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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.

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

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

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 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

For patients with Heterozygous Familial Hypercholesterolaemia (HeFH) or adult patients with clinical atherosclerotic cardiovascular disease (ASCVD), who are already on maximal tolerated statin, but whose LDL-C level still cannot reach therapeutic target, Repatha can be used as an adjunct to diet.

Clarification statement: Clinical ASCVD is defined as clinical atherosclerotic cardiovascular disease, including acute coronary artery syndrome, history of myocardial infarction, stable or unstable angina, history of revascularization of coronary artery or other arteries, stroke, transient ischemic attack, and peripheral arterial disease suspected to be caused by atherosclerosis, etc.

For adult patients with primary hyperlipidemia (heterozygous familial and non-familial) or mixed dyslipidemia who are statin-intolerant or for whom a statin is contraindicated, Repatha can be used alone or in combination with other lipid-lowering therapies as an adjunct to diet.

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

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 Bone Metastasis from Solid Tumors

XGEVA® is indicated for the prevention of skeletal-related events 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.

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

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Amgen Taiwan

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