Glatopa
Glatiramer Acetate · Injection, Solution · Subcutaneous
• 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 [see Warnings and Precautions ( 5.1 )] .
• Glatopa is contraindicated in patients with a history of hypersensitivity reactions to glatiramer acetate injection, including anaphylaxis. If an anaphylactic reaction occurs, treatment with Glatopa must be immediately discontinued. Unless a clear alternative etiology is identified, Glatopa must be permanently…
Uses
Glatopa 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. Glatopa 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 ( 1 ).
Dosage and administration
• For subcutaneous injection only; doses are not interchangeable ( 2.1 )
• Glatopa 20 mg/mL per day ( 2.1 )
• Glatopa 40 mg/mL three times per week ( 2.1 )
• Before use, allow the solution to warm to room temperature ( 2.2 ) 2.1 Recommended Dose Glatopa is for subcutaneous use only [see Dosage and Administration ( 2.2 )] . Do not administer intravenously. The dosing schedule depends on the product strength that is selected. The recommended doses are:
• Glatopa 20 mg per mL: administer once per day or
• Glatopa 40 mg per mL: administer three times per week and at least 48 hours apart. Glatopa 20 mg per mL and Glatopa 40 mg per mL are not interchangeable. 2.2 Instructions for Use Remove one blister-packaged pre-filled syringe from the refrigerated carton. Let the pre-filled syringe stand at room temperature for 20 minutes to allow the solution to warm to room temperature. Visually inspect the syringe for particulate matter and discoloration prior to administration. The solution in the syringe should appear clear, colorless to slightly yellow. If particulate matter or discoloration is observed, discard the syringe. Areas for subcutaneous self-injection include arms, abdomen, hips, and thighs. The pre-filled syringe is for single use only. Discard unused portions. Using an autoinjector that is not compatible for use with Sandoz's Glatopa may increase the risk for medication errors, such as dose omission or administration of a partial dose [see Warnings and Precautions ( 5.7 )] .
Dosage forms and strengths
• Injection: 20 mg per mL in a single-dose, pre-filled syringe with a white plunger. For subcutaneous use only.
• Injection: 40 mg per mL in a single-dose, pre-filled syringe with a blue plunger. For subcutaneous use only.
• Injection: 20 mg per mL in a single-dose, pre-filled syringe with a white plunger. ( 3 )
• Injection: 40 mg per mL in a single-dose, pre-filled syringe with a blue plunger. ( 3 )
Contraindications
Glatiramer acetate injection is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. Reactions have included anaphylaxis [see Warnings and Precautions ( 5.1 )]. Known hypersensitivity to glatiramer acetate or mannitol ( 4 )
Warnings and precautions
• Immediate Post-Injection Reaction (flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea, throat constriction, and/or urticaria), may occur within seconds to minutes after injection and are generally transient and self-limiting ( 5.2 )
• Chest pain, usually transient ( 5.3 )
• Lipoatrophy and skin necrosis may occur. Instruct patients in proper injection technique and to rotate injection sites ( 5.4 )
• Glatiramer acetate injection can modify immune response ( 5.5 )
• Hepatic Injury: if signs or symptoms of hepatic dysfunction occur, consider discontinuing glatiramer acetate injection ( 5.6 )
• Glatiramer Acetate Products and Administration Errors: Using an optional autoinjector that is not compatible for use with Sandoz’s Glatopa may increase the risk for medication errors, such as dose omission or administration of a partial dose. ( 5.7 ) 5.1 Anaphylactic Reactions Life-threatening and fatal anaphylaxis has been reported with glatiramer acetate injection [see Adverse Reactions ( 6.2 )] . Glatopa is contraindicated in patients with a history of hypersensitivity reactions to glatiramer acetate injection, including anaphylaxis [see Contraindications ( 4 )] . Anaphylaxis can occur at any time following initiation of glatiramer acetate injection therapy, from as early as after the first dose, up to years after initiation of treatment. Anaphylaxis occurred within an hour of a glatiramer acetate injection in most of the reported cases. Some signs and symptoms of anaphylactic reactions may overlap with those of immediate post-injection reactions [see Warnings and Precautions ( 5.2 )] . All patients receiving treatment with glatiramer acetate injection and caregivers should be informed about the signs and symptoms of anaphylactic reactions, and that they must seek immediate emergency medical care in case of experiencing such symptoms. If an anaphylactic reaction occurs, treatment with glatiramer acetate injection must be immediately discontinued. Unless a clear alternative etiology is identified, glatiramer acetate injection must be permanently discontinued [see Contraindications ( 4 )] . 