Amgen Taiwan

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.

AMGEVITA^® (adalimumab)

Product License No. 001098

Rheumatoid Arthritis

AMGEVITA is indicated for reducing signs and symptoms, including major clinical response and clinical remission, and inhibiting the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis and had an inadequate response to one or more than one disease-modifying anti-rheumatic drugs (DMARDs).

AMGEVITA can be used alone or in combination with methotrexate (MTX) or other DMARDs.

Psoriatic Arthritis

Indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous DMARD treatment has been inadequate.

AMGEVITA can be used alone or in combination with MTX or other DMARDs.

Ankylosing Spondylitis

Indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

Crohn's Disease

Indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely Crohn's disease who have had an inadequate response to conventional therapy.

AMGEVITA is also indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderate to severe CD who had lost response to or are intolerant to infliximab.

Plaque Psoriasis

Indicated for treating adult patients with moderate to severe plaque psoriasis who had lost response to, had a contraindication to, or are intolerant to other systematic treatments, including cyclosporine, MTX or other photochemical therapies.

Ulcerative Colitis

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

Intestinal Behcet's Disease

AMGEVITA is indicated for use in patients with Intestinal Behcet's Disease who have lost response to conventional treatment.

Hidradenitis Suppurativa

AMGEVITA is indicated for the treatment of moderate to severe hidradenitis suppurativa (also known as acne inversa) in adult patients with an inadequate response to conventional systematic therapy.

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 or in whom corticosteroid treatment is inappropriate.

Indications and Usage for Pediatric Patients

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 DMARDs.

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

Pediatric Crohn's Disease

AMGEVITA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderate to severe CD who have had an inadequate response to corticosteroids and immunomodulators.

AMGEVITA^® Approved Package Insert

AMGEVITA^® Approved Medication Guide

For informational purposes only. This is not an offer for sale. AMGEVITA^® is currently not available commercially and will not be commercially available in Taiwan until a later date.

BLINCYTO^® (blinatumomab)

Product License No. 001040

1.1 MRD-positive B-cell Precursor ALL
BLINCYTO is indicated for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.

1.2 Relapsed or Refractory B-cell Precursor ALL
BLINCYTO is indicated for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

BLINCYTO^® Approved Package Insert

BLINCYTO^® Medication Guide

KANJINTI^® Powder for concentrate for solution for infusion 420mg

API: Trastuzumab
Product License No. 001111
Indication:

KANJINTI is indicated for treatment of patients with HER2 overexpression or HER2 gene amplification early breast cancer or metastatic breast cancer:

1. Early Breast Cancer (EBC)
2. Metastatic Breast Cancer (MBC)
3. Metastatic Gastric Cancer (mGC))

KANJINTI in combination with capecitabine (or 5-fluorouracil) and Cisplatin is indicated for the treatment of adult patients with HER2 overexpression metastatic adenocarcinoma of the stomach (or gastroesophageal junction) who have not received prior chemotherapy.

KANJINTI ^® Approved Package Insert

KANJINTI^® Powder for concentrate for solution for infusion 150mg

API: Trastuzumab
Product License No. 001110
Indication:

KANJINTI is indicated for treatment of patients with HER2 overexpression or HER2 gene amplification early breast cancer or metastatic breast cancer:

1. Early Breast Cancer (EBC)
2. Metastatic Breast Cancer (MBC)
3. Metastatic Gastric Cancer (mGC))

KANJINTI ^® Approved Package Insert

Kyprolis^® (carfilzomib)

Product License No. 027068

1.1 Combination Therapy
Kyprolis is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.

Kyprolis^® Approved Package Insert

Kyprolis^® (carfilzomib) for injection 30mg

Product License No. 027490

1.1 1.1 Combination Therapy
Kyprolis is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.

Kyprolis^® Approved Package Insert

Parsabiv^® (etelcalcetide)

Product License No. 027639

PARSABIV is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

Limitations of Use: PARSABIV has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with chronic kidney disease who are not on hemodialysis and is not recommended for use in these populations.

Parsabiv^® Approved Package Insert

Prolia^® (denosumab)

Product License No. 000918

Treatment of postmenopausal women with osteoporosis at high risk for fracture.

Explanation: For postmenopausal women with osteoporosis in any one of the following situations:

those patients with a history of osteoporotic fracture, or multiple risk factors for fracture;
or those who have failed or are intolerant to other available osteoporosis therapies.

