Coartem
Encyclopedia
The combination artemether
/lumefantrine
(trade names Coartem and Riamet) is an artemisinin
-based combination therapy (ACT) indicated for the treatment of acute uncomplicated plasmodium
falciparum malaria
. Coartem is produced by the Swiss pharmaceutical company, Novartis
.
Artemether is a derivative of artemisinin
, and lumefantrine
(or benflumetol) is an antimalarial drug. Coartem is an effective and well-tolerated malaria treatment, providing cure rates of up to 97%, even in areas of multi-drug resistance.
In 2001, Coartem became the first fixed dose artemisinin
-based combination therapy to meet the World Health Organization
's (WHO) pre-qualification criteria for efficacy, safety and quality.
In 2002, artemether/lumefantrine tablets were added to the WHO's Essential Medicines list, an index of essential drugs which help guide the purchasing decisions of Member States and UN agencies.
Coartem is approved in over 80 countries worldwide, including various countries in Africa, as well as Swissmedic
, the European Medicines Agency
(EMA) and the U.S. Food and Drug Administration (FDA).
Since 2001, Novartis has supplied 250 million treatments of Coartem without profit for public sector use in Africa, saving an estimated 630,000 lives.
, although mild forms in most cases. Other fairly common side effects (more than 3% of patients) include sleep disorder, tinnitus
, tremor
, palpitation
, as well as unspecific reactions like vertigo
, gastrointestinal disorders, itch
and nasopharyngitis.
. The combination with halofantrine
, another antimalarial, can cause a life-threatening QT prolongation.
Drugs and other substances influencing the activity of the liver enzyme CYP3A4
, including grapefruit juice
, can either increase or lower blood levels of artemether/lumefantrine, depending on the sort of substance. This can either lead to more severe side effects or to reduced efficiency.
Novartis has lowered the price of Coartem by 50% since 2001, increasing access to patients around the world. The first significant price reduction occurred in 2006, when the price of Coartem decreased from an average of US $1.57 to US $1.00. In 2006, due to an improved supply situation for the natural ingredient artemisinin, Novartis was able to undertake the pharmaceutical industry’s most aggressive manufacturing scale-up of its kind from 4 million treatments in 2004 to 62 million treatments in 2006. Novartis and its partners invested heavily in expanding production capacity at their facilities in China, and Suffern, New York. This increase in production capacity ensured that supplies of Coartem met demand which enabled Novartis to further decrease the price of Coartem.
In April 2008, Novartis further reduced the public sector price of Coartem by approximately 20%, to an average of US $0.80 (or US $0.37 for a child’s treatment pack). This price reduction was made possible through production efficiency gains.
Prior to this program, Novartis was criticised for a court case they launched against India
, seeking to prohibit the marketing of cheap generic drugs. An Indian court ruled against Novartis, saying that the case was a "threat to people suffering from cancer [...] and other diseases who are too poor to pay for them".
-based combination therapy developed specifically for children suffering from malaria. Coartem Dispersible contains the same amount of artemether and lumefantrine as Coartem. A phase III study published in The Lancet showed that Coartem Dispersible provides a high cure rate of 97.8% for uncomplicated Plasmodium falciparum
malaria, which is comparable to that of Coartem (98.5%). Investigators also reported that it had a good safety profile.
The sweet-tasting Coartem Dispersible tablets disperse quickly in small amounts of water, easing administration and ensuring effective dosing.
Novartis and MMV provide malaria case management educational programs, which include hands-on training for local healthcare workers, customized training manuals, and user-friendly packaging to ensure that Coartem Dispersible is properly used and to improve patient compliance. Like Coartem, Coartem Dispersible is provided to the public sector without profit.
Coartem is now available in the United States through major wholesalers. This distribution model will allow patients in need to have access to the drug within 24 hours through retail pharmacies across the country. Novartis will sell the entire 24-tablet adult course of Coartem therapy for $69.60, on par with other currently available branded antimalarial treatments. The amount one pays at the pharmacy will depend upon insurance coverage and what the pharmacy charges for the medication.
Coartem was granted priority review by the FDA, a treatment typically granted to address urgent, unmet medical needs. Along with FDA approval, Novartis was awarded a one-time priority review voucher to be used for a future new drug application.
Artemether/lumefantrine tablets are available in Pakistan under trade name Artelum by W. Woodwards Pakistan.
Artemether
Artemether is an antimalarial for the treatment of multi-drug resistant strains of falciparum malaria. It is combined with Lumefantrine and sold by Novartis under the brand names Riamet and Co-Artem.-Chemical nature:...
/lumefantrine
Lumefantrine
Lumefantrine is an antimalarial drug. It is only used in combination with artemether. The term "co-artemether" is sometimes used to describe this combination....
(trade names Coartem and Riamet) is an artemisinin
Artemisinin
Artemisinin , also known as Qinghaosu , and its derivatives are a group of drugs that possess the most rapid action of all current drugs against falciparum malaria. Treatments containing an artemisinin derivative are now standard treatment worldwide for falciparum malaria...
