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Prescribing Information Great Britain

Prescribing Information: Dupixent (dupilumab) solution for injection in a
pre-filled syringe or pen (Asthma)
Please refer to the Summary of Product Characteristics (SmPC) before prescribing.


Presentations: Dupixent 200 mg solution for injection in a pre-filled syringe or pen, containing 200 mg of dupilumab in 1.14 ml solution (175 mg/ml) or Dupixent 300 mg solution for injection in a pre-filled syringe or pen, containing 300 mg of dupilumab in 2 ml solution (150 mg/ml). Indication: Dupixent is indicated in adults and adolescents (>= 12 years old) as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with high dose ICS plus another medicinal product for maintenance treatment.
Dosage and Administration: Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of asthma. Dupixent should be administered as subcutaneous (SC) injection, into the thigh or abdomen, except for the 5 cm around the navel. A patient may self-inject dupilumab or the patient’s caregiver may administer dupilumab if their healthcare professional determines that this is appropriate. Proper training should be provided to patients and/or caregivers on the preparation and administration of dupilumab prior to use according to the Instructions for Use (IFU). The upper arm can be used as an injection site if not self-injecting. It is recommended to rotate the injection site with each injection and it should not be injected into skin that is tender, damaged or has bruises or scars. Adults and adolescents: an initial dose of 400mg (two 200mg injections), followed by 200mg EOW. Patients with severe asthma, who are on oral corticosteroids or, have co-morbid moderate-to-severe atopic dermatitis, or adults with co-morbid severe chronic rhinosinusitis with nasal polyposis: an initial dose of 600mg (two 300mg injections consecutively in different injection sites), followed by 300mg every other week (EOW). Patients receiving concomitant oral corticosteroids may reduce their steroid dose once clinical improvement with dupilumab has occurred. Steroid reductions should be accomplished gradually. Dupilumab is intended for long-term treatment. The need for continued therapy should be considered at least on an annual basis as determined by physician assessment of the patient’s level of asthma control. Missed dose: If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time. Special populations: Elderly (≥65 years): No dose adjustment recommended. Renal impairment: No dose adjustment in patients with mild or moderate renal impairment. Very limited data available in patients with severe renal impairment. Hepatic impairment: No data available. Body weight: No dose adjustment is recommended for patients with asthma ≥12 years.
Contraindications: Hypersensitivity to the active substance or to any of the excipients.
Warnings and Precautions: Dupilumab should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm or status asthmaticus. Systemic, topical, or inhaled corticosteroids should not be discontinued abruptly upon initiation of therapy with dupilumab. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy. Biomarkers of type 2 inflammation may be suppressed by systemic corticosteroid use. This should be taken into consideration to determine type 2 status in patients taking oral corticosteroids. Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hypersensitivity: If a systemic hypersensitivity reaction (immediate or delayed) occurs, administration of Dupixent should be discontinued immediately and appropriate therapy initiated. Cases of anaphylactic reaction, angioedema and serum sickness/serum sickness-like reaction have been reported. Anaphylactic reactions and angioedema have occurred from minutes to up to seven days after the dupilumab injection. Eosinophilic conditions: Cases of eosinophilic pneumonia and vasculitis, consistent with eosinophilic granulomatosis with polyangiitis (EGPA) have been reported. Physicians should be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients with eosinophilia. Patients may present with serious systemic eosinophilia sometimes presenting with clinical features of eosinophilic pneumonia or vasculitis consistent with eosinophilic granulomatosis with polyangiitis. Often these conditions are treated with systemic corticosteroid therapy. These events usually, but not always, may be associated with the reduction of oral corticosteroid therapy. Helminth infection: Patients with known helminth infection were excluded from the clinical trials. Dupixent may influence the immune response against helminth infections by inhibiting IL-4/IL-13 signaling. Patients with pre-existing helminth infections should be treated before initiating Dupixent. If patients become infected while receiving treatment with Dupixent and do not respond to anti-helminth treatment, treatment with Dupixent should be discontinued until infection resolves. Conjunctivitis and keratitis related events: Conjunctivitis and keratitis related events have been reported with dupilumab, predominantly in atopic dermatitis patients. Some patients reported visual disturbances (e.g. blurred vision) associated with conjunctivitis or keratitis. Patients should be advised to report new onset or worsening eye symptoms to their healthcare provider. Patients treated with Dupixent who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis should undergo ophthalmological examination, as appropriate. Atopic dermatitis or CRSwNP patients with comorbid asthma: Patients on dupilumab for moderate-to-severe atopic dermatitis or severe CRSwNP who also have comorbid asthma should not adjust or stop their asthma treatments without consultation with their physicians. Patients with comorbid asthma should be monitored carefully following discontinuation of Dupixent. Vaccinations: Live and live-attenuated vaccines should not be given concurrently with Dupixent as clinical safety and efficacy has not been established. It is recommended that patients should be brought up to date with live and liveattenuated immunisations in agreement with current immunisation guidelines prior to treatment with Dupixent. Sodium content: This medicinal product contains less than 1 mmol sodium (23 mg) per 300 mg dose, i.e. is essentially “sodium-free”. Interactions: Patients receiving Dupixent may receive concurrent inactive or non-live vaccinations. One study evaluating the pharmacokinetic effects of Dupixent on CYP substrates did not indicate clinically relevant effects of Dupixent on CYP1A2, CYP3A, CYP2C19, CYP2D6 or CYP2C9 activity. Fertility, pregnancy and lactation: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. There are limited data from the use of Dupixent in pregnant women. Animal studies do not indicate harmful effects. Dupixent should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. It is unknown whether Dupixent is excreted in human milk or absorbed systemically after ingestion. A decision must be made whether to discontinue breast-feeding or to discontinue Dupixent therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Adverse Reactions: Very common (≥1/10): Injection site erythema. Common (≥1/100 to <1/10): Injection site oedema, injection site pain and injection site pruritus. Rare (≥1/10,000 to <1/1,000): Keratitis. Very rare (<1/10,000): Anaphylactic reaction. Not Known: Angioedema, arthralgia Legal Classification: POM. List Price: 4 week pack containing 2 x pre-filled syringes or pens: £1,264.89. Marketing Authorisation Holder: Aventis Pharma Ltd, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK. Marketing Authorisation Numbers: 2 x 200 mg prefilled syringe: PLGB 04425/0874; 2 x 300 mg pre-filled syringe: PLGB 04425/0820. 2 x 200 mg pre-filled pen: PLGB 04425/0875; 2 x 300 mg pre-filled pen: PLGB 04425/0771. Further information is available from: Medical Information, Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK.
uk-medicalinformation@sanofi.com. Date of Preparation: June 2021.
MAT-GB-2102837(v1.0)


Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Adverse events should also be reported to the Sanofi drug safety department on Tel: 0800 090 2314.
Alternatively, send via email to UK-drugsafety@sanofi.com



Prescribing Information Northern Ireland
and Republic of Ireland

Prescribing Information: Dupixent (dupilumab) solution for injection in a
pre-filled syringe or pen (Asthma)
Please refer to the Summary of Product Characteristics (SmPC) before prescribing.


Presentations: Dupixent 200 mg solution for injection in a pre-filled syringe or pen, containing 200 mg of dupilumab in 1.14 ml solution (175 mg/ml) or Dupixent 300 mg solution for injection in a pre-filled syringe or pen, containing 300 mg of dupilumab in 2 ml solution (150 mg/ml). Indication: Dupixent is indicated in adults and adolescents (>= 12 years old) as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with high dose ICS plus another medicinal product for maintenance treatment.
Dosage and Administration: Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of asthma. Dupixent should be administered as subcutaneous (SC) injection, into the thigh or abdomen, except for the 5 cm around the navel. A patient may self-inject dupilumab or the patient’s caregiver may administer dupilumab if their healthcare professional determines that this is appropriate. Proper training should be provided to patients and/or caregivers on the preparation and administration of dupilumab prior to use according to the Instructions for Use (IFU). The upper arm can be used as an injection site if not self-injecting. It is recommended to rotate the injection site with each injection and it should not be injected into skin that is tender, damaged or has bruises or scars. Adults and adolescents: an initial dose of 400mg (two 200mg injections), followed by 200mg EOW. Patients with severe asthma, who are on oral corticosteroids or, have co-morbid moderate-to-severe atopic dermatitis, or adults with co-morbid severe chronic rhinosinusitis with nasal polyposis: an initial dose of 600mg (two 300mg injections consecutively in different injection sites), followed by 300mg every other week (EOW). Patients receiving concomitant oral corticosteroids may reduce their steroid dose once clinical improvement with dupilumab has occurred. Steroid reductions should be accomplished gradually. Dupilumab is intended for long-term treatment. The need for continued therapy should be considered at least on an annual basis as determined by physician assessment of the patient’s level of asthma control. Missed dose: If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time. Special populations: Elderly (≥65 years): No dose adjustment recommended. Renal impairment: No dose adjustment in patients with mild or moderate renal impairment. Very limited data available in patients with severe renal impairment. Hepatic impairment: No data available. Body weight: No dose adjustment is recommended for patients with asthma ≥12 years.
Contraindications: Hypersensitivity to the active substance or to any of the excipients.
Warnings and Precautions: Dupilumab should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm or status asthmaticus. Systemic, topical, or inhaled corticosteroids should not be discontinued abruptly upon initiation of therapy with dupilumab. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy. Biomarkers of type 2 inflammation may be suppressed by systemic corticosteroid use. This should be taken into consideration to determine type 2 status in patients taking oral corticosteroids. Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hypersensitivity: If a systemic hypersensitivity reaction (immediate or delayed) occurs, administration of Dupixent should be discontinued immediately and appropriate therapy initiated. Cases of anaphylactic reaction, angioedema and serum sickness/serum sickness-like reaction have been reported. Anaphylactic reactions and angioedema have occurred from minutes to up to seven days after the dupilumab injection. Eosinophilic conditions: Cases of eosinophilic pneumonia and vasculitis, consistent with eosinophilic granulomatosis with polyangiitis (EGPA) have been reported. Physicians should be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients with eosinophilia. Patients may present with serious systemic eosinophilia sometimes presenting with clinical features of eosinophilic pneumonia or vasculitis consistent with eosinophilic granulomatosis with polyangiitis. Often these conditions are treated with systemic corticosteroid therapy. These events usually, but not always, may be associated with the reduction of oral corticosteroid therapy. Helminth infection: Patients with known helminth infection were excluded from the clinical trials. Dupixent