Glatopa injection

Glatiramer is a combination of four amino acids (proteins) that affect the immune system.

Glatiramer is used to treat multiple sclerosis (MS) and to prevent relapse of MS.

Glatiramer will not cure MS, but it can make relapses occur less often.

Glatiramer may also be used for purposes not listed in this medication guide.

You should not use this medication if you are allergic to glatiramer or to mannitol.

To make sure glatiramer is safe for you, tell your doctor about your other medical conditions.

This medicine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether glatiramer passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Applies to glatiramer: subcutaneous kit, subcutaneous powder for solution, subcutaneous solution

Along with its needed effects, glatiramer (the active ingredient contained in Glatopa) 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 while taking glatiramer:

• Anxiety
• bleeding, hard lump, hives or welts, itching, pain, redness, or swelling at the place of injection
• chest pain
• cough
• excessive muscle tone
• fast, irregular, pounding, or racing heartbeat or pulse
• flushing
• joint pain
• lower back or side pain
• neck pain
• painful or difficult urination
• skin rash
• swelling or puffiness of the face
• swollen lymph glands
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• troubled breathing

• Agitation
• bloating or swelling
• chills
• confusion
• difficulty with swallowing
• feeling faint, dizzy, or lightheaded
• fever
• headache, severe and throbbing
• itching of the vagina or outside genitals
• muscle aches
• pain
• pain during sexual intercourse
• purple spots under the skin
• rapid weight gain
• 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
• swelling or puffiness of the face
• thick, white curd-like vaginal discharge without odor or with mild odor
• tightness in the chest
• tingling of the hands or feet
• trembling or shaking of the hands or feet
• unusual weight gain or loss

• Back pain
• 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
• muscle pain
• 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

Some side effects of glatiramer 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:

• Headache
• increased sweating
• lack or loss of strength
• nausea
• sore throat
• stuffy or runny nose
• unusual tiredness or weakness
• vomiting

• Double vision
• seeing double
• weight gain

Applies to glatiramer: subcutaneous kit, subcutaneous powder for injection, subcutaneous solution

Local

Very common (10% or more): Injection site erythema (43%), injection site pain (40%), injection site pruritus (27%), injection site mass (26%), injection site edema (19%)
Common (1% to 10%): Injection site inflammation, injection site reaction, injection site hypersensitivity, injection site fibrosis, injection site atrophy
Uncommon (0.1% to 1%): Injection site hematoma, injection site abscess, injection site hypertrophy, injection site melanosis[Ref]

Cardiovascular

Very common (10% or more): Vasodilation (20%), chest pain (13%)
Common (1% to 10%): Palpitations, tachycardia, hypertension
Uncommon (0.1% to 1%): Hypotension, midsystolic click, systolic murmur, atrial fibrillation, bradycardia, fourth heart sound, postural hypotension, varicose veins, warts, dry skin
Postmarketing reports: Thrombosis, peripheral vascular disease, pericardial effusion, myocardial infarct, deep thrombophlebitis, coronary occlusion, congestive heart failure, cardiomyopathy, cardiomegaly, arrhythmia, angina pectoris[Ref]

Hematologic

Common (1% to 10%): Lymphadenopathy
Uncommon (0.1% to 1%): Leukopenia, anemia, cyanosis, eosinophilia, hematemesis, lymphedema, pancytopenia, splenomegaly[Ref]

Gastrointestinal

Very common (10% or more): Nausea (15%)
Common (1% to 10%): Vomiting, dysphagia, gastroenteritis
Uncommon (0.1% to 1%): Dry mouth, stomatitis, burning sensation on tongue, cholecystitis, colitis, esophageal ulcer, esophagitis, gastrointestinal carcinoma, gum hemorrhage, increased appetite, melena, mouth ulceration, pancreas disorder, pancreatitis, rectal hemorrhage, tenesmus, tongue discoloration, duodenal ulcer, circumoral paresthesia[Ref]

Respiratory

Very common (10% or more): Dyspnea (14%)
Common (1% to 10%): Rhinitis, bronchitis, cough, laryngospasm, hyperventilation, hay fever
Uncommon (0.1% to 1%): Asthma, pneumonia, epistaxis, hypoventilation, voice alteration
Postmarketing reports: Pulmonary embolus, pleural effusion, carcinoma of lung[Ref]

