DailyMed Label: Acthar

DailyMed Label: Acthar

2024

DailyMed Prescription

Acthar

Repository Corticotropin

Mallinckrodt ARD LLC

NDC: 63004-8710

NDC: 63004-8711

NDC: 63004-8712

NDC: 63004-8710

NDC: 63004-8710

NDC: 63004-8712

NDC: 63004-8712

NDC: 63004-8711

NDC: 63004-8711

Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides. The Acthar Gel manufacturing process converts the initial porcine pituitary extract with low ACTH content into a mixture having modified porcine ACTH and other related peptide analogs solubilized in gelatin. A major component in the formulated complex mixture is N-25 deamidated porcine ACTH (1-39). Acthar Gel is supplied as a sterile preparation in 16% gelatin to provide a prolonged release after intramuscular or subcutaneous injection. Acthar Gel also contains 0.5% phenol, not more than 0.1% cysteine (added), sodium hydroxide and/or acetic acid to adjust pH and Water for Injection.

Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age. ( 1.1 ) Acthar Gel is indicated for the treatment of exacerbations of multiple sclerosis in adults. ( 1.2 ) Acthar Gel may be used for the following disorders and diseases: rheumatic ( 1.3 ); collagen ( 1.4 ); dermatologic ( 1.5 ); allergic states ( 1.6 ); ophthalmic ( 1.7 ); respiratory ( 1.8 ); and edematous state. ( 1.9 ) Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age. Acthar Gel is indicated for the treatment of acute exacerbations of multiple sclerosis in adults. Controlled clinical trials have shown Acthar Gel to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis; Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); Ankylosing spondylitis. During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis). Severe erythema multiforme, Stevens-Johnson syndrome. Serum sickness. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis; iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis; anterior segment inflammation. Symptomatic sarcoidosis. To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.

Acthar Gel vial is for either intramuscular or subcutaneous injection. ( 2.1 ) Acthar Gel single-dose pre-filled SelfJect injector: is for subcutaneous administration by adults only. ( 2.1 ) used to administer single doses of 40 units or 80 units only. ( 2.1 ) Infantile spasms: doses must be administered intramuscularly using the Acthar gel vial. The recommended dose is 150 U/m 2 divided into twice daily injections of 75 U/m 2 . After 2 weeks of treatment, dosing should be gradually tapered and discontinued over a 2-week period. Acthar Gel single-dose pre-filled SelfJect injector is not to be used for the treatment of infantile spasms ( 2.2 ) Acute exacerbations of multiple sclerosis: daily intramuscular or subcutaneous doses of 80 to 120 units for 2-3 weeks may be administered. It may be necessary to taper the dose. ( 2.3 ) Other disorders and diseases: individualize dosing depending on the disease and patient. The usual dose is 40 to 80 units given intramuscularly or subcutaneously every 24 to 72 hours. It may be necessary to taper the dose. ( 2.4 ) Acthar Gel vial is intended for either intramuscular or subcutaneous injection. Acthar Gel single-dose pre-filled SelfJect injector is for subcutaneous administration by adults (18 years of age and older) only. The single-dose pre-filled SelfJect injector should only be used to administer single doses of either 40 units or 80 units. For administration of doses other than 40 units or 80 units, use the Acthar Gel multi-dose vial. In the treatment of infantile spasms, Acthar Gel must be administered intramuscularly using the Acthar gel vial. Do not use the Acthar Gel single-dose pre-filled SelfJect injector for the treatment of infantile spasms. The recommended regimen is a daily dose of 150 U/m 2 (divided into twice daily intramuscular (IM) injections of 75 U/m 2 ) administered over a 2-week period. Dosing with Acthar Gel should then be gradually tapered over a 2-week period to avoid adrenal insufficiency. The following is one suggested tapering schedule: 30 U/m 2 in the morning for 3 days; 15 U/m 2 in the morning for 3 days; 10 U/m 2 in the morning for 3 days; and 10 U/m 2 every other morning for 6-days. Acthar Gel is typically dosed based on body surface area (BSA). For calculation of body surface area, use the following formula: Equation Formula The recommended dose is daily intramuscular or subcutaneous doses of 80 to 120 units for 2-3 weeks for acute exacerbations. Dosage should be individualized according to the medical condition of each patient. Frequency and dose of the drug should be determined by considering the severity of the disease and the initial response of the patient. Although drug dependence does not occur, sudden withdrawal of Acthar Gel after prolonged use may lead to adrenal insufficiency or recurrent symptoms which make it difficult to stop the treatment. It may be necessary to taper the dose and increase the injection interval to gradually discontinue the medication. Dosage should be individualized according to the disease under treatment and the general medical condition of each patient. Frequency and dose of the drug should be determined by considering severity of the disease and the initial response of the patient. The usual dose of Acthar Gel is 40 to 80 units given intramuscularly or subcutaneously every 24 to 72 hours. Although drug dependence does not occur, sudden withdrawal of Acthar Gel after prolonged use may lead to adrenal insufficiency or recurrent symptoms which make it difficult to stop the treatment. It may be necessary to taper the dose and increase the injection interval to gradually discontinue the medication. Visually inspect the liquid for particulate matter and discoloration prior to administration. Acthar Gel must not be injected if the solution is cloudy or contains particulate matter. Acthar Gel Multi-Dose Vial Warm to room temperature before using. Take caution to not over-pressurize the vial prior to withdrawing the product. Acthar Gel Single-Dose Pre-filled SelfJect Injector Preparation Prior to injection, remove from the refrigerator and sealed tray and allow to sit for 45 minutes to warm to room temperature. Administration Read the FDA-approved Instructions for Use carefully before administering. Administer by subcutaneous injection only. Acthar Gel single-dose pre-filled SelfJect injector is not for intramuscular injection. Inject in the upper thigh, abdomen, or back of arm. Avoid injecting within 1 inch of navel, knee, or groin area. Avoid areas with scars, tattoos, warts, birthmarks, or stretch marks, or where the skin is irritated. Rotate injection sites. Do not use the same site more than one time per week.

