Nucala

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Severe asthma in patients aged 12 years and older:
• 100 mg administered subcutaneously once every 4 weeks. ( 2.1 )
• Severe asthma in patients aged 6 to 11 years:
• 40 mg administered subcutaneously once every 4 weeks. ( 2.1 )
• CRSwNP: 100 mg administered subcutaneously once every 4 weeks. ( 2.1 )
• COPD: 100 mg administered subcutaneously once every 4 weeks. ( 2.1 )
• EGPA: 300 mg administered subcutaneously once every 4 weeks. ( 2.1 )
• HES:
• 300 mg administered subcutaneously once every 4 weeks. ( 2.1 ) 2.1 Recommended Dosage NUCALA is for subcutaneous use only, and should be injected into the upper arm, thigh, or abdomen [see Dosage and Administration ( 2.2 , 2.3 )]. Table 1. Recommended Dosage of NUCALA a 300 mg dose is administered as 3 separate 100 mg dose injections administered at least 5 cm (approximately 2 inches) apart. Indication
• Adults Pediatric Patients Severe asthma 100 mg every 4 weeks
• 12 to 17 years of age: 100 mg every 4 weeks
• 6 to 11 years of age:
• 40 mg every 4 weeks Chronic rhinosinusitis with nasal polyps 100 mg every 4 weeks Not applicable Chronic obstructive pulmonary disease 100 mg every 4 weeks Not applicable Eosinophilic granulomatosis with polyangiitis 300 mg a every 4 weeks Not applicable Hypereosinophilic syndrome 300 mg a every 4 weeks 12 to 17 years of age:
• 300 mg a every 4 weeks 2.2 Preparation and Administration of NUCALA for Injection Vial NUCALA for injection should be reconstituted and administered by a healthcare professional. In line with clinical practice, monitoring of patients after administration of biologic agents is recommended [see Warnings and Precautions ( 5.1 )] . Reconstitution Instructions 1. Reconstitute NUCALA for injection in the vial with 1.2 mL of Sterile Water for Injection, USP, preferably using a 2- or 3-mL syringe and a 21-gauge needle. The reconstituted solution will contain a concentration of 100 mg/mL mepolizumab. Do not mix with other medications. 2. Direct the stream of Sterile Water for Injection vertically onto the center of the lyophilized powder, which may have a cake-like appearance. Gently swirl the vial for 10 seconds with a circular motion at 15-second intervals until the powder is dissolved. Note:
• 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 Sterile Water for Injection has been added, but it may take additional time. 3. If a mechanical reconstitution device (swirler) is used to reconstitute NUCALA for injection, swirl at 450 rpm for no longer than 10 minutes. Alternatively, swirling at 1,000 rpm for no longer than 5 minutes is acceptable. 4. 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, the solution must not be administered. 5. If the reconstituted solution is not used immediately:
• store below 30°C (86°F),
• do not freeze, and
• discard if not used within 8 hours of reconstitution. Administration of 100 mg Dose 1. For subcutaneous administration, preferably using a 1-mL polypropylene syringe fitted with a disposable 21- to 27-gauge x 0.5-inch (13-mm) needle. 2. Just before administration, remove 1 mL of reconstituted NUCALA for injection. Do not shake the reconstituted solution during the procedure as this could lead to product foaming or precipitation. 3. Administer the 1 mL injection (equivalent to 100 mg of mepolizumab) subcutaneously into the upper arm, thigh, or abdomen. Administration of 40 mg Dose 1. For subcutaneous administration, preferably using a 1-mL polypropylene syringe fitted with a disposable 21- to 27-gauge x 0.5-inch (13-mm) needle. 2. Just before administration, remove 0.4 mL of reconstituted NUCALA for injection. Do not shake the reconstituted solution during the procedure as this could lead to product foaming or precipitation. 3. Administer the 0.4 mL injection (equivalent to 40 mg of mepolizumab) subcutaneously into the upper arm, thigh, or abdomen. Each vial of NUCALA for injection should be used for a single patient, and any remainder of the contents should be discarded. 2.3 Preparation and Administration of NUCALA Injection Prefilled Autoinjector and Prefilled Syringes NUCALA injection is intended for use under the guidance of a healthcare provider. The 100 mg/mL prefilled autoinjector and 100 mg/mL prefilled syringe are only for use in
• adults and adolescents aged 12 years and older. A patient may self-inject, or the patient caregiver may administer NUCALA injection 100 mg/mL subcutaneously after the healthcare provider determines it is appropriate. The 40 mg/0.4 mL prefilled syringe is only for use in children aged 6 to 11 years and must be administered by the healthcare provider or the patient caregiver. The patient caregiver may administer NUCALA injection 40 mg/0.4 mL subcutaneously after the healthcare provider determines it is appropriate. Provide proper training in subcutaneous injection technique and on the preparation and administration of NUCALA injection prior to use [see Instructions for Use] . 1. Remove the prefilled autoinjector or prefilled syringe from the refrigerator and allow it to sit at room temperature for 30 minutes prior to injection. Do not warm NUCALA injection in any other way. 2. Prior to administration, visually inspect the window of the prefilled autoinjector or the prefilled syringe for particulate matter or discoloration. NUCALA injection should be clear to opalescent, colorless to pale yellow to pale brown in color.
