Authors:
, , , , , , , , , , , , , , , , , and
ProCite
RefWorks
Reference Manager
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EndNote
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1.
White NJ, 2005. Intermittent presumptive treatment for malaria. PLoS Med 2: e3.
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2.
Magill A, 2016. For the Record: A History of Malaria Chemoprophylaxis. Available at: https://wwwnc.cdc.gov/travel/yellowbook/2016/infectious-diseases-related-to-travel/for-the-record-a-history-of-malaria-chemoprophylaxis. Accessed December 19, 2018.
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3.
Chaudhuri RN, Chakravarty NK, Chaudhuri MN, Janardan Poti S, 1952. Chemotherapy and chemoprophylaxis of malaria; clinical trials in 500 cases and mass prophylaxis in a hyperendemic area. Br Med J 1: 568–574.
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4.
Beadle C, Hoffman SL, 1993. History of malaria in the United States Naval Forces at war: World War I through the Vietnam conflict. Clin Infect Dis 16: 320–329.
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5.
Mayne Pharma, 1967. Doxteric Label. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050795Orig1s019lbl.pdf. Accessed December 19, 2018.
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6.
Lobel HO, Miani M, Eng T, Bernard KW, Hightower AW, Campbell CC, 1993. Long-term malaria prophylaxis with weekly mefloquine. Lancet 341: 848–851.
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7.
Roxane Laboratories, 2013. Mefloquine Label. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076523s007lbl.pdf. Accessed January 27, 2019.
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8.
Glaxo Smith Kline, Malarone Label. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021078s022lbl.pdf. Accessed December 19, 2018.
-
9.
Pearlman EJ, Doberstyn EB, Sudsok S, Thiemanun W, Kennedy RS, Canfield CJ, 1980. Chemosuppressive field trials in Thailand. IV. The suppression of Plasmodium falciparum and Plasmodium vivax parasitemias by mefloquine (WR 142,490, A 4-quinolinemethanol). Am J Trop Med Hyg 29: 1131–1137.
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10.
Blasco B, Leroy D, Fidock DA, 2017. Antimalarial drug resistance: linking Plasmodium falciparum parasite biology to the clinic. Nat Med 23: 917–928.
-
11.
Sutherland CJ, Laundy M, Price N, Burke M, Fivelman QL, Pasvol G, Klein JL, Chiodini PL, 2008. Mutations in the Plasmodium falciparum cytochrome b gene are associated with delayed parasite recrudescence in malaria patients treated with atovaquone-proguanil. Malar J 7: 240.
-
12.
Burrows JN, van Huijsduijnen RH, Möhrle JJ, Oeuvray C, Wells TN, 2013. Designing the next generation of medicines for malaria control and eradication. Malar J 12: 187.
-
13.
Kersgard CM, Hickey PW, 2013. Adult malaria chemoprophylaxis prescribing patterns in the military health system from 2007–2011. Am J Trop Med Hyg 89: 317–325.
-
14.
WHO, 1992. Review of Central Nervous System Adverse Events Related to the Antimalarial Drug, Mefloquine (1985–1990). Available at: http://apps.who.int/iris/handle/10665/61327. Accessed December 19, 2018.
-
15.
Saunders DL, Garges E, Manning JE, Bennett K, Schaffer S, Kosmowski AJ, Magill AJ, 2015. Safety, tolerability, and compliance with long-term antimalarial chemoprophylaxis in American soldiers in Afghanistan. Am J Trop Med Hyg 93: 584–590.
-
16.
Arguin PM, Tan KR, 2018. Malaria in CDC Yellow Book 2018. Available at: https://wwwnc.cdc.gov/travel/yellowbook/2018/infectious-diseases-related-to-travel/malaria. Accessed December 19, 2018.
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17.
Hill DR, Baird JK, Parise ME, Lewis LS, Ryan ET, Magill AJ, 2006. Primaquine: report from CDC expert meeting on malaria chemoprophylaxis. Am J Trop Med Hyg 75:402–415.
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18.