Injection available as: 400 USP Units/5 mL (80 USP Units/mL) in a multi-dose vial for subcutaneous or intramuscular injection. 40 USP Units/0.5 mL in a single-dose pre-filled SelfJect injector for subcutaneous injection. 80 USP Units/mL in a single-dose pre-filled SelfJect injector for subcutaneous injection. Acthar Gel (repository corticotropin injection) is a clear light amber solution mobile at room temperature. Injection available as: 5 mL multi-dose vial containing 80 USP units/mL, for intramuscular or subcutaneous use. ( 3 ) 40 USP Units/0.5 mL Acthar Gel single-dose pre-filled SelfJect injector for subcutaneous injection. ( 3 ) 80 USP Units/mL Acthar Gel single-dose pre-filled SelfJect injector for subcutaneous injection. ( 3 )

Acthar Gel is contraindicated: for intravenous administration. in infants under 2 years of age who have suspected congenital infections. with concomitant administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of Acthar Gel. in patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction, or sensitivity to proteins of porcine origin. Acthar Gel is contraindicated: for intravenous administration ( 4 ) in infants under 2 years of age who have suspected congenital infections ( 4 ) with concomitant administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of Acthar Gel ( 4 ) in patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction, or sensitivity to proteins of porcine origin ( 4 )

