Generic Name
Glatiramer Acetate
Brand Names
Copaxone, Glatopa
FDA approval date: April 28, 2008
Form: Injection
What is Copaxone (Glatiramer Acetate)?
COPAXONE is indicated for the treatment of relapsing forms of multiple sclerosis , to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. COPAXONE is indicated for the treatment of relapsing forms of multiple sclerosis , to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults .
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Brand Information
Copaxone (Glatiramer Acetate)
WARNING:ANAPHYLACTIC REACTIONS
Cases of life-threatening and fatal anaphylaxis have been reported with COPAXONE. Anaphylaxis can occur at any time following initiation of therapy, from as early as after the first dose, up to years following initiation of therapy.
- Make patients aware of the symptoms of anaphylaxis, which may overlap with those of an immediate post-injection reaction; instruct them to seek immediate medical care should these symptoms occur. Prompt identification of anaphylaxis is important to avoid a delay in treatment
- COPAXONE is
1INDICATIONS AND USAGE
COPAXONE is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
2DOSAGE FORMS AND STRENGTHS
- Injection: 20 mg per mL in a single-dose, prefilled syringe with a white plunger. For subcutaneous use only.
- Injection: 40 mg per mL in a single-dose, prefilled syringe with a blue plunger. For subcutaneous use only.
3CONTRAINDICATIONS
COPAXONE is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. Reactions have included anaphylaxis
4ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in the labeling:
- Anaphylactic Reactions
- Immediate Post-Injection Reaction
- Chest Pain
- Lipoatrophy and Skin Necrosis
- Potential Effects on Immune Response
- Hepatic Injury
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Incidence in Controlled Clinical Trials
COPAXONE 20 mg per mL per day
Among 563 patients treated with COPAXONE in blinded placebo-controlled trials, approximately 5% of the subjects discontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with discontinuation were: injection site reactions, dyspnea, urticaria, vasodilatation, and hypersensitivity. The most common adverse reactions were: injection site reactions, vasodilatation, rash, dyspnea, and chest pain.
Table 1 lists signs and symptoms that occurred in at least 2% of patients treated with COPAXONE 20 mg per mL in the placebo-controlled trials. These signs and symptoms were numerically more common in patients treated with COPAXONE than in patients treated with placebo. Adverse reactions were usually mild in intensity.
*Injection site atrophy comprises terms relating to localized lipoatrophy at injection site
Adverse reactions which occurred only in 4 to 5 more subjects in the COPAXONE group than in the placebo group (less than 1% difference), but for which a relationship to COPAXONE could not be excluded, were arthralgia and herpes simplex.
Laboratory analyses were performed on all patients participating in the clinical program for COPAXONE. Clinically-significant laboratory values for hematology, chemistry, and urinalysis were similar for both COPAXONE and placebo groups in blinded clinical trials. In controlled trials one patient discontinued treatment due to thrombocytopenia (16 x10
Data on adverse reactions occurring in the controlled clinical trials of COPAXONE 20 mg per mL were analyzed to evaluate differences based on sex. No clinically-significant differences were identified. Ninety-six percent of patients in these clinical trials were Caucasian. The majority of patients treated with COPAXONE were between the ages of 18 and 45. Consequently, data are inadequate to perform an analysis of the adverse reaction incidence related to clinically-relevant age subgroups.
Other Adverse Reactions
In the paragraphs that follow, the frequencies of less commonly reported adverse clinical reactions are presented. Because the reports include reactions observed in open and uncontrolled premarketing studies (n= 979), the role of COPAXONE in their causation cannot be reliably determined. Furthermore, variability associated with adverse reaction reporting, the terminology used to describe adverse reactions, etc., limit the value of the quantitative frequency estimates provided. Reaction frequencies are calculated as the number of patients who used COPAXONE and reported a reaction divided by the total number of patients exposed to COPAXONE. All reported reactions are included except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug. Reactions are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions:
Body as a Whole:
Frequent: Abscess
Infrequent: Injection site hematoma, moon face, cellulitis, hernia, injection site abscess, serum sickness, suicide attempt, injection site hypertrophy, injection site melanosis, lipoma, and photosensitivity reaction.
