Kelfer Capsule
Deferiprone
250mg
Cipla Ltd.
| Pack size | 50's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 10.00 AED |
Available as:
Indications
Kelfer Capsule is used for:
Thalassaemia, Iron overload, Sickle cell disease
Adult Dose
Transfusional Iron Overload
Iron chelator indicated for the treatment of transfusional iron overload caused by thalassemia syndromes when current chelation therapy is inadequate
Approval based on serum ferritin level reduction; no controlled trials demonstrating a direct treatment benefit (eg, improvement in disease-related symptoms, functioning, or increased survival)
Initial: 25 mg/kg (actual body weight) PO TID
Maximum dose: 100 mg/kg/day
Round the dose to the nearest 250 mg
Child Dose
Transfusional Iron Overload
Iron chelator indicated for treatment of transfusional iron overload in children aged >3 years caused by thalassemia syndromes, sickle cell disease, or other anemias
Approval based on serum ferritin level reduction; no controlled trials demonstrating a direct treatment benefit (eg, improvement in disease-related symptoms, functioning, or increased survival)
<3 years: Safety and efficacy not established
500-mg tablet (aged >8 yr)
Initial: 25 mg/kg (actual body weight) PO TID
Maximum dose: 100 mg/kg/day
Round the dose to the nearest 250 mg
Renal Dose
Renal impairment
Mild-to-severe (eGFR 15-89 mL/min/1.73 m2): No dose adjustment necessary
ESRD: Unknown
Administration
May be taken with or without food.
Contra Indications
Agranulocytosis, pregnancy and lactation.
Precautions
Deferiprone can cause agranulocytosis that can lead to serious infections and death. Neutropenia may precede the development of agranulocytosis.
Measure the absolute neutrophil count (ANC) before starting Deferiprone and monitor regularly while on therapy.
Interrupt Deferiprone therapy if neutropenia develops.
Interrupt Deferiprone if infection develops and monitor the ANC more frequently.
Advise patients taking Deferiprone to report immediately any symptoms indicative of infection.
Liver Enzyme Elevations: Monitor monthly and discontinue for persistent elevations.
Zinc Deficiency: Monitor during therapy and supplement for deficiency.
Embryo-Fetal Toxicity: Can cause fetal harm.
MONITORING PARAMETERS
Monitor neutrophil count weekly and discontinue treatment if neutropenia develops.
Monitor plasma-zinc concentration.
Pregnancy-Lactation
Pregnancy
Limited available data with use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage
Verify the pregnancy status of females of reproductive potential prior to initiating therapy
Contraception
Females: Advise females of reproductive potential to avoid pregnancy during treatment and 6 months of contraception is recommended after cessation of therapy; advise females to immediately report pregnancy
Males: Advise males with female sexual partners of reproductive potential to use effective contraception during treatment and 3 months of contraception is recommended after cessation of therapy
Lactation
There is no information regarding the presence of deferiprone in human milk, the effects on the breastfed child, or the effects on milk production
Because of the potential for serious adverse reactions, including the potential for tumorigenicity shown for deferiprone in animal studies, advise not to breastfeed during treatment and for 2 weeks after last dose
Interactions
Avoid using deferiprone with aluminium-containing antacids as it can chelate trivalent metal ions.
Drugs Associated with Neutropenia or Agranulocytosis: Avoid coadministration. If co-administration is unavoidable, closely monitor the absolute neutrophil count.
UGT1A6 Inhibitors: Avoid co-administration.
Polyvalent Cations: Allow at least a 4-hour interval between administration of Deferiprone and drugs or supplements containing polyvalent cations (e.g., iron, aluminum, or zinc).
Adverse Effects
Side effects of Deferiprone :
>10%
Chromaturia (14.6%),Nausea (12.6%),Abdominal pain/discomfort (10.4%)
1-10%
Arthralgia (9.8%),Vomiting (9.8%),Increased ALT (7.5%),Decreased neutrophil count (7.3%),Neutropenia (6.2%),Increased appetite (4%),Diarrhea (3%),Headache (2.5%),Dyspepsia (2%),Back pain (2%),Extremity pain (1.9%),Increased weight (1.9%),Agranulocytosis (1.7%),Arthropathy (1.4%),Increased AST (1.2%),Decreased appetite (1.1%)
Mechanism of Action
Deferiprone is an orally effective iron-chelating agent. It is being used when desferrioxamine is unsuitable or contraindicated.
Note
Kelfer 250mg Capsule manufactured by Cipla Ltd.. Its generic name is Deferiprone. Kelfer is availble in Bangladesh.
Farmaco BD drug index information on Kelfer Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.