Dupixent

The starting dose of Dupixent (Dupilumab) for adults is 600 mg injected subcutaneously (under the skin). After the first dose, 300 mg is injected subcutaneously every 2 weeks.

For adolescents 12 to 17 years old, who weigh less than 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.

If you are injecting Dupixent (Dupilumab) yourself, your doctor will show you how to use Dupixent (Dupilumab) properly. If you are not sure how to use it or have questions about how to use it, contact your doctor. Before using Dupixent (Dupilumab), 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 Dupixent (Dupilumab) 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 Dupixent (Dupilumab) exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is less than 7 days before your next dose, skip the missed dose and continue with your regular dosing schedule. 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.

Dupixent (Dupilumab) should be clear and colourless. Do not use Dupixent (Dupilumab) if you notice particles or anything unusual in the appearance of the solution.

Store Dupixent (Dupilumab) in the refrigerator. Keep the syringe in the outer carton to protect it from light. Remove the pre-filled syringe from the refrigerator and allow it to sit at room temperature for 45 minutes before injecting. Keep Dupixent (Dupilumab) 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.

In addition to its desired action, this medication may cause some adverse effects, notably: it may increase your risk of an eye infection; it may cause redness and swelling at the injection site. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

300 mg Pre-Filled Syringe

Each mL of clear, slightly opalescent, colourless-to-pale-yellow, sterile, preservative-free solution, contains 150 mg of Dupixent (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 Dupixent (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 Dupixent (Dupilumab) if you are allergic to Dupixent (Dupilumab) or any ingredients of the medication.

There may be an interaction between Dupixent (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 Dupixent (Dupilumab). 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.

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 Dupixent (Dupilumab).

Allergic reactions: Some people may develop an allergic reaction to Dupixent (Dupilumab). 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.

Eye problems: Inflammation of the cornea of the eye and the white part of the eye have been reported by people using Dupixent (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: Dupixent (Dupilumab) may weaken your resistance to parasite infections. If you already have a parasite infection it should be treated before starting Dupixent (Dupilumab). 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.

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

Pregnancy: Dupixent (Dupilumab) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Dupixent (Dupilumab), contact your doctor immediately.

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

Children: The safety and effectiveness of using Dupixent (Dupilumab) have not been established for children under the age of 12 years.

This product must be injected under the skin (subcutaneously), according to the technique you were shown. Be sure to choose a different injection site each time. This medication is typically used only once every two weeks. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Use it regularly and continuously to maintain its beneficial effects. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. Dispose of used syringes and needles safely. Your pharmacist can tell you the best way to do this. If you forget a dose, contact your pharmacist.