HIGHLIGHTS OF PRESCRIBING INFORMATION an initial dose of

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14 CLINICAL STUDIES 16 HOW SUPPLIED STORAGE AND HANDLING. 16 1 How Supplied,14 1 Atopic Dermatitis 16 2 Storage and Handling. 14 2 Asthma 17 PATIENT COUNSELING INFORMATION, Sections or subsections omitted from the full prescribing information are not. 14 3 Chronic Rhinosinusitis with Nasal Polyposis listed. FULL PRESCRIBING INFORMATION Rotate the injection site with each injection DO NOT inject DUPIXENT into skin that is. tender damaged bruised or scarred,1 INDICATIONS AND USAGE. If a dose is missed instruct the patient to administer the injection within 7 days from the. DUPIXENT is indicated for the following diseases missed dose and then resume the patient s original schedule If the missed dose is not. 1 1 Atopic Dermatitis administered within 7 days instruct the patient to wait until the next dose on the original. DUPIXENT is indicated for the treatment of patients aged 12 years and older with. moderate to severe atopic dermatitis whose disease is not adequately controlled with The DUPIXENT Instructions for Use contains more detailed instructions on the. topical prescription therapies or when those therapies are not advisable DUPIXENT can preparation and administration of DUPIXENT see Instructions for Use. be used with or without topical corticosteroids 2 5 Preparation for Use of DUPIXENT Pre filled Syringe with Needle Shield. 1 2 Asthma Before injection remove DUPIXENT pre filled syringe from the refrigerator and allow. DUPIXENT to reach room temperature 45 minutes for the 300 mg 2 mL pre filled syringe. DUPIXENT is indicated as an add on maintenance treatment in patients with moderate and 30 minutes for the 200 mg 1 14 mL pre filled syringe without removing the needle. to severe asthma aged 12 years and older with an eosinophilic phenotype or with oral cap. corticosteroid dependent asthma, Inspect DUPIXENT visually for particulate matter and discoloration prior to administration. Limitation of Use DUPIXENT is a clear to slightly opalescent colorless to pale yellow solution Do not use. DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus if the liquid contains visible particulate matter is discolored or cloudy other than clear to. slightly opalescent colorless to pale yellow DUPIXENT does not contain preservatives. 1 3 Chronic Rhinosinusitis with Nasal Polyposis therefore discard any unused product remaining in the pre filled syringe. DUPIXENT is indicated as an add on maintenance treatment in adult patients with 3 DOSAGE FORMS AND STRENGTHS. inadequately controlled chronic rhinosinusitis with nasal polyposis CRSwNP DUPIXENT is a clear to slightly opalescent colorless to pale yellow solution available as. 2 DOSAGE AND ADMINISTRATION Injection 300 mg 2 mL in a single dose pre filled syringe with needle shield. DUPIXENT is administered by subcutaneous injection Injection 200 mg 1 14 mL in a single dose pre filled syringe with needle shield. 2 1 Atopic Dermatitis 4 CONTRAINDICATIONS, Dosing in Adults DUPIXENT is contraindicated in patients who have known hypersensitivity to dupilumab.
or any of its excipients see Warnings and Precautions 5 1. The recommended dose of DUPIXENT for adult patients is an initial dose of 600 mg two. 300 mg injections followed by 300 mg given every other week 5 WARNINGS AND PRECAUTIONS. Dosing in Adolescents 5 1 Hypersensitivity, Hypersensitivity reactions including generalized urticaria rash erythema nodosum and. The recommended dose of DUPIXENT for patients 12 to 17 years of age is specified in serum sickness or serum sickness like reactions were reported in less than 1 of subjects. Table 1 who received DUPIXENT in clinical trials Two subjects in the atopic dermatitis develop. ment program experienced serum sickness or serum sickness like reactions that were. Table 1 Dose of DUPIXENT for Subcutaneous Administration in Adolescent associated with high titers of antibodies to dupilumab One subject in the asthma. Patients development program experienced anaphylaxis see Adverse Reactions 6 2 If a. Body Weight Initial Dose Subsequent Doses every clinically significant hypersensitivity reaction occurs institute appropriate therapy and. other week discontinue DUPIXENT see Adverse Reactions 6 1 6 2. less than 60 kg 400 mg two 200 mg 200 mg 5 2 Conjunctivitis and Keratitis. injections Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who. received DUPIXENT Conjunctivitis was the most frequently reported eye disorder Most. 60 kg or more 600 mg two 300 mg 300 mg subjects with conjunctivitis recovered or were recovering during the treatment period. injections Keratitis was reported in 1 of the DUPIXENT group 1 per 100 subject years and in. 0 of the placebo group 0 per 100 subject years in the 16 week atopic dermatitis. monotherapy trials In the 52 week DUPIXENT topical corticosteroids TCS atopic. Concomitant Topical Therapies dermatitis trial keratitis was reported in 4 of the DUPIXENT TCS group 12 per 100. DUPIXENT can be used with or without topical corticosteroids Topical calcineurin subject years and in 0 of the placebo TCS group 0 per 100 subject years Most. inhibitors may be used but should be reserved for problem areas only such as the face subjects with keratitis recovered or were recovering during the treatment period see. Adverse Reactions 6 1,neck intertriginous and genital areas. Among asthma subjects the frequencies of conjunctivitis and keratitis were similar. 