Kelfer

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Kelfer uses


1 INDICATIONS AND USAGE

Kelfer® (deferiprone) is indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.

Approval is based on a reduction in serum ferritin levels. There are no controlled trials demonstrating a direct treatment benefit, such as improvement in disease-related symptoms, functioning, or increased survival .

Limitation of Use:


Kelfer® (deferiprone) is an iron chelator indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate. (1)

Approval is based on a reduction in serum ferritin levels. There are no controlled trials demonstrating a direct treatment benefit, such as improvement in disease-related symptoms, functioning, or increased survival. (1)

Limitation of Use

2 DOSAGE AND ADMINISTRATION

The recommended initial dose of Kelfer is 25 mg/kg, orally, three times per day for a total of 75 mg/kg/day. The maximum dose is 33 mg/kg, three times per day for a total of 99 mg/kg/day.

Dose adjustments up to 33 mg/kg, orally, three times per day should be tailored to the individual patient’s response and therapeutic goals. The maximum recommended total daily dose is 99 mg/kg per day. The dose should be rounded by the prescriber to the nearest 250 mg (half-tablet).

Body Weight (kg) Dose (mg) Number of tablets
20 500 1
30 750 1.5
40 1000 2
50 1250 2.5
60 1500 3
70 1750 3.5
80 2000 4
90 2250 4.5
Body Weight (kg) Dose (mg) Number of tablets
20 660 1.5
30 990 2
40 1320 2.5
50 1650 3.5
60 1980 4
70 2310 4.5
80 2640 5.5
90 2970 6

Monitor serum ferritin concentration every two to three months to assess the effects of Kelfer on body iron stores. Dose adjustments should be tailored to the individual patient’s response and therapeutic goals (maintenance or reduction of body iron burden). If the serum ferritin falls consistently below 500 mcg/L, consider temporarily interrupting Kelfer therapy.

2.1 Interactions with Foods, Vitamins and Antacids

Allow at least a 4-hour interval between Kelfer and other medications or supplements containing polyvalent cations such as iron, aluminum, and zinc .

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3 DOSAGE FORMS AND STRENGTHS

500 mg film-coated tablets with a functional score.

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Agranulocytosis/Neutropenia

Fatal agranulocytosis can occur with Kelfer use. Kelfer can also cause neutropenia, which may foreshadow agranulocytosis. Measure the absolute neutrophil count (ANC) before starting Kelfer therapy and monitor the ANC weekly on therapy.

Interrupt Kelfer therapy if neutropenia develops (ANC < 1.5 x 109/L).

Interrupt Kelfer if infection develops, and monitor the ANC more frequently.

Advise patients taking Kelfer to immediately interrupt therapy and report to their physician if they experience any symptoms indicative of infection.

In pooled clinical trials, the incidence of agranulocytosis was 1.7% of patients. The mechanism of Ferriprox-associated agranulocytosis is unknown. Agranulocytosis and neutropenia usually resolve upon discontinuation of Kelfer, but there have been reports of agranulocytosis leading to death.

Implement a plan to monitor for and to manage agranulocytosis/neutropenia prior to initiating Kelfer treatment.

For neutropenia (ANC < 1.5 x 109/L and > 0.5 x 109/L):

Instruct the patient to immediately discontinue Kelfer and all other medications with a potential to cause neutropenia.

Obtain a complete blood cell (CBC) count, including a white blood cell (WBC) count corrected for the presence of nucleated red blood cells, an absolute neutrophil count (ANC), and a platelet count daily until recovery (ANC ≥ 1.5 x 109/L).

For agranulocytosis (ANC < 0.5 x 109/L):

Consider hospitalization and other management as clinically appropriate.

Do not resume Kelfer in patients who have developed agranulocytosis unless potential benefits outweigh potential risks. Do not rechallenge patients who develop neutropenia with Kelfer unless potential benefits outweigh potential risks.

