Kodatef Tablet, Film Coated
Product Images NDC 71475-258

Product Visual Gallery

This gallery contains 62 technical images submitted to the FDA as part of the official labeling for Kodatef (NDC 71475-258). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by 60 Degrees Pharmaceuticals, Inc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Dear Hcp Letter Page 1 (Dear Hcp Letter Kodatef 7feb2025 Page 01)

This document is an important prescribing information letter from 60 Degrees Pharmaceuticals, Inc. dated February 2025. It informs healthcare providers about the temporary importation of unapproved Kodatef (tafenoquine succinate) tablets from Australia to address a domestic shortage of FDA-approved Arakoda (tafenoquine) tablets. The letter includes a product description table detailing Kodatef as an oral film-coated tablet with 100 mg strength, packaged in blister cards containing eight tablets each, with two blister cards per carton. Additional product codes, NDC, lot number, and expiry date are also listed.*

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Dear Hcp Letter Page 2 (Dear Hcp Letter Kodatef 7feb2025 Page 02)

Text panel providing key information about the unapproved drug Kodatef (tafenoquine). It covers the active ingredient, malaria prophylaxis indication, packaging details including blister cards in a cardboard carton, availability through specialty pharmacy Infuserve America, and notes on comparison with Arakoda. Additional details include barcode and QR code information, medication guide reference, and patient testing advisories.*

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Dear Hcp Letter Page 3 (Dear Hcp Letter Kodatef 7feb2025 Page 03)

This document page provides information about reporting adverse events for the drug Kodatef (tafenoquine). It encourages healthcare providers and patients to report issues to 60 Degrees Pharmaceuticals and the FDA's MedWatch program, including contact phone numbers, fax, and online reporting links. It also includes contact details for 60 Degrees Pharmaceuticals' Medical Information Team and mentions enclosed prescribing information and product comparison documents.*

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Dear Hcp Letter Page 4 (Dear Hcp Letter Kodatef 7feb2025 Page 04)

This image is a portion of the Australian product information for Kodatef (tafenoquine succinate) oral film-coated tablets. It includes sections on the name of the medicine, qualitative and quantitative composition specifying 125.5 mg tafenoquine succinate per tablet equivalent to 100 mg tafenoquine free base, pharmaceutical form describing dark pink capsule-shaped tablets debossed with "TQ100", and clinical particulars covering therapeutic indications for malaria prophylaxis, dose and method of administration, and warnings related to glucose-6-phosphate dehydrogenase deficiency testing and pregnancy exclusion.*

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Dear Hcp Letter Page 5 (Dear Hcp Letter Kodatef 7feb2025 Page 05)

Data tables presenting dosing regimen and instructions for missed doses of Kodatef (tafenoquine) 100 mg film-coated tablets. The first table outlines loading, maintenance, and final doses with timing and quantities. The second table details replacement guidelines for various missed doses, including loading and maintenance doses.*

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Dear Hcp Letter Page 6 (Dear Hcp Letter Kodatef 7feb2025 Page 06)

This text panel details safety and adverse effects information for Kodatef (tafenoquine) tablets. It covers psychiatric effects, haematological and gastrointestinal effects, pharmacokinetics in hepatic and renal impairment, elderly and pediatric use, effects on laboratory tests, and interactions with other medicines. The content discusses clinical trial observations including adverse reactions, limitations in certain patient populations, and potential drug interactions.*

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Dear Hcp Letter Page 7 (Dear Hcp Letter Kodatef 7feb2025 Page 07)

A text panel from the Kodatef (tafenoquine) prescribing information covering sections on fertility, pregnancy and lactation. It includes details on effects on fertility in animal studies, pregnancy category and contraindications, use in lactation, and mentions potential interactions with other haemolytic drugs. The panel also briefly notes effects on ability to drive and use machines and references adverse effects discussed elsewhere in the product information.*

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Dear Hcp Letter Page 8 (Dear Hcp Letter Kodatef 7feb2025 Page 08)

This text panel provides clinical trial experience, serious adverse events, treatment discontinuations, and laboratory abnormalities related to tafenoquine in Kodatef. It summarizes safety data from trials involving healthy subjects, including adverse events and eye findings such as vortex keratopathy, hematological changes, and common adverse events in clinical studies.*

