ARAKODA- tafenoquine tablet, film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

TAFENOQUINE (UNII: 262P8GS9L9) (TAFENOQUINE - UNII:262P8GS9L9)

Tersedia dari:

60 Degrees Pharmaceuticals, LLC

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

ARAKODA is indicated for the prophylaxis of malaria in patients aged 18 years and older. ARAKODA is contraindicated in: The use of ARAKODA during pregnancy may cause hemolytic anemia in a fetus who is G6PD-deficient. Treatment with ARAKODA during pregnancy is not recommended. If a pregnancy is detected during ARAKODA use, discontinue ARAKODA as soon as possible and switch to an alternative prophylactic drug for malaria during pregnancy [see Warnings and Precautions (5.2)] . Available data with use of ARAKODA in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal studies, there were increased abortions, with and without maternal toxicity when tafenoquine was given orally to pregnant rabbits at and above doses equivalent to about 0.4 times the clinical exposure based on body surface area comparisons. No fetotoxicity was observed at doses about 1.5 times the clinical exposure (based on body surface area compariso

Ringkasan produk:

How Supplied ARAKODA tablets contain 100 mg of tafenoquine (equivalent to 125.5 mg of tafenoquine succinate) and are dark pink, film-coated, capsule-shaped, and debossed with ‘TQ100’ on one side. ARAKODA tablets are packed in blister packs or bottles. For the blister pack presentation, ARAKODA tablets are packed in polyamide aluminum and PVC formable laminate backed blisters with a polyethylene terephthalate aluminum foil cover. Each blister card contains 8 tablets. Each package contains 2 blister cards (16 tablets) housed in a contiguous outer paperboard child-resistant carton component (NDC 71475-257-01). For the bottle presentation, ARAKODA tablets are packed in 40 cc, 33 mm white high-density polyethylene bottles with a 33 mm polypropylene screw-top child resistant cap with an induction seal liner. Each bottle contains 8 tablets (NDC 71475-257-02). Storage Store at 20°C to 25°C (68°F to 77°F). Temperature excursions are permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense only in the original carton.

Status otorisasi:

New Drug Application

Selebaran informasi

60 Degrees Pharmaceuticals, LLC
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MEDICATION GUIDE
MEDICATION GUIDE
ARAKODA (AIR-uh-KOH-duh)
(tafenoquine)
tablets, for oral use
What is the most important information I should know about ARAKODA?
ARAKODA can cause serious side effects including:
•
Breakdown of red blood cells (hemolytic anemia). See “Do not take
ARAKODA if you:”
ARAKODA can cause a breakdown of red blood cells (hemolysis) in people
with glucose-6-
phosphate dehydrogenase (G6PD) deficiency. Your healthcare provider
will test you for G6PD
deficiency before you start taking ARAKODA. Signs of hemolytic anemia
may not happen right
away (delayed reaction).Tell your healthcare provider or get emergency
medical help right away if
you develop signs of hemolytic anemia which include darkening of the
urine, dizziness, confusion,
feeling tired, light-headedness, or shortness of breath, pale skin or
yellowing of the skin and whites
of the eyes.
•
Decrease of oxygen in your blood caused by a certain type of abnormal
red blood cell
(methemoglobinemia). Signs and symptoms of methemoglobinemia may not
happen right away
(delayed reaction). Get medical help right away if you have bluish
coloring of the lips or skin,
headache, fatigue, shortness of breath, or lack of energy.
•
Mental health (psychiatric) symptoms. See “Do not take ARAKODA if
you:”
Sleep problems, depression, anxiety and psychosis have happened while
taking ARAKODA.
Psychiatric symptoms may not happen right away (delayed reaction). Get
emergency medical help
right away if you develop hallucinations (seeing or hearing things
that are really not there),
delusions (false or strange thoughts or beliefs), or if you get
confused or have problems thinking
while taking ARAKODA. Call your healthcare provider if you develop
changes in your mood,
anxiety, trouble sleeping (insomnia), or nightmares for 3 days or
longer while taking ARAKODA.
•
ARAKODA can have other serious side effects. See “What are the
possible side effects of
ARAKODA?”
What is ARAKODA?
•
ARAKODA is a prescripti

Karakteristik produk

ARAKODA- TAFENOQUINE TABLET, FILM COATED
60 DEGREES PHARMACEUTICALS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ARAKODA™ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ARAKODA™.
ARAKODA™ (TAFENOQUINE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2018
INDICATIONS AND USAGE
ARAKODA is an antimalarial indicated for the prophylaxis of malaria in
patients aged 18 years and older.
(1)
DOSAGE AND ADMINISTRATION
•
•
REGIMEN NAME
TIMING
DOSAGE
Loading regimen
For each of the 3 days before
travel to a malarious area
200 mg (2 of the 100 mg tablets) once daily for
3 days
Maintenance regimen
While in the malarious area
200 mg (2 of the 100 mg tablets) once weekly –
start 7 days after the last loading regimen dose
Terminal prophylaxis
regimen
In the week following exit from
the malarious area
200 mg (2 of the 100 mg tablets) one-time 7
days after the last maintenance dose
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 100 mg of tafenoquine (3)
CONTRAINDICATIONS
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
All patients must be tested for glucose-6-phosphate dehydrogenase
(G6PD) deficiency prior to
prescribing ARAKODA. (2.1)
Pregnancy testing is recommended for females of reproductive potential
prior to initiating treatment
with ARAKODA. (2.1)
Administer ARAKODA with food. (2.2)
See full prescribing information for instructions on how to replace
missed doses. (2.2)
G6PD deficiency or unknown G6PD status (4)
Breastfeeding by a lactating woman when the infant is found to be G6PD
deficient or if G6PD status is
unknown (4, 8.2)
Patients with a history of psychotic disorders or current psychotic
symptoms (4, 5.4)
Known hypersensitivity reactions to tafenoquine, other
8-aminoquinolines, or any component of
ARAKODA. (4)
Hemolytic Anemia: G6PD testing must be performed before prescribing
ARAKODA due to the risk of
hemolytic anemia. Monitor patients for signs or symptoms of hemolysis.
(5.1)
G6PD Deficiency in Pregnancy or L