Besremi: Uses, Side Effects and Dosage

INSTRUCTIONS FOR USE

BESREMi [bez-reh-me]

(ropeginterferon alfa-2b-njft)

injection, for subcutaneous use

Single-dose prefilled syringe

Store the BESREMi carton in the refrigerator between 36°F to 46°F (2°C to 8°C) (Figure B).

• Keep your BESREMi prefilled syringes in their original carton (Figure B) while stored.
• Do not freeze the prefilled syringes.
• Do not use a prefilled syringe that has been frozen or left in direct sunlight.
• Keep BESREMi prefilled syringes, needles, and all medicines out of the reach of children.

• 

Read this Instructions for Use before using your single-dose BESREMi prefilled syringe for the first time and each time you get a new prescription. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment. Ask your healthcare provider about the right way to prepare and give your BESREMi injection.

• Your healthcare provider will tell you the prescribed dose that you should take and the right amount of BESREMi to measure in the prefilled syringe for your dose. Each time you inject, be sure that you know the prescribed dose of BESREMi to inject. Your dose may change over time.
• BESREMi is for subcutaneous (under the skin) injection only.
• BESREMi is for one-time use only. Do not reuse your prefilled syringe or needle.
• Do not use a prefilled syringe or needle that is damaged or broken. Contact your healthcare provider for a replacement prefilled syringe or additional needles.
• Inject BESREMi into the top of the thighs or lower stomach-area just under the skin. Do not inject BESREMi into any other area of the body.
• Throw away (dispose of) the BESREMi prefilled syringe with needle attached right away after use, even if there is medicine left in the prefilled syringe. See Step 10 in the section "Dispose of used prefilled syringes and needles."

Take the BESREMi carton out of the refrigerator (Figure E).

Check the expiration date ("EXP") on the top panel of the carton to make sure it has not passed (Figure F).

Do not use the prefilled syringe if the expiration date has passed.

Let carton containing the BESREMi prefilled syringe sit on a clean work surface for 15 to 30 minutes to allow it to come to room temperature (Figure G).

Do not warm the prefilled syringe any other way.

After allowing the prefilled syringe to come to room temperature for 15 to 30 minutes inside the carton, gather the following additional supplies.

Alcohol Swab (Figure H).

FDA-cleared Sharps Disposal Container (Figure I)

A paper towel, sink, or trash can to minimize mess during dose adjustment (Figure J).

Optional Items: Gauze or Cotton Ball and a Small Adhesive Bandage (Figure K).

Wash your hands with soap and water, then dry your hands (Figure L).

Open the carton and remove the clear plastic tray that holds the BESREMi prefilled syringe and needle package (Figure M).

Remove the needle package and BESREMi prefilled syringe from the plastic tray. Hold the prefilled syringe by the middle of the syringe body during removal (Figure N).

Check the liquid medicine in the prefilled syringe (Figure O). The liquid should be clear and colorless to slightly yellow, and should not have particles.

Do not use the prefilled syringe if the liquid is cloudy, discolored, or contains particles. Contact your healthcare provider or pharmacist.

Check the syringe to see if it is damaged or broken (Figure O).

Do not use if it shows any signs of damage or breakage. Contact your healthcare provider or pharmacist.

Carefully open the needle package, remove the needle, and set it aside (Figure P).

Throw away the packaging into household trash.

Hold the prefilled syringe as shown. Remove the prefilled syringe cap by unscrewing it counter-clockwise (Figure Q).

Throw away the syringe cap into household trash.

Do not allow the tip of the prefilled syringe to touch anything.

Attach the needle to the prefilled syringe by firmly pushing it into the collar of the syringe and then screwing (turn clock-wise) it on until it feels securely attached (Figure R).

The needle should now be assembled to the prefilled syringe (Figure S).

Choose one of the following injection sites (Figure T):

• Lower stomach (abdomen) area, at least 2 inches away from the belly button,

• Top of thighs.

  Do not inject into skin that is irritated, red, bruised, infected, or scarred.

  BESREMi is for subcutaneous (under the skin) injection only.

  Rotate (change) the injection site for each injection.

• 

Clean the chosen injection site with an alcohol swab and let it air dry (Figure U).

Do not blow on or touch the injection site after it has been cleaned.

Pull the pink needle shield back (Figure V).