5.2 Embryofetal Toxicity

Based on evidence of genotoxicity and developmental toxicity in animal studies, Kelfer can cause fetal harm when administered to a pregnant woman. In animal studies, administration of Kelfer during the period of organogenesis resulted in embryofetal death and malformations at doses lower than equivalent human clinical doses. If Kelfer is used during pregnancy or if the patient becomes pregnant while taking Kelfer, the patient should be apprised of the potential hazard to the fetus. Women of reproductive potential should be advised to avoid pregnancy when taking Kelfer .

5.3 Laboratory Tests

Serum Liver Enzyme Activities

In clinical studies, 7.5% of 642 subjects treated with Kelfer developed increased ALT values. Four (0.62%) Ferriprox-treated subjects discontinued the drug due to increased serum ALT levels and 1 (0.16%) due to an increase in both ALT and AST.

Monitor serum ALT values monthly during therapy with Kelfer, and consider interruption of therapy if there is a persistent increase in the serum transaminase levels.

Plasma Zinc Concentration

Decreased plasma zinc concentrations have been observed on Kelfer therapy. Monitor plasma zinc, and supplement in the event of a deficiency.

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6 ADVERSE REACTIONS

6.1 Clinical Trial Experience

The following adverse reactions are also discussed in other sections of the labeling: Agranulocytosis/Neutropenia . Elevated ALT (5.3), Decreased plasma zinc concentrations (5.3).

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.

Adverse reaction information for Kelfer represents the pooled data collected from 642 patients who participated in single arm or active-controlled clinical studies.

The most serious adverse reaction reported in clinical trials with Kelfer was agranulocytosis .

The most common adverse reactions reported during clinical trials were chromaturia, nausea, vomiting, abdominal pain, alanine aminotransferase increased, arthralgia and neutropenia.

The table below lists the adverse drug reactions that occurred in at least 1% of patients treated with Kelfer in clinical trials.

Body System % Subjects
Preferred Term
BLOOD AND LYMPHATIC SYSTEM DISORDERS
Neutropenia 6.2
Agranulocytosis 1.7
GASTROINTESTINAL DISORDERS
Nausea 12.6
Abdominal pain/discomfort 10.4
Vomiting 9.8
Diarrhea 3.0
Dyspepsia 2.0
INVESTIGATIONS
Alanine Aminotransferase increased 7.5
Neutrophil count decreased 7.3
Weight increased 1.9
Aspartate Aminotransferase increased 1.2
METABOLISM AND NUTRITION DISORDERS
Increased appetite 4.0
Decreased appetite 1.1
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Arthralgia 9.8
Back pain 2.0
Pain in extremity 1.9
Arthropathy 1.4
NERVOUS SYSTEM DISORDERS
Headache 2.5
URINARY DISORDERS
Chromaturia 14.6

Gastrointestinal symptoms such as nausea, vomiting, and abdominal pain were the most frequent adverse reactions reported by patients participating in clinical trials and led to the discontinuation of Kelfer therapy in 1.6% of patients.

Chromaturia (reddish/brown discoloration of the urine) is a result of the excretion of the iron in the urine.

6.2 Postmarketing Experience

The following additional adverse reactions have been reported in patients receiving Kelfer. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure.

Blood and lymphatic system disorders: thrombocytosis, pancytopenia.

Cardiac disorders: atrial fibrillation, cardiac failure.

Congenital, familial and genetic disorders: hypospadias.

Eye disorders: diplopia, papilledema, retinal toxicity.

Gastrointestinal disorders: enterocolitis, rectal hemorrhage, gastric ulcer, pancreatitis, parotid gland enlargement.

General disorders and administration site conditions: chills, pyrexia, edema peripheral, multi-organ failure.

Hepatobiliary disorders : jaundice, hepatomegaly.

Immune system disorders: anaphylactic shock, hypersensitivity.

Infections and infestations: cryptococcal cutaneous infection, enteroviral encephalitis, pharyngitis, pneumonia, sepsis, furuncle, infectious hepatitis, rash pustular, subcutaneous abscess.