The adverse effects of Acthar Gel are related primarily to its steroidogenic effects. Not all of the adverse events described below have been seen after treatment with Acthar Gel, but they might be expected to occur because they are steroidogenic effects [see Adverse Reactions (6.3) ] . Infections: Increased susceptibility to new infection and increased risk of exacerbation, dissemination or reactivation of latent infections. Signs and symptoms of infection may be masked. ( 5.1 ) Adrenal Insufficiency after Prolonged Therapy: Monitor for effects of hypothalamic-pituitary-adrenal axis suppression after stopping treatment. ( 5.2 ) Cushing's Syndrome: May occur after prolonged therapy. Monitor for signs and symptoms. ( 5.2 ) Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia: Monitor blood pressure and sodium and potassium levels. ( 5.3 ) Masking of Symptoms of Other Underlying Disease/Disorders: Monitor patients for signs of other underlying disease/disorders that may be masked. ( 5.5 ) Gastrointestinal Perforation and Bleeding: There is a risk for gastric ulcers and bleeding. There is an increased risk of perforation in patients with certain GI disorders. Signs and symptoms may be masked. Monitor for signs of perforation and bleeding. ( 5.6 ) Behavioral and Mood Disturbances: May include euphoria, insomnia, mood swings, personality changes, severe depression and psychosis. Existing conditions may be aggravated. ( 5.7 ) Comorbid Diseases: Symptoms of diabetes and myasthenia gravis may be worsened with treatment. ( 5.8 ) Ophthalmic Effects: Monitor for cataracts, infections and glaucoma. ( 5.9 ) Immunogenicity Potential: Neutralizing antibodies with chronic administration may lead to a loss of endogenous ACTH activity. ( 5.10 ) Use in Patients with Hypothyroidism or Liver Cirrhosis: May result in an enhanced effect. ( 5.11 ) Negative Effects on Growth and Physical Development: Monitor pediatric patients on long term therapy. ( 5.12 ) Decrease in Bone Density: Monitor for osteoporosis in patients on long term therapy. ( 5.13 ) Acthar Gel may increase the risks related to infections with any pathogen, including viral, bacterial, fungal, protozoan or helminthic infections. Patients with latent tuberculosis or tuberculin reactivity should be observed closely, and if therapy is prolonged, chemoprophylaxis should be instituted. Treatment with Acthar Gel can cause hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome. These conditions should be monitored especially with chronic use. Suppression of the HPA may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Patients should be monitored for signs of insufficiency such as weakness, hyperpigmentation, weight loss, hypotension and abdominal pain. The symptoms of adrenal insufficiency in infants treated for infantile spasms can be difficult to identify. The symptoms are non-specific and may include anorexia, fatigue, lethargy, weakness, excessive weight loss, hypotension and abdominal pain. It is critical that parents and caregivers be made aware of the possibility of adrenal insufficiency when discontinuing Acthar Gel and should be instructed to observe for, and be able to recognize, these symptoms [see Patient Counseling Information (17) ] . The recovery of the adrenal gland may take from days to months so patients should be protected from the stress (e.g., trauma or surgery) by the use of corticosteroids during the period of stress. The adrenal insufficiency may be minimized by tapering of the dose when discontinuing treatment. Signs or symptoms of Cushing's syndrome may occur during therapy but generally resolve after therapy is stopped. Patients should be monitored for these signs and symptoms such as deposition of adipose tissue in characteristics sites (e.g., moon face, truncal obesity), cutaneous striae, easy bruisability, decreased bone mineralization, weight gain, muscle weakness, hyperglycemia, and hypertension. Acthar Gel can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium and calcium. Dietary salt restriction and potassium supplementation may be necessary. Caution should be used in the treatment of patients with hypertension or renal insufficiency. Acthar Gel is contraindicated in patients with congestive heart failure [see Contraindications (4) ] . Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of Acthar Gel. Killed or inactivated vaccines may be administered; however, the response to such vaccines can not be predicted. Other immunization procedures should be undertaken with caution in patients who are receiving Acthar Gel, especially when high doses are administered, because of the possible hazards of neurological complications and lack of antibody response. Acthar Gel often acts by masking symptoms of other diseases/disorders without altering the course of the other disease/disorder. Patients should be monitored carefully during and for a period following discontinuation of therapy for signs of infection, abnormal cardiac function, hypertension, hyperglycemia, change in body weight and fecal blood loss. Acthar Gel can cause GI bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain gastrointestinal disorders. Signs of gastrointestinal perforation, such as peritoneal irritation, may be masked by the therapy. Use caution where there is the possibility of impending perforation, abscess or other pyogenic infections, diverticulitis, fresh intestinal anastomoses, and active or latent peptic ulcer. Use of Acthar Gel may be associated with central nervous system effects ranging from euphoria, insomnia, irritability (especially in infants), mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated. These effects are reversible once Acthar Gel therapy is stopped. Patients with a comorbid disease may have that disease worsened. Caution should be used when prescribing Acthar Gel in patients with diabetes and myasthenia gravis. Prolonged use of Acthar Gel may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves and may enhance the establishment of secondary ocular infections due to fungi and viruses. Acthar Gel is immunogenic. Limited available data suggest that a patient may develop antibodies to Acthar Gel after chronic administration and loss of endogenous ACTH and Acthar Gel activity. Prolonged administration of Acthar Gel may increase the risk of hypersensitivity reactions. Cases of anaphylaxis have been reported in the postmarketing setting. Use in patients with sensitivity to porcine protein is contraindicated, and the possibility of sensitivity should be considered during the course of treatment should symptoms arise. There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver. Long-term use of Acthar Gel may have negative effects on growth and physical development in pediatric patients. Changes in appetite are seen with Acthar Gel therapy, with the effects becoming more frequent as the dose or treatment period increases. These effects are reversible once Acthar Gel therapy is stopped. Growth and physical development of pediatric patients on prolonged therapy should be carefully monitored. Decrease in bone formation and an increase in bone resorption both through an effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function may occur. These, together with a decrease in the protein matrix of the bone (secondary to an increase in protein catabolism) and reduced sex hormone production, may lead to inhibition of bone growth in children and adolescents and to the development of osteoporosis at any age. Special consideration should be given to patients at increased risk of osteoporosis (i.e., postmenopausal women) before initiating therapy, and bone density should be monitored in patients on long term therapy.