5.2 Immediate Post-Injection Reaction Approximately 16% of patients exposed to glatiramer acetate injection 20 mg per mL in the 5 placebo-controlled trials compared to 4% of those on placebo, and approximately 2% of patients exposed to glatiramer acetate injection 40 mg per mL in a placebo-controlled trial compared to none on placebo, experienced a constellation of symptoms that may occur immediately (within seconds to minutes, with the majority of symptoms observed within 1 hour) after injection and included at least two of the following: flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea, constriction of the throat, and urticaria. These events are termed immediate post-injection reactions. The symptoms of an immediate post-injection reaction may overlap with those of anaphylaxis; prompt identification of anaphylaxis is important to avoid a delay in treatment. In general, symptoms of an immediate post-injection reaction have onset several months after the initiation of treatment, although they may occur earlier, and a given patient may experience one or several episodes of these symptoms. Whether or not any of these symptoms actually represent a specific syndrome is uncertain. Typically, the symptoms were transient and self-limited and did not require treatment; however, there have been reports of patients with similar symptoms who developed fatal anaphylaxis and/or received emergency medical care. Whether an immunologic or nonimmunologic mechanism mediates these episodes, or whether several similar episodes seen in a given patient have identical mechanisms, is unknown. 5.3 Chest Pain Approximately 13% of glatiramer acetate injection 20 mg per mL patients in the 5 placebo-controlled studies compared to 6% of placebo patients, and approximately 2% of patients exposed to glatiramer acetate injection 40 mg per mL in a placebo-controlled trial compared to 1% of placebo patients, experienced at least one episode of transient chest pain. While some of these episodes occurred in the context of the Immediate Post-Injection Reaction described above, many did not. The temporal relationship of this chest pain to an injection was not always known. The pain was usually transient, often unassociated with other symptoms, and appeared to have no clinical sequelae. Some patients experienced more than one such episode, and episodes usually began at least 1 month after the initiation of treatment. The pathogenesis of this symptom is unknown. 5.4 Lipoatrophy and Skin Necrosis At injection sites, localized lipoatrophy and, rarely, injection site skin necrosis may occur. Lipoatrophy occurred in approximately 2% of patients exposed to glatiramer acetate injection 20 mg per mL in the 5 placebo-controlled trials compared to none on placebo, and 0.5% of patients exposed to glatiramer acetate injection 40 mg per mL in a single placebo-controlled trial and none on placebo. Skin necrosis has only been observed in the post-marketing setting. Lipoatrophy may occur at various times after treatment onset (sometimes after several months) and is thought to be permanent. There is no known therapy for lipoatrophy. To assist in possibly minimizing these events, the patient should be advised to follow proper injection technique and to rotate injection sites with each injection. 5.5 Potential Effects on Immune Response Because glatiramer acetate injection can modify immune response, it may interfere with immune functions. For example, treatment with glatiramer acetate injection may interfere with the recognition of foreign antigens in a way that would undermine the body’s tumor surveillance and its defenses against infection. There is no evidence that glatiramer acetate injection does this, but there has not been a systematic evaluation of this risk.