Investigations: blood bilirubin increased, blood creatinine phosphokinase increased.

Metabolism and nutrition disorders: metabolic acidosis, dehydration.

Musculoskeletal and connective tissue disorders: myositis, chondropathy, trismus.

Nervous system disorders: cerebellar syndrome, cerebral hemorrhage, convulsion, gait disturbance, intracranial pressure increased, psychomotor skills impaired, pyramidal tract syndrome, somnolence.

Psychiatric disorders: bruxism, depression, obsessive-compulsive disorder.

Renal disorders: glycosuria, hemoglobinuria.

Respiratory, thoracic and mediastinal disorders: acute respiratory distress syndrome, epistaxis, hemoptysis, pulmonary embolism.

Skin, subcutaneous tissue disorders: hyperhidrosis, periorbital edema, photosensitivity reaction, pruritis, urticaria, rash, Henoch-Schönlein purpura.

Vascular disorders: hypotension, hypertension.

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7 DRUG INTERACTIONS

7.1 Drugs Associated with Neutropenia or Agranulocytosis

Avoid concomitant use of Kelfer with other drugs known to be associated with neutropenia or agranulocytosis; however, if this is not possible, closely monitor the absolute neutrophil count .

7.2 UDP-Glucuronosyltransferases

Kelfer is primarily eliminated via metabolism to the 3-O-glucuronide. In vitro studies suggest that UDP glucuronosyltransferase (UGT) 1A6 is primarily responsible for the glucuronidation of Kelfer which can be reduced up to 78% in the presence of the UGT1A6 inhibitor phenylbutazone. However, the clinical significance of coadministration of Kelfer with a UGT1A6 inhibitor (e.g. diclofenac, probenecid, or silymarin (milk thistle)) on the systemic exposure of Kelfer has not been determined. Closely monitor patients for adverse reactions that may require downward dose titration or interruption when Kelfer is concomitantly administered with a UGT1A6 inhibitor.

7.3 Polyvalent Cations

Concurrent use of Kelfer with foods, mineral supplements, and antacids that contain polyvalent cations has not been studied. However, since Kelfer has the potential to bind polyvalent cations (e.g., iron, aluminum, and zinc), allow at least a 4-hour interval between Kelfer and other medications (e.g., antacids), or supplements containing these polyvalent cations .

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category D

Risk Summary

Based on evidence of genotoxicity and developmental toxicity in animal studies, Kelfer can cause fetal harm when administered to a pregnant woman. In animal studies, administration of Kelfer during the period of organogenesis resulted in embryofetal death and malformations at doses lower than equivalent human clinical doses. There are no studies in pregnant women, and available human data are limited. If Kelfer is used during pregnancy or if the patient becomes pregnant while taking Kelfer, the patient should be apprised of the potential hazard to the fetus.

Animal Data

Skeletal and soft tissue malformations occurred in offspring of rats and rabbits that received Kelfer orally during organogenesis at the lowest doses tested (25 mg/kg per day in rats; 10 mg/kg per day in rabbits). These doses were equivalent to 3% to 4% of the maximum recommended human dose (MRHD) based on body surface area. No maternal toxicity was evident at these doses.

Embryofetal lethality and maternal toxicity occurred in pregnant rabbits given 100 mg/kg/day Kelfer orally during the period of organogenesis. This dose is equivalent to 32% of the MRHD based on body surface area.

8.3 Nursing Mothers

It is not known whether Kelfer is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants from Kelfer, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4 Pediatric Use

The safety and effectiveness of Kelfer tablets for oral use in pediatric patients have not been established.