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Dear Hcp Letter Page 9 (Dear Hcp Letter Kodatef 7feb2025 Page 09)

A data table showing selected adverse reactions occurring in 1% or more of subjects receiving Kodatef (tafenoquine) compared to Mefloquine in two clinical trial contexts: deployed military personnel in Trial 033 and non-deployed subjects in pooled Trials 043, 045, 030, and 057. The table breaks down adverse reactions by categories such as nervous system disorders, musculoskeletal disorders, gastrointestinal disorders, and psychiatric disorders, with percentage incidences for each drug group.*

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Dear Hcp Letter Page 10 (Dear Hcp Letter Kodatef 7feb2025 Page 10)

A data table and text listing adverse events reported in less than 1% of subjects receiving Kodatef (tafenoquine) in clinical trials. The table includes counts of abnormal ALT and psychiatric disorders such as sleep symptoms, insomnia, and depression. Below the table, detailed text enumerates various adverse reactions by system organ class and provides information on overdose and pharmacodynamic properties.*

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Dear Hcp Letter Page 11 (Dear Hcp Letter Kodatef 7feb2025 Page 11)

This image shows a text excerpt discussing the safety pharmacology and clinical trials of tafenoquine, specifically the prophylaxis of malaria. It includes details of in vitro and in vivo studies, a clinical trial comparing tafenoquine and mefloquine in healthy adults, and a data table summarizing prophylactic outcomes for trial subjects receiving tafenoquine 200 mg or mefloquine 250 mg.*

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Dear Hcp Letter Page 12 (Dear Hcp Letter Kodatef 7feb2025 Page 12)

Data tables presenting prophylactic outcomes during and after post-exposure phases comparing tafenoquine 200 mg and mefloquine 250 mg followed by primaquine. Tables include number of subjects, prophylactic success and failure rates, treatment differences with confidence intervals, and summary of relapse cases. Summary includes pharmacokinetic data population details and key pharmacokinetic parameters for tafenoquine such as volume of distribution, clearance, absorption rate constant, half-life, and steady-state concentration values.*

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Dear Hcp Letter Page 13 (Dear Hcp Letter Kodatef 7feb2025 Page 13)

This text panel provides pharmacokinetic information for tafenoquine, including absorption, distribution, metabolism, excretion, dose-PK relationships, PK-PD relationships, and drug-drug interactions. It details plasma concentration comparisons under fed and fasting conditions, protein binding, excretion routes in animals, and interaction with various enzymes and drug transporters.*

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Dear Hcp Letter Page 14 (Dear Hcp Letter Kodatef 7feb2025 Page 14)

This page contains sections from the Kodatef (tafenoquine) prescribing information, including preclinical safety data on genotoxicity and carcinogenicity, a list of excipients such as microcrystalline cellulose and mannitol, storage instructions to keep the product below 306C in the original container, and details on the tablet packaging in blister cards with aluminum and PVC laminate.*

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Dear Hcp Letter Page 15 (Dear Hcp Letter Kodatef 7feb2025 Page 15)

Chemical structure diagram of tafenoquine succinate, the active ingredient in Kodatef 100 mg film-coated tablets. The image includes the molecular formula C24H28F3N3O3·C4H6O4 and molecular weights, along with the chemical name and depiction of the structural formula for tafenoquine succinate.*

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Dear Hcp Letter Page 16 (Dear Hcp Letter Kodatef 7feb2025 Page 16)

A summary table of changes dated May 12, 2022, listing revisions for the pharmaceutical drug Kodatef (tafenoquine). It includes updated information such as transitioning from tablets to film-coated tablets, text updates in composition, storage, physicochemical properties, changes in excipient names, and an update to the sponsor address.*

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Dear Hcp Letter Page 17 (Dear Hcp Letter Kodatef 7feb2025 Page 17)

A data table comparing prescribing information sections for two tafenoquine oral film-coated tablet products, Arakoda and Kodatef. The table details similarities and differences in indications, dosing, adverse reaction reporting, and safety testing instructions, highlighting text differences in red.*

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Dear Hcp Letter Page 18 (Dear Hcp Letter Kodatef 7feb2025 Page 18)