may influence the immune response against helminth infections by inhibiting IL-4/IL-13 signaling. Patients with pre-existing helminth infections should be treated before initiating Dupixent. If patients become infected while receiving treatment with Dupixent and do not respond to anti-helminth treatment, treatment with Dupixent should be discontinued until infection resolves. Conjunctivitis and keratitis related events: Conjunctivitis and keratitis related events have been reported with dupilumab, predominantly in atopic dermatitis patients. Some patients reported visual disturbances (e.g. blurred vision) associated with conjunctivitis or keratitis. Patients should be advised to report new onset or worsening eye symptoms to their healthcare provider. Patients treated with Dupixent who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis should undergo ophthalmological examination, as appropriate. Atopic dermatitis or CRSwNP patients with comorbid asthma: Patients on dupilumab for moderate-to-severe atopic dermatitis or severe CRSwNP who also have comorbid asthma should not adjust or stop their asthma treatments without consultation with their physicians. Patients with comorbid asthma should be monitored carefully following discontinuation of Dupixent. Vaccinations: Live and live-attenuated vaccines should not be given concurrently with Dupixent as clinical safety and efficacy has not been established. It is recommended that patients should be brought up to date with live and liveattenuated immunisations in agreement with current immunisation guidelines prior to treatment with Dupixent. Sodium content: This medicinal product contains less than 1 mmol sodium (23 mg) per 300 mg dose, i.e. is essentially “sodium-free”. Interactions: Patients receiving Dupixent may receive concurrent inactive or non-live vaccinations. One study evaluating the pharmacokinetic effects of Dupixent on CYP substrates did not indicate clinically relevant effects of Dupixent on CYP1A2, CYP3A, CYP2C19, CYP2D6 or CYP2C9 activity. Fertility, pregnancy and lactation: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. There are limited data from the use of Dupixent in pregnant women. Animal studies do not indicate harmful effects. Dupixent should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. It is unknown whether Dupixent is excreted in human milk or absorbed systemically after ingestion. A decision must be made whether to discontinue breast-feeding or to discontinue Dupixent therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Adverse Reactions: Common (≥1/100 to <1/10): Arthralgia, conjunctivitis*, conjunctivitis allergic*, eosinophilia, Injection site reactions (erythema, oedema, pruritis, pain, and swelling), oral herpes*. Uncommon (≥ 1/1,000 to < 1/100): Angioedema, blepharitis*, eye pruritis*, keratitis*. Rare (≥1/10,000 to <1/1,000): Anaphylactic reaction, serum sickness reaction, serum sickness-like reaction, ulcerative keratitis*. *Eye disorders and oral herpes occurred predominately in atopic dermatitis studies. The frequencies for eye pruritus and blepharitis were common and ulcerative keratitis was uncommon in atopic dermatitis studies. Serious adverse reactions: eczema herpeticum, and immunogenicity have also been reported. Adolescents (12–17 years): The safety profile of Dupixent in adolescents aged 12-17 years followed through week 52 and through a longterm study was similar to the safety profile from studies in adults with asthma. For full details please consult SmPC.
Legal Classification: POM. List Price GB & NI: 4 week pack containing 2 x pre-filled syringes or pens: £1,264.89. IE: Price on application. Marketing Authorisation Holder: Sanofi-Aventis groupe - 54, rue La Bo tie, 75008 Paris, France. Marketing Authorisation Numbers: 2 x 200 mg prefilled syringe: EU/1/17/1229/010; 2 x 300 mg pre-filled syringe: EU/1/17/1229/006. 2 x 200 mg pre-filled pen: EU/1/17/1229/014; 2 x 300 mg pre-filled pen: EU/1/17/1229/018. Further information is available from: GB & NI: Medical Information, Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK. uk-medicalinformation@sanofi.com. IE: Sanofi, 18 Riverwalk, Citywest Business Campus, Dublin 24 or contact IEmedinfo@sanofi.com. Date of Preparation: June 2021.
MAT-IE-2101011(v1.0)


Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Adverse events should also be reported to the Sanofi drug safety department on Tel: 0800 090 2314.
Alternatively, send via email to UK-drugsafety@sanofi.com

In Ireland: www.hpra.ie email: medsafety@hpra.ie Adverse events should also be reported to Sanofi Ireland Ltd. Tel: 01 403 5600. Alternatively, send via email to IEPharmacovigilance@sanofi.com

References

  1. Sanofi Genzyme. Dupixent Summary of Product Characteristics, December 2020.