Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Copaxone
  2. Glatopa

Descriptions


Glatiramer injection is used to treat relapsing-forms of multiple sclerosis (MS). This medicine will not cure multiple sclerosis, but may extend the time between relapses.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of glatiramer injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies on the relationship of age to the effects of glatiramer injection have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.

Pregnancy

Information about this glatiramer-subcutaneous-route
Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Tofacitinib

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergy to mannitol—Should not be used in patients with this condition.
  • Infection—May decrease your body's ability to fight infections.

Proper Use

A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the hips, stomach, thighs, or upper arms. You or your caregiver may be trained to prepare and inject the medicine at home. Be sure that you understand how to use the medicine.

If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into skin areas that have scars or dents.

This medicine should come with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

To use the injection:

  • First, gather the items you will need on a clean cloth or towel in a well-lighted area.
  • Wash your hands with soap and water. Do not touch your hair or skin afterwards.
  • Remove one prefilled syringe from the carton in the refrigerator. Take the syringe out of the protective wrapper. Allow 20 minutes for the syringe to warm up to room temperature before injecting the medicine.
  • Check the liquid in the prefilled syringe. It should be clear or colorless to slightly yellow. If the liquid is cloudy or has particles in it, do not use the syringe. Take out another syringe and follow the same steps for warming.
  • Choose an injection site on your body. Clean the injection site with a fresh alcohol wipe, and let it dry.
  • Pick up the 1-milliliter prefilled syringe and hold it as you would a pencil, using the hand you write with. Remove the plastic cover from the needle, but do not touch the needle itself.
  • Pinch about a 2-inch fold of skin between your thumb and index finger.
  • Insert the needle into the 2-inch fold of skin. It may help to steady your hand by resting the heel of your hand against your body.
  • When the needle is all the way in, release the fold of skin.
  • Inject the medicine by holding the syringe steady while pushing down on the plunger. The injection should take just a few seconds.
  • Pull the needle straight out.
  • Press a dry clean cotton ball on the injection site for a few seconds, but do not massage it.
  • Put the plastic cover back on the needle.
  • Throw away any unused medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For injection dosage form (solution):
    • For multiple sclerosis (MS):
      • Adults—20 milligrams (mg) injected under the skin once a day, or 40 mg injected under the skin 3 times per week (at least 48 hours apart).
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

You may also store glatiramer injection at room temperature for up to 1 month. Avoid exposing this medicine to higher temperatures or bright or intense light.

Throw away used needles in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Some patients have a reaction to this medicine a few minutes after receiving a shot. The symptoms might include: chest pain, flushing, fast, irregular, or pounding heartbeat, anxiety, trouble breathing, a tight feeling in the throat, or hives. These symptoms will usually go away without treatment in a short time. Call your doctor right away if these symptoms become worse or do not go away. This reaction can happen even if you have used the medicine regularly for several months. Also, chest pain can occur by itself, but should not last more than a few minutes.

This medicine may cause serious skin problems, including a permanent depression (dent) under the skin at the injection site. Contact your doctor right away if you notice any of these side effects at the injection site: depressed or indented skin, blue-green to black skin discoloration, or pain, redness, or sloughing (peeling) of the skin.

Do not stop using this medicine without first checking with your doctor.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Anxiety
  2. bleeding, hard lump, hives or welts, itching, pain, redness, or swelling at the injection site
  3. chest pain
  4. cough
  5. excessive muscle tone
  6. fast, irregular, pounding, or racing heartbeat or pulse
  7. feeling of warmth
  8. joint pain
  9. lower back or side pain
  10. neck pain
  11. painful or difficult urination
  12. redness of the face, neck, arms, and occasionally, upper chest
  13. skin rash
  14. swelling or puffiness of the face
  15. swollen, painful, or tender lymph glands in the neck, armpit, or groin
  16. troubled breathing

Less common

  1. Agitation
  2. bloating or swelling
  3. chills
  4. confusion
  5. difficulty with swallowing
  6. feeling faint, dizzy, or lightheaded
  7. fever
  8. headache, severe and throbbing
  9. itching of the vagina or outside genitals
  10. muscle aches
  11. pain
  12. pain during sexual intercourse
  13. purple spots under the skin
  14. rapid weight gain
  15. red streaks on the skin
  16. shakiness in the legs, arms, hands, or feet
  17. small lumps under the skin
  18. spasm of the throat
  19. strong urge to urinate
  20. sweating
  21. swelling of the fingers, arms, feet, or legs
  22. thick, white curd-like vaginal discharge without odor or with mild odor
  23. tightness in the chest
  24. tingling of the hands or feet
  25. trembling or shaking of the hands or feet
  26. unusual weight gain or loss

Rare

  1. Blood in the urine
  2. burning or stinging of the skin
  3. continuous, uncontrolled back-and-forth or rolling eye movements
  4. decreased sexual ability
  5. diarrhea
  6. difficulty with moving
  7. ear pain
  8. fast breathing
  9. irritation of the mouth and tongue (thrush)
  10. loss of appetite
  11. menstrual pain or changes
  12. painful cold sores or blisters on the lips, nose, eyes, or genitals
  13. sensation of motion, usually whirling, either of oneself or of one's surroundings
  14. speech problems
  15. vision problems

Incidence not known

  1. Abnormal vaginal bleeding or discharge
  2. back pain, sudden and severe
  3. bleeding gums
  4. blindness
  5. blurred vision
  6. chest discomfort or heaviness
  7. clear or bloody discharge from the nipple
  8. cloudy urine
  9. coughing up blood
  10. dark urine
  11. decreased urine output
  12. decreased vision
  13. difficult or frequent urination
  14. dilated neck veins
  15. dimpling of the breast skin
  16. drowsiness
  17. extreme tiredness or weakness
  18. eye pain
  19. gaseous abdominal pain
  20. general feeling of discomfort or illness
  21. general tiredness and weakness
  22. hair loss
  23. headache
  24. increased menstrual flow or vaginal bleeding
  25. inverted nipple
  26. joint swelling
  27. large amount of cholesterol in the blood
  28. light-colored stools
  29. lump in the breast or under the arm
  30. lump or swelling in the stomach
  31. muscle weakness, sudden and progressing
  32. nausea
  33. nosebleed
  34. pain or discomfort the in arms or jaw
  35. paralysis
  36. persistent crusting or scaling of the nipple
  37. prolonged bleeding from cuts
  38. puffiness or swelling of the eyelids or around the eyes, lips, or tongue
  39. rapid, shallow breathing
  40. recurrent fever
  41. red or black, tarry stools
  42. redness or swelling of the breast
  43. seizures
  44. severe headache
  45. sore on the skin of the breast that does not heal
  46. sore throat
  47. stiff neck or back
  48. stomach bloating, burning, cramping, or pain
  49. tearing
  50. tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
  51. unusual tiredness or weakness
  52. upper right abdominal pain
  53. vomiting
  54. yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Lack or loss of strength
  2. stuffy or runny nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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