Cardiovascular:
Frequent: Hypertension.
Infrequent: Hypotension, midsystolic click, systolic murmur, atrial fibrillation, bradycardia, fourth heart sound, postural hypotension, and varicose veins.
Digestive:
Infrequent: Dry mouth, stomatitis, burning sensation on tongue, cholecystitis, colitis, esophageal ulcer, esophagitis, gastrointestinal carcinoma, gum hemorrhage, hepatomegaly, increased appetite, melena, mouth ulceration, pancreas disorder, pancreatitis, rectal hemorrhage, tenesmus, tongue discoloration, and duodenal ulcer.
Endocrine:
Infrequent: Goiter, hyperthyroidism, and hypothyroidism.
Gastrointestinal:
Frequent: Bowel urgency, oral moniliasis, salivary gland enlargement, tooth caries, and ulcerative stomatitis.
Hemic and Lymphatic:
Infrequent: Leukopenia, anemia, cyanosis, eosinophilia, hematemesis, lymphedema, pancytopenia, and splenomegaly.
Metabolic and Nutritional:
Infrequent: Weight loss, alcohol intolerance, Cushing’s syndrome, gout, abnormal healing, and xanthoma.
Musculoskeletal:
Infrequent: Arthritis, muscle atrophy, bone pain, bursitis, kidney pain, muscle disorder, myopathy, osteomyelitis, tendon pain, and tenosynovitis.
Nervous:
Frequent: Abnormal dreams, emotional lability, and stupor.
Infrequent: Aphasia, ataxia, convulsion, circumoral paresthesia, depersonalization, hallucinations, hostility, hypokinesia, coma, concentration disorder, facial paralysis, decreased libido, manic reaction, memory impairment, myoclonus, neuralgia, paranoid reaction, paraplegia, psychotic depression, and transient stupor.
Respiratory:
Frequent: Hyperventilation and hay fever.
Infrequent: Asthma, pneumonia, epistaxis, hypoventilation, and voice alteration.
Skin and Appendages:
Frequent: Eczema, herpes zoster, pustular rash, skin atrophy, and warts.
Infrequent: Dry skin, skin hypertrophy, dermatitis, furunculosis, psoriasis, angioedema, contact dermatitis, erythema nodosum, fungal dermatitis, maculopapular rash, pigmentation, benign skin neoplasm, skin carcinoma, skin striae, and vesiculobullous rash.
Special Senses:
Frequent: Visual field defect.
Infrequent: Dry eyes, otitis externa, ptosis, cataract, corneal ulcer, mydriasis, optic neuritis, photophobia, and taste loss.
Urogenital:
Frequent: Amenorrhea, hematuria, impotence, menorrhagia, suspicious papanicolaou smear, urinary frequency, and vaginal hemorrhage.
Infrequent: Vaginitis, flank pain (kidney), breast engorgement, breast enlargement, carcinoma in situ cervix, fibrocystic breast, kidney calculus, nocturia, ovarian cyst, priapism, pyelonephritis, abnormal sexual function, and urethritis.
COPAXONE 40 mg per mL three times per week
Among 943 patients treated with COPAXONE 40 mg per mL three times per week in a blinded, placebo-controlled trial, approximately 3% of the subjects discontinued treatment because of an adverse reaction. The most common adverse reactions were injection site reactions, which were also the most common cause of discontinuation.
Table 2 lists signs and symptoms that occurred in at least 2% of patients treated with COPAXONE 40 mg per mL in the blinded, placebo-controlled trial. These signs and symptoms were numerically more common in patients treated with COPAXONE 40 mg per mL than in patients treated with placebo. Adverse reactions were usually mild in intensity.
No new adverse reactions appeared in subjects treated with COPAXONE 40 mg per mL three times per week as compared to subjects treated with COPAXONE 20 mg per mL per day in clinical trials and during postmarketing experience. Data on adverse reactions occurring in the controlled clinical trial of COPAXONE 40 mg per mL were analyzed to evaluate differences based on sex. No clinically significant differences were identified. Ninety-eight percent of patients in this clinical trial were Caucasian and the majority were between the ages of 18 and 50. Consequently, data are inadequate to perform an analysis of the adverse reaction incidence related to clinically-relevant age groups.
