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Dosing and administration for ORENCIA® (abatacept) IV

ORENCIA IV is a 30-minute infusion1

Following an initial intravenous dose, ORENCIA IV should be administered at 2 and 4 weeks, then every 4 weeks following

Month 1
Continue

Day 1

1st Dose

Day 15

2nd Dose

Day 29

3rd Dose

Every 4 weeks thereafter

Actual day of dosing may vary based on patient scheduling.

ORENCIA IV adult dosing by weight1

Each vial of ORENCIA IV contains 250 mg of lyophilized powder. Based on your adult patient’s weight, the appropriate dose may require 2, 3, or 4 vials.

Body weight of patient*
Dose (mg)
Number of vials
Billable units (abatacept per 10 mg)
<60 kg (<132 lb)
500 mg
2
50
60 kg to 100 kg (132 lb to 220 lb)
750 mg
3
75
>100 kg (>220 lb)
1000 mg
4
100

*1 kg=2.2 lb.

Each vial provides 250 mg of ORENCIA for administration.

ORENCIA IV dosing and administration guide

Download and print the go-to guide for preparing and administering ORENCIA IV

Preparation and administration1

To complete an infusion you’ll need:

  • ORENCIA IV lyophilized powder in preservative-free, single-use vials (2, 3, or 4 vials based on patient body weight)
  • Sterile water for injection, USP
  • Sterile, nonpyrogenic, low-protein–binding filter (pore size of 0.2 to 1.2 μm)
  • 100-mL infusion bag or bottle of 0.9% Sodium Chloride Injection, USP
  • Silicone-free disposable syringe
  • 18- to 21-gauge needles
  • Sharps container
  • Alcohol swabs

General infusion instructions1

For more detailed administration information, watch the ORENCIA IV Infusion video HERE or see the Full Prescribing Information

Remove flip-top

1. Use aseptic technique throughout. Remove flip-top from ORENCIA vial and wipe the top with an alcohol swab.

Reconstitute

2. Reconstitute the ORENCIA powder in each vial with 10 mL of Sterile Water for Injection, USP, using only the silicone-free disposable syringe provided with each vial and an 18- to 21-gauge needle. If syringe is dropped or becomes contaminated, use a new one.

For information on obtaining additional syringes, contact Bristol-Myers Squibb at 1-877-ORENCIA. Discard any solution prepared using siliconized syringes.

Insert syringe needle

3. Insert the syringe needle into the vial through the center of the rubber stopper and direct the stream of Sterile Water for Injection, USP, to the glass wall of the vial. Do not use the vial if the vacuum is not present. Do not shake.

Rotate the vial

4. Rotate the vial with a gentle swirling motion until contents completely dissolve. After mixing, each milliliter will contain 25 mg (250 mg/10 mL) of ORENCIA® (abatacept).

Vent the vial

5. Vent the vial with a needle to dissipate any foam that may be present. The solution should be clear and colorless to pale yellow. Do not use if opaque particles, discoloration, or other foreign particles are present.

Further dilute

6. Further dilute the reconstituted ORENCIA solution to 100-mL as follows: from a 100-mL infusion bag or bottle, withdraw a volume of 0.9% Sodium Chloride Injection, USP, equal to the volume of the reconstituted ORENCIA solution (for 2 vials remove 20 mL, for 3 vials remove 30 mL, for 4 vials remove 40 mL).

Slowly add the reconstituted ORENCIA solution from each vial to the infusion bag or bottle using the same silicone-free disposable syringe provided with each vial.

Gently mix

7. Gently mix. Do not shake the bag or bottle. The concentration of the fully diluted ORENCIA solution in the infusion bag or bottle will be approximately 5, 7.5, or 10 mg of ORENCIA per mL of solution depending on whether 2, 3, or 4 vials of ORENCIA are used. Discard any unused portion in the vials.

Prior to administration, visually inspect the ORENCIA solution for particulate matter and discoloration. Discard if any particulate matter or discoloration is observed.

Administer fully

8. Administer the entire, fully diluted ORENCIA solution over a period of 30 minutes with an infusion set and a sterile, nonpyrogenic, low-protein–binding filter (pore size of 0.2 μm to 1.2 μm).

Complete the infusion within 24 hours of reconstitution of the ORENCIA vials. The fully diluted ORENCIA solution may be stored at room temperature or refrigerated at 36°F to 46°F (2°C to 8°C) before use.

See the Full Prescribing Information for detailed administration information.

Storage and handling for ORENCIA IV1

  • ORENCIA lyophilized powder must be refrigerated at 36°F to 46°F (2°C to 8°C)
  • Do not use beyond the expiration date on the vial
  • Protect the vials from light by storing in the original package until time of use
*
If there are any product defects, call 1-800-ORENCIA to receive a new vial.

ORENCIA® (abatacept) indicated for moderate to severe RA

Selected Important Safety Information

Concomitant Use with TNF Antagonists: Concurrent therapy with ORENCIA® (abatacept) and a biologic DMARD is not recommended. In controlled clinical trials, adult patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63%) and serious infections (4.4%) compared to patients treated with only TNF antagonists (43% and 0.8%, respectively), without an important enhancement of efficacy.

Reference:

  1. ORENCIA (abatacept) [package insert]. Princeton, NJ: Bristol-Myers Squibb.
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