• Do not use NUCALA injection if the product exhibits discoloration, cloudiness, or particulate matter.
• Do not use the NUCALA prefilled autoinjector or prefilled syringe if dropped on a hard surface. 3. Administer the subcutaneous injection into the thigh or abdomen, avoiding the 5 cm (approximately 2 inches) around the navel. The upper arm can also be used if a caregiver administers the subcutaneous injection. 4. For use in EGPA and HES, ensure injection sites for each subcutaneous injection are separated by at least 5 cm (approximately 2 inches). 5. Never give injections into areas where the skin is tender, bruised, red, or hard. 6. If a dose is missed, administer a dose as soon as possible. Thereafter, the patient can resume dosing on the usual day of administration. If the next dose is already due, then administer as planned.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• Severe Asthma The safety and effectiveness of NUCALA for severe asthma, and with an eosinophilic phenotype, have been established in pediatric patients aged 6 years and older.
• Use of NUCALA in adolescents aged 12 to 17 years is supported by evidence from adequate and well-controlled trials in
• adults and adolescents.
• A total of 28 adolescents aged 12 to 17 years with severe asthma were enrolled in the Phase 3 asthma trials.
• Of these, 25 were enrolled in the 32-week exacerbation trial (MENSA) and had a mean age of 14.8 years.
• Patients had a history of 2 or more exacerbations in the previous year despite regular use of medium- or high-dose ICS plus additional controller(s) with or without OCS and had blood eosinophils of ≥150 cells/mcL at screening or ≥300 cells/mcL within 12 months prior to enrollment. [See Clinical Studies ( 14.1 ).] Patients had a reduction in the rate of exacerbations that trended in favor of NUCALA.
• Of the 19 adolescents who received NUCALA, 9 received 100 mg and the mean apparent clearance in these patients was 35% less than that of
• adults.
• The safety profile observed in adolescents was generally similar to that of the overall population in the Phase 3 studies [see Adverse Reactions ( 6.1 )] .
• Use of NUCALA in pediatric patients aged 6 to 11 years with severe asthma, and with an eosinophilic phenotype, is supported by evidence from adequate and well-controlled trials in
• adults and adolescents with additional pharmacokinetic, pharmacodynamic, and safety data in children aged 6 to 11 years.
• A single open-label clinical trial was conducted in 36 children aged 6 to 11 years (mean age:
• 8.6 years, 31% female) with severe asthma.
• Enrollment criteria were the same as for adolescents in the 32-week exacerbation trial (MENSA).
• Based upon the pharmacokinetic data from this trial, a subcutaneous dose of 40 mg every 4 weeks was determined to have similar exposure to
• adults and adolescents administered a subcutaneous dose of 100 mg [ see Clinical Pharmacology ( 12.3 )] .
• The effectiveness of NUCALA in pediatric patients aged 6 to 11 years is extrapolated from efficacy in
• adults and adolescents with support from pharmacokinetic analyses showing similar drug exposure levels for 40 mg administered subcutaneously every 4 weeks in children aged 6 to 11 years compared with
• adults and adolescents [ see Clinical Pharmacology ( 12.3 )] .
