Cabenuva: Package Insert and Label Information (Page 7 of 7)

What is CABENUVA?

CABENUVA is a prescription medicine that is used without other human immunodeficiency virus-1 (HIV-1) medicines to treat HIV-1 infection in people 12 years of age and older who weigh at least 77 pounds (35 kg) to replace their current HIV-1 medicines when their healthcare provider determines that they meet certain requirements.

HIV-1 is the virus that causes acquired immune deficiency syndrome (AIDS).

CABENUVA contains 2 different medicines:

•

cabotegravir

•

rilpivirine

It is not known if CABENUVA is safe and effective in children younger than 12 years of age or weighing less than 77 pounds (35 kg).

Before you receive CABENUVA, tell your healthcare provider about all your medical conditions, including if you:

•

have ever had a skin rash or an allergic reaction to medicines that contain cabotegravir or rilpivirine.

•

have or have had liver problems, including hepatitis B or C infection.

•

have ever had mental health problems.

•

are pregnant or plan to become pregnant. It is not known if CABENUVA will harm your unborn baby. CABENUVA can remain in your body for up to 12 months or longer after the last injection.

Pregnancy Registry. There is a pregnancy registry for women who take CABENUVA during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

•

are breastfeeding or plan to breastfeed. Do not breastfeed if you take CABENUVA.

o

You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.

o

It is not known if CABENUVA can pass to your baby in your breast milk. Talk with your healthcare provider about the best way to feed your baby during treatment with CABENUVA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some medicines interact with CABENUVA. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

You can ask your healthcare provider or pharmacist for a list of medicines that interact with CABENUVA.

Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take CABENUVA with other medicines.

How will I receive CABENUVA?

•

Your healthcare provider will inject CABENUVA into the muscle of each side of your buttocks or on the same side of your buttocks at least 2 cm apart.

•

You will receive CABENUVA as 2 injections (cabotegravir and rilpivirine), either one time every month or one time every 2 months.

•

Before receiving your first injection doses of CABENUVA, your healthcare provider may have you take 1 VOCABRIA (cabotegravir) tablet and 1 EDURANT (rilpivirine) tablet 1 time a day for 1 month (at least 28 days). This will allow your healthcare provider to assess how well you tolerate these medicines.

•

CABENUVA is a long-acting medicine and may stay in your system for 12 months or longer after your last injection.

•

Stay under the care of a healthcare provider during treatment with CABENUVA. It is important that you attend your planned appointments to receive your injection doses of CABENUVA.

•

If you miss or plan to miss a scheduled monthly or every-2-month injection of CABENUVA by more than 7 days, call your healthcare provider right away to discuss your treatment options.

•

If you stop treatment with CABENUVA you will need to take other medicines to treat your HIV-1 infection and reduce the risk of developing viral resistance. Call your healthcare provider right away to discuss your treatment options.

These are not all the possible side effects of CABENUVA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.

General information about the safe and effective use of CABENUVA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for information about CABENUVA that is written for health professionals.

What are the ingredients in CABENUVA?

Cabotegravir extended-release injectable suspension:

Active ingredient: cabotegravir

Inactive ingredients: mannitol, polyethylene glycol (PEG) 3350, polysorbate 20, and Water for Injection.

Rilpivirine extended-release injectable suspension:

Active ingredient: rilpivirine

Inactive ingredients: citric acid monohydrate, poloxamer 338, Water for Injection, glucose monohydrate to ensure isotonicity, sodium dihydrogen phosphate monohydrate, and sodium hydroxide to adjust pH.

Overview:

A complete dose of CABENUVA requires two injections: 400 mg (2 mL) of cabotegravir and 600 mg (2 mL) of rilpivirine.

Cabotegravir and rilpivirine are suspensions that do not need further dilution or reconstitution.

The preparation steps for both medicines are the same.

Cabotegravir and rilpivirine are for gluteal intramuscular use only. Each injection must be administered to separate gluteal intramuscular sites (on opposite sides or at least 2 cm apart). The administration order is not important.

Note: The ventrogluteal site is recommended.

Storage information

Store in refrigerator at 2°C to 8°C (36°F to 46°F).

Do not freeze.

Prior to administration:

•

Before preparing the injections, the vials may sit in the carton at room temperature (maximum temperature of 25°C [77°F]) for up to 6 hours; do not put back into the refrigerator. If not used within 6 hours, the medicines must be discarded.

•

Once the medicines have been drawn into the syringes, they can remain in the syringes for up to 2 hours before injection. The filled syringes should not be placed in the refrigerator. If the medicines remain in the syringes for more than 2 hours, the filled syringes and needles must be discarded.

•

It is recommended to label each syringe with the time that the medicine has been drawn into the syringe if the medicine is not administered immediately.

