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Products

At Amgen, our mission is to serve patients. As a science-based, patient-focused organisation, we discover and develop innovative therapies to treat serious illnesses.Our medicines have made a dramatic difference in the lives of millions.

Amgen is committed to patient safety and continually monitors the safety and quality of our products. If you want to contact Amgen for any of the following reasons, please call us on +44 (0)1223 436441 (UK and Ireland), Freephone: 1800 535160 (Ireland) and provide us with the details:

  • You think you may have experienced an adverse event ('side effect') after taking or using an Amgen product.
  • You think there may be a defect or quality issue with the Amgen product you have received.
  • You have a general medical information enquiry about your Amgen product.

If you are in the UK, you may also report adverse events or product defects directly to the Medicines and Healthcare products Regulatory Agency (MHRA)  where you can also find reporting forms and information.

If you are in Ireland, you may also report adverse events or product defects to the Health Products Regulatory Authority (HPRA) where you can also find reporting forms and information.

To read more about the Falsified Medicines Directive and the impact this may have on Amgen packaging, click here.


Below you will find information on Amgen’s product portfolio. Prescribing information and patient information leaflets for each product can be downloaded through the links. These links direct you straight to the Electronic Medicines Compendium (eMC) and Medicines.ie websites; and provide information about all medicines available in the UK and Ireland respectively.

Please note that this information is specific to the UK and Ireland, and is not intended to replace the advice of a qualified doctor.

A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z

AMGEVITA® (adalimumab)

Rheumatoid arthritis

AMGEVITA in combination with methotrexate, is indicated for:

  • the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
  • the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

AMGEVITA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

AMGEVITA reduces the rate of progression of joint damage as measured by x-ray and improves physical function, when given in combination with methotrexate.

Juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis

AMGEVITA in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). AMGEVITA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has not been studied in patients aged less than 2 years.

Enthesitis-related arthritis

AMGEVITA is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy.

Axial spondyloarthritis

Ankylosing spondylitis (AS)

AMGEVITA is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.

Axial spondyloarthritis without radiographic evidence of AS

AMGEVITA is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs.

Psoriatic arthritis

AMGEVITA is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. AMGEVITA reduces the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease and improves physical function.

Psoriasis

AMGEVITA is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.

Paediatric plaque psoriasis

AMGEVITA is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.

Hidradenitis suppurativa (HS)

AMGEVITA is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic HS therapy.

Crohn's disease

AMGEVITA is indicated for treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.

Paediatric Crohn's disease

AMGEVITA is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy, a corticosteroid, and an immunomodulator, or who are intolerant to or have contraindications for such therapies.

Ulcerative colitis

AMGEVITA is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

Uveitis

AMGEVITA is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.

AMGEVITA® - UK Summary of Product Characteristics and Patient Information Leaflets

AMGEVITA® - Ireland Summary of Product Characteristics and Patient Information Leaflets

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Aranesp® (darbepoetin alfa)

Aranesp® (darbepoetin alfa) is indicated for the treatment of symptomatic anaemia associated with chronic renal failure in adults and paediatric patients and the treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy. Aranesp® is available in a pre-filled syringe or in a pre-filled pen.

Aranesp® - UK Summary of Product Characteristics and Patient Information Leaflets

Aranesp® - Ireland Summary of Product Characteristics and Patient Information Leaflets

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Blincyto® (blinatumomab)

Blincyto® (blinatumomab) is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL).

Blincyto® is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.

Blincyto® - UK Summary of Product Characteristics and Patient Information Leaflets

Blincyto® - Ireland Summary of Product Characteristics and Patient Information Leaflets

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Imlygic® (talimogene laherparepvec)

Imlygic® (talimogene laherparepvec) is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease.

Imlygic® - UK Summary of Product Characteristics and Patient Information Leaflets

Imlygic® - Ireland Summary of Product Characteristics and Patient Information Leaflets

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KANJINTI® (trastuzumab)

Breast Cancer

Metastatic breast cancer

KANJINTI is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC):

  • as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone-receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.
  • in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.
  • in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.
  • in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab. 

Early breast cancer

KANJINTI is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC):

  • following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1).
  • following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.
  • in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
  • in combination with neoadjuvant chemotherapy followed by adjuvant KANJINTI therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4 and 5.1).

KANJINTI should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see sections 4.4 and 5.1).

Metastatic gastric cancer

KANJINTI in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

KANJINTI should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC 2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result. Accurate and validated assay methods should be used (see sections 4.4 and 5.1).