• The safety profile and pharmacodynamic response observed in this trial for children aged 6 to 11 years were similar to that seen in
• adults and adolescents [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.2 )] .
• The safety and effectiveness in pediatric patients aged younger than 6 years with severe asthma have not been established.
• Chronic Rhinosinusitis with Nasal Polyps The safety and effectiveness in patients aged younger than 18 years with CRSwNP have not been established.
• Chronic Obstructive Pulmonary Disease The safety and effectiveness in pediatric patients aged younger than 18 years with COPD have not been established.
• COPD is largely a disease of adult patients.
• Eosinophilic Granulomatosis with Polyangiitis The safety and effectiveness in patients aged younger than 18 years with EGPA have not been established.
• Hypereosinophilic Syndrome The safety and effectiveness of NUCALA for HES have been established in adolescent patients aged 12 years and older.
• The safety and effectiveness in pediatric patients aged younger than 12 years with HES have not been established.
• Use of NUCALA for this indication is supported by evidence from an adequate and well-controlled study (NCT02836496) in
• adults and adolescents and an open-label extension study (NCT03306043).
• One adolescent received NUCALA during the controlled study and this patient and an additional 3 adolescents received NUCALA during the open-label extension study [see Clinical Studies ( 14.5 )] .
• The 1 adolescent treated with NUCALA in the 32-week trial did not have a HES flare or an adverse event reported.
• All adolescents received 300 mg of NUCALA for 20 weeks in the open-label extension.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Of the total number of patients treated with NUCALA (n = 4106) for severe asthma, HES, EGPA, CRSwNP, and COPD, 1073 (26%) were 65 years of age and older and 241 (6%) were 75 years of age and older [see Clinical Studies ( 14 )] .
• No overall differences in safety and effectiveness were observed between these patients and younger patients.
• Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity in some older individuals cannot be ruled out.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following adverse reactions are described in greater detail in other sections:
• Hypersensitivity reactions [see Warnings and Precautions ( 5.1 )]
• Opportunistic infections:
• herpes zoster [see Warnings and Precautions ( 5.3 )] Most common adverse reactions (incidence ≥5%):
• Asthma: Headache, injection site reaction, back pain, and fatigue. ( 6.1 )
• CRSwNP: Oropharyngeal pain and arthralgia. ( 6.1 )
• COPD: Back pain, diarrhea, and cough. ( 6.1 )
• EGPA and HES:
• Most common adverse reactions are similar to asthma. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adult and Adolescent Patients Aged 12 Years and Older with Severe Asthma A total of 1,327 patients with severe asthma were evaluated in 3 randomized, placebo-controlled, multicenter trials of 24 to 52 weeks’ duration (Severe Asthma Trials DREAM, MENSA, and SIRIUS). Of these, 1,192 had a history of 2 or more exacerbations in the year prior to enrollment despite regular use of high-dose ICS plus additional controller(s) (Severe Asthma Trials DREAM and MENSA), and 135 patients required daily oral corticosteroids (OCS) in addition to regular use of high-dose ICS plus additional controller(s) to maintain asthma control (Severe Asthma Trial SIRIUS). All patients had markers of eosinophilic airway inflammation [see Clinical Studies ( 14.1 )] . Of the patients enrolled, 59% were female, 85% were White, and ages ranged from 12 to 82 years. Mepolizumab was administered subcutaneously or intravenously once every 4 weeks; 263 patients received NUCALA (mepolizumab 100 mg subcutaneously) for at least 24 weeks. Serious adverse events that occurred in more than 1 patient and in a greater percentage of patients receiving NUCALA 100 mg (n = 263) than placebo (n = 257) included 1 event, herpes zoster (2 patients vs. 0 patients, respectively). The incidence of adverse reactions in the first 24 weeks of treatment in the 2 confirmatory efficacy and safety trials MENSA and SIRIUS with NUCALA 100 mg is shown in Table 2 . Table 2. Adverse Reactions with NUCALA with ≥3% Incidence and More Common than Placebo in Patients with Severe Asthma (MENSA and SIRIUS) Adverse Reaction NUCALA (Mepolizumab 100 mg Subcutaneous) (n = 263) % Placebo (n = 257) % Headache 19 18 Injection site reaction 8 3 Back pain 5 4 Fatigue 5 4 Influenza 3 2 Urinary tract infection 3 2 Abdominal pain upper 3 2 Pruritus 3 2 Eczema 3 <1 Muscle spasms 3 <1 52-Week Trial:
