Glatopa

Glatopa is a prescription medication used to treat relapsing-forms of multiple sclerosis. Glatopa belongs to a group of drugs called immunomodulators. These work to treat relapsing form multiple sclerosis through a mechanism which is currently not yet fully understood.

This medication is available in an injectable form to be given directly under the skin (subcutaneously), typically once per day.

Common side effects of Glatopa include temporary pain and/or redness at the injection site, a temporary skin rash, and nausea.

Glatopa is a prescription medication used to treat relapsing-forms of multiple sclerosis.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Glatopa may be found in some form under the following brand names:

• Copaxone

Serious side effects have been reported with Glatopa. See the “Glatopa Precautions” section.

Common side effects of Glatopa include the following:

• injection site reactions such as redness, pain, swelling, itching, and lumps
• rash
• shortness of breath
• flushing
• chest pain
• nausea
• anxiety

This is not a complete list of Glatopa side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been fully evaluated] by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Glatopa including the following: 

• Post-injection reactions. Post-injection reactions consisting of chest pain, heart palpitations, anxiety, difficulty breathing, and/or skin itching have been reported in patients using Glatopa. In general, these reactions typically have their onset several months after the initiation of treatment. If you experience such reactions, discontinue use and seek emergency medical attention immediately.
• Death of skin and/or fat cells at/around the injection site. Although rare, localized death of skin and/or fat cells at/around the injection site has occurred in patients using Glatopa. To reduce your risk for experiencing these events, be sure to exactly follow your physician's instructions on proper injection technique and rotate injection sites with each injection.
• Reduced immune system function. Due to the mechanism of action of Glatopa, there exists the potential for altered and/or reduced immune function. Consult with your physician about your risk for developing reduced immune system function before beginning treatment with Glatopa.

Do not take Glatopa if you are allergic to Glatopa or to any of its ingredients, glatiramer, or mannitol

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Glatopa, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Glatopa, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Glatopa or to any of its ingredients, glatiramer, or mannitol
• have any immunosuppressing conditions
• have any skin conditions
• have ever experienced a reaction after injecting a medication or having a medication injected
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Glatopa falls into category B. There are no well-done studies that have been done in humans with Glatopa. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication. Glatopa should only be used during pregnancy only if clearly needed. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Glatopa crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Glatopa.

Use Glatopa exactly as prescribed

• Glatopa is available in an injectable form to be given directly under the skin (subcutaneously), typically once per day.
• You should receive your first dose of Glatopa 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.
• Always exactly follow your physician's instructions on injection of Glatopa; for additional information on proper administration, you may refer to the following section.
• Do not inject Glatopa in your veins (intravenously).
• Do not re-use your Glatopa prefilled syringes.
• Do not share your Glatopa prefilled syringes with another person. You may give another person an infection or get an infection from them

Preparation

Gather the following supplies:

• 1 blister pack with a Glatopa prefilled syringe with needle attached
• Alcohol wipe 
• Dry cotton ball 
• A place to record your injections, like a notebook 
• Sharps disposal container 

1. Remove only 1 blister pack from the Glatopa prefilled syringe carton
2. 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
3. Let the blister pack, with the syringe inside, warm to room temperature for about 20 minutes
4. Wash your hands; be careful not to touch your face or hair after washing your hands
5. Look closely at your Glatopa 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
6. 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

Choosing your injection area

Talk with your doctor about the injection areas that are best for you

The possible injection areas on your body include:

• your stomach area (abdomen) around the belly button (avoid about 2 inches around the belly button)
• fleshy areas of the upper hips, always below the waist
• fleshy areas of the upper back portion of the arms
• arms; fleshy areas of the upper back portion
• thighs; about 2 inches above the knee and 2 inches below the groin

• For each Glatopa dose, choose a different injection area from 1 of the areas shown above
• 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

Injecting Glatopa

Prepare to give your injection; there are some injection areas on your body that are hard to reach (like the back of your arm), and 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 Glatopa where the skin has scarring or “dents”; using scarred or dented skin for your injections may make your skin worse

1. Clean the injection site using the alcohol wipe and allow your skin to air dry
2. Pick up the syringe with 1 hand and hold it like a pencil 
3. Remove the needle cover with your other hand and set it aside
4. Pinch about a 2 inch fold of skin between your thumb and index finger
5. Rest the heel of your hand holding the syringe against your skin at the injection site
6. Insert the needle at a 90 degree angle straight into your skin; when the needle is all the way into your skin, release the fold of skin
7. To inject the medicine, hold the syringe steady and slowly push down the plunger
8. After you have injected all of the medicine, pull the needle straight out
9. 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

Disposal of Glatopa

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:

• 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
• 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 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

The recommended dose of Glatopa for the treatment of relapsing-forms of multiple sclerosis is 20 mg injected subcutaneously, typically once per day.

If you take too much Glatopa, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Glatopa refrigerated at 2°C to 8°C (36°F to 46°F)
• Avoid exposure to higher temperatures or intense light
• Do not freeze Glatopa
• If a Glatopa syringe freezes, it should be discarded
• Keep this and all medicines out of the reach of children