Side effects
The following serious adverse reactions are described elsewhere in the labeling:
• Anaphylactic Reactions [see Warnings and Precautions ( 5.1 )]
• Immediate Post-Injection Reaction [see Warnings and Precautions ( 5.2 )]
• Chest Pain [see Warnings and Precautions ( 5.3 )]
• Lipoatrophy and Skin Necrosis [see Warnings and Precautions ( 5.4 )]
• Potential Effects on Immune Response [see Warnings and Precautions ( 5.5 )]
• Hepatic Injury [see Warnings and Precautions ( 5.6 )]
• In controlled studies of glatiramer acetate injection 20 mg/mL, most common adverse reactions (≥10% and ≥1.5 times higher than placebo) were: injection site reactions, vasodilatation, rash, dyspnea, and chest pain ( 6.1 )
• In a controlled study of glatiramer acetate injection 40 mg/mL, most common adverse reactions (≥10% and ≥1.5 times higher than placebo) were: injection site reactions ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 Glatiramer Acetate Injection 20 mg per mL per day Among 563 patients treated with glatiramer acetate injection 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 glatiramer acetate injection 20 mg per mL in the placebo-controlled trials. These signs and symptoms were numerically more common in patients treated with glatiramer acetate injection than in patients treated with placebo. Adverse reactions were usually mild in intensity . Table 1: Adverse Reactions in Controlled Clinical Trials with an Incidence ≥2% of patients and more frequent with Glatiramer Acetate Injection (20 mg per mL daily) than with Placebo Glatiramer Acetate Injection 20 mg/mL (n=563) % Placebo (n=564) % Blood And Lymphatic System Disorders Lymphadenopathy 7 3 Cardiac Disorders Palpitations 9 4 Tachycardia 5 2 Eye Disorders Eye Disorder 3 1 Diplopia 3 2 Gastrointestinal Disorders Nausea 15 11 Vomiting 7 4 Dysphagia 2 1 General Disorders and Administration Injection Site Erythema 43 10 Site Conditions Injection Site Pain 40 20 Injection Site Pruritus 27 4 Injection Site Mass 26 6 Asthenia 22 21 Pain 20 17 Injection Site Edema 19 4 Chest Pain 13 6 Injection Site Inflammation 9 1 Edema 8 2 Injection Site Reaction 8 1 Pyrexia 6 5 Injection Site Hypersensitivity 4 0 Local Reaction 3 1 Chills 3 1 Face Edema 3 1 Edema Peripheral 3 2 Injection Site Fibrosis 2 1 Injection Site Atrophy 2 0 Immune System Disorders Hypersensitivity 3 2 Infections and Infestations Infection 30 28 Influenza 14 13 Rhinitis 7 5 Bronchitis 6 5 Gastroenteritis 6 4 Vaginal Candidiasis 4 2 Metabolism and Nutrition Disorders Weight Increased 3 1 Musculoskeletal and Connective Back Pain 12 10 Tissue Disorders Neoplasms Benign, Malignant and Benign Neoplasm of Skin 2 1 Unspecified (Incl Cysts And Polyps) Nervous System Disorders Tremor 4 2 Migraine 4 2 Syncope 3 2 Speech Disorder 2 1 Psychiatric Disorders Anxiety 13 10 Nervousness 2 1 Renal and Urinary Disorders Micturition Urgency 5 4 Respiratory, Thoracic and Mediastinal Dyspnea 14 4 Disorders Cough 6 5 Laryngospasm 2 1 Skin and Subcutaneous Tissue Rash 19 11 Disorders Hyperhidrosis 7 5 Pruritus 5 4 Urticaria 3 1 Skin Disorder 3 1 Vascular Disorders Vasodilatation 20 5 * 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 glatiramer acetate injection group than in the placebo group (less than 1% difference), but for which a relationship to glatiramer acetate injection could not be excluded, were arthralgia and herpes simplex. Laboratory analyses were performed on all patients participating in the clinical program for glatiramer acetate injection. Clinically-significant laboratory values for hematology, chemistry, and urinalysis were similar for both glatiramer acetate injection and placebo groups in blinded clinical trials. In controlled trials one patient discontinued treatment due to thrombocytopenia (16 x 10 9 /L), which resolved after discontinuation of treatment. Data on adverse reactions occurring in the controlled clinical trials of glatiramer acetate injection 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 glatiramer acetate injection 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 glatiramer acetate injection 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.
Use in specific populations
8.1 Pregnancy Risk Summary Available data from pharmacovigilance and published observational studies over decades of use with glatiramer acetate during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes (see Data) . Administration of glatiramer acetate by subcutaneous injection to pregnant rats and rabbits resulted in no adverse effects on embryo-fetal or offspring development ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Data from pharmacovigilance and published observational studies have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes when glatiramer acetate was used during pregnancy. However, the published comparative observational studies have methodological limitations, such as short exposure duration during pregnancy, confounding, selection bias, and exposure misclassification. Animal Data In rats or rabbits receiving glatiramer acetate by subcutaneous injection during the period of organogenesis, no adverse effects on embryo-fetal development were observed at doses up to 37.5 mg/kg/day (18 and 36 times, respectively, the therapeutic human dose of 20 mg/day on a mg/m 2 basis). In rats receiving subcutaneous glatiramer acetate at doses of up to 36 mg/kg from day 15 of pregnancy throughout lactation, no significant effects on delivery or on offspring growth and development were observed. 8.2 Lactation Risk Summary There are no data on the presence of glatiramer acetate in human milk. Based on the low systemic exposure, breastfeeding is not expected to result in clinically relevant exposure of the infant to the drug [see Clinical Pharmacology ( 12.3 )] . There are no data on the effects of glatiramer acetate on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for glatiramer acetate injection and any potential adverse effects on the breastfed infant from glatiramer acetate injection or from the underlying maternal condition. 8.4 Pediatric Use The safety and effectiveness of glatiramer acetate injection have not been established in patients under 18 years of age. 8.5 Geriatric Use Glatiramer acetate injection has not been studied in elderly patients. 8.6 Use in Patients with Impaired Renal Function The pharmacokinetics of glatiramer acetate in patients with impaired renal function have not been determined.
