100 mg solution for injection in a pre-filled pen mepolizumab
What Nucala is and what it is used for
Nucala contains the active substance mepolizumab, a monoclonal antibody, a type of protein that is designed to recognize a specific target substance in the body. It is used to treat severe asthma and EGPA ( eosinophilic granulomatous polyangiitis) in adults, adolescents, and children from 6 years of age. It is also used to treat chronic rhinosinusitis with nasal polyps and HES (hypereosinophilic syndrome) in adults.
Mepolizumab, the active substance in Nucala, blocks a protein called interleukin ‑5. By blocking the effect of this protein, the production of eosinophils (a type of white blood cell ) in the bone marrow is limited and the number of eosinophils in the blood and lungs is reduced.
Severe eosinophilic asthma
Some people with severe asthma have too many eosinophils ( a type of white blood cell ) in their blood and lungs. This disease is called eosinophilic asthma – the type of asthma that Nucala can treat.
Nucala can reduce the number of asthma attacks if you or your child are already using high-dose inhaled drugs but still do not have good control over your asthma.
If you are taking medicines called oral corticosteroids, Nucala may also help reduce the daily dose you need to control your asthma.
Chronic rhinosinusitis with nasal polyps
Chronic rhinosinusitis with nasal polyps is a disease that means that you have too many eosinophils ( a type of white blood cell ) in the blood and the mucous membranes of the nose and sinuses. It can lead to symptoms such as nasal congestion and lost sense of smell and the growth of polyps (soft tissue growths) inside the nose.
Nucala reduces the number of eosinophils in the blood and can reduce the size of the polyps, relieve nasal congestion and reduce the need to operate on the nasal polyps.
Nucala may also require you to take fewer oral corticosteroids to relieve your symptoms.
Eosinophilic granulomatous polyangiitis (EGPA)
EGPA is a disease that means that you have too many eosinophils ( a type of white blood cell ) in the blood and tissues and that you also have a type of vasculitis. Vasculitis means “inflammation of the blood vessels”. The disease mainly affects the lungs and sinuses but often also other organs such as the skin, heart, and kidneys.
Nucala may control and delay the flare-up of EGPA symptoms. It can also help reduce the daily dose of oral corticosteroids you need to control your symptoms.
Hypereosinophilic Syndrome (HES)
Hypereosinophilic syndrome (HES) is a disease characterized by a high number of eosinophils (a type of white blood cell ) in the blood. These cells can damage the body’s organs, especially the heart, lungs, nerves, and skin.
Nucala can relieve symptoms and prevent relapses. If you are taking medicines called oral corticosteroids, Nucala can also help reduce the daily dose you need to control your symptoms/relapses in HES.
What you need to know before using Nucala
Do not use Nucala:
- if you are allergic to mepolizumab or any of the other ingredients of this medicine (listed in section 6).
- Consult a doctor if you think this applies to you.
Warnings and cautions
Talk to your doctor before using this medicine.
Deteriorating asthma
Some people experience asthma-related side effects or their asthma may worsen during treatment with Nucala.
- Tell your doctor or nurse if you do not get control of your asthma or if your asthma worsens after you start treatment with Nucala.
Allergic reactions and reactions at the injection site
Drugs of this type ( monoclonal antibodies ) can cause severe allergic reactions when injected into the body (see section 4, “Possible side effects”).
If you have had a similar reaction to any injection or medicine,
- Tell your doctor before giving Nucala.
Parasite infections
Nucala can weaken your resistance to infection caused by parasites. If you already have a parasite infection, it should be treated before starting treatment with Nucala. If you live in a region where such infections are common or if you travel to such a region:
- consult a doctor if you think any of these may apply to you.
Children and young people
Severe eosinophilic asthma
The pre-filled pen is not intended for use in children under 12 years of age for the treatment of severe eosinophilic asthma.
For children between 6 and 11 years of age, contact a doctor who will prescribe a recommended dose that will be administered by a nurse or doctor.
Chronic rhinosinusitis with nasal polyps
This medicine is not intended for use in children or adolescents under 18 years of age for the treatment of chronic rhinosinusitis with nasal polyps.
EGPA ( eosinophilic granulomatous polyangiitis)
This medicine is not intended for use in children under 6 years of age for the treatment of EGPA.
HES (hypereosinophilic syndrome)
This medicine is not intended for use in adolescents and children under 18 years of age for the treatment of HES.
Other drugs and Nucala
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Other medicines for asthma, chronic rhinosinusitis with nasal polyps, EGPA or HES
- Do not suddenly stop taking your existing medicines for asthma , chronic rhinosinusitis with nasal polyps, EGPA or HES once you have started taking Nucala. Such drugs (especially so-called oral corticosteroids ) must be discontinued gradually under the supervision of a doctor and depending on how you respond to Nucala.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
It is not known whether the ingredients in Nucala can pass into breast milk. If you are breastfeeding, you must consult your doctor before using Nucala.