-based combination therapy (ACT) indicated for the treatment of acute uncomplicated plasmodium
Plasmodium
Plasmodium is a genus of parasitic protists. Infection by these organisms is known as malaria. The genus Plasmodium was described in 1885 by Ettore Marchiafava and Angelo Celli. Currently over 200 species of this genus are recognized and new species continue to be described.Of the over 200 known...
falciparum malaria
Malaria
Malaria is a mosquito-borne infectious disease of humans and other animals caused by eukaryotic protists of the genus Plasmodium. The disease results from the multiplication of Plasmodium parasites within red blood cells, causing symptoms that typically include fever and headache, in severe cases...
. Coartem is produced by the Swiss pharmaceutical company, Novartis
Novartis
Novartis International AG is a multinational pharmaceutical company based in Basel, Switzerland, ranking number three in sales among the world-wide industry...
.
Artemether is a derivative of artemisinin
Artemisinin
Artemisinin , also known as Qinghaosu , and its derivatives are a group of drugs that possess the most rapid action of all current drugs against falciparum malaria. Treatments containing an artemisinin derivative are now standard treatment worldwide for falciparum malaria...
, and lumefantrine
Lumefantrine
Lumefantrine is an antimalarial drug. It is only used in combination with artemether. The term "co-artemether" is sometimes used to describe this combination....
(or benflumetol) is an antimalarial drug. Coartem is an effective and well-tolerated malaria treatment, providing cure rates of up to 97%, even in areas of multi-drug resistance.
In 2001, Coartem became the first fixed dose artemisinin
Artemisinin
Artemisinin , also known as Qinghaosu , and its derivatives are a group of drugs that possess the most rapid action of all current drugs against falciparum malaria. Treatments containing an artemisinin derivative are now standard treatment worldwide for falciparum malaria...
-based combination therapy to meet the World Health Organization
World Health Organization
The World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...
's (WHO) pre-qualification criteria for efficacy, safety and quality.
In 2002, artemether/lumefantrine tablets were added to the WHO's Essential Medicines list, an index of essential drugs which help guide the purchasing decisions of Member States and UN agencies.
Coartem is approved in over 80 countries worldwide, including various countries in Africa, as well as Swissmedic
Swissmedic
Swissmedic, the Swiss Agency for Therapeutic Products, is the Swiss surveillance authority for medicines and medical devices, registered in Berne. It started operations on 1 January 2002 as successor of Interkantonale Kontrollstelle für Heilmittel , which was itself the successor of Schweizerische...
, the European Medicines Agency
European Medicines Agency
The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
(EMA) and the U.S. Food and Drug Administration (FDA).
Since 2001, Novartis has supplied 250 million treatments of Coartem without profit for public sector use in Africa, saving an estimated 630,000 lives.
Side effects
Coartem can cause anaphylactic reactions. The drug frequently causes headache, dizziness and anorexiaAnorexia (symptom)
Anorexia is the decreased sensation of appetite...
, although mild forms in most cases. Other fairly common side effects (more than 3% of patients) include sleep disorder, tinnitus
Tinnitus
Tinnitus |ringing]]") is the perception of sound within the human ear in the absence of corresponding external sound.Tinnitus is not a disease, but a symptom that can result from a wide range of underlying causes: abnormally loud sounds in the ear canal for even the briefest period , ear...
, tremor
Tremor
A tremor is an involuntary, somewhat rhythmic, muscle contraction and relaxation involving to-and-fro movements of one or more body parts. It is the most common of all involuntary movements and can affect the hands, arms, eyes, face, head, vocal folds, trunk, and legs. Most tremors occur in the...
, palpitation
Palpitation
A palpitation is an abnormality of heartbeat that causes a conscious awareness of its beating, whether it is too slow, too fast, irregular, or at its normal frequency. The word may also refer to this sensation itself...
, as well as unspecific reactions like vertigo
Vertigo
Vertigo is a form of dizziness.Vertigo may also refer to:* Vertigo , a 1958 film by Alfred Hitchcock**Vertigo , its soundtrack** Vertigo effect, or Dolly zoom, a special effect in film, named after the movie...
, gastrointestinal disorders, itch
Itch
Itch is a sensation that causes the desire or reflex to scratch. Itch has resisted many attempts to classify it as any one type of sensory experience. Modern science has shown that itch has many similarities to pain, and while both are unpleasant sensory experiences, their behavioral response...
and nasopharyngitis.
Interactions
Coartem has a potential to prolong the QT interval, so combinations with other drugs having that property can cause irregular heartbeat, potentially leading to lethal ventricular fibrillationVentricular fibrillation
Ventricular fibrillation is a condition in which there is uncoordinated contraction of the cardiac muscle of the ventricles in the heart, making them quiver rather than contract properly. Ventricular fibrillation is a medical emergency and most commonly identified arrythmia in cardiac arrest...
. The combination with halofantrine
Halofantrine
Halofantrine is a drug used to treat malaria. Halofantrine's structure contains a substituted phenanthrene, and is related to the antimalarial drugs quinine and lumefantrine. Marketed as Halfan, halofantrine is never used to prevent malaria and its mode of action is unknown...
