirox (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Chelating agent
Pharmacotherapeutic Group
Other therapeutic products; iron-chelating agents
Pharmacological Action
Complexing agent. It is a tridentate ligand with high affinity for iron (III) and binds it in a 2:1 ratio.
It enhances iron excretion, primarily in the feces. Deferasirox has low affinity for zinc and copper and does not cause a persistent decrease in the serum levels of these metals.
It has been shown that with daily use of deferasirox at doses of 20 mg/kg and 30 mg/kg for 1 year in adults and children with β-thalassemia on ongoing blood transfusions, total body iron stores were reduced; liver iron concentration decreased on average by nearly 0.4 mg Fe/g and 0.9 mg Fe/g of liver dry weight, respectively, and serum ferritin concentration decreased on average by nearly 36 µg/L and 926 µg/L, respectively. When used at the same doses, the ratio of iron excretion to iron intake was 1.02 (which is an indicator of normal iron balance) and 1.67 (which corresponds to increased iron excretion from the body). A similar therapeutic response was observed with the use of deferasirox in patients with iron overload and other types of anemia. The use of deferasirox at a daily dose of 10 mg/kg for 1 year allowed maintenance of normal liver iron content, serum ferritin concentration, and contributed to the achievement of iron balance (equilibrium between iron intake and excretion) in patients who rarely receive blood transfusions or exchange transfusions.
Pharmacokinetics
Deferasirox is well absorbed after oral administration, with a mean Tmax in plasma of about 1.5-4 hours. The absolute bioavailability (by AUC) of deferasirox after oral administration is about 70% compared to IV administration. At steady state, the Cmax and AUC0-24h of deferasirox increase nearly linearly with the dose. Deferasirox accumulates in the body, with an accumulation factor of 1.3-2.3. Deferasirox is highly bound to plasma proteins (99%), almost exclusively to albumin; it has a small apparent Vd – approximately 14 L in adults.
When taken with food, the bioavailability of deferasirox increases to varying degrees.
The main pathway of deferasirox metabolism is glucuronidation followed by biliary excretion. Deconjugation of glucuronides in the intestine and subsequent reabsorption (enterohepatic recirculation) is likely to occur. Oxidative metabolism of deferasirox mediated by CYP450 is less pronounced in humans (about 8%). There is no evidence of enzyme induction or inhibition when the drug is used at therapeutic doses.
In vitro, no inhibition of deferasirox metabolism by hydroxyurea was observed.
Deferasirox and its metabolites are excreted primarily in the feces (84% of the dose). Renal excretion of deferasirox and its metabolites is minimal (8% of the dose). The mean T1/2 ranges from 8 to 16 hours.
The overall bioavailability of deferasirox in adolescents (from 12 to 17 years) and children (from 2 to 12 years) after single and multiple doses was lower than in adult patients. In children under 6 years of age, bioavailability is 50% lower than in adults. However, this is not clinically significant, as the drug dosage regimen is established individually.
Indications
Chronic post-transfusional iron overload in adults and children aged 2 years and older.
ICD codes
| ICD-10 code | Indication |
| E83.1 | Disorders of iron metabolism (hemochromatosis) |
| T80 | Complications following infusion, transfusion and therapeutic injection |
| ICD-11 code | Indication |
| 5C64.10 | Iron overload disease |
| 5C64.1Z | Disorders of iron metabolism, unspecified |
| NE80.Z | Injury or harm arising from infusion, transfusion, or therapeutic injection, not elsewhere classified, unspecified |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Tablets, Capsules
Therapy with deferasirox is recommended to be started after transfusion of more than 20 units (about 100 ml/kg) of packed red blood cells or in the presence of clinical data indicating the development of chronic iron overload (for example, with a serum ferritin concentration of more than 1000 µg/L).
It is taken orally. The recommended initial dose is 10-30 mg/kg/day, depending on the amount of packed red blood cells the patient received per month. It is recommended to monitor serum ferritin concentration monthly and, if necessary, adjust the dose of deferasirox every 3-6 months, based on changes in serum ferritin levels. Dose adjustment should be carried out gradually, increasing or decreasing the dose at one time by 5-10 mg/kg. The direction of dose adjustment is determined by individual treatment efficacy and therapeutic goals (maintenance or reduction of iron content). The use of a dose of more than 30 mg/kg is not recommended, as experience with higher doses is limited. If the serum ferritin concentration is significantly below 500 µg/L, consideration should be given to interrupting treatment with deferasirox.
