Patient information: uses, side effects, how to take - Leuprolide and Isopropyl Alcohol

WHAT IS LEUPROLIDE ACETATE INJECTION?

Leuprolide acetate injection is chemically similar to gonadotropin releasing hormone (GnRH or LH-RH) a hormone which occurs naturally in your body.

Normally, your body releases small amounts of LH-RH and this leads to events which stimulate the production of sex hormones.

However, when you inject leuprolide acetate injection, the normal events that lead to sex hormone production are interrupted and testosterone is no longer produced by the testes.

Leuprolide acetate injection must be injected because, like insulin which is injected by diabetics, leuprolide acetate is inactive when taken by mouth.

If you were to discontinue the drug for any reason, your body would begin making testosterone again.

DIRECTIONS FOR USING LEUPROLIDE ACETATE INJECTION

1. Wash hands thoroughly with soap and water.
2. When using a new vial of leuprolide acetate injection, flip off the plastic cover to expose the grey rubber stopper. Wipe metal ring and rubber stopper with an alcohol wipe each time you use leuprolide acetate injection. Check the liquid in the vial for particulate matter and discoloration prior to use. DO NOT USE if the liquid is not clear or has particles and replace with a new vial.
3. Remove needle cap and inject the needle in the center of the rubber stopper on the leuprolide acetate injection vial.
4. Take cover off needle. Push the needle through the center of the rubber stopper on the leuprolide acetate injection vial.
5. Push the plunger all the way in to inject air into the vial.
6. Keep the needle in the vial and turn the vial upside down. Check to make sure the tip of the needle is in the liquid. Slowly pull back on the plunger, until the syringe fills to the 0.2 mL or 20 unit mark.
7. Toward the end of a two-week period, the amount of leuprolide acetate injection left in the vial will be small. Take special care to hold the vial straight and to keep the needle tip in liquid while pulling back on the plunger.
8. Keeping the needle in the vial and the vial upside down, check for air bubbles in the syringe. If you see any, push the plunger slowly in to push the air bubble back into the vial. Keep the tip of the needle in the liquid and pull the plunger back again to fill to the 0.2 mL or 20 unit mark.
9. Do this again if necessary to eliminate air bubbles.
10. To protect your skin, inject each daily dose at a different injection site.
11. Choose an injection site. Cleanse the injection site with another alcohol wipe.
12. Hold the syringe in one hand. Hold the skin taut, or pull up a little flesh with the other hand, as you were instructed.
13. Holding the syringe as you would a pencil, inject the needle all the way into the skin at a 90° angle. Push the plunger to administer the injection.
14. Hold an alcohol wipe down on your skin where the needle is inserted and withdraw the needle at the same angle it was inserted.
15. Use the disposable syringe only once and dispose of it properly as you were instructed. Needles thrown into a garbage bag could accidentally stick someone. NEVER LEAVE SYRINGES, NEEDLES OR DRUGS WHERE CHILDREN CAN REACH THEM.

SOME SPECIAL ADVICE

You may experience hot flashes when using leuprolide acetate injection. During the first few weeks of treatment you may experience increased bone pain, increased difficulty in urinating, and less commonly but most importantly, you may experience the onset or aggravation of nerve symptoms. In any of these events, discuss the symptoms with your doctor. Like other treatment options, leuprolide acetate injection may cause impotence. Notify your doctor if you develop new or worsened symptoms after beginning leuprolide acetate injection treatment.
You may experience some irritation at the injection site, such as burning, itching or swelling. These reactions are usually mild and go away. If they do not, tell your doctor.
If you have experienced an allergic reaction to other drugs like leuprolide acetate injection, you should not use this drug.
Do not stop taking your injections because you feel better. You need an injection every day to make sure leuprolide acetate injection keeps working for you.
If you need to use an alternate to the syringe supplied with leuprolide acetate injection, low-dose insulin syringes should be utilized.
When the drug level gets low, take special care to hold the vial straight up and down and to keep the needle tip in liquid while pulling back on the plunger.
Do not try to get every last drop out of the vial. This will increase the possibility of drawing air into the syringe and getting an incomplete dose. Some extra drug has been provided so that you can withdraw the recommended number of doses.
Tell your pharmacist when you will need leuprolide acetate injection so it will be at the pharmacy when you need it.
Store below 77°F (25°C). Do not store near a radiator or other very warm place. Do not freeze. Protect from light; store vial in carton until use.
Do not leave your drug or hypodermic syringes where anyone can pick them up.
Keep this and all other medications out of reach of children.

meitheal®

Mfd. for Meitheal Pharmaceuticals

Chicago, IL 60631 (USA)

Mfd. by Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.

Nanjing, China 210061

April 2026

8S6AAMK-03

INSTRUCTIONS FOR USE

Leuprolide Acetate (loo' proe lide as' e tate) Injection

Read the Instructions for Use before you start using leuprolide acetate injection and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. Your doctor should show you how to draw up leuprolide acetate injection and give the injection the right way before you inject the first time.

Do not share your syringes with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

Supplies you will need for the leuprolide acetate injection:

1 vial of leuprolide acetate injection
a sterile 0.5 ml syringe (See Figure A) with an attached 28 gauge, ½ inch sterile needle
1 cotton gauze (not supplied in the kit)
2 alcohol swabs
1 puncture resistant sharps container (See “Disposal of used syringes, needles, and vials”)

Figure A

Preparing the L euprolide Acetate Injection

Step 1.

Wash hands thoroughly (See Figure B) and dry them with a clean towel.

Figure B

Step 2.

Check the liquid in the vial. It should look clear. Do not use if it is not clear or if it has particles in it.
If using a new vial, flip off the plastic cover to expose the grey rubber stopper.
Use an alcohol swab to clean the metal ring and the grey rubber stopper on the medicine vial every day, just before you use it (See Figure C).

Figure C

Step 3.

Remove outer wrapping from 1 syringe (See Figure D).

Figure D

Step 4.

Pull the syringe plunger back until the tip is at the proper mark for the prescribed dose (See Figure E).

Figure E

Step 5.

Uncover needle by pulling the cap straight off (See Figure F). Do not touch the needle.

Figure F

Step 6.

Place the vial on a clean flat surface.
Inject the needle through the center of the rubber stopper on the vial (See Figure G).
Push the plunger all the way in to inject air into the vial.

Figure G

Step 7.

Keep the needle in the vial.
Lift the vial and turn it straight upside down.
Check to see that the needle tip is in the liquid (See Figure H).

Figure H

Step 8.

With the needle tip still in the liquid, slowly pull back the plunger until syringe fills to the proper mark (See Figure I).
If any bubbles appear in the syringe, remove them by pushing the plunger up slowly.

Figure I

Giving Leuprolide Acetate Injection

Step 9.

Choose a different injection site each day.
Clean the injection site with a new alcohol swab.
Hold the skin fold between your thumb and your index finger or as you were instructed by your doctor.
Inject the needle straight into the skin quickly, as shown by your doctor in a 90° angle (See Figure J).
Push the plunger to inject the medicine.

Figure J

Step 10.

Remove the needle at the same angle it was inserted (90°) (See Figure K).
Wipe the skin with a cotton gauze.

Figure K

Disposal of used needles, syringes, and vials

Step 11.

Put the used needles, syringes, and vials in a FDA-cleared sharps disposal container right away after use (See Figure L). Do not throw away (dispose of) loose needles, syringes, or vials in your 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, syringes, and vials. 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.

Figure L

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