Pregnancy
8.1 Pregnancy Risk Summary Available data from pharmacovigilance and published observational studies over decades of use with glatiramer acetate during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes (see Data) . Administration of glatiramer acetate by subcutaneous injection to pregnant rats and rabbits resulted in no adverse effects on embryo-fetal or offspring development ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Data from pharmacovigilance and published observational studies have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes when glatiramer acetate was used during pregnancy. However, the published comparative observational studies have methodological limitations, such as short exposure duration during pregnancy, confounding, selection bias, and exposure misclassification. Animal Data In rats or rabbits receiving glatiramer acetate by subcutaneous injection during the period of organogenesis, no adverse effects on embryo-fetal development were observed at doses up to 37.5 mg/kg/day (18 and 36 times, respectively, the therapeutic human dose of 20 mg/day on a mg/m 2 basis). In rats receiving subcutaneous glatiramer acetate at doses of up to 36 mg/kg from day 15 of pregnancy throughout lactation, no significant effects on delivery or on offspring growth and development were observed.
Pediatric use
8.4 Pediatric Use The safety and effectiveness of glatiramer acetate injection have not been established in patients under 18 years of age.
Geriatric use
8.5 Geriatric Use Glatiramer acetate injection has not been studied in elderly patients.
Description
Glatiramer acetate, the active ingredient of Glatopa, 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: Glatopa is a clear, colorless to slightly yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 1 mL of glatiramer acetate injection 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. The biological activity of glatiramer acetate is determined by its ability to block the induction of experimental autoimmune encephalomyelitis (EAE) in mice. structural-formula
Mechanism of action
12.1 Mechanism of Action The mechanism(s) by which glatiramer acetate exerts its effects in patients with MS are not fully understood. However, glatiramer acetate is thought to act by modifying immune processes that are believed to be responsible for the pathogenesis of MS. This hypothesis is supported by findings of studies that have been carried out to explore the pathogenesis of experimental autoimmune encephalomyelitis, a condition induced in animals through immunization against central nervous system derived material containing myelin and often used as an experimental animal model of MS. Studies in animals and in vitro systems suggest that upon its administration, glatiramer acetate-specific suppressor T-cells are induced and activated in the periphery. Because glatiramer acetate can modify immune functions, concerns exist about its potential to alter naturally-occurring immune responses. There is no evidence that glatiramer acetate does this, but this has not been systematically evaluated [see Warnings and Precautions ( 5.5 )] .
How supplied
Glatopa (glatiramer acetate injection) is a clear, colorless to slightly yellow, sterile, nonpyrogenic solution in a 1 mL single-dose glass syringe with attached 1/2 inch length, 29 gauge needle supplied as:
• 20 mg per mL in a single-dose, pre-filled syringe with a white plunger, in individual blister packages supplied in 30-count cartons (NDC 0781-3234-34)
• 40 mg per mL in a single-dose, pre-filled syringe with a blue plunger, in individual blister packages supplied in 12-count cartons (NDC 0781-3250-89) 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 [see Warnings and Precautions ( 5.7 ) and Patient Counseling Information ( 17 )] . Store Glatopa refrigerated at 2°C to 8°C (36°F to 46°F). If needed, the patient may store Glatopa 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 Glatopa. If a Glatopa syringe freezes, it should be discarded.
