• Artesunate for Injection

    A New Treatment for Patients with Life-Threatening Disease

  • Amivas (US), LLC

    Focused on Unmet Needs and Lifesaving Medicines

  • Amivas (US), LLC

    Providing Therapies in Response to Life-threatening Situations

  • Amivas (US), LLC

    Committed, Responsive, Compassionate

Amivas (US), LLC is an Australian, Canadian, and US joint venture focused on the development, manufacturing, and commercialization of therapeutics for the treatment of infectious diseases.

Amivas (US), LLC was formed in response to the urgent need for a US -based firm to assume responsibility for the manufacture and distribution of Artesunate for Injection, for severe malaria after quinidine gluconate was discontinued by the manufacturer.

With FDA approval of its first commercial product, Amivas (US), LLC is proud to join the global effort to fight and eradicate malaria.

For more information about Amivas (US), LLC and Artesunate for Injection, please see our most recent press release.

IV Treatments Malaria

Read about a new severe malaria product and how to order. This innovative malaria treatment is our first registered medication for slow bolus intravenous delivery. Artesunate for Injection is administered during hospitalization. It is suitable for the treatment of patients with severe malaria.

Malaria, symptoms and treatments

Malaria is a serious and sometimes fatal disease caused by a parasite that commonly infects a certain type of mosquito which feeds on humans. People who get malaria are typically very sick with high fevers, shaking chills, and flu-like illness. Although malaria can be a deadly disease, illness and death from malaria can usually be prevented.

About 2,000 cases of malaria are diagnosed in the United States each year. The vast majority of cases in the United States are in travellers and immigrants returning from countries where malaria transmission occurs, many from sub-Saharan Africa and South Asia.

Source: Center for Disease Control and Prevention www.cdc.gov

UNCOMPLICATED MALARIA

The classical (but rarely observed) malaria attack lasts 6–10 hours. It consists of

  • A cold stage (sensation of cold, shivering)
  • A hot stage (fever, headaches, vomiting; seizures in young children); and
  • Finally a sweating stage (sweats, return to normal temperature, tiredness).

Classically (but infrequently observed) the attacks occur every second day with the “tertian” parasites (P. falciparum, P. vivax, and P. ovale) and every third day with the “quartan” parasite (P. malariae).

More commonly, the patient presents with a combination of the following symptoms:

  • Fever
  • Chills
  • Sweats
  • Headaches
  • Nausea and vomiting
  • Body aches
  • General malaise

In countries where cases of malaria are infrequent, these symptoms may be attributed to influenza, a cold, or other common infections, especially if malaria is not suspected. Conversely, in countries where malaria is frequent, residents often recognize the symptoms as malaria and treat themselves without seeking diagnostic confirmation (“presumptive treatment”).
Physical findings may include the following:

  • Elevated temperatures
  • Perspiration
  • Weakness
  • Enlarged spleen
  • Mild jaundice
  • Enlargement of the liver
  • Increased respiratory rate

Diagnosis of malaria depends on the demonstration of parasites in the blood, usually by microscopy. Additional laboratory findings may include mild anemia, mild decrease in blood platelets (thrombocytopenia), elevation of bilirubin, and elevation of aminotransferases.

SEVERE MALARIA

Severe malaria occurs when infections are complicated by serious organ failures or abnormalities in the patient’s blood or metabolism. The manifestations of severe malaria include the following:

  • Cerebral malaria, with abnormal behavior, impairment of consciousness, seizures, coma, or other neurologic abnormalities
  • Severe anemia due to hemolysis (destruction of the red blood cells)
  • Hemoglobinuria (hemoglobin in the urine) due to hemolysis
  • Acute respiratory distress syndrome (ARDS), an inflammatory reaction in the lungs that inhibits oxygen exchange, which may occur even after the parasite counts have decreased in response to treatment
  • Abnormalities in blood coagulation
  • Low blood pressure caused by cardiovascular collapse
  • Acute kidney injury
  • Hyperparasitemia, where more than 5% of the red blood cells are infected by malaria parasites
  • Metabolic acidosis (excessive acidity in the blood and tissue fluids), often in association with hypoglycemia
  • Hypoglycemia (low blood glucose). Hypoglycemia may also occur in pregnant women with uncomplicated malaria, or after treatment with quinine.

Severe malaria is a medical emergency and should be treated urgently and aggressively.

Source: Center for Disease Control and Prevention www.cdc.gov

Treatment of Severe Malaria is described on the CDC webpage:

https://www.cdc.gov/malaria/diagnosis_treatment/artesunate.html

CDC Treatment Guidelines are available here:

https://www.cdc.gov/malaria/resources/pdf/treatment_guidelines_101819.pdf

ΗOW TO OBTAIN ARTESUNATE FOR INJECTION:

  1. Healthcare providers treating with patients with severe malaria or who cannot tolerate oral medications should call CDC to obtain IV artesunate. The CDC Malaria Hotline (770-488-7788) is available Monday–Friday, 9 am–5 pm EST.
  2. Outside these hours, providers should call 770-488-7100 and ask to speak with the CDC Malaria Branch clinician on call.
  3. Please have the following information ready to provide to the CDC Malaria Branch clinician:
  4. Patient’s information (name, date of birth, sex, weight, medical record number)
  5. Patient’s detailed clinical and laboratory information
  6. Hospital name and address
  7. Treating physician’s contact information (name, phone number, email address)
  8. Pharmacist’s contact information (name, phone number, email address)

Source: Center for Disease Control and Prevention www.cdc.gov

The Treatment Protocol for Malaria Drug Resistance Testing in the United States is described on the CDC webpage:

https://www.cdc.gov/malaria/diagnosis_treatment/drug_resistance.html

Please refer to this publication:

Download Boland WHO pdf

Source: Center for Disease Control and Prevention www.cdc.gov

Malaria cases should be reported to the CDC using the following form:

Report Malaria, download this form