2 2 Asthma between DUPIXENT and placebo see Adverse Reactions 6 1. The recommended dose of DUPIXENT for adults and adolescents 12 years of age and In subjects with CRSwNP the frequency of conjunctivitis was 2 in the DUPIXENT group. older is compared to 1 in the placebo group in the 24 week safety pool these subjects. an initial dose of 400 mg two 200 mg injections followed by 200 mg given every recovered There were no cases of keratitis reported in the CRSwNP development. other week or program see Adverse Reactions 6 1, Advise patients to report new onset or worsening eye symptoms to their healthcare. an initial dose of 600 mg two 300 mg injections followed by 300 mg given every provider. other week,5 3 Eosinophilic Conditions, for patients with oral corticosteroids dependent asthma or with co morbid moderate Patients being treated for asthma may present with serious systemic eosinophilia. to severe atopic dermatitis for which DUPIXENT is indicated start with an initial dose sometimes presenting with clinical features of eosinophilic pneumonia or vasculitis. of 600 mg followed by 300 mg given every other week consistent with eosinophilic granulomatosis with polyangiitis conditions which are often. 2 3 Chronic Rhinosinusitis with Nasal Polyposis treated with systemic corticosteroid therapy These events may be associated with the. reduction of oral corticosteroid therapy Physicians should be alert to vasculitic rash. The recommended dose of DUPIXENT for adult patients is 300 mg given every other worsening pulmonary symptoms cardiac complications and or neuropathy presenting in. week their patients with eosinophilia Cases of eosinophilic pneumonia were reported in adult. 2 4 Important Administration Instructions patients who participated in the asthma development program and cases of vasculitis. consistent with eosinophilic granulomatosis with polyangiitis have been reported with. DUPIXENT is intended for use under the guidance of a healthcare provider A patient may DUPIXENT in adult patients who participated in the asthma development program as well. self inject DUPIXENT after training in subcutaneous injection technique using the pre filled as in adult patients with co morbid asthma in the CRSwNP development program A causal. syringe Provide proper training to patients and or caregivers on the preparation and association between DUPIXENT and these conditions has not been established. administration of DUPIXENT prior to use according to the Instructions for Use. 5 4 Acute Asthma Symptoms or Deteriorating Disease. For atopic dermatitis and asthma patients taking an initial 600 mg dose administer each DUPIXENT should not be used to treat acute asthma symptoms or acute exacerbations. of the two DUPIXENT 300 mg injections at different injection sites Do not use DUPIXENT to treat acute bronchospasm or status asthmaticus Patients. For asthma patients taking an initial 400 mg dose administer each of the two DUPIXENT should seek medical advice if their asthma remains uncontrolled or worsens after initiation. 200 mg injections at different injection sites of treatment with DUPIXENT. Administer subcutaneous injection into the thigh or abdomen except for the 2 inches 5 5 5 Reduction of Corticosteroid Dosage. cm around the navel The upper arm can also be used if a caregiver administers the Do not discontinue systemic topical or inhaled corticosteroids abruptly upon initiation of. injection therapy with DUPIXENT Reductions in corticosteroid dose if appropriate should be. gradual and performed under the direct supervision of a physician Reduction in Safety through Week 52 Trial 3. corticosteroid dose may be associated with systemic withdrawal symptoms and or unmask. conditions previously suppressed by systemic corticosteroid therapy In the DUPIXENT with concomitant TCS trial Trial 3 through Week 52 the proportion of. subjects who discontinued treatment because of adverse events was 1 8 in DUPIXENT. 5 6 Patients with Co morbid Asthma 300 mg Q2W TCS group and 7 6 in the placebo TCS group Two subjects. Advise patients with atopic dermatitis or CRSwNP who have co morbid asthma not to discontinued DUPIXENT because of adverse reactions atopic dermatitis 1 subject and. adjust or stop their asthma treatments without consultation with their physicians exfoliative dermatitis 1 subject. 5 7 Parasitic Helminth Infections The safety profile of DUPIXENT TCS through Week 52 was generally consistent with. the safety profile observed at Week 16, Patients with known helminth infections were excluded from participation in clinical studies.