A text panel comparing the dosage and administration instructions for two tafenoquine tablet products: ARAKODA and KODATEF. The panel includes instructions on KODATEF film-coated tablets, emphasizing swallowing whole, possible better gastrointestinal tolerance with food, lack of studied dosage adjustments for renal or hepatic impairment, and warnings that KODATEF is not for acute malaria treatment. It also outlines dosing limits for malaria prophylaxis and notes the lack of data on repeated use after initial dosing.*

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Dear Hcp Letter Page 19 (Dear Hcp Letter Kodatef 7feb2025 Page 19)

A data table titled "Dosing Regimen for KODATEF" outlining dosage instructions for tafenoquine 100 mg film-coated tablets. It lists loading, maintenance, and final (terminal) doses with timing related to travel to and from malarious areas, specifying 200 mg doses given as two tablets at various intervals for malaria prophylaxis.*

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Dear Hcp Letter Page 20 (Dear Hcp Letter Kodatef 7feb2025 Page 20)

A table labeled 'Missed Doses of KODATEF' describing how to replace missed doses of Kodatef tablets. It lists missed doses including loading and maintenance doses and instructions for replacement doses involving 200 mg (two 100 mg film-coated tablets) on specified days to complete the dosing schedule.*

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Dear Hcp Letter Page 21 (Dear Hcp Letter Kodatef 7feb2025 Page 21)

This image is a text panel comparing three dosage forms and strengths, contraindications, and hypersensitivity reactions of tafenoquine products Arakoda and Kodatef. It describes Arakoda tablets as dark pink, film-coated, capsule-shaped with TQ100 debossed. Kodatef tablets are similarly described. The panel lists contraindications including G6PD deficiency, breastfeeding where infant G6PD status is unknown, psychotic disorders, and known hypersensitivity. Hypersensitivity reactions symptoms for both products are also noted.*

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Dear Hcp Letter Page 22 (Dear Hcp Letter Kodatef 7feb2025 Page 22)

Text comparing warnings and precautions for hemolytic anemia for two tafenoquine tablet products: ARAKODA and KODATEF oral film-coated tablets. Both panels discuss the need for G6PD deficiency testing before prescribing due to hemolysis risk and mention clinical trial observations of hemoglobin declines in patients with normal enzyme levels, advising monitoring for symptoms and discontinuation signs.*

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Dear Hcp Letter Page 23 (Dear Hcp Letter Kodatef 7feb2025 Page 23)

This image shows a section of drug safety information comparing two tafenoquine products, Arakoda and Kodatef, focusing on pregnancy and lactation warnings. It highlights potential harm to the fetus due to G6PD deficiency, contraindications during pregnancy, and the recommendation for effective contraception during treatment and afterward for both products.*

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Dear Hcp Letter Page 24 (Dear Hcp Letter Kodatef 7feb2025 Page 24)

This image displays a side-by-side safety information comparison between two tafenoquine tablet products: ARAKODA and KODATEF, both oral film-coated tablets. The content addresses risks to breastfeeding infants, methemoglobinemia, and hematological effects, highlighting precautions and clinical trial findings related to these products.*

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Dear Hcp Letter Page 25 (Dear Hcp Letter Kodatef 7feb2025 Page 25)

The image shows a split text panel comparing psychiatric effects and warnings for two oral film-coated tafenoquine tablet products: ARAKODA and KODATEF. It details reported psychiatric adverse reactions such as sleep disturbances, depression, anxiety, and suicide attempts during clinical trials, along with patient exclusions and precautions related to psychiatric disorders.*

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Dear Hcp Letter Page 26 (Dear Hcp Letter Kodatef 7feb2025 Page 26)

This image shows a text panel comparing hypersensitivity reactions, contraindications, delayed adverse reactions and effects on ability to drive of two oral film-coated tafenoquine tablets: Arakoda and Kodatef. The panel highlights serious hypersensitivity reactions, contraindications including known hypersensitivity to tafenoquine and related compounds, and delayed adverse effects like hemolytic anemia and psychiatric effects, with some text in black and red for emphasis.*

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Dear Hcp Letter Page 27 (Dear Hcp Letter Kodatef 7feb2025 Page 27)