• Adverse reactions from the Severe Asthma Trial DREAM with 52 weeks of treatment with mepolizumab 75 mg intravenously (n = 153) or placebo (n = 155) and with ≥3% incidence and more common than placebo and not shown in Table 2 were:
• abdominal pain, allergic rhinitis, asthenia, bronchitis, cystitis, dizziness, dyspnea, ear infection, gastroenteritis, lower respiratory tract infection, musculoskeletal pain, nasal congestion, nasopharyngitis, nausea, pharyngitis, pyrexia, rash, toothache, viral infection, viral respiratory tract infection, and vomiting. In addition, 3 cases of herpes zoster occurred in patients receiving mepolizumab 75 mg intravenously compared with 2 patients in the placebo group. Systemic Reactions, including Hypersensitivity Reactions:
• In the Severe Asthma Trials DREAM, MENSA, and SIRIUS described above, the percentage of patients who experienced systemic (allergic and non-allergic) reactions was 3% in the group receiving NUCALA 100 mg and 5% in the placebo group. Systemic allergic/hypersensitivity reactions were reported by 1% of patients in the group receiving NUCALA 100 mg and 2% of patients in the placebo group. The most commonly reported manifestations of systemic allergic/hypersensitivity reactions reported in the group receiving NUCALA 100 mg included rash, pruritus, headache, and myalgia. Systemic non-allergic reactions were reported by 2% of patients in the group receiving NUCALA 100 mg and 3% of patients in the placebo group. The most commonly reported manifestations of systemic non‑allergic reactions reported in the group receiving NUCALA 100 mg included rash, flushing, and myalgia. A majority of the systemic reactions in patients receiving NUCALA 100 mg (5/7) were experienced on the day of dosing. Injection Site Reactions:
• Injection site reactions (e.g., pain, erythema, swelling, itching, burning sensation) occurred at a rate of 8% in patients receiving NUCALA 100 mg compared with 3% in patients receiving placebo. Long-Term Safety:
• Nine hundred ninety-eight patients received NUCALA 100 mg in open-label extension studies, during which additional cases of herpes zoster were reported. The overall adverse event profile has been similar to the severe asthma trials described above. Adverse Reactions in Pediatric Patients Aged 6 to 11 Years with Severe Asthma The safety data for NUCALA is based upon 1 open-label clinical trial that enrolled 36 patients with severe asthma aged 6 to 11 years. Patients received 40 mg (for those weighing <40 kg) or 100 mg (for those weighing ≥40 kg) of NUCALA administered subcutaneously once every 4 weeks. Patients received NUCALA for 12 weeks (initial short phase). After a treatment interruption of 8 weeks, 30 patients received NUCALA for a further 52 weeks (long phase). The adverse reaction profile for patients aged 6 to 11 years was similar to that observed in patients aged 12 years and older. Adverse Reactions in Adult Patients with Chronic Rhinosinusitis with Nasal Polyps A total of 407 patients with CRSwNP were evaluated in 1 randomized, placebo-controlled, multicenter, 52-week treatment trial. Patients received NUCALA 100 mg or placebo subcutaneously once every 4 weeks. Patients had recurrent CRSwNP with a history of prior surgery and were on nasal corticosteroids for at least 8 weeks prior to screening [see Clinical Studies ( 14.2 )] . Of the patients enrolled, 35% were female, 93% were White, and ages ranged from 18 to 82 years. Table 3 summarizes adverse reactions that occurred in ≥3% of patients treated with NUCALA and more frequently than in patients treated with placebo in the CRSwNP trial. Table 3. Adverse Reactions with NUCALA with ≥3% Incidence and More Common than Placebo in Patients with Chronic Rhinosinusitis with Nasal Polyps Adverse Reaction NUCALA (Mepolizumab 100 mg Subcutaneous) (n = 206) % Placebo (n = 201) % Oropharyngeal pain 8 5 Arthralgia 6 2 Abdominal pain upper 3 2 Diarrhea 3 2 Pyrexia 3 2 Nasal dryness 3 <1 Rash 3 <1 Systemic Reactions, including Hypersensitivity Reactions:
• In the 52-week trial, the percentage of patients who experienced systemic (allergic [type I hypersensitivity] and other) reactions was <1% in the group receiving NUCALA 100 mg and <1% in the placebo group. Systemic allergic (type I hypersensitivity) reactions were reported by <1% of patients in the group receiving NUCALA 100 mg and no patients in the placebo group. The manifestations of systemic allergic (type I hypersensitivity) reactions included urticaria, erythema, and rash and 1 of the 3 reactions occurred on the day of dosing. Other systemic reactions were reported by no patients in the group receiving NUCALA 100 mg and <1% of patients in the placebo group. Injection Site Reactions:
• Injection site reactions (e.g., erythema, pruritus) occurred at a rate of 2% in patients receiving NUCALA 100 mg compared with <1% in patients receiving placebo. Adverse Reactions in
• Adults with Chronic Obstructive Pulmonary Disease The safety data below reflects the safety of NUCALA in
• adults with inadequately controlled COPD and an eosinophilic phenotype. NUCALA was evaluated in a pooled safety population that consisted of 2089 patients with COPD in 3 randomized, placebo-controlled, multicenter trials of 52 to 104 weeks duration, including MATINEE and METREX [see Clinical Studies ( 14.3 )] , and Trial 3. Trial 3 enrolled COPD
• adults with a peripheral blood eosinophil count ≥150 cells/µL at screening or ≥300 cells/µL in the year prior. The pooled safety population received NUCALA 100 mg (n = 1043) or placebo (n = 1046), administered subcutaneously once every 4 weeks, in addition to background triple inhaled therapies (e.g., ICS, long-acting beta agonist [LABA], and long-acting muscarinic antagonist [LAMA]). Table 4 summarizes adverse reactions that occurred in ≥3% of patients treated with NUCALA and more frequently than in patients treated with placebo in COPD trials. Table 4. Adverse Reactions with NUCALA with ≥3% Incidence and More Common than Placebo in Patients with Chronic Obstructive Pulmonary Disease in a Pooled Safety Population (MATINEE, METREX, and Trial 3) Adverse Reaction NUCALA (Mepolizumab 100 mg Subcutaneous) (n = 1043) % Placebo (n = 1046) % Back pain 7 6 Diarrhea 5 4 Cough 5 4 Oropharyngeal pain 4 2 Urinary tract infection 4 3 Pain in extremity 4 3 Herpes Zoster:
• In the pooled safety population, 14 (1%) patients in the NUCALA group compared to 7 (0.7%) patients in the placebo group experienced herpes zoster. Adverse Reactions in Patients with Eosinophilic Granulomatosis with Polyangiitis A total of 136 patients with EGPA were evaluated in 1 randomized, placebo-controlled, multicenter, 52-week treatment trial. Patients received 300 mg of NUCALA or placebo subcutaneously once every 4 weeks. Patients enrolled had a diagnosis of EGPA for at least 6 months prior to enrollment with a history of relapsing or refractory disease and were on a stable dosage of oral prednisolone or prednisone of greater than or equal to 7.5 mg/day (but not greater than 50 mg/day) for at least 4 weeks prior to enrollment [see Clinical Studies ( 14.4 )] . Of the patients enrolled, 59% were female, 92% were White, and ages ranged from 20 to 71 years. No additional adverse reactions were identified to those reported in the severe asthma trials. Systemic Reactions, including Hypersensitivity Reactions:
• In the 52-week trial, the percentage of patients who experienced systemic (allergic and non‑allergic) reactions was 6% in the group receiving 300 mg of NUCALA and 1% in the placebo group. Systemic allergic/hypersensitivity reactions were reported by 4% of patients in the group receiving 300 mg of NUCALA and 1% of patients in the placebo group. The manifestations of systemic allergic/hypersensitivity reactions reported in the group receiving 300 mg of NUCALA included rash, pruritus, flushing, fatigue, hypertension, warm sensation in trunk and neck, cold extremities, dyspnea, and stridor. Systemic non-allergic reactions were reported by 1 (1%) patient in the group receiving 300 mg of NUCALA and no patients in the placebo group. The reported manifestation of systemic non-allergic reactions reported in the group receiving 300 mg of NUCALA was angioedema. Half of the systemic reactions in patients receiving 300 mg of NUCALA (2/4) were experienced on the day of dosing. Injection Site Reactions:
• Injection site reactions (e.g., pain, erythema, swelling) occurred at a rate of 15% in patients receiving 300 mg of NUCALA compared with 13% in patients receiving placebo. Adverse Reactions in Adult and Adolescent Patients with Hypereosinophilic Syndrome A total of 108 adult and adolescent patients aged 12 years and older with HES were evaluated in a randomized, placebo‑controlled, multicenter, 32-week treatment trial. Patients with non-hematologic secondary HES or FIP1L1‑PDGFRα kinase-positive HES were excluded from the trial. Patients received 300 mg of NUCALA or placebo subcutaneously once every 4 weeks. Patients must have been on a stable dose of background HES therapy for the 4 weeks prior to randomization [see Clinical Studies ( 14.5 )] . Of the patients enrolled, 53% were female, 93% were White, and ages ranged from 12 to 82 years. No additional adverse reactions were identified to those reported in the severe asthma trials. Systemic Reactions, including Hypersensitivity Reactions:
• In the trial, no systemic allergic (type I hypersensitivity) reactions were reported. Other systemic reactions were reported by 1 (2%) patient in the group receiving 300 mg of NUCALA and no patients in the placebo group. The reported manifestation of other systemic reaction was multifocal skin reaction experienced on the day of dosing. Injection Site Reactions:
• Injection site reactions (e.g., burning, itching) occurred at a rate of 7% in patients receiving 300 mg of NUCALA compared with 4% in patients receiving placebo. 6.2 Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during post-approval use of NUCALA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to NUCALA or a combination of these factors. Immune System Disorders Hypersensitivity reactions, including anaphylaxis.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
• Hypersensitivity Reactions Inform patients that hypersensitivity reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred after administration of NUCALA.
• Instruct patients to contact their healthcare provider if such reactions occur.
• Not for Acute Symptoms or Deteriorating Disease Inform patients that NUCALA does not treat acute asthma symptoms or acute exacerbations of asthma or COPD.
• Inform patients to seek medical advice if their asthma remains uncontrolled or COPD symptoms worsen after initiation of treatment with NUCALA.
• Opportunistic Infections:
• Herpes Zoster Inform patients that herpes zoster infections have occurred in patients receiving NUCALA and where medically appropriate, inform patients that vaccination should be considered.
• Reduction of Corticosteroid Dosage Inform patients to not discontinue systemic or inhaled corticosteroids except under the direct supervision of a physician.
• Inform patients that reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
• Trademarks are owned by or licensed to the GSK group of companies.
• Manufactured by GlaxoSmithKline LLC Philadelphia, PA 19104 U.S.
• License No. 1727 Distributed by GlaxoSmithKline Durham, NC 27701 ©2025 GSK group of companies or its licensor.
• NCL:13PI

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS For Injection
• 100 mg white to off-white lyophilized powder in a single-dose vial for reconstitution. Injection
• 100 mg/mL as a clear to opalescent, colorless to pale yellow to pale brown solution in a single-dose prefilled autoinjector.
• 100 mg/mL as a clear to opalescent, colorless to pale yellow to pale brown solution in a single-dose prefilled glass syringe.
• 40 mg/0.4 mL as a clear to opalescent, colorless to pale yellow to pale brown solution in a single-dose prefilled glass syringe.