60 Degrees Pharmaceuticals, 2018. ARAKOTA Label. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210607lbl.pdf. Accessed December 19, 2018.
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19.
Nasveld PE et al. Tafenoquine Study Team, 2010. Randomized, double-blind study of the safety, tolerability, and efficacy of tafenoquine versus mefloquine for malaria prophylaxis in nonimmune subjects. Antimicrob Agents Chemother 54: 792–798.
-
20.
Dow GS, McCarthy WF, Reid M, Smith B, Tang D, Shanks GD, 2014. A retrospective analysis of the protective efficacy of tafenoquine and mefloquine as prophylactic anti-malarials in non-immune individuals during deployment to a malaria-endemic area. Malar J 13: 49.
-
21.
Li Q, O’Neil M, Xie L, Caridha D, Zeng Q, Zhang J, Pybus B, Hickman M, Melendez V, 2014. Assessment of the prophylactic activity and pharmacokinetic profile of oral tafenoquine compared to primaquine for inhibition of liver stage malaria infections. Malar J 13: 141.
-
22.
McCarthy JS, Smith B, Reid M, Berman J, Marquart L, Dobbin C, West L, Read LT, Dow G, 2018. Blood schizonticidal activity and safety of tafenoquine when administered as chemoprophylaxis to healthy, non-immune participants followed by blood stage Plasmodium falciparum challenge: a randomized, double-blinded, placebo-controlled phase 1b study. Clin Infect Dis. doi: 10.1093/cid/ciy939.
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23.
GlaxoSmithKline, 2018. Krintofel label. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210795s000lbl.pdf. Accessed December 19, 2018.
-
24.
Lacerda MVG et al. 2019. Single-dose tafenoquine to prevent relapse of Plasmodium vivax malaria. N Engl J Med 380: 215–228.
-
25.
Beutler E, 1991. Glucose-6-phosphate dehydrogenase deficiency. N Eng J Med 324: 169–174.
-
26.
Dow GS, Brown T, Reid M, Smith B, Toovey S, 2017. Tafenoquine is not neurotoxic following supertherapeutic dosing in rats. Travel Med Infect Dis 17: 28–34.
-
27.
Dow G, Bauman R, Caridha D, Cabezas M, Du F, Gomez-Lobo R, Park M, Smith K, Cannard K, 2006. Mefloquine induces dose-related neurological effects in a rat model. Antimicrob Agents Chemother 50: 1045–1053.
-
28.
Food and Drug Administration, 2018. ARAKODA NDA Approval Letter. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210607Orig1s000ltr.pdf. Accessed December 19, 2018.
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29.
Sanofi-Aventis US. Primaquine Label. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008316s023lbl.pdf.
-
30.
60 Degrees Pharmaceuticals, 2018. Arakoda Tablets for the Prevention of Malaria in Adults. Briefing document for the Antimicrobial Drugs Advisory Committee. Available at: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/UCM614202.pdf.
-
31.
Gutteridge WE, 1991. Antimalarial drugs currently in development. J R Soc Med 82 (Suppl 17): 63–66.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 1099 | 794 | 64 |
| Full Text Views | 862 | 13 | 0 |
| PDF Downloads | 251 | 12 | 0 |
Approval of Tafenoquine for Malaria Chemoprophylaxis
Jonathan D. Berman
Jonathan D. Berman
Fast Track Drugs and Biologics, North Potomac, Maryland
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Malaria chemoprophylaxis has become increasingly prominent now that it is used for vulnerable populations in endemic regions in addition to nonimmune travelers to those regions. The objective would be a drug with > 95% efficacy and that is easily tolerated, including in children and pregnant women. For individuals who prefer weekly rather than daily drug administration, a further objective is a product that is administered weekly. The deficiencies of present agents are parasite resistance to chloroquine, neuropsychiatric liability of mefloquine, the need for daily dosing for atovaquone–proguanil, and daily dosing plus adverse reactions for doxycycline. A primaquine analogue, tafenoquine, has a 17-day half-life and was approved for weekly prophylaxis in the United States and in Australia in 2018. Weekly tafenoquine was equal to mefloquine in efficacy in nonimmunes. The tafenoquine label contains a contraindication for preexisting psychosis, but not for the broad number of other neuropsychiatric disorders which are listed as contraindications in the mefloquine label. As an 8-aminoquinoline, tafenoquine is contraindicated for glucose-6-phosphate dehydrogenase (G6PD)-deficient persons or in pregnancy if the fetus might be G6PD deficient. Other possible significant adverse reactions for tafenoquine are declines in hemoglobin levels reported in some G6PD-normal patients, asymptomatic elevations in methemoglobin, and minor psychiatric events. The lack of broad neuropsychiatric adverse reactions suggests that tafenoquine may have a role as the weekly prophylactic of choice for G6PD-normal persons.