Adverse Reactions
From the CNS: often – headache; sometimes – dizziness, anxiety, sleep disorders.
From the digestive system: often – diarrhea, constipation, vomiting, nausea, abdominal pain, abdominal distension, dyspepsia, increased activity of hepatic transaminases; sometimes – gastritis, hepatitis, cholelithiasis.
From the urinary system: very often – increased serum creatinine concentration; often – proteinuria; regardless of causal relationship – acute renal failure (increase in serum creatinine to more than 2 times the ULN; normalization of creatinine levels was usually observed after discontinuation of therapy).
From the sensory organs: sometimes – early cataract, maculopathy, hearing loss.
From the respiratory system: sometimes – pain in the larynx and pharynx.
Dermatological reactions: often – rash, itching; sometimes – pigmentation disorder; regardless of causal relationship – leukocytoclastic vasculitis, urticaria.
Allergic reactions regardless of causal relationship – in most cases, hypersensitivity reactions (including anaphylactic reactions and angioedema) were observed in the first months of treatment.
Other: sometimes – increased body temperature, edema, feeling of tiredness. Cases of cytopenia (mainly in patients with pre-existing bone marrow dysfunction), including neutropenia and thrombocytopenia (causal relationship not established), have been reported.
Contraindications
Hypersensitivity to deferasirox.
Use in Pregnancy and Lactation
There are no clinical data on the use of deferasirox during pregnancy. Experimental studies have shown some reproductive toxicity of deferasirox at doses toxic to the maternal organism. The potential risk to humans is unknown.
It is not recommended to use Deferasirox during pregnancy, except in cases where the expected benefit to the mother outweighs the possible risk to the fetus.
Experimental studies have established that Deferasirox is rapidly and significantly excreted in breast milk, with no effect on offspring noted.
It is not known whether Deferasirox is excreted in human breast milk. Deferasirox should not be used during lactation (breastfeeding).
Use in Hepatic Impairment
Use with caution in patients with impaired liver function.
Monthly monitoring of liver function is recommended. If a progressive increase in hepatic transaminase activity occurs, not associated with any other causes, therapy with deferasirox should be interrupted. Immediately after determining the cause of the biochemical changes or after normalization of indicators, consideration can be given to cautiously resuming therapy with deferasirox at a lower dose with subsequent gradual increase.
Use in Renal Impairment
Use with caution in patients with impaired renal function.
Given the increased risk of complications, when using deferasirox in patients with impaired renal function or receiving drugs that have a negative effect on renal function, it is recommended to determine serum creatinine levels weekly during the first month of therapy, and then monthly.
During treatment with deferasirox, the level of proteinuria should be monitored monthly.
Pediatric Use
The use of deferasirox is not accompanied by growth retardation in children. However, as a precautionary measure, the child’s body weight and height should be regularly monitored (every 12 months) during treatment.
There is no experience with the use of deferasirox in children under 2 years of age.
Special Precautions
Use with caution in patients with impaired renal or liver function.
Deferasirox has been used only in patients with serum creatinine levels within the age-specific normal range and with hepatic transaminase activity not exceeding the ULN by more than 5 times.
In case of severe hypersensitivity reactions, Deferasirox should be discontinued immediately and appropriate therapy initiated.
It is recommended to determine serum creatinine levels twice before starting treatment and monitor this indicator monthly during therapy. The dose of deferasirox should be adjusted according to changes in serum creatinine. In case of a progressive increase in serum creatinine exceeding the ULN, therapy with deferasirox should be interrupted. The decision to resume treatment is made based on the specific clinical situation.
Given the increased risk of complications, when using deferasirox in patients with impaired renal function or receiving drugs that have a negative effect on renal function, it is recommended to determine serum creatinine levels weekly during the first month of therapy, and then monthly.
During treatment with deferasirox, the level of proteinuria should be monitored monthly.
