Nucala

For the treatment of eosinophilic asthma, the recommended dose of Nucala (Mepolizumab) for adults and adolescents over 12 years old is 100 mg injected subcutaneously (under the skin) once every 4 weeks. The dose for children ages 6 years to 12 years is 40 mg injected subcutaneously once every 4 weeks.

For the treatment of eosinophilic granulomatosis with polyangiitis, the recommended dose of Nucala (Mepolizumab) for adults is 300 mg injected subcutaneously once every 4 weeks.

Nucala (Mepolizumab) is first given under the supervision of a qualified health care professional in a clinic or doctor's office where side effects, such as a Anaphylaxis (severe allergic reaction), can be treated immediately. If appropriate, you may be trained to give yourself injections of Nucala (Mepolizumab). Do not attempt to prepare or inject Nucala (Mepolizumab) on your own until you completely understand how to mix and inject a dose. If you are having difficulty giving yourself injections, talk to your health care provider.

It is important Nucala (Mepolizumab) be given exactly as recommended by your doctor. If you miss an appointment to receive Nucala (Mepolizumab), contact your doctor as soon as possible to reschedule your appointment. If you are injecting Nucala (Mepolizumab) yourself and you miss a dose, inject it as soon as possible and continue with your regular schedule. If it almost time for your next injection, 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.

The powder form of Nucala (Mepolizumab) should be stored in its original carton at room temperature. Protect it from light and moisture, and keep it out of the reach of children. The pre-filled autoinjector or pre-filled syringes should be stored in the refrigerator, protected from light. They may be kept at room temperature for up to 7 days if kept in the unopen carton and protected from light. Once the outer carton is removed, Nucala (Mepolizumab) should be injected within 8 hours.

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 cause headaches; it may cause stomach ache; it may cause back pain; it may cause unusual tiredness; it may cause stinging or itching; 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.

Lyophilized powder
Each vial of sterile, preservative-free, lyophilized powder for subcutaneous injection contains 144 mg of Nucala (Mepolizumab). Once reconstituted with 1.2 mL of sterile water for injection USP, each mL of solution provides 100 mg Nucala (Mepolizumab). Nonmedicinal ingredients: sucrose, sodium phosphate dibasic, heptahydrate, and polysorbate 80 with a pH of 7.0. The vial stopper is latex-free.

Solution for Injection
Each 1 mL of clear-to-opalescent, colourless to pale yellow or pale brown, preservative-free solution for subcutaneous use contains 100 mg of Nucala (Mepolizumab). Nonmedicinal ingredients: citric acid monohydrate, EDTA disodium dihydrate, polysorbate 80, sodium phosphate dibasic heptahydrate, and sucrose.

Supplied as a pre-filled autoinjector or safety syringe.

Do not take Nucala (Mepolizumab) if you are allergic to Nucala (Mepolizumab) or any ingredients of the medication.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that 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. 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.

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 Nucala (Mepolizumab).

Allergic reactions: Any biologic medication such as Nucala (Mepolizumab) can cause severe allergic reactions. If you experience itching, rash, dizziness or fainting, difficulty breathing, or swelling of the throat or tongue, seek medical help immediately. These reactions usually occur soon after receiving a dose of the medication, but sometimes occur days after the dose and can occur at any time during your treatment with Nucala (Mepolizumab).

Asthma symptoms: Nucala (Mepolizumab) is not intended for use during an asthma attack. Use your reliever medications when you have an episode of wheezing or difficulty breathing.

If your asthma worsens after you start using Nucala (Mepolizumab), let your doctor know.

Infections: People using Nucala (Mepolizumab) may be at an increased risk of developing parasitic infections caused by helminths (worms). If you travel to areas where parasitic worm infections are common, discuss with your doctor how you can avoid developing these infections and what symptoms of these infections to be aware of.

Other medications: Nucala (Mepolizumab) is not intended to replace other asthma medications. Continue to use your "preventers" (long-acting bronchodilators and corticosteroids) and "relievers" (fast-acting bronchodilators) as prescribed by your doctor.

Pregnancy: Nucala (Mepolizumab) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Nucala (Mepolizumab) or less than 4 months after stopping Nucala (Mepolizumab), contact your doctor immediately.

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

Children: The safety and effectiveness of using Nucala (Mepolizumab) to treat eosinophilic asthma have not been established for children under 6 years old. The safety and effectiveness of using Nucala (Mepolizumab) to treat eosinophilic granulomatosis with polyangitis have not been established for children under 18 years old.

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 a month. However, your pharmacist may have suggested a different schedule that is more appropriate for you. If you forget a dose, the injection should be administered as soon as possible, then continue with the next scheduled dose as planned.