4.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of COPAXONE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Body as a Whole: sepsis; SLE syndrome; hydrocephalus; enlarged abdomen; allergic reaction
Cardiovascular System: thrombosis; peripheral vascular disease; pericardial effusion; myocardial infarct; deep thrombophlebitis; coronary occlusion; congestive heart failure; cardiomyopathy; cardiomegaly; arrhythmia; angina pectoris
Digestive System: tongue edema; stomach ulcer; hemorrhage; eructation
Hemic and Lymphatic System: thrombocytopenia; lymphoma-like reaction; acute leukemia
Hepatobiliary Disorders: cholelithiasis; liver function abnormality; cirrhosis of the liver; hepatitis; hepatic injury [see Warnings and Precautions (
Immune System Disorders: hypersensitivity reactions (including anaphylactic reactions) [see Boxed Warning and Warnings and Precautions (.
Metabolic and Nutritional Disorders: hypercholesterolemia
Musculoskeletal System: rheumatoid arthritis; generalized spasm
Nervous System: myelitis; meningitis; CNS neoplasm; cerebrovascular accident; brain edema; abnormal dreams; aphasia; convulsion; neuralgia
Respiratory System: pulmonary embolus; pleural effusion; carcinoma of lung
Special Senses: glaucoma; blindness
Urogenital System: urogenital neoplasm; urine abnormality; ovarian carcinoma; nephrosis; kidney failure; breast carcinoma; bladder carcinoma; urinary frequency
5DESCRIPTION
Glatiramer acetate, the active ingredient of COPAXONE, consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine with an average molar fraction of 0.141, 0.427, 0.095, and 0.338, respectively. The average molecular weight of glatiramer acetate is 5,000 – 9,000 daltons. Glatiramer acetate is identified by specific antibodies.
Chemically, glatiramer acetate is designated L-glutamic acid polymer with L-alanine, L-lysine and L-tyrosine, acetate (salt). Its structural formula is:
(Glu, Ala, Lys, Tyr)
(C
CAS - 147245-92-9
COPAXONE is a clear, colorless to slightly yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 1 mL of COPAXONE solution contains 20 mg or 40 mg of glatiramer acetate and the following inactive ingredient: 40 mg of mannitol. The pH of the solutions is approximately 5.5 to 7.0. The biological activity of glatiramer acetate is determined by its ability to block the induction of experimental autoimmune encephalomyelitis (EAE) in mice.
6CLINICAL STUDIES
Evidence supporting the effectiveness of COPAXONE derives from five placebo-controlled trials, four of which used a COPAXONE dose of 20 mg per mL per day and one of which used a COPAXONE dose of 40 mg per mL three times per week.
COPAXONE 20 mg per mL per day
Study 1 was performed at a single center. Fifty patients were enrolled and randomized to receive daily doses of either COPAXONE, 20 mg per mL subcutaneously, or placebo (COPAXONE: n=25; placebo: n=25). Patients were diagnosed with RRMS by standard criteria, and had at least 2 exacerbations during the 2 years immediately preceding enrollment. Patients were ambulatory, as evidenced by a score of no more than 6 on the Kurtzke Disability Scale Score (DSS), a standard scale ranging from 0–Normal to 10–Death due to MS. A score of 6 is defined as one at which a patient is still ambulatory with assistance; a score of 7 means the patient must use a wheelchair.
Patients were examined every 3 months for 2 years, as well as within several days of a presumed exacerbation. To confirm an exacerbation, a blinded neurologist had to document objective neurologic signs, as well as document the existence of other criteria (e.g., the persistence of the neurological signs for at least 48 hours).
The protocol-specified primary outcome measure was the proportion of patients in each treatment group who remained exacerbation free for the 2 years of the trial, but two other important outcomes were also specified as endpoints: the frequency of attacks during the trial, and the change in the number of attacks compared with the number which occurred during the previous 2 years.
