Arakoda

ARAKODA- tafenoquine tablet, film coated
60 Degrees Pharmaceuticals, LLC

1 INDICATIONS AND USAGE

ARAKODA is indicated for the prophylaxis of malaria in patients aged 18 years and older.

2 DOSAGE AND ADMINISTRATION

2.1 Tests to be Performed Prior to ARAKODA Dose Initiation

All patients must be tested for glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to prescribing ARAKODA [see Contraindications (4), Warnings and Precautions (5.1)].

Pregnancy testing is recommended for females of reproductive potential prior to initiating treatment with ARAKODA [see Use in Specific Populations (8.1 and 8.3)].

2.2 Recommended Dosage and Administration Instructions

The recommended dosage of ARAKODA is described in Table 1 below. ARAKODA can be administered for up to 6 months of continuous dosing.

Table 1: Recommended Dosage of ARAKODA in Patients (18 Years of Age and Older)

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) taken one time, 7 days after the last maintenance dose

Administer ARAKODA with food. [see Clinical Pharmacology (12.3)].
Swallow the tablet whole. Do not break, crush or chew the tablets.
Complete the full course of ARAKODA including the loading dose and the terminal dose.
Table 2: How to Replace Missed Doses of ARAKODA

Dose(s) Missed

How to Replace Missed Dose(s):

1 Loading dose

1 dose of 200 mg (2 of the 100 mg tablets) so that a total of 3 daily loading doses have been taken. Begin maintenance dose 1 week after the last loading dose.

2 Loading doses

2 doses of 200 mg (2 of the 100 mg tablets) on 2 consecutive days so that a total of 3 daily loading doses have been taken. Begin maintenance dose 1 week after the last loading dose.

1 Maintenance (weekly) dose

1 dose of 200 mg (2 of the 100 mg tablets) on any day up to the time of the next scheduled weekly dose.

2 Maintenance (weekly) doses

1 dose of 200 mg (2 of the 100 mg tablets) on any day up to the time of the next scheduled weekly dose.

3 or more Maintenance (weekly) doses

2 doses of 200 mg (2 of the 100 mg tablets), taken as 200 mg (2 of the 100 mg tablets) once daily for 2 days up to the time of the next weekly dose.

Terminal prophylaxis dose

1 dose of 200 mg (2 of the 100 mg tablets) as soon as remembered.

3 DOSAGE FORMS AND STRENGTHS

ARAKODA tablets are dark pink, film-coated, capsule-shaped tablets debossed with ‘TQ100’ on one side containing 100 mg of tafenoquine.

4 CONTRAINDICATIONS

ARAKODA is contraindicated in:

patients with G6PD deficiency or unknown G6PD status due to the risk of hemolytic anemia [see Warnings and Precautions (5.2)].
breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if the G6PD status of the infant is unknown [see Warnings and Precautions (5.3), Use in Specific Populations (8.2)].
patients with a history of psychotic disorders or current psychotic symptoms (i.e., hallucinations, delusions, and/or grossly disorganized behavior) [see Warnings and Precautions (5.4)]
patients with known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of ARAKODA [see Warnings and Precautions ( 5.5)].

5 WARNINGS AND PRECAUTIONS

5.1 Hemolytic Anemia

Due to the risk of hemolytic anemia in patients with G6PD deficiency, G6PD testing must be performed before prescribing ARAKODA [see Contraindications (4)]. Due to the limitations with G6PD tests, physicians need to be aware of residual risk of hemolysis and adequate medical support and follow-up to manage hemolytic risk should be available. Treatment with ARAKODA is contraindicated in patients with G6PD deficiency or unknown G6PD status [see Contraindications (4)]. In clinical trials, declines in hemoglobin levels were reported in some G6PD-normal patients [see Adverse Reactions (6.1)]. Monitor patients for clinical signs or symptoms of hemolysis [see Warnings and Precautions (5.6)]. Advise patients to discontinue ARAKODA and seek medical attention if signs of hemolysis occur.

5.2 G6PD Deficiency in Pregnancy and Lactation

Potential Harm to the Fetus

The use of ARAKODA during pregnancy may cause hemolytic anemia in a G6PD-deficient fetus. Even if a pregnant woman has normal levels of G6PD, the fetus could be G6PD deficient. Advise females of reproductive potential that treatment with ARAKODA during pregnancy is not recommended and to avoid pregnancy or use effective contraception during treatment and for 3 months after the last dose of ARAKODA. 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 Use in Specific Populations (8.1 and 8.3)].

Potential Harm to the Breastfeeding Infant

A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to ARAKODA through breast milk. Infant G6PD status should be checked before breastfeeding begins. ARAKODA is contraindicated in breastfeeding women when the infant is found to be G6PD deficient or the G6PD status of the infant is unknown [see Contraindications (4)]. Advise the woman with a G6PD-deficient infant or if the G6PD status of the infant is unknown not to breastfeed during treatment with ARAKODA and for 3 months after the final dose [see Use in Specific Populations (8.2)].

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