Glatect

A centrally acting central muscle relaxant with sedative properties. It is claimed to inhibit muscle spasm by exerting an effect primarily at the level of the spinal cord and subcortical areas of the brain. (From Martindale, The Extra Pharmacopoea, 30th ed, p1202)

Glatect injection is indicated for the treatment of patients with relapsing forms of multiple sclerosis.

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

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

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

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

Recommended Dose

​Glatect injection is for subcutaneous use only. Do not administer intravenously. The dosing schedule depends on the product strength that is selected. The recommended dose is:

​Glatect injection 20 mg per mL and Glatect injection 40 mg per mL are not interchangeable.

Instructions for Use

​Remove one blister-packaged prefilled syringe from the refrigerated carton. Let the prefilled 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 prefilled syringe is for single use only. Discard unused portions.

See also:
What is the most important information I should know about Glatect?

Glatect injection is contraindicated in patients with known hypersensitivity to Glatect or mannitol.

Use Glatect exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Glatect is injected under the skin. You may be shown how to use injections at home. Do not self inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash and dry your hands before preparing the syringe and giving the injection.

Glatect prefilled syringes are for a single use only. Throw away the vial or syringe after each injection.

Before using the prefilled syringe, take it out of the refrigerator and let it warm at room temperature for 20 minutes. Do not warm the medication in a microwave or hot water. Do not remove air bubbles from the prefilled syringe or you may accidentally remove a small amount of the medicine.

Do not use Glatect if it has changed colors or has particles in it. Call your doctor for a new prescription.

Use a different place on your body each time you give yourself an injection. Your doctor will show you the places on your body where you can safely inject the medication. Do not inject Glatect into the same place two times within 1 week.

Do not stop using this medicine without first talking with your doctor.

Use a disposable needle only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Store the prefilled syringes and vials (bottles) of Glatect in the refrigerator. Do not allow the medicine to freeze.

You may also store Glatect at room temperature, away from moisture, light, and high heat. Glatect will keep for up to 30 days if stored at room temperature. Throw away any unused Glatect that has been at room temperature for longer than 30 days.

Glatect is used for the treatment of multiple sclerosis (disease in which the immune system [the cells responsible for defense in the body], damages the insulating covers [myelin sheath] of the brain and spinal cord cells leading to different types of physical, metal and psychiatric problems) and to reduce the frequency of recurrences of the attacks of multiple sclerosis in ambulatory patients (who can walk without help) with relapsing, remitting multiple sclerosis characterized by at least two attacks in the past two year period.

See also:
What other drugs will affect Glatect?

The concomitant use of alcohol or other central nervous system depressants may have an additive effect.

See also:
What are the possible side effects of Glatect?

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 clinical practice.

Incidence in Controlled Clinical Trials

Glatect Injection 20 mg per mL per Day

Among 563 patients treated with Glatect 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 treatment-emergent signs and symptoms that occurred in at least 2% of patients treated with Glatect injection 20 mg per mL in the placebo-controlled trials. These signs and symptoms were numerically more common in patients treated with Glatect than in patients treated with placebo. Adverse reactions were usually mild in intensity.

Adverse reactions which occurred only in 4 to 5 more subjects in the Glatect group than in the placebo group (less than 1% difference), but for which a relationship to Glatect could not be excluded, were arthralgia and herpes simplex.

Laboratory analyses were performed on all patients participating in the clinical program for Glatect. Clinically-significant laboratory values for hematology, chemistry, and urinalysis were similar for both Glatect and placebo groups in blinded clinical trials. In controlled trials one patient discontinued treatment due to thrombocytopenia (16 x109/L), which resolved after discontinuation of treatment.

Data on adverse reactions occurring in the controlled clinical trials of Glatect 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 Glatect 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 Glatect 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 Glatect and reported a reaction divided by the total number of patients exposed to Glatect. 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: Frequent adverse reactions are defined as those occurring in at least 1/100 patients and infrequent adverse reactions are those occurring in 1/100 to 1/1,000 patients.

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), abortion, breast engorgement, breast enlargement, carcinoma in situ cervix, fibrocystic breast, kidney calculus, nocturia, ovarian cyst, priapism, pyelonephritis, abnormal sexual function, and urethritis.

Glatect Injection 40 mg per mL 3 Times per Week: Among 943 patients treated with Glatect injection 40 mg per mL 3 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 treatment-emergent signs and symptoms that occurred in at least 2% of patients treated with Glatect injection 40 mg per mL in the blinded, placebo-controlled trial. These signs and symptoms were numerically more common in patients treated with Glatect injection 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 Glatect injection 40 mg per mL 3 times per week as compared to subjects treated with Glatect injection 20 mg per mL per day in clinical trials and during postmarketing experience. Data on adverse reactions occurring in the controlled clinical trial of Glatect injection 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.

Postmarketing Experience

The following adverse events occurring under treatment with Glatect injection 20 mg per mL since market introduction and not mentioned above have been identified during postapproval use of Glatect. Because these events 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; anaphylactoid 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; liver function abnormality; liver damage; hepatitis; eructation; cirrhosis of the liver; cholelithiasis

Hemic and Lymphatic System: thrombocytopenia; lymphoma-like reaction; acute leukemia

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