Your pack contains:

•

1 vial of Cabotegravir

•

1 vial of Rilpivirine

•

2 vial adapters

•

2 syringes

•

2 syringe labels

•

2 injection needles (23 gauge, 1½ inch)

Consider the patient’s build and use medical judgment to select an appropriate injection needle length.

You will also need:

•

Non-sterile gloves

•

4 alcohol wipes

•

4 gauze pads

•

A suitable sharps container

Preparation:

1. Inspect both vials.

(click image for full-size original)

Figure A

•

Check that the expiration date has not passed. See Figure A.

•

Inspect the vials immediately. If you can see foreign matter, do not use the product.

Note: The Cabotegravir vial has a brown tint to the glass.

Do not use if the expiration date has passed.

2. Wait 15 minutes.

(click image for full-size original)

Figure B

•

Wait at least 15 minutes before you are ready to give the injection to allow the medicine to come to room temperature. See Figure B.

3. Shake the vial vigorously.

Figure C

•

Hold the vial firmly, and vigorously shake for a full 10 seconds. See Figure C.

•

Invert the vial and confirm the suspension is uniform. It should look uniform.

•

If the suspension is not uniform, shake the vial again.

•

It is also normal to see small air bubbles.

4. Remove the vial cap.

(click image for full-size original)

Figure D

5. Peel open the vial adapter.

(click image for full-size original)

Figure E

•

Peel off the paper backing from the vial adapter packaging. See Figure E.

Note: Keep the adapter in place in its packaging for the next step.

6. Attach the vial adapter.

(click image for full-size original)

Figure F

•

Press the vial adapter straight down onto the vial using the packaging, as shown.The vial adapter should snap securely into place.

•

When you are ready, lift off the vial adapter packaging as shown. See Figure F.

7. Prepare the syringe.

(click image for full-size original)

Figure G

•

Remove the syringe from its packaging.

•

Draw 1 mL of air into the syringe. This will make it easier to draw up the medicine later. See Figure G.

8. Attach the syringe.

(click image for full-size original)

Figure H

•

Hold the vial adapter and vial firmly, as shown.

•

Screw the syringe firmly onto the vial adapter.

•

Press the plunger all the way down to push the air into the vial. See Figure H.

9. Slowly draw up the dose.

(click image for full-size original)

Figure I

•

Invert the syringe and vial and slowly withdraw as much of the medicine as possible into the syringe. There may be more medicine than the dose amount. See Figure I.

10. Unscrew the syringe.

(click image for full-size original)

Figure J

•

Unscrew the syringe from the vial adapter, holding the vial adapter as shown. See Figure J.

Note: Keep the syringe upright to avoid leakage. Check that the suspension looks uniform and milky white.

11. Attach the needle and affix syringe label.

(click image for full-size original)

Figure K

•

Peel open the needle packaging part way to expose the needle base.

•

Keeping the syringe upright, firmly twist the syringe onto the needle.

•

Remove the needle packaging from the needle. See Figure K.

•

Write the name of the medicine on the syringe label. Affix the label to the syringe making sure the gradations remain visible.

Injection:

12. Prepare the injection site.

(click image for full-size original)

Figure L

Injections must be administered to a gluteal site. See Figure L.

Select from the following areas for the injection:

•

Ventrogluteal, as shown (recommended)

•

Dorsogluteal, not shown (upper outer quadrant)

Note: For gluteal intramuscular use only.Do not inject intravenously.

13. Remove the cap.

(click image for full-size original)

Figure M

•

Fold the needle guard away from the needle. See Figure M.

•

Pull off the injection needle cap.

14. Remove extra liquid from the syringe.

Figure N

•

Hold the syringe with the needle pointing up. Press the plunger to the 2-mL dosing mark to remove extra liquid and any air bubbles. See Figure N.

Note: Clean the injection site with an alcohol wipe. Allow the skin to air dry before continuing.

15. Stretch the skin.

Figure O

Use the z-track injection technique to minimize medicine leakage from the injection site.

•

Firmly drag the skin covering the injection site, displacing it by about an inch (2.5 cm). See Figure O.

•

Keep it held in this position for the injection.

16. Insert the needle.

(click image for full-size original)

Figure P

•

Insert the needle to its full depth, or deep enough to reach the muscle. See Figure P.

17. Inject the dose of medicine.

(click image for full-size original)

Figure Q

•

Still holding the skin stretched – slowly press the plunger all the way down. See Figure Q.

•

Ensure the syringe is empty.

•

Withdraw the needle and release the stretched skin immediately.

18. Assess the injection site.

(click image for full-size original)

Figure R

•

Apply pressure to the injection site using a gauze pad. See Figure R.

•

A small bandage may be used if bleeding occurs.

Do not massage the area.

19. Make the needle safe.

Figure S

•

Fold the needle guard over the needle.

•

Gently apply pressure using a hard surface to lock the needle guard in place.

