Patient Medication Information: uses, side effects, how to take - Amivas-Artesunate
Serious warnings and precautions box
What AMIVAS-ARTESUNATE is used for:
- AMIVAS-ARTESUNATE is used for the initial treatment of severe malaria in adults and children.
- After treatment with AMIVAS-ARTESUNATE, you will be given oral medicines to fully treat your malaria.
- AMIVAS-ARTESUNATE does not treat malaria caused by certain types of parasites. You may also be given other medicines while you are receiving AMIVAS-ARTESUNATE. Your healthcare professional will decide if AMIVAS-ARTESUNATE is right for you.
How AMIVAS-ARTESUNATE works:
AMIVAS-ARTESUNATE belongs to a group of medicines known as “antimalarial agents”. It destroys the membrane of the parasite that causes malaria which leads to its death.
The ingredients in AMIVAS-ARTESUNATE are:
Medicinal ingredient: artesunate.
Non-medicinal ingredients (diluent): disodium phosphate dihydrate, monosodium phosphate monohydrate, phosphoric acid, concentrated, sodium hydroxide, water for injection.
AMIVAS-ARTESUNATE may cause serious side effects, including:
- Hemolytic anemia which is a condition where red blood cells in your body are destroyed faster than they can be made. This leads to a lack of red blood cells. Your healthcare professional will monitor you for signs of hemolytic anemia while you are receiving AMIVAS-ARTESUNATE and for 4 weeks after you started your treatment. Talk to your healthcare professional if you get any symptoms of hemolytic anemia while you are receiving AMIVAS-ARTESUNATE. See “Serious side effects and what to do about them” for symptoms.
- Severe allergic reactions. Stop taking AMIVAS-ARTESUNATE and get immediate medical help if you get any symptoms of a severe allergic reaction. See “Serious side effects and what to do about them” for symptoms.
AMIVAS-ARTESUNATE comes in the following dosage forms:
Powder for solution: 110 mg per vial of artesunate.
AMIVAS-ARTESUNATE is provided as a 110 mg of powder in a vial and must be dissolved in the supplied diluent solution before it is injected. The concentration of the solution to be injected is 10 mg of artesunate per mL.
Do not use AMIVAS-ARTESUNATE if:
- you are allergic to artesunate, to any other treatment for malaria that contains an artemisinin such as artemether or dihydroartemisinin
- you are allergic to any of the other ingredients in AMIVAS-ARTESUNATE or to any part of the container
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AMIVAS-ARTESUNATE. Talk about any health conditions or problems you may have, including if you:
- have a condition called anemia where you have a low amount of healthy red blood cells.
Other warnings you should know about:
Pregnancy:
Tell your healthcare professional before taking AMIVAS-ARTESUNATE if you are pregnant, think you may be pregnant or are planning to become pregnant. AMIVAS-ARTESUNATE could harm an unborn baby. However, not treating severe malaria in a pregnant woman can seriously harm the mother and unborn baby. Talk to your doctor about the treatment of severe malaria in pregnancy. If you are pregnant and receive AMIVAS-ARTESUNATE, your healthcare professional will tell you about a pregnancy registry. This registry monitors the effects of taking AMIVAS-ARTESUNATE when pregnant. Your healthcare professional will encourage you to report your pregnancy to Amivas, Inc. at 1-855-526-4827 (1-855-5AMIVAS) or at www.amivas.com/our-products.
Breastfeeding:
Tell your healthcare professional before taking AMIVAS-ARTESUNATE if you are breastfeeding or planning to breastfeed. This is because AMIVAS-ARTESUNATE may pass into your breastmilk and harm your baby. Your healthcare professional will tell you if can breastfeed your baby while you are receiving taking AMIVAS-ARTESUNATE.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with AMIVAS-ARTESUNATE:
- rifampicin, a medicine used to treat bacterial infections
- ritonavir and nevirapine, medicines used to treat HIV infection
- carbamazepine and phenytoin, medicines used to treat epilepsy
- diclofenac, a medicine used to treat pain or inflammation
- axitinib, vandetanib and imatinib , medicines used to treat certain cancers
AMIVAS-ARTESUNATE may increase or decrease the blood levels of some other medicines. Your healthcare professional will advise and monitor you on the medicines you take during your treatment.
How to take AMIVAS-ARTESUNATE:
- AMIVAS-ARTESUNATE will be given to you by a healthcare professional.
- Your healthcare professional will make sure that AMIVAS-ARTESUNATE is prepared correctly before it is given to you.
- It will be given to you by a slow injection directly into a vein.
- You will be given at least three doses of AMIVAS-ARTESUNATE. Each dose will be given 12 hours apart. After three doses, if you still cannot take medicines by mouth, you will be given one dose of AMIVAS-ARTESUNATE once a day (every 24 hours) until you are able to take a different malaria treatment by mouth.