This is a text panel comparing adverse reactions and warnings for ARAKODA and KODATEF (tafenoquine succinate) oral film-coated tablets. It lists clinically significant adverse reactions including hemolytic anemia, methemoglobinemia, psychiatric effects, and hypersensitivity reactions, with additional notes on gastrointestinal effects and special warnings. The text also references clinical trial experience and pharmacological properties for these products.*

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Dear Hcp Letter Page 28 (Dear Hcp Letter Kodatef 7feb2025 Page 28)

A comparative text panel showing drug interaction information for two tafenoquine products: ARAKODA and KODATEF. The panel outlines potential interactions with organic cation transporter substrates and other medicines, highlighting specific drugs such as dofetilide, procainamide, metformin, and dapsone. The text is in black with some key terms in red, arranged in two columns under headings. Page number 12 is visible at the bottom.*

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Dear Hcp Letter Page 29 (Dear Hcp Letter Kodatef 7feb2025 Page 29)

This image shows a side-by-side text excerpt comparing pregnancy-related use and risk information for two tafenoquine products, ARAKODA and KODATEF. Both are described as tafenoquine tablets or film-coated tablets for oral use, with detailed warnings about use during pregnancy and risks for G6PD-deficient fetuses.*

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Dear Hcp Letter Page 30 (Dear Hcp Letter Kodatef 7feb2025 Page 30)

This text panel compares two tafenoquine products, Arakoda and Kodatef. It details animal data on dose-related abortions in pregnant rabbits and maternal toxicity in rats, including dosage effects and observations of no malformations. The text also addresses effects on fertility, maternal toxicity, and foetotoxicity at various dosages during organogenesis.*

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Dear Hcp Letter Page 31 (Dear Hcp Letter Kodatef 7feb2025 Page 31)

A comparison table presenting lactation risk information for two tafenoquine products: ARAKODA film-coated tablets and KODATEF oral film-coated tablets. It details risk summaries, clinical considerations, and warnings about G6PD deficiency exposure during breastfeeding. The KODATEF section also includes animal study data on effects observed at specific oral doses during gestation and lactation.*

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Dear Hcp Letter Page 32 (Dear Hcp Letter Kodatef 7feb2025 Page 32)

This text panel compares product information for ARAKODA and KODATEF, both oral film-coated tablets containing tafenoquine. It includes sections on pregnancy testing, contraception, pediatric use, geriatric use, and renal impairment. The panel notes safety considerations for females of reproductive potential, lack of established safety in pediatric patients, clinical trial limitations in the elderly, and limited pharmacokinetic data in renal impairment patients.*

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Dear Hcp Letter Page 33 (Dear Hcp Letter Kodatef 7feb2025 Page 33)

A text panel comparing ARAKODA and KODATEF (tafenoquine succinate) oral film-coated tablets. It includes sections on hepatic impairment and overdose. The hepatic impairment section states pharmacokinetics have not been studied in patients with hepatic impairment. The overdose section notes no reported overdose cases for both drugs and details symptoms and management guidelines for KODATEF overdose, including gastrointestinal symptoms and hematologic events.*

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Dear Hcp Letter Page 34 (Dear Hcp Letter Kodatef 7feb2025 Page 34)

Chemical structure of tafenoquine succinate is shown in a black-and-white molecular diagram featuring rings, chemical bonds, and functional groups including trifluoromethyl and methyl groups. The image displays the molecular formula and chemical name, highlighting tafenoquine succinate as an active pharmaceutical ingredient.*

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Dear Hcp Letter Page 35 (Dear Hcp Letter Kodatef 7feb2025 Page 35)

A text panel comparing excipients and pharmacology between tafenoquine tablets branded as Arakoda and Kodatef. The Kodatef section lists excipients such as microcrystalline cellulose, mannitol, and titanium dioxide. It also includes pharmacodynamic properties describing the mechanism of action of tafenoquine against malaria parasites, mentioning involvement with redox reactions. The Arakoda section briefly mentions tafenoquine as an antimalarial agent.*

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Dear Hcp Letter Page 36 (Dear Hcp Letter Kodatef 7feb2025 Page 36)

A text panel comparing pharmacodynamics and safety pharmacology data for tafenoquine tablets marketed under the names Arakoda and Kodatef. It includes evaluation of tafenoquine's effect on the QT interval in healthy adults and describes in vitro and in vivo studies related to cardiac electrophysiology and heart conductance.*

