Glatiramer Acetate Glatiramer
Refer to the “Also Known As” section to reference different products that include the same medication as Glatiramer Acetate.
Brand Name: Glatiramer Acetate
Generic Name: GLATIRAMER
Drug Type: HUMAN PRESCRIPTION DRUG
Dosage Form: INJECTION, SOLUTION
Packager: Mylan Pharmaceuticals Inc.
Data Current As Of: 2021-05-10
Warnings and Precautions, Hepatic Injury (5.5) 7/2020
Indications & Usage
Glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults (1).
Interactions between glatiramer acetate and other drugs have not been fully evaluated. Results from existing clinical trials do not suggest any significant interactions of glatiramer acetate with therapies commonly used in MS patients, including the concurrent use of corticosteroids for up to 28 days. Glatiramer acetate has not been formally evaluated in combination with interferon beta.
Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Immediate Post-Injection Reaction: Advise patients that glatiramer acetate may cause various symptoms after injection, including flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea, constriction of the throat, and urticaria. These symptoms occur within seconds to minutes after injection and are generally transient and self-limited and do not require specific treatment. Inform patients that these symptoms may occur early or may have their onset several months after the initiation of treatment. A patient may experience one or several episodes of these symptoms.
Chest Pain: Advise patients that they may experience transient chest pain either as part of the Immediate Post-Injection Reaction or in isolation. Inform patients that the pain should be transient. Some patients may experience more than one such episode, usually beginning at least one month after the initiation of treatment. Patients should be advised to seek medical attention if they experience chest pain of unusual duration or intensity.
Lipoatrophy and Skin Necrosis at Injection Site: Advise patients that localized lipoatrophy, and rarely, skin necrosis may occur at injection sites. Instruct patients to follow proper injection technique and to rotate injection areas and sites with each injection to minimize these risks.
Hepatic Injury: Advise patients that hepatic injury, including hepatic failure and hepatitis with jaundice, has been reported with the use of glatiramer acetate injection. Educate patients about the signs and symptoms of hepatic injury and instruct patients to report them immediately to their healthcare provider [see Warnings and Precautions (5.5)].
Lactation: Advise patients to notify their healthcare provider if they are breastfeeding or intend to breastfeed during glatiramer acetate injection therapy [see Use in Specific Populations (8.2)].
Instructions for Use: Instruct patients to read the glatiramer acetate injection Patient Information leaflet carefully. Glatiramer acetate injection 20 mg per mL and glatiramer acetate injection 40 mg per mL are not interchangeable. Glatiramer acetate injection 40 mg per mL is administered three times per week. Caution patients to use aseptic technique. The first injection should be performed under the supervision of a health care professional. Instruct patients to rotate injection areas and sites with each injection. Caution patients against the reuse of needles or syringes. Instruct patients in safe disposal procedures.
Storage Conditions: Advise patients that the recommended storage condition for glatiramer acetate injection is refrigeration at 2˚ to 8˚C (36˚ to 46˚F). If needed, the patient may store glatiramer acetate injection at room temperature, 15˚ to 30˚C (59˚ to 86˚F), for up to one month, but refrigeration is preferred. Glatiramer acetate injection should not be exposed to higher temperatures or intense light. Do not freeze glatiramer acetate injection.
Glatiramer Acetate Injection
(gla tir′ a mer as′ e tate)
for subcutaneous use
Read this Patient Information before you start using glatiramer acetate injection and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
What is glatiramer acetate injection?
Glatiramer acetate injection is a prescription medicine that is used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
It is not known if glatiramer acetate injection is safe and effective in children under 18 years of age.
Who should not use glatiramer acetate injection?
- Do not use glatiramer acetate injection if you are allergic to glatiramer acetate, mannitol or any of the ingredients in glatiramer acetate injection. See the end of this leaflet for a complete list of the ingredients in glatiramer acetate injection.
What should I tell my doctor before using glatiramer acetate injection?
Before you use glatiramer acetate injection, tell your doctor if you:
- are pregnant or plan to become pregnant. It is not known if glatiramer acetate will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if glatiramer acetate passes into your breast milk. Talk to your doctor about the best way to feed your baby while using glatiramer acetate injection.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Glatiramer acetate injection may affect the way other medicines work, and other medicines may affect how glatiramer acetate injection works.
Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist when you get a new medicine.
How should I use glatiramer acetate injection?
- For detailed instructions, see the Instructions for Use at the end of this leaflet for complete information on how to use glatiramer acetate injection.
- Your doctor will tell you how much glatiramer acetate injection to use and when to use it.
- Glatiramer acetate injection is given by injection under your skin (subcutaneously).
- Use glatiramer acetate injection exactly as your doctor tells you to use it.
- Since every body type is different, talk with your doctor about the injection areas that are best for you.
- You should receive your first dose of glatiramer acetate injection with a doctor or nurse present. This might be at your doctor’s office or with a visiting home health nurse who will teach you how to give your glatiramer acetate injections.
What are the possible side effects of glatiramer acetate injection?
Glatiramer acetate injection may cause serious side effects, including:
- Immediate Post-Injection Reactions. Serious side effects may happen right after or within minutes after you inject glatiramer acetate injection at any time during your course of treatment. Call your doctor right away if you have any of these immediate post-injection reaction symptoms including:
- If you have symptoms of an immediate post-injection reaction, do not give yourself more injections until a doctor tells you to.
- Chest Pain. You can have chest pain as part of an immediate post-injection reaction or by itself. This type of chest pain usually lasts a few minutes and can begin around 1 month after you start using glatiramer acetate injection. Call your doctor right away if you have chest pain while using glatiramer acetate injection.
- Damage to your skin. Damage to the fatty tissue just under your skin’s surface (lipoatrophy) and, rarely, death of your skin tissue (necrosis) can happen when you use glatiramer acetate injection. Damage to the fatty tissue under your skin can cause a “dent” at the injection site that may not go away. You can reduce your chance of developing these problems by:
- ofollowing your doctor’s instructions for how to use glatiramer acetate injection
- ochoosing a different injection area each time you use glatiramer acetate injection. See Step 4 in the Instructions for Use, “Choose your injection area”.
- Liver problems. Liver problems, including liver failure, can occur with glatiramer acetate injection. Call your healthcare provider right away if you have symptoms, such as:
- oloss of appetite
- odark colored urine and pale stools
- oyellowing of your skin or the white part of your eye
- obleeding more easily than normal
The most common side effects of glatiramer acetate injection include:
- skin problems at your injection site including:
- shortness of breath
- flushing (vasodilation)
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of glatiramer acetate injection. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store glatiramer acetate injection?
- Store glatiramer acetate injection in the refrigerator between 2° to 8°C (36° to 46°F).
- When you are not able to refrigerate glatiramer acetate injection, you may store it for up to 1 month at room temperature between 15° to 30°C (59° to 86°F).
- Protect glatiramer acetate injection from light or high temperature.
- Do not freeze glatiramer acetate syringes. If a syringe freezes, throw it away in a sharps disposal container. See Step 13 in the Instructions for Use, “Dispose of your needles and syringes”.
Keep glatiramer acetate injection and all medicines out of the reach of children.
General information about the safe and effective use of glatiramer acetate injection.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use glatiramer acetate injection for a condition for which it was not prescribed. Do not give glatiramer acetate injection to other people, even if they have the same symptoms as you have. It may harm them.
This Patient Information Leaflet summarizes the most important information about glatiramer acetate injection. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about glatiramer acetate injection that is written for health professionals.
For more information, go to www.glatirameracetate.com or call 1-844-695-2667.
What are the ingredients in glatiramer acetate injection?
Active ingredient: glatiramer acetate
Inactive ingredients: mannitol
Instructions for Use
Glatiramer Acetate Injection
(gla tir′ a mer as′ e tate)
for subcutaneous use
For subcutaneous injection only.
Do not inject glatiramer acetate injection in your veins (intravenously).
Do not re-use your glatiramer acetate prefilled syringes.
Do not share your glatiramer acetate prefilled syringes with another person. You may give another person an infection or get an infection from them.
You should receive your first dose of glatiramer acetate injection with a doctor or nurse present. This might be at your doctor’s office or with a visiting home health nurse who will show you how to give your own injections.
Glatiramer acetate injection comes in a 40 mg prefilled syringe with needle attached. How often a dose is given depends on the product strength that is prescribed. Your doctor will prescribe the correct dose for you.