, another antimalarial, can cause a life-threatening QT prolongation.
Drugs and other substances influencing the activity of the liver enzyme CYP3A4
CYP3A4
Cytochrome P450 3A4 , a member of the cytochrome P450 mixed-function oxidase system, is one of the most important enzymes involved in the metabolism of xenobiotics in the body. CYP3A4 is involved in the oxidation of the largest range of substrates of all the CYPs. As a result, CYP3A4 is present in...
, including grapefruit juice
Grapefruit juice
Grapefruit juice is the fruit juice from grapefruits. It is rich in Vitamin C and ranges from sweet-tart to very sour. It is considered by some cultures to be a mystical tonic which promotes health and vigor. Certain civilizations have had holy men who live on Grapefruit juice alone...
, can either increase or lower blood levels of artemether/lumefantrine, depending on the sort of substance. This can either lead to more severe side effects or to reduced efficiency.
Access to treatment
Coartem is provided without profit to developing countries using grants from the Global Fund to Fight AIDS, Tuberculosis and Malaria, US President’s Malaria Initiative along with other donors.Novartis has lowered the price of Coartem by 50% since 2001, increasing access to patients around the world. The first significant price reduction occurred in 2006, when the price of Coartem decreased from an average of US $1.57 to US $1.00. In 2006, due to an improved supply situation for the natural ingredient artemisinin, Novartis was able to undertake the pharmaceutical industry’s most aggressive manufacturing scale-up of its kind from 4 million treatments in 2004 to 62 million treatments in 2006. Novartis and its partners invested heavily in expanding production capacity at their facilities in China, and Suffern, New York. This increase in production capacity ensured that supplies of Coartem met demand which enabled Novartis to further decrease the price of Coartem.
In April 2008, Novartis further reduced the public sector price of Coartem by approximately 20%, to an average of US $0.80 (or US $0.37 for a child’s treatment pack). This price reduction was made possible through production efficiency gains.
Prior to this program, Novartis was criticised for a court case they launched against India
India
India , officially the Republic of India , is a country in South Asia. It is the seventh-largest country by geographical area, the second-most populous country with over 1.2 billion people, and the most populous democracy in the world...
, seeking to prohibit the marketing of cheap generic drugs. An Indian court ruled against Novartis, saying that the case was a "threat to people suffering from cancer [...] and other diseases who are too poor to pay for them".
Coartem Dispersible
In January 2009, Novartis and Medicines for Malaria Venture (MMV) launched Coartem Dispersible, the first artemisininArtemisinin
Artemisinin , also known as Qinghaosu , and its derivatives are a group of drugs that possess the most rapid action of all current drugs against falciparum malaria. Treatments containing an artemisinin derivative are now standard treatment worldwide for falciparum malaria...
-based combination therapy developed specifically for children suffering from malaria. Coartem Dispersible contains the same amount of artemether and lumefantrine as Coartem. A phase III study published in The Lancet showed that Coartem Dispersible provides a high cure rate of 97.8% for uncomplicated Plasmodium falciparum
Plasmodium falciparum
Plasmodium falciparum is a protozoan parasite, one of the species of Plasmodium that cause malaria in humans. It is transmitted by the female Anopheles mosquito. Malaria caused by this species is the most dangerous form of malaria, with the highest rates of complications and mortality...
malaria, which is comparable to that of Coartem (98.5%). Investigators also reported that it had a good safety profile.
The sweet-tasting Coartem Dispersible tablets disperse quickly in small amounts of water, easing administration and ensuring effective dosing.
Novartis and MMV provide malaria case management educational programs, which include hands-on training for local healthcare workers, customized training manuals, and user-friendly packaging to ensure that Coartem Dispersible is properly used and to improve patient compliance. Like Coartem, Coartem Dispersible is provided to the public sector without profit.
Approval in the United States
On April 8, 2009, the U.S. Food and Drug Administration (FDA) announced that Coartem was approved for the treatment of acute, uncomplicated malaria infections in adults and children weighing at least five kilograms (approximately 11 pounds) becoming the first ACT approved in the United States. Millions of Americans travel to malaria-endemic regions on business or pleasure, and cases of travelers’ malaria continue to be a problem. In addition, many of the US military are stationed in malaria-endemic countries. US patients now have access to ACTs, the standard of care and treatment for malaria.Coartem is now available in the United States through major wholesalers. This distribution model will allow patients in need to have access to the drug within 24 hours through retail pharmacies across the country. Novartis will sell the entire 24-tablet adult course of Coartem therapy for $69.60, on par with other currently available branded antimalarial treatments. The amount one pays at the pharmacy will depend upon insurance coverage and what the pharmacy charges for the medication.
Coartem was granted priority review by the FDA, a treatment typically granted to address urgent, unmet medical needs. Along with FDA approval, Novartis was awarded a one-time priority review voucher to be used for a future new drug application.
Artemether/lumefantrine tablets are available in Pakistan under trade name Artelum by W. Woodwards Pakistan.