•

The needle guard will make a click when it locks. See Figure S.

After injection:

20. Dispose safely.

(click image for full-size original)

Figure T

•

Dispose of used needles, syringes, vials, and vial adapters according to local health and safety laws. See Figure T.

Repeat for 2nd medicine.

•

If you have not yet injected both medicines, use the same steps for preparation and injection of the other medicine.

•

The second medicine must be injected into a separate gluteal intramuscular site (on opposite sides or at least 2 cm apart).

Questions and Answers

1. How long can the medicines be left out of the refrigerator?

It is best to inject the medicines as soon as they reach room temperature. However, the vials may sit in the carton at room temperature (maximum temperature of 25°C [77°F]) for up to 6 hours; do not put back into the refrigerator. If not used within 6 hours, the medicines must be discarded.

2. How long can the medicines be left in the syringes?

It is best to inject the (room temperature) medicines as soon as possible after drawing them up. However, the medicines can remain in the syringes for up to 2 hours before injection. The filled syringes should not be placed in the refrigerator.

If the medicines remain in the syringes for more than 2 hours, the filled syringes and needles must be discarded.

3. Why do I need to inject air into the vials?

Injecting 1 mL of air into the vials makes it easier to draw up the medicines into the syringes. Without the air, some liquid may flow back into the vials unintentionally, leaving less medicine than intended in the syringes.

4. Does the order in which I give the medicines matter?

No, the order is unimportant.

5. Is it safe to warm the vials up to room temperature more quickly?

It is best to let the vials come to room temperature naturally. However, you can use the warmth of your hands to speed up the warm-up time, but make sure the vials do not get above 25°C (77°F).

Do not use any other heating methods.

Overview:

A complete dose of CABENUVA requires two injections: 600 mg (3 mL) of cabotegravir and 900 mg (3 mL) of rilpivirine.

Cabotegravir and rilpivirine are suspensions that do not need further dilution or reconstitution.

The preparation steps for both medicines are the same.

Cabotegravir and rilpivirine are for gluteal intramuscular use only. Each injection must be administered to separate gluteal intramuscular sites (on opposite sides or at least 2 cm apart). The administration order is not important.

Note: The ventrogluteal site is recommended.

Storage information

Store in refrigerator at 2°C to 8°C (36°F to 46°F).

Do not freeze.

Prior to administration:

•

Before preparing the injections, the vials may sit in the carton at room temperature (maximum temperature of 25°C [77°F]) for up to 6 hours; do not put back into the refrigerator. If not used within 6 hours, the medicines must be discarded.

•

Once the medicines have been drawn into the syringes, they can remain in the syringes for up to 2 hours before injection. The filled syringes should not be placed in the refrigerator. If the medicines remain in the syringes for more than 2 hours, the filled syringes and needles must be discarded.

•

It is recommended to label the syringe with each time that the medicine has been drawn into the syringe if the medicine is not administered immediately.

Your pack contains:

•

1 vial of Cabotegravir

•

1 vial of Rilpivirine

•

2 vial adapters

•

2 syringes

•

2 syringe labels

•

2 injection needles (23 gauge, 1½ inch)

Consider the patient’s build and use medical judgment to select an appropriate injection needle length.

You will also need:

•

Non-sterile gloves

•

4 alcohol wipes

•

4 gauze pads

•

A suitable sharps container

Preparation:

1. Inspect both vials.

(click image for full-size original)

Figure A

•

Check that the expiration date has not passed. See Figure A.

•

Inspect the vials immediately. If you can see foreign matter, do not use the product.

Note: The Cabotegravir vial has a brown tint to the glass.

Do not use if the expiration date has passed.

2. Wait 15 minutes.

(click image for full-size original)

Figure B

•

Wait at least 15 minutes before you are ready to give the injection to allow the medicine to come to room temperature. See Figure B.

3. Shake the vial vigorously.

Figure C

•

Hold the vial firmly, and vigorously shake for a full 10 seconds. See Figure C.

•

Invert the vial and confirm the suspension is uniform. It should look uniform.

•

If the suspension is not uniform, shake the vial again.

•

It is also normal to see small air bubbles.

4. Remove the vial cap.

(click image for full-size original)

Figure D

•

Remove the cap from the vial. See Figure D.

•

Wipe the rubber stopper with an alcohol wipe.

Do not allow anything to touch the rubber stopper after wiping it.

5. Peel open the vial adapter.

(click image for full-size original)

Figure E

•

Peel off the paper backing from the vial adapter packaging. See Figure E.

Note: Keep the adapter in place in its packaging for the next step.

6. Attach the vial adapter.

(click image for full-size original)

Figure F

•

Press the vial adapter straight down onto the vial using the packaging, as shown.The vial adapter should snap securely into place.

•

When you are ready, lift off the vial adapter packaging as shown. See Figure F.