8.5 Geriatric Use

Safety and effectiveness in elderly individuals have not been established. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

8.6 Renal Impairment

An open-label, non-randomized, parallel group clinical study was conducted to evaluate the effect of impaired renal function on the safety, tolerability, and pharmacokinetics of a single 33 mg/kg oral dose of Kelfer. Subjects were categorized into 4 groups based on estimated glomerular filtration rate : healthy volunteers (eGFR ≥ 90 mL/min/1.73m2), mild renal impairment (eGFR 60–89 mL/min/1.73m2), moderate renal impairment (eGFR 30–59 mL/min/1.73m2), and severe renal impairment (eGFR 15–29 mL/min/1.73m2). Systemic exposure to Kelfer and to its metabolite Kelfer 3-O-glucuronide was assessed by the PK parameters Cmax and AUC.

Regardless of the degree of renal impairment, the majority of the dose of Kelfer was excreted in the urine over the first 24 hours as Kelfer 3-O-glucuronide. No significant effect of renal impairment was seen on systemic exposure to Kelfer. Systemic exposure to the inactive 3-O-glucuronide increased with decreasing eGFR. Based on the results of this study, no adjustment of the Kelfer dosage regimen is required in patients with impaired renal function.

8.7 Hepatic Impairment

The influence of severe hepatic impairment on the pharmacokinetics of Kelfer and Kelfer 3-O-glucuronide has not been evaluated. Safety and efficacy of Kelfer have not been evaluated in patients with severe hepatic impairment.

An open-label, non-randomized, parallel group clinical study was conducted to evaluate the effect of impaired hepatic function on the safety, tolerability, and pharmacokinetics of a single 33 mg/kg oral dose of Kelfer. Subjects were categorized into 3 groups based on the Child-Pugh classification score: healthy volunteers, mild hepatic impairment (Class A: 5– 6 points), and moderate hepatic impairment (Class B: 7– 9 points). Systemic exposure to Kelfer and to its metabolite Kelfer 3-O-glucuronide was assessed by the PK parameters Cmax and AUC. The PK of both Kelfer and Kelfer 3-O-glucuronide was generally similar in all subjects, regardless of degree of liver impairment. A serious adverse event of acute liver and renal injury was seen in one subject with moderate hepatic impairment. Based on the results of this study, no adjustment of the Kelfer dosage regimen is required in patients with mildly or moderately impaired hepatic function.

10 OVERDOSAGE

No cases of acute overdose have been reported. There is no specific antidote to Kelfer overdose.

Neurological disorders such as cerebellar symptoms, diplopia, lateral nystagmus, psychomotor slowdown, hand movements and axial hypotonia have been observed in children treated with 2.5 to 3 times the recommended dose for more than one year. The neurological disorders progressively regressed after Kelfer discontinuation.

11 DESCRIPTION

Kelfer (deferiprone) tablets contain 500 mg Kelfer (3-hydroxy-1,2-dimethylpyridin-4-one), a synthetic, orally active, iron-chelating agent. Kelfer has the following structural formula:


Kelfer is a white to pinkish-white crystalline powder. It is sparingly soluble in deionized water and has a melting point range of 272°C - 278°C.

Kelfer tablets are white to off-white, capsule-shaped tablets, and imprinted with “APO” score “500” on one side and plain on the other. The tablets can be broken in half along the score. Each tablet contains 500 mg Kelfer and the following inactive ingredients: Tablet core - microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide; Coating - hydroxypropyl methyl cellulose, polyethylene glycol, titanium dioxide.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Kelfer is a chelating agent with an affinity for ferric ion. Kelfer binds with ferric ions to form neutral 3:1 (deferiprone:iron) complexes that are stable over a wide range of pH values. Kelfer has a lower binding affinity for other metals such as copper, aluminum and zinc than for iron.

12.2 Pharmacodynamics

No clinical studies were performed to assess the relationship between the dose of Kelfer and the amount of iron eliminated from the body.

Cardiac Electrophysiology

At a dose 1.5 times the maximum recommended dose, Kelfer does not prolong the QT interval to any clinically relevant extent.

