Dupixent Injection
Dupilumab
200mg/1.14ml
SANOFI-AVENTIS GROUPE.
| Pack size | 2 Pre-Filled Syringe with Needle Shield |
|---|---|
| Dispensing mode | POM |
| Source | FRANCE |
| Agent | CITY MEDICAL STORE |
| Retail Price | 6751.00 AED |
Indications
Dupixent Injection is used for:
Atopic Dermatitis, Asthma, Chronic Rhinosinusitis
Adult Dose
Atopic Dermatitis
Indicated for patients aged >12 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
600 mg (ie, two 300-mg injections) SC once, and then 300 mg SC every other week
Can be used with or without topical corticosteroids
Topical calcineurin inhibitors may be used, but should be reserved for problem areas only (eg, face, neck, intertriginous, and genital areas)
Asthma
Indicated as an add-on maintenance treatment for moderate-to-severe asthma in patients aged ?12 years with eosinophilic phenotype or PO corticosteroid dependent asthma
400 mg SC once, then 200 mg q2weeks, OR
600 mg SC once, then 300 mg q2weeks
For patients with PO corticosteroid-dependent asthma or comorbid moderate-to-severe atopic dermatitis (for which dupilumab is indicated), administer 600 mg initial dose then 300 mg q2weeks
Chronic Rhinosinusitis
Indicated as add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP)
300 mg SC q2Weeks
Child Dose
Atopic Dermatitis
Indicated for moderate-to-severe atopic dermatitis in adolescents aged ?12 yr whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable; may be used with or without topical corticosteroids
<12 years: Safety and efficacy not established
>12 years
>60 kg: 600 mg (ie, two 300-mg injections) SC once, and then 300 mg SC every other week
<60 kg: 400 mg (ie, two 200-mg injections) SC once, and then 200 mg SC every other week
Topical calcineurin inhibitors may be used, but should be reserved for problem areas only (eg, face, neck, intertriginous, and genital areas)
Asthma
Indicated as an add-on maintenance treatment for moderate-to-severe asthma in patients aged ?12 years with eosinophilic phenotype or PO corticosteroid dependent asthma
<12 years: Safety and efficacy not established
>12 years
400 mg SC once, then 200 mg q2weeks, OR
600 mg SC once, then 300 mg q2weeks
For patients with PO corticosteroid-dependent asthma or comorbid moderate-to-severe atopic dermatitis (for which dupilumab is indicated), administer 600 mg initial dose then 300 mg q2weeks
Renal Dose
Administration
SC Preparation
Remove syringe from the refrigerator and allow to reach room temperature (45 min for 300-mg syringe or 30 min for 200-mg syringe) without removing the needle cap
Inspect visually for particulate matter and discoloration prior to administration
Dupilumab is a clear to slightly opalescent, colorless-to-pale yellow solution; do not use if the liquid contains visible particulate matter, is discolored, or is cloudy (other than clear to slightly opalescent, colorless-to-pale yellow)
Does not contain preservatives; therefore, discard any unused product that remains in the syringe
SC Administration
For SC injection only
May self-administer SC into the thigh or abdomen, except for the 2 inches around the navel
May inject in the upper arm if administered by a caregiver
For atopic dermatitis and asthma initial doses (ie, two 300-mg or two 200-mg injection), administer each injection at different injection sites
Rotate injection site with each injection
Do not inject into skin that is tender, damaged, bruised, or scarred
Contra Indications
Known hypersensitivity to dupilumab or its excipients
Precautions
Hypersensitivity reactions, including anaphylaxis, generalized urticaria, rash, erythema nodosum, and serum sickness or serum sicknesslike reactions, reported; if clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue dupilumab
Conjunctivitis and keratitis reported more frequently in the treatment group during clinical trials for atopic dermatitis and CRSwNP; however, when treating asthma, incidence was similar to placebo
Patients with asthma may present with serious systemic eosinophilia, including clinical features of eosinophilic pneumonia or vasculitis consistent with eosinophilic granulomatosis with polyangiitis; these events may be associated with reduction of PO corticosteroids; monitor for rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy in patients with eosinophilia
Do not use to treat acute bronchospasm or status asthmaticus
Do not abruptly discontinue corticosteroid therapy upon initiation; reduce corticosteroid doses gradually, if appropriate, under physician supervision
Instruct patients with atopic dermatitis or CRSwNP who have comorbid asthma not to adjust or stop their asthma therapy without consulting their physician
Patients with pre-existing helminth infections were excluded from clinical trials; treat infections before initiating; if patient becomes infected and is unresponsive to antihelminths, discontinue dupilumab until infection resolves
Pregnancy-Lactation
Pregnancy
Available data from case reports and case series on use in pregnant women have not identified drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; human IgG antibodies are known to cross the placental barrier; therefore, drug may be transmitted from mother to developing fetus; there are adverse effects on maternal and fetal outcomes associated with asthma in pregnancy
In women with poorly or moderately controlled asthma, evidence demonstrates there is an increased risk of preeclampsia in mother and prematurity, low birth weight, and small for gestational age in the neonate; level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control
Lactation
There are no data on presence of dupilumab in human milk, effects on breastfed infant, or on milk production; maternal IgG is known to be present in human milk; effects of local gastrointestinal exposure and limited systemic exposure to dupilumab on breastfed infant are unknown; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition
Interactions
Avoid coadministration with live vaccines
CYP450 substrates
The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (eg, interleukin [IL]-1, IL-6, IL-10, TNF-alpha, IFN) during chronic inflammation
Dupilumab may modulate serum levels of some cytokines
Therefore, upon initiating or discontinuing dupilumab in patients who are receiving concomitant drugs that are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (eg, for warfarin) or drug concentration (eg, for cyclosporine) and consider dosage modification of the CYP450 substrate
Adverse Effects
Side effects of Dupilumab :
1-10%
Injection site reactions (10%)
Conjunctivitis (9-10%)
Blepharitis (<1-5%)
Oral herpes (3-4%)
Keratitis (<1-4%)
Immunogenicity, neutralizing (2%)
Eye pruritus (1-2%)
Other herpes simplex virus infection (1-2%)
Dry eye (<1-2%)
<1%
Eosinophilia
Mechanism of Action
Monoclonal antibody that inhibits interleukin-4 (IL-4) and IL-13 signaling by specifically binding to the IL-4R-alpha subunit shared by the IL-4 and IL-13 receptor complexes
Blocking the IL-4R-alpha subunit inhibits IL-4 and IL-13 cytokine-induced responses, including the release of proinflammatory cytokines, chemokines, and IgE
Note
Dupixent 200mg/1.14ml Injection manufactured by SANOFI-AVENTIS GROUPE.. Its generic name is Dupilumab. Dupixent is availble in United Arab Emirates.
Farmaco UAE drug index information on Dupixent Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.