It is unknown if DUPIXENT will influence the immune response against helminth infections Adolescents with Atopic Dermatitis. Treat patients with pre existing helminth infections before initiating therapy with The safety of DUPIXENT was assessed in a trial of 250 subjects 12 to 17 years of age. DUPIXENT If patients become infected while receiving treatment with DUPIXENT and do with moderate to severe atopic dermatitis Trial 6 The safety profile of DUPIXENT in. not respond to anti helminth treatment discontinue treatment with DUPIXENT until the these subjects through Week 16 was similar to the safety profile from studies in adults with. infection resolves atopic dermatitis, 6 ADVERSE REACTIONS The long term safety of DUPIXENT was assessed in an open label extension study in. subjects 12 to 17 years of age with moderate to severe atopic dermatitis Trial 7 The. The following adverse reactions are discussed in greater detail elsewhere in the labeling safety profile of DUPIXENT in subjects followed through Week 52 was similar to the safety. Hypersensitivity see Warnings and Precautions 5 1 profile observed at Week 16 in Trial 6 The long term safety profile of DUPIXENT observed. in adolescents was consistent with that seen in adults with atopic dermatitis. Conjunctivitis and Keratitis see Warnings and Precautions 5 2. 6 1 Clinical Trials Experience, A total of 2888 adult and adolescent subjects with moderate to severe asthma AS were. Because clinical trials are conducted under widely varying conditions adverse reaction evaluated in 3 randomized placebo controlled multicenter trials of 24 to 52 weeks. rates observed in the clinical trials of a drug cannot be directly compared to rates in the duration AS Trials 1 2 and 3 Of these 2678 had a history of 1 or more severe. clinical trials of another drug and may not reflect the rates observed in practice exacerbations in the year prior to enrollment despite regular use of medium to high dose. Adults with Atopic Dermatitis inhaled corticosteroids plus an additional controller s AS Trials 1 and 2 A total of 210. subjects with oral corticosteroid dependent asthma receiving high dose inhaled corticos. Three randomized double blind placebo controlled multicenter trials Trials 1 2 and 3 teroids plus up to two additional controllers were enrolled AS Trial 3 The safety. and one dose ranging trial Trial 4 evaluated the safety of DUPIXENT in subjects with population AS Trials 1 and 2 was 12 87 years of age of which 63 were female and. moderate to severe atopic dermatitis The safety population had a mean age of 38 years 82 were white DUPIXENT 200 mg or 300 mg was administered subcutaneously Q2W. 41 of subjects were female 67 were white 24 were Asian and 6 were black in following an initial dose of 400 mg or 600 mg respectively. terms of co morbid conditions 48 of the subjects had asthma 49 had allergic rhinitis. 37 had food allergy and 27 had allergic conjunctivitis In these 4 trials 1472 subjects In AS Trials 1 and 2 the proportion of subjects who discontinued treatment due to adverse. were treated with subcutaneous injections of DUPIXENT with or without concomitant events was 4 of the placebo group 3 of the DUPIXENT 200 mg Q2W group and 6. topical corticosteroids TCS of the DUPIXENT 300 mg Q2W group. A total of 739 subjects were treated with DUPIXENT for at least 1 year in the development Table 3 summarizes the adverse reactions that occurred at a rate of at least 1 in subjects. program for moderate to severe atopic dermatitis treated with DUPIXENT and at a higher rate than in thei. 8 4 Pediatric Use 8 5 Geriatric Use 10 OVERDOSE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12 1 Mechanism of Action 12 2 Pharmacodynamics 12 3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13 1 Carcinogenesis Mutagenesis Impairment of Fertility 14 CLINICAL STUDIES 14 1 Atopic Dermatitis 14 2 Asthma 14 3 Chronic Rhinosinusitis with Nasal Polyposis 16 HOW SUPPLIED STORAGE AND HANDLING 16 1 How

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