Description
Glatiramer injection is used to treat relapsing-forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. 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.
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.
- Ozanimod
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.
- Liver disease—Use with caution. May make this condition worse.
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. Do not inject this medicine into your veins.
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.
This medicine comes in a prefilled syringe. It may also be given using an autoinjector that is compatible with glatiramer. Do not use an autoinjector that is not meant to be used with this medicine. Make sure your doctor, nurse, or pharmacist instructs you on how to prepare and administer this medicine. Also, read all instructions carefully to make sure you know how to use your device.
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.
- For multiple sclerosis (MS):
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.
Do not keep outdated medicine or medicine no longer needed.
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 have depressed or indented skin, blue-green to black skin discoloration, or pain, redness, or sloughing (peeling) of the skin at the injection site.
Symptoms of your MS may return and become worse after stopping treatment with this medicine. Do not stop using this medicine without checking first with your doctor.
This medicine may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem (eg, liver failure, hepatitis with jaundice).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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
- Anxiety
- bleeding, hard lump, hives or welts, itching, pain, redness, or swelling at the injection site
- chest pain
- cough or hoarseness
- excessive muscle tone
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling of warmth
- fever or chills
- joint pain
- lower back or side pain
- neck pain
- painful or difficult urination
- redness of the face, neck, arms, and occasionally, upper chest
- skin rash
- swelling or puffiness of the face
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- trouble breathing
Less common
- Agitation
- bloating or swelling
- chest tightness
- confusion
- difficulty with swallowing
- feeling faint, dizzy, or lightheaded
- headache, severe and throbbing
- itching of the vagina or outside genitals
- muscle aches or pain
- pain during sexual intercourse
- purple spots under the skin
- red streaks on the skin
- shakiness in the legs, arms, hands, or feet
- small lumps under the skin
- spasm of the throat
- strong urge to urinate
- sweating
- swelling of the fingers, arms, feet, or legs
- thick, white curd-like vaginal discharge without odor or with mild odor
- tingling of the hands or feet
- trembling or shaking of the hands or feet
- unusual weight gain or loss
Rare
- Blood in the urine
- burning or stinging of the skin
- continuous, uncontrolled back-and-forth or rolling eye movements
- decreased sexual ability
- diarrhea
- difficulty with moving
- ear pain
- fast breathing
- irritation of the mouth and tongue (thrush)
- loss of appetite
- menstrual pain or changes
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- sensation of motion, usually whirling, either of oneself or of one's surroundings
- speech problems
- vision problems
Incidence not known
- Abnormal vaginal bleeding or discharge
- back pain, sudden and severe
- bleeding gums
- blindness
- blurred or decreased vision
- chest discomfort or heaviness
- clear or bloody discharge from the nipple
- cloudy urine
- coughing up blood
- dark urine
- decreased urine output
- difficult or frequent urination
- dilated neck veins
- dimpling of the breast skin
- drowsiness
- extreme tiredness or weakness
- eye pain
- gaseous stomach pain
- general feeling of discomfort or illness
- general tiredness and weakness
- hair loss
- headache
- heartburn
- increased menstrual flow or vaginal bleeding
- indigestion
- inverted nipple
- joint swelling
- large amount of cholesterol in the blood
- light-colored stools
- lump in the breast or under the arm
- lump or swelling in the stomach
- muscle weakness, sudden and progressing
- nausea
- nerve pain
- nosebleed
- pain or discomfort the in arms or jaw
- paralysis
- persistent crusting or scaling of the nipple
- prolonged bleeding from cuts
- puffiness or swelling of the eyelids or around the eyes, lips, or tongue
- rapid, shallow breathing
- recurrent fever
- red or black, tarry stools
- redness or swelling of the breast
- seizures
- sore on the skin of the breast that does not heal
- sore throat
- stiff neck or back
- stomach bloating, burning, cramping, or pain
- tearing
- tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
- unusual tiredness or weakness
- upper right abdominal or stomach pain
- vomiting
- 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
- Lack or loss of strength
- stuffy or runny nose
Less common
- Double vision
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.
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