- It is very important that you take oral medicines to fully treat your malaria after you have received at least three doses of AMIVAS-ARTESUNATE.
- During your treatment, your healthcare professional will closely monitor your health.
- Follow all instructions given to you by your healthcare professional.
Usual dose:
Your healthcare professional will decide how much AMIVAS-ARTESUNATE you will receive. It will be based on your weight.
Overdose:
If you think that you have received too much AMIVAS-ARTESUNATE, tell your healthcare professional right away. Your healthcare professional will take appropriate measures to treat any overdosage.
| If you think you, or a person you are caring for, has been given too much AMIVAS-ARTESUNATE, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
|---|
Missed Dose:
Your healthcare professional will manage your treatment and will avoid missing a dose. If a dose is missed, your healthcare professional will give you the missed dose as soon as possible. They will continue giving your remaining doses 12 or 24 hours apart.
Possible side effects from using AMIVAS-ARTESUNATE:
These are not all the possible side effects you may have when taking AMIVAS-ARTESUNATE. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- Diarrhea
- Stomach pain
- Inflammation of a vein
- Altered sense of taste
- Blocked or runny nose
- Headache
- Constipation
- Pain at injection site
- Flushing
Serious side effects and what to do about them
| Frequency / Side Effect / Symptom | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Anemia (low amount of healthy red blood cells): tiredness, weakness, pale skin, dizziness, shortness of breath | X | ||
| Blackwater fever (sudden destruction of red blood cells): dark red or brown urine, yellowing of the skin or eyes, fever, chills, fast heart beat | X | ||
| Coma (being unconscious for a prolonged time): closed eyes, no response to pain or stimuli, no reflexes, low heart beat, irregular breathing | X | ||
| Convulsions (rapid, involuntary muscle contractions): uncontrollable shaking or limb movement | X | ||
| Kidney failure (kidneys not working properly, which may require a medical procedure called dialysis):peeing less often or with less urine, swelling of the legs, ankles or feet, tiredness, loss of appetite, nausea, confusion | X | ||
| UNCOMMON | |||
| Hypotension (low blood pressure): Light-headedness, dizziness, weakness, blurred vision, fatigue or tiredness, fainting | X | ||
| Leukocytosis (high amount of white blood cells): fever, pain, difficulty breathing, hives and itching, weight loss, vision problems, bleeding form the intestines or mouth | X | ||
| Leukopenia (low amount of white blood cells): fever, fatigue, weakness, frequent infections, mouth sores or ulcers, sore throat, flu-like symptoms | X | ||
| Stevens-Johnson syndrome (severe skin reaction): redness, blistering or peeling of the skin or inside of the lips, eyes, mouth, nasal passages or genitals, fever, chills, headache, cough, body aches or swollen glands. | X | ||
Serious side effects and what to do about them
| Frequency / Side Effect / Symptom | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Thrombocytopenia (low amount of platelets in blood): easy bruising, bleeding for longer than usual, red or purple dots or spot on the skin, bleeding gums, blood in stool or urine | X | ||
| UNKNOWN | |||
| Acute respiratory distress syndrome (lung injury when fluids build up in the lungs): severe shortness of breath, difficulty breathing, cough, chest pain, fast breathing, rapid heart beat, lips and fingernails turning bluish | X | ||
| Disseminated intravascular coagulation (serious condition that causes abnormal blood clotting): uncontrollable bleeding, blood in stool or urine, bruising, confusion, memory loss, difficulty breathing, fever | X | ||
| Hemolytic anemia (a condition where red blood cells in your body are destroyed faster than they can be made): dark-coloured urine, dizziness or confusion, yellowing of the skin (jaundice), pale skin, muscle pain, nausea, vomiting, weakness or fatigue, shortness of breath, heart beats fast. | X | ||
| Liver problems (liver being damaged or not working properly): yellowing of the skin and eyes , abdominal pain, dark urine, fatigue, nausea, vomiting, itching | X | ||
| Neurological sequelae (problems with the brain or the nerves): trouble walking or staying steady, weakness or paralysis on one side of the body, shaking, change in mood or behavior, generalized weakness, confusion, agitation | X | ||
| Pneumonia (infection of the lung): fever, chills, cough, chest pain, shortness of breath, fatigue | X | ||
| Pulmonary edema (fluids in the lung): shortness of breath especially when lying down, wheezing, cough, rapid heart beat, feeling of anxious | X | ||
| Severe allergic reaction: difficulty breathing or swallowing, swelling of your face, mouth, tongue or throat, reddening of the face, rash or hives, loss of consciousness. | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
AMIVAS-ARTESUNATE will be stored by your healthcare professional between 15°C and 30°C.
Keep out of reach and sight of children.
If you want more information about AMIVAS-ARTESUNATE:
- Talk to your healthcare professional.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (Drug Product Database: Access the database); the manufacturer’s website, amivas.com, or by calling 1-866-333-5458.
Date of Authorization: 2025-08-02