Monthly monitoring of liver function is recommended. If a progressive increase in hepatic transaminase activity occurs, not associated with any other causes, therapy with deferasirox should be interrupted. Immediately after determining the cause of the biochemical changes or after normalization of indicators, consideration can be given to cautiously resuming therapy with deferasirox at a lower dose with subsequent gradual increase.
Since skin rash often resolves spontaneously, if a mild to moderate skin rash develops, treatment with deferasirox can be continued without dose adjustment. If a more severe rash develops, treatment should be temporarily discontinued. After the rash disappears, deferasirox can be started at a lower dose with subsequent increase.
If diarrhea and/or vomiting develop during therapy with deferasirox, adequate hydration should be ensured.
During treatment, it is recommended to determine hearing acuity and perform an ophthalmological examination (including fundus ophthalmoscopy) before starting deferasirox and during further therapy with the drug, at regular intervals of 12 months. If hearing or vision impairments develop, consideration should be given to reducing the dose or discontinuing treatment.
Hematological parameters should be monitored during treatment. If cytopenia of unclear etiology develops, treatment should be temporarily suspended. After normalization of hematological parameters, therapy with deferasirox can be resumed.
To assess the effectiveness of therapy with deferasirox, it is recommended to determine serum ferritin concentration every month. If the serum ferritin concentration consistently decreases to a value below 500 µg/L, consideration should be given to interrupting treatment.
Do not use Deferasirox in combination with other drugs that form complexes with iron ions, as the safety of using such a combination has not been established.
Use in pediatrics
The use of deferasirox is not accompanied by growth retardation in children. However, as a precautionary measure, the child’s body weight and height should be regularly monitored (every 12 months) during treatment.
There is no experience with the use of deferasirox in children under 2 years of age.
Effect on ability to drive vehicles and operate machinery
If dizziness occurs during treatment, patients should exercise caution when driving vehicles and operating machinery.
Drug Interactions
Deferasirox should not be used simultaneously with aluminum-containing antacid preparations.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Film-coated tablets 180 mg
Film-coated tablets 360 mg
Marketing Authorization Holder
Hetero Labs, Limited (India)
Manufactured By
Makiz-Pharma, LLC (Russia)
Or
Annora Pharma, Private Limited (India)
Dosage Forms
 |
Deferasirox | Film-coated tablets 180 mg |
| Film-coated tablets 360 mg |
Dosage Form, Packaging, and Composition
Film-coated tablets
| 1 tab. | |
| Deferasirox | 180 mg |
10 pcs. – blister packs (10 pcs.) – cardboard packs (100 pcs.) – By prescription
10 pcs. – blister packs (3 pcs.) – cardboard packs (30 pcs.) – By prescription
10 pcs. – blister packs (6 pcs.) – cardboard packs (60 pcs.) – By prescription
10 pcs. – blister packs (9 pcs.) – cardboard packs (90 pcs.) – By prescription
10 pcs. – blister packs 90-500 pcs. – cardboard boxes (10 pcs.) – In-Bulk
Film-coated tablets
| 1 tab. | |
| Deferasirox | 360 mg |
10 pcs. – blister packs (10 pcs.) – cardboard packs (100 pcs.) – By prescription
10 pcs. – blister packs (3 pcs.) – cardboard packs (30 pcs.) – By prescription
10 pcs. – blister packs (6 pcs.) – cardboard packs (60 pcs.) – By prescription
10 pcs. – blister packs (9 pcs.) – cardboard packs (90 pcs.) – By prescription
10 pcs. – blister packs 90-500 pcs. – cardboard boxes (10 pcs.) – In-Bulk
Capsules 90 mg: 12, 30, 36 or 90 pcs.
Capsules 180 mg: 12, 30, 36 or 90 pcs.
Capsules 360 mg: 12, 30, 36 or 90 pcs.
Marketing Authorization Holder
BASIS, LLC (Russia)
Manufactured By
Novamedica Innotech, LLC (Russia)
Dosage Forms
|
Deferasirox | Capsules 90 mg: 12, 30, 36 or 90 pcs. |
| Capsules 180 mg: 12, 30, 36 or 90 pcs. | ||
| Capsules 360 mg: 12, 30, 36 or 90 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin No. 3 white, contents – white or almost white powder.
| 1 caps. | |
| Deferasirox | 90 mg |
Excipients: microcrystalline cellulose PH101, crospovidone type B, povidone K30, poloxamer 188, colloidal silicon dioxide, magnesium stearate.