Table 3 presents the values of the three outcomes described above, as well as several protocol-specified secondary measures. These values are based on the intent-to-treat population (i.e., all patients who received at least 1 dose of treatment and who had at least 1 on-treatment assessment):
*Progression was defined as an increase of at least 1 point on the DSS, persisting for at least 3 consecutive months.
Study 2 was a multicenter trial of similar design which was performed in 11 US centers. A total of 251 patients (COPAXONE: n=125; placebo: n=126) were enrolled. The primary outcome measure was the Mean 2-Year Relapse Rate. Table 4 presents the values of this outcome for the intent-to-treat population, as well as several secondary measures:
In both studies, COPAXONE exhibited a clear beneficial effect on relapse rate, and it is based on this evidence that COPAXONE is considered effective.
In Study 3, 481 patients who had recently (within 90 days) experienced an isolated demyelinating event and who had lesions typical of multiple sclerosis on brain MRI were randomized to receive either COPAXONE 20 mg per mL (n=243) or placebo (n=238). The primary outcome measure was time to development of a second exacerbation. Patients were followed for up to three years or until they reached the primary endpoint. Secondary outcomes were brain MRI measures, including number of new T2 lesions and T2 lesion volume.
Time to development of a second exacerbation was significantly delayed in patients treated with COPAXONE compared to placebo (Hazard Ratio = 0.55; 95% confidence interval 0.40 to 0.77; Figure 1). The Kaplan-Meier estimates of the percentage of patients developing a relapse within 36 months were 42.9% in the placebo group and 24.7% in the COPAXONE group.
Figure 1: Time to Second Exacerbation
Patients treated with COPAXONE demonstrated fewer new T2 lesions at the last observation (rate ratio 0.41; confidence interval 0.28 to 0.59; p < 0.0001). Additionally, baseline-adjusted T2 lesion volume at the last observation was lower for patients treated with COPAXONE (ratio of 0.89; confidence interval 0.84 to 0.94; p = 0.0001).
Study 4 was a multinational study in which MRI parameters were used both as primary and secondary endpoints. A total of 239 patients with RRMS (COPAXONE: n=119; and placebo: n=120) were randomized. Inclusion criteria were similar to those in the second study with the additional criterion that patients had to have at least one Gd-enhancing lesion on the screening MRI. The patients were treated in a double-blind manner for nine months, during which they underwent monthly MRI scanning. The primary endpoint for the double-blind phase was the total cumulative number of T1 Gd-enhancing lesions over the nine months. Table 5 summarizes the results for the primary outcome measure monitored during the trial for the intent-to-treat cohort.
Figure 2 displays the results of the primary outcome on a monthly basis.
Figure 2: Median Cumulative Number of Gd-Enhancing Lesions
COPAXONE 40 mg per mL three times per week
Study 5 was a double-blind, placebo-controlled, multinational study with a total of 1404 patients with RRMS randomized in a 2:1 ratio to receive either COPAXONE 40 mg per mL (n=943) or placebo (n=461) three times a week for 12 months. Patients had a median of 2 relapses in the 2 years prior to screening and had not received any interferon-beta for at least 2 months prior to screening. Baseline EDSS scores ranged from 0 to 5.5 with a median of 2.5. Neurological evaluations were performed at baseline, every three months, and at unscheduled visits for suspected relapse or early termination. MRI was performed at baseline, months 6 and 12, or early termination. A total of 91% of those assigned to COPAXONE and 93% of those assigned to placebo completed treatment at 12 months.
The primary outcome measure was the total number of confirmed relapses (persistence of neurological symptoms for at least 48 hours confirmed on examination with objective signs). The effect of COPAXONE on several magnetic resonance imaging (MRI) variables, including number of new or enlarging T2 lesions and number of enhancing lesions on T1-weighted images, was also measured at months 6 and 12.
Table 6 presents the results for the intent-to-treat population.
