Dupixent

**For the treatment of atopic dermatitis, the starting dose of dupilumab for adults is 600 mg injected subcutaneously (under the skin). **After the first dose, 300 mg is injected subcutaneously every 2 weeks.

For children and adolescents 6 to 17 years old, the dose is based on body weight. For children who weigh between 15 kg and 30 kg, the starting dose is 600 mg injected subcutaneously (under the skin). After the first dose, 300 mg is injected every 4 weeks. For children and adolescents who weigh between 30 kg and 60 kg, the starting dose is 400 mg injected subcutaneously (under the skin). After the first dose, 200 mg is injected every 2 weeks. For adolescents who weigh 60 kg or more, the starting dose is 600 mg, followed by 300 mg injected subcutaneously every 2 weeks.

For the treatment of severe eosinophilic asthma, for adults and adolescents aged 12 years and older, the starting dose of dupilumab is 400 mg injected subcutaneously (under the skin). After the first dose, 200 mg is injected subcutaneously every 2 weeks. Depending on your response, your doctor may increase the dose to 300 mg injected every 2 weeks. For children 6 to 11 years old, the dose is based on body weight. For children weighing 15 kg to less than 30 kg the dose is 100 mg injected subcutaneously every 2 weeks or 300 mg every 4 weeks. For children weighing 30 kg to less than 60 kg the dose is 200 mg every 2 weeks or 300 mg every 4 weeks. For children weighing 60 kg or more the dose is 200 mg every 2 weeks.

For the treatment of severe asthma that is dependent on corticosteroids, the starting dose of dupilumab for adults and adolescents aged 12 years and older is 600 mg injected subcutaneously (under the skin).** **After the first dose, 300 mg is injected subcutaneously every 2 weeks.

For the treatment of CRSwNP, the adult dose of dupilumab is 300 mg injected subcutaneously (under the skin) every 2 weeks.

If you are injecting this medication yourself, your doctor will show you how to use this medication properly. If you are not sure how to use it or have questions about how to use it, contact your doctor. Before using this medication, thoroughly read the patient information provided and ask your doctor any questions you might have. If a caregiver will be giving you the injections, your doctor should instruct them on how to give the injection.

Use a different injection site for each dose. You should avoid injecting this medication into an area of skin that is sore, red, infected, bruised, or otherwise damaged. If you are having difficulty giving yourself injections, talk to your health care provider.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. **If your doctor has recommended a dose different from the ones listed here, **do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If your dosing schedule is every 2 weeks, and you miss a dose, and it has been less than 7 days since the missed dose, take it as soon as possible and continue with your regular schedule. If more than 7 days have passed since the missed dose, skip the missed dose and continue with your regular dosing schedule.

If your dosing schedule is every 4 weeks, and you miss a dose, and it has been less than 7 days since the missed dose, take it as soon as possible and continue with your regular schedule. If more than 7 days have passed, take the missed dose and start a new 4-week schedule from the time you remember to take the missed dose. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Dupilumab should be clear and colourless. Do not use dupilumab if you notice particles or anything unusual in the appearance of the solution. Do not shake this medication.

Store this medication in the refrigerator. Keep it in its outer carton to protect it from light. Remove it from the refrigerator and allow it to sit at room temperature for 45 minutes for the 300 mg syringe or pen, or 30 minutes for the 200 mg syringe before injecting. If necessary, this medication may be kept at room temperature for up to 14 days. Keep this medication out of the reach and sight of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

300 mg Pre-Filled Syringe
Each mL of clear, slightly opalescent, colourless-to-pale-yellow, sterile, preservative-free solution, contains 150 mg of dupilumab. *Nonmedicinal ingredients: *L-arginine hydrochloride, L-histidine, polysorbate 80, sodium acetate, sucrose, and water for injection, adjusted to pH 5.9 with acetic acid.

200 mg Pre-Filled Syringe
Each mL of clear, slightly opalescent, colourless-to-pale-yellow, sterile, preservative-free solution, contains 175 mg of dupilumab. *Nonmedicinal ingredients: *L-arginine hydrochloride, L-histidine, polysorbate 80, sodium acetate, sucrose, and water for injection, adjusted to pH 5.9 with acetic acid.