7. Prepare the syringe.

(click image for full-size original)

Figure G

•

Remove the syringe from its packaging.

•

Draw 1 mL of air into the syringe. This will make it easier to draw up the medicine later. See Figure G.

8. Attach the syringe.

(click image for full-size original)

Figure H

•

Hold the vial adapter and vial firmly, as shown.

•

Screw the syringe firmly onto the vial adapter.

•

Press the plunger all the way down to push the air into the vial. See Figure H.

9. Slowly draw up the dose.

•

Invert the syringe and vial and slowly withdraw as much of the medicine as possible into the syringe. There may be more medicine than the dose amount. See Figure I.

10. Unscrew the syringe.

(click image for full-size original)

Figure J

•

Unscrew the syringe from the vial adapter, holding the vial adapter as shown. See Figure J.

Note: Keep the syringe upright to avoid leakage. Check that the suspension looks uniform and milky white.

11. Attach the needle and affix syringe label.

•

Peel open the needle packaging part way to expose the needle base.

•

Keeping the syringe upright, firmly twist the syringe onto the needle.

•

Remove the needle packaging from the needle. See Figure K.

•

Write the name of the medicine on the syringe label. Affix the label to the syringe making sure the gradations remain visible.

Injection:

12. Prepare the injection site.

(click image for full-size original)

Figure L

Injections must be administered to a gluteal site. See Figure L.

Select from the following areas for the injection:

•

Ventrogluteal, as shown (recommended)

•

Dorsogluteal, not shown (upper outer quadrant)

Note: For gluteal intramuscular use only.Do not inject intravenously.

13. Remove the cap.

(click image for full-size original)

Figure M

•

Fold the needle guard away from the needle. See Figure M.

•

Pull off the injection needle cap.

14. Remove extra liquid from the syringe.

(click image for full-size original)

Figure N

•

Hold the syringe with the needle pointing up. Press the plunger to the 3-mL dosing mark to remove extra liquid and any air bubbles. See Figure N.

Note: Clean the injection site with an alcohol wipe. Allow the skin to air dry before continuing.

15. Stretch the skin.

Figure O

Use the z-track injection technique to minimize medicine leakage from the injection site.

•

Firmly drag the skin covering the injection site, displacing it by about an inch (2.5 cm). See Figure O.

•

Keep it held in this position for the injection.

16. Insert the needle.

(click image for full-size original)

Figure P

•

Insert the needle to its full depth, or deep enough to reach the muscle. See Figure P.

17. Inject the dose of medicine.

(click image for full-size original)

Figure Q

•

Still holding the skin stretched – slowly press the plunger all the way down. See Figure Q.

•

Ensure the syringe is empty.

•

Withdraw the needle and release the stretched skin immediately.

18. Assess the injection site.

(click image for full-size original)

Figure R

•

Apply pressure to the injection site using a gauze pad. See Figure R.

•

A small bandage may be used if bleeding occurs.

Do not massage the area.

19. Make the needle safe.

Figure S

•

Fold the needle guard over the needle.

•

Gently apply pressure using a hard surface to lock the needle guard in place.

•

The needle guard will make a click when it locks. See Figure S.

After injection:

20. Dispose safely.

(click image for full-size original)

Figure T

•

Dispose of used needles, syringes, vials, and vial adapters according to local health and safety laws. See Figure T.

Repeat for 2nd medicine.

•

If you have not yet injected both medicines, use the same steps for preparation and injection of the other medicine.

•

The second medicine must be injected into a separate gluteal intramuscular site (on opposite sides or at least 2 cm apart).

Questions and Answers

1. How long can the medicines be left out of the refrigerator?

It is best to inject the medicines as soon as they reach room temperature. However, the vials may sit in the carton at room temperature (maximum temperature of 25°C [77°F]) for up to 6 hours; do not put back into the refrigerator. If not used within 6 hours, the medicines must be discarded.

2. How long can the medicines be left in the syringes?

It is best to inject the (room temperature) medicines as soon as possible after drawing them up. However, the medicines can remain in the syringes for up to 2 hours before injection. The filled syringes should not be placed in the refrigerator.

If the medicines remain in the syringes for more than 2 hours, the filled syringes and needles must be discarded.

3. Why do I need to inject air into the vials?

Injecting 1 mL of air into the vials makes it easier to draw up the medicines into the syringes. Without the air, some liquid may flow back into the vials unintentionally, leaving less medicine than intended in the syringes.

4. Does the order in which I give the medicines matter?

No, the order is unimportant.

5. Is it safe to warm the vials up to room temperature more quickly?

It is best to let the vials come to room temperature naturally. However, you can use the warmth of your hands to speed up the warm-up time, but make sure the vials do not get above 25°C (77°F).

Do not use any other heating methods.

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

©2023 ViiV Healthcare group of companies or its licensor.

CBN:5IFU3