Capsule composition
Capsule size No. 3
Body (titanium dioxide 2.0000%, gelatin up to 100%)
Cap (titanium dioxide 2.0000%, gelatin up to 100%).
4 pcs. – blister pack (3) – cardboard packs.
4 pcs. – blister pack (9) – cardboard packs.
10 pcs. – blister pack (3) – cardboard packs.
10 pcs. – blister pack (9) – cardboard packs.
Capsules hard gelatin No. 0 white, contents – white or almost white powder.
| 1 caps. | |
| Deferasirox | 180 mg |
Excipients: microcrystalline cellulose PH101, crospovidone type B, povidone K30, poloxamer 188, colloidal silicon dioxide, magnesium stearate.
Capsule composition
Capsule size No. 0
Body (titanium dioxide 2.0000%, gelatin up to 100%)
Cap (titanium dioxide 2.0000%, gelatin up to 100%).
4 pcs. – blister pack (3) – cardboard packs.
4 pcs. – blister pack (9) – cardboard packs.
10 pcs. – blister pack (3) – cardboard packs.
10 pcs. – blister pack (9) – cardboard packs.
Capsules hard gelatin No. 000 white, contents – white or almost white powder.
| 1 caps. | |
| Deferasirox | 360 mg |
Excipients: microcrystalline cellulose PH101, crospovidone type B, povidone K30, poloxamer 188, colloidal silicon dioxide, magnesium stearate.
Capsule composition
Capsule size No. 000
Body (titanium dioxide 2.0000%, gelatin up to 100%)
Cap (titanium dioxide 2.0000%, gelatin up to 100%).
4 pcs. – contour cell packaging (3) – cardboard packs.
4 pcs. – contour cell packaging (9) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (9) – cardboard packs.
Dispersible tablets 125 mg: 28, 30, 60, or 84 pcs.
Dispersible tablets 250 mg: 28, 30, 60, or 84 pcs.
Dispersible tablets 500 mg: 28, 30, 60, or 84 pcs.
Marketing Authorization Holder
LIFE SCIENCES OHFK, LLC (Russia)
Manufactured By
OHFK, JSC (Russia)
Dosage Forms
|
Deferasirox | Dispersible tablets 125 mg: 28, 30, 60, or 84 pcs. |
| Dispersible tablets 250 mg: 28, 30, 60, or 84 pcs. | ||
| Dispersible tablets 500 mg: 28, 30, 60, or 84 pcs. |
Dosage Form, Packaging, and Composition
Dispersible tablets round, flat-cylindrical, almost white in color, with a bevel on both sides and a score on one side; the presence of multiple inclusions of a darker color is allowed.
| 1 tab. | |
| Deferasirox | 125 mg |
Excipients: crospovidone (type A), povidone K17, sodium lauryl sulfate, sodium stearyl fumarate, colloidal silicon dioxide, lactose monohydrate.
28 pcs. – jars (1) – cardboard packs with insert.
84 pcs. – jars (1) – cardboard packs with insert.
10 pcs. – contour cell packaging (3) – cardboard packs with insert.
10 pcs. – contour cell packaging (6) – cardboard packs with insert.
Dispersible tablets round, flat-cylindrical, almost white in color, with a bevel on both sides and a score on one side; the presence of multiple inclusions of a darker color is allowed.
| 1 tab. | |
| Deferasirox | 250 mg |
Excipients: crospovidone (type A), povidone K17, sodium lauryl sulfate, sodium stearyl fumarate, colloidal silicon dioxide, lactose monohydrate.
28 pcs. – jars (1) – cardboard packs with insert.
84 pcs. – jars (1) – cardboard packs with insert.
10 pcs. – contour cell packaging (3) – cardboard packs with insert.
10 pcs. – contour cell packaging (6) – cardboard packs with insert.
Dispersible tablets round, flat-cylindrical, almost white in color, with a bevel on both sides and a score on one side; the presence of multiple inclusions of a darker color is allowed.
| 1 tab. | |
| Deferasirox | 500 mg |
Excipients: crospovidone (type A), povidone K17, sodium lauryl sulfate, sodium stearyl fumarate, colloidal silicon dioxide, lactose monohydrate.