The following clinically significant adverse reactions are described elsewhere in the labeling:

Formal drug-drug interaction studies have not been performed. Acthar Gel may accentuate the electrolyte loss associated with diuretic therapy. Acthar Gel may accentuate electrolyte loss associated with diuretics. ( 7 )

Pediatric Use: Prolonged use of Acthar Gel in children may inhibit skeletal growth. If use is necessary, it should be given intermittently with careful observation. ( 5.12 , 5.13 , and 8.4 ) Pregnancy: May cause fetal harm. ( 8.1 ) Risk Summary Based on Acthar Gel's pharmacological effect of stimulating an endogenous steroid response [see Clinical Pharmacology (12.1) ] , Acthar Gel may cause fetal harm when administered to a pregnant woman. The published literature on systemic corticosteroid use during pregnancy, which may be relevant, suggests potential concerns. Intrauterine growth restriction, decreased birth weight, and preterm birth have been reported with maternal use of corticosteroids; however, the underlying maternal condition may also contribute to these risks. Hypoadrenalism has also been reported in infants after high-dose and/or long-term use of corticosteroids during pregnancy (see Clinical Considerations ) . The potential adverse developmental effects of Acthar Gel have not been adequately assessed in animals. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. 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. Clinical Considerations Fetal-Neonatal Adverse Reactions Hypoadrenalism has been reported in infants born to mothers treated with systemic corticosteroids during pregnancy. Infants born to mothers treated with Acthar Gel should be carefully observed for signs of hypoadrenalism, such as poor feeding, irritability, weakness, and vomiting, and managed accordingly [see Warnings and Precautions (5.2) ] . Risk Summary There are no available data on the presence of corticotropin in either human or animal milk, the effects on the breastfed infant, or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Acthar Gel and any potential adverse effects on the breastfed infant from Acthar Gel or from the underlying maternal condition. Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children less than 2 years of age. Both serious and other adverse reactions can occur in this population [see Warnings and Precautions (5) and Adverse Reactions (6.1) ] . The efficacy of Acthar Gel for the treatment of infantile spasms in infants and children less than 2 years of age was evaluated in a randomized, single blinded (video EEG interpreter blinded) clinical trial and an additional active control supportive trial [see Clinical Studies (14) ] . A responding patient was defined as having both complete cessation of spasms and elimination of hypsarrhythmia. Safety in the pediatric population for infantile spasms was evaluated by retrospective chart reviews and data from non-sponsor conducted clinical trials [see Adverse Reactions (6.1) ] . While the types of adverse reactions seen in infants and children under 2 years of age treated for infantile spasms are similar to those seen in older patients, their frequency and severity may be different due to the very young age of the infant, the underlying disorder, the duration of therapy and the dosage regimen. Effects on growth are of particular concern [see Warnings and Precautions (5.12) ] . Serious adverse reactions observed in adults may also occur in children [see Warnings and Precautions (5) ] .