Author Notes
Disclosure: J. D. B. is under contract as consultant with the U.S. Army to aid in tafenoquine registration applications, and has submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest.
Author’s address: Jonathan D. Berman, Fast Track Drugs and Biologics, North Potomac, MD, E-mail: jberman@fasttrackresearch.com.
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1.
White NJ, 2005. Intermittent presumptive treatment for malaria. PLoS Med 2: e3.
-
2.
Magill A, 2016. For the Record: A History of Malaria Chemoprophylaxis. Available at: https://wwwnc.cdc.gov/travel/yellowbook/2016/infectious-diseases-related-to-travel/for-the-record-a-history-of-malaria-chemoprophylaxis. Accessed December 19, 2018.
-
3.
Chaudhuri RN, Chakravarty NK, Chaudhuri MN, Janardan Poti S, 1952. Chemotherapy and chemoprophylaxis of malaria; clinical trials in 500 cases and mass prophylaxis in a hyperendemic area. Br Med J 1: 568–574.
-
4.
Beadle C, Hoffman SL, 1993. History of malaria in the United States Naval Forces at war: World War I through the Vietnam conflict. Clin Infect Dis 16: 320–329.
-
5.
Mayne Pharma, 1967. Doxteric Label. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050795Orig1s019lbl.pdf. Accessed December 19, 2018.
-
6.
Lobel HO, Miani M, Eng T, Bernard KW, Hightower AW, Campbell CC, 1993. Long-term malaria prophylaxis with weekly mefloquine. Lancet 341: 848–851.
-
7.
Roxane Laboratories, 2013. Mefloquine Label. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076523s007lbl.pdf. Accessed January 27, 2019.
-
8.
Glaxo Smith Kline, Malarone Label. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021078s022lbl.pdf. Accessed December 19, 2018.
-
9.
Pearlman EJ, Doberstyn EB, Sudsok S, Thiemanun W, Kennedy RS, Canfield CJ, 1980. Chemosuppressive field trials in Thailand. IV. The suppression of Plasmodium falciparum and Plasmodium vivax parasitemias by mefloquine (WR 142,490, A 4-quinolinemethanol). Am J Trop Med Hyg 29: 1131–1137.
-
10.
Blasco B, Leroy D, Fidock DA, 2017. Antimalarial drug resistance: linking Plasmodium falciparum parasite biology to the clinic. Nat Med 23: 917–928.
-
11.
Sutherland CJ, Laundy M, Price N, Burke M, Fivelman QL, Pasvol G, Klein JL, Chiodini PL, 2008. Mutations in the Plasmodium falciparum cytochrome b gene are associated with delayed parasite recrudescence in malaria patients treated with atovaquone-proguanil. Malar J 7: 240.
-
12.
Burrows JN, van Huijsduijnen RH, Möhrle JJ, Oeuvray C, Wells TN, 2013. Designing the next generation of medicines for malaria control and eradication. Malar J 12: 187.
-
13.
Kersgard CM, Hickey PW, 2013. Adult malaria chemoprophylaxis prescribing patterns in the military health system from 2007–2011. Am J Trop Med Hyg 89: 317–325.
-
14.
WHO, 1992. Review of Central Nervous System Adverse Events Related to the Antimalarial Drug, Mefloquine (1985–1990). Available at: http://apps.who.int/iris/handle/10665/61327. Accessed December 19, 2018.
