Kyntheum Prescribing Information

Prescribing Information for UK:

Abbreviated Prescribing Information for Kyntheum® (brodalumab) 210 mg solution for injection in pre-filled syringe

Please refer to the full Summary of Product Characteristics (SmPC) (www.medicines.org.uk/emc) before prescribing.

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Indication: Treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.

Active ingredient: Each pre-filled syringe contains 210 mg brodalumab in 1.5 ml solution. 1 ml solution contains 140 mg brodalumab.

Dosage and administration: Posology: Adults: The recommended dose is 210 mg administered by subcutaneous injection at weeks 0, 1, and 2 followed by 210 mg every 2 weeks. Consideration should be given to discontinuing treatment in patients who have shown no response after 12-16 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks. Administer by subcutaneous (SC) injection. Each pre-filled syringe is for single use only. Elderly: No dose adjustment recommended. Hepatic and renal impairment: No dose recommendations can be made. Children and adolescents below the age of 18 years: Safety and efficacy of Kyntheum have not been established. Method of administration: Kyntheum should not be injected into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis. The pre-filled syringe must not be shaken. After proper training in SC injection technique, patients may self-inject Kyntheum when deemed appropriate by a physician. Patients should be instructed to inject the full amount of Kyntheum according to the instructions provided in the package leaflet.

Contraindications: Hypersensitivity to the active substance or to any of the excipients. Active Crohn’s disease. Clinically important active infections (e.g. active tuberculosis).

Precautions and warnings: Crohn’s disease: Exercise caution when prescribing Kyntheum to patients with a history of Crohn’s disease. They should be followed for signs and symptoms of active Crohn’s disease. If patients develop active Crohn’s disease, treatment should be discontinued permanently. Suicidal ideation and behaviour: A causal association between treatment with Kyntheum and increased risk of suicidal ideation and behaviour has not been established. Carefully weigh the risk and benefit of treatment with Kyntheum for patients with a history of depression and/or suicidal ideation or behaviour, or patients who develop such symptoms. Patients, caregivers and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal ideation, anxiety, or other mood changes, and they should contact their healthcare provider if such events occur. If a patient suffers from new or worsening symptoms of depression and/or suicidal ideation or behaviour is identified, it is recommended to discontinue treatment with Kyntheum. Infections: Kyntheum may increase the risk of infections. Caution should be exercised when considering the use of Kyntheum in patients with a chronic infection or a history of recurrent infection. Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur.

If a patient develops a serious infection, they should be closely monitored and Kyntheum should not be administered until the infection resolves. Kyntheum should not be given to patients with active tuberculosis. Anti-tuberculosis therapy should be considered prior to initiation of Kyntheum in patients with latent tuberculosis. Reduced absolute neutrophil count: A decrease in absolute neutrophil count, generally transient and reversible, has been observed in 5.6% of patients receiving Kyntheum. Vaccinations: It is recommended that patients be brought up-to-date with all immunisations in accordance with local immunisation guidelines prior to initiation of treatment with Kyntheum. Live vaccines should not be given concurrently with Kyntheum. The safety and efficacy of Kyntheum in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.

Drug interactions: Live vaccines should not be given concurrently with Kyntheum.

Fertility, pregnancy and lactation: Women of childbearing potential: Use an effective method of contraception during treatment and for at least 12 weeks after treatment. Pregnancy: There are no or limited amount of data from the use of brodalumab in pregnant women. As a precautionary measure, it is preferable to avoid the use of Kyntheum in pregnancy. Benefit risk for exposure of the infant to live vaccines following third trimester exposure to Kyntheum should be discussed with a physician. Breast-feeding: It is unknown whether brodalumab is excreted in human milk. A risk to the newborns/infants cannot be excluded. Whether to discontinue breast-feeding or discontinue Kyntheum therapy should be decided, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility: No data are available on the effect of brodalumab on human fertility.

Side effects: Common (≥1/100 to <1/10): Influenza, tinea infections (including tinea pedis, tinea versicolor, tinea cruris), neutropenia, headache, oropharyngeal pain, diarrhoea, nausea, arthralgia, myalgia, fatigue, injection site reactions (including injection site erythema, pain, pruritus, bruising, haemorrhage). Uncommon (≥1/1,000 to <1/100): Candida infections (including oral, genital and oesophageal infections), conjunctivitis.

See SmPC for a full list of side effects.
Precautions for storage: Store in a refrigerator (2°C-8°C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light. Kyntheum may be stored at room temperature (up to 25°C) once, in the outer carton, for a maximum single period of 14 days. Once Kyntheum has been removed from the refrigerator and has reached room temperature (up to 25°C) it must either be used within 14 days or discarded.
Legal category: POM.
Marketing authorisation number and holder: EU/1/16/1155/001, LEO Pharma A/S, Ballerup, Denmark.
Basic NHS price: 2 pre-filled syringes: £1,280 (each syringe contains 210 mg/1.5 ml).
Last revised: March 2018

Further information can be found in the Summary of Product Characteristics or from: LEO Pharma, Horizon, Honey Lane, Hurley, Berkshire SL6 6RJ. e-mail: medical-info.uk@leo-pharma.com

Reporting of Suspected Adverse Reactions

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 Drug Safety at LEO Pharma
by calling +44 (0)1844 347333
or e-mail medical-info.uk@leo-pharma.com
® Registered trademark

Prescribing Information for Ireland:

Abbreviated Prescribing Information for Kyntheum® (brodalumab) 210 mg solution for injection in pre-filled syringe

Please refer to the full Summary of Product Characteristics (SmPC) (www.medicines.ie) before prescribing.