Acthar Gel (repository corticotropin injection) is a clear light amber solution mobile at room temperature. Acthar Gel is supplied in the following configurations: Strength Package size NDC number 80 USP Units/mL 5 mL multi-dose vial (1 count) 63004-8710-1 40 USP Units/0.5 mL single-dose pre-filled SelfJect injector (4 count) 63004-8712-4 80 USP Units/mL single-dose pre-filled SelfJect injector (4 count) 63004-8711-4 Store Acthar Gel vial and Acthar Gel single-dose pre-filled SelfJect injector under refrigeration between 2°C to 8°C (36°F to 46°F) in the carton to protect from light. After removing the single-dose pre-filled SelfJect injector from the refrigerator, it can be stored at room temperature between 20°C to 25°C (68°F to 77°F) for up to 24 hours. Do not heat, freeze, or put the Acthar Gel single-dose pre-filled SelfJect injector into direct sunlight. Dispense single-dose pre-filled SelfJect injectors in the original sealed carton with the enclosed Instructions for Use.

The mechanism of action of Acthar Gel in the treatment of infantile spasms is unknown. Acthar Gel and endogenous ACTH stimulate the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances. Prolonged administration of large doses of Acthar Gel induces hyperplasia and hypertrophy of the adrenal cortex and continuous high output of cortisol, corticosterone and weak androgens. The release of endogenous ACTH is under the influence of the nervous system via the regulatory hormone released from the hypothalamus and by a negative corticosteroid feedback mechanism. Elevated plasma cortisol suppresses ACTH release. Acthar Gel is also reported to bind to melanocortin receptors. The trophic effects of endogenous ACTH and Acthar Gel on the adrenal cortex are not well understood beyond the fact that they appear to be mediated by cyclic AMP. ACTH rapidly disappears from the circulation following its intravenous administration; in people, the plasma half-life is about 15 minutes. The pharmacokinetics of Acthar Gel have not been adequately characterized. The maximal effects of a trophic hormone on a target organ are achieved when optimal amounts of hormone are acting continuously. Thus, a fixed dose of Acthar Gel will demonstrate a linear increase in adrenocortical secretion with increasing duration for the infusion.

Carcinogenesis Adequate studies of the carcinogenic potential of Acthar Gel have not been conducted. Mutagenesis The genotoxic potential of Acthar Gel has not been adequately evaluated. Impairment of Fertility The potential effects of Acthar Gel on fertility have not been adequately assessed in animals.