Patient 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 [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.7 )] . Anaphylactic Reactions Advise patients and their caregivers that Glatopa may cause life-threatening and fatal anaphylactic reactions shortly after injection, and that reactions may occur months to years after initiation of treatment [see Warnings and Precautions ( 5.1 )] . Inform patients and their caregivers about the signs and symptoms specific for anaphylactic reactions, and that signs and symptoms of anaphylactic reactions may overlap with those of immediate post-injection reactions. Instruct them to seek immediate emergency medical care if they experience any signs or symptoms of an anaphylactic reaction [see Warnings and Precautions ( 5.1 , 5.2 )] . Patients should be advised to also contact their healthcare provider, and that treatment should be discontinued immediately and permanently if anaphylactic reactions occur. Immediate Post-Injection Reaction Advise patients that Glatopa 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 [see Warnings and Precautions ( 5.2 )] . These symptoms occur within seconds to minutes after injection and are generally transient, self-limited, and do not require specific treatment. Inform patients that these symptoms may occur early or may have their onset several months after the initiation of treatment. A patient may experience one or several episodes of these symptoms. 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 [see Warnings and Precautions ( 5.1 , 5.2 )] . Chest Pain Advise patients that they may experience transient chest pain either as part of the Immediate Post-Injection Reaction or in isolation [see Warnings and Precautions ( 5.3 )] . Inform patients that the pain should be transient. Some patients may experience more than one such episode, usually beginning at least one month after the initiation of treatment. Patients should be advised to seek medical attention if they experience chest pain of unusual duration or intensity. Lipoatrophy and Skin Necrosis at Injection Site Advise patients that localized lipoatrophy, and rarely, skin necrosis may occur at injection sites [see Warnings and Precautions ( 5.4 )] . Instruct patients to follow proper injection technique and to rotate injection areas and sites with each injection to minimize these risks. Hepatic Injury Advise patients that hepatic injury, including hepatic failure and hepatitis with jaundice, has been reported with the use of Glatopa. Educate patients about the signs and symptoms of hepatic injury and instruct patients to report them immediately to their healthcare provider [see Warning and Precautions ( 5.6 )] . Pregnancy Instruct patients that if they are pregnant or plan to become pregnant while taking Glatopa they should inform their healthcare provider [see Use in Specific Populations ( 8.1 )] . Lactation Advise patients to notify their healthcare provider if they are breastfeeding or intend to breastfeed during Glatopa therapy [see Use in Specific Populations ( 8.2 )]. Instructions for Use Instruct patients to read the Glatopa Patient Information leaflet carefully. Glatopa 20 mg per mL and Glatopa 40 mg per mL are not interchangeable. Glatiramer acetate injection 20 mg per mL is administered daily and glatiramer acetate injection 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 Glatopa is refrigeration at 36°F to 46°F (2°C to 8°C). If needed, the patient may store Glatopa at room temperature, 59°F to 86°F (15°C to 30°C), for up to one month, but refrigeration is preferred. Glatopa should not be exposed to higher temperatures or intense light. Do not freeze Glatopa.
Label text from the FDA structured product label by Sandoz Inc (revised Jul 15, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Glatiramer Acetate in 4 products
Glatopa NDC products (4)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 63629-8815 | Glatiramer Acetate 20 mg/mL Injection, Solution | Bryant Ranch Prepack | ANDA |
| 63629-8816 | Glatiramer Acetate 40 mg/mL Injection, Solution | Bryant Ranch Prepack | ANDA |
| 0781-3234 | Glatiramer Acetate 20 mg/mL Injection, Solution | Sandoz Inc | ANDA |
| 0781-3250 | Glatiramer Acetate 40 mg/mL Injection, Solution | Sandoz Inc | ANDA |
Frequently asked questions
What is Glatopa used for?
Glatopa 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. Glatopa is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive…
What are the side effects of Glatopa?
The following serious adverse reactions are described elsewhere in the labeling: • Anaphylactic Reactions [see Warnings and Precautions ( 5.1 )] • Immediate Post-Injection Reaction [see Warnings and Precautions ( 5.2 )] • Chest Pain [see Warnings and Precautions ( 5.3 )] • Lipoatrophy and Skin Necrosis [see Warnings and Precautions ( 5.4 )] • Potential Effects on Immune Response [see Warnings and… See the full label for the complete list.
Who makes Glatopa?
Glatopa is listed by 2 labelers in the FDA NDC directory, including Bryant Ranch Prepack, Sandoz Inc.