Benlysta Caution For Usage





Agencia Lei Va Hong
Full Prescribing Info
Caution For Usage
Special precautions for disposal and other handling: Powder for concentrate for solution for infusion: Preparation of the solution for infusion: Reconstitution: Reconstitution and dilution must be carried out under aseptic conditions.
Allow 10-15 minutes for the vial to warm to room temperature (15°C - 25°C).
It is recommended that a 21-25 gauge needle be used when piercing the vial stopper for reconstitution and dilution.
The 120 mg and 400 mg single-use vial of belimumab is reconstituted with 1.5 ml and 4.8 ml of water for injections, respectively, to yield a final concentration of 80 mg/ml belimumab.
The stream of water for injections should be directed toward the side of the vial to minimize foaming. Gently swirl the vial for 60 seconds. Allow the vial to sit at room temperature (15°C - 25°C) during reconstitution, gently swirling the vial for 60 seconds every 5 minutes until the powder is dissolved. Do not shake. Reconstitution is typically complete within 10 to 15 minutes after the water has been added, but it may take up to 30 minutes.
Protect the reconstituted solution from sunlight.
If a mechanical reconstitution device is used to reconstitute Benlysta it should not exceed 500 rpm and the vial should be swirled for no longer than 30 minutes.
Once reconstitution is completed, the solution should be opalescent and colorless to pale yellow and without particles. Small air bubbles, however, are expected and acceptable.
After reconstitution, a volume of 1.5 ml and 5 ml (corresponding to 120 mg and 400 mg belimumab, respectively) can be withdrawn from each vial.
Dilution: The reconstituted medicinal product is diluted to 250 ml with sodium chloride 9 mg/ml (0.9%) solution for injection.
5% glucose intravenous solutions are incompatible with Benlysta and must not be used.
From a 250 ml infusion bag or bottle of sodium chloride 9 mg/ml (0.9%) solution for injection, withdraw and discard a volume equal to the volume of the reconstituted Benlysta solution required for the patient's dose. Then add the required volume of the reconstituted Benlysta solution into the infusion bag or bottle. Gently invert the bag or bottle to mix the solution. Any unused solution in the vials must be discarded.
Inspect the Benlysta solution visually for particulate matter and discoloration prior to administration. Discard the solution if any particulate matter or discoloration is observed.
The total time from reconstitution of Benlysta to completion of infusion should not exceed 8 hours.
Method of administration: Benlysta is infused over a 1 hour period.
Benlysta should not be infused concomitantly in the same intravenous line with other agents. No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of Benlysta with other agents.
No incompatibilities between Benlysta and polyvinylchloride or polyolefin bags have been observed.
Disposal: Any unused product or waste material should be disposed of in accordance with local requirements.
Solution for injection: Comprehensive instructions for subcutaneous administration of Benlysta in a pre-filled pen are provided as follows (see Step-by-step instructions).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Step-by-step instructions for using the pre-filled pen: Once-Weekly: Follow these instructions on how to use the pre-filled pen correctly. Failure to follow these instructions may affect proper function of the pre-filled pen. The patient should also receive training on how to use the pre-filled pen.
Benlysta is for use under the skin only (subcutaneous).
1. Gather and check supplies: Gather supplies: Remove one sealed tray containing a pre-filled pen from the refrigerator.
Find a comfortable, well-lit and clean surface and place the following supplies within reach: Benlysta pre-filled pen, alcohol swab (not included in the pack), gauze pad or cotton wool ball (not included in the pack), empty container with a tight-fitting lid for pen disposal (not included in the pack).
Do not perform the injection if the patient does not have all the supplies listed.
Check the expiry date: Peel back the film of the tray and remove the pre-filled pen.
Check the expiry date on the pre-filled pen.
Do not use if the expiry date has passed.
2. Prepare and inspect the pre-filled pen: Allow to come to room temperature: Leave the pen at room temperature for 30 minutes. Injecting cold Benlysta may take longer and may be uncomfortable.
Do not warm the pen in any other way. For example, do not warm it in a microwave oven, hot water or direct sunlight.
Do not remove the ring cap during this step.
Inspect the Benlysta solution: Look in the inspection window to check that the Benlysta solution is colourless to slightly yellow in colour.
It is normal to see one or more air bubbles in the solution.
Do not use if the solution looks cloudy, discoloured or has particles.
3. Choose and clean the injection site: Choose the injection site: Choose an injection site (abdomen or thigh).
Do not inject into the exact same site each time. This is to avoid the skin becoming hardened.
Do not inject in areas where the skin is tender, bruised, red or hard.
Do not inject within 5 cm (2 inches) of the navel (belly button).
Clean the injection site: Wash the hands.
Clean the injection site by wiping it with an alcohol swab. Allow the skin to air dry.
Do not touch this area again before giving the injection.
4. Prepare for the injection: Remove the ring cap.
Do not remove the ring cap until immediately before the injection.
Remove the ring cap by pulling or twisting it off. The ring cap may be twisted off either clockwise or anti-clockwise.
Do not put the ring cap back onto the pen.
Position the pen: Hold the pen comfortably so that the patient can view the inspection window. This is important so that the patient can confirm a complete dose.
If needed, firm the injection site by pulling or stretching the skin.
Position the pen straight over the injection site (at a 90° angle). Make sure the gold needle guard is flat on the skin.
5. Inject Benlysta: Start the injection: Firmly press the pen all the way down onto the injection site and hold in place.
This will insert the needle and start the injection.
The patient may hear a first "click" at the start of the injection. The patient will see the purple indicator start to move through the inspection window.
Complete the injection: Continue to hold the pen down until the purple indicator has stopped moving. The patient may hear a second "click" a few seconds before the purple indicator stops moving.
The injection may take up to 15 seconds to complete.
When the injection is complete, lift the pen from the injection site.
6. Dispose and inspect: Dispose of the used pen: Do not put the ring cap back onto the pen.
Dispose of the used pen and ring cap in an empty container with a tight-fitting lid.
Ask the doctor or pharmacist for instructions on how to properly dispose of a used pen or container of used pens.
Do not recycle or throw the used pen, or container of used pens, in household waste.
Inspect the injection site: There may be a small amount of blood at the injection site.
If needed, press a cotton ball or gauze pad on the injection site.
Do not rub the injection site.
Incompatibilities: Powder for concentrate for solution for infusion: Benlysta is not compatible with 5% glucose.
This medicinal product must not be mixed with other medicinal products except those previously mentioned in Special precautions for disposal and other handling.
Solution for injection: None known.
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