12.3 Pharmacokinetics

Kelfer is rapidly absorbed from the upper part of the gastrointestinal tract, appearing in the blood within 5 to 10 minutes of oral administration. Peak serum concentrations occur approximately 1 hour after a single dose in fasted healthy subjects and patients, and up to 2 hours after a single dose in the fed state. Administration with food decreased the Cmax of Kelfer by 38% and the AUC by 10%. While a food effect cannot be ruled out, the magnitude of the exposure change does not warrant dose adjustment.

In healthy subjects, the mean maximum concentration (Cmax) of Kelfer in serum was 20 mcg/mL, and the mean total area under the concentration-time curve (AUC) was 53 mcg∙h/mL following oral administration of a 1,500 mg dose of Kelfer tablets in the fasting state. Dose proportionality over the labeled dosage range of 25 to 33 mg/kg three times per day (75 to 99 mg/kg per day) has not been studied. The elimination half life (t1/2) of Kelfer was 1.9 hours. The accumulation of Kelfer and its glucuronide metabolite at the highest approved dosage level of 33 mg/kg three times per day has not been studied. The volume of distribution of Kelfer is 1.6 L/kg in thalassemia patients, and approximately 1 L/kg in healthy subjects. The plasma protein binding of Kelfer in humans is less than 10%.

In humans, the majority of the Kelfer is metabolized, primarily by UGT1A6. The contribution of extrahepatic (e.g., renal) UGT1A6 is unknown. The major metabolite of Kelfer is the 3-O-glucuronide, which lacks iron binding capability. Peak serum concentration of the glucuronide occurs 2 to 4 hours after administration of Kelfer in fasting subjects.

More than 90% of Kelfer is eliminated from plasma within 5 to 6 hours of ingestion. Following oral administration, 75% to 90% is recovered in the urine in the first 24 hours, primarily as metabolite.

Specific Populations

The pharmacokinetics of Kelfer has not been studied in geriatric or pediatric populations, and the influence of race, gender, or obesity has not been established.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been conducted with Kelfer. However, in view of the genotoxicity results, and the findings of mammary gland hyperplasia and mammary gland tumors in rats treated with Kelfer in the 52-week toxicology study, tumor formation in carcinogenicity studies must be regarded as likely.

Kelfer was positive in a mouse lymphoma cell assay in vitro. Kelfer was clastogenic in an in vitro chromosomal aberration test in mice and in a chromosomal aberration test in Chinese Hamster Ovary cells. Kelfer given orally or intraperitoneally was clastogenic in a bone marrow micronucleus assay in non-iron-loaded mice. A micronucleus test was also positive when mice predosed with iron dextran were treated with Kelfer. Kelfer was not mutagenic in the Ames bacterial reverse mutation test.

A fertility and early embryonic development study of Kelfer was conducted in rats. Sperm counts, motility and morphology were unaffected by treatment with Kelfer. There were no effects observed on male or female fertility or reproductive function at the highest dose which was 25% of the MRHD based on body surface area.

14 CLINICAL STUDIES

In a prospective, planned, pooled analysis of patients from several studies, the efficacy of Kelfer was assessed in transfusion-dependent iron overload patients in whom previous iron chelation therapy had failed or was considered inadequate due to poor tolerance. The main criterion for chelation failure was serum ferritin > 2,500 mcg/L before treatment with Kelfer. Kelfer therapy (35-99 mg/kg/day) was considered successful in individual patients who experienced a ≥ 20% decline in serum ferritin within one year of starting therapy.

Data from a total of 236 patients were analyzed. Of the 224 patients with thalassemia who received Kelfer monotherapy and were eligible for serum ferritin analysis, 105 (47%) were male and 119 (53%) were female. The mean age of these patients was 18.2 years.

For the patients in the analysis, the endpoint of at least a 20% reduction in serum ferritin was met in 50% (of 236 subjects), with a 95% confidence interval of 43% to 57%.

A small number of patients with thalassemia and iron overload were assessed by measuring the change in the number of milliseconds (ms) in the cardiac MRI T2* value before and after treatment with Kelfer for one year. There was an increase in cardiac MRI T2* from a mean at baseline of 11.8 ± 4.9 ms to a mean of 15.1 ± 7.0 ms after approximately one year of treatment. The clinical significance of this observation is not known.

16 HOW SUPPLIED/STORAGE AND HANDLING

Kelfer® (deferiprone) tablets are white to off-white, capsule-shaped tablets, film-coated, and have a functional score imprinted with “APO” score “500” on one side and are plain on the other. They are provided in a 100 count HDPE bottle with a child-resistant cap.

500 mg film-coated tablets, 100 tablets NDC 52609-0006-1

Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF).

Keep Kelfer out of the reach and sight of children.

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling (Medication Guide)


Distributed by ApoPharma USA, Inc., Rockville, MD, United States of America, 20850. Manufactured by Apotex Inc., Toronto, Ontario, Canada, M9L 1T9

MEDICATION GUIDE

Kelfer® (Feh’ ri prox)

(deferiprone)

tablets

Read this Medication Guide before you start taking Kelfer and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Kelfer?

Kelfer can cause serious side effects, including a very low white blood cell count in your blood. One type of white blood cell that is important for fighting infections is called a neutrophil. If your neutrophil count is low (neutropenia), you may be at risk of developing a serious infection that can lead to death. Neutropenia is common with Kelfer and can become severe in some people. Severe neutropenia is known as agranulocytosis. If you develop agranulocytosis, you will be at risk of developing serious infections that can lead to death.

Your healthcare provider should do a blood test before you start Kelfer and weekly during treatment to check your neutrophil count. If you develop neutropenia, your healthcare provider should check your blood counts every day until your white blood cell count improves.

Stop taking Kelfer and get medical help right away if you develop any of these symptoms of infection:


See “What are the possible side effects of Kelfer?” for more information about side effects.

What is Kelfer?

Kelfer is a prescription medicine used to treat people with thalassemia syndromes who have iron overload from blood transfusions, when current iron removal (chelation) therapy does not work well enough.

It is not known if Kelfer tablets are safe and effective:


Who should not take Kelfer?

Do not take Kelfer if yo u are allergic to Kelfer or any of the ingredients in Kelfer. See the end of this Medication Guide for a complete list of ingredients in Kelfer.

What should I tell my healthcare provider before taking Kelfer?

Before you take Kelfer, tell your healthcare provider if you:


Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Especially tell your healthcare provider if you take:


Ask your healthcare provider or pharmacist if your medicine is one that is listed above.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Kelfer?


What are the possible side effects of Kelfer?

Kelfer can cause serious side effects, including:


The most common side effects of Kelfer include:


Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Kelfer. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800-FDA-1088.

How should I store Kelfer?


Keep Kelfer and all medicines out of the reach of children.

General information about the safe and effective use of Kelfer.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Kelfer for a condition for which it was not prescribed. Do not give Kelfer to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about Kelfer. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about Kelfer that is written for health professionals.

For more information call 1-866-949-0995.

What are the ingredients in Kelfer?

Active ingredients: Kelfer

Inactive ingredients:

Tablet core: microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide.

Coating: hydroxypropyl methyl cellulose, polyethylene glycol, titanium dioxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by:

ApoPharma USA, Inc., Rockville, MD, United States of America, 20850.

Manufactured by:

Apotex Inc., Toronto, Ontario, Canada, M9L 1T9.

Revised February 2015

Trademark disclaimers.

ApoPharma USA, Inc. NDC 52609-0006-1

Kelfer tablets

500 mg

Rx only

100 Tablets

Kelfer pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Kelfer available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Kelfer destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Kelfer Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Kelfer pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."FERRIPROX (DEFERIPRONE) TABLET, FILM COATED [APOPHARMA USA, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."DEFERIPRONE: 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. "deferiprone". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Kelfer?

Depending on the reaction of the Kelfer after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Kelfer 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 Kelfer 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 Kelfer, 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 Kelfer 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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Click here to find out how other users of our website are taking it. For any doubts or queries on how and when the medicine is administered, contact your health care provider immediately.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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