KANJINTI® - UK Summary of Product Characteristics and Patient Information Leaflets

KANJINTI® - Ireland Summary of Product Characteristics and Patient Information Leaflets

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Kyprolis® (carfilzomib)

Kyprolis® in combination with either lenalidomide and dexamethasone or dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Kyprolis® - UK Summary of Product Characteristics and Patient Information Leaflets

Kyprolis® - Ireland Summary of Product Characteristics and Patient Information Leaflets

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Mimpara® (cinacalcet HCl)

Mimpara® (cinacalcet) is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy and the treatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end-stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy. 

It is also indicated for the reduction of hypercalcaemia in patients with:

  • Parathyroid carcinoma
  • Primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated

Mimpara® - UK Summary of Product Characteristics and Patient Information Leaflets

Mimpara® - Ireland Summary of Product Characteristics and Patient Information Leaflets

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NEUPOGEN® (filgrastim)

NEUPOGEN® (filgrastim) is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.

The safety and efficacy of NEUPOGEN® are similar in adults and children receiving cytotoxic chemotherapy.

NEUPOGEN® is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs).

In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an ANC of ≤ 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of NEUPOGEN® is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.

NEUPOGEN® is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

NEUPOGEN® - UK Summary of Product Characteristics and Patient Information Leaflets

NEUPOGEN® - Ireland Summary of Product Characteristics and Patient Information Leaflets

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Neulasta® (pegfilgrastim)

Neulasta® (pegfilgrastim) is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Neulasta® - UK Summary of Product Characteristics and Patient Information Leaflets

Neulasta® - Ireland Summary of Product Characteristics and Patient Information Leaflets

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Nplate® (romiplostim)

Nplate® is indicated for chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). 

Nplate® - UK Summary of Product Characteristics and Patient Information Leaflets

Nplate® - Ireland Summary of Product Characteristics and Patient Information Leaflets

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Parsabiv®▼(etelcalcetide)

Parsabiv® (etelcalcetide) is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy.

Parsabiv® - UK Summary of Product Characteristics and Patient Information Leaflets

Parsabiv® FAQs for UK healthcare professionals only

Parsabiv® - Ireland Summary of Product Characteristics and Patient Information Leaflets

Parsabiv® FAQs for Irish healthcare professionals only

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Prolia® (denosumab)

Prolia® (denosumab) is indicated for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. It is also indicated for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures.

Prolia® (denosumab) is indicated for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.

Prolia® - UK Summary of Product Characteristics and Patient Information Leaflets

Visit Prolia.co.uk  (A site for UK healthcare professionals and UK patients who have been prescribed Prolia®)

Prolia® - Ireland Summary of Product Characteristics and Patient Information Leaflets

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Repatha® (evolocumab)

Hypercholesterolaemia and mixed dyslipidaemia Repatha® (evolocumab) is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:

  • in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,
  • alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Homozygous familial hypercholesterolaemia

Repatha® is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.

Established atherosclerotic cardiovascular disease

Repatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:

  • in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,
  • alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Repatha® - UK Summary of Product Characteristics and Patient Information Leaflets

Repatha® - Ireland Summary of Product Characteristics and Patient Information Leaflets

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Vectibix® (panitumumab)

Vectibix® (panitumumab) is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC):

  • in first-line in combination with FOLFOX or FOLFIRI.
  • in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).
  • as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

The combination of Vectibix® with oxaliplatin-containing chemotherapy is contraindicated for patients with mutant RAS mCRC or for whom RAS mCRC status is unknown.

Vectibix® - UK Summary of Product Characteristics and Patient Information Leaflets

Vectibix® - Ireland Summary of Product Characteristics and Patient Information Leaflets

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XGEVA® (denosumab)

XGEVA® (denosumab) is indicated for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone and for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

XGEVA® - UK Summary of Product Characteristics and Patient Information Leaflets

XGEVA® - Ireland Summary of Product Characteristics and Patient Information Leaflets

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Total of 12 Products

Amgen is committed to patient safety and continually monitors the safety and quality of our products. Adverse events and product quality issues should be reported.

▼ This product is subject to additional monitoring.

For the UK - reporting forms and information can be found at http://yellowcard.mhra.gov.uk/

For Ireland - reporting forms and information can be found at http://www.hpra.ie/

Adverse events and product quality issues should also be reported to Amgen. To report a potential adverse event or quality issue with an Amgen product, or for medical information enquiries, please call +44 (0) 1223 436441 (UK and Ireland) Freephone: 1800 535160 (Ireland).

Job Code: UKIE-CC-NPS-0918-067857

Date of preparation: September 2018