Dupixent eczema injection 300 mg manufactured by Dupilumab. Dupixent Dupilumab cost in india best at Yourmedikart. uses moderate-to-severe atopic dermatitis

Product DUPIXENT 300 MG

GENERIC NAME : Dupilumab

WHAT IS DUPILUMAB USED FOR AND HOW DOES IT WORK?

Dupilumab uses moderate-to-severe atopic dermatitis, moderate-to-severe asthma, severe chronic rhinosinusitis with nasal polyps.

Dupilumab is available under the following different brand names: Dupixent.

dupilumab cost in india

 

WHAT ARE THE DOSAGES OF DUPILUMAB?

Dosages of Dupilumab:

Adult and Pediatric Dosage Forms and Strengths

Solution for Injection

  • 300 mg/2mL
  • 200 mg/1.14mL
  • Available as a single-dose prefilled syringe

Dosage Considerations – Should Give as Follows:

Moderate-to-Severe Atopic Dermatitis

  • Dupixent 300 mg Indicated when dermatitis is not adequately controlled with topical prescription therapies or when those therapies are not advisable
  • Adults: 600 mg (i.e., two 300-mg injections) subcutaneously (SC) once, and then 300 mg SC every other week
  • Can use with or without topical corticosteroids

Children 12 years and older:

  • 60 kg or greater: 600 mg (i.e., two 300-mg injections) SC once, and then 300 mg SC every other week
  • Less than 60 kg: 400 mg (i.e., two 200-mg injections) SC once, and then 200 mg SC every other week
  • It may  use with or without topical corticosteroids

Children under 12 years: Safety and efficacy not established.

Moderate-to-Severe Asthma

Indicated as add-on maintenance treatment for patients with an eosinophilic phenotype or orally corticosteroid dependent asthma/

Adults and children 12 years and older:

  • 400 mg SC once, then 200 mg every 2 weeks, OR
  • 600 mg SC once, then 300 mg every 2 weeks
  • 600 mg initial, then 300 mg every 2 weeks for patients with orally corticosteroid-dependent asthma or comorbid moderate-to-severe atopic dermatitis (for which dupilumab is indicated)

Children under 12 years: Safety and efficacy not established

Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

  • Indicated as add-on maintenance treatment
  • Adults: 300 mg SC every 2 Weeks

Dosing Considerations

  • Topical calcineurin inhibitors may use, for topical dermatitis, but should  reserve for problem areas only (e.g., face, neck, intertriginous, and genital areas)
  • Not indicated for acute bronchospasm or status asthmaticus
DUPIXENT injection is an injectable medicine that is administer by subcutaneous injection and is intend for use under the guidance of a healthcare provider.

This medication is used to treat a skin condition called DUPIXENT eczema (atopic dermatitis). It is also used along with other medications to help control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. In addition, dupilumab may use to reduce symptoms caused by nasal polyps and the long-term swelling of the sinuses and nasal passage (chronic rhinosinusitis with nasal polyposis). Dupilumab belongs to a class of drugs known as monoclonal antibodies. Dupixent eczema injection 300 mg manufactured by Dupilumab. Dupixent Dupilumab cost in india best at Yourmedikart. uses moderate-to-severe atopic dermatitis.It works by blocking certain natural proteins in your body (interleukin-4 and interleukin-13) that may cause inflammation and swelling.

Info
  • A patient may self-inject DUPIXENT—or a caregiver may administer DUPIXENT injection—after training has been provided by a healthcare provider on proper subcutaneous injection technique using the pre-filled syringe or pre-filled pen
    • The DUPIXENT injection pre-filled syringe should give by a caregiver in children younger than 12 years of age
    • In adolescents 12 years of age and older, it is recommended that DUPIXENT  administer by or under the supervision of an adult
  • It is important to provide proper training to patients and/or caregivers on the preparation and administration of DUPIXENT prior to use
  • After administration, advise patients to follow sharps disposal recommendations
  • Patients and/or caregivers should read the Instructions for Use—either 200 mg or 300 mg pre-filled pen or pre-filled syringe—prior to injecting
  • Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with DUPIXENT injection

Dosage Forms & Strengths

injectable solution

  • 300mg/2mL (single-dose prefilled syringe or pen)
  • 200mg/1.14mL (single-dose prefilled syringe or pen)