-
15.
Saunders DL, Garges E, Manning JE, Bennett K, Schaffer S, Kosmowski AJ, Magill AJ, 2015. Safety, tolerability, and compliance with long-term antimalarial chemoprophylaxis in American soldiers in Afghanistan. Am J Trop Med Hyg 93: 584–590.
-
16.
Arguin PM, Tan KR, 2018. Malaria in CDC Yellow Book 2018. Available at: https://wwwnc.cdc.gov/travel/yellowbook/2018/infectious-diseases-related-to-travel/malaria. Accessed December 19, 2018.
-
17.
Hill DR, Baird JK, Parise ME, Lewis LS, Ryan ET, Magill AJ, 2006. Primaquine: report from CDC expert meeting on malaria chemoprophylaxis. Am J Trop Med Hyg 75:402–415.
-
18.
60 Degrees Pharmaceuticals, 2018. ARAKOTA Label. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210607lbl.pdf. Accessed December 19, 2018.
-
19.
Nasveld PE et al. Tafenoquine Study Team, 2010. Randomized, double-blind study of the safety, tolerability, and efficacy of tafenoquine versus mefloquine for malaria prophylaxis in nonimmune subjects. Antimicrob Agents Chemother 54: 792–798.
-
20.
Dow GS, McCarthy WF, Reid M, Smith B, Tang D, Shanks GD, 2014. A retrospective analysis of the protective efficacy of tafenoquine and mefloquine as prophylactic anti-malarials in non-immune individuals during deployment to a malaria-endemic area. Malar J 13: 49.
-
21.
Li Q, O’Neil M, Xie L, Caridha D, Zeng Q, Zhang J, Pybus B, Hickman M, Melendez V, 2014. Assessment of the prophylactic activity and pharmacokinetic profile of oral tafenoquine compared to primaquine for inhibition of liver stage malaria infections. Malar J 13: 141.
-
22.
McCarthy JS, Smith B, Reid M, Berman J, Marquart L, Dobbin C, West L, Read LT, Dow G, 2018. Blood schizonticidal activity and safety of tafenoquine when administered as chemoprophylaxis to healthy, non-immune participants followed by blood stage Plasmodium falciparum challenge: a randomized, double-blinded, placebo-controlled phase 1b study. Clin Infect Dis. doi: 10.1093/cid/ciy939.
-
23.
GlaxoSmithKline, 2018. Krintofel label. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210795s000lbl.pdf. Accessed December 19, 2018.
-
24.
Lacerda MVG et al. 2019. Single-dose tafenoquine to prevent relapse of Plasmodium vivax malaria. N Engl J Med 380: 215–228.
-
25.
Beutler E, 1991. Glucose-6-phosphate dehydrogenase deficiency. N Eng J Med 324: 169–174.
-
26.
Dow GS, Brown T, Reid M, Smith B, Toovey S, 2017. Tafenoquine is not neurotoxic following supertherapeutic dosing in rats. Travel Med Infect Dis 17: 28–34.
-
27.
Dow G, Bauman R, Caridha D, Cabezas M, Du F, Gomez-Lobo R, Park M, Smith K, Cannard K, 2006. Mefloquine induces dose-related neurological effects in a rat model. Antimicrob Agents Chemother 50: 1045–1053.
-
28.
Food and Drug Administration, 2018. ARAKODA NDA Approval Letter. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210607Orig1s000ltr.pdf. Accessed December 19, 2018.
-
29.
Sanofi-Aventis US. Primaquine Label. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008316s023lbl.pdf.
-
30.
60 Degrees Pharmaceuticals, 2018. Arakoda Tablets for the Prevention of Malaria in Adults. Briefing document for the Antimicrobial Drugs Advisory Committee. Available at: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/UCM614202.pdf.
-
31.
Gutteridge WE, 1991. Antimalarial drugs currently in development. J R Soc Med 82 (Suppl 17): 63–66.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 1099 | 794 | 64 |
| Full Text Views | 862 | 13 | 0 |
| PDF Downloads | 251 | 12 | 0 |