Coartem^® /Riamet^®

Prescribing Riamet^®

Before prescribing, please read full local prescribing information

Riamet^® is indicated for the treatment, including standby emergency treatment, of adults and children 12 years of age and above, weighing 35 kg and above with acute, uncomplicated infections due to P. falciparum or mixed infections including P. falciparum. Because Riamet^® is effective against both drug-sensitive and drug-resistant P. falciparum it is also recommended for malaria infections acquired in areas where the parasites may be resistant to other antimalarials.

Consideration should be given to official guidance regarding the appropriate use of antimalarial agents.

Riamet^® is available in countries free of malaria.  

• It is for the treatment of infected travellers returning from endemic areas.
• In some countries it can also be used as standby emergency treatment by non-immune travellers going to endemic areas who are unable to obtain medical care within 24 hours of suspected malaria symptoms.

Riamet^® is contraindicated during the first trimester of pregnancy. During the second and third trimester, treatment should only be considered if the expected benefit to the mother outweighs the risk to the foetus.

Riamet^® is contraindicated in those with hypersensitivity to the active substances or any of the excipients; in cases of severe malaria and in the first trimester of pregnancy. During the second and third trimester, treatment should only be considered if the expected benefit to the mother outweighs the risk to the foetus. Riamet^® is also contraindicated in patients with a history of symptomatic cardiac arrhythmias, clinical relevant bradycardia or severe heart disease. Also in patients with a family history of congential prolongation of the QTc interval or sudden death, disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia. Drugs that are known to be metabolised by cytochrome enzyme CYP2D6 or drugs that are known to prolong the QTc interval should not be used concomitantly with Riamet^® .

Riamet^® is not indicated for prophylaxis, or for treating severe malaria, including cerebral malaria, or malaria with pulmonary oedema or renal failure. Riamet^® is not indicated for and has not been evaluated in, the treatment of malaria due to P. vivax, P. malariae or P. ovale. Riamet^® is active against the blood stages of P. vivax, but is not active against hypnozoites. Therefore, an 8-amino-quinoline derivative such as primaquine should be given sequentially after Riamet^® in cases of mixed infections of P. falciparum and P. vivax to achieve hypnozoites eradication.

Other precautions

Use with caution in patients with severe hepatic or renal insufficiency and patients refusing food intake. No specific studies have been carried out in these patients, therefore no specific dose adjustment recommendation can be made. Driving and use of machinery is not recommended due to risk of dizziness and fatigue. Special care should be taken with patients previously treated with halofantrine, mefloquine or quinine.

Riamet^® is effective against all P. falciparum malaria parasites, including those resistant to current therapies:

Riamet^® demonstrates significant benefits over some other current antimalarial therapies:

• high cure rates (~95% in evaluable patients) even in multi-drug resistant areas ^6,8
• low recrudescence rates
• fast control of malaria symptoms, avoiding progression to cerebral malaria ⁶
• Decreases parasite strains responsible for the transmission of the disease
• good tolerability ^6,3,9
• easy fixed-dose combination regimen, simplifying compliance.

Dosage

Riamet^® is for non-immune travellers (12 years of age and above, weighing 35 kg and above) who are visiting endemic areas. (see key symptoms of malaria) . It should be taken as standby emergency treatment within 24 hours of suspected malaria, but only if typical symptoms appear (within 1 week or more after entering a risk area) where no medical care is available. Riamet^® is not a substitute for prophylactic therapy (if appropriate), or for routine measures to avoid mosquito bites.

Riamet^® should be prescribed for patients to carry with them as oral emergency standby medication:

• on trips to an area with medium to low risk of infection with P. falciparum malaria
• in addition to prophylaxis on trips to an area with a high risk of infection with multi-drug resistant P. falciparum malaria or where multi-drug resistance is developing.

Ensure that patients understand the key symptoms of malaria and advise them to seek medical help as soon as these symptoms appear. Patients must be advised to use Riamet^® if symptoms suggesting malaria occur (see key symptoms of malaria) and medical assistance is not available within 24 hours.

Dosage schedule

Riamet^® is currently registered in Switzerland for a bodyweight of >5 kg.

Dosage and method of administration

The dose should be taken with high fat food or drinks such as milk. Patients should be encouraged to resume normal eating as soon as food can be tolerated since this improves absorption of artemether and lumefantrine. Note that patients with acute malaria are frequently averse to food.
In the event of vomiting within 1 hour of administration a repeat dose should be taken.

Special populations

Dosage in elderly patients

Although no studies have been carried out in the elderly, no special precautions or dosage adjustments are considered necessary in such patients.

Dosage in patients with renal or hepatic impairment

No specific studies have been carried out in these groups of patients and no specific dose adjustment recommendations can be made for these patients.

Most patients with acute malaria present with some degree of related hepatic impairment. The adverse event profile did not differ in patients with and those without hepatic impairment. Moreover, baseline abnormalities in liver function tests improved in nearly all patients after treatment with Riamet^®.

New and recrudescent infections in adults, children and infants

Data for a limited number of patients show that new and recrudescent infections can be treated with a second course of Riamet^®.

Drug interactions

Should not be given concurrently with other antimalarials unless there is no other treatment option.

Pregnancy and breast-feeding

Riamet^® treatment is contraindicated during the first trimester of pregnancy. During the second and third trimester, treatment should only be considered if the expected benefit to the mother outweighs the risk to the foetus.

As Riamet^® is contraindicated during the first trimester of pregnancy, women should not conceive while on Riamet^® treatment for malaria. This includes women prescribed Riamet^® for standby emergency treatment of malaria during their travel, in case they may require treatment for malaria.

Women of child-bearing potential should be advised to practice contraception during travel with standby emergency treatment, while on Riamet^® and until the start of next menstruation after the treatment.

Breast-feeding women should not take Riamet^®. Due to the long elimination half-life of lumefantrine (4 to 6 days), it is recommended that breast-feeding should not resume before day 28 unless potential benefits to mother and child outweigh the risk of Riamet^® treatment.

For further information on Coartem^® or Riamet^®, click here to see the combined monograph.

Click to see Coartem^®/Riamet^® studies