The effectiveness of Acthar Gel as a treatment for infantile spasms was demonstrated in a single blinded (video EEG interpreter blinded) clinical trial in which patients were randomized to receive either a 2-week course of treatment with Acthar Gel (75 U/m 2 intramuscular twice daily) or prednisone (1 mg/kg by mouth twice daily). The primary outcome was a comparison of the number of patients in each group who were treatment responders, defined as a patient having complete suppression of both clinical spasms and hypsarrhythmia on a full sleep cycle video EEG performed 2 weeks following treatment initiation, rated by an investigator blinded to treatment. Thirteen of 15 patients (86.7%) responded to Acthar Gel as compared to 4 of 14 patients (28.6%) given prednisone (p<0.002). The 2-week treatment was followed by a 2-week period of taper. Nonresponders to the prednisone treatment were eligible to receive Acthar Gel treatment. Seven of 8 patients (87.5%) responded to Acthar Gel after not responding to prednisone. Similarly, the 2 nonresponder patients from the Acthar Gel treatment were eligible to receive treatment with prednisone. One of the 2 patients (50%) responded to the prednisone treatment after not responding to Acthar Gel. A supportive single-blind, randomized clinical trial comparing high-dose, long-duration treatment (150 U/m 2 once daily for 3 weeks, n=30) of Acthar Gel with low-dose, short-duration treatment (20 U once daily for 2 weeks, n=29) for the treatment of infantile spasms was also evaluated in infants and children less than 2 years of age. Nonresponders (defined as in the previously described study) in the low-dose group received a dose escalation at 2 weeks to 30 U once daily. Nominal statistical superiority of the high dose treatment, as compared to the low dose treatment, was observed for cessation of spasms but not for the resolution of hypsarrhythmia.

ACTHAR ® GEL [AK-thar jel] (repository corticotropin injection) for subcutaneous use only 40 USP Units/0.5 mL Single-Dose Pre-filled SelfJect™ Injector Before use After the Injection is Complete Important Information The Acthar Gel single-dose pre-filled SelfJect injector is for under the skin (subcutaneous) injection only. 1. Read These Instructions Contact your healthcare provider if you are unsure of how to give the injection. This is not an auto-injector. The Handle must be pushed down by hand. This is a single-dose injector (for 1-time use only). The injector has a Needle Guard to protect you after use. 2. Prepare to Use the Acthar Gel single-dose prefilled SelfJect Injector Take the injector out of the refrigerator and remove it from its injector tray to warm at room temperature for a minimum of 45 minutes. Do not use the injector right after removing from the refrigerator. The injector does not work as well when cold. Do not heat. Check the expiration date (EXP) on the package. Complete this injection in a clean, well-lit room. Gather alcohol swab, adhesive bandage, and a sharps disposal container. 3. Choose and Clean the Injection Site For under the skin (subcutaneous) injection only. Choose 1 of these sites for injection: - Upper thigh - Belly (abdomen), not within 1-inch of belly button (navel) - Back of arm (only if someone else is giving the injection) Choose a different site for each injection Do not inject through clothing Wash your hands well with soap and water. Avoid injecting into: - Irritated skin (red, swollen, or painful) - Tattoos, warts, scars, or birthmarks - Within 1-inch of knee or groin area - Stretch marks Clean the injection site with an alcohol swab. 4. Inspect and Uncap Inspect the medicine in the Window. The medicine should be a clear light yellow or orange solution. Do not use if the medicine is cloudy or you see particles. It is normal to see air bubbles. Pull Bottom Cap off to remove it and throw it away. Do not recap the injector as this may damage the needle. Avoid touching the Gray Needle Guard. Use the injector right away. 5. Inject (a) Place the injector straight on the cleaned skin at a 90-degree angle. Do not pinch the skin. (b) Slowly push down the Handle to inject the medicine. Do not lift the injector during the injection You may hear a "click" when the injection begins. (c) The injection is complete when the Green Colored Body disappears and you may hear a "click." 6. Lift and Throw Away (Dispose of) Lift the injector straight up at a 90-degree angle off the injection site. The Needle Guard is locked when you see the yellow band. Place the injector in an approved sharps disposal container according to local regulations. Do not throw away (dispose of) in your household trash. MCK-0131 Rev 9 Image Image Image Image Image Image Image Image Image Image Image Image Image

NDC 63004-8710-1 Acthar ® Gel (repository corticotropin injection) 400 USP units/5 mL (80 USP units/mL) For intramuscular or subcutaneous use. 5 mL multiple-dose vial Dispense the enclosed Medication Guide to each Infantile Spasm patient. Rx only PRINCIPAL DISPLAY PANEL - 5 mL Vial Carton