Who are we?
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnwesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Our belief—and the core of our strategy—is that innovative, highly
differentiated medicines that provide large clinical benefits in addressing serious diseases are medicines that will not only help patients, but also will help reduce the social and economic burden of disease in society today.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology innovator since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Drugs Disributed by Amgen Europe B.V
Recombinant Human Erythropoietin. Darbepoetin Alfa 10, 20, 30, 40, 50, 60, 80, 100, 150, 300, 500 mcg. PREFILL. SYRINGES (for single use only, with/out automat. needle guard): 4 x 10 μg; 20 μg; 30 μg; 40 μg; 50 μg; 60 μg; 80 μg; 100 μg, 150 μg; 1 x 300 μg, 500 μg. For I.V. and S.C. admin. Similar efficacy in I.V. and S.C. admin.
PREFILL. PEN (SureClick) (single use only): 1 x 20 μg, 40 μg, 60 μg, 80 μg, 100 μg,150 μg, 300 μg, 500 μg. S.C. admin only.
Tmt. anem. assoc. with chron. ren. fail. in adults and pediatric subjects 1 yrs of age and over. Aranesp 150, 300, 500 -also tmt. anem. in adult cancer pts. with non-myeloid malignancies receiv. chemother.
C/I: Hpersenes. Poorly control. hypertens.
Monoclonal Antibody. Blinatumomab 12.5 mcg/ml. VIAL (concent. for sol. for infus.+ stabilizer sol. for infus.): 1×35mcg. Recommen. dly. dose is by pt. wt. Pts. greater than or equal to 45 kg receive a fixed-dose and for pts. less than 45 kg, the dose is calculat. using the pt’s. body surface area. (BSA).
Recommen. dose for adult pts. at least 45 kg in wt. (fixed-dose): 1st Cycle: Start. dose Days 1–7: 9 mcg/d via cont. infus.
Subseq. dose Days 8–28: 28 mcg/d via cont. infus. 2 week-tmt. free interval (Days 29 – 42).
2nd cycle & subseq. cycles: (Days 1–28): 28 mcg/d via cont. infus.
Pts. Less than 45 kg (BSA-based dose):
Days 1-7: 5 mcg/m²/day via cont. infus.
Days 8-28: (not to exceed 9 mcg/day).
Days 8-28: 15 mcg/m²/d via contin. infus. (not to exceed 28 mcg/d).
Days 1-28: 15 mcg/m²/d via contin. infus. (not to exceed 28 mcg/d).
MRD positive B-precursor ALL for Philadelphia chromosome negat.: Pts. may receive 1 cycle of induct. tmt. follow. by up to 3 addit. cycles of consolidation tmt. A single cycle of tmt. induct. or consolidation is 28 d. (4 wks.) of contin. IV infus. follow. by a 14 d. (2 wk.) tmt. -free interv. (total 42 d.). The majority of pts. who respond to blinatumomab
achieve a response after 1 cycle. Therefore, the potent. benefit and risks assoc. with contin. ther. in pts. who do not show haematolog. and/or clinical improve. after 1 tmt. cycle should be assessed by the treating physician. See lit.
Indicated as monother. for the tmt. of adults with Philadelphia chromosome neg. CD19 posit. relapsed or refract. B-precursor acute lymphoblast. leukemia (ALL).
Indicated as monother. for the tmt. of adults with Philadelphia chromosome neg. CD19 positive B-precursor ALL in first or second complete remiss. with minimal residual dis. (MRD) greater than or equal to 0.1%.
Indicated as monother. for the tmt. of pediatr. pts. aged 1 year or older with Philadelphia chromosome neg. CD19 posit. B-cell precursor ALL which is refract. or in relapse after receiv. at least two prior therapies or in relapse after receiv. prior allogeneic hematopoiet. stem cell transplantat.
Limitations of use: After failure of two previous tmts. and with no CNS involvem.
C/I: Hyperses, lact.
Antineoplastic, Immunomodulator Agent. Talimogene Laherparepvec 10^6 PFU/ml, 10^8 PFU/ml. Talimogene laherparepvec, attenuate. herpes S. virus type-1 (HSV-1) derived by funct. deletion of 2 genes (ICP34.5& ICP47) and insert. of coding sequen. for human granulocyte macrophage colony-stimulat. factor (GM-CSF).