In postmenopausal women with osteoporosis, Prolia^® reduces the incidence of vertebral, non-vertebral, and hip fractures.

Treatment to increase bone mass in men with osteoporosis at high risk for fracture.

Explanation: Prolia^® is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

Treatment of Glucocorticoid-Induced Osteoporosis.

Explanation: Prolia^® is indicated for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months. High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

Treatment of bone loss in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer.

Explanation: Prolia^® also reduced the incidence of vertebral fractures for these patients.

Prolia^® Approved Package Insert

Prolia^® Medication Guide

"Amgen" Repatha^® (evolocumab)

Orphan Drug Product License No. 000018

Homozygous familial hypercholesterolaemia: Repatha is indicated as an adjunct treatment to diet and other lipid-lowering therapy (e.g., statins, ezetimibe, LDL apheresis) to reduce LDL-C. However, patients with LDLR-negative mutations are exempt.

Limitations of Use: The effect of Repatha on cardiovascular morbidity and mortality has not yet been determined.

"Amgen" Repatha^® Approved Package Insert

Repatha^® (evolocumab)

Product License No. 001033

1.1 Prevention of Cardiovascular Events

In adults with established cardiovascular disease, REPATHA is indicated to reduce the risk of myocardial infarction, stroke, and coronary revascularization.

1.2 Primary Hyperlipidemia (Including Heterozygous Familial Hypercholesterolemia)

REPATHA is indicated as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C).

Repatha^® Approved Package Insert

Vectibix^® (panitumumab)

Product License No. 000941

Vectibix^® 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.
as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

Vectibix^® Approved Package Insert

XGEVA^® (denosumab)

Product License No. 000924

1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors

XGEVA^® is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in adult patients with bone metastases from solid tumors.

Limitation of Use: XGEVA^® is not indicated for the prevention of skeletal-related events in patients with multiple myeloma.

1.2 Giant Cell Tumor of Bone

XGEVA^® is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity [see Clinical Trials (14.2)].

1.3 Hypercalcemia of Malignancy

XGEVA^® is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

XGEVA^® Approved Package Insert

XGEVA^® Medication Guide

MVASI^® (bevacizumab)

Product License No. 001117

Metastatic Colorectal Cancer (mCRC)

1. Indicated for the first-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with intravenous 5-fluorouracil–based chemotherapy.

2. In combination with 5-fluorouracil/leucovorin/oxaliplatin-based chemotherapy, is indicated for the treatment of bevacizumab-naïve patients with metastatic carcinoma of the colon or rectum following prior fluoropyrimidine-based chemotherapy failure.

3. In combination with fluoropyrimidine-irinotecan-based or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line MVASI-containing chemotherapy regimen.

Metastatic Breast Cancer (mBC)

1. In combination with paclitaxel is indicated for first-line treatment of adult patients with HER2 (-) metastatic breast cancer.

High-grade Glioma (WHO Grade IV) – Glioblastoma

1. Indicated alone for the treatment of adult patients with recurrent Glioblastoma multiforme following standard radio- and chemotherapy Temozolomide failure.

Advanced, Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Carcinoma (NSCLC)

1. In combination with carboplatin and paclitaxel, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer.

2. In combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations.

Persistent, Recurrent, or Metastatic Cervical Cancer

1. In combination with paclitaxel and cisplatin, is indicated for the treatment of persistent, recurrent, or metastatic carcinoma of the cervix.

2. In combination with paclitaxel and topotecan is indicated for the treatment of patients who cannot receive platinum therapy but with persistent, recurrent, or metastatic carcinoma of the cervix.

MVASI^® Approved Package Insert

MVASI^® Medication Guide

Products

AMGEVITA® (adalimumab)

BLINCYTO® (blinatumomab)

KANJINTI® Powder for concentrate for solution for infusion 420mg

KANJINTI® Powder for concentrate for solution for infusion 150mg

Kyprolis® (carfilzomib)

Kyprolis® (carfilzomib) for injection 30mg

Parsabiv® (etelcalcetide)

Prolia® (denosumab)

"Amgen" Repatha® (evolocumab)

Repatha® (evolocumab)

Vectibix® (panitumumab)

XGEVA® (denosumab)

MVASI® (bevacizumab)

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