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Prescribing Information Great Britain

Prescribing Information: Dupixent (dupilumab) solution for injection in a pre-filled syringe or pen (Atopic Dermatitis)
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 for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. Dupixent is indicated for the treatment of severe atopic dermatitis in children 6 to 11 years old who are candidates for systemic therapy.
Dosage and Administration: Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of atopic dermatitis. Dupixent should be administered as subcutaneous (SC) injection, into the thigh or abdomen, except for the 5 cm around the navel. The upper arm can be used if not self-administered. Dupixent can be used with or without topical corticosteroids. Topical calcineurin inhibitors should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas. Adults: the recommended initial dose of Dupixent is 600 mg (two 300 mg injections), followed by 300 mg given every other week (EOW). Adolescents (12-17 years) with body weight <60 kg: the recommended initial dose of Dupixent is 400 mg (two 200 mg SC injections), followed by 200 mg EOW. Adolescents (12-17 years) with body weight ≥60 kg: the recommended initial dose of Dupixent is 600 mg (two 300 mg SC injections) followed by 300 mg EOW. Children 6 to 11 years of age with body weight 15 kg to <60 kg: the recommended initial dose of Dupixent is 300 mg on Day 1, followed by 300 mg on Day 15. Subsequent doses of 300 mg every 4 weeks (Q4W) starting 4 weeks after Day 15 dose. The dose may be increased to 200mg EOW in these patients based on physician’s assessment. Children 6 to 11 years of age with body weight ≥ 60 kg: the recommended initial dose of Dupixent is 600 mg (two 300 mg injections), followed by 300 mg EOW. Missed dose: If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time. No or partial response: Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment for atopic dermatitis. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks. If Dupixent treatment interruption becomes necessary, patients can still be successfully re-treated. Proper training should be provided to patients and/or caregivers on the preparation and administration of Dupixent prior to use according to the Instructions for Use (IFU) section in the package leaflet. Special populations: Elderly patients (≥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. Paediatric patients <6 years: No data available. Method of administration: The dupilumab pre-filled pen is not intended for use in children below 12 years of age. For children 6 to 11 years of age with severe atopic dermatitis, the dupilumab pre-filled syringe is the presentation appropriate for administration to this population.
Contraindications: Hypersensitivity to the active substance or to any of the excipients.
Warnings and Precautions: 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. Anaphylactic reactions and angioedema have occurred from minutes up to seven days post injection. 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. Comorbid asthma: Patients with 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 live-attenuated 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 effects: 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, infections and immunogenicity have also been reported. Adolescents (12-17 years) and children (6-11 years): The long-term safety profile of Dupixent observed in patients 6-17 years of age was consistent with that seen in adults with atopic dermatitis. For full details please consult SmPC.
Legal Classification: POM. List Price: 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 pre-filled 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: September 2021.
MAT-GB-2104013 (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 0902 314.
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 (Atopic Dermatitis)
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 for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. Dupixent is indicated for the treatment of severe atopic dermatitis in children 6 to 11 years old who are candidates for systemic therapy.
Dosage and Administration: Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of atopic dermatitis. Dupixent should be administered as subcutaneous (SC) injection, into the thigh or abdomen, except for the 5 cm around the navel. The upper arm can be used if not self-administered. Dupixent can be used with or without topical corticosteroids. Topical calcineurin inhibitors should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas. Adults: the recommended initial dose of Dupixent is 600 mg (two 300 mg injections), followed by 300 mg given every other week (EOW). Adolescents (12-17 years) with body weight <60 kg: the recommended initial dose of Dupixent is 400 mg (two 200 mg SC injections), followed by 200 mg EOW. Adolescents (12-17 years) with body weight ≥60 kg: the recommended initial dose of Dupixent is 600 mg (two 300 mg SC injections) followed by 300 mg EOW. Children 6 to 11 years of age with body weight 15 kg to <60 kg: the recommended initial dose of Dupixent is 300 mg on Day 1, followed by 300 mg on Day 15. Subsequent doses of 300 mg every 4 weeks (Q4W) starting 4 weeks after Day 15 dose. The dose may be increased to 200mg EOW in these patients based on physician’s assessment. Children 6 to 11 years of age with body weight ≥ 60 kg: the recommended initial dose of Dupixent is 600 mg (two 300 mg injections), followed by 300 mg EOW. Missed dose: If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time. No or partial response: Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment for atopic dermatitis. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks. If Dupixent treatment interruption becomes necessary, patients can still be successfully re-treated. Proper training should be provided to patients and/or caregivers on the preparation and administration of Dupixent prior to use according to the Instructions for Use (IFU) section in the package leaflet. Special populations: Elderly patients (≥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. Paediatric patients <6> No data available. Method of administration: The dupilumab pre-filled pen is not intended for use in children below 12 years of age. For children 6 to 11 years of age with severe atopic dermatitis, the dupilumab pre-filled syringe is the presentation appropriate for administration to this population.
Contraindications: Hypersensitivity to the active substance or to any of the excipients.
Warnings and Precautions: 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. Anaphylactic reactions and angioedema have occurred from minutes up to seven days post injection. 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. Comorbid asthma: Patients with 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 live-attenuated 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 effects: 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*†, facial rash, 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, infections and immunogenicity have also been reported. Adolescents (12-17 years) and children (6-11 years): The long-term safety profile of Dupixent observed in patients 6-17 years of age was consistent with that seen in adults with atopic dermatitis.
Legal Classification: POM. List Price GB & NI: 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 Boétie, 75008 Paris, France. Marketing Authorisation Numbers: 2 x 200 mg pre-filled 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: October 2021. MAT-IE-2101453(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 0902 314.
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

AD, atopic dermatitis.

References

  1. DUPIXENT Summary of Product Characteristics. September 2021.