Note: The pink needle shield will be used after the injection to cover the needle and protect you from needle-stick injuries.

Hold the syringe from the syringe body.

Remove the clear needle cap by pulling it straight off (Figure W). Throw away the needle cap into household trash.

Do not recap needle.

Hold the prefilled syringe with the needle pointing up.

Tap on the body of the prefilled syringe to move any air bubbles to the top (Figure X).

Check your prescription to identify your prescribed dose (Figure Y). Depending on your prescribed dose, you may have to adjust the dose in the syringe by getting rid of (discarding) some medicine from the prefilled syringe before you inject the medicine.

To set your dose follow the 4 steps below:

1. 1. Hold the prefilled syringe at eye level with the needle pointing straight up over a paper towel, sink, or trash can.
2. 2. Check that you can see the dose lines and number markings on the prefilled syringe.
3. 3. Pinch the end of the plunger as shown (Figure Z).
4. 4.

   Slowly push up on the plunger to remove liquid medicine until the top edge of the gray stopper lines up with the marking for your prescribed dose (Figure Z). Keep holding straight up as you set the dose.

   Important: If you accidentally remove too much liquid medicine, do not inject. Contact your healthcare provider or pharmacist.

Pinch the chosen injection site (Figure AA).

While pinching the skin, insert the needle at a 45 to 90 degree angle into the pinched skin (Figure AB).

Then release the pinched skin.

Inject the medicine by slowly pressing down on the plunger all the way until it stops (Figure AC).

After all the liquid medicine is injected, remove the needle from the skin (Figure AD).

Cover needle

Carefully push the pink needle shield over the needle until it snaps into place and covers the needle (Figure AE). This helps prevent needle-stick injuries.

Do not recap the needle using the needle cap. Only use the pink needle shield to cover the needle.

Dispose of used prefilled syringes and needles.

• Put your used prefilled syringes and needles in a FDA-cleared sharps disposal container right away after use (Figure AF). Do not throw away (dispose of) loose prefilled syringes and needles in the household trash.

• 

• If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and
  • properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
• Do not dispose of your sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
• Always keep the sharps disposal container out of the reach of children.

For additional information about BESREMi and a video demonstration on how to use BESREMi, go to:

www.BESREMi.com

Manufactured by:

PharmaEssentia Corporation

2F-5 No. 3 YuanQu Street

Nangang Dist. Taipei, Taiwan

U.S. License number: 2155

Distributed by:

PharmaEssentia Corporation

35 Corporate Drive, Suite 325, Burlington, MA 01803, USA

BESREMi is a trademark/registered trademark of PharmaEssentia

Copyright 2021 PharmaEssentia

INSTRUCTIONS FOR USE

BESREMi Pen^TM [bez-reh-me p-eh-n]

(ropeginterferon alfa-2b-njft)

injection, for subcutaneous use

Single-dose prefilled pen injector

Read this Instructions for Use before using your single-dose BESREMi Pen and each time you get a new prescription. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment. Ask your healthcare provider about the right way to prepare and give your BESREMi injection.

• Your healthcare provider will tell you the prescribed dose that you should take using BESREMi. Each time you inject, be sure that you know the prescribed dose of BESREMi to inject. Your dose may change over time.
• BESREMi Pens are for one-time use only. A single-use safety needle is provided with the pen and cannot be removed from the pen after attaching. Do not reuse the pen or needle.
• BESREMi is for subcutaneous (under the skin) injection only. Do not inject into a vein.
• Do not use BESREMi Pen if: it is damaged or broken, the expiration date has passed, or the liquid is cloudy, discolored, or contains particles.
• Contact your pharmacist for a replacement pen or needles.
• Inject BESREMi into the lower stomach (abdomen) area or top of the thighs. Do not inject BESREMi into any other area of the body. See Step 5 for injection site information.
• Throw away (dispose of) the BESREMi Pen with the needle attached into a sharps disposal container right away after use, even if there is still medicine in the pen. See Step 14 for disposal instructions.

Store the BESREMi Pen carton in the refrigerator between 36°F to 46°F (2°C to 8°C) (Figure B).

Keep the BESREMi Pen in the original carton to protect it from light (Figure B).

Do not freeze the BESREMi Pen.

Keep the BESREMi Pen, needles, and all medicines out of the reach of children.

