Glatiramer Injection

Glatiramer is a prescription medication used to treat relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease). 

• Glatiramer is available under various brand names: Copaxone, Glatopa 

Common side effects of Glatiramer include:

• feeling short of breath.
• flushing (sudden warmth, redness, or tingly feeling);
• rash; or
• redness, pain, itching, swelling, or a lump where the injection was given.

Serious side effects of Glatiramer include:

• hives, 
• difficult breathing,
• swelling of the face, lips, tongue, or throat,
• itching, rash, swelling, warmth, skin redness, tingling, anxiety, fast or pounding heartbeats, chest pain, tightness in the throat, or trouble breathing.
• chest pain (may occur alone or with other side effects shortly after an injection); or
• hollowing or other skin changes at the injection site.

Rare side effects of Glatiramer include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Solution for injection

• 20 mg/mL (once daily dosing)
• 40 mg/mL (3 times/week dosing)

Multiple sclerosis, relapsing: 

Adult dosage

• SUBQ: 20 mg once daily or 40 mg 3 times per week administered at least 48 hours apart.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Glatiramer has severe interactions with no other drugs.
• Glatiramer has serious interactions with at least 65 other drugs.
• Glatiramer has moderate interactions with the following drugs:
  • astragalus
  • denosumab
  • echinacea
  • fingolimod
  • Haemophilusus influenzae type b vaccine
  • influenza virus vaccine quadrivalent, recombinant
  • influenza virus vaccine trivalent, recombinant
  • isavuconazonium sulfate
  • maitake
  • mercaptopurine
  • ocrelizumab
  • ofatumumab SC
  • ozanimod
  • poliovirus vaccine inactivated
  • siponimod
  • sipuleucel-T
  • trastuzumab
  • trastuzumab deruxtecan
  • zoster vaccine recombinant
• Glatiramer has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to glatiramer or to mannitol.

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Glatiramer?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Glatiramer?”

Cautions

• Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
• Risk of immediate post-injection reactions (in general, symptoms appear several months following treatment initiation), including transient chest pain (seek prompt medical attention if prolonged or unusually intense chest pain); other symptoms include flushing, palpitations, anxiety, dyspnea, constriction of the throat, and urticaria
• Cases of hepatic injury, some severe, including liver failure and hepatitis with jaundice, reported; hepatic injury has occurred from days to years after initiating treatment; if signs or symptoms of liver dysfunction occur, consider discontinuation of therapy
• Lipoatrophy and skin necrosis may occur at injection site at various times after treatment onset (sometimes after several months) and is thought to be permanent; there is no known therapy for lipoatrophy; to minimize these events, patient must follow injection technique and rotate sites daily
• May impair body's ability to fight infection by interfering with immune function
• Therapy may potentially undermine the body’s tumor surveillance and defense system against infection

Pregnancy and Lactation

• Tell your doctor if you are pregnant
• Available human data in pregnant women are not sufficient to support conclusions about drug-associated risk for major birth defects and miscarriage
• Lactation
  • Tell your doctor if you are breastfeeding.
  • There are no data on presence of drug in human milk, effects on breastfed infants, or on milk production
  • Based on low systemic exposure because of substantial local hydrolysis of glatiramer acetate following subcutaneous administration, breastfeeding not expected to result in clinically relevant exposure of infant to the drug
  • Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on infant from underlying maternal condition