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

.

Indication: Treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.

Active ingredient: Each pre-filled syringe contains 210 mg brodalumab in 1.5 ml solution. 1 ml solution contains 140 mg brodalumab.

Dosage and administration: Posology: Adults: The recommended dose is 210 mg administered by subcutaneous injection at weeks 0, 1, and 2 followed by 210 mg every 2 weeks. Consideration should be given to discontinuing treatment in patients who have shown no response after 12-16 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks. Administer by subcutaneous (SC) injection. Each pre-filled syringe is for single use only. Elderly: No dose adjustment recommended. Hepatic and renal impairment: No dose recommendations can be made. Children and adolescents below the age of 18 years: Safety and efficacy of Kyntheum have not been established. Method of administration: Kyntheum should not be injected into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis. The pre-filled syringe must not be shaken. After proper training in SC injection technique, patients may self-inject Kyntheum when deemed appropriate by a physician. Patients should be instructed to inject the full amount of Kyntheum according to the instructions provided in the package leaflet.

Contraindications: Hypersensitivity to the active substance or to any of the excipients. Active Crohn’s disease. Clinically important active infections (e.g. active tuberculosis).

Precautions and warnings: Crohn’s disease: Exercise caution when prescribing Kyntheum to patients with a history of Crohn’s disease. They should be followed for signs and symptoms of active Crohn’s disease. If patients develop active Crohn’s disease, treatment should be discontinued permanently. Suicidal ideation and behaviour: A causal association between treatment with Kyntheum and increased risk of suicidal ideation and behaviour has not been established. Carefully weigh the risk and benefit of treatment with Kyntheum for patients with a history of depression and/or suicidal ideation or behaviour, or patients who develop such symptoms. Patients, caregivers and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal ideation, anxiety, or other mood changes, and they should contact their healthcare provider if such events occur. If a patient suffers from new or worsening symptoms of depression and/or suicidal ideation or behaviour is identified, it is recommended to discontinue treatment with Kyntheum. Infections: Kyntheum may increase the risk of infections. Caution should be exercised when considering the use of Kyntheum in patients with a chronic infection or a history of recurrent infection. Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur.

If a patient develops a serious infection, they should be closely monitored and Kyntheum should not be administered until the infection resolves. Kyntheum should not be given to patients with active tuberculosis. Anti-tuberculosis therapy should be considered prior to initiation of Kyntheum in patients with latent tuberculosis. Reduced absolute neutrophil count: A decrease in absolute neutrophil count, generally transient and reversible, has been observed in 5.6% of patients receiving Kyntheum. Vaccinations: It is recommended that patients be brought up-to-date with all immunisations in accordance with local immunisation guidelines prior to initiation of treatment with Kyntheum. Live vaccines should not be given concurrently with Kyntheum. The safety and efficacy of Kyntheum in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.

Drug interactions: Live vaccines should not be given concurrently with Kyntheum.

Fertility, pregnancy and lactation: Women of childbearing potential: Use an effective method of contraception during treatment and for at least 12 weeks after treatment. Pregnancy: There are no or limited amount of data from the use of brodalumab in pregnant women. As a precautionary measure, it is preferable to avoid the use of Kyntheum in pregnancy. Benefit risk for exposure of the infant to live vaccines following third trimester exposure to Kyntheum should be discussed with a physician. Breast-feeding: It is unknown whether brodalumab is excreted in human milk. A risk to the newborns/infants cannot be excluded. Whether to discontinue breast-feeding or discontinue Kyntheum therapy should be decided, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility: No data are available on the effect of brodalumab on human fertility.

Side effects: Common (≥1/100 to <1/10): Influenza, tinea infections (including tinea pedis, tinea versicolor, tinea cruris), neutropenia, headache, oropharyngeal pain, diarrhoea, nausea, arthralgia, myalgia, fatigue, injection site reactions (including injection site erythema, pain, pruritus, bruising, haemorrhage). Uncommon (≥1/1,000 to <1/100): Candida infections (including oral, genital and oesophageal infections), conjunctivitis.

See SmPC for a full list of side effects.
Precautions for storage: Store in a refrigerator (2°C-8°C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light. Kyntheum may be stored at room temperature (up to 25°C) once, in the outer carton, for a maximum single period of 14 days. Once Kyntheum has been removed from the refrigerator and has reached room temperature (up to 25°C) it must either be used within 14 days or discarded.
Legal category: POM.
Marketing authorisation number and holder: EU/1/16/1155/001, LEO Pharma A/S, Ballerup, Denmark.
Last revised: September2017

Further information can be found in the Summary of Product Characteristics or from: LEO Pharma, Cashel Road, Dublin 12, Ireland.
e-mail: medical-info.ie@leo-pharma.com

Reporting of Suspected Adverse Reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. 
It allows continued monitoring of the benefit/risk balance of the medicinal product. 
Healthcare professionals are asked to report any suspected adverse reactions via
HPRA Pharmacovigilance,
Earlsfort Terrace, Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517,
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

Adverse events should also be reported to Drug Safety at LEO Pharma 
by calling +353 1 4908924 or e-mail medical-info.ie@leo-pharma.com

Return to the Kyntheum® treatment page

UK-MAT-23646 May 2019