300 mg Pre-Filled Pen
Each mL of clear, slightly opalescent, colourless-to-pale-yellow, sterile, preservative-free solution, contains 150 mg of dupilumab. *Nonmedicinal ingredients: *L-arginine hydrochloride, L-histidine, polysorbate 80, sodium acetate, sucrose, and water for injection, adjusted to pH 5.9 with acetic acid.

200 mg Pre-Filled Pen
Each mL of clear, slightly opalescent, colourless-to-pale-yellow, sterile, preservative-free solution, contains 175 mg of dupilumab. *Nonmedicinal ingredients: *L-arginine hydrochloride, L-histidine, polysorbate 80, sodium acetate, sucrose, and water for injection, adjusted to pH 5.9 with acetic acid.

100 mg Pre-Filled Syringe
Each mL of clear, slightly opalescent, colourless-to-pale-yellow, sterile, preservative-free solution, contains 150 mg of dupilumab. *Nonmedicinal ingredients: *L-arginine hydrochloride, L-histidine, polysorbate 80, sodium acetate, sucrose, and water for injection, adjusted to pH 5.9 with acetic acid.

Do not take this medication if you are allergic to dupilumab or any ingredients of the medication.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• cold sores

• dry, itchy, or red eyes

• facial rash or redness

• headache

• joint pain

• red, swollen, or itchy eyelids

• redness, itching, or swelling at the injection site

• trouble sleeping

• upset stomach

Although most of the side effects listed below don't happen very often,they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following sideeffects occur:

• eye pain or vision changes

• symptoms of an eye infection (e.g., swollen red eyes, eye pain when exposed to light, discharge from the eye)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

• symptoms of serum sickness (e.g., fever, feeling unwell, swollen lymph nodes, hives, itchiness, skin rash, or joint pain)

**Some people may experience side effects other than those listed. **Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

**Allergic reactions: **Some people may develop an allergic reaction to this medication. Signs of an allergic reaction include a severe rash, hives, swollen face or throat, or difficulty breathing. If these occur, contact your doctor immediately.

Another form of allergic reaction that can happen, although rarely, is serum sickness. Symptoms of serum sickness include fever, feeling unwell, swollen lymph nodes, hives, joint pain, skin rash, or itchiness.

If you have symptoms of either type of allergic reaction, contact your doctor immediately.

**Asthma symptoms: This medication is not intended to stop an asthma attack. Keep your "rescue" inhaler available for episodes of breathing problems. **If you experience worsening asthma symptoms, contact your doctor as soon as possible.

Corticosteroids: If you are taking corticosteroids (inhaled, by mouth, or applied to the skin) to help manage your condition, do not abruptly stop or discontinue these medications once you start using dupilumab. Over time you may require less corticosteroid, but any changes to your dose should be done slowly and under the guidance of your doctor.

Eye problems: Inflammation of the cornea of the eye and the white part of the eye have been reported by people using dupilumab. If you experience symptoms such as red eyes, moderate-to-severe eye pain, a feeling of grittiness in the eye, or increased sensitivity to light, contact your doctor as soon as possible.

Parasite infections: This medication may weaken your resistance to parasite infections. If you already have a parasite infection it should be treated before starting this medication. If you are living in or travelling to a region where parasite infections are frequent, discuss with your doctor any special precautions that may be needed.

Stopping this medication: Do not stop taking dupilumab without first talking to your doctor. Stopping dupilumab may require adjustments to other medications you use to control your condition.

Vaccines: Live vaccines (e.g., yellow fever, BCG, cholera, typhoid, varicella) should not be given when you are taking dupilumab.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if dupilumab passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children under the age of 6 years for the treatment of atopic dermatitis or for treatment of severe asthma. The safety and effectiveness of using this medication have not been established for children under the age of 18 years for the treatment of CRSwNP.

There may be an interaction between dupilumab and any of the following:

• live vaccines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,

• change one of the medications to another,

• change how you are taking one or both of the medications, or

• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Dupixent