ARTESUNATE kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ARTESUNATE (UNII: 60W3249T9M) (.ALPHA.-DIHYDROARTEMISININ - UNII:X0UIV26ABX)

Available from:

Amivas, Inc

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Artesunate for Injection is indicated for the initial treatment of severe malaria in adult and pediatric patients. Treatment of severe malaria with Artesunate for Injection should always be followed by a complete treatment course of an appropriate oral antimalarial regimen [see Dosage and Administration (2.1)] . Limitations of Use Artesunate for Injection does not treat the hypnozoite liver stage forms of Plasmodium and will therefore not prevent relapses of malaria due to Plasmodium vivax or Plasmodium ovale . Concomitant therapy with an antimalarial agent such as an 8-aminoquinoline drug is necessary for the treatment of severe malaria due to P. vivax or P. ovale [see Dosage and Administration (2.1)] . Known serious hypersensitivity to artesunate, such as anaphylaxis [See Warnings and Precautions (5.2) and Adverse Reactions (6.2)] . There are serious risks to the mother and fetus associated with untreated severe malaria during pregnancy; delaying treatment of severe malaria in pregnancy may result in ser

Product summary:

Artesunate for Injection is supplied as follows: Artesunate for Injection single-dose vial: NDC 73607-002-01 Sterile Diluent for Constitution single-dose vial: NDC 73607-003-02 Packages of 4 total vials (2 vials of Artesunate for Injection, 110 mg and 2 vials sterile diluent for Artesunate for Injection): NDC 73607-011-11 Store vials of Artesunate for Injection and sterile diluent in the carton at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Do not freeze. Avoid exposure to heat. Keep protected from light. Do not use beyond the expiration date.

Authorization status:

New Drug Application

Summary of Product characteristics

ARTESUNATE- ARTESUNATE
AMIVAS, INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ARTESUNATE FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ARTESUNATE FOR
INJECTION.
ARTESUNATE FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2020
INDICATIONS AND USAGE
Artesunate for Injection is an antimalarial indicated for the initial
treatment of severe malaria in adult and
pediatric patients. Treatment of severe malaria with Artesunate for
Injection should always be followed by a
complete treatment course of an appropriate oral antimalarial regimen.
(1)
Limitations of Use
Artesunate for Injection does not treat the hypnozoite liver stage
forms of _Plasmodium_ and will therefore
not prevent relapses of malaria due to _Plasmodium vivax_ or
_Plasmodium ovale_. Concomitant therapy with
an antimalarial agent such as an 8-aminoquinoline drug is necessary
for the treatment of severe malaria
due _to P. vivax_ or _P. ovale_. (1)
DOSAGE AND ADMINISTRATION
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•
•
•
DOSAGE FORMS AND STRENGTHS
For Injection: 110 mg of artesunate as a powder in a single-dose vial
for constitution with the supplied
sterile diluent. (3)
CONTRAINDICATIONS
Serious hypersensitivity to artesunate, such as anaphylaxis. (4)
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
The most common adverse reactions (incidence of 2% or greater)
reported with Artesunate for Injection in
clinical trials of severe malaria include acute renal failure
requiring dialysis, hemoglobinuria, and jaundice.
(6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AMIVAS, INC AT
[1-855-526-4827 (1-855-
5AMIVAS)] OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Nevirapine or ritonavir antiretrovirals
If used concomitantly, monitor for possible reduced
antimalarial efficacy. (7, 12.3)
Strong UGT inducers (e.g., rifampin,
carbamazepine, phenytoin)
The recommended dosage of Artesunate for Injection is 2.4 mg/kg
administered intravenously at 0
hours, 12 hours, and