106- 1×106 (1 million) plaque form. units (PFU)/mL.
108- 1×108 (100 million) plaque form. units (PFU)/mL
VIAL (sol. for inj.): 1. Dosage must be ajust. individ.
Tmt. of adult. with unresect. melanoma that is regional. or distant. metastat. (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral dis.
C/I: Pts. with a history of hypersens. to talimogene laherparepvec.
Severely immunocompromised pts. (e.g. pts. with severe congen. or acquired cellular and/or humoral immune deficien.).
Monoclonal Antibody. Trastuzumab 150, 420 mg. VIAL (Pwdr. for concentrate for sol. for infus.): 1. Dosage must be ajust. individ accord. pt. med. cond. and indication.
Tmt. of pts. with metast. breast canc. who have tumors that overexpress HER2;
As a single agent, for the tmt. of those pts. who have received one or more chemother. regim. for their metast. dis.
In comb. with Paclitaxel or Docetaxel for the tmt. of those pts. who have not received chemother. for their metast. dis.
In comb. with an aromatase inhib. for the tmt. of postmenopaus. pt. with hormonereceptor positive metast. breast canc.
Early breast cancer (EBC) – pts. with HER2 positive early breast cancer follow. surg. and chemother. (neoadjuv./ adjuvant) either alone or in comb. with chemother. exclude. anthracyclines.
The drug should only be used in pts. whose tumors have either HER2 overexpres. or HER2 gene amplificat. as determ. by an accurate and validated assay. HER2 Metastat. gast. cancer (MGC)- in comb. with capecitabine or 5-fluorouracil and cisplatin is indic. for the tmt. of pts. with HER2-positive metast. adenocarcinoma of the stomach or gastroesophag. junction who have not received prior anti-cancer tmt. for their metastat. dis.
Trastuzumab should only be used in pts. with metastat. gast. cancer (MGC) whose tumours have HER2 overexpres. as defined by IHC 2+ and a confirmatory FISH+ result, or IHC 3+, as determ. by an accurate and validated assay.
C/I: Hypersens. Severe dyspnea at rest due to complicat. of advanced malig. or require. supplement. oxygen ther.
Proteasome Inhibitor. Carfilzomib 60 mg/vial. SINGLE DOSE VIALS (lyophilized cake/ pwdr. for reconst.): 1×10,30,60 mg.
Monother.: IV as a 10-min. infus. In Cycles 1 through 12, admin. Carfilzomib on two consecut. d., each wk. for three wks. follow. by a 12-d. rest period. Each 28-d. period is consid. one tmt. cycle. From Cycle 13, omit the Day 8 and 9 doses of Carfilzomib. Premedicate with dexamethasone 4 mg oral. or IV 30 min. to 4 hrs. before each Carfilzomib dose in Cycle 1, then as needed to help prevent infus. reactions. The recomm. start. dose of Carfilzomib is 20 mg/m² in Cycle 1 on Days 1 and 2. If tolerated, escalate the dose to 27 mg/m² on Day 8 of Cycle 1. Tmt. may cont. until dis. progres. or unacceptab. toxicity occurs.
For comb. with Dexamethasone and comb. with Lenalidomide and Dexamethasone: See lit.
In comb. with dexamethasone or with lenalidomide plus dexamethasone for the tmt. of pts. with relapsed or refract. multiple myeloma who have received one to three prior lines of ther.
As a single agent for the tmt. of pts. with multiple myeloma who have received at least two prior therapies includ. bortezomib and an immunomodulat. agent and have demonstr. dis. progres. on or within 60 d. of completion of the last ther. Approval is based on response rate. Clinical benefit, such as improv. in survival or sympt., has not been verified.
Colony Stimulating Factor. Pegfilgrastim 6 mg / 0.6 ml. PREFILL SYRINGE (ready-to-use) 1 x 6
mg/0.06 ml. One 6 mg dose for ea.
chemother. cycle S.C. inject. approx.
24 hrs follow. cytotox. chemother.
Reduct. durat. neutropen., incidence of
febrile neutropen. in pts. treated with cytotox. chemother. for malignancy (with
the except. of chron. myeloid leukem. and