Nucala Solution for Injection in Pre-Filled Syringe
Mepolizumab
100 mg / ml
GlaxoSmithKline Trading Services Limited
| Pack size | 1 Pre-Filled Syringe |
|---|---|
| Dispensing mode | POM |
| Source | IRELAND |
| Agent | Modern Pharmaceutical Co. |
| Retail Price | 5197.50 AED |
Indications
Nucala Solution for Injection in Pre-Filled Syringe is used for:
Add-on treatment for severe refractory eosinophilic, asthma in adult patients.
Adult Dose
Asthma
Indicated for add-on maintenance treatment of patients with severe asthma aged >12 year, and with an eosinophilic phenotype
100 mg SC once every 4 wk.
Child Dose
Asthma
Indicated for add-on maintenance treatment of patients with severe asthma aged >12 year, and with an eosinophilic phenotype
<12 years: Safety and efficacy not established
>12 years: 100 mg SC q4wk
Renal Dose
Administration
SC Preparation
Reconstitute each vial with 1.2 mL sterile water for injection (SWI), preferably using a 2- or 3-mL syringe and a 21-G needle
Reconstituted solution yields a concentration of 100 mg/mL
Preparation of the 300-mg dose for treatment of EGPA requires the reconstitution of 3 separate 100-mg vials
Do not mix with other medications
Direct the stream of SWI vertically onto the center of the lyophilized cake
Gently swirl the vial for 10 seconds with a circular motion at 15-second intervals until the powder is dissolved
Do NOT shake the reconstituted solution during the procedure as this may lead to product foaming or precipitation
Reconstitution is typically complete within 5 minutes after the SWI has been added, but it may take additional time
If a mechanical reconstitution device (swirler) is used, swirl at 450 rpm for no longer than 10 minutes; alternatively, may swirl at 1000 rpm for no longer than 5 minutes
Visually inspect the reconstituted solution for particulate matter and clarity before use
The solution should be clear to opalescent and colorless to pale yellow or pale brown, essentially particle free; small air bubbles, however, are expected and acceptable
If particulate matter remains in the solution or if the solution appears cloudy or milky, discard the solution
SC Administration
Do NOT shake solution; gently swirl
For subcutaneous (SC) use only
Use a 1-mL polypropylene syringe fitted with a disposable 21- to 27-G x 0.5-inch (13-mm) needle
Administer SC into the upper arm, thigh, or abdomen
300-mg dose: Administer as 3 separate 100-mg injections; individual 100-mg injections should be administered at least 5-cm (~2-inches) apart if administered at the same site
Contra Indications
Hypersensitivity.
Precautions
Should not be used to treat acute asthma exacerbations. Asthma-related adverse events or exacerbations may occur. Abrupt discontinuation of corticosteroid after initiation of Nucala therapy is not recommended. Acute & delayed systemic reactions, including hypersensitivity reactions. Patients w/ pre-existing helminth infections. Pregnancy & lactation.
Pregnancy-Lactation
Pregnancy
Data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk
Monoclonal antibodies, such as mepolizumab, are transported across the placenta in a linear fashion as pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimesters of pregnancy
Clinical considerations
In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate
Closely monitor the level of asthma control in pregnant women and treatment adjusted as necessary to maintain optimal control
Animal data
In a prenatal and postnatal development study, pregnant cynomolgus monkeys received mepolizumab from gestation days 20 to 140 at doses that produced exposures up to ~9 times that achieved with the MRHD (on an AUC basis with maternal IV doses up to 100 mg/kg once every 4 weeks)
Mepolizumab did not elicit adverse effects on fetal or neonatal growth (including immune function) up to 9 months after birth
Examinations for internal or skeletal malformations were not performed
Mepolizumab crossed the placenta in cynomolgus monkeys
Concentrations of mepolizumab were ~2.4 times higher in infants than in mothers up to day 178 postpartum
Lactation
Unknown if distributed in human breast milk
However, mepolizumab is a humanized monoclonal antibody (IgG1 kappa), and immunoglobulin G (IgG) is present in human milk in small amounts
Present in the milk of cynomolgus monkeys postpartum following dosing during pregnancy; levels in milk were ?0.5% of maternal serum concentration
Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Interactions
Adverse Effects
Side effects of Mepolizumab :
>10%
Headache (19%)
Injection site reactions (8-15%)
1-10%
Systemic allergic/nonallergic reactions (2-6%)
Back pain (5%)
Fatigue (5%)
Systemic allergic/hypersensitivity reactions (1-4%)
Influenza (3%)
Urinary tract infection (3%)
Upper abdominal pain (3%)
Pruritus (3%)
Eczema (3%)
Muscle spasms (3%)
Frequency Not Defined
Abdominal pain
Allergic rhinitis
Asthenia
Bronchitis
Cystitis
Dizziness
Dyspnea
Ear infection
Gastroenteritis
Lower respiratory tract infection
Musculoskeletal pain
Nasal congestion
Nasopharyngitis
Toothache
Viral infection
Viral respiratory tract infection
Mechanism of Action
Humanized IgG1 kappa monoclonal antibody specific for IL-5; binds IL-5, and therefore stops IL-5 from binding to its receptor on the surface of eosinophils
Inhibiting IL-5 binding to eosinophils reduces blood, tissue, and sputum eosinophil levels
Note
Nucala 100 mg / ml Solution for Injection in Pre-Filled Syringe manufactured by GlaxoSmithKline Trading Services Limited. Its generic name is Mepolizumab. Nucala is availble in United Arab Emirates.
Farmaco UAE drug index information on Nucala Solution for Injection in Pre-Filled Syringe is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.