Instructions for using your glatiramer acetate 40 mg prefilled syringe:
- Glatiramer acetate injection 40 mg is injected 3 times each week in the fatty layer under your skin (subcutaneously).
- Glatiramer acetate injection 40 mg should be given on the same 3 days each week, if possible for example, Monday, Wednesday, and Friday. Give your glatiramer acetate injections at least 48 hours (2 days) apart.
- Each glatiramer acetate 40 mg prefilled syringe is for single use (1 time use) only.
- The glatiramer acetate injection 40 mg dose is packaged in boxes of 12 prefilled syringes with needles attached. Glatiramer acetate 40 mg prefilled syringes have light blue plungers.
How do I inject glatiramer acetate injection?
Step 1: Gather the supplies you will need to inject glatiramer acetate injection. See Figure A.
- 1 blister pack with a glatiramer acetate prefilled syringe with needle attached
- Alcohol wipe (not supplied)
- Dry cotton ball (not supplied)
- A place to record your injections, like a notebook (not supplied)
- Sharps disposal container (not supplied). See Step 13 below, “Dispose of your needles and syringes”.
Step 2: Remove only 1 blister pack from the glatiramer acetate prefilled syringe carton. See Figure B.
- Place the supplies you will need on a clean, flat surface in a well-lit area.
- After you remove 1 blister pack from the carton, keep all unused syringes in the carton and store them in the refrigerator.
- Let the blister pack, with the syringe inside, warm to room temperature for about 20 minutes.
- Wash your hands. Be careful not to touch your face or hair after washing your hands.
Step 3: Look closely at your glatiramer acetate prefilled syringe.
- There may be small air bubbles in the syringe. Do not try to push the air bubble from the syringe before giving your injection so you do not lose any medicine.
- Check the liquid medicine in the syringe before you give your injection. The liquid in the syringe should look clear, and colorless, and may look slightly yellow. If the liquid is cloudy or contains any particles, do not use the syringe and throw it away in a sharps disposal container. See Step 13 below, “Dispose of your needles and syringes.”
Step 4: Choose your injection area. See Figure C.
See the injection areas you should use on your body. Talk with your doctor about the injection areas that are best for you.
- The possible injection areas on your body include (See Figure C):
- oyour stomach area (abdomen) around the belly button
- othe back of your upper arms
- oupper hips (below your waist)
- oyour thighs (above your knees)
- For each glatiramer acetate injection dose, choose a different injection area from 1 of the areas shown above. See Figure C.
- Do not stick the needle in the same place (site) more than 1 time each week. Each injection area contains multiple injection sites for you to choose from. Avoid injecting in the same site over and over again.
- Keep a record of the sites where you give your injection each day so you will remember where you already injected.
Step 5: Prepare to give your injection.
- There are some injection areas on your body that are hard to reach (like the back of your arm). You may need help from someone who has been instructed on how to give your injection if you cannot reach certain injection areas.
- Do not inject in sites where the skin has scarring or “dents”. Using scarred or dented skin for your injections may make your skin worse.
Step 6: Clean your injection site.
- Clean the injection site using the alcohol wipe and allow your skin to air dry. See Figure D.
Step 7: Pick up the syringe with 1 hand and hold it like a pencil. Remove the needle cover with your other hand and set it aside. See Figure E.
Step 8: Pinch about a 2 inch fold of skin between your thumb and index finger. See Figure F.
Step 9: Giving your injection.
- Rest the heel of your hand holding the syringe against your skin at the injection site. Insert the needle at a 90 degree angle straight into your skin. See Figure G.
- When the needle is all the way into your skin, release the fold of skin. See Figure H.
Step 10: Give your glatiramer acetate injection.
To inject the medicine, hold the syringe steady and slowly push down the plunger. See Figure I.
Step 11: Remove the needle.
After you have injected all of the medicine, pull the needle straight out. See Figure J.
Step 12: Use a clean, dry cotton ball to gently press on the injection site for a few seconds. Do not rub the injection site or re-use the needle or syringe. See Figure K.
Step 13: Dispose of your needles and syringes.
- Put your used needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.
- If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- omade of a heavy-duty plastic,
- ocan be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- oupright and stable during use,
- oleak-resistant, and
- oproperly 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.
This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.