28 pcs. – jars (1) – cardboard packs with insert.
84 pcs. – jars (1) – cardboard packs with insert.
10 pcs. – contour cell packaging (3) – cardboard packs with insert.
10 pcs. – contour cell packaging (6) – cardboard packs with insert.
Dispersible tablets 125 mg: 28, 30, or 84 pcs.
Dispersible tablets 250 mg: 28, 30, or 84 pcs.
Dispersible tablets 500 mg: 28, 30, or 84 pcs.
Marketing Authorization Holder
Canonpharma Production, CJS (Russia)
Dosage Forms
|
Deferasirox Canon | Dispersible tablets 125 mg: 28, 30, or 84 pcs. |
| Dispersible tablets 250 mg: 28, 30, or 84 pcs. | ||
| Dispersible tablets 500 mg: 28, 30, or 84 pcs. |
Dosage Form, Packaging, and Composition
Dispersible tablets round, flat-cylindrical with a bevel, white or almost white in color.
| 1 tab. | |
| Deferasirox | 125 mg |
Excipients: crospovidone, lactose monohydrate, sodium lauryl sulfate, sodium stearyl fumarate, povidone K30, microcrystalline cellulose PH102.
7 pcs. – contour cell packaging (4) – cardboard packs.
7 pcs. – contour cell packaging (12) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
28 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
84 pcs. – polymer jars (1) – cardboard packs.
Dispersible tablets round, flat-cylindrical with a bevel, white or almost white in color.
| 1 tab. | |
| Deferasirox | 250 mg |
Excipients: crospovidone, lactose monohydrate, sodium lauryl sulfate, sodium stearyl fumarate, povidone K30, microcrystalline cellulose PH102.
7 pcs. – contour cell packaging (4) – cardboard packs.
7 pcs. – contour cell packaging (12) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
28 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
84 pcs. – polymer jars (1) – cardboard packs.
Dispersible tablets round, flat-cylindrical with a bevel, white or almost white in color.
| 1 tab. | |
| Deferasirox | 500 mg |
Excipients: crospovidone, lactose monohydrate, sodium lauryl sulfate, sodium stearyl fumarate, povidone K30, microcrystalline cellulose PH102.
7 pcs. – contour cell packaging (4) – cardboard packs.
7 pcs. – contour cell packaging (12) – cardboard packs.
28 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
84 pcs. – polymer jars (1) – cardboard packs.
Film-coated tablets, 90 mg
Film-coated tablets 180 mg
Film-coated tablets 360 mg
Marketing Authorization Holder
Jodas Expoim, LLC (Russia)
Manufactured By
Oxford Laboratories, Pvt. Ltd. (India)
Dosage Forms
|
Deferasirox J | Film-coated tablets, 90 mg |
| Film-coated tablets 180 mg | ||
| Film-coated tablets 360 mg |
Dosage Form, Packaging, and Composition
Film-coated tablets
| Deferasirox | 90 mg |
10 pcs. – contour cell packaging (3 pcs.) – cardboard packs (30 pcs.) – Prescription only
10 pcs. – contour cell packaging (9 pcs.) – cardboard packs (90 pcs.) – Prescription only
30 pcs. – jars – cardboard packs (30 pcs.) – Prescription only
Film-coated tablets
| Deferasirox | 180 mg |
10 pcs. – contour cell packaging (3 pcs.) – cardboard packs (30 pcs.) – Prescription only
10 pcs. – contour cell packaging (9 pcs.) – cardboard packs (90 pcs.) – Prescription only
30 pcs. – jars – cardboard packs (30 pcs.) – Prescription only
Film-coated tablets
| Deferasirox | 360 mg |
10 pcs. – contour cell packaging (3 pcs.) – cardboard packs (30 pcs.) – Prescription only
10 pcs. – contour cell packaging (9 pcs.) – cardboard packs (90 pcs.) – Prescription only
30 pcs. – jars – cardboard packs (30 pcs.) – Prescription only
Dispersible tablets 125 mg: 28 or 84 pcs.
