Pasurta

Pasurta Patient Counseling Information

erenumab

Manufacturer:

Novartis

Distributor:

DKSH
Full Prescribing Info
Patient Counseling Information
INSTRUCTIONS FOR USE AND HANDLING: Instruction for use of the 70 mg/mL Solution for injection in a Single-Use prefilled Syringe: Important: Before you use a Pasurta prefilled syringe, read this important information: Storing your Pasurta prefilled syringe: Keep the syringe out of the sight and reach of children.
Keep the syringe in the original carton to protect from light or physical damage.
The syringe should be kept in the refrigerator at 2°C to 8°C.
Throw away Pasurta that has been left at room temperature (up to 30°C) for more than 14 days.
Do not store the syringe in extreme heat or cold. For example, avoid storing in your car.
Do not freeze.
Using your Pasurta prefilled syringe: Do not try to inject Pasurta before receiving training from the doctor or nurse.
Do not use a syringe after the expiry date stated on the label.
Do not shake the syringe.
Do not remove the gray needle cap from the syringe until you are ready to inject.
Do not freeze or use the syringe if it has been frozen.
Do not use a syringe if it has been dropped on a hard surface. Part of the syringe may be broken even if you cannot see the break. Use a new syringe, and contact your healthcare provider (doctor, nurse or pharmacist).
This product contains natural rubber latex within the gray needle cap. The product may cause allergic responses in individuals who are sensitized to latex. Tell your healthcare provider if you are allergic to latex.
For more information or help contact your health care provider.
Step 1: Prepare: Read this before you inject.
Check your prescription.
Your healthcare provider has prescribed a 70 mg or a 140 mg dose.
For a 70 mg dose, inject one syringe of 70 mg/mL.
For a 140 mg dose, inject two syringes of 70 mg/mL one after the other.
To avoid discomfort at the site of injection, leave the syringes at room temperature for at least 30 minutes before injecting.
A) Remove the Pasurta prefilled syringe(s) from the carton. Grab the syringe barrel to remove the syringe(s) from the tray.
Place your finger and thumb on the edge of the tray to secure it while you remove the syringe(s).
Hold the syringe(s) at the barrel.
B) Inspect the Pasurta prefilled syringe(s).
Always hold the syringe(s) by the syringe barrel.
Make sure the medicine in the syringe(s) is clear and colorless to slightly yellow.
Leave the syringe(s) at room temperature for at least 30 minutes before injecting.
Do not use the syringe(s) if the medicine is cloudy or discolored or contains flakes or particles.
Do not use the syringe(s) if any part appears cracked or broken.
Do not use the syringe(s) if the syringe has been dropped.
Do not use the syringe(s) if the gray needle cap is missing or not securely attached.
Do not use the syringe(s) if the expiry date printed on the label has passed.
In all cases, use a new syringe, and in case of doubts contact your health care provider.
C) Gather all materials needed for the injections. Wash your hands thoroughly with soap and water.
On a clean, well-lit work surface, place the: One or two new syringes (dependent on your prescribed dose); Alcohol wipe(s); Cotton ball(s) or gauze pad(s); Adhesive bandage(s); Sharps disposal container.
D) Prepare and clean the injection site(s).
Only use these injection sites: The thigh; Stomach area (abdomen), except for a five cm area right around the navel; Outer area of upper arm (only if someone else is giving you the injection).
Clean your injection site with an alcohol wipe. Let your skin dry.
Do not touch this area again before injecting.
Choose a different site each time you give yourself an injection if you need to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection.
Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting directly into a raised, thick, red, or scaly skin patch or lesion, or areas with scars or stretch marks.
Step 2: Get ready.
E) Pull the gray needle cap straight out and away from your body, only when you are ready to inject.
Do not leave the gray needle cap off for more than five minutes. This can dry out the medicine.
It is normal to see a drop of liquid at the end of the needle.
Do not twist or bend the gray needle cap.
Do not put the gray needle cap back onto the syringe.
Do not remove the gray needle cap from the syringe until you are ready to inject.
F) Pinch the injection site to create a firm surface.
Pinch skin firmly between your thumb and fingers, creating an area about five cm wide.
Important: Keep skin pinched while injecting.
Step 3: Inject.
G) While pinching, with the gray needle cap off, insert the syringe into the skin at an angle of 45 to 90 degrees.
Do not place your finger on the plunger rod while inserting the needle.
H) Using slow and constant pressure, push the plunger rod all the way down until it stops moving.
I) When done, release your thumb, and gently lift the syringe off of the skin.
Important: When you remove the syringe, if it looks like the solution is still in the syringe barrel, this means you have not received a full dose. Call your healthcare provider immediately.
Step 4: Finish.
J) Discard the used syringe and the gray needle cap.
Put the used Pasurta syringe in a sharps disposal container right away after use. Do not throw away (dispose of) the syringe in your household trash.
Talk with your healthcare provider about proper disposal. There may be local regulations for disposal.
Do not reuse the syringe.
Do not recycle the syringe or sharps disposal container or throw them into household trash.
Important: Always keep the sharps disposal container out of the sight and reach of children.
K) Examine the injection site.
If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. Apply an adhesive bandage if needed.
If you were prescribed the 140 mg dose using two 70 mg/mL syringes repeat steps 1D to 3 with the second syringe to inject your full dose.
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