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Dear Hcp Letter Page 37 (Dear Hcp Letter Kodatef 7feb2025 Page 37)

Text comparing pharmacokinetic properties and absorption of two tafenoquine tablet products, Arakoda and Kodatef. The text includes clinical study details, plasma concentration comparisons under fed and fasted conditions, and dose-PK relationships. It contains pharmacokinetic parameters, such as Cmax, Tmax, and AUC, and mentions tablet dosing and study data in healthy adult subjects.*

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Dear Hcp Letter Page 38 (Dear Hcp Letter Kodatef 7feb2025 Page 38)

This image shows a text panel comparing two tafenoquine tablets: ARAKODA and KODATEF. It includes information on pharmacokinetics in specific populations, clinical trial data, and pharmacokinetic parameters such as volume of distribution, clearance, absorption rate, half-life, and concentration values. The text highlights patient demographics, trial details, and pharmacokinetic modeling results.*

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Dear Hcp Letter Page 39 (Dear Hcp Letter Kodatef 7feb2025 Page 39)

This image shows pharmacokinetic information comparing Arakoda (tafenoquine) tablet, film coated, and Kodatef (tafenoquine succinate) oral film-coated tablets. It includes data on distribution, elimination/excretion, and metabolism, highlighting protein binding, volume of distribution, clearance, and metabolic activity in humans and animals. The text is organized in a side-by-side table format with headings and details in black and red text.*

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Dear Hcp Letter Page 40 (Dear Hcp Letter Kodatef 7feb2025 Page 40)

This image is a text excerpt from pharmacokinetics sections comparing two tafenoquine oral film-coated tablets: Arakoda and Kodatef. It details drug interaction studies, noting no significant effects on cytochrome P450 substrates and discusses tafenoquine's inhibition of certain transporters like OCT2, MATE1, and MATE2-K, as well as considerations for coadministration with other drugs such as procainamide and metformin.*

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Dear Hcp Letter Page 41 (Dear Hcp Letter Kodatef 7feb2025 Page 41)

A text panel comparing product information for ARAKODA (tafenoquine tablets, film coated) and KODATEF (tafenoquine succinate oral film-coated tablets). It covers the microbiology, mechanism of action, antimicrobial activity, and resistance of tafenoquine, along with pharmacodynamic properties. The text includes detailed scientific descriptions of tafenoquine's effects on malaria parasites and its activity stages.*

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Dear Hcp Letter Page 42 (Dear Hcp Letter Kodatef 7feb2025 Page 42)

This image displays a split-page excerpt from the prescribing information of tafenoquine products, branded as Arakoda and Kodatef oral film-coated tablets. It covers sections 13 Nonclinical Toxicology and 5.3 Preclinical Safety Data, focusing on carcinogenesis, mutagenesis, and genotoxicity data derived from studies in rats, mice, and in vitro assays, discussing the relevance of findings to human carcinogenic risk.*

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Dear Hcp Letter Page 43 (Dear Hcp Letter Kodatef 7feb2025 Page 43)

This image shows a drug facts table comparing fertility study data for two tafenoquine products: Arakoda and Kodatef (tafenoquine succinate) oral film-coated tablets. It details effects on fertility, including dosing information and effects observed in rats and rabbits. The text highlights impacts on viable fetuses, implantation sites, and maternal toxicity, with some text in red emphasizing no effect on fertility at certain doses and dose-related abortions in animal studies.*

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Dear Hcp Letter Page 44 (Dear Hcp Letter Kodatef 7feb2025 Page 44)

This image shows text from the drug supply and storage section for tafenoquine tablets branded as Kodatef and Arakoda. It details the packaging forms including blister packs and bottles, the storage temperature requirements, and the tablet description as film-coated. The text also includes manufacturer and sponsor information.*

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Dear Hcp Letter Page 45 (Dear Hcp Letter Kodatef 7feb2025 Page 45)

A split table comparing information on two tafenoquine products: ARAKODA tablets and KODATEF oral film-coated tablets. The left side references ARAKODA patient counseling and medication guide, noting no equivalent warning or section in its prescribing information, while the right side details KODATEF with sections on special warnings and precautions, including effects on laboratory tests, and pharmacokinetic properties. Text distinguishes each product and highlights differences in patient information and warnings.*