Dispersible tablets 250 mg: 28 or 84 pcs.
Dispersible tablets 500 mg: 28 or 84 pcs.
Marketing Authorization Holder
PSK Pharma, LLC (Russia)
Dosage Forms
|
Deferasirox PSK | Dispersible tablets 125 mg: 28 or 84 pcs. |
| Dispersible tablets 250 mg: 28 or 84 pcs. | ||
| Dispersible tablets 500 mg: 28 or 84 pcs. |
Dosage Form, Packaging, and Composition
Dispersible tablets round, biconvex with beveled edges on both sides, white or almost white with a marbled surface.
| 1 tab. | |
| Deferasirox | 125 mg |
Excipients: microcrystalline cellulose PH101, microcrystalline cellulose PH102, crospovidone XL, sodium lauryl sulfate, povidone K30, colloidal silicon dioxide (Aerosil 200), magnesium stearate, sodium chloride.
7 pcs. – blisters (4) – cardboard packs.
7 pcs. – blisters (12) – cardboard packs.
28 pcs. – polyethylene bottles (1) – cardboard packs.
84 pcs. – polyethylene bottles (1) – cardboard packs.
Dispersible tablets round, biconvex with beveled edges on both sides, white or almost white with a marbled surface.
| 1 tab. | |
| Deferasirox | 250 mg |
Excipients: microcrystalline cellulose PH101, microcrystalline cellulose PH102, crospovidone XL, sodium lauryl sulfate, povidone K30, colloidal silicon dioxide (Aerosil 200), magnesium stearate, sodium chloride.
7 pcs. – blisters (4) – cardboard packs.
7 pcs. – blisters (12) – cardboard packs.
28 pcs. – polyethylene bottles (1) – cardboard packs.
84 pcs. – polyethylene bottles (1) – cardboard packs.
Dispersible tablets round, biconvex with beveled edges on both sides, white or almost white with a marbled surface.
| 1 tab. | |
| Deferasirox | 500 mg |
Excipients: microcrystalline cellulose PH101, microcrystalline cellulose PH102, crospovidone XL, sodium lauryl sulfate, povidone K30, colloidal silicon dioxide (Aerosil 200), magnesium stearate, sodium chloride.
7 pcs. – blisters (4) – cardboard packs.
7 pcs. – blisters (12) – cardboard packs.
28 pcs. – polyethylene bottles (1) – cardboard packs.
84 pcs. – polyethylene bottles (1) – cardboard packs.
Film-coated tablets 90 mg: 30 or 90 pcs.
Film-coated tablets 180 mg: 30 or 90 pcs.
Film-coated tablets 360 mg: 30 or 90 pcs.
Marketing Authorization Holder
PSK Pharma, LLC (Russia)
Dosage Forms
|
Deferasirox PSK | Film-coated tablets 90 mg: 30 or 90 pcs. |
| Film-coated tablets 180 mg: 30 or 90 pcs. | ||
| Film-coated tablets 360 mg: 30 or 90 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets red-brown in color, capsule-shaped, smooth on both sides; the core is white or almost white.
| 1 tab. | |
| Deferasirox | 90 mg |
Excipients: microcrystalline cellulose PH101, croscarmellose sodium, povidone K30, poloxamer 188, microcrystalline cellulose PH102, colloidal silicon dioxide (aerosil 200), magnesium stearate.
Instacoat shell hypromellose, macrogol, sodium lauryl sulfate, titanium dioxide, iron oxide red, iron oxide yellow.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (9) – cardboard packs.
Film-coated tablets red-brown in color, capsule-shaped, smooth on both sides; the core is white or almost white.
| 1 tab. | |
| Deferasirox | 180 mg |
Excipients: microcrystalline cellulose PH101, croscarmellose sodium, povidone K30, poloxamer 188, microcrystalline cellulose PH102, colloidal silicon dioxide (aerosil 200), magnesium stearate.
Instacoat shell hypromellose, macrogol, sodium lauryl sulfate, titanium dioxide, iron oxide red, iron oxide yellow.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (9) – cardboard packs.
