Paliperidonedosage

Administer INVEGA HAFYERA by gluteal injection once every 6 months by a healthcare professional. Do not administer by any other route. See Full Prescribing Information for complete dosing information. Initiate INVEGA HAFYERA when the next once-a-month or every three-month paliperidone palmitate extended-release injectable suspension dose is scheduled. Dose is based on the previous once-a-month or every-three-month product.: INVEGA HAFYERA Doses for Adults Adequately Treated with Once-a-month paliperidone palmitate extended-release injectable suspension (PP1M) Switching from the PP1M 39 mg, 78 mg and 117 mg doses was not studied. If the Last Dose of PP1M is: Initiate INVEGA HAFYERA at the Following Dose: 156 mg 1,092 mg 234 mg 1,560 mg INVEGA HAFYERA Doses for Adults Adequately Treated with Every-three-month paliperidone palmitate injectable suspension (PP3M) Switching from the PP3M 273 mg and 410 mg doses was not studied. If the Last Dose of PP3M is: Initiate INVEGA HAFYERA at the Following Dose: 546 mg 1,092 mg 819 mg 1,560 mg Missed Doses: Refer to the Full Prescribing Information. See Full Prescribing Information for important preparation and administration information. Moderate to severe renal impairment (creatinine clearance <50 mL/min): INVEGA HAFYERA is not recommended. Mild renal impairment (creatinine clearance ≥ 50 mL/min to < 80 mL/min): Adjust dosage and stabilize the patient using PP1M before transitioning to INVEGA HAFYERA, or from PP1M to PP3M before transitioning to INVEGA HAFYERA. See appropriate table above.

2.1 Important

Dosage and Administration Information INVEGA HAFYERA must be administered as a gluteal intramuscular injection by a healthcare professional once every 6 months. Do not administer by any other route. Initiate INVEGA HAFYERA only after adequate treatment has been established with either: A once-a-month paliperidone palmitate extended-release injectable suspension (e.g., INVEGA SUSTENNA), referred to as PP1M, once monthly for at least four months; or An every-three-month paliperidone palmitate extended-release injectable suspension (e.g., INVEGA TRINZA), referred to as PP3M, once every three months for at least one three-month injection cycle. See Prescribing Information of the PP1M and PP3M products for the recommended dosage of these products.

2.2 Recommended

Dosage for INVEGA HAFYERA Switching to INVEGA HAFYERA from a PP1M Product The recommended initial INVEGA HAFYERA dose is based on the previous PP1M dose (see Table 1 ). Initiate INVEGA HAFYERA when the next PP1M dose is scheduled. INVEGA HAFYERA may be administered up to 1 week before or 1 week after the next scheduled PP1M dose. When switching from PP1M to INVEGA HAFYERA, the two injection cycles immediately preceding the switch should be the same dosage strength before starting INVEGA HAFYERA. Table 1. Initial INVEGA HAFYERA Dose for Adult Patients Switching from a PP1M PP1M: Once-a-month paliperidone palmitate extended-release injectable suspension Product Last Dose of PP1M There are no equivalent doses of INVEGA HAFYERA for 39 mg, 78 mg, or 117 mg doses of a PP1M product, which were not studied. Initial Dose of INVEGA HAFYERA 156 mg 1,092 mg 234 mg 1,560 mg Switching to INVEGA HAFYERA from a PP3M Product The recommended initial INVEGA HAFYERA dose is based on the previous PP3M dose (see Table 2 ). Initiate INVEGA HAFYERA when the next PP3M dose is scheduled. INVEGA HAFYERA may be administered up to 2 weeks before or 2 weeks after the next scheduled PP3M dose. Table 2. Initial INVEGA HAFYERA Dose for Adult Patients Switching from a PP3M PP3M: Every-three-month paliperidone palmitate extended-release injectable suspension Product Last Dose of PP3M There are no equivalent doses of INVEGA HAFYERA for the 273 mg or 410 mg doses of a PP3M product, which were not studied. Initial Dose of INVEGA HAFYERA 546 mg 1,092 mg 819 mg 1,560 mg Dosing Interval and Dosage Adjustments of INVEGA HAFYERA Following the initial dose, administer INVEGA HAFYERA once every 6 months. If needed, dosage adjustment can be made every 6 months between the dose of 1,092 mg to 1,560 mg based on individual response and tolerability. Because of the potential longer duration of INVEGA HAFYERA, the patient's response to an adjusted dose may not be apparent for several months.