Driving and using machines
Your ability to drive or use machines is unlikely to be affected by the side effects that Nucala may cause.
Nucala contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per 100 mg dose, ie it is essentially ‘sodium-free’.
How to use Nucala
Nucala is given as an injection just under the skin ( subcutaneous injection ).
Your doctor or nurse will decide if you or your carer can inject Nucala. If appropriate, your doctor or nurse will show you or your caregiver how to inject Nucala correctly.
Severe eosinophilic asthma
The recommended dose for adults and adolescents from the age of 12 is 100 mg. You will receive 1 injection every four weeks.
Chronic rhinosinusitis with nasal polyps
The recommended dose for adults is 100 mg. You will receive 1 injection every four weeks.
EGPA ( eosinophilic granulomatous polyangiitis)
The recommended dose for adults and adolescents from the age of 12 is 300 mg. You will receive 3 injections every four weeks.
Children 6 to 11 years
Children weighing 40 kg or more:
The recommended dose is 200 mg. You will receive 2 injections every four weeks.
Children weighing less than 40 kg:
The recommended dose is 100 mg. You will receive 1 injection every four weeks.
There should be at least 5 cm spacing between the injection sites.
HES (hypereosinophilic syndrome)
The recommended dose for adults is 300 mg. You will receive 3 injections every four weeks.
There should be at least 5 cm spacing between the injection sites.
Instructions on how to dispense the pre-filled pen are provided on the other side of this leaflet.
If you take more Nucala than you should
If you think you have injected too much Nucala, talk to your doctor for advice.
If you miss a dose of Nucala
You or your caregiver should inject the next dose as soon as you remember. If you have not discovered that you have missed a dose until it is time to take the next dose, inject the next dose as planned. If you are not sure, ask your doctor, pharmacist, or nurse.
Discontinuation of treatment with Nucala
Do not stop injecting yourself with Nucala unless your doctor tells you to. If you stop or stop treatment with Nucala, your symptoms and seizures may return.
If your symptoms worsen while you are being injected with Nucala:
- Contact a doctor.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects of Nucala are usually mild to moderate but can sometimes be serious.
Allergic reactions
Some people may have allergic or allergic reactions. Such reactions may be common (they may affect up to 1 in 10 people ). They usually occur within minutes to hours after injection one but the symptoms can sometimes come up to several days later.
The symptoms can be:
- feeling of pressure over the chest, cough, difficulty breathing
- fainting, dizziness, carousel sensation (due to drop in blood pressure)
- swelling of the eyelids, face, lips, tongue or mouth
- hives
- rash.
- Seek medical attention immediately if you think you (or your child) have a reaction.
If you have had a similar reaction to any injection or medicine,
- Tell your doctor before you (or your child) are given Nucala.
Other side effects include:
Very common:
may affect more than 1 in 10 people:
- headache.
Common:
may affect up to 1 in 10 people:
- chest infection – symptoms may include cough and fever (high body temperature)
- urinary tract infection (blood in the urine, painful and frequent urination, fever, low back pain)
- upper abdominal pain (stomach pain or discomfort in the upper abdomen)
- fever (high body temperature)
- eczema (itchy red spots on the skin)
- injection site reaction (pain, redness , swelling, itching and burning in the skin in the area where the injection was given)
- back pain
- pharyngitis (sore throat)
- nasal congestion.
Rare;
can occur in up to 1 in 1,000 people:
- severe allergic reaction ( anaphylaxis ).
- If you get any of these symptoms, tell your doctor or nurse immediately .
How to store Nucala
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C to 8 ° C).
Do not freeze.
Store in the original package. Sensitive to light.
Nucala pre-filled pen can be removed from the refrigerator and stored with unopened packaging at room temperature (up to 30 ° C) and protected from light for up to 7 days. Discard if it has been out of the refrigerator for more than 7 days.
Contents of the package and other information
Content declaration
The active substance is mepolizumab.
1 ml pre-filled pen contains 100 mg mepolizumab,
The other ingredients are sucrose, dibasic sodium phosphate heptahydrate, citric acid monohydrate, polysorbate 80, disodium edetate, water for injections.
What the medicine looks like and contents of the pack
Nucala is supplied as 1 ml clear to opalescent, colorless to pale yellow to pale brown solution in a disposable pre-filled pen.
Nucala is available in packs containing 1 pre-filled pen or in a multi-pack of 3×1 pre-filled pens or 9 x 1 pre-filled pens.
Marketing Authorisation Holder
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
Manufacturer
GlaxoSmithKline Manufacturing SPA
Strada Provinciale Atlanta, 90
43056 San Polo di Torrile, Parma
Italy
Contact the representative of the marketing authorization holder to find out more about this medicine:
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