SPC

Question 1

What are the indications for Nucala?

Answer 1

Severe Eosinophilic Asthma
Chronic Rhinosinusitis with Nasal Polyps
EGPA
HES

Question 2

What are the formulations for Nucala?

Answer 2

100mg solution for injection in PFP, PFS for adults and adolescents aged 12 years and above; and 40mg solution in PFS for children ages 6-11 years old.

Question 3

What is the dosing schedule for SEA?

Answer 3

100mg SC once every 4 weeks

Question 4

What is the dosing schedule for CRSwNP?

Answer 4

100mg SC once every 4 weeks

Question 5

What is the dosing schedule for HES?

Answer 5

300mg SC once every 4 weeks

Question 6

What is the dosing schedule for EGPA?

Answer 6

300mg SC once every 4 weeks

Question 7

What are some of the excipients in Nucala?

Answer 7

Sucrose
Sodium phosphate dibasic heptahydrate
Citric acid monohydrate
Polysorbate 80
Disodium edate
Water for injections

Question 8

What data is there on Nucala’s use in pregnant patients?

Answer 8

There is limited data (<300 patients), but not contraindicated. Nucala crosses the placental barrier in monkeys, so should only be considered when the expected benefit to the mother is greater than any possible risk to the foetus.

Question 9

What are the most common adverse events from RCTs?

Answer 9

Headache (20%)
Injection site reactions (8%)
Back pain (6%)

Question 10

What is mepolizumab’s mechanism of action?

Answer 10

Humanised monoclonal antibody (IgG1, kappa), which targets human interleukin-5 (IL-5) with high affinity and specificity.
Mepolizumab inhibits the bioactivity of IL-5 by blocking the binding of IL-5 to the alpha sub chain of the IL-5 receptor complex expressed on the eosinophil cell surface, thereby inhibiting IL-5 signaling and reducing the production and survival of eosinophils.

Question 11

What is Nucala’s shelf life?

Answer 11

3 years

Question 12

Storage

Answer 12

Store in a refrigerator 2C-8C.
Do not freeze.
Store in original carton to protect from light.
Pen/syringe can be removed from the fridge and left unopened for up to 7 days at room temperature (30C) when protected from light.
Pen/syringe must be administered within 8 hours after removing from carton.

Question 13

NICE reimbursement for EOS >400uL in previous 12 months

Answer 13

AND 3+ exacerbations needing systemic corticosteroids in previous 12 months

Question 14

NICE reimbursement for EOS >300uL in previous 12 months

Answer 14

AND 4+ exacerbations needing systemic corticosteroids in previous 12 months OR continuous OCS equivalent to 5mg prednisolone per day over previous 6 months