2.3 Missed Doses

Dosing Window To avoid a missed dose, patients may be given the injection up to 2 weeks before or 3 weeks after the scheduled 6-month dose. Missed Dose If a dose of INVEGA HAFYERA is missed, re-initiate with a PP1M product using the re-initiation regimens described in Tables 3 and 4. More than 6 Months and 3 Weeks, up to but Less than 8 Months Since Last Dose If more than 6 months and 3 weeks but less than 8 months have elapsed since the last dose of INVEGA HAFYERA, do not administer the next dose of INVEGA HAFYERA. Instead, use the re-initiation regimen shown in Table 3: Table 3. Re-initiation Regimen for Missed Dose (more than 6 months and 3 weeks, but less than 8 months since last dose) Last Dose of INVEGA HAFYERA Administer PP1M Product PP1M: Once-a-month paliperidone palmitate extended-release injectable suspension into deltoid muscle Administer INVEGA HAFYERA into gluteal muscle Day 1 1 month after Day 1 1,092 mg 156 mg 1,092 mg 1,560 mg 234 mg 1,560 mg 8 Months Up to and including 11 Months Since Last Dose If 8 months but up to and including 11 months have elapsed since the last dose of INVEGA HAFYERA, do not administer the next dose of INVEGA HAFYERA. Instead, use the re-initiation regimen shown in Table 4: Table 4. Re-initiation Regimen for Missed Dose (8 months up to and including 11 months since last dose) Last dose of INVEGA HAFYERA Administer PP1M Product PP1M: Once-a-month paliperidone palmitate extended-release injectable suspension into deltoid muscle Administer INVEGA HAFYERA into gluteal muscle Day 1 Day 8 1 month after Day 8 1,092 mg 156 mg 156 mg 1,092 mg 1,560 mg 156 mg 156 mg 1,560 mg More than 11 Months Since Last Dose If more than 11 months have elapsed since the last dose of INVEGA HAFYERA, re-initiate treatment with a PP1M product as described in the prescribing information for that product. INVEGA HAFYERA can then be resumed after the patient has been adequately treated with a PP1M product for at least 4 months.

2.4 Dosage Recommendations in

Patients with Renal Impairment INVEGA HAFYERA has not been systematically studied in patients with renal impairment. For patients with mild renal impairment (creatinine clearance ≥50 mL/min to < 80 mL/min [Cockcroft-Gault Formula]), adjust dosage and stabilize the patient using PP1M before transitioning from PP1M to INVEGA HAFYERA, or from PP1M to PP3M before transitioning to INVEGA HAFYERA (see Table 1 ). Refer to the Prescribing Information of PP1M or PP3M product for the recommended PP1M or PP3M dosage in patients with mild renal impairment. INVEGA HAFYERA is not recommended in patients with moderate or severe renal impairment (creatinine clearance <50 mL/min).