Film-coated tablets red-brown in color, capsule-shaped, smooth on both sides; the core is white or almost white.
| 1 tab. | |
| Deferasirox | 360 mg |
Excipients: microcrystalline cellulose PH101, croscarmellose sodium, povidone K30, poloxamer 188, microcrystalline cellulose PH102, colloidal silicon dioxide (aerosil 200), magnesium stearate.
Instacoat shell hypromellose, macrogol, sodium lauryl sulfate, titanium dioxide, iron oxide red, iron oxide yellow.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (9) – cardboard packs.
Dispersible tablets 250 mg: 28, 30, or 84 pcs.
Dispersible tablets 500 mg: 28, 30, or 84 pcs.
Marketing Authorization Holder
Sun Pharmaceutical Industries, Ltd. (India)
Dosage Forms
|
Deferasirox Sun | Dispersible tablets 250 mg: 28, 30, or 84 pcs. |
| Dispersible tablets 500 mg: 28, 30, or 84 pcs. |
Dosage Form, Packaging, and Composition
Dispersible tablets almost white, round, flat-cylindrical, with beveled edges.
| 1 tab. | |
| Deferasirox | 250 mg |
Excipients: microcrystalline cellulose (Avicel pH 102) – 170 mg, crospovidone (Polyplasdone XL) – 170 mg, lactose monohydrate (Pharmatose 200 M) – 128.435 mg, lactose monohydrate (Supertab 11 SD) – 85 mg, povidone (Plasdone K-29/32) – 25.5 mg, magnesium stearate (LIGA Magnesium stearate MF-2-V-Vegetable) – 8.5 mg, colloidal silicon dioxide – 8.313 mg, sodium lauryl sulfate – 4.25 mg.
7 pcs. – contour cell packaging (4) – cardboard packs.
7 pcs. – contour cell packaging (12) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
Dispersible tablets almost white, round, flat-cylindrical, with beveled edges.
| 1 tab. | |
| Deferasirox | 500 mg |
Excipients: microcrystalline cellulose (Avicel pH 102) – 340 mg, crospovidone (Polyplasdone XL) – 340 mg, lactose monohydrate (Pharmatose 200 M) – 256.87 mg, lactose monohydrate (Supertab 11 SD) – 170 mg, povidone (Plasdone K-29/32) – 51 mg, magnesium stearate (LIGA Magnesium stearate MF-2-V-Vegetable) – 17 mg, colloidal silicon dioxide – 16.626 mg, sodium lauryl sulfate – 8.5 mg.
7 pcs. – contour cell packaging (4) – cardboard packs.
7 pcs. – contour cell packaging (12) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
Film-coated tablets, 90 mg
Film-coated tablets 180 mg
Film-coated tablets 360 mg
Marketing Authorization Holder
Velpharm-M, LLC (Russia)
Manufactured By
Velpharm, LLC (Russia)
Or
Velpharm-M, LLC (Russia)
Dosage Forms
|
Deferasirox Velpharm | Film-coated tablets, 90 mg |
| Film-coated tablets 180 mg | ||
| Film-coated tablets 360 mg |
Dosage Form, Packaging, and Composition
Film-coated tablets
| 1 tab. | |
| Deferasirox | 90 mg |
10 pcs. – contour cell packaging (3 pcs.) – cardboard packs (30 pcs.) – Prescription only
10 pcs. – contour cell packaging (9 pcs.) – cardboard packs (90 pcs.) – Prescription only
30 pcs. – jars – cardboard packs (30 pcs.) – Prescription only
90 pcs. – jars – cardboard packs (90 pcs.) – Prescription only
Film-coated tablets
| 1 tab. | |
| Deferasirox | 180 mg |
10 pcs. – contour cell packaging (3 pcs.) – cardboard packs (30 pcs.) – Prescription only
10 pcs. – contour cell packaging (9 pcs.) – cardboard packs (90 pcs.) – Prescription only
30 pcs. – jars – cardboard packs (30 pcs.) – Prescription only
90 pcs. – jars – cardboard packs (90 pcs.) – Prescription only
Film-coated tablets
| 1 tab. | |
| Deferasirox | 360 mg |
10 pcs. – contour cell packaging (3 pcs.) – cardboard packs (30 pcs.) – Prescription only
10 pcs. – contour cell packaging (9 pcs.) – cardboard packs (90 pcs.) – Prescription only
30 pcs. – jars – cardboard packs (30 pcs.) – Prescription only
90 pcs. – jars – cardboard packs (90 pcs.) – Prescription only
Dispersible tablets 125 mg: 7 or 28 pcs.
