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..
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.
Pediatric Uveitis
AMGEVITA is indicated for the treatment of chronic non-infectious anterior uveitis in patients 2 years of age and older, as well as for pediatric patients with poor responses to conventional treatment.
AMGEVITA® Approved Package Insert
AMGEVITA® Approved Medication Guide
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).
Product License No. 001137
Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture
Indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture.
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 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.
Product name: Kyprolis for injection
Product License No. 027068
Relapsed Or Refractory Multiple Myeloma
Kyprolis is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with:
Product name: Kyprolis for injection 30 mg
Product License No. 027490
Relapsed Or Refractory Multiple Myeloma
Kyprolis is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with:
Product License No. 028291
LUMAKRAS is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), who have received at least one prior systemic therapy.
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
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.
Epithelial ovarian, fallopian tube or primary peritoneal cancer
1. In combination with carboplatin and paclitaxel followed by MVASI alone as treatment for patients with stage III or IV epithelial ovarian, fallopian tube or primary peritoneal cancer after initial surgical resection.
2. In combination with carboplatin and gemcitabine, for treatment of patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who have undergone first-line platinum-based chemotherapy to relapse at least 6 months apart (i.e., sensitive to platinum-based therapy), and who have not received bevacizumab or other vascular endothelial growth factor (VEGF) inhibitors or VEGF receptor-targeted agents.
3. In combination with carboplatin and paclitaxel, followed by treatment with MVASI alone, as treatment for patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are sensitive to platinum-based therapy.
4. In combination with paclitaxel, topotecan or pegylated liposomal doxorubicin for treatment of patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who have undergone platinum-based chemotherapy to relapse within 6 months (i.e., resistant to platinum-based therapy), and who have received no more than 2 prior chemotherapy regimens and have not received bevacizumab or other vascular endothelial growth factor (VEGF) inhibitors or VEGF receptor-targeted agents.
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.
Product name: OTEZLA Film-coated tablets 10mg
Product License No. 027209
Psoriatic Arthritis
Monotherapy or in combination with non-biological DMARDs is indicated in treatment of adult patients with active psoriatic arthritis.
Plaque Psoriasis
Indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.
Oral Ulcers Associated with Behçet’s Disease
Indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.
Product name: OTEZLA Film-coated tablets 20mg
Product License No. 027210
Psoriatic Arthritis
Monotherapy or in combination with non-biological DMARDs is indicated in treatment of adult patients with active psoriatic arthritis.
Plaque Psoriasis
Indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.
Oral Ulcers Associated with Behçet’s Disease
Indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.
Product name: OTEZLA Film-coated tablets 30mg
Product License No. 027211
Psoriatic Arthritis
Monotherapy or in combination with non-biological DMARDs is indicated in treatment of adult patients with active psoriatic arthritis.
Plaque Psoriasis
Indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.
Oral Ulcers Associated with Behçet’s Disease
Indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.
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.
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:
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.
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.
Product name: Repatha® (evolocumab)
Product license number: 001033
REPATHA is indicated:
• In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization
• As an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C
• As an adjunct to diet and other LDL-C-lowering therapies in children and adolescent patients aged 10 years and older with HeFH, to reduce LDL-C
Product name: RIABNI Concentrate for
Solution for Infusion
Product License No. 001195
Non-Hodgkin’s Lymphoma
- Used in adult patients with low-grade B-cell non-Hodgkin’s lymphoma that is recurrent or resistant to chemotherapy.
- Used in combination with CVP chemotherapy in adult patients with indolent (follicular tissue) B-cell non-Hodgkin’s lymphoma who have not received therapy previously.
- Used in combination with CHOP or other forms of chemotherapy in adult patients with CD20 positive diffuse large B-cell non-Hodgkin’s lymphoma.
- Used as maintenance therapy in adult patients with follicular lymphoma following response to the induction therapy.
Rheumatoid Arthritis (RA)
Used in combination with methotreaxate in treating adult patients who received inhibitor therapy with one or more (inclusive) tumor necrosis factors (TNF) that was ineffective, or intolerant adult patients with active RA. Verified via x-ray that it is able to slow the progression of structural joint damage when used in combination with methotrexate.
Chronic Lymphocytic Leukemia
Used in combination with fludarabine and cyclophosphamide as first-line treatment for patients with CD20-positive chronic lymphocytic leukemia (CLL). Used in combination with chemotherapy as treatment for recurrent or refractory CD20+ CLL patients.
Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA)
Used in combination with glucocorticoids in treating adult granulomatosis with polyangiitis (GPA, also known as Wegener’s granulomatosis) and microscopic polyantiitis (MPA).
Pemphigus Vulgaris (PV)
Used in combination with glucocorticoids in treating adult patients with moderate to severe PV.
Product License No. 000941
Vectibix® is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC):
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.