Hepatic

Postmarketing reports: Cirrhosis of the liver, cholelithiasis hepatomegaly[Ref]

Dermatologic

Very common (10% or more): Rash (19%)
Common (1% to 10%): Hyperhidrosis, pruritus, urticaria, skin disorder, eczema, herpes zoster, pustular rash, skin atrophy, warts
Uncommon (0.1% to 1%): Dry skin, skin hypertrophy, dermatitis, furunculosis, psoriasis, angioedema, contact dermatitis, erythema nodosum, fungal dermatitis, maculopapular rash, pigmentation, benign skin neoplasm, skin carcinoma, skin striae, vesiculobullous rash
Postmarketing reports: Thrombocytopenia[Ref]

Endocrine

Uncommon (0.1% to 1%): Goitre, hyperthyroidism, hypothyroidism[Ref]

Genitourinary

Common (1% to 10%): Vaginal candidiasis, micturition urgency, amenorrhea, hematuria, impotence, menorrhagia, suspicious Papanicolaou smear, urinary frequency, vaginal hemorrhage
Uncommon (0.1% to 1%): Decreased libido, vaginitis, abortion, breast engorgement, breast enlargement, carcinoma in situ cervix, fibrocystic breast, kidney calculus, nocturia, ovarian cyst, priapism, pyelonephritis, abnormal sexual function, urethritis
Postmarketing reports: Urogenital neoplasm, urine abnormality, ovarian carcinoma, nephrosis, breast carcinoma, bladder carcinoma[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity, allergic reaction, anaphylactoid reaction[Ref]

Immunologic

Very common (10% or more): Infection (30%), influenza (14%)
Common (1% to 10%): Abscess
Uncommon (0.1% to 1%): Cellulitis, serum sickness[Ref]

Metabolic

Common (1% to 10%): Weight gain
Postmarketing reports: Hypercholesterolemia[Ref]

Musculoskeletal

Very common (10% or more): Back pain (12%)
Common (1% to 10%): Chills
Uncommon (0.1% to 1%): Lipoma, arthritis, muscle atrophy, bone pain, bursitis, muscle disorder, myopathy, osteomyelitis, tendon pain, tenosynovitis
Postmarketing reports: Systemic lupus erythematosus (SLE), rheumatoid arthritis, generalized spasm[Ref]

Nervous system

Very common (10% or more): Pain (20%)
Common (1% to 10%): Tremor, migraine, syncope, speech disorder
Uncommon (0.1% to 1%): Convulsion, hypokinesia, coma, facial paralysis, myoclonus, neuralgia, paraplegia
Postmarketing reports: Hydrocephalus, myelitis, meningitis, CNS neoplasm, cerebrovascular accident, brain edema, neuralgia[Ref]

Ocular

Common (1% to 10%): Eye disorder, diplopia, visual field defect
Uncommon (0.1% to 1%): Photosensitivity, dry eyes, otitis externa, ptosis, cataract, corneal ulcer, mydriasis, optic neuritis, photophobia
Postmarketing reports: Glaucoma, vision loss[Ref]

Oncologic

Common (1% to 10%): Benign neoplasm of skin
Postmarketing reports: Lymphoma-like reaction, acute leukemia[Ref]

Other

Very common (10% or more): Asthenia (22%)
Common (1% to 10%): Edema, face edema, peripheral edema
Uncommon (0.1% to 1%): Aphasia, ataxia, taste loss[Ref]

Psychiatric

Very common (10% or more): Anxiety (13%)
Common (1% to 10%): Nervousness, abnormal dreams, emotional lability, stupor
Uncommon (0.1% to 1%): Suicide attempt, depersonalization, hallucinations, hostility, concentration disorder, manic reaction, memory impairment, paranoid reaction, psychotic depression, transient stupor[Ref]

Renal

Uncommon (0.1% to 1%): Kidney pain, kidney calculus
Postmarketing reports: Kidney failure[Ref]

Some side effects of Glatopa may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.