Atopic Dermatitis

Indicated for moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies or when those therapies not advisable

600 mg (ie, two 300-mg injections) SC once, and then 300 mg SC every other week

Can use with or without topical corticosteroids

Moderate-to-Severe Asthma

Indicated as add-on maintenance treatment for patients 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

600 mg initial, then 300 mg q2weeks for patients with PO corticosteroid-dependent asthma or comorbid moderate-to-severe atopic dermatitis (for which dupilumab is indicated)

Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Indicated as add-on maintenance treatment

300 mg SC q2Weeks

Eosinophilic Esophagitis

Indicated for eosinophilic esophagitis

300 mg SC qWeek

Dosing Considerations

Topical calcineurin inhibitors may use, for topical dermatitis, but should reserve for problem areas only (eg, face, neck, intertriginous, and genital areas)

Not indicated for acute bronchospasm or status asthmaticus

Vaccinations

  • Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines before initiating treatment

Orphan Designations

Bullous pemphigoid

Side Effects

  • Redness, irritation, or pain at the injection site may occur. Swelling/redness/itching of the eyes or eyelids may also occur. Dupixent 300 mg If any of these effects last or get worse, tell your doctor or pharmacist promptly.
  • Remember that this medication has prescribe because your doctor has judged that the benefit to you is greater than the risk of side effects. Dupixent 300 mg Many people using this medication do not have serious side effects.
  • Tell your doctor right away if you have any serious side effects, including: other eye problems (such as eye pain, changes in vision), joint pain.
  • Rarely, people with asthma who also use a steroid medication have had symptoms that may due to stopping or lowering the dose of their steroid. Tell your doctor right away if you develop symptoms such as fever that doesn’t go away, chest pain, or numbness/tingling in your arms or legs. Do not stop or change the dose of your steroid medication without your doctor’s direction.
  • A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
  • This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
  • In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
  • In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. Dupixent eczema injection 300 mg manufactured by Dupilumab. Dupixent Dupilumab cost in india best at Yourmedikart. uses moderate-to-severe atopic dermatitis

Precautions

  • Before using dupilumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
  • Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain type of infection (helminth).
  • Tell your health care professional that you are using dupilumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).
  • Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
  • During pregnancy, this medication should  use only when clearly needed. Discuss the risks and benefits with your doctor.
  • It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Consult your pharmacist or physician.

 

USE IN SPECIFIC POPULATIONS

  • Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to Dupixent 300 mg during pregnancy. To enroll or obtain information call 1-877-311-8972 or go to mothertobaby Available data from case reports and case series with DUPIXENT use in pregnant women have not identified a 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, DUPIXENT eczema may  transmitted from the mother to the developing fetus.
  • Lactation: There are no data on the presence of Dupixent 300 mg in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is know to  present in human milk. The developmental and health benefits of breastfeeding should  considered along with the mother’s clinical need for DUPIXENT and any potential adverse effects on the breastfed child from DUPIXENT or from the underlying maternal condition.

INDICATIONS

Atopic Dermatitis: Dupixent 300 mg is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can use with or without topical corticosteroids.

Asthma: Dupixent 300 mg is indicated as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. Limitation of Use: DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus.

Chronic rhinosinusitis with nasal polyposis (CRSwNP): DUPIXENT eczema is indicated as an add-on maintenance treatment in adult patients with inadequately controlled CRSwNP.

Eosinophilic Esophagitis: DUPIXENT Dupixent 300 mg is indicated for the treatment of adult and pediatric patients aged 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis.

CONTRAINDICATION: 

DUPIXENT Dupixent 300 mg is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have  report. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT eczema.

Conjunctivitis and Keratitis:

Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received DUPIXENT eczema versus placebo, with conjunctivitis the most frequently reported eye disorder. Also occurred more frequently in chronic rhinosinusitis with nasal polyposis subjects who received DUPIXENT injection compared to those who received placebo. Conjunctivitis and keratitis have  report with DUPIXENT injection postmarketing settings, predominantly in atopic dermatitis patients. Some patients reported visual disturbances (e.g., blurred vision) associated with conjunctivitis or keratitis. Advise patients to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate.