7HOW SUPPLIED/STORAGE AND HANDLING
COPAXONE (glatiramer acetate injection) is a clear, colorless to slightly yellow, sterile, nonpyrogenic solution supplied as:
- 20 mg per mL in a single-dose, prefilled syringe with a white plunger, in individual blister packages supplied in 30-count cartons (NDC 68546-317-30).
- 40 mg per mL in a single-dose, prefilled syringe with a blue plunger, in individual blister packages supplied in 12-count cartons (NDC 68546-325-12).
Some glatiramer acetate products can be administered by an optional compatible autoinjector. Compatible autoinjectors are supplied separately if available, but the availability of compatible autoinjectors may change with time
Store COPAXONE refrigerated at 2°C to 8°C (36°F to 46°F). If needed, the patient may store COPAXONE at room temperature, 15°C to 30°C (59°F to 86°F), for up to one month, but refrigeration is preferred. Avoid exposure to higher temperatures or intense light. Do not freeze COPAXONE. If a COPAXONE syringe freezes, it should be discarded.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Important Administration Instructions
Advise patients with new or existing glatiramer acetate prescriptions to consult their pharmacist or healthcare provider if they would like information about using an optional compatible autoinjector device, if available.
Additionally, advise patients who would like to use an autoinjector for administration, should one be available, that not all available autoinjectors are compatible with all glatiramer acetate products and the availability of compatible autoinjectors may change with time. If you have questions about the availability or compatibility of an autoinjector, contact the manufacturer of the prescribed glatiramer acetate product for more information.
Advise patients that using an optional autoinjector that is not compatible with the glatiramer acetate product may increase the risk for medication errors, such as missing a dose or administration of a partial dose
Anaphylactic Reactions
Advise patients and their caregivers that COPAXONE may cause life-threatening and fatal anaphylactic reactions shortly after injection, and that reactions may occur months to years after initiation of treatment
Immediate Post-Injection Reaction
Advise patients that COPAXONE may cause immediate post-injection reactions, characterized by various symptoms after injection, including flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea, constriction of the throat, and urticaria
Advise patients that the symptoms of an immediate post-injection reaction may overlap with those of an anaphylactic reaction. Advise patients to contact their healthcare provider if they experience any signs or symptoms of an immediate post-injection reaction
Chest Pain
Advise patients that they may experience transient chest pain either as part of the Immediate Post-Injection Reaction or in isolation
Lipoatrophy and Skin Necrosis at Injection Site
Advise patients that localized lipoatrophy, and rarely, skin necrosis may occur at injection sites
Hepatic Injury
Advise patients that hepatic injury, including hepatic failure and hepatitis with jaundice, has been reported with the use of COPAXONE. Educate patients about the signs and symptoms of hepatic injury and instruct patients to report them immediately to their healthcare provider
Pregnancy
Instruct patients that if they are pregnant or plan to become pregnant while taking COPAXONE they should inform their healthcare provider
Lactation
Advise patients to notify their healthcare provider if they are breastfeeding or intend to breastfeed during COPAXONE therapy
Instructions for Use
Instruct patients to read the COPAXONE Patient Information leaflet carefully. COPAXONE 20 mg per mL and COPAXONE 40 mg per mL are not interchangeable. COPAXONE 20 mg per mL is administered daily and COPAXONE 40 mg per mL is administered three times per week. Caution patients to use aseptic technique. The first injection should be performed under the supervision of a health care professional. Instruct patients to rotate injection areas and sites with each injection. Caution patients against the reuse of needles or syringes. Instruct patients in safe disposal procedures.
Storage Conditions
Advise patients that the recommended storage condition for COPAXONE is refrigeration at 36
Manufactured for: Teva Neuroscience, Inc., Parsippany, NJ 07054
9MEDICATION GUIDE
This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: January 2025
10Instructions for Use
COPAXONE (co-PAX-own)
(glatiramer acetate injection)
for subcutaneous use
For subcutaneous injection only.
Do not inject COPAXONE in your veins (intravenously).
Do not re-use your COPAXONE prefilled syringes.
Do not share your COPAXONE prefilled syringes with another person. You may give another person an infection or get an infection from them.
