Opfolda Dosage

Pregnancy Evaluation Prior to Initiating Treatment

Verify the pregnancy status of females of reproductive potential prior to initiating OPFOLDA in combination with Pombiliti [see Use in Specific Populations (8.1, 8.3)].

Recommended Dosage and Administration

OPFOLDA must be administered in combination with Pombiliti (see Figure 1 for the dosing timeline). Refer to the Pombiliti Prescribing Information for Pombiliti dosage and administration recommendations.

The recommended dosage of OPFOLDA is based on actual body weight. For patients weighing:

• ≥50 kg, the recommended dosage is 260 mg orally every other week.
• ≥40 kg to <50 kg, the recommended dosage is 195 mg orally every other week.

Start OPFOLDA in combination with Pombiliti 2 weeks after the last ERT dose. Take OPFOLDA approximately 1 hour before intravenous administration of Pombiliti. Swallow the OPFOLDA capsules whole only with unsweetened beverages (e.g., water, tea or coffee with no cream, sugar, or sweeteners). Do not consume other beverages or food for at least 2 hours prior to and 2 hours after administration of OPFOLDA.

Missed Dose
If the OPFOLDA dosage is missed, Pombiliti should not be administered and treatment should be rescheduled at least 24 hours after OPFOLDA was last taken. If OPFOLDA in combination with Pombiliti are both missed, re-start treatment as soon as possible.

Figure 1. Dosing Timeline

Recommended Dosage in Patients with Renal Impairment

The recommended dosage of OPFOLDA in patients with moderate or severe renal impairment is shown in Table 1 [see Clinical Pharmacology (12.3)].

Table 1. Recommended OPFOLDA Dosage in Patients with Moderate or Severe Renal Impairment

For patients with mild renal impairment (creatinine clearance based on the Cockcroft-Gault equation, CLcr 60-89 mL/minute), the recommended OPFOLDA dosage is the same as for patients with normal renal function.