Eosinophilic Conditions:

 Patients treat for asthma may present with serious systemic eosinophilia sometimes presenting with clinical features of eosinophilic pneumonia or vasculitis consistent with eosinophilic granulomatosis with polyangiitis (EGPA), conditions which are often treated with systemic corticosteroid therapy. These events may associate with the reduction of oral corticosteroid therapy. Healthcare providers should  alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients with eosinophilia. Cases of eosinophilic pneumonia were reported in adult subjects who participate in the asthma development program and cases of vasculitis consistent with EGPA have report with DUPIXENT in adult subjects who participate in the asthma development program as well as in adult subjects with co-morbid asthma in the CRSwNP development program. A causal association between DUPIXENT and these conditions has not  established.

Acute Asthma Symptoms or Deteriorating Disease: 

Do not use DUPIXENT eczema to treat acute asthma symptoms, acute exacerbations, acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of DUPIXENT.

Risk Associate with Abrupt Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation of DUPIXENT. Reductions in corticosteroid dose, if appropriate, should gradual and perform under the direct supervision of a healthcare provider. Dupixent eczema injection 300 mg manufactured by Dupilumab. Dupixent Dupilumab cost in india best at Yourmedikart. uses moderate-to-severe atopic dermatitis Reduction in corticosteroid dose may  associate with systemic withdrawal symptoms and/or unmask conditions previously suppress by systemic corticosteroid therapy.

Patients with Co-morbid Asthma: Advise patients with comorbid asthma not to adjust or stop their asthma treatments without consultation with their physicians.

Arthralgia: Arthralgia has  report with the use of DUPIXENT with some patients reporting gait disturbances or decrease mobility associate with joint symptoms; some cases result in hospitalization. Advise patients to report new onset or worsening joint symptoms. If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of DUPIXENT.

Parasitic (Helminth) Infections:

Firstly It is unknown if DUPIXENT eczema will influence the immune response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with DUPIXENT injection . If patients become infected while receiving treatment with DUPIXENT and do not respond to anti-helminth treatment, discontinue treatment with DUPIXENT injection until the infection resolves. Helminth infections (5 cases of enterobiasis and 1 case of ascariasis) were reported in pediatric patients 6 to 11 years old in the pediatric asthma development program.

Vaccinations: Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating DUPIXENT. Avoid use of live vaccines in patients treated with DUPIXENT.

ADVERSE REACTIONS:

  • Atopic dermatitis: The most common adverse reactions (incidence ≥1%) in patients are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other her
  • Secondly simplex virus infection, dry eye, and eosinophilia. The safety profile in pediatric patients through Week 16 was similar to that of adults with atopic dermatitis. In an open-label extension study, the long-term safety profile of DUPIXENT eczema ± TCS in pediatric patients observe through Week 52 was consistent with that seen in adults with atopic dermatitis, with hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) report in patients 6 months to 5 years of age. Dupixent dupilumab cost in india best at Yourmedikat These cases did not lead to study drug discontinuation.
  • Asthma: The most common adverse reactions (incidence ≥1%) are injection site reactions, oropharyngeal pain, and eosinophilia.
  • Chronic rhinosinusitis with nasal polyposis: The most common adverse reactions (incidence ≥1%) are injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.
  • Eosinophilic esophagitis: The most common adverse reactions (incidence ≥2%) are injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Dupixent Dupilumab cost in india best at Yourmedikart.

Notes

Do not share this medication with others.

Missed Dose

It is important to get each dose of this medication as schedule. If you miss a dose, give a dose if it is less than 7 days from the missed dose. If it is more than 7 days from the missed dose (and you are using this drug every 2 weeks), then skip the missed dose and go back to your regular schedule. Do not double the dose to catch up. If you are using this medication every 4 weeks and it is more than 7 days from the missed dose, then start a new dosing schedule with the first dose given right away. Do not double the dose to catch up.

Storage

Store this medication in the refrigerator. Do not freeze. Similarly Keep the product in the original carton to protect from light. This medication may also  store at room temperature for up to 14 days. Dupixent dupilumab cost in india best at Yourmedikat. If stored at room temperature, use or discard after 14 days. Dupixent eczema injection 300 mg manufactured by Dupilumab. Dupixent Dupilumab cost in india best at Yourmedikart. uses moderate-to-severe atopic dermatitis

Do not flush medications down the toilet or pour them into a drain unless instruct to do so. After that Properly discard this product when it is expired or no longer need. Consult your pharmacist or local waste disposal company.

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