You should receive your first dose of COPAXONE with a healthcare provider or nurse present. This might be at your healthcare provider’s office or with a visiting home health nurse who will show you how to give your own injections.
COPAXONE comes in either a 20 mg Prefilled Syringe with needle attached or a 40 mg Prefilled Syringe with needle attached. How often a dose is given depends on the product strength that is prescribed. Your healthcare provider will prescribe the correct dose for you.
If you plan to use your glatiramer acetate product with an autoinjector, ask your healthcare provider or pharmacist to make sure that your autoinjector is meant to be used with your glatiramer acetate product. If you use an autoinjector that is not meant to be used with your glatiramer acetate product, you might not get the correct dose of your medicine.
Instructions for Using Your COPAXONE 20 mg Prefilled Syringe:
- COPAXONE 20 mg is injected 1 time each day, in the fatty layer under your skin (subcutaneously).
- Each COPAXONE 20 mg prefilled syringe is for single use (1 time use) only.
- The COPAXONE 20 mg dose is packaged in boxes of 30 prefilled syringes with needles attached. COPAXONE 20 mg prefilled syringes have
Instructions for Using Your COPAXONE 40 mg Prefilled Syringe:
- COPAXONE 40 mg is injected 3 times each week, in the fatty layer under your skin (subcutaneously).
- COPAXONE 40 mg should be given on the same 3 days each week, if possible, for example, Monday, Wednesday, and Friday. Give your COPAXONE injections at least 48 hours (2 days) apart.
- Each COPAXONE 40 mg prefilled syringe is for single use (1 time use) only.
- The COPAXONE 40 mg dose is packaged in boxes of 12 prefilled syringes with needles attached. COPAXONE 40 mg prefilled syringes have
How do I inject COPAXONE?
Step 1: Gather the supplies you will need to inject COPAXONE. See Figure A.
- 1 blister pack with a COPAXONE Prefilled Syringe with needle attached
- Alcohol wipe (not supplied)
- Dry cotton ball (not supplied)
- A place to record your injections, like a notebook (not supplied)
- Sharps disposal container (not supplied).
Step 2: Remove only 1 blister pack from the COPAXONE prefilled syringe carton. See Figure B.
- 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.
- Let the blister pack, with the syringe inside, warm to room temperature for about 20 minutes.
- Wash your hands. Be careful not to touch your face or hair after washing your hands.
Step 3: Look closely at your COPAXONE prefilled syringe.
- There may be small air bubbles in the syringe.
- 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.
Step 4: Choose your injection area. See Figure C.
See the injection areas you should use on your body. Talk with your healthcare provider about the injection areas that are best for you.
- The possible injection areas on your body include
- For each COPAXONE 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
Step 5: Prepare to give your injection.
- There are some injection areas on your body that are hard to reach (like the back of your arm). 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 in sites where the skin has scarring or “dents”. Using scarred or dented skin for your injections may make your skin worse.
Step 6: Clean your injection site.
- Clean the injection site using the alcohol wipe and allow your skin to air dry.
Step 7: Pick up the syringe with 1 hand and hold it like a pencil. Remove the needle cover with your other hand and set it aside. See Figure E.
Step 8: Pinch about a 2 inch fold of skin between your thumb and index finger. See Figure F.
Step 9: Giving your injection.
- Rest the heel of your hand holding the syringe against your skin at the injection site. 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.
Step 10: Give your COPAXONE injection.
To inject the medicine, hold the syringe steady and slowly push down the plunger.
Step 11: Remove the needle.
After you have injected all of the medicine, pull the needle straight out.
Step 12: 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. See Figure K.
Step 13: Dispose of your needles and syringes.
- Put your used needles and syringes in a FDA-cleared sharps disposal container right away after use.
- If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- 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.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured for: Teva Neuroscience, Inc., Parsippany, NJ 07054
COPIFU-008
11Package/Label Display Panel, 20 mg/mL
NDC 68546-317-30
12Package/Label Display Panel,40 mg/mL
NDC 68546-325-12