Dispersible tablets 250 mg: 7 or 28 pcs.
Dispersible tablets 500 mg: 7 or 28 pcs.
Marketing Authorization Holder
Amedart LLC (Russia)
Dosage Forms
|
Deferasirox-Amedart | Dispersible tablets 125 mg: 7 or 28 pcs. |
| Dispersible tablets 250 mg: 7 or 28 pcs. | ||
| Dispersible tablets 500 mg: 7 or 28 pcs. |
Dosage Form, Packaging, and Composition
Dispersible tablets round, biconvex, white or almost white in color.
| 1 tab. | |
| Deferasirox | 125 mg |
Excipients: mannitol, colloidal silicon dioxide, crospovidone, sodium lauryl sulfate, sodium stearyl fumarate, povidone K30.
7 pcs. – jars (1) – cardboard packs.
28 pcs. – jars (1) – cardboard packs.
Dispersible tablets round, biconvex, white or almost white in color.
| 1 tab. | |
| Deferasirox | 250 mg |
Excipients: mannitol, colloidal silicon dioxide, crospovidone, sodium lauryl sulfate, sodium stearyl fumarate, povidone K30.
7 pcs. – jars (1) – cardboard packs.
28 pcs. – jars (1) – cardboard packs.
Dispersible tablets round, biconvex, white or almost white in color.
| 1 tab. | |
| Deferasirox | 500 mg |
Excipients: mannitol, colloidal silicon dioxide, crospovidone, sodium lauryl sulfate, sodium stearyl fumarate, povidone K30.
7 pcs. – jars (1) – cardboard packs.
28 pcs. – jars (1) – cardboard packs.
Dispersible tablets 125 mg: 28 or 84 pcs.
Dispersible tablets 250 mg: 28 or 84 pcs.
Dispersible tablets 500 mg: 28 or 84 pcs.
Marketing Authorization Holder
Chemical Diversity Research Institute LLC (Russia)
Dosage Forms
|
Deferasirox-Himrar | Dispersible tablets 125 mg: 28 or 84 pcs. |
| Dispersible tablets 250 mg: 28 or 84 pcs. | ||
| Dispersible tablets 500 mg: 28 or 84 pcs. |
Dosage Form, Packaging, and Composition
Dispersible tablets round, flat-cylindrical, white or almost white in color with a beveled edge.
| 1 tab. | |
| Deferasirox | 125 mg |
Excipients: crospovidone, lactose monohydrate, lactose monohydrate (SuperTab® 14SD), microcrystalline cellulose PH102, povidone K30, sodium lauryl sulfate, magnesium stearate, colloidal silicon dioxide.
7 pcs. – contour cell packaging (4) – cardboard packs with an insert.
7 pcs. – contour cell packaging (12) – cardboard packs with an insert.
Dispersible tablets round, flat-cylindrical, white or almost white in color with a beveled edge.
| 1 tab. | |
| Deferasirox | 250 mg |
Excipients: crospovidone, lactose monohydrate, lactose monohydrate (SuperTab® 14SD), microcrystalline cellulose PH102, povidone K30, sodium lauryl sulfate, magnesium stearate, colloidal silicon dioxide.
7 pcs. – contour cell packaging (4) – cardboard packs with an insert.
7 pcs. – contour cell packaging (12) – cardboard packs with an insert.
Dispersible tablets round, flat-cylindrical, white or almost white in color with a beveled edge.
| 1 tab. | |
| Deferasirox | 500 mg |
Excipients: crospovidone, lactose monohydrate, lactose monohydrate (SuperTab® 14SD), microcrystalline cellulose PH102, povidone K30, sodium lauryl sulfate, magnesium stearate, colloidal silicon dioxide.
7 pcs. – contour cell packaging (4) – cardboard packs with an insert.
7 pcs. – contour cell packaging (12) – cardboard packs with an insert.
![Deferasirox [Tablets, Capsules] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Deferasirox [Tablets, Capsules] 2")