2.5 Instructions for

Preparation and Administration To be prepared and administered by a healthcare provider only. Read the instructions for preparation and administration below and consider referring to the separate Healthcare Provider "Instructions for Use" for preparation and administration considerations. For gluteal intramuscular injection only. Do not inject by any other route. As a universal precaution, always wear gloves. Inspect INVEGA HAFYERA for particulate matter and discoloration prior to administration. Do not mix with any other product or diluent. After shaking, INVEGA HAFYERA should appear uniform, thick and milky white. Do not use needles from the PP1M or PP3M products or other commercially-available needles to reduce the risk of blockage. Avoid inadvertent injection into a blood vessel. Administer the dose in a single injection; do not administer the dose in divided injections. Inject slowly, deep into the upper-outer quadrant of the gluteal muscle. Future injections should be alternated between the two gluteal muscles. Incomplete Administration Proper shaking can reduce the likelihood for an incomplete injection. Storing the carton in a horizontal orientation improves the ability to resuspend this highly concentrated product. Follow the full instructions for preparation and administration to avoid an incomplete injection. In the event of an incompletely administered dose, do not re-inject the dose remaining in the syringe and do not administer another dose of INVEGA HAFYERA. Closely monitor and treat the patient with oral paliperidone supplementation as clinically appropriate until the next scheduled 6-month injection of INVEGA HAFYERA. See Prescribing Information of the oral paliperidone product for the recommended dosage of these products. Administer every 6 months INVEGA HAFYERA (paliperidone palmitate) Shake syringe with the syringe tip cap pointing up VERY FAST for at least 15 seconds, rest briefly, then shake again for 15 seconds. For Gluteal Intramuscular injection only. Preparation INVEGA HAFYERA requires longer and faster shaking than once-a-month paliperidone palmitate extended-release injectable suspension (e.g., INVEGA SUSTENNA). INVEGA HAFYERA must be administered by a healthcare professional as a single injection. Do not divide dose into multiple injections. INVEGA HAFYERA is intended for gluteal intramuscular use only. Inject slowly, deep into the muscle taking care to avoid injection into a blood vessel. Dosing Administer INVEGA HAFYERA once every 6 months. Thin Wall Safety Needle Thin wall safety needle is designed to be used with INVEGA HAFYERA. Therefore, it is important to only use the needle provided in the INVEGA HAFYERA suspension kit. Dose pack contents Prefilled Syringe Thin Wall Safety Needle 20G × 1½" Only use the needle included in this kit 1.

Prepare for the injection: this highly concentrated product requires specific steps to resuspend Hold syringe with the tip cap pointing up Syringe tip cap pointing up Shake syringe VERY FAST for at least 15 seconds, rest briefly, then shake again for 15 seconds To ensure complete resuspension shake syringe with: Short, VERY FAST up and down motion Loose wrist Proceed to the next step immediately after shaking. Check suspension for solid product Mixed well Not mixed well STOP Uniform, thick and milky white It is normal to see air bubbles Solid product on sides and top of syringe Uneven mix Thin liquid Product may clog. Shake syringe with the syringe tip cap pointing up VERY FAST for at least 15 seconds, rest, then shake again for 15 seconds. Open needle pouch Peel off the pouch cover. Place pouch with the needle inside on a clean surface. Remove syringe tip cap and attach needle Hold the syringe with the tip cap pointing up. Twist and pull off the cap. Attach the safety needle to the syringe using a gentle twisting motion to avoid needle hub cracks or damage. Always check for signs of damage or leakage prior to administration. Pull back plunger Hold the syringe upright. Gently pull back the plunger to clear the syringe tip of any solid product. This will make pressing the plunger easier during the injection. Remove air bubbles Press the plunger carefully until a drop of liquid comes out of the needle tip. 2. Slowly inject entire content and confirm Select and clean a gluteal injection site Wipe the gluteal site with an alcohol swab and allow it to dry. Do not touch, fan or blow on the injection site after you have cleaned it. Remove needle sheath Pull the needle sheath away from the needle in a straight motion. Do not twist the sheath, as this may loosen the needle from the syringe. Slowly inject and confirm Use slow, firm, consistent pressure to press the plunger completely. This should take approximately 30 seconds. Continue to press the plunger if you feel resistance. This is normal. Remove needle from the muscle. 3. After the injection Secure needle After the injection is complete, use your thumb or a flat surface to secure the needle in the safety device. The needle is secure when you hear a "click" sound. Dispose of properly and check injection site Dispose of the syringe in an approved sharps container. There may be a small amount of blood or liquid at the injection site. Hold pressure over the skin with a cotton ball or gauze pad until any bleeding stops. Do not rub the injection site. If needed, cover injection site with a bandage. Image Image Image Image Image Image Image Image Image Image Image Image Image Image Image Image Image Image Image Image Image Image Image