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Dear Hcp Letter Page 46 (Dear Hcp Letter Kodatef 7feb2025 Page 46)

Text excerpt titled 'ARAKODA – Clinical Trial Summaries' describing clinical trials experience, including trial settings, subject numbers, conditions, and adverse reactions reporting for the drug tafenoquine. It summarizes five controlled clinical trials involving 3,184 subjects, detailing trial locations and comparator arms, along with a mention of adverse reactions reported in certain trials.*

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Dear Hcp Letter Page 47 (Dear Hcp Letter Kodatef 7feb2025 Page 47)

Table showing selected adverse reactions occurring in 1% or more of subjects receiving ARAKODA in pooled clinical trials compared to placebo and Mefloquine. It lists rates of nervous system disorders, musculoskeletal disorders, gastrointestinal disorders, laboratory investigations, and psychiatric disorders, with specific symptoms such as headache, dizziness, back pain, diarrhea, nausea, vomiting, ALT increase, and sleep-related symptoms.*

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Dear Hcp Letter Page 48 (Dear Hcp Letter Kodatef 7feb2025 Page 48)

A data table titled 'Selected Adverse Reactions Occurring in ≥1% of Subjects Receiving ARAKODA in Trial 3 (Deployed Subjects)' comparing adverse reaction rates between ARAKODA (n=492) and Mefloquine (n=162). Reactions are grouped by disorder types such as nervous system, ear and labyrinth, musculoskeletal, gastrointestinal, and psychiatric disorders. Percentages are listed for each reaction, showing differences in incidence rates for symptoms including headache, dizziness, motion sickness, back pain, diarrhea, nausea, vomiting, sleep symptoms, insomnia, abnormal dreams, and anxiety.*

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Dear Hcp Letter Page 49 (Dear Hcp Letter Kodatef 7feb2025 Page 49)

A text panel listing clinically significant adverse reactions reported in trials 1 to 5 for ARAKODA (tafenoquine) including ocular adverse reactions, laboratory abnormalities, and adverse reactions occurring in less than 1% of subjects. Specific conditions such as keratopathy, methemoglobinemia, and various disorders affecting blood, ear, eye, liver, immune system, nervous system, psychiatric, and skin are mentioned.*

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Dear Hcp Letter Page 50 (Dear Hcp Letter Kodatef 7feb2025 Page 50)

A data table titled "Incidence of Parasitemia and Protective Efficacy of ARAKODA at 15 weeks for Trial 1" comparing placebo and ARAKODA groups. It lists the number of subjects, subjects free of parasitemia, subjects with parasitemia, subjects with missing data, and protective efficacy with confidence intervals. Additional text explains the clinical trial setup and notes on dosing and statistical analysis.*

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Dear Hcp Letter Page 51 (Dear Hcp Letter Kodatef 7feb2025 Page 51)

A table presenting incidence of parasitemia and protective efficacy of ARAKODA compared to placebo at week 12 in Trial 2. It displays number of subjects, subjects free of parasitemia, subjects with parasitemia, subjects with missing data, and protective efficacy percentages with confidence intervals. The table includes notes on dosing regimen and statistical analysis.*

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Dear Hcp Letter Page 52 (Dear Hcp Letter Kodatef 7feb2025 Page 52)

Text panel titled "Clinical Trial 7" describing a randomized, double-blind, placebo-controlled trial of ARAKODA for prophylactic activity against blood-stage Plasmodium falciparum parasites in healthy, non-immune volunteers. The panel summarizes subject demographics, dosing schedules, and efficacy endpoints measured by parasite detection via PCR assay.*

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Dear Hcp Letter Page 53 (Dear Hcp Letter Kodatef 7feb2025 Page 53)

This image is a text extract titled 'KODATEF – Clinical Trial Summaries' discussing adverse effects (undesirable effects) from clinical trials of tafenoquine for malaria prevention. It summarizes trial populations, trial locations, and safety evaluations, including serious adverse events and treatment discontinuations reported in tafenoquine-treated subjects compared to placebo controls.*

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Dear Hcp Letter Page 54 (Dear Hcp Letter Kodatef 7feb2025 Page 54)

A text panel describing adverse reactions and findings related to Kodatef (tafenoquine) treatment, including eye findings, laboratory abnormalities, and common adverse events observed in clinical trials. The panel covers vortex keratopathy incidence, retinal abnormalities, methaemoglobinemia, hemoglobin decreases, and other adverse reactions.*

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Dear Hcp Letter Page 55 (Dear Hcp Letter Kodatef 7feb2025 Page 55)

A data table titled 'Selected Adverse Reactions Occurring in ≥1% of Subjects Receiving KODATEF in Trial 033 (Deployed Subjects).' It compares the incidence percentages of various adverse reactions between KODATEF (tafenoquine) and Mefloquine groups, listing categories such as nervous system disorders, ear and labyrinth disorders, musculoskeletal disorders, gastrointestinal disorders, and psychiatric disorders, with detailed adverse reactions and their respective percentage incidences for each drug group.*

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Dear Hcp Letter Page 56 (Dear Hcp Letter Kodatef 7feb2025 Page 56)

Data table presenting selected adverse reactions occurring in 1% or more of subjects receiving Kodatef (tafenoquine) compared with placebo and mefloquine in pooled clinical trials 043, 045, 030, and 057. The table details percentages for nervous system disorders, musculoskeletal disorders, gastrointestinal disorders, investigations, and psychiatric disorders, including headache, dizziness, back pain, diarrhea, nausea, vomiting, ALT increased, insomnia, and depression.*

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Dear Hcp Letter Page 57 (Dear Hcp Letter Kodatef 7feb2025 Page 57)

A text excerpt from a drug label describing reported adverse events associated with the drug Kodatef (tafenoquine) including blood and lymphatic, ear, eye, hepatobiliary, immune system, nervous system, psychiatric, and skin disorders. It also outlines information about clinical trials supporting its use for malaria prophylaxis, mentioning trial phases and subject demographics.*

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Dear Hcp Letter Page 58 (Dear Hcp Letter Kodatef 7feb2025 Page 58)

Table showing prophylactic outcomes during the prophylactic treatment phase in Trial 033 comparing Tafenoquine 200 mg and Mefloquine 250 mg. The table presents the number of subjects and prophylactic failure rates (0%) in both treatment groups, along with prophylactic success rates (100%) and treatment difference confidence intervals. Footnotes detail the dosing regimens for both drugs.*

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Dear Hcp Letter Page 59 (Dear Hcp Letter Kodatef 7feb2025 Page 59)

A data table titled 'Prophylactic Outcome During the post-exposure Phase' for Trial 033 comparing tafenoquine 200 mg with mefloquine 250 mg followed by primaquine. It lists the number of subjects, prophylactic success and failure rates, and treatment difference with confidence intervals. Additional text provides context on failure rates, relapse timing, and extended follow-up outcomes.*

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Dear Hcp Letter Page 60 (Dear Hcp Letter Kodatef 7feb2025 Page 60)

Comparison image showing folded carton labels for Arakoda and Kodatef tablets. Kodatef label features a mostly white background with blue and green chevron design, stating tafenoquine (as succinate) 100 mg, 16 film-coated tablets, manufactured by Biocelect. Includes prescription-only medicine warnings, barcodes, and dosage details. The Arakoda label shows similar text and layout with the same color scheme, indicating tafenoquine 100 mg tablets by 60 Degrees Pharmaceuticals.*

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Dear Hcp Letter Page 61 (Dear Hcp Letter Kodatef 7feb2025 Page 61)

Kodatef 100 mg film-coated tablets blister pack front and back views, showing the name Kodatef, active ingredient tafenoquine (as succinate), and labeler Biocelect. The pack contains multiple tablets arranged in a 2x4 grid with visible lot and expiration date imprints on the back of the aluminum foil blister.*

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Kodatef Carton Label (Kodatef Carton Label)

Packaging label for Kodatef 100 mg film-coated tablets containing tafenoquine (as succinate). The label displays the brand name Kodatef, active ingredient tafenoquine, strength 100 mg, and tablet count of 16. The labeler is Biocelect, and the packaging notes this is a prescription-only medicine. The label design uses blue, green, and white colors with dosage and safety information included on the box.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.