• For injection:
• 100 mg of lyophilized powder in a single-dose vial for reconstitution. ( 3 )
• Injection:
• 100 mg/mL, single-dose prefilled autoinjector or single-dose prefilled syringe. ( 3 )
• Injection: 40 mg/0.4 mL, single-dose prefilled syringe. ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• NUCALA for Injection NUCALA (mepolizumab) for injection is a sterile, preservative-free, white to off-white, lyophilized powder for reconstitution and subcutaneous injection in a single-dose glass vial with a flip-off seal. The vial stopper is not made with natural rubber latex. NUCALA for injection is supplied as:
• 100-mg single-dose vials in cartons of 1 (NDC 0173-0881-01). Store vials below 77°F (25°C). Do not freeze. Store in the original carton to protect from light. NUCALA Injection NUCALA (mepolizumab) injection is a sterile, preservative-free, clear to opalescent, colorless to pale yellow to pale brown solution for subcutaneous use. Each single-dose prefilled autoinjector delivers 100 mg of mepolizumab in 1 mL of solution. Each single-dose prefilled syringe delivers 100 mg of mepolizumab in 1 mL of solution or 40 mg of mepolizumab in 0.4 mL of solution. The autoinjectors and syringes are not made with natural rubber latex. NUCALA injection is supplied as:
• 100 mg/mL, single-dose, prefilled autoinjector with attached 29-gauge, half-inch needle in cartons of 1 (NDC 0173-0892-01).
• 100 mg/mL, single-dose, prefilled glass syringe with attached 29-gauge, half-inch needle with a needle guard in cartons of 1 (NDC 0173-0892-42).
• 40 mg/0.4 mL, single-dose, prefilled glass syringe with attached 29-gauge, half-inch needle with a needle guard in cartons of 1 (NDC 0173-0904-42). Prior to Dispensing:
• Refrigerate prefilled autoinjectors and prefilled syringes at 36°F to 46°F (2°C to 8°C). Keep the product in the original carton to protect from light. Do not freeze. Do not shake.
• Avoid exposure to heat. Following Dispensing:
• Refrigerate prefilled autoinjectors and prefilled syringes at 36°F to 46°F (2°C to 8°C). Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake.
• Avoid exposure to heat. If necessary, an unopened carton can be stored outside the refrigerator at up to 86°F (30°C) for up to 7 days. Discard if left out of the refrigerator for more than 7 days. NUCALA injection must be administered within 8 hours after removal from the carton. Discard if not administered within 8 hours.

Quoted from the official label, section “How Supplied”.

What is in it

• Mepolizumab is a humanized IL-5 antagonist monoclonal antibody.
• Mepolizumab is produced by recombinant DNA technology in Chinese hamster ovary cells.
• Mepolizumab has a molecular weight of approximately 149 kDa.
• NUCALA for injection is a sterile, preservative-free, white to off-white, lyophilized powder in a single-dose vial for subcutaneous injection after reconstitution.
• Upon reconstitution with 1.2 mL of Sterile Water for Injection, USP, the resulting concentration is 100 mg/mL and delivers 1 mL [see Dosage and Administration ( 2.2 )] .
• Each vial delivers 100 mg of mepolizumab, polysorbate 80 (0.67 mg), sodium phosphate dibasic heptahydrate (7.14 mg), and sucrose (160 mg), with a pH of 7.0.
• The vial stopper is not made with natural rubber latex.
• NUCALA injection is a sterile, preservative-free, clear to opalescent, colorless to pale yellow to pale brown solution for subcutaneous use.
• NUCALA injection is supplied in a single-dose, 1-mL, prefilled autoinjector with a fixed 29‑gauge, half-inch needle and in a single-dose, 1-mL, prefilled syringe with a fixed 29‑gauge, half-inch needle with a needle guard.
• Each 1 mL delivers 100 mg mepolizumab, citric acid monohydrate (0.95 mg), EDTA disodium dihydrate (0.019 mg), polysorbate 80 (0.20 mg), sodium phosphate dibasic heptahydrate (4.16 mg), and sucrose (120 mg), with a pH of 6.3.
• NUCALA injection is supplied in a single-dose, 0.4-mL, prefilled syringe with a fixed 29-gauge, half-inch needle with a needle guard.
• Each 0.4 mL delivers 40 mg mepolizumab, citric acid monohydrate (0.38 mg), EDTA disodium dihydrate (0.0074 mg), polysorbate 80 (0.08 mg), sodium phosphate dibasic heptahydrate (1.66 mg), and sucrose (48 mg), with a pH of 6.3.
• The prefilled autoinjector and prefilled syringe are not made with natural rubber latex.

Quoted from the official label, section “Description”.

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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