1.2 Let the carton containing the BESREMi Pen sit on a flat, clean work surface for 15 to 30 minutes to allow it to come to room temperature between 59˚F to 77 ˚F (15 ˚C to 25 ˚C). (Figure D).

Do not warm the BESREMi Pen any other way.

1. 3. Wash hands, check expiration date, and remove BESREMi Pen from carton

3.2 Check the expiration date (EXP) on the carton to make sure it has not passed (Figure I).

Do not use the BESREMi Pen if the expiration date has passed.

4.2 Check the BESREMi Pen to see if it is damaged or broken (Figure L).

Do not use the BESREMi Pen if it shows any signs of damage or breakage.

4.3 Check the liquid medicine in the BESREMi Pen (Figure M). The liquid should appear clear and colorless to slightly yellow in color.

Do not use the BESREMi Pen if the liquid is cloudy, discolored, or contains particles.

5.1 Choose one of the following injection sites (Figure N):

• Lower stomach (abdomen) area, at least 2 inches away from the belly button, or
• Top of thighs.

Rotate (change) the injection site for each injection.

Do not inject into skin that is irritated, red, bruised, infected, or scarred.

Do not inject into a vein. BESREMi Pen is for subcutaneous (under the skin) injection only.

5.2 Clean the chosen injection site with an alcohol swab and let it air dry (Figure O). Throw away the alcohol swab after use.

Do not blow on or touch the cleaned injection site.

7.1 Attach the capped needle by pushing it straight onto the BESREMi Pen until you feel or hear it “snap” into place (Figure R).

Turn or rotate the needle in either direction until it “clicks” into place (Figure S). The needle is attached when it no longer turns or rotates freely.

7.2 Remove the needle cover by pulling it off (Figure T) and throw it away.

Do not recap the needle.

8.1 Turn the dose selector until the flow check drop symbol is centered in the dose window (Figure U).

Do not dial your prescribed dose when doing the flow check. You will be instructed to do so in Step 10.1.

8.2 Hold the BESREMi Pen with the needle pointing up (Figure V).

8.3 Press and hold the injection button all the way in until the dose window returns to “0” (Figure V).

9.2 If you do not see liquid at the tip of the needle, repeat Steps 8.1 to 8.3 again (dial to drop symbol and press injection button) up to 3 more times for a total of 7 cycles.

Important: If you still do not see liquid at the tip of the needle after 7 cycles, get a new BESREMi Pen carton and start over from Step 1.

10.2 Set your dose by turning the dose selector clockwise until the prescribed dose is centered in the dose window (Figure Z).

It is normal to hear a clicking sound as you dial.

Check to make sure the number in the dose window is the correct prescribed dose before giving the injection.

If you accidentally turn the dose selector past the prescribed dose, turn the dose selector back to the correct dose.

12.2 Keep holding the injection button down after the dose window returns to “0” and count to 5 to make sure the full dose is delivered (Figure AD).

Note: There may still be liquid remaining in the pen cartridge after the injection. This is normal.

13.1 Remove the needle from the skin by lifting the pen straight up (Figure AE).

The blue needle shield will cover the needle.

14.1 Put the used BESREMi Pen, with the needle still attached, into a sharps disposal container right away after use (Figure AF).

Important: Do not recap the needle or attempt to remove it.

Do not reuse the BESREMi Pen. Throw it away in a sharps disposal container after use, even if there is still medicine left in the BESREMi Pen.

• If you do not have a sharps disposal container, you may use a household container that is:

  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and
  • properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.
• Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
• Always keep the sharps disposal container out of the reach of children.

14.2 If there is a small amount of blood or liquid at the injection site, press a gauze or cotton ball over the injection site until the bleeding stops (Figure AG).

If needed, you may apply a small adhesive bandage.

Do not rub the injection site.

For additional information about BESREMi Pen and a video demonstration on how to use BESREMi Pen, go to:

www.BESREMi.com

Distributed by:

PharmaEssentia USA Corporation

35 Corporate Drive, Suite 325, Burlington, MA 01803, USA

Manufactured by:

PharmaEssentia Corporation

13F, No. 3, Park St., Nangang Dist., Taipei 115, Taiwan

U.S. License number: 